Receiving a chronic disease diagnosis can be paralyzing, with a wide range of associated emotions. A patient’s family, physicians, and other health care professionals can provide a source of support, but, often, the strongest support comes from those who can empathize.

Someone who has lived with a diagnosis can provide guidance and empathy at a more personal level because, to them, it is just that – personal. Fred Schick and Betsy Glaeser have done just that by taking their personal experiences and using them to help others navigate their diagnoses.

Improving patients’ lives is the core focus of the American College of Chest Physicians and the CHEST Foundation. Events like the Belmont Stakes Dinner and Auction provide an opportunity for us to recognize and celebrate powerful stories such as Fred and Betsy’s, while also raising funds to support important initiatives that will improve patient care. Please consider joining the fight against lung disease by making a donation to the CHEST Foundation today at chestfoundation.org/donate.
 

Patient Advocate – Fred Schick

Increasing awareness of pulmonary fibrosis

Fred Schick of the Chicagoland area was diagnosed with idiopathic pulmonary fibrosis (IPF) in 2017 after years of searching for the root cause of his worsening symptoms.

Fred started experiencing shortness of breath and labored breathing—once to the extent that he needed to be pulled out of the water on vacation despite being an active swimmer. Because Fred was a former cardiac patient, his doctors looked to his heart for a diagnosis.

It wasn’t until his primary care physician retired that he started seeing a new doctor who took a different look at his symptoms. In hearing about the strong changes in his exercise endurance, this particular doctor made the decision to refer Fred to a pulmonologist, which ultimately led Fred on the right path to his IPF diagnosis.
 

Helping others navigate the path

In his 5 years since being diagnosed with IPF, Fred uses his experience to advocate for others living with this illness. Active in support groups for those with IPF, he is especially focused on helping others navigate the first few months after receiving their diagnosis.

Fred knows from experience that receiving the IPF diagnosis is something to come to terms with but encourages others to look to him for an example of how to live with the illness.

“The first thing I say to someone who has been recently diagnosed with pulmonary fibrosis is, ‘Whatever you’ve read on the Internet, don’t believe it,’ because there are a lot of people who live well beyond the 3- to 5-year expectancy you’ll see in your Google search.”

“I also encourage everyone to be their own health advocate – tell your doctor if anything in your life is abnormal because you know your body better than anyone.”

Like Fred, many living with IPF wait years for a diagnosis because of the commonality in the way the symptoms present, including shortness of breath, fatigue, difficulty breathing, and others. To address this delay, the American College of Chest Physicians, supported by the CHEST Foundation, partnered with the Three Lakes Foundation to create an initiative led by a steering committee of pulmonologists and primary care physicians to join together to shorten the time to diagnosis for interstitial lung diseases like IPF. Among other activities, the steering committee will work to create tools for physicians to use during patient intake that can more quickly bring IPF into the conversation when it is pertinent.
 

Patient Advocate – Betsy Glaeser

Blazing the trail for NTM

Local to New York, Betsy Glaeser was diagnosed with pulmonary nontuberculous mycobacteria disease (NTM) more than 20 years ago.

Leading up to her diagnosis, Betsy was frequently short of breath with overwhelming fatigue and fevers. She was hospitalized multiple times for pneumonia and treated again and again with short-term standard antibiotics. At the time (1998), there were no clinical programs dedicated to NTM, and when her sputum was tested, it was only for pneumonia.

As a financial consultant required to travel 4 days per week for work, Betsy grew especially concerned about her illness when she developed hemoptysis and began coughing up blood. Lacking local resources, she sought care at the Mayo Clinic in Rochester, Minnesota, where she received her NTM diagnosis.

Based on the severity of her illness and her worsening symptoms, the recommendation of the Mayo Clinic was that she stop working. After 30 years of challenging jobs, quitting was very painful, but a Mayo doctor asked Betsy a very poignant question that resonated with her: “Are you planning to die for your employer?”

With that, she left her job and sought care for her illness. As her NTM developed a second, more resistant strain associated with her disease, requiring daily, constant treatment, Betsy was fortunate to be accepted into the National Institutes of Health NTM protocol, which has directed her care, coordinated with NYU-Langone.

Despite the challenges of having NTM, Betsy maintains an active and enriching life.
 

Leading with experience

Betsy uses her diagnosis and her experience with NTM to help others who are hearing their diagnoses for the first time. She serves as a charter member and co-leader of a New York NTM patient support group and serves as a member of the NTM Info & Research (NTMir) Board of Directors.

Her goal is to ensure that no one living with NTM feels alone or frightened.

“Not so long ago – and now, too, even – there were doctors who did not know how to treat NTM,” says Betsy. “But, it has really gotten better – as I’ve progressed through all of my medications and lived with this disease, NTM has progressed as well. I hope I helped expand NTM knowledge with my lived experiences, but I’ve been so fortunate to receive medical care from those doctors who knew the most about NTM.”

Receiving a chronic disease diagnosis can be paralyzing, with a wide range of associated emotions. A patient’s family, physicians, and other health care professionals can provide a source of support, but, often, the strongest support comes from those who can empathize.

Someone who has lived with a diagnosis can provide guidance and empathy at a more personal level because, to them, it is just that – personal. Fred Schick and Betsy Glaeser have done just that by taking their personal experiences and using them to help others navigate their diagnoses.

Improving patients’ lives is the core focus of the American College of Chest Physicians and the CHEST Foundation. Events like the Belmont Stakes Dinner and Auction provide an opportunity for us to recognize and celebrate powerful stories such as Fred and Betsy’s, while also raising funds to support important initiatives that will improve patient care. Please consider joining the fight against lung disease by making a donation to the CHEST Foundation today at chestfoundation.org/donate.
 

Patient Advocate – Fred Schick

Increasing awareness of pulmonary fibrosis

Fred Schick of the Chicagoland area was diagnosed with idiopathic pulmonary fibrosis (IPF) in 2017 after years of searching for the root cause of his worsening symptoms.

Fred started experiencing shortness of breath and labored breathing—once to the extent that he needed to be pulled out of the water on vacation despite being an active swimmer. Because Fred was a former cardiac patient, his doctors looked to his heart for a diagnosis.

It wasn’t until his primary care physician retired that he started seeing a new doctor who took a different look at his symptoms. In hearing about the strong changes in his exercise endurance, this particular doctor made the decision to refer Fred to a pulmonologist, which ultimately led Fred on the right path to his IPF diagnosis.
 

Helping others navigate the path

In his 5 years since being diagnosed with IPF, Fred uses his experience to advocate for others living with this illness. Active in support groups for those with IPF, he is especially focused on helping others navigate the first few months after receiving their diagnosis.

Fred knows from experience that receiving the IPF diagnosis is something to come to terms with but encourages others to look to him for an example of how to live with the illness.

“The first thing I say to someone who has been recently diagnosed with pulmonary fibrosis is, ‘Whatever you’ve read on the Internet, don’t believe it,’ because there are a lot of people who live well beyond the 3- to 5-year expectancy you’ll see in your Google search.”

“I also encourage everyone to be their own health advocate – tell your doctor if anything in your life is abnormal because you know your body better than anyone.”

Like Fred, many living with IPF wait years for a diagnosis because of the commonality in the way the symptoms present, including shortness of breath, fatigue, difficulty breathing, and others. To address this delay, the American College of Chest Physicians, supported by the CHEST Foundation, partnered with the Three Lakes Foundation to create an initiative led by a steering committee of pulmonologists and primary care physicians to join together to shorten the time to diagnosis for interstitial lung diseases like IPF. Among other activities, the steering committee will work to create tools for physicians to use during patient intake that can more quickly bring IPF into the conversation when it is pertinent.
 

Patient Advocate – Betsy Glaeser

Blazing the trail for NTM

Local to New York, Betsy Glaeser was diagnosed with pulmonary nontuberculous mycobacteria disease (NTM) more than 20 years ago.

Leading up to her diagnosis, Betsy was frequently short of breath with overwhelming fatigue and fevers. She was hospitalized multiple times for pneumonia and treated again and again with short-term standard antibiotics. At the time (1998), there were no clinical programs dedicated to NTM, and when her sputum was tested, it was only for pneumonia.

As a financial consultant required to travel 4 days per week for work, Betsy grew especially concerned about her illness when she developed hemoptysis and began coughing up blood. Lacking local resources, she sought care at the Mayo Clinic in Rochester, Minnesota, where she received her NTM diagnosis.

Based on the severity of her illness and her worsening symptoms, the recommendation of the Mayo Clinic was that she stop working. After 30 years of challenging jobs, quitting was very painful, but a Mayo doctor asked Betsy a very poignant question that resonated with her: “Are you planning to die for your employer?”

With that, she left her job and sought care for her illness. As her NTM developed a second, more resistant strain associated with her disease, requiring daily, constant treatment, Betsy was fortunate to be accepted into the National Institutes of Health NTM protocol, which has directed her care, coordinated with NYU-Langone.

Despite the challenges of having NTM, Betsy maintains an active and enriching life.
 

Leading with experience

Betsy uses her diagnosis and her experience with NTM to help others who are hearing their diagnoses for the first time. She serves as a charter member and co-leader of a New York NTM patient support group and serves as a member of the NTM Info & Research (NTMir) Board of Directors.

Her goal is to ensure that no one living with NTM feels alone or frightened.

“Not so long ago – and now, too, even – there were doctors who did not know how to treat NTM,” says Betsy. “But, it has really gotten better – as I’ve progressed through all of my medications and lived with this disease, NTM has progressed as well. I hope I helped expand NTM knowledge with my lived experiences, but I’ve been so fortunate to receive medical care from those doctors who knew the most about NTM.”

Receiving a chronic disease diagnosis can be paralyzing, with a wide range of associated emotions. A patient’s family, physicians, and other health care professionals can provide a source of support, but, often, the strongest support comes from those who can empathize.

Someone who has lived with a diagnosis can provide guidance and empathy at a more personal level because, to them, it is just that – personal. Fred Schick and Betsy Glaeser have done just that by taking their personal experiences and using them to help others navigate their diagnoses.

Improving patients’ lives is the core focus of the American College of Chest Physicians and the CHEST Foundation. Events like the Belmont Stakes Dinner and Auction provide an opportunity for us to recognize and celebrate powerful stories such as Fred and Betsy’s, while also raising funds to support important initiatives that will improve patient care. Please consider joining the fight against lung disease by making a donation to the CHEST Foundation today at chestfoundation.org/donate.
 

Patient Advocate – Fred Schick

Increasing awareness of pulmonary fibrosis

Fred Schick of the Chicagoland area was diagnosed with idiopathic pulmonary fibrosis (IPF) in 2017 after years of searching for the root cause of his worsening symptoms.

Fred started experiencing shortness of breath and labored breathing—once to the extent that he needed to be pulled out of the water on vacation despite being an active swimmer. Because Fred was a former cardiac patient, his doctors looked to his heart for a diagnosis.

It wasn’t until his primary care physician retired that he started seeing a new doctor who took a different look at his symptoms. In hearing about the strong changes in his exercise endurance, this particular doctor made the decision to refer Fred to a pulmonologist, which ultimately led Fred on the right path to his IPF diagnosis.
 

Helping others navigate the path

In his 5 years since being diagnosed with IPF, Fred uses his experience to advocate for others living with this illness. Active in support groups for those with IPF, he is especially focused on helping others navigate the first few months after receiving their diagnosis.

Fred knows from experience that receiving the IPF diagnosis is something to come to terms with but encourages others to look to him for an example of how to live with the illness.

“The first thing I say to someone who has been recently diagnosed with pulmonary fibrosis is, ‘Whatever you’ve read on the Internet, don’t believe it,’ because there are a lot of people who live well beyond the 3- to 5-year expectancy you’ll see in your Google search.”

“I also encourage everyone to be their own health advocate – tell your doctor if anything in your life is abnormal because you know your body better than anyone.”

Like Fred, many living with IPF wait years for a diagnosis because of the commonality in the way the symptoms present, including shortness of breath, fatigue, difficulty breathing, and others. To address this delay, the American College of Chest Physicians, supported by the CHEST Foundation, partnered with the Three Lakes Foundation to create an initiative led by a steering committee of pulmonologists and primary care physicians to join together to shorten the time to diagnosis for interstitial lung diseases like IPF. Among other activities, the steering committee will work to create tools for physicians to use during patient intake that can more quickly bring IPF into the conversation when it is pertinent.
 

Patient Advocate – Betsy Glaeser

Blazing the trail for NTM

Local to New York, Betsy Glaeser was diagnosed with pulmonary nontuberculous mycobacteria disease (NTM) more than 20 years ago.

Leading up to her diagnosis, Betsy was frequently short of breath with overwhelming fatigue and fevers. She was hospitalized multiple times for pneumonia and treated again and again with short-term standard antibiotics. At the time (1998), there were no clinical programs dedicated to NTM, and when her sputum was tested, it was only for pneumonia.

As a financial consultant required to travel 4 days per week for work, Betsy grew especially concerned about her illness when she developed hemoptysis and began coughing up blood. Lacking local resources, she sought care at the Mayo Clinic in Rochester, Minnesota, where she received her NTM diagnosis.

Based on the severity of her illness and her worsening symptoms, the recommendation of the Mayo Clinic was that she stop working. After 30 years of challenging jobs, quitting was very painful, but a Mayo doctor asked Betsy a very poignant question that resonated with her: “Are you planning to die for your employer?”

With that, she left her job and sought care for her illness. As her NTM developed a second, more resistant strain associated with her disease, requiring daily, constant treatment, Betsy was fortunate to be accepted into the National Institutes of Health NTM protocol, which has directed her care, coordinated with NYU-Langone.

Despite the challenges of having NTM, Betsy maintains an active and enriching life.
 

Leading with experience

Betsy uses her diagnosis and her experience with NTM to help others who are hearing their diagnoses for the first time. She serves as a charter member and co-leader of a New York NTM patient support group and serves as a member of the NTM Info & Research (NTMir) Board of Directors.

Her goal is to ensure that no one living with NTM feels alone or frightened.

“Not so long ago – and now, too, even – there were doctors who did not know how to treat NTM,” says Betsy. “But, it has really gotten better – as I’ve progressed through all of my medications and lived with this disease, NTM has progressed as well. I hope I helped expand NTM knowledge with my lived experiences, but I’ve been so fortunate to receive medical care from those doctors who knew the most about NTM.”

Affecting around 400,000 people in the United States, interstitial lung diseases (ILD), like pulmonary fibrosis (PF), present with symptoms that are similar to other more common lung diseases, frequently resulting in misdiagnosis or delayed diagnosis. Some studies show that reaching a proper diagnosis for rarer lung diseases can take upwards of several years.

Despite scientific advancements and increased information available, timely and accurate diagnosis for PF remains a challenge. The course of the disease varies from person to person and can progress rapidly in some cases, increasing the necessity to have the condition diagnosed in its earliest stages. By the time patients learn they have PF, the condition may require reliance on oxygen use and hospitalizations, and it can lead to poor quality of life and a significantly shortened lifespan.

To address this issue, Three Lakes Foundation (TLF) and the American College of Chest Physicians (CHEST) recently announced their collaboration on a multiphase educational initiative led by a steering committee of medical experts aiming to reduce the time it takes to diagnose patients with ILDs like PF. Composed of pulmonologists, primary care physicians, and a nursing professional, the steering committee will work to create materials that will aid in identifying and diagnosing complex lung diseases quicker.

“As a catalyst for change in the PF community, Three Lakes Foundation spoke with patients, health care professionals, physicians, and advocacy groups to advance an understanding of the PF diagnostic experience,” said Dana Ball, executive director for Three Lakes Foundation. “We approached CHEST when it became apparent that primary care physicians could use specific tools to identify high-risk patients with pulmonary conditions. This collaboration is the result of our common need to increase awareness among health care professionals and to improve patient outcomes.”

Members of the expert steering committee include individuals from leading medical institutions, health systems, and organizations across the country:

• Daniel F. Dilling, MD, FCCP, Professor of Medicine, Division of Pulmonary and Critical Care, Loyola University Chicago, Stritch School of Medicine, Maywood, IL.
• Andrew Duggan, MPH, Patient Engagement and Innovation Leader representing Three Lakes Foundation, Boston, MA.
• Jessica Glennie, APRN, MSN, Nurse Practitioner, Interstitial Lung Disease Clinic, Cleveland Clinic, Cleveland, OH.
• Timothy Hernandez, MD, Family Medicine Physician, Chief Executive Officer of Entira Family Clinics, San Antonio, TX.
• Corey D. Kershaw, MD, FCCP, Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine, University of Texas Southwestern Medical Center, Dallas, TX.
• Tejaswini Kulkarni, MD, MPH, FCCP, Assistant Professor, Director, Interstitial Lung Disease Program, Division of Pulmonary, Allergy and Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, AL.
• William Lago, MD, Family Medicine Physician, Wooster Family Health Center, Cleveland Clinic Foundation, Wooster, OH.
• Andrew H. Limper, MD, FCCP, Annenberg Professor of Pulmonary Medicine, Professor of Biochemistry and Molecular Biology, Director – Thoracic Disease Research Unit, Mayo Clinic College of Medicine, Rochester, MN.
• Anoop M. Nambiar, MD, MS, FCCP, Professor of Medicine, Founding Director of the UT Health San Antonio Center for Interstitial Lung Diseases, Division of Pulmonary and Critical Care Medicine, Department of Medicine, The University of Texas Health Science Center at San Antonio and South Texas Veterans Health Care System, San Antonio, TX.
• Mary Beth Scholand, MD, Associate Professor of Internal Medicine, Division of Pulmonary Diseases, Director, Interstitial Lung Program, University of Utah, Salt Lake City, UT

“While interstitial lung diseases do not affect a substantial amount of the population, those touched by the disease are impacted tremendously,” says steering committee member and pulmonologist, Dr. Andrew H. Limper. “Any delay in receiving a diagnosis is time that could be dedicated to finding a treatment therapy that can improve their quality of life. I look forward to the work of this committee helping to shape how patients with ILDs are diagnosed and treated in the future.”

Starting with data-gathering surveys sent to both primary care physicians and pulmonologists, the committee will evaluate the findings to develop tools that can be used to aid in diagnosing complex lung diseases.

“Having experts from both pulmonary and primary care medicine as members of the steering committee is critical,” says steering committee member and family medicine physician, Dr. William Lago. “Patients first see their family medicine or primary care clinicians and, all too often, the most complex lung diseases present in ways that are indistinguishable from more common conditions like asthma and COPD. Bringing together experts in both fields will yield the best results in creating a path to diagnosis.”

Three Lakes Foundation is providing the initial funding for CHEST to begin designing an educational intervention that addresses the gaps in knowledge and practice and will play an active role in overseeing the development of the program.

For more information on the Bridging Specialties^™: Timely Diagnosis for Patients With ILD initiative and to sign up for updates, visit info.chestnet.org/bridging-specialties-timely-diagnosis-for-ild-patients.

Affecting around 400,000 people in the United States, interstitial lung diseases (ILD), like pulmonary fibrosis (PF), present with symptoms that are similar to other more common lung diseases, frequently resulting in misdiagnosis or delayed diagnosis. Some studies show that reaching a proper diagnosis for rarer lung diseases can take upwards of several years.

Despite scientific advancements and increased information available, timely and accurate diagnosis for PF remains a challenge. The course of the disease varies from person to person and can progress rapidly in some cases, increasing the necessity to have the condition diagnosed in its earliest stages. By the time patients learn they have PF, the condition may require reliance on oxygen use and hospitalizations, and it can lead to poor quality of life and a significantly shortened lifespan.

To address this issue, Three Lakes Foundation (TLF) and the American College of Chest Physicians (CHEST) recently announced their collaboration on a multiphase educational initiative led by a steering committee of medical experts aiming to reduce the time it takes to diagnose patients with ILDs like PF. Composed of pulmonologists, primary care physicians, and a nursing professional, the steering committee will work to create materials that will aid in identifying and diagnosing complex lung diseases quicker.

“As a catalyst for change in the PF community, Three Lakes Foundation spoke with patients, health care professionals, physicians, and advocacy groups to advance an understanding of the PF diagnostic experience,” said Dana Ball, executive director for Three Lakes Foundation. “We approached CHEST when it became apparent that primary care physicians could use specific tools to identify high-risk patients with pulmonary conditions. This collaboration is the result of our common need to increase awareness among health care professionals and to improve patient outcomes.”

Members of the expert steering committee include individuals from leading medical institutions, health systems, and organizations across the country:

• Daniel F. Dilling, MD, FCCP, Professor of Medicine, Division of Pulmonary and Critical Care, Loyola University Chicago, Stritch School of Medicine, Maywood, IL.
• Andrew Duggan, MPH, Patient Engagement and Innovation Leader representing Three Lakes Foundation, Boston, MA.
• Jessica Glennie, APRN, MSN, Nurse Practitioner, Interstitial Lung Disease Clinic, Cleveland Clinic, Cleveland, OH.
• Timothy Hernandez, MD, Family Medicine Physician, Chief Executive Officer of Entira Family Clinics, San Antonio, TX.
• Corey D. Kershaw, MD, FCCP, Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine, University of Texas Southwestern Medical Center, Dallas, TX.
• Tejaswini Kulkarni, MD, MPH, FCCP, Assistant Professor, Director, Interstitial Lung Disease Program, Division of Pulmonary, Allergy and Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, AL.
• William Lago, MD, Family Medicine Physician, Wooster Family Health Center, Cleveland Clinic Foundation, Wooster, OH.
• Andrew H. Limper, MD, FCCP, Annenberg Professor of Pulmonary Medicine, Professor of Biochemistry and Molecular Biology, Director – Thoracic Disease Research Unit, Mayo Clinic College of Medicine, Rochester, MN.
• Anoop M. Nambiar, MD, MS, FCCP, Professor of Medicine, Founding Director of the UT Health San Antonio Center for Interstitial Lung Diseases, Division of Pulmonary and Critical Care Medicine, Department of Medicine, The University of Texas Health Science Center at San Antonio and South Texas Veterans Health Care System, San Antonio, TX.
• Mary Beth Scholand, MD, Associate Professor of Internal Medicine, Division of Pulmonary Diseases, Director, Interstitial Lung Program, University of Utah, Salt Lake City, UT

“While interstitial lung diseases do not affect a substantial amount of the population, those touched by the disease are impacted tremendously,” says steering committee member and pulmonologist, Dr. Andrew H. Limper. “Any delay in receiving a diagnosis is time that could be dedicated to finding a treatment therapy that can improve their quality of life. I look forward to the work of this committee helping to shape how patients with ILDs are diagnosed and treated in the future.”

Starting with data-gathering surveys sent to both primary care physicians and pulmonologists, the committee will evaluate the findings to develop tools that can be used to aid in diagnosing complex lung diseases.

“Having experts from both pulmonary and primary care medicine as members of the steering committee is critical,” says steering committee member and family medicine physician, Dr. William Lago. “Patients first see their family medicine or primary care clinicians and, all too often, the most complex lung diseases present in ways that are indistinguishable from more common conditions like asthma and COPD. Bringing together experts in both fields will yield the best results in creating a path to diagnosis.”

Three Lakes Foundation is providing the initial funding for CHEST to begin designing an educational intervention that addresses the gaps in knowledge and practice and will play an active role in overseeing the development of the program.

For more information on the Bridging Specialties^™: Timely Diagnosis for Patients With ILD initiative and to sign up for updates, visit info.chestnet.org/bridging-specialties-timely-diagnosis-for-ild-patients.

Affecting around 400,000 people in the United States, interstitial lung diseases (ILD), like pulmonary fibrosis (PF), present with symptoms that are similar to other more common lung diseases, frequently resulting in misdiagnosis or delayed diagnosis. Some studies show that reaching a proper diagnosis for rarer lung diseases can take upwards of several years.

Despite scientific advancements and increased information available, timely and accurate diagnosis for PF remains a challenge. The course of the disease varies from person to person and can progress rapidly in some cases, increasing the necessity to have the condition diagnosed in its earliest stages. By the time patients learn they have PF, the condition may require reliance on oxygen use and hospitalizations, and it can lead to poor quality of life and a significantly shortened lifespan.

To address this issue, Three Lakes Foundation (TLF) and the American College of Chest Physicians (CHEST) recently announced their collaboration on a multiphase educational initiative led by a steering committee of medical experts aiming to reduce the time it takes to diagnose patients with ILDs like PF. Composed of pulmonologists, primary care physicians, and a nursing professional, the steering committee will work to create materials that will aid in identifying and diagnosing complex lung diseases quicker.

“As a catalyst for change in the PF community, Three Lakes Foundation spoke with patients, health care professionals, physicians, and advocacy groups to advance an understanding of the PF diagnostic experience,” said Dana Ball, executive director for Three Lakes Foundation. “We approached CHEST when it became apparent that primary care physicians could use specific tools to identify high-risk patients with pulmonary conditions. This collaboration is the result of our common need to increase awareness among health care professionals and to improve patient outcomes.”

Members of the expert steering committee include individuals from leading medical institutions, health systems, and organizations across the country:

• Daniel F. Dilling, MD, FCCP, Professor of Medicine, Division of Pulmonary and Critical Care, Loyola University Chicago, Stritch School of Medicine, Maywood, IL.
• Andrew Duggan, MPH, Patient Engagement and Innovation Leader representing Three Lakes Foundation, Boston, MA.
• Jessica Glennie, APRN, MSN, Nurse Practitioner, Interstitial Lung Disease Clinic, Cleveland Clinic, Cleveland, OH.
• Timothy Hernandez, MD, Family Medicine Physician, Chief Executive Officer of Entira Family Clinics, San Antonio, TX.
• Corey D. Kershaw, MD, FCCP, Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine, University of Texas Southwestern Medical Center, Dallas, TX.
• Tejaswini Kulkarni, MD, MPH, FCCP, Assistant Professor, Director, Interstitial Lung Disease Program, Division of Pulmonary, Allergy and Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, AL.
• William Lago, MD, Family Medicine Physician, Wooster Family Health Center, Cleveland Clinic Foundation, Wooster, OH.
• Andrew H. Limper, MD, FCCP, Annenberg Professor of Pulmonary Medicine, Professor of Biochemistry and Molecular Biology, Director – Thoracic Disease Research Unit, Mayo Clinic College of Medicine, Rochester, MN.
• Anoop M. Nambiar, MD, MS, FCCP, Professor of Medicine, Founding Director of the UT Health San Antonio Center for Interstitial Lung Diseases, Division of Pulmonary and Critical Care Medicine, Department of Medicine, The University of Texas Health Science Center at San Antonio and South Texas Veterans Health Care System, San Antonio, TX.
• Mary Beth Scholand, MD, Associate Professor of Internal Medicine, Division of Pulmonary Diseases, Director, Interstitial Lung Program, University of Utah, Salt Lake City, UT

“While interstitial lung diseases do not affect a substantial amount of the population, those touched by the disease are impacted tremendously,” says steering committee member and pulmonologist, Dr. Andrew H. Limper. “Any delay in receiving a diagnosis is time that could be dedicated to finding a treatment therapy that can improve their quality of life. I look forward to the work of this committee helping to shape how patients with ILDs are diagnosed and treated in the future.”

Starting with data-gathering surveys sent to both primary care physicians and pulmonologists, the committee will evaluate the findings to develop tools that can be used to aid in diagnosing complex lung diseases.

“Having experts from both pulmonary and primary care medicine as members of the steering committee is critical,” says steering committee member and family medicine physician, Dr. William Lago. “Patients first see their family medicine or primary care clinicians and, all too often, the most complex lung diseases present in ways that are indistinguishable from more common conditions like asthma and COPD. Bringing together experts in both fields will yield the best results in creating a path to diagnosis.”

Three Lakes Foundation is providing the initial funding for CHEST to begin designing an educational intervention that addresses the gaps in knowledge and practice and will play an active role in overseeing the development of the program.

For more information on the Bridging Specialties^™: Timely Diagnosis for Patients With ILD initiative and to sign up for updates, visit info.chestnet.org/bridging-specialties-timely-diagnosis-for-ild-patients.

Airways disorders network, bronchiectasis section

Phenotyping bronchiectasis: Focus on eosinophilic bronchiectasis

Bronchiectasis has been often linked to neutrophilic inflammation; however, 20% may have a predominantly eosinophilic inflammation.

Eosinophilic bronchiectasis has been associated with a distinct airway microbiome. Shoemark and colleagues showed in an analysis of 1,007 patients from five countries that 22.6% of patients had blood eosinophil counts (BEC) of >300 cells/μL. BEC of <100 cells/μL were associated with higher bronchiectasis severity and increased mortality (Shoemark et al. Am J Respir Crit Care Med. 2022;205[8]:894-902).

BEC of >300 cells/μL were correlated with Streptococcus- and Pseudomonas-dominated microbiome profiles. Compared with patients with BEC of <100 cells/μL, patients with 100-299 cells/μL (hazard ratio [HR], 2.38; 95% confidence interval, 1.33–4.25; P = .003) and those with >300 cells/μL (HR, 3.99; 95% confidence interval, 2.20–7.85; P = .0001) were associated with shorter time to exacerbation.

Eosinophilic inflammation is a risk factor for exacerbations in patients with P. aeruginosa infection and may be considered as a treatable trait. Shoemark and colleagues’ data show that quality of life was improved with inhaled corticosteroid treatment in patients with bronchiectasis who had blood eosinophil counts of >3%, and eosinophils contribute to bronchiectasis exacerbations.

Diffuse lung disease and lung transplant network, occupational and environmental health section

A ubiquitous invasion: The rise of microplastics

About 6.3 billion tons of plastic waste were produced between 1950 and 2015.¹ Their degradation into submillimeter fragments of 1 μm to 5 mm, is called microplastics (MP).² MP are vectors of pollutants, pathologic microorganisms, and chemical additives used in their fabrication.³ Exposure to MP is unavoidable as they are bio-persistent and ubiquitous, even indoors.⁴ MP have been detected in the snow of large metropolitan areas and in remote locations.⁵ Humans are exposed to MP via oral ingestion and inhalation. A Brazilian study of human lung autopsy specimens revealed the presence of MP in 13 of 20 subjects.³

In vitro studies have suggested a causal role of polystyrene-MP in the development of chronic pulmonary disease through the formation of reactive oxygen species, inhibition of cell proliferation, and cellular morphology aberration.⁶ MP can cause local effects due to macrophage-induced inflammation, or alternatively, be transported distantly to the pleura and the systemic circulation.

In addition, MP may disrupt the endocrine pathway due to its estrogenic effects.⁷ Larger MPs of 8 to 10 µm, like nylon, have been associated with interstitial lung disease.⁸ Lung biopsies from workers exposed to airborne synthetic fibers (acrylic, polyester, and terylene) have revealed different degrees of inflammation, granulomas, and interstitial fibrosis.⁹ Factory workers exposed to polyvinyl chloride dust have increased risk of exertional dyspnea and decreased pulmonary function.¹⁰ Due to the pervasive nature of MP, it is essential to establish the global burden of airborne MP and to determine its role in lung health.

Bathmapriya Balakrishnan, MD 
Member-at-Large
 

*Tyler Church, DO 
Fellow-in-Training Member

*Disclaimer: The views expressed in this article are those of the author(s) and do not reflect the official policy of the Department of Army/Navy/Air Force, Department of Defense, or U.S. Government.
 

References

1. Rhodes CJ. Plastic pollution and potential solutions. Sci Prog. 2018;101(3):207-60.

2. Danopoulos E et al. Microplastic contamination of drinking water: A systematic review. PLoS One. 2020;15(7):e0236838.

3. Amato-Lourenço LF et al. Presence of airborne microplastics in human lung tissue. J Hazard Mater. 2021;416:126.

4. Al Horr Y et al. Occupant productivity and office indoor environment quality: A review of the literature. Building and Environment. 2016;105:369-89.

5. Bergmann M et al. White and wonderful? Microplastics prevail in snow from the Alps to the Arctic. Sci Adv. 2019;5:eaax1157.

6. Dong CD et al. Polystyrene microplastic particles: In vitro pulmonary toxicity assessment. J Hazard Mater. 2020;385:121575.

7. Amato-Lourenço LF et al. An emerging class of air pollutants: Potential effects of microplastics to respiratory human health. Sci Total Environ. 2020;749:141676.

8. Kern DG et al. Flock worker’s lung: Chronic interstitial lung disease in the nylon flocking industry. Ann Intern Med. 1998;129[4]:261-72. Erratum in: Ann Intern Med. 1999;130[3]:246.

9. Pimentel JC et al. Respiratory disease caused by synthetic fibers: a new occupational disease. Thorax. 1975;30:204-19.

10. Soutar CA et al. Epidemiological study of respiratory disease in workers exposed to polyvinyl chloride dust. Thorax. 1980;35:644-52.
 

Critical care network, palliative and end-of-life section

Discussing code status with families of critically ill patients

Discussing code status with patients is complex and emotional, especially when critically ill.

The complexity further increases when these conversations have to take place with family members.

Here are some practical tips to help have these conversations in a concise and compassionate manner.  

Introduction  

• Introduce yourself, and make sure to identify the correct decision-maker.   
• Get to know the patient.  

–What kind of person are they?  

–What brings them joy?  

• Find out what the family knows about the current clinical condition of their family member.   

–What have you been hearing from the medical team?  

–What are you worried about?  

Update    

• Fill in the gaps – update them on the clinical condition and ongoing management.  
• Discuss how you think they will respond to current management and further management options.   
• Allow them to process the information.  

Provide a medical recommendation    

• Example: We are worried he might die, and if his heart stops, interventions like CPR or intubation would not work, and we would not recommend them.  
• Do not pressure for a decision right away. (You can say “We do not need a decision today, so please take time to process this information.”)  

Respond to emotions    

• I can’t image how hard this must be.  
• Offer chaplain services if that is important to them.  

Things to avoid 

• Avoid aggressive language.  

–We will have to pound on their chest, break ribs.   

–They would be suffering.  

• Blaming or judgmental language.  

While this complex discussion r equires individualization, these tips will help set a framework for goals of care conversations that lead to high quality care for patients that aligns with their goals.   

Reference

Goldfish and Rosielle. Language for Routine Code Status Discussions, Fast Facts and Concepts #365, Palliative Care Network of Wisconsin.

Syed Nazeer Mahmood, MD
Fellow-in-Training Member

Anne Kelemen, LCSW
Member-at-Large

Airways disorders network, bronchiectasis section

Phenotyping bronchiectasis: Focus on eosinophilic bronchiectasis

Bronchiectasis has been often linked to neutrophilic inflammation; however, 20% may have a predominantly eosinophilic inflammation.

Eosinophilic bronchiectasis has been associated with a distinct airway microbiome. Shoemark and colleagues showed in an analysis of 1,007 patients from five countries that 22.6% of patients had blood eosinophil counts (BEC) of >300 cells/μL. BEC of <100 cells/μL were associated with higher bronchiectasis severity and increased mortality (Shoemark et al. Am J Respir Crit Care Med. 2022;205[8]:894-902).

BEC of >300 cells/μL were correlated with Streptococcus- and Pseudomonas-dominated microbiome profiles. Compared with patients with BEC of <100 cells/μL, patients with 100-299 cells/μL (hazard ratio [HR], 2.38; 95% confidence interval, 1.33–4.25; P = .003) and those with >300 cells/μL (HR, 3.99; 95% confidence interval, 2.20–7.85; P = .0001) were associated with shorter time to exacerbation.

Eosinophilic inflammation is a risk factor for exacerbations in patients with P. aeruginosa infection and may be considered as a treatable trait. Shoemark and colleagues’ data show that quality of life was improved with inhaled corticosteroid treatment in patients with bronchiectasis who had blood eosinophil counts of >3%, and eosinophils contribute to bronchiectasis exacerbations.

Diffuse lung disease and lung transplant network, occupational and environmental health section

A ubiquitous invasion: The rise of microplastics

About 6.3 billion tons of plastic waste were produced between 1950 and 2015.¹ Their degradation into submillimeter fragments of 1 μm to 5 mm, is called microplastics (MP).² MP are vectors of pollutants, pathologic microorganisms, and chemical additives used in their fabrication.³ Exposure to MP is unavoidable as they are bio-persistent and ubiquitous, even indoors.⁴ MP have been detected in the snow of large metropolitan areas and in remote locations.⁵ Humans are exposed to MP via oral ingestion and inhalation. A Brazilian study of human lung autopsy specimens revealed the presence of MP in 13 of 20 subjects.³

In vitro studies have suggested a causal role of polystyrene-MP in the development of chronic pulmonary disease through the formation of reactive oxygen species, inhibition of cell proliferation, and cellular morphology aberration.⁶ MP can cause local effects due to macrophage-induced inflammation, or alternatively, be transported distantly to the pleura and the systemic circulation.

In addition, MP may disrupt the endocrine pathway due to its estrogenic effects.⁷ Larger MPs of 8 to 10 µm, like nylon, have been associated with interstitial lung disease.⁸ Lung biopsies from workers exposed to airborne synthetic fibers (acrylic, polyester, and terylene) have revealed different degrees of inflammation, granulomas, and interstitial fibrosis.⁹ Factory workers exposed to polyvinyl chloride dust have increased risk of exertional dyspnea and decreased pulmonary function.¹⁰ Due to the pervasive nature of MP, it is essential to establish the global burden of airborne MP and to determine its role in lung health.

Bathmapriya Balakrishnan, MD 
Member-at-Large
 

*Tyler Church, DO 
Fellow-in-Training Member

*Disclaimer: The views expressed in this article are those of the author(s) and do not reflect the official policy of the Department of Army/Navy/Air Force, Department of Defense, or U.S. Government.
 

References

1. Rhodes CJ. Plastic pollution and potential solutions. Sci Prog. 2018;101(3):207-60.

2. Danopoulos E et al. Microplastic contamination of drinking water: A systematic review. PLoS One. 2020;15(7):e0236838.

3. Amato-Lourenço LF et al. Presence of airborne microplastics in human lung tissue. J Hazard Mater. 2021;416:126.

4. Al Horr Y et al. Occupant productivity and office indoor environment quality: A review of the literature. Building and Environment. 2016;105:369-89.

5. Bergmann M et al. White and wonderful? Microplastics prevail in snow from the Alps to the Arctic. Sci Adv. 2019;5:eaax1157.

6. Dong CD et al. Polystyrene microplastic particles: In vitro pulmonary toxicity assessment. J Hazard Mater. 2020;385:121575.

7. Amato-Lourenço LF et al. An emerging class of air pollutants: Potential effects of microplastics to respiratory human health. Sci Total Environ. 2020;749:141676.

8. Kern DG et al. Flock worker’s lung: Chronic interstitial lung disease in the nylon flocking industry. Ann Intern Med. 1998;129[4]:261-72. Erratum in: Ann Intern Med. 1999;130[3]:246.

9. Pimentel JC et al. Respiratory disease caused by synthetic fibers: a new occupational disease. Thorax. 1975;30:204-19.

10. Soutar CA et al. Epidemiological study of respiratory disease in workers exposed to polyvinyl chloride dust. Thorax. 1980;35:644-52.
 

Critical care network, palliative and end-of-life section

Discussing code status with families of critically ill patients

Discussing code status with patients is complex and emotional, especially when critically ill.

The complexity further increases when these conversations have to take place with family members.

Here are some practical tips to help have these conversations in a concise and compassionate manner.  

Introduction  

• Introduce yourself, and make sure to identify the correct decision-maker.   
• Get to know the patient.  

–What kind of person are they?  

–What brings them joy?  

• Find out what the family knows about the current clinical condition of their family member.   

–What have you been hearing from the medical team?  

–What are you worried about?  

Update    

• Fill in the gaps – update them on the clinical condition and ongoing management.  
• Discuss how you think they will respond to current management and further management options.   
• Allow them to process the information.  

Provide a medical recommendation    

• Example: We are worried he might die, and if his heart stops, interventions like CPR or intubation would not work, and we would not recommend them.  
• Do not pressure for a decision right away. (You can say “We do not need a decision today, so please take time to process this information.”)  

Respond to emotions    

• I can’t image how hard this must be.  
• Offer chaplain services if that is important to them.  

Things to avoid 

• Avoid aggressive language.  

–We will have to pound on their chest, break ribs.   

–They would be suffering.  

• Blaming or judgmental language.  

While this complex discussion r equires individualization, these tips will help set a framework for goals of care conversations that lead to high quality care for patients that aligns with their goals.   

Reference

Goldfish and Rosielle. Language for Routine Code Status Discussions, Fast Facts and Concepts #365, Palliative Care Network of Wisconsin.

Syed Nazeer Mahmood, MD
Fellow-in-Training Member

Anne Kelemen, LCSW
Member-at-Large

Airways disorders network, bronchiectasis section

Phenotyping bronchiectasis: Focus on eosinophilic bronchiectasis

Bronchiectasis has been often linked to neutrophilic inflammation; however, 20% may have a predominantly eosinophilic inflammation.

Eosinophilic bronchiectasis has been associated with a distinct airway microbiome. Shoemark and colleagues showed in an analysis of 1,007 patients from five countries that 22.6% of patients had blood eosinophil counts (BEC) of >300 cells/μL. BEC of <100 cells/μL were associated with higher bronchiectasis severity and increased mortality (Shoemark et al. Am J Respir Crit Care Med. 2022;205[8]:894-902).

BEC of >300 cells/μL were correlated with Streptococcus- and Pseudomonas-dominated microbiome profiles. Compared with patients with BEC of <100 cells/μL, patients with 100-299 cells/μL (hazard ratio [HR], 2.38; 95% confidence interval, 1.33–4.25; P = .003) and those with >300 cells/μL (HR, 3.99; 95% confidence interval, 2.20–7.85; P = .0001) were associated with shorter time to exacerbation.

Eosinophilic inflammation is a risk factor for exacerbations in patients with P. aeruginosa infection and may be considered as a treatable trait. Shoemark and colleagues’ data show that quality of life was improved with inhaled corticosteroid treatment in patients with bronchiectasis who had blood eosinophil counts of >3%, and eosinophils contribute to bronchiectasis exacerbations.

Diffuse lung disease and lung transplant network, occupational and environmental health section

A ubiquitous invasion: The rise of microplastics

About 6.3 billion tons of plastic waste were produced between 1950 and 2015.¹ Their degradation into submillimeter fragments of 1 μm to 5 mm, is called microplastics (MP).² MP are vectors of pollutants, pathologic microorganisms, and chemical additives used in their fabrication.³ Exposure to MP is unavoidable as they are bio-persistent and ubiquitous, even indoors.⁴ MP have been detected in the snow of large metropolitan areas and in remote locations.⁵ Humans are exposed to MP via oral ingestion and inhalation. A Brazilian study of human lung autopsy specimens revealed the presence of MP in 13 of 20 subjects.³

In vitro studies have suggested a causal role of polystyrene-MP in the development of chronic pulmonary disease through the formation of reactive oxygen species, inhibition of cell proliferation, and cellular morphology aberration.⁶ MP can cause local effects due to macrophage-induced inflammation, or alternatively, be transported distantly to the pleura and the systemic circulation.

In addition, MP may disrupt the endocrine pathway due to its estrogenic effects.⁷ Larger MPs of 8 to 10 µm, like nylon, have been associated with interstitial lung disease.⁸ Lung biopsies from workers exposed to airborne synthetic fibers (acrylic, polyester, and terylene) have revealed different degrees of inflammation, granulomas, and interstitial fibrosis.⁹ Factory workers exposed to polyvinyl chloride dust have increased risk of exertional dyspnea and decreased pulmonary function.¹⁰ Due to the pervasive nature of MP, it is essential to establish the global burden of airborne MP and to determine its role in lung health.

Bathmapriya Balakrishnan, MD 
Member-at-Large
 

*Tyler Church, DO 
Fellow-in-Training Member

*Disclaimer: The views expressed in this article are those of the author(s) and do not reflect the official policy of the Department of Army/Navy/Air Force, Department of Defense, or U.S. Government.
 

References

1. Rhodes CJ. Plastic pollution and potential solutions. Sci Prog. 2018;101(3):207-60.

2. Danopoulos E et al. Microplastic contamination of drinking water: A systematic review. PLoS One. 2020;15(7):e0236838.

3. Amato-Lourenço LF et al. Presence of airborne microplastics in human lung tissue. J Hazard Mater. 2021;416:126.

4. Al Horr Y et al. Occupant productivity and office indoor environment quality: A review of the literature. Building and Environment. 2016;105:369-89.

5. Bergmann M et al. White and wonderful? Microplastics prevail in snow from the Alps to the Arctic. Sci Adv. 2019;5:eaax1157.

6. Dong CD et al. Polystyrene microplastic particles: In vitro pulmonary toxicity assessment. J Hazard Mater. 2020;385:121575.

7. Amato-Lourenço LF et al. An emerging class of air pollutants: Potential effects of microplastics to respiratory human health. Sci Total Environ. 2020;749:141676.

8. Kern DG et al. Flock worker’s lung: Chronic interstitial lung disease in the nylon flocking industry. Ann Intern Med. 1998;129[4]:261-72. Erratum in: Ann Intern Med. 1999;130[3]:246.

9. Pimentel JC et al. Respiratory disease caused by synthetic fibers: a new occupational disease. Thorax. 1975;30:204-19.

10. Soutar CA et al. Epidemiological study of respiratory disease in workers exposed to polyvinyl chloride dust. Thorax. 1980;35:644-52.
 

Critical care network, palliative and end-of-life section

Discussing code status with families of critically ill patients

Discussing code status with patients is complex and emotional, especially when critically ill.

The complexity further increases when these conversations have to take place with family members.

Here are some practical tips to help have these conversations in a concise and compassionate manner.  

Introduction  

• Introduce yourself, and make sure to identify the correct decision-maker.   
• Get to know the patient.  

–What kind of person are they?  

–What brings them joy?  

• Find out what the family knows about the current clinical condition of their family member.   

–What have you been hearing from the medical team?  

–What are you worried about?  

Update    

• Fill in the gaps – update them on the clinical condition and ongoing management.  
• Discuss how you think they will respond to current management and further management options.   
• Allow them to process the information.  

Provide a medical recommendation    

• Example: We are worried he might die, and if his heart stops, interventions like CPR or intubation would not work, and we would not recommend them.  
• Do not pressure for a decision right away. (You can say “We do not need a decision today, so please take time to process this information.”)  

Respond to emotions    

• I can’t image how hard this must be.  
• Offer chaplain services if that is important to them.  

Things to avoid 

• Avoid aggressive language.  

–We will have to pound on their chest, break ribs.   

–They would be suffering.  

• Blaming or judgmental language.  

While this complex discussion r equires individualization, these tips will help set a framework for goals of care conversations that lead to high quality care for patients that aligns with their goals.   

Reference

Goldfish and Rosielle. Language for Routine Code Status Discussions, Fast Facts and Concepts #365, Palliative Care Network of Wisconsin.

Syed Nazeer Mahmood, MD
Fellow-in-Training Member

Anne Kelemen, LCSW
Member-at-Large

The Relationship Between Insurance Status and The Affordable Care Act on Asthma Outcomes Among Low-Income Us Adults. By Dr. Rajat Suri et al.

Characteristics and Outcomes of Intensive Care Unit Patients With Respiratory Syncytial Virus Compared to Those With Influenza Infection: A Multicentre Matched Cohort Study. By Dr. Julien Coussement et al

“Can Do, Do Do” Quadrants and 6-Year All-Cause Mortality in Patients with COPD. By Dr. Anouk W. Vaes et al.

Trends in Geriatric Conditions Among Older Adults Admitted to US ICUs Between 1998 and 2015. By Dr. Julien Cobert et al.

Setting and Titrating Positive End-Expiratory Pressure. By Dr. Scott J. Millington et al.

COVID-19 in Lymphangioleiomyomatosis: An International Study of Outcomes and Impact of Mechanistic Target of Rapamycin Inhibition. By Dr. Bruno Guedes Baldi et al.

Perceptions of Life Support and Advance Care Planning During the COVID-19 Pandemic: A Global Study of Twitter Users. By Vishal R. Patel et al.

Framework for Integrating Equity Into Machine Learning Models: A Case Study. By Dr. Juan C. Rojas et al.

Comparison of Guidelines for Evaluation of Suspected Pulmonary Embolism in Pregnancy: A Cost-Effectiveness Analysis. By John Austin McCandlish et al.

Relationship Between CPAP Termination and All-Cause Mortality: A French Nationwide Database Analysis. By Dr. Jean-Louis Pépin et al.

Clinical Outcomes of Immune Checkpoint Inhibitor Therapy in Patients With Advanced Non-small Cell Lung Cancer and Preexisting Interstitial Lung Diseases: A Systematic Review and Meta-Analysis. By Dr. Meng Zhang, et al.

The Impact of Persistent Smoking After Surgery on Long-Term Outcomes After Stage I Non–Small Cell Lung Cancer Resection. By Dr. Brendan T. Heiden et al.

The Relationship Between Insurance Status and The Affordable Care Act on Asthma Outcomes Among Low-Income Us Adults. By Dr. Rajat Suri et al.

Characteristics and Outcomes of Intensive Care Unit Patients With Respiratory Syncytial Virus Compared to Those With Influenza Infection: A Multicentre Matched Cohort Study. By Dr. Julien Coussement et al

“Can Do, Do Do” Quadrants and 6-Year All-Cause Mortality in Patients with COPD. By Dr. Anouk W. Vaes et al.

Trends in Geriatric Conditions Among Older Adults Admitted to US ICUs Between 1998 and 2015. By Dr. Julien Cobert et al.

Setting and Titrating Positive End-Expiratory Pressure. By Dr. Scott J. Millington et al.

COVID-19 in Lymphangioleiomyomatosis: An International Study of Outcomes and Impact of Mechanistic Target of Rapamycin Inhibition. By Dr. Bruno Guedes Baldi et al.

Perceptions of Life Support and Advance Care Planning During the COVID-19 Pandemic: A Global Study of Twitter Users. By Vishal R. Patel et al.

Framework for Integrating Equity Into Machine Learning Models: A Case Study. By Dr. Juan C. Rojas et al.

Comparison of Guidelines for Evaluation of Suspected Pulmonary Embolism in Pregnancy: A Cost-Effectiveness Analysis. By John Austin McCandlish et al.

Relationship Between CPAP Termination and All-Cause Mortality: A French Nationwide Database Analysis. By Dr. Jean-Louis Pépin et al.

Clinical Outcomes of Immune Checkpoint Inhibitor Therapy in Patients With Advanced Non-small Cell Lung Cancer and Preexisting Interstitial Lung Diseases: A Systematic Review and Meta-Analysis. By Dr. Meng Zhang, et al.

The Impact of Persistent Smoking After Surgery on Long-Term Outcomes After Stage I Non–Small Cell Lung Cancer Resection. By Dr. Brendan T. Heiden et al.

The Relationship Between Insurance Status and The Affordable Care Act on Asthma Outcomes Among Low-Income Us Adults. By Dr. Rajat Suri et al.

Characteristics and Outcomes of Intensive Care Unit Patients With Respiratory Syncytial Virus Compared to Those With Influenza Infection: A Multicentre Matched Cohort Study. By Dr. Julien Coussement et al

“Can Do, Do Do” Quadrants and 6-Year All-Cause Mortality in Patients with COPD. By Dr. Anouk W. Vaes et al.

Trends in Geriatric Conditions Among Older Adults Admitted to US ICUs Between 1998 and 2015. By Dr. Julien Cobert et al.

Setting and Titrating Positive End-Expiratory Pressure. By Dr. Scott J. Millington et al.

COVID-19 in Lymphangioleiomyomatosis: An International Study of Outcomes and Impact of Mechanistic Target of Rapamycin Inhibition. By Dr. Bruno Guedes Baldi et al.

Perceptions of Life Support and Advance Care Planning During the COVID-19 Pandemic: A Global Study of Twitter Users. By Vishal R. Patel et al.

Framework for Integrating Equity Into Machine Learning Models: A Case Study. By Dr. Juan C. Rojas et al.

Comparison of Guidelines for Evaluation of Suspected Pulmonary Embolism in Pregnancy: A Cost-Effectiveness Analysis. By John Austin McCandlish et al.

Relationship Between CPAP Termination and All-Cause Mortality: A French Nationwide Database Analysis. By Dr. Jean-Louis Pépin et al.

Clinical Outcomes of Immune Checkpoint Inhibitor Therapy in Patients With Advanced Non-small Cell Lung Cancer and Preexisting Interstitial Lung Diseases: A Systematic Review and Meta-Analysis. By Dr. Meng Zhang, et al.

The Impact of Persistent Smoking After Surgery on Long-Term Outcomes After Stage I Non–Small Cell Lung Cancer Resection. By Dr. Brendan T. Heiden et al.

ATLANTA – Potential once-daily male oral contraceptives have passed a first clinical hurdle, showing a degree of testosterone suppression that should be sufficient for a contraceptive effect without causing symptomatic hypogonadism, according to phase 1 study results to be presented at the annual meeting of the Endocrine Society.

Credit: Flickr/Marco Verch Professional Photographer/CC by 2.0

There are two pills in development and the studies so far suggest that both or a combination might be able to provide an acceptable balance of efficacy and tolerability, according to Tamar Jacobsohn, a researcher in the Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md.

The two drugs evaluated in this study are dimethandrolone undecanoate (DMAU) and 11b-methyl-19-nortestosterone-17b-dodecylcarbonate (11b-MNTDC). Both are bifunctional prodrugs with androgenic and progestogenic effects. The prodrugs are designed to be cleaved after ingestion so that the active hormones are released over 24 hours, permitting once-daily dosing.

“As potent androgens, these steroids suppress gonadotropin secretion, leading to markedly decreased serum testosterone production,” explained Ms. Jacobsohn in an interview.

However, she noted that there is still a long way to go on this research path. While the phase 1 studies have shown tolerability, the biology involved in suppressing sperm production suggests that men would need to take these pills daily for about 3 months at the very beginning of contraceptive treatment, until adequate sperm suppression is achieved to prevent pregnancy.

“We are working toward a phase 2 trial that will include a contraceptive efficacy endpoint, but there are lots of steps to get there, including more early phase studies,” she noted.

“There is a huge unmet need in terms of male contraceptive methods,” said Arthi Thirumalai, MBBS, an endocrinologist and assistant professor of medicine at the University of Washington School of Medicine in Seattle.

Senior author of a 2020 review article on male contraception, Dr. Thirumalai said in an interview that prodrugs and other hormonal methods to lower testosterone and suppress sperm production are attractive because of convenience, efficacy, and reversibility,

“We hope that oral formulations can be used to address this need,” said Dr. Thirumalai, who has participated in several experimental and clinical studies of male contraception methods. She is, in fact, one of the many coauthors of the data presented by Ms. Jacobsohn.

Ms. Jacobsohn emphasized: “Development of an effective, reversible male contraceptive method will improve reproductive options for men and women, have a major impact on public health by decreasing unintended pregnancy, and allow men to have an increasingly active role in family planning.”

Phase 1 results with DMAU and MNTDC

The work that led to phase 1 studies suggested that each of the drugs — DMAU and MNTDC — might provide adequate hormone suppression to reduce sperm counts without inducing unacceptable symptoms of hypogonadism. To test this potential, dose-ranging phase 1 studies with an endpoint of testosterone suppression were conducted with each one.

In the two placebo-controlled phase 1a studies, which are to be presented in a poster on June 13, healthy male subjects were randomly assigned to two pills of active therapy, four pills of active therapy, or placebo. In the two studies combined, 39 subjects received DMAU, 30 received 11b-MNTDC, and 28 received placebo.

Efficacy was evaluated by measuring testosterone levels. Tolerability was largely based on patient questionnaires.

At the end of 7 days, testosterone levels remained at reference levels (400 to 600 ng/dL) in those who received placebo. The levels fell to less than 100 ng/dL in all subjects assigned to an active agent regardless of which agent or dose was used.

From day 7 to 28, there was less median suppression of testosterone on 200 mg than 400 mg daily (92.7 ng/dL vs. 49.6 ng/dL; P < .001), but both remained below the target of 100 ng/dL, Ms. Jacobsohn reported.

The difference in degree of testosterone suppression did not appear to influence tolerability.

Subjects on four vs. two daily pills “did not report a significant difference in general satisfaction or their willingness to use the pills in the future or recommend them to other men,” said Ms. Jacobson, presenting P values for these outcomes among subjects on active therapy relative to placebo that were not significant, ranging from 0.48 to 0.85.

Overall, there were no serious adverse events. Mild side effects associated with hypogonadism did occur, but “all resolved by the end of the study,” she said.

Zero sperm production is not the goal. Lowering it sufficiently is

Dr. Thirumalai said the need for a male contraceptive is strong. While condoms have a substantial failure rate, vasectomy is not reliably reversible even though the majority of men agree that the responsibility for preventing pregnancy should be shared, she said.

Dr. Thirumalai’s earlier review article found that clinical trials of hormonal suppression to provide male contraception have been conducted for at least 30 years. The challenge has been finding an effective therapy that is well tolerated.

Drugs that combine both androgenic and progestogenic activity might be the answer. By manipulating hormones that lower testosterone, sperm production is reduced without eliminating a man’s ability to ejaculate. Zero sperm production is not the goal, according to data in Dr. Thirumalai’s review article.

Rather, studies suggest that when ejaculate contains less than 1 million sperm per mL (levels typically range from 15 to 200 million sperm/mL), the antipregnancy efficacy is similar to that achieved with female oral contraceptives.

However, clinical trials to demonstrate that this can be achieved safely have yet to be conducted.

Ms. Jacobsohn said that sperm half-life is about 3 months. This means that patients would need to be on hormonal therapy for a period of about this duration before reliable contraception is achieved.

In other words, the efficacy endpoint used in this current study [of 28 days duration] does not ensure effective contraception, but Ms. Jacobsohn suggested this is nevertheless an important step forward in clinical development.

Ms. Jacobsohn and Dr. Thirumalai report no relevant financial relationships.

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

ATLANTA – Potential once-daily male oral contraceptives have passed a first clinical hurdle, showing a degree of testosterone suppression that should be sufficient for a contraceptive effect without causing symptomatic hypogonadism, according to phase 1 study results to be presented at the annual meeting of the Endocrine Society.

Credit: Flickr/Marco Verch Professional Photographer/CC by 2.0

There are two pills in development and the studies so far suggest that both or a combination might be able to provide an acceptable balance of efficacy and tolerability, according to Tamar Jacobsohn, a researcher in the Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md.

The two drugs evaluated in this study are dimethandrolone undecanoate (DMAU) and 11b-methyl-19-nortestosterone-17b-dodecylcarbonate (11b-MNTDC). Both are bifunctional prodrugs with androgenic and progestogenic effects. The prodrugs are designed to be cleaved after ingestion so that the active hormones are released over 24 hours, permitting once-daily dosing.

“As potent androgens, these steroids suppress gonadotropin secretion, leading to markedly decreased serum testosterone production,” explained Ms. Jacobsohn in an interview.

However, she noted that there is still a long way to go on this research path. While the phase 1 studies have shown tolerability, the biology involved in suppressing sperm production suggests that men would need to take these pills daily for about 3 months at the very beginning of contraceptive treatment, until adequate sperm suppression is achieved to prevent pregnancy.

“We are working toward a phase 2 trial that will include a contraceptive efficacy endpoint, but there are lots of steps to get there, including more early phase studies,” she noted.

“There is a huge unmet need in terms of male contraceptive methods,” said Arthi Thirumalai, MBBS, an endocrinologist and assistant professor of medicine at the University of Washington School of Medicine in Seattle.

Senior author of a 2020 review article on male contraception, Dr. Thirumalai said in an interview that prodrugs and other hormonal methods to lower testosterone and suppress sperm production are attractive because of convenience, efficacy, and reversibility,

“We hope that oral formulations can be used to address this need,” said Dr. Thirumalai, who has participated in several experimental and clinical studies of male contraception methods. She is, in fact, one of the many coauthors of the data presented by Ms. Jacobsohn.

Ms. Jacobsohn emphasized: “Development of an effective, reversible male contraceptive method will improve reproductive options for men and women, have a major impact on public health by decreasing unintended pregnancy, and allow men to have an increasingly active role in family planning.”

Phase 1 results with DMAU and MNTDC

The work that led to phase 1 studies suggested that each of the drugs — DMAU and MNTDC — might provide adequate hormone suppression to reduce sperm counts without inducing unacceptable symptoms of hypogonadism. To test this potential, dose-ranging phase 1 studies with an endpoint of testosterone suppression were conducted with each one.

In the two placebo-controlled phase 1a studies, which are to be presented in a poster on June 13, healthy male subjects were randomly assigned to two pills of active therapy, four pills of active therapy, or placebo. In the two studies combined, 39 subjects received DMAU, 30 received 11b-MNTDC, and 28 received placebo.

Efficacy was evaluated by measuring testosterone levels. Tolerability was largely based on patient questionnaires.

At the end of 7 days, testosterone levels remained at reference levels (400 to 600 ng/dL) in those who received placebo. The levels fell to less than 100 ng/dL in all subjects assigned to an active agent regardless of which agent or dose was used.

From day 7 to 28, there was less median suppression of testosterone on 200 mg than 400 mg daily (92.7 ng/dL vs. 49.6 ng/dL; P < .001), but both remained below the target of 100 ng/dL, Ms. Jacobsohn reported.

The difference in degree of testosterone suppression did not appear to influence tolerability.

Subjects on four vs. two daily pills “did not report a significant difference in general satisfaction or their willingness to use the pills in the future or recommend them to other men,” said Ms. Jacobson, presenting P values for these outcomes among subjects on active therapy relative to placebo that were not significant, ranging from 0.48 to 0.85.

Overall, there were no serious adverse events. Mild side effects associated with hypogonadism did occur, but “all resolved by the end of the study,” she said.

Zero sperm production is not the goal. Lowering it sufficiently is

Dr. Thirumalai said the need for a male contraceptive is strong. While condoms have a substantial failure rate, vasectomy is not reliably reversible even though the majority of men agree that the responsibility for preventing pregnancy should be shared, she said.

Dr. Thirumalai’s earlier review article found that clinical trials of hormonal suppression to provide male contraception have been conducted for at least 30 years. The challenge has been finding an effective therapy that is well tolerated.

Drugs that combine both androgenic and progestogenic activity might be the answer. By manipulating hormones that lower testosterone, sperm production is reduced without eliminating a man’s ability to ejaculate. Zero sperm production is not the goal, according to data in Dr. Thirumalai’s review article.

Rather, studies suggest that when ejaculate contains less than 1 million sperm per mL (levels typically range from 15 to 200 million sperm/mL), the antipregnancy efficacy is similar to that achieved with female oral contraceptives.

However, clinical trials to demonstrate that this can be achieved safely have yet to be conducted.

Ms. Jacobsohn said that sperm half-life is about 3 months. This means that patients would need to be on hormonal therapy for a period of about this duration before reliable contraception is achieved.

In other words, the efficacy endpoint used in this current study [of 28 days duration] does not ensure effective contraception, but Ms. Jacobsohn suggested this is nevertheless an important step forward in clinical development.

Ms. Jacobsohn and Dr. Thirumalai report no relevant financial relationships.

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

ATLANTA – Potential once-daily male oral contraceptives have passed a first clinical hurdle, showing a degree of testosterone suppression that should be sufficient for a contraceptive effect without causing symptomatic hypogonadism, according to phase 1 study results to be presented at the annual meeting of the Endocrine Society.

Credit: Flickr/Marco Verch Professional Photographer/CC by 2.0

There are two pills in development and the studies so far suggest that both or a combination might be able to provide an acceptable balance of efficacy and tolerability, according to Tamar Jacobsohn, a researcher in the Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md.

The two drugs evaluated in this study are dimethandrolone undecanoate (DMAU) and 11b-methyl-19-nortestosterone-17b-dodecylcarbonate (11b-MNTDC). Both are bifunctional prodrugs with androgenic and progestogenic effects. The prodrugs are designed to be cleaved after ingestion so that the active hormones are released over 24 hours, permitting once-daily dosing.

“As potent androgens, these steroids suppress gonadotropin secretion, leading to markedly decreased serum testosterone production,” explained Ms. Jacobsohn in an interview.

However, she noted that there is still a long way to go on this research path. While the phase 1 studies have shown tolerability, the biology involved in suppressing sperm production suggests that men would need to take these pills daily for about 3 months at the very beginning of contraceptive treatment, until adequate sperm suppression is achieved to prevent pregnancy.

“We are working toward a phase 2 trial that will include a contraceptive efficacy endpoint, but there are lots of steps to get there, including more early phase studies,” she noted.

“There is a huge unmet need in terms of male contraceptive methods,” said Arthi Thirumalai, MBBS, an endocrinologist and assistant professor of medicine at the University of Washington School of Medicine in Seattle.

Senior author of a 2020 review article on male contraception, Dr. Thirumalai said in an interview that prodrugs and other hormonal methods to lower testosterone and suppress sperm production are attractive because of convenience, efficacy, and reversibility,

“We hope that oral formulations can be used to address this need,” said Dr. Thirumalai, who has participated in several experimental and clinical studies of male contraception methods. She is, in fact, one of the many coauthors of the data presented by Ms. Jacobsohn.

Ms. Jacobsohn emphasized: “Development of an effective, reversible male contraceptive method will improve reproductive options for men and women, have a major impact on public health by decreasing unintended pregnancy, and allow men to have an increasingly active role in family planning.”

Phase 1 results with DMAU and MNTDC

The work that led to phase 1 studies suggested that each of the drugs — DMAU and MNTDC — might provide adequate hormone suppression to reduce sperm counts without inducing unacceptable symptoms of hypogonadism. To test this potential, dose-ranging phase 1 studies with an endpoint of testosterone suppression were conducted with each one.

In the two placebo-controlled phase 1a studies, which are to be presented in a poster on June 13, healthy male subjects were randomly assigned to two pills of active therapy, four pills of active therapy, or placebo. In the two studies combined, 39 subjects received DMAU, 30 received 11b-MNTDC, and 28 received placebo.

Efficacy was evaluated by measuring testosterone levels. Tolerability was largely based on patient questionnaires.

At the end of 7 days, testosterone levels remained at reference levels (400 to 600 ng/dL) in those who received placebo. The levels fell to less than 100 ng/dL in all subjects assigned to an active agent regardless of which agent or dose was used.

From day 7 to 28, there was less median suppression of testosterone on 200 mg than 400 mg daily (92.7 ng/dL vs. 49.6 ng/dL; P < .001), but both remained below the target of 100 ng/dL, Ms. Jacobsohn reported.

The difference in degree of testosterone suppression did not appear to influence tolerability.

Subjects on four vs. two daily pills “did not report a significant difference in general satisfaction or their willingness to use the pills in the future or recommend them to other men,” said Ms. Jacobson, presenting P values for these outcomes among subjects on active therapy relative to placebo that were not significant, ranging from 0.48 to 0.85.

Overall, there were no serious adverse events. Mild side effects associated with hypogonadism did occur, but “all resolved by the end of the study,” she said.

Zero sperm production is not the goal. Lowering it sufficiently is

Dr. Thirumalai said the need for a male contraceptive is strong. While condoms have a substantial failure rate, vasectomy is not reliably reversible even though the majority of men agree that the responsibility for preventing pregnancy should be shared, she said.

Dr. Thirumalai’s earlier review article found that clinical trials of hormonal suppression to provide male contraception have been conducted for at least 30 years. The challenge has been finding an effective therapy that is well tolerated.

Drugs that combine both androgenic and progestogenic activity might be the answer. By manipulating hormones that lower testosterone, sperm production is reduced without eliminating a man’s ability to ejaculate. Zero sperm production is not the goal, according to data in Dr. Thirumalai’s review article.

Rather, studies suggest that when ejaculate contains less than 1 million sperm per mL (levels typically range from 15 to 200 million sperm/mL), the antipregnancy efficacy is similar to that achieved with female oral contraceptives.

However, clinical trials to demonstrate that this can be achieved safely have yet to be conducted.

Ms. Jacobsohn said that sperm half-life is about 3 months. This means that patients would need to be on hormonal therapy for a period of about this duration before reliable contraception is achieved.

In other words, the efficacy endpoint used in this current study [of 28 days duration] does not ensure effective contraception, but Ms. Jacobsohn suggested this is nevertheless an important step forward in clinical development.

Ms. Jacobsohn and Dr. Thirumalai report no relevant financial relationships.

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

COPENHAGEN – Use of the dual interleukin (IL)–17 inhibitor bimekizumab (Bimzelx) was associated with rapid reductions in signs and symptoms of radiographic axial spondyloarthritis, reported investigators in the BE MOBILE 2 phase 3 trial.

At least half of all patients achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 2.1 by week 24 of treatment with bimekizumab, and there were marked reductions in objective signs of inflammation, reported Désiréé van der Heijde, MD, PhD, of Leiden (Netherlands) University Medical Center.

“The safety we have seen in this trial was consistent with what we have seen [with bimekizumab] in other trials and other diseases,” she said at the annual European Congress of Rheumatology.
 

IL-17 inhibitor times 2

Bimekizumab is a monoclonal immunoglobulin 1 antibody that selectively inhibits IL-17A and IL-17F. It is approved in the European Union for treating adults with moderate to severe plaque psoriasis.

In the BE MOBILE 2 trial, investigators enrolled patients aged 18 years and older who had ankylosing spondylitis, who met modified New York criteria, who had active disease at screening and at baseline, as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or more and spinal pain of 4 or more on a scale of 0-10, and whose disease failed to respond to two different NSAIDs or who were either intolerant of or had contraindications to NSAIDs.

The patients were randomly assigned on a 2:1 basis to receive either bimekizumab 160 mg every 4 weeks (221 patients) or placebo (111 patients) for 16 weeks. All patients were switched over at 16 weeks to bimekizumab maintenance for up to 1 year of total treatment.

Dr. Van der Heijde reported 24-week data from the trial, including data from 8 weeks of additional follow-up.
 

All endpoints met

The trial met its primary endpoint of 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40) at week 16. There was a 44.8% improvement with bimekizumab, compared with 22.6% with placebo (P < .001).

All secondary endpoints also favored the bimekizumab arm, including ASAS 40 among patients who had not previously received a tumor necrosis factor (TNF)–alpha inhibitor, ASAS 20, BASDAI functional index, ankylosing spondylitis quality-of-life index, and others.

Responses to bimekizumab were consistent across subpopulations of patients with or without prior TNF-alpha inhibitor exposure, Dr. van der Heidje said.

In addition, use of bimekizumab was associated with a significant improvement from baseline, compared with placebo, in objective measures of inflammation, including MRI spine Berlin score at week 16 (mean, –2.3 vs. 0; P < .001), Spondylitis Research Consortium of Canada (SPARCC) MRI sacroiliac joint score at week 16 (mean, –5.6 vs. 1.1), and high-sensitivity C-reactive protein at week 16 (mean, 2.4 vs. 6.3 mg/L; P < .001).

The most frequent treatment-related adverse events were nasopharyngitis, diarrhea, and oral candidiasis, all of which were more common in the bimekizumab arm, as well as headache, the incidence of which was similar between the arms.

Overall, 6.4% of patients taking bimekizumab had fungal infections, compared with none in the placebo group. The infections were mild or moderate, localized, and mucocutaneous in nature. Only two patients discontinued the drug because of fungal infections: one for oral candidiasis, and one for esophageal candidiasis.

‘Promising results’

Fabian Proft, MD, head of the clinical trials unit at Charité University Hospital in Berlin, who was not involved in the study, told this news organization that the data looked very good.

“These are the first phase 3 data on dual inhibition of IL-17A and F with bimekizumab in axial spondyloarthritis, and the data are really promising,” he said. “For nonradiographic disease, the data also look very promising, and when we’re looking into the future, it might be a therapeutic option for us as treating rheumatologists.”

The study was funded by UCB Pharma. Dr. van der Heijde has received consulting fees from the company and others. Dr. Proft has consulted for and has been on the speaker’s bureau for UCB and other pharmaceutical companies.

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

COPENHAGEN – Use of the dual interleukin (IL)–17 inhibitor bimekizumab (Bimzelx) was associated with rapid reductions in signs and symptoms of radiographic axial spondyloarthritis, reported investigators in the BE MOBILE 2 phase 3 trial.

At least half of all patients achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 2.1 by week 24 of treatment with bimekizumab, and there were marked reductions in objective signs of inflammation, reported Désiréé van der Heijde, MD, PhD, of Leiden (Netherlands) University Medical Center.

“The safety we have seen in this trial was consistent with what we have seen [with bimekizumab] in other trials and other diseases,” she said at the annual European Congress of Rheumatology.
 

IL-17 inhibitor times 2

Bimekizumab is a monoclonal immunoglobulin 1 antibody that selectively inhibits IL-17A and IL-17F. It is approved in the European Union for treating adults with moderate to severe plaque psoriasis.

In the BE MOBILE 2 trial, investigators enrolled patients aged 18 years and older who had ankylosing spondylitis, who met modified New York criteria, who had active disease at screening and at baseline, as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or more and spinal pain of 4 or more on a scale of 0-10, and whose disease failed to respond to two different NSAIDs or who were either intolerant of or had contraindications to NSAIDs.

The patients were randomly assigned on a 2:1 basis to receive either bimekizumab 160 mg every 4 weeks (221 patients) or placebo (111 patients) for 16 weeks. All patients were switched over at 16 weeks to bimekizumab maintenance for up to 1 year of total treatment.

Dr. Van der Heijde reported 24-week data from the trial, including data from 8 weeks of additional follow-up.
 

All endpoints met

The trial met its primary endpoint of 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40) at week 16. There was a 44.8% improvement with bimekizumab, compared with 22.6% with placebo (P < .001).

All secondary endpoints also favored the bimekizumab arm, including ASAS 40 among patients who had not previously received a tumor necrosis factor (TNF)–alpha inhibitor, ASAS 20, BASDAI functional index, ankylosing spondylitis quality-of-life index, and others.

Responses to bimekizumab were consistent across subpopulations of patients with or without prior TNF-alpha inhibitor exposure, Dr. van der Heidje said.

In addition, use of bimekizumab was associated with a significant improvement from baseline, compared with placebo, in objective measures of inflammation, including MRI spine Berlin score at week 16 (mean, –2.3 vs. 0; P < .001), Spondylitis Research Consortium of Canada (SPARCC) MRI sacroiliac joint score at week 16 (mean, –5.6 vs. 1.1), and high-sensitivity C-reactive protein at week 16 (mean, 2.4 vs. 6.3 mg/L; P < .001).

The most frequent treatment-related adverse events were nasopharyngitis, diarrhea, and oral candidiasis, all of which were more common in the bimekizumab arm, as well as headache, the incidence of which was similar between the arms.

Overall, 6.4% of patients taking bimekizumab had fungal infections, compared with none in the placebo group. The infections were mild or moderate, localized, and mucocutaneous in nature. Only two patients discontinued the drug because of fungal infections: one for oral candidiasis, and one for esophageal candidiasis.

‘Promising results’

Fabian Proft, MD, head of the clinical trials unit at Charité University Hospital in Berlin, who was not involved in the study, told this news organization that the data looked very good.

“These are the first phase 3 data on dual inhibition of IL-17A and F with bimekizumab in axial spondyloarthritis, and the data are really promising,” he said. “For nonradiographic disease, the data also look very promising, and when we’re looking into the future, it might be a therapeutic option for us as treating rheumatologists.”

The study was funded by UCB Pharma. Dr. van der Heijde has received consulting fees from the company and others. Dr. Proft has consulted for and has been on the speaker’s bureau for UCB and other pharmaceutical companies.

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

COPENHAGEN – Use of the dual interleukin (IL)–17 inhibitor bimekizumab (Bimzelx) was associated with rapid reductions in signs and symptoms of radiographic axial spondyloarthritis, reported investigators in the BE MOBILE 2 phase 3 trial.

At least half of all patients achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 2.1 by week 24 of treatment with bimekizumab, and there were marked reductions in objective signs of inflammation, reported Désiréé van der Heijde, MD, PhD, of Leiden (Netherlands) University Medical Center.

“The safety we have seen in this trial was consistent with what we have seen [with bimekizumab] in other trials and other diseases,” she said at the annual European Congress of Rheumatology.
 

IL-17 inhibitor times 2

Bimekizumab is a monoclonal immunoglobulin 1 antibody that selectively inhibits IL-17A and IL-17F. It is approved in the European Union for treating adults with moderate to severe plaque psoriasis.

In the BE MOBILE 2 trial, investigators enrolled patients aged 18 years and older who had ankylosing spondylitis, who met modified New York criteria, who had active disease at screening and at baseline, as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or more and spinal pain of 4 or more on a scale of 0-10, and whose disease failed to respond to two different NSAIDs or who were either intolerant of or had contraindications to NSAIDs.

The patients were randomly assigned on a 2:1 basis to receive either bimekizumab 160 mg every 4 weeks (221 patients) or placebo (111 patients) for 16 weeks. All patients were switched over at 16 weeks to bimekizumab maintenance for up to 1 year of total treatment.

Dr. Van der Heijde reported 24-week data from the trial, including data from 8 weeks of additional follow-up.
 

All endpoints met

The trial met its primary endpoint of 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40) at week 16. There was a 44.8% improvement with bimekizumab, compared with 22.6% with placebo (P < .001).

All secondary endpoints also favored the bimekizumab arm, including ASAS 40 among patients who had not previously received a tumor necrosis factor (TNF)–alpha inhibitor, ASAS 20, BASDAI functional index, ankylosing spondylitis quality-of-life index, and others.

Responses to bimekizumab were consistent across subpopulations of patients with or without prior TNF-alpha inhibitor exposure, Dr. van der Heidje said.

In addition, use of bimekizumab was associated with a significant improvement from baseline, compared with placebo, in objective measures of inflammation, including MRI spine Berlin score at week 16 (mean, –2.3 vs. 0; P < .001), Spondylitis Research Consortium of Canada (SPARCC) MRI sacroiliac joint score at week 16 (mean, –5.6 vs. 1.1), and high-sensitivity C-reactive protein at week 16 (mean, 2.4 vs. 6.3 mg/L; P < .001).

The most frequent treatment-related adverse events were nasopharyngitis, diarrhea, and oral candidiasis, all of which were more common in the bimekizumab arm, as well as headache, the incidence of which was similar between the arms.

Overall, 6.4% of patients taking bimekizumab had fungal infections, compared with none in the placebo group. The infections were mild or moderate, localized, and mucocutaneous in nature. Only two patients discontinued the drug because of fungal infections: one for oral candidiasis, and one for esophageal candidiasis.

‘Promising results’

Fabian Proft, MD, head of the clinical trials unit at Charité University Hospital in Berlin, who was not involved in the study, told this news organization that the data looked very good.

“These are the first phase 3 data on dual inhibition of IL-17A and F with bimekizumab in axial spondyloarthritis, and the data are really promising,” he said. “For nonradiographic disease, the data also look very promising, and when we’re looking into the future, it might be a therapeutic option for us as treating rheumatologists.”

The study was funded by UCB Pharma. Dr. van der Heijde has received consulting fees from the company and others. Dr. Proft has consulted for and has been on the speaker’s bureau for UCB and other pharmaceutical companies.

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

When Esther Freeman, MD, PhD, thinks back on what she learned about monkeypox during her training as a dermatologist and an infectious disease epidemiologist, it was widely considered a viral disease with rare outbreaks limited primarily to Central and Western Africa.

“Monkeypox is something we have traditionally only seen very rarely in the U.S.,” Dr. Freeman, director of Global Health Dermatology at Massachusetts General Hospital and Harvard Medical School, Boston, said in an interview. “In the past, outbreaks in the U.S. have been related to international travel or import of exotic pets, which is very different than what we’re seeing as a global community now.”

Courtesy Dr. Ester Freeman

A different clinical presentation

The clinical presentation of monkeypox cases in the current outbreak also differs from that of previous outbreaks. In the past, monkeypox rashes often morphed from a macule to a pustule and commonly affected the face, hands, feet, and trunk, with some patients harboring as many as 200 lesions at once. That pattern still occurs, but increasingly, the presentation is characterized by a more localized spread, especially in the genital region, which Dr. Freeman described as “unusual and not an area we traditionally thought of in the past as a focus for monkeypox.”

Also, affected individuals in the current outbreak may develop fewer lesions, sometimes between 1 and 5 instead of up to 200. “This doesn’t apply to everybody, but it is a bit of a different picture than what we’ve seen in case descriptions and photographs in the past from places like Central Africa,” she said. “What’s being reported out of case clusters from the United Kingdom and Spain is a mix, where some people are having more generalized involvement while others have more localized involvement.” Visual examples of the monkey pox rash can be found in photos from the United Kingdom, the country with the highest number of confirmed cases, on the CDC’s website, and in a report from Spain.

Clusters of monkeypox cases have been reported worldwide in men who have sex with men, “but this is not limited to a particular subgroup of people,” emphasizes Dr. Freeman, who is also a member of the American Academy of Dermatology’s Ad Hoc Task Force to Develop Monkeypox Content, which created an online resource for clinicians. “There are several mechanisms of spread, but direct contact with lesions or infected fluids is one,” she notes.

Moreover, “lesions associated with herpes, syphilis, and molluscum can look similar to a monkeypox lesion. If you have a patient with a new genital lesion and you’re not sure what it is, testing for monkeypox in addition to classic sexually transmitted infections like HSV or syphilis would be reasonable during the current outbreak situation.”

The 2022 monkeypox outbreak may pale in comparison to the spread of COVID-19 in terms of case numbers and societal impact, but dermatologists may be the first point of contact for a person infected with the monkeypox virus. “It’s important for dermatologists to be able to recognize monkeypox, because by recognizing cases, we can stop the outbreak,” Dr. Freeman said. “In theory, an infected person could show up in your clinic, regardless of where you practice in the U.S. But at the same time, it’s important not to panic. This is not COVID-19 all over again; this is different. Yes, it is an outbreak, but we already have a vaccine that works against monkeypox, and while one of the possible modes of transmission for monkeypox is respiratory, it’s much harder to transmit that way than SARS-CoV-2 – it requires closer and longer contact.”

Confirmation of a monkeypox virus infection is based on results of a PCR test based on swabs of a lesion. The AAD task force recommends contacting the local hospital epidemiologist, infection control personnel, and/or state health department about suspected cases, “as different locations will have different regulations on where to send the [PCR] test. If appropriate, the state health department will contact the CDC.”

According to the CDC, current recommendations for personal protective equipment for possible and confirmed monkeypox cases include gown, gloves, a National Institute for Occupational Safety and Health-approved N-95 mask, and eye protection.

 

Topical antiviral an option

If the lesions in a patient with suspected monkeypox have turned into pustules while waiting for the PCR test results, one option is to prescribe 3%-5% topical cidofovir, according to Stephen K. Tyring, MD, PhD, of the departments of dermatology, microbiology & molecular genetics, and internal medicine at the University of Texas Health Science Center, Houston. “That’s the effective antiviral that is most available,” he said. Generic cidofovir is also now available.

Dr. Tyring recommends rapid referral of immunocompromised patients with suspected monkeypox to an infectious disease expert and/or consulting with the CDC. “The pediatric population also seems to be at somewhat more risk, as has been seen in sub-Saharan Africa,” said Dr. Tyring, who is one of the editors of the textbook Tropical Dermatology. “Also, by definition, pregnant women are at more risk because their immune systems aren’t up to par. You also want to make sure that if monkeypox is on a person’s skin that they don’t get it in their eyes, because they could lose their vision.” He added that sub-Saharan Africa has a monkeypox mortality of up to 10%, “which is something we don’t see in the U.S. or Europe. Those of us who grew up in the 20th century got routine smallpox vaccines, and we therefore probably have a degree of immunity to monkeypox. But for the past 40 years or so, unless you are in the military, you are not going to get a routine vaccine to prevent smallpox.”
 

Incubation period, appearance of lesions

Monkeypox has a long incubation period. According to Dr. Freeman, from the point of exposure to the development of symptomatic lesions is typically 7-14 days but can vary from 5-21 days. “It’s important for people to be aware that their exposure may have been in the more distant past, not just a few days ago” she said. “Identifying cases as quickly as possible gives us a window where we can vaccinate close contacts.”

Dr. Freeman and Dr. Tyring reported having no relevant financial disclosures.

CDC guidance on vaccination before and after exposure to monkeypox can be found here . A general Q&A for health care professionals from the CDC can be found here.

When Esther Freeman, MD, PhD, thinks back on what she learned about monkeypox during her training as a dermatologist and an infectious disease epidemiologist, it was widely considered a viral disease with rare outbreaks limited primarily to Central and Western Africa.

“Monkeypox is something we have traditionally only seen very rarely in the U.S.,” Dr. Freeman, director of Global Health Dermatology at Massachusetts General Hospital and Harvard Medical School, Boston, said in an interview. “In the past, outbreaks in the U.S. have been related to international travel or import of exotic pets, which is very different than what we’re seeing as a global community now.”

Courtesy Dr. Ester Freeman

A different clinical presentation

The clinical presentation of monkeypox cases in the current outbreak also differs from that of previous outbreaks. In the past, monkeypox rashes often morphed from a macule to a pustule and commonly affected the face, hands, feet, and trunk, with some patients harboring as many as 200 lesions at once. That pattern still occurs, but increasingly, the presentation is characterized by a more localized spread, especially in the genital region, which Dr. Freeman described as “unusual and not an area we traditionally thought of in the past as a focus for monkeypox.”

Also, affected individuals in the current outbreak may develop fewer lesions, sometimes between 1 and 5 instead of up to 200. “This doesn’t apply to everybody, but it is a bit of a different picture than what we’ve seen in case descriptions and photographs in the past from places like Central Africa,” she said. “What’s being reported out of case clusters from the United Kingdom and Spain is a mix, where some people are having more generalized involvement while others have more localized involvement.” Visual examples of the monkey pox rash can be found in photos from the United Kingdom, the country with the highest number of confirmed cases, on the CDC’s website, and in a report from Spain.

Clusters of monkeypox cases have been reported worldwide in men who have sex with men, “but this is not limited to a particular subgroup of people,” emphasizes Dr. Freeman, who is also a member of the American Academy of Dermatology’s Ad Hoc Task Force to Develop Monkeypox Content, which created an online resource for clinicians. “There are several mechanisms of spread, but direct contact with lesions or infected fluids is one,” she notes.

Moreover, “lesions associated with herpes, syphilis, and molluscum can look similar to a monkeypox lesion. If you have a patient with a new genital lesion and you’re not sure what it is, testing for monkeypox in addition to classic sexually transmitted infections like HSV or syphilis would be reasonable during the current outbreak situation.”

The 2022 monkeypox outbreak may pale in comparison to the spread of COVID-19 in terms of case numbers and societal impact, but dermatologists may be the first point of contact for a person infected with the monkeypox virus. “It’s important for dermatologists to be able to recognize monkeypox, because by recognizing cases, we can stop the outbreak,” Dr. Freeman said. “In theory, an infected person could show up in your clinic, regardless of where you practice in the U.S. But at the same time, it’s important not to panic. This is not COVID-19 all over again; this is different. Yes, it is an outbreak, but we already have a vaccine that works against monkeypox, and while one of the possible modes of transmission for monkeypox is respiratory, it’s much harder to transmit that way than SARS-CoV-2 – it requires closer and longer contact.”

Confirmation of a monkeypox virus infection is based on results of a PCR test based on swabs of a lesion. The AAD task force recommends contacting the local hospital epidemiologist, infection control personnel, and/or state health department about suspected cases, “as different locations will have different regulations on where to send the [PCR] test. If appropriate, the state health department will contact the CDC.”

According to the CDC, current recommendations for personal protective equipment for possible and confirmed monkeypox cases include gown, gloves, a National Institute for Occupational Safety and Health-approved N-95 mask, and eye protection.

 

Topical antiviral an option

If the lesions in a patient with suspected monkeypox have turned into pustules while waiting for the PCR test results, one option is to prescribe 3%-5% topical cidofovir, according to Stephen K. Tyring, MD, PhD, of the departments of dermatology, microbiology & molecular genetics, and internal medicine at the University of Texas Health Science Center, Houston. “That’s the effective antiviral that is most available,” he said. Generic cidofovir is also now available.

Dr. Tyring recommends rapid referral of immunocompromised patients with suspected monkeypox to an infectious disease expert and/or consulting with the CDC. “The pediatric population also seems to be at somewhat more risk, as has been seen in sub-Saharan Africa,” said Dr. Tyring, who is one of the editors of the textbook Tropical Dermatology. “Also, by definition, pregnant women are at more risk because their immune systems aren’t up to par. You also want to make sure that if monkeypox is on a person’s skin that they don’t get it in their eyes, because they could lose their vision.” He added that sub-Saharan Africa has a monkeypox mortality of up to 10%, “which is something we don’t see in the U.S. or Europe. Those of us who grew up in the 20th century got routine smallpox vaccines, and we therefore probably have a degree of immunity to monkeypox. But for the past 40 years or so, unless you are in the military, you are not going to get a routine vaccine to prevent smallpox.”
 

Incubation period, appearance of lesions

Monkeypox has a long incubation period. According to Dr. Freeman, from the point of exposure to the development of symptomatic lesions is typically 7-14 days but can vary from 5-21 days. “It’s important for people to be aware that their exposure may have been in the more distant past, not just a few days ago” she said. “Identifying cases as quickly as possible gives us a window where we can vaccinate close contacts.”

Dr. Freeman and Dr. Tyring reported having no relevant financial disclosures.

CDC guidance on vaccination before and after exposure to monkeypox can be found here . A general Q&A for health care professionals from the CDC can be found here.

When Esther Freeman, MD, PhD, thinks back on what she learned about monkeypox during her training as a dermatologist and an infectious disease epidemiologist, it was widely considered a viral disease with rare outbreaks limited primarily to Central and Western Africa.

“Monkeypox is something we have traditionally only seen very rarely in the U.S.,” Dr. Freeman, director of Global Health Dermatology at Massachusetts General Hospital and Harvard Medical School, Boston, said in an interview. “In the past, outbreaks in the U.S. have been related to international travel or import of exotic pets, which is very different than what we’re seeing as a global community now.”

Courtesy Dr. Ester Freeman

A different clinical presentation

The clinical presentation of monkeypox cases in the current outbreak also differs from that of previous outbreaks. In the past, monkeypox rashes often morphed from a macule to a pustule and commonly affected the face, hands, feet, and trunk, with some patients harboring as many as 200 lesions at once. That pattern still occurs, but increasingly, the presentation is characterized by a more localized spread, especially in the genital region, which Dr. Freeman described as “unusual and not an area we traditionally thought of in the past as a focus for monkeypox.”

Also, affected individuals in the current outbreak may develop fewer lesions, sometimes between 1 and 5 instead of up to 200. “This doesn’t apply to everybody, but it is a bit of a different picture than what we’ve seen in case descriptions and photographs in the past from places like Central Africa,” she said. “What’s being reported out of case clusters from the United Kingdom and Spain is a mix, where some people are having more generalized involvement while others have more localized involvement.” Visual examples of the monkey pox rash can be found in photos from the United Kingdom, the country with the highest number of confirmed cases, on the CDC’s website, and in a report from Spain.

Clusters of monkeypox cases have been reported worldwide in men who have sex with men, “but this is not limited to a particular subgroup of people,” emphasizes Dr. Freeman, who is also a member of the American Academy of Dermatology’s Ad Hoc Task Force to Develop Monkeypox Content, which created an online resource for clinicians. “There are several mechanisms of spread, but direct contact with lesions or infected fluids is one,” she notes.

Moreover, “lesions associated with herpes, syphilis, and molluscum can look similar to a monkeypox lesion. If you have a patient with a new genital lesion and you’re not sure what it is, testing for monkeypox in addition to classic sexually transmitted infections like HSV or syphilis would be reasonable during the current outbreak situation.”

The 2022 monkeypox outbreak may pale in comparison to the spread of COVID-19 in terms of case numbers and societal impact, but dermatologists may be the first point of contact for a person infected with the monkeypox virus. “It’s important for dermatologists to be able to recognize monkeypox, because by recognizing cases, we can stop the outbreak,” Dr. Freeman said. “In theory, an infected person could show up in your clinic, regardless of where you practice in the U.S. But at the same time, it’s important not to panic. This is not COVID-19 all over again; this is different. Yes, it is an outbreak, but we already have a vaccine that works against monkeypox, and while one of the possible modes of transmission for monkeypox is respiratory, it’s much harder to transmit that way than SARS-CoV-2 – it requires closer and longer contact.”

Confirmation of a monkeypox virus infection is based on results of a PCR test based on swabs of a lesion. The AAD task force recommends contacting the local hospital epidemiologist, infection control personnel, and/or state health department about suspected cases, “as different locations will have different regulations on where to send the [PCR] test. If appropriate, the state health department will contact the CDC.”

According to the CDC, current recommendations for personal protective equipment for possible and confirmed monkeypox cases include gown, gloves, a National Institute for Occupational Safety and Health-approved N-95 mask, and eye protection.

 

Topical antiviral an option

If the lesions in a patient with suspected monkeypox have turned into pustules while waiting for the PCR test results, one option is to prescribe 3%-5% topical cidofovir, according to Stephen K. Tyring, MD, PhD, of the departments of dermatology, microbiology & molecular genetics, and internal medicine at the University of Texas Health Science Center, Houston. “That’s the effective antiviral that is most available,” he said. Generic cidofovir is also now available.

Dr. Tyring recommends rapid referral of immunocompromised patients with suspected monkeypox to an infectious disease expert and/or consulting with the CDC. “The pediatric population also seems to be at somewhat more risk, as has been seen in sub-Saharan Africa,” said Dr. Tyring, who is one of the editors of the textbook Tropical Dermatology. “Also, by definition, pregnant women are at more risk because their immune systems aren’t up to par. You also want to make sure that if monkeypox is on a person’s skin that they don’t get it in their eyes, because they could lose their vision.” He added that sub-Saharan Africa has a monkeypox mortality of up to 10%, “which is something we don’t see in the U.S. or Europe. Those of us who grew up in the 20th century got routine smallpox vaccines, and we therefore probably have a degree of immunity to monkeypox. But for the past 40 years or so, unless you are in the military, you are not going to get a routine vaccine to prevent smallpox.”
 

Incubation period, appearance of lesions

Monkeypox has a long incubation period. According to Dr. Freeman, from the point of exposure to the development of symptomatic lesions is typically 7-14 days but can vary from 5-21 days. “It’s important for people to be aware that their exposure may have been in the more distant past, not just a few days ago” she said. “Identifying cases as quickly as possible gives us a window where we can vaccinate close contacts.”

Dr. Freeman and Dr. Tyring reported having no relevant financial disclosures.

CDC guidance on vaccination before and after exposure to monkeypox can be found here . A general Q&A for health care professionals from the CDC can be found here.

Despite a new meta-analysis claiming to show that testosterone replacement therapy for men with hypogonadism does not increase the risk of cardiovascular outcomes such as myocardial infarction or stroke, experts say the jury is still out.

A more definitive answer for cardiovascular safety of testosterone therapy will come from the TRAVERSE dedicated cardiovascular outcome trial, sponsored by AbbVie, which will have up to 5 years of follow-up, with results expected later this year.

The current meta-analysis by Jemma Hudson of Aberdeen (Scotland) University and colleagues was published online in The Lancet Healthy Longevity. The work will also be presented June 13 at ENDO 2022, the Endocrine Society’s annual meeting in Atlanta, Georgia, by senior author Channa Y. Jayasena, MD, PhD.

In 2014, the U.S. Food and Drug Administration mandated a label on testosterone products warning of possible increased cardiovascular risks and to reserve the therapy for symptomatic hypogonadism only. In contrast, the European Medicines Agency concluded that when hypogonadism is properly diagnosed and managed, there is currently no clear, consistent evidence that testosterone therapy causes increased cardiovascular risk.

To address this uncertainty, Dr. Hudson and colleagues formed a global collaborative to obtain individual patient data on cardiovascular outcomes from randomized controlled trials of testosterone therapy for men with hypogonadism.

They pooled data from 35 trials published from 1992 to Aug. 27, 2018, including 17 trials (3,431 patients) for which the researchers obtained patient-level data. The individual trials were 3-12 months long, except for one 3-year trial.

During a mean follow-up of 9.5 months, there was no significant increase in cardiovascular outcomes in men randomized to testosterone therapy versus placebo (odds ratio, 1.07; P = .62), nor were there any significantly increased risks of death, stroke, or different types of cardiovascular outcome, although those numbers were small.  

This is “the most comprehensive study to date investigating the safety of testosterone treatment of hypogonadism,” according to the researchers. “The current results provide some reassurance about the short-term to medium-term safety of testosterone to treat male hypogonadism,” they conclude.

However, they also acknowledge that “long-term data are needed to fully evaluate the safety of testosterone.”

Erin D. Michos, MD, coauthor of an accompanying editorial, told this news organization, “This study doesn’t say to me that low testosterone necessarily needs to be treated. It’s still not indicated in people just for a low number [for blood testosterone] with less-severe symptoms. It really comes down to each individual person, how symptomatic they are, and their cardiovascular risk.”

‘Trial is not definitive’

Dr. Michos is not the only person to be skeptical. Together with Steven Nissen, MD, an investigator for the TRAVERSE trial, she agrees that this new evidence is not yet decisive, largely because the individual trials in the meta-analysis were short and not designed as cardiovascular outcome trials.

Dr. Nissen, a cardiologist at Cleveland Clinic, added that the individual trials were heterogeneous, with “very few real cardiovascular events,” so the meta-analysis “is not definitive,” he said in an interview.

While this meta-analysis “that pooled together a lot of smaller studies is reassuring that there’s no signal of harm, it’s really inconclusive because the follow-up was really short – a mean of only 9.5 months – and you really need a larger study with longer follow up to be more conclusive,” Dr. Michos noted.

“We should have more data soon” from TRAVERSE, said Dr. Michos, from the division of cardiology, Johns Hopkins University, Baltimore, who is not involved with that study.

Meanwhile, “I don’t think [this analysis] changes the current recommendations,” she said.

“We should continue to use caution as indicated by the FDA label and only use testosterone therapy selectively in people who have true symptoms of hypogonadism,” and be cautious about using it particularly in men at higher cardiovascular risk because of family history or known personal heart disease.

On the other hand, the meta-analysis did not show harm, she noted, “so we don’t necessarily need to pull patients off therapy if they are already taking it. But I wouldn’t right now just start new patients on it unless they had a strong indication.”

“Certainly, great caution is advised regarding the use of testosterone replacement therapy in people with established atherosclerosis due to the findings of plaque progression in the testosterone trials and the excess cardiovascular events observed in the TOM trial, write Dr. Michos and fellow editorialist Matthew J. Budoff, MD, of University of California, Los Angeles, in their editorial.
 

Earlier data inconclusive

Testosterone concentrations progressively decline in men with advancing age, at about 2% per year, Dr. Michos and Dr. Budoff write. In addition, men with obesity or with diabetes have low levels of testosterone, Dr. Michos noted.

Low testosterone blood levels have been associated with insulin resistance, inflammation, dyslipidemia, and atherosclerosis. Testosterone replacement therapy has been used to increase libido, improve erectile dysfunction, and boost energy levels, mood, and muscle strength.

But it is well known that testosterone increases hematocrit, which has the potential to increase the risk of venous thromboembolism.

Two large observational studies have reported increased risks of myocardial infarction, stroke, and death in men taking testosterone, compared with nonusers, but the study designs have been widely criticized, Dr. Hudson and coauthors say in their article.  

A placebo-controlled trial was stopped early by its data- and safety-monitoring board following increased cardiovascular events in men aged 65 and older who received 6 months of testosterone. Other controlled trials have not observed these effects, but none was sufficiently powered.
 

Meta-analysis results

Dr. Hudson and colleagues performed a meta-analysis of 35 trials in 5,601 men aged 18 years and older with low baseline testosterone (≤ 350 nmol/dL) who had been randomized to testosterone replacement therapy or placebo for at least 3 months, for which there were data on mortality, stroke, and cardiovascular outcomes.

The men were a mean age of 65, had a mean body mass index of 30 kg/m², and most (88%) were White. A quarter had angina, 8% had a previous myocardial infarction, and 27% had diabetes. 

Cardiovascular and cerebrovascular outcomes were not primary outcomes.

During a mean follow-up of 9.5 months, in the 13 trials that provided this information, the rate of cardiovascular events was similar in the men who received testosterone (120/1,601, 7.5%) compared with those who received placebo (110/1,519, 7.2%).

In the 14 trials that provided this information, fewer deaths were reported during testosterone treatment (6/1,621, 0.4%) than during placebo treatment (12/1,537, 0.8%), but these numbers were too small to establish whether testosterone reduced mortality risk.

The most common cardiovascular events were arrhythmia, followed by coronary heart disease, heart failure, and myocardial infarction.

Patient age, baseline testosterone, smoking status, or diabetes status were not associated with cardiovascular risk.

The only detected adverse effects were edema and a modest lowering of HDL cholesterol.

“Men who develop sexual dysfunction, unexplained anemia, or osteoporosis should be tested for low testosterone,” senior author of the meta-analysis Dr. Jayasena said in an email to this news organization.

However, Dr. Jayasena added, “Mass screening for testosterone has no benefit in asymptomatic men.”

“Older men may still benefit from testosterone, but only if they have the clinical features [of hypogonadism] and low testosterone levels,” he concluded.  

The current study is supported by the Health Technology Assessment program of the National Institute for Health Research. The TRAVERSE trial is sponsored by AbbVie. Dr. Jayasena has reported receiving research grants from LogixX Pharma. Dr. Hudson has reported no relevant financial relationships. Disclosures for the other authors are listed in the article. Dr. Michos has reported receiving support from the Amato Fund in Women’s Cardiovascular Health at Johns Hopkins School of Medicine and serving on medical advisory boards for Novartis, Esperion, Amarin, and AstraZeneca outside the submitted work. Dr. Budoff has reported receiving grant support from General Electric.
 

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

Despite a new meta-analysis claiming to show that testosterone replacement therapy for men with hypogonadism does not increase the risk of cardiovascular outcomes such as myocardial infarction or stroke, experts say the jury is still out.

A more definitive answer for cardiovascular safety of testosterone therapy will come from the TRAVERSE dedicated cardiovascular outcome trial, sponsored by AbbVie, which will have up to 5 years of follow-up, with results expected later this year.

The current meta-analysis by Jemma Hudson of Aberdeen (Scotland) University and colleagues was published online in The Lancet Healthy Longevity. The work will also be presented June 13 at ENDO 2022, the Endocrine Society’s annual meeting in Atlanta, Georgia, by senior author Channa Y. Jayasena, MD, PhD.

In 2014, the U.S. Food and Drug Administration mandated a label on testosterone products warning of possible increased cardiovascular risks and to reserve the therapy for symptomatic hypogonadism only. In contrast, the European Medicines Agency concluded that when hypogonadism is properly diagnosed and managed, there is currently no clear, consistent evidence that testosterone therapy causes increased cardiovascular risk.

To address this uncertainty, Dr. Hudson and colleagues formed a global collaborative to obtain individual patient data on cardiovascular outcomes from randomized controlled trials of testosterone therapy for men with hypogonadism.

They pooled data from 35 trials published from 1992 to Aug. 27, 2018, including 17 trials (3,431 patients) for which the researchers obtained patient-level data. The individual trials were 3-12 months long, except for one 3-year trial.

During a mean follow-up of 9.5 months, there was no significant increase in cardiovascular outcomes in men randomized to testosterone therapy versus placebo (odds ratio, 1.07; P = .62), nor were there any significantly increased risks of death, stroke, or different types of cardiovascular outcome, although those numbers were small.  

This is “the most comprehensive study to date investigating the safety of testosterone treatment of hypogonadism,” according to the researchers. “The current results provide some reassurance about the short-term to medium-term safety of testosterone to treat male hypogonadism,” they conclude.

However, they also acknowledge that “long-term data are needed to fully evaluate the safety of testosterone.”

Erin D. Michos, MD, coauthor of an accompanying editorial, told this news organization, “This study doesn’t say to me that low testosterone necessarily needs to be treated. It’s still not indicated in people just for a low number [for blood testosterone] with less-severe symptoms. It really comes down to each individual person, how symptomatic they are, and their cardiovascular risk.”

‘Trial is not definitive’

Dr. Michos is not the only person to be skeptical. Together with Steven Nissen, MD, an investigator for the TRAVERSE trial, she agrees that this new evidence is not yet decisive, largely because the individual trials in the meta-analysis were short and not designed as cardiovascular outcome trials.

Dr. Nissen, a cardiologist at Cleveland Clinic, added that the individual trials were heterogeneous, with “very few real cardiovascular events,” so the meta-analysis “is not definitive,” he said in an interview.

While this meta-analysis “that pooled together a lot of smaller studies is reassuring that there’s no signal of harm, it’s really inconclusive because the follow-up was really short – a mean of only 9.5 months – and you really need a larger study with longer follow up to be more conclusive,” Dr. Michos noted.

“We should have more data soon” from TRAVERSE, said Dr. Michos, from the division of cardiology, Johns Hopkins University, Baltimore, who is not involved with that study.

Meanwhile, “I don’t think [this analysis] changes the current recommendations,” she said.

“We should continue to use caution as indicated by the FDA label and only use testosterone therapy selectively in people who have true symptoms of hypogonadism,” and be cautious about using it particularly in men at higher cardiovascular risk because of family history or known personal heart disease.

On the other hand, the meta-analysis did not show harm, she noted, “so we don’t necessarily need to pull patients off therapy if they are already taking it. But I wouldn’t right now just start new patients on it unless they had a strong indication.”

“Certainly, great caution is advised regarding the use of testosterone replacement therapy in people with established atherosclerosis due to the findings of plaque progression in the testosterone trials and the excess cardiovascular events observed in the TOM trial, write Dr. Michos and fellow editorialist Matthew J. Budoff, MD, of University of California, Los Angeles, in their editorial.
 

Earlier data inconclusive

Testosterone concentrations progressively decline in men with advancing age, at about 2% per year, Dr. Michos and Dr. Budoff write. In addition, men with obesity or with diabetes have low levels of testosterone, Dr. Michos noted.

Low testosterone blood levels have been associated with insulin resistance, inflammation, dyslipidemia, and atherosclerosis. Testosterone replacement therapy has been used to increase libido, improve erectile dysfunction, and boost energy levels, mood, and muscle strength.

But it is well known that testosterone increases hematocrit, which has the potential to increase the risk of venous thromboembolism.

Two large observational studies have reported increased risks of myocardial infarction, stroke, and death in men taking testosterone, compared with nonusers, but the study designs have been widely criticized, Dr. Hudson and coauthors say in their article.  

A placebo-controlled trial was stopped early by its data- and safety-monitoring board following increased cardiovascular events in men aged 65 and older who received 6 months of testosterone. Other controlled trials have not observed these effects, but none was sufficiently powered.
 

Meta-analysis results

Dr. Hudson and colleagues performed a meta-analysis of 35 trials in 5,601 men aged 18 years and older with low baseline testosterone (≤ 350 nmol/dL) who had been randomized to testosterone replacement therapy or placebo for at least 3 months, for which there were data on mortality, stroke, and cardiovascular outcomes.

The men were a mean age of 65, had a mean body mass index of 30 kg/m², and most (88%) were White. A quarter had angina, 8% had a previous myocardial infarction, and 27% had diabetes. 

Cardiovascular and cerebrovascular outcomes were not primary outcomes.

During a mean follow-up of 9.5 months, in the 13 trials that provided this information, the rate of cardiovascular events was similar in the men who received testosterone (120/1,601, 7.5%) compared with those who received placebo (110/1,519, 7.2%).

In the 14 trials that provided this information, fewer deaths were reported during testosterone treatment (6/1,621, 0.4%) than during placebo treatment (12/1,537, 0.8%), but these numbers were too small to establish whether testosterone reduced mortality risk.

The most common cardiovascular events were arrhythmia, followed by coronary heart disease, heart failure, and myocardial infarction.

Patient age, baseline testosterone, smoking status, or diabetes status were not associated with cardiovascular risk.

The only detected adverse effects were edema and a modest lowering of HDL cholesterol.

“Men who develop sexual dysfunction, unexplained anemia, or osteoporosis should be tested for low testosterone,” senior author of the meta-analysis Dr. Jayasena said in an email to this news organization.

However, Dr. Jayasena added, “Mass screening for testosterone has no benefit in asymptomatic men.”

“Older men may still benefit from testosterone, but only if they have the clinical features [of hypogonadism] and low testosterone levels,” he concluded.  

The current study is supported by the Health Technology Assessment program of the National Institute for Health Research. The TRAVERSE trial is sponsored by AbbVie. Dr. Jayasena has reported receiving research grants from LogixX Pharma. Dr. Hudson has reported no relevant financial relationships. Disclosures for the other authors are listed in the article. Dr. Michos has reported receiving support from the Amato Fund in Women’s Cardiovascular Health at Johns Hopkins School of Medicine and serving on medical advisory boards for Novartis, Esperion, Amarin, and AstraZeneca outside the submitted work. Dr. Budoff has reported receiving grant support from General Electric.
 

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

Despite a new meta-analysis claiming to show that testosterone replacement therapy for men with hypogonadism does not increase the risk of cardiovascular outcomes such as myocardial infarction or stroke, experts say the jury is still out.

A more definitive answer for cardiovascular safety of testosterone therapy will come from the TRAVERSE dedicated cardiovascular outcome trial, sponsored by AbbVie, which will have up to 5 years of follow-up, with results expected later this year.

The current meta-analysis by Jemma Hudson of Aberdeen (Scotland) University and colleagues was published online in The Lancet Healthy Longevity. The work will also be presented June 13 at ENDO 2022, the Endocrine Society’s annual meeting in Atlanta, Georgia, by senior author Channa Y. Jayasena, MD, PhD.

In 2014, the U.S. Food and Drug Administration mandated a label on testosterone products warning of possible increased cardiovascular risks and to reserve the therapy for symptomatic hypogonadism only. In contrast, the European Medicines Agency concluded that when hypogonadism is properly diagnosed and managed, there is currently no clear, consistent evidence that testosterone therapy causes increased cardiovascular risk.

To address this uncertainty, Dr. Hudson and colleagues formed a global collaborative to obtain individual patient data on cardiovascular outcomes from randomized controlled trials of testosterone therapy for men with hypogonadism.

They pooled data from 35 trials published from 1992 to Aug. 27, 2018, including 17 trials (3,431 patients) for which the researchers obtained patient-level data. The individual trials were 3-12 months long, except for one 3-year trial.

During a mean follow-up of 9.5 months, there was no significant increase in cardiovascular outcomes in men randomized to testosterone therapy versus placebo (odds ratio, 1.07; P = .62), nor were there any significantly increased risks of death, stroke, or different types of cardiovascular outcome, although those numbers were small.  

This is “the most comprehensive study to date investigating the safety of testosterone treatment of hypogonadism,” according to the researchers. “The current results provide some reassurance about the short-term to medium-term safety of testosterone to treat male hypogonadism,” they conclude.

However, they also acknowledge that “long-term data are needed to fully evaluate the safety of testosterone.”

Erin D. Michos, MD, coauthor of an accompanying editorial, told this news organization, “This study doesn’t say to me that low testosterone necessarily needs to be treated. It’s still not indicated in people just for a low number [for blood testosterone] with less-severe symptoms. It really comes down to each individual person, how symptomatic they are, and their cardiovascular risk.”

‘Trial is not definitive’

Dr. Michos is not the only person to be skeptical. Together with Steven Nissen, MD, an investigator for the TRAVERSE trial, she agrees that this new evidence is not yet decisive, largely because the individual trials in the meta-analysis were short and not designed as cardiovascular outcome trials.

Dr. Nissen, a cardiologist at Cleveland Clinic, added that the individual trials were heterogeneous, with “very few real cardiovascular events,” so the meta-analysis “is not definitive,” he said in an interview.

While this meta-analysis “that pooled together a lot of smaller studies is reassuring that there’s no signal of harm, it’s really inconclusive because the follow-up was really short – a mean of only 9.5 months – and you really need a larger study with longer follow up to be more conclusive,” Dr. Michos noted.

“We should have more data soon” from TRAVERSE, said Dr. Michos, from the division of cardiology, Johns Hopkins University, Baltimore, who is not involved with that study.

Meanwhile, “I don’t think [this analysis] changes the current recommendations,” she said.

“We should continue to use caution as indicated by the FDA label and only use testosterone therapy selectively in people who have true symptoms of hypogonadism,” and be cautious about using it particularly in men at higher cardiovascular risk because of family history or known personal heart disease.

On the other hand, the meta-analysis did not show harm, she noted, “so we don’t necessarily need to pull patients off therapy if they are already taking it. But I wouldn’t right now just start new patients on it unless they had a strong indication.”

“Certainly, great caution is advised regarding the use of testosterone replacement therapy in people with established atherosclerosis due to the findings of plaque progression in the testosterone trials and the excess cardiovascular events observed in the TOM trial, write Dr. Michos and fellow editorialist Matthew J. Budoff, MD, of University of California, Los Angeles, in their editorial.
 

Earlier data inconclusive

Testosterone concentrations progressively decline in men with advancing age, at about 2% per year, Dr. Michos and Dr. Budoff write. In addition, men with obesity or with diabetes have low levels of testosterone, Dr. Michos noted.

Low testosterone blood levels have been associated with insulin resistance, inflammation, dyslipidemia, and atherosclerosis. Testosterone replacement therapy has been used to increase libido, improve erectile dysfunction, and boost energy levels, mood, and muscle strength.

But it is well known that testosterone increases hematocrit, which has the potential to increase the risk of venous thromboembolism.

Two large observational studies have reported increased risks of myocardial infarction, stroke, and death in men taking testosterone, compared with nonusers, but the study designs have been widely criticized, Dr. Hudson and coauthors say in their article.  

A placebo-controlled trial was stopped early by its data- and safety-monitoring board following increased cardiovascular events in men aged 65 and older who received 6 months of testosterone. Other controlled trials have not observed these effects, but none was sufficiently powered.
 

Meta-analysis results

Dr. Hudson and colleagues performed a meta-analysis of 35 trials in 5,601 men aged 18 years and older with low baseline testosterone (≤ 350 nmol/dL) who had been randomized to testosterone replacement therapy or placebo for at least 3 months, for which there were data on mortality, stroke, and cardiovascular outcomes.

The men were a mean age of 65, had a mean body mass index of 30 kg/m², and most (88%) were White. A quarter had angina, 8% had a previous myocardial infarction, and 27% had diabetes. 

Cardiovascular and cerebrovascular outcomes were not primary outcomes.

During a mean follow-up of 9.5 months, in the 13 trials that provided this information, the rate of cardiovascular events was similar in the men who received testosterone (120/1,601, 7.5%) compared with those who received placebo (110/1,519, 7.2%).

In the 14 trials that provided this information, fewer deaths were reported during testosterone treatment (6/1,621, 0.4%) than during placebo treatment (12/1,537, 0.8%), but these numbers were too small to establish whether testosterone reduced mortality risk.

The most common cardiovascular events were arrhythmia, followed by coronary heart disease, heart failure, and myocardial infarction.

Patient age, baseline testosterone, smoking status, or diabetes status were not associated with cardiovascular risk.

The only detected adverse effects were edema and a modest lowering of HDL cholesterol.

“Men who develop sexual dysfunction, unexplained anemia, or osteoporosis should be tested for low testosterone,” senior author of the meta-analysis Dr. Jayasena said in an email to this news organization.

However, Dr. Jayasena added, “Mass screening for testosterone has no benefit in asymptomatic men.”

“Older men may still benefit from testosterone, but only if they have the clinical features [of hypogonadism] and low testosterone levels,” he concluded.  

The current study is supported by the Health Technology Assessment program of the National Institute for Health Research. The TRAVERSE trial is sponsored by AbbVie. Dr. Jayasena has reported receiving research grants from LogixX Pharma. Dr. Hudson has reported no relevant financial relationships. Disclosures for the other authors are listed in the article. Dr. Michos has reported receiving support from the Amato Fund in Women’s Cardiovascular Health at Johns Hopkins School of Medicine and serving on medical advisory boards for Novartis, Esperion, Amarin, and AstraZeneca outside the submitted work. Dr. Budoff has reported receiving grant support from General Electric.
 

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

CHARLOTTE, N.C. – Overnight sleep electroencephalography (EEG) contains an abundance of brain wave data that could be mined to identify an individual’s risk for a host of health outcomes, including dementia, cognitive impairment, and cardiovascular events, a researcher reported at the annual meeting of the Associated Professional Sleep Societies. “Sleep EEGs contain decodable information about the risk of unfavorable outcomes,” said Haoqi Sun, PhD, an instructor of neurology at Massachusetts General Hospital, Boston, and lead study author. “The results suggest that it’s feasible to use sleep to identify people with high risk of unfavorable outcomes and it strengthens the concept of sleep as a window into brain and general health.”

The researchers performed a quantitative analysis of sleep data collected on 8,673 adults who had diagnostic sleep studies that included polysomnography (PSG). The analysis used ICD codes to consider these 11 health outcomes: dementia, mild cognitive impairment (MCI) or dementia, ischemic stroke, intracranial hemorrhage, atrial fibrillation, myocardial infarction, type 2 diabetes, hypertension, bipolar disorder, depression, and mortality.

Then, Dr. Sun explained, they extracted 86 spectral and time-domain features of REM and non-REM sleep from sleep EEG recordings, and analyzed that data by adjusting for eight covariates including age, sex, body mass index, and use of benzodiazepines, antidepressants, sedatives, antiseizure drugs, and stimulants.

Participants were partitioned into three sleep-quality groups: poor, average, and good. The outcome-wise mean prediction difference in 10-year cumulative incidence was 2.3% for the poor sleep group, 0.5% for the average sleep group, and 1.3% for the good sleep group.

The outcomes with the three greatest poor to average risk ratios were dementia (6.2; 95% confidence interval, 4.5-9.3), mortality (5.7; 95% CI, 5-7.5) and MCI or dementia (4; 95% CI, 3.2-4.9).
 

Ready for the clinic?

In an interview, Dr. Sun said the results demonstrated the potential of using EEG brain wave data to predict health outcomes on an individual basis, although he acknowledged that most of the 86 sleep features the researchers used are not readily available in the clinic.

He noted the spectral features used in the study can be captured through software compatible with PSG. “From there you can identify the various bands, the different frequency ranges, and then you can easily see within this range whether a person has a higher power or lower power,” he said. However, the spindle and slow-oscillation features that researchers used in the study are beyond the reach of most clinics.
 

Next steps

This research is in its early stage, Dr. Sun said, but at some point the data collected from sleep studies could be paired with machine learning to make the model workable for evaluating individual patients. “Our goal is to first make this individualized,” he said. “We want to minimize the noise in the recording and minimize the night-to-night variability in the findings. There is some clinical-informed approach and there is also some algorithm-informed approach where you can minimize the variation over time.”

The model also has the potential to predict outcomes, particularly with chronic diseases such as diabetes and dementia, well before a diagnosis is made, he said.
 

‘Fascinating’ and ‘provocative’

Donald Bliwise, PhD, professor of neurology at Emory Sleep Center in Atlanta, said the study was “fascinating; it’s provocative; it’s exciting and interesting,” but added, “Sleep is vital for health. That’s abundantly clear in a study like that, but trying to push it a little bit further with all of these 86 measurements of the EEG, I think it becomes complicated.”

The study methodology, particularly the use of cumulative incidence of various diseases, was laudable, he said, and the use of simpler EEG-measured sleep features, such as alpha band power, “make intuitive sense.”

But it’s less clear on how the more sophisticated features the study model used – for example, kurtosis of theta frequency or coupling between spindle and slow oscillation – rank on sleep quality, he said, adding that the researchers have most likely done that but couldn’t add that into the format of the presentation.

“Kurtosis of the theta frequency band we don’t get on everyone in the sleep lab,” Dr. Bliwise said. “We might be able to, but I don’t know how to quite plug that into a turnkey model.”

The clinical components of the study were conducted by M. Brandon Westover, MD, PhD, at Massachusetts General Hospital, and Robert J. Thomas, MD, at Beth Israel Deaconess Medical Center, both in Boston. The study received support from the American Academy of Sleep Medicine Foundation. Dr. Sun has no relevant disclosures. Dr. Bliwise has no disclosures.

CHARLOTTE, N.C. – Overnight sleep electroencephalography (EEG) contains an abundance of brain wave data that could be mined to identify an individual’s risk for a host of health outcomes, including dementia, cognitive impairment, and cardiovascular events, a researcher reported at the annual meeting of the Associated Professional Sleep Societies. “Sleep EEGs contain decodable information about the risk of unfavorable outcomes,” said Haoqi Sun, PhD, an instructor of neurology at Massachusetts General Hospital, Boston, and lead study author. “The results suggest that it’s feasible to use sleep to identify people with high risk of unfavorable outcomes and it strengthens the concept of sleep as a window into brain and general health.”

The researchers performed a quantitative analysis of sleep data collected on 8,673 adults who had diagnostic sleep studies that included polysomnography (PSG). The analysis used ICD codes to consider these 11 health outcomes: dementia, mild cognitive impairment (MCI) or dementia, ischemic stroke, intracranial hemorrhage, atrial fibrillation, myocardial infarction, type 2 diabetes, hypertension, bipolar disorder, depression, and mortality.

Then, Dr. Sun explained, they extracted 86 spectral and time-domain features of REM and non-REM sleep from sleep EEG recordings, and analyzed that data by adjusting for eight covariates including age, sex, body mass index, and use of benzodiazepines, antidepressants, sedatives, antiseizure drugs, and stimulants.

Participants were partitioned into three sleep-quality groups: poor, average, and good. The outcome-wise mean prediction difference in 10-year cumulative incidence was 2.3% for the poor sleep group, 0.5% for the average sleep group, and 1.3% for the good sleep group.

The outcomes with the three greatest poor to average risk ratios were dementia (6.2; 95% confidence interval, 4.5-9.3), mortality (5.7; 95% CI, 5-7.5) and MCI or dementia (4; 95% CI, 3.2-4.9).
 

Ready for the clinic?

In an interview, Dr. Sun said the results demonstrated the potential of using EEG brain wave data to predict health outcomes on an individual basis, although he acknowledged that most of the 86 sleep features the researchers used are not readily available in the clinic.

He noted the spectral features used in the study can be captured through software compatible with PSG. “From there you can identify the various bands, the different frequency ranges, and then you can easily see within this range whether a person has a higher power or lower power,” he said. However, the spindle and slow-oscillation features that researchers used in the study are beyond the reach of most clinics.
 

Next steps

This research is in its early stage, Dr. Sun said, but at some point the data collected from sleep studies could be paired with machine learning to make the model workable for evaluating individual patients. “Our goal is to first make this individualized,” he said. “We want to minimize the noise in the recording and minimize the night-to-night variability in the findings. There is some clinical-informed approach and there is also some algorithm-informed approach where you can minimize the variation over time.”

The model also has the potential to predict outcomes, particularly with chronic diseases such as diabetes and dementia, well before a diagnosis is made, he said.
 

‘Fascinating’ and ‘provocative’

Donald Bliwise, PhD, professor of neurology at Emory Sleep Center in Atlanta, said the study was “fascinating; it’s provocative; it’s exciting and interesting,” but added, “Sleep is vital for health. That’s abundantly clear in a study like that, but trying to push it a little bit further with all of these 86 measurements of the EEG, I think it becomes complicated.”

The study methodology, particularly the use of cumulative incidence of various diseases, was laudable, he said, and the use of simpler EEG-measured sleep features, such as alpha band power, “make intuitive sense.”

But it’s less clear on how the more sophisticated features the study model used – for example, kurtosis of theta frequency or coupling between spindle and slow oscillation – rank on sleep quality, he said, adding that the researchers have most likely done that but couldn’t add that into the format of the presentation.

“Kurtosis of the theta frequency band we don’t get on everyone in the sleep lab,” Dr. Bliwise said. “We might be able to, but I don’t know how to quite plug that into a turnkey model.”

The clinical components of the study were conducted by M. Brandon Westover, MD, PhD, at Massachusetts General Hospital, and Robert J. Thomas, MD, at Beth Israel Deaconess Medical Center, both in Boston. The study received support from the American Academy of Sleep Medicine Foundation. Dr. Sun has no relevant disclosures. Dr. Bliwise has no disclosures.

CHARLOTTE, N.C. – Overnight sleep electroencephalography (EEG) contains an abundance of brain wave data that could be mined to identify an individual’s risk for a host of health outcomes, including dementia, cognitive impairment, and cardiovascular events, a researcher reported at the annual meeting of the Associated Professional Sleep Societies. “Sleep EEGs contain decodable information about the risk of unfavorable outcomes,” said Haoqi Sun, PhD, an instructor of neurology at Massachusetts General Hospital, Boston, and lead study author. “The results suggest that it’s feasible to use sleep to identify people with high risk of unfavorable outcomes and it strengthens the concept of sleep as a window into brain and general health.”

The researchers performed a quantitative analysis of sleep data collected on 8,673 adults who had diagnostic sleep studies that included polysomnography (PSG). The analysis used ICD codes to consider these 11 health outcomes: dementia, mild cognitive impairment (MCI) or dementia, ischemic stroke, intracranial hemorrhage, atrial fibrillation, myocardial infarction, type 2 diabetes, hypertension, bipolar disorder, depression, and mortality.

Then, Dr. Sun explained, they extracted 86 spectral and time-domain features of REM and non-REM sleep from sleep EEG recordings, and analyzed that data by adjusting for eight covariates including age, sex, body mass index, and use of benzodiazepines, antidepressants, sedatives, antiseizure drugs, and stimulants.

Participants were partitioned into three sleep-quality groups: poor, average, and good. The outcome-wise mean prediction difference in 10-year cumulative incidence was 2.3% for the poor sleep group, 0.5% for the average sleep group, and 1.3% for the good sleep group.

The outcomes with the three greatest poor to average risk ratios were dementia (6.2; 95% confidence interval, 4.5-9.3), mortality (5.7; 95% CI, 5-7.5) and MCI or dementia (4; 95% CI, 3.2-4.9).
 

Ready for the clinic?

In an interview, Dr. Sun said the results demonstrated the potential of using EEG brain wave data to predict health outcomes on an individual basis, although he acknowledged that most of the 86 sleep features the researchers used are not readily available in the clinic.

He noted the spectral features used in the study can be captured through software compatible with PSG. “From there you can identify the various bands, the different frequency ranges, and then you can easily see within this range whether a person has a higher power or lower power,” he said. However, the spindle and slow-oscillation features that researchers used in the study are beyond the reach of most clinics.
 

Next steps

This research is in its early stage, Dr. Sun said, but at some point the data collected from sleep studies could be paired with machine learning to make the model workable for evaluating individual patients. “Our goal is to first make this individualized,” he said. “We want to minimize the noise in the recording and minimize the night-to-night variability in the findings. There is some clinical-informed approach and there is also some algorithm-informed approach where you can minimize the variation over time.”

The model also has the potential to predict outcomes, particularly with chronic diseases such as diabetes and dementia, well before a diagnosis is made, he said.
 

‘Fascinating’ and ‘provocative’

Donald Bliwise, PhD, professor of neurology at Emory Sleep Center in Atlanta, said the study was “fascinating; it’s provocative; it’s exciting and interesting,” but added, “Sleep is vital for health. That’s abundantly clear in a study like that, but trying to push it a little bit further with all of these 86 measurements of the EEG, I think it becomes complicated.”

The study methodology, particularly the use of cumulative incidence of various diseases, was laudable, he said, and the use of simpler EEG-measured sleep features, such as alpha band power, “make intuitive sense.”

But it’s less clear on how the more sophisticated features the study model used – for example, kurtosis of theta frequency or coupling between spindle and slow oscillation – rank on sleep quality, he said, adding that the researchers have most likely done that but couldn’t add that into the format of the presentation.

“Kurtosis of the theta frequency band we don’t get on everyone in the sleep lab,” Dr. Bliwise said. “We might be able to, but I don’t know how to quite plug that into a turnkey model.”

The clinical components of the study were conducted by M. Brandon Westover, MD, PhD, at Massachusetts General Hospital, and Robert J. Thomas, MD, at Beth Israel Deaconess Medical Center, both in Boston. The study received support from the American Academy of Sleep Medicine Foundation. Dr. Sun has no relevant disclosures. Dr. Bliwise has no disclosures.

NATIONAL HARBOR, MD – Just 2 days before she spoke in a presentation at the annual meeting of the Consortium of Multiple Sclerosis Centers, University of Colorado neurologist Anna Shah, MD, asked a 26-year-old patient with MS about whether she planned to have children. Absolutely not, the young woman replied. “I read online that I can give birth to a baby with MS, which is crazy.”

The patient didn’t understand the risk of having a child with MS – it’s thought to be 2%-5% if one parent has the condition – but she wouldn’t have learned the facts if Dr. Shah hadn’t asked the right questions. “It’s really important for us as a community to know how to be proactive with discussions [about pregnancy],” she said.

As she noted, an estimated 75% of patients with MS are women, most are diagnosed during prime child-bearing years, and many pregnancies in general – an estimated half – are not planned. And while a higher percentage of women with MS are having children than in the past, she said, misinformation remains common. In fact, physicians can be part of the problem.

Dr. Shaw highlighted a 2019 Italian survey that found that 16% of 395 people with MS reported that they were discouraged from having children, mainly by medical professionals, after their diagnosis. Seven percent said they never wanted to become parents because of their MS. A 2021 survey of 332 patients with MS in the United States, United Kingdom, France, Germany, Italy, and Spain, found that 56% reported that MS played a role in their decisions about family planning, and 14% of those decided not to have children.

In regard to women of child-bearing age, Dr. Shah recommends that family planning and contraception should be discussed at the initial visit and every subsequent visit. Open-ended, individualized questions are key. “We don’t know what patients don’t share with us,” she said.

Make sure to consider the timing of any plans to have children, she said. If the patient wants to have children within a year, talk about matters such as whether disease activity is well-controlled (6-12 months of good control is ideal) and whether current disease-modifying therapies are safe. Make sure to get a baseline prepartum MRI scan, she said.

If the patients don’t want to have children, make sure they are using a reliable strategy to avoid conception. Be aware that modafinil – “not one that immediately comes to mind” – may decrease the efficacy of oral contraceptives, she said, as can anticonvulsants (phenytoin, carbamazepine, oxcarbazepine, topiramate, and primidone). Oral contraceptives, meanwhile, may decrease levels of lamotrigine.

What if a patient has trouble conceiving? There are some hints in research that MS may boost the risk of infertility in women, Dr. Shah said. That’s why she recommends that colleagues consider referring a patient to an infertility specialist after attempting conception for 6 months as opposed to the general recommendation for 12 months.

Dr. Shah disclosed advisory board service (Genentech) and development of nonbranded educational programming through Novartis and the National Committee for Quality Assurance.

NATIONAL HARBOR, MD – Just 2 days before she spoke in a presentation at the annual meeting of the Consortium of Multiple Sclerosis Centers, University of Colorado neurologist Anna Shah, MD, asked a 26-year-old patient with MS about whether she planned to have children. Absolutely not, the young woman replied. “I read online that I can give birth to a baby with MS, which is crazy.”

The patient didn’t understand the risk of having a child with MS – it’s thought to be 2%-5% if one parent has the condition – but she wouldn’t have learned the facts if Dr. Shah hadn’t asked the right questions. “It’s really important for us as a community to know how to be proactive with discussions [about pregnancy],” she said.

As she noted, an estimated 75% of patients with MS are women, most are diagnosed during prime child-bearing years, and many pregnancies in general – an estimated half – are not planned. And while a higher percentage of women with MS are having children than in the past, she said, misinformation remains common. In fact, physicians can be part of the problem.

Dr. Shaw highlighted a 2019 Italian survey that found that 16% of 395 people with MS reported that they were discouraged from having children, mainly by medical professionals, after their diagnosis. Seven percent said they never wanted to become parents because of their MS. A 2021 survey of 332 patients with MS in the United States, United Kingdom, France, Germany, Italy, and Spain, found that 56% reported that MS played a role in their decisions about family planning, and 14% of those decided not to have children.

In regard to women of child-bearing age, Dr. Shah recommends that family planning and contraception should be discussed at the initial visit and every subsequent visit. Open-ended, individualized questions are key. “We don’t know what patients don’t share with us,” she said.

Make sure to consider the timing of any plans to have children, she said. If the patient wants to have children within a year, talk about matters such as whether disease activity is well-controlled (6-12 months of good control is ideal) and whether current disease-modifying therapies are safe. Make sure to get a baseline prepartum MRI scan, she said.

If the patients don’t want to have children, make sure they are using a reliable strategy to avoid conception. Be aware that modafinil – “not one that immediately comes to mind” – may decrease the efficacy of oral contraceptives, she said, as can anticonvulsants (phenytoin, carbamazepine, oxcarbazepine, topiramate, and primidone). Oral contraceptives, meanwhile, may decrease levels of lamotrigine.

What if a patient has trouble conceiving? There are some hints in research that MS may boost the risk of infertility in women, Dr. Shah said. That’s why she recommends that colleagues consider referring a patient to an infertility specialist after attempting conception for 6 months as opposed to the general recommendation for 12 months.

Dr. Shah disclosed advisory board service (Genentech) and development of nonbranded educational programming through Novartis and the National Committee for Quality Assurance.

NATIONAL HARBOR, MD – Just 2 days before she spoke in a presentation at the annual meeting of the Consortium of Multiple Sclerosis Centers, University of Colorado neurologist Anna Shah, MD, asked a 26-year-old patient with MS about whether she planned to have children. Absolutely not, the young woman replied. “I read online that I can give birth to a baby with MS, which is crazy.”

The patient didn’t understand the risk of having a child with MS – it’s thought to be 2%-5% if one parent has the condition – but she wouldn’t have learned the facts if Dr. Shah hadn’t asked the right questions. “It’s really important for us as a community to know how to be proactive with discussions [about pregnancy],” she said.

As she noted, an estimated 75% of patients with MS are women, most are diagnosed during prime child-bearing years, and many pregnancies in general – an estimated half – are not planned. And while a higher percentage of women with MS are having children than in the past, she said, misinformation remains common. In fact, physicians can be part of the problem.

Dr. Shaw highlighted a 2019 Italian survey that found that 16% of 395 people with MS reported that they were discouraged from having children, mainly by medical professionals, after their diagnosis. Seven percent said they never wanted to become parents because of their MS. A 2021 survey of 332 patients with MS in the United States, United Kingdom, France, Germany, Italy, and Spain, found that 56% reported that MS played a role in their decisions about family planning, and 14% of those decided not to have children.

In regard to women of child-bearing age, Dr. Shah recommends that family planning and contraception should be discussed at the initial visit and every subsequent visit. Open-ended, individualized questions are key. “We don’t know what patients don’t share with us,” she said.

Make sure to consider the timing of any plans to have children, she said. If the patient wants to have children within a year, talk about matters such as whether disease activity is well-controlled (6-12 months of good control is ideal) and whether current disease-modifying therapies are safe. Make sure to get a baseline prepartum MRI scan, she said.

If the patients don’t want to have children, make sure they are using a reliable strategy to avoid conception. Be aware that modafinil – “not one that immediately comes to mind” – may decrease the efficacy of oral contraceptives, she said, as can anticonvulsants (phenytoin, carbamazepine, oxcarbazepine, topiramate, and primidone). Oral contraceptives, meanwhile, may decrease levels of lamotrigine.

What if a patient has trouble conceiving? There are some hints in research that MS may boost the risk of infertility in women, Dr. Shah said. That’s why she recommends that colleagues consider referring a patient to an infertility specialist after attempting conception for 6 months as opposed to the general recommendation for 12 months.

Dr. Shah disclosed advisory board service (Genentech) and development of nonbranded educational programming through Novartis and the National Committee for Quality Assurance.