News

During the month of November, CHEST displayed white ribbons around its headquarters in Glenview, Illinois, to raise awareness for lung cancer screening and early detection.

According to the World Health Organization, lung cancer kills more people yearly than breast, colon, and prostate cancers combined, and there are 2.1 million lung cancer cases worldwide. The risk of death can be drastically reduced through early detection of cancer and appropriate treatment.

“Lung Cancer Awareness Month was an opportunity for us to shine the spotlight on a disease that is impacting the lives of so many,” said Robert Musacchio, PhD, CEO of CHEST. “As a society of 22,000 respiratory professionals, we continuously provide the latest resources to our members, including the latest guidelines for lung cancer screening. Leveraging the awareness month, we wanted to spread the message throughout our local community that the best way to combat lung cancer is through early screening and detection.”

To identify and diagnose lung cancer in its earlier stages, it is recommended to seek lung cancer screening with a low-dose tomography scan (also known as low-dose CT or LDCT scan). Individuals who meet the below criteria are considered to be at high risk for developing lung cancer and should be screened:

• 50 to 80 years of age;
• have a 20 pack-year history of smoking (one pack a day for 20 years, two packs a day for 10 years, etc.); or
• currently smoke or have quit within the last 15 years.

To secure the ribbons, CHEST worked with an organization called the White Ribbon Project, which promotes awareness about lung cancer by changing public perception of the disease. Started by lung cancer survivor Heidi Onda and her husband, Pierre Onda, MD, the white ribbon initiative has spurred a movement to build community, reframe education, increase awareness, and remove the stigma against lung cancer.

“We are grateful for the advocacy and support of the American College of Chest Physicians in raising awareness for lung cancer,” Ms. Onda said. “We believe as a team of survivors, caregivers, those who have lost loved ones, advocates, the medical and science communities, industry representatives, advocacy organizations, legislators, and cancer centers that we can change the public perception of lung cancer. Anyone with lungs can get lung cancer, no one deserves it, and awareness and early detection of the disease are crucial.”

During the month of November, CHEST displayed white ribbons around its headquarters in Glenview, Illinois, to raise awareness for lung cancer screening and early detection.

According to the World Health Organization, lung cancer kills more people yearly than breast, colon, and prostate cancers combined, and there are 2.1 million lung cancer cases worldwide. The risk of death can be drastically reduced through early detection of cancer and appropriate treatment.

“Lung Cancer Awareness Month was an opportunity for us to shine the spotlight on a disease that is impacting the lives of so many,” said Robert Musacchio, PhD, CEO of CHEST. “As a society of 22,000 respiratory professionals, we continuously provide the latest resources to our members, including the latest guidelines for lung cancer screening. Leveraging the awareness month, we wanted to spread the message throughout our local community that the best way to combat lung cancer is through early screening and detection.”

To identify and diagnose lung cancer in its earlier stages, it is recommended to seek lung cancer screening with a low-dose tomography scan (also known as low-dose CT or LDCT scan). Individuals who meet the below criteria are considered to be at high risk for developing lung cancer and should be screened:

• 50 to 80 years of age;
• have a 20 pack-year history of smoking (one pack a day for 20 years, two packs a day for 10 years, etc.); or
• currently smoke or have quit within the last 15 years.

To secure the ribbons, CHEST worked with an organization called the White Ribbon Project, which promotes awareness about lung cancer by changing public perception of the disease. Started by lung cancer survivor Heidi Onda and her husband, Pierre Onda, MD, the white ribbon initiative has spurred a movement to build community, reframe education, increase awareness, and remove the stigma against lung cancer.

“We are grateful for the advocacy and support of the American College of Chest Physicians in raising awareness for lung cancer,” Ms. Onda said. “We believe as a team of survivors, caregivers, those who have lost loved ones, advocates, the medical and science communities, industry representatives, advocacy organizations, legislators, and cancer centers that we can change the public perception of lung cancer. Anyone with lungs can get lung cancer, no one deserves it, and awareness and early detection of the disease are crucial.”

During the month of November, CHEST displayed white ribbons around its headquarters in Glenview, Illinois, to raise awareness for lung cancer screening and early detection.

According to the World Health Organization, lung cancer kills more people yearly than breast, colon, and prostate cancers combined, and there are 2.1 million lung cancer cases worldwide. The risk of death can be drastically reduced through early detection of cancer and appropriate treatment.

“Lung Cancer Awareness Month was an opportunity for us to shine the spotlight on a disease that is impacting the lives of so many,” said Robert Musacchio, PhD, CEO of CHEST. “As a society of 22,000 respiratory professionals, we continuously provide the latest resources to our members, including the latest guidelines for lung cancer screening. Leveraging the awareness month, we wanted to spread the message throughout our local community that the best way to combat lung cancer is through early screening and detection.”

To identify and diagnose lung cancer in its earlier stages, it is recommended to seek lung cancer screening with a low-dose tomography scan (also known as low-dose CT or LDCT scan). Individuals who meet the below criteria are considered to be at high risk for developing lung cancer and should be screened:

• 50 to 80 years of age;
• have a 20 pack-year history of smoking (one pack a day for 20 years, two packs a day for 10 years, etc.); or
• currently smoke or have quit within the last 15 years.

To secure the ribbons, CHEST worked with an organization called the White Ribbon Project, which promotes awareness about lung cancer by changing public perception of the disease. Started by lung cancer survivor Heidi Onda and her husband, Pierre Onda, MD, the white ribbon initiative has spurred a movement to build community, reframe education, increase awareness, and remove the stigma against lung cancer.

“We are grateful for the advocacy and support of the American College of Chest Physicians in raising awareness for lung cancer,” Ms. Onda said. “We believe as a team of survivors, caregivers, those who have lost loved ones, advocates, the medical and science communities, industry representatives, advocacy organizations, legislators, and cancer centers that we can change the public perception of lung cancer. Anyone with lungs can get lung cancer, no one deserves it, and awareness and early detection of the disease are crucial.”

Starting January 1, 2025, current President-Elect, John A. Howington, MD, MBA, FCCP, will become the new President of CHEST. Dr. Howington is a general thoracic surgeon and has been involved with the CHEST organization since first attending a CHEST Annual Meeting in 1997. 

Before Dr. Howington steps into the role of President, he spoke with CHEST for a glimpse into his aspirations for 2025.



What would you like to accomplish as President of CHEST?

First, I want to express my gratitude for the honor and privilege of serving as the 87th President of CHEST. The organization is well-served by a high functioning Board of Regents and an incredible staff. My primary goal is to build on the success and momentum of the presidential years of Dr. Buckley and Dr. Addrizzo-Harris. Their annual meetings were a huge success, and the energy and enthusiasm of our members are palpable.

I feel very strongly that great things are ahead of us in the fields of pulmonary medicine and critical care. The CHEST organization will continue to focus on our mission to crush lung disease and stay true to our values of community, inclusivity, innovation, advocacy, and integrity. With 2025 marking the 90th anniversary of the college, I very much look forward to sharing the impact of the organization and showcasing what is yet to come. 

We will continue to collaborate with sister societies and like-minded industry partners to improve the quality of patient care and support clinicians in our field. Specifically, I look forward to continuing the momentum we’ve seen in early identification of lung cancer and increasing cure rates. Working as a team of interventional pulmonologists, respiratory therapists, advanced practice providers, thoracic surgeons, and more, we can make a real impact on what it means to be diagnosed with lung cancer. 



What do you consider to be CHEST’s greatest strength, and how will you build upon this during your presidency? 

CHEST’s greatest strength is the people involved with the organization. There is such a wonderful culture of inclusivity and innovation cultivated by the outstanding staff, committed volunteers, and expert faculty leaders. We have focused on continuous board development for the last eight years and are seeing the benefits in the strategic and innovative steps the Board of Regents have taken to better serve our members and patients. It’s an honor to step into the role of leading such an extraordinary group. 



What are some of the challenges facing CHEST, and how will you address them? 

While not unique to CHEST, stress and burnout remain an issue in the field of health care. Clinicians are asked to do more with limited resources to provide high-quality care to an increasing number of patients with widely varying needs. We will continue to focus on providing guidance on best practices in the field of chest medicine and sharing innovations that reduce the burdens of health care delivery. To help alleviate the stress put on clinicians, we want to do our part to help remove anything that stands between a clinician and their ability to provide the best care for patients. 



What do you ask of members to support you during your presidency? 

What I would ask of our members is that they reach out to connect. I want to both celebrate your wins in the field and work with your suggestions to improve CHEST. Making the organization stronger is a collaborative effort, and every voice matters. My email starting January 1 is president@chestnet.org, and if you need some writing inspiration, I’ve got some suggested prompts:

• Share with me a recent personal success or that of a colleague; we want to help spread the word.
• What do you find most rewarding in your practice?
• What’s a recurring challenge you face in practice?
• What is CHEST getting right? Where can we improve?

I look forward to hearing from you.

Warmest regards, 

John A. Howington, MD, MBA, FCCP

Starting January 1, 2025, current President-Elect, John A. Howington, MD, MBA, FCCP, will become the new President of CHEST. Dr. Howington is a general thoracic surgeon and has been involved with the CHEST organization since first attending a CHEST Annual Meeting in 1997. 

Before Dr. Howington steps into the role of President, he spoke with CHEST for a glimpse into his aspirations for 2025.



What would you like to accomplish as President of CHEST?

First, I want to express my gratitude for the honor and privilege of serving as the 87th President of CHEST. The organization is well-served by a high functioning Board of Regents and an incredible staff. My primary goal is to build on the success and momentum of the presidential years of Dr. Buckley and Dr. Addrizzo-Harris. Their annual meetings were a huge success, and the energy and enthusiasm of our members are palpable.

I feel very strongly that great things are ahead of us in the fields of pulmonary medicine and critical care. The CHEST organization will continue to focus on our mission to crush lung disease and stay true to our values of community, inclusivity, innovation, advocacy, and integrity. With 2025 marking the 90th anniversary of the college, I very much look forward to sharing the impact of the organization and showcasing what is yet to come. 

We will continue to collaborate with sister societies and like-minded industry partners to improve the quality of patient care and support clinicians in our field. Specifically, I look forward to continuing the momentum we’ve seen in early identification of lung cancer and increasing cure rates. Working as a team of interventional pulmonologists, respiratory therapists, advanced practice providers, thoracic surgeons, and more, we can make a real impact on what it means to be diagnosed with lung cancer. 



What do you consider to be CHEST’s greatest strength, and how will you build upon this during your presidency? 

CHEST’s greatest strength is the people involved with the organization. There is such a wonderful culture of inclusivity and innovation cultivated by the outstanding staff, committed volunteers, and expert faculty leaders. We have focused on continuous board development for the last eight years and are seeing the benefits in the strategic and innovative steps the Board of Regents have taken to better serve our members and patients. It’s an honor to step into the role of leading such an extraordinary group. 



What are some of the challenges facing CHEST, and how will you address them? 

While not unique to CHEST, stress and burnout remain an issue in the field of health care. Clinicians are asked to do more with limited resources to provide high-quality care to an increasing number of patients with widely varying needs. We will continue to focus on providing guidance on best practices in the field of chest medicine and sharing innovations that reduce the burdens of health care delivery. To help alleviate the stress put on clinicians, we want to do our part to help remove anything that stands between a clinician and their ability to provide the best care for patients. 



What do you ask of members to support you during your presidency? 

What I would ask of our members is that they reach out to connect. I want to both celebrate your wins in the field and work with your suggestions to improve CHEST. Making the organization stronger is a collaborative effort, and every voice matters. My email starting January 1 is president@chestnet.org, and if you need some writing inspiration, I’ve got some suggested prompts:

• Share with me a recent personal success or that of a colleague; we want to help spread the word.
• What do you find most rewarding in your practice?
• What’s a recurring challenge you face in practice?
• What is CHEST getting right? Where can we improve?

I look forward to hearing from you.

Warmest regards, 

John A. Howington, MD, MBA, FCCP

Starting January 1, 2025, current President-Elect, John A. Howington, MD, MBA, FCCP, will become the new President of CHEST. Dr. Howington is a general thoracic surgeon and has been involved with the CHEST organization since first attending a CHEST Annual Meeting in 1997. 

Before Dr. Howington steps into the role of President, he spoke with CHEST for a glimpse into his aspirations for 2025.



What would you like to accomplish as President of CHEST?

First, I want to express my gratitude for the honor and privilege of serving as the 87th President of CHEST. The organization is well-served by a high functioning Board of Regents and an incredible staff. My primary goal is to build on the success and momentum of the presidential years of Dr. Buckley and Dr. Addrizzo-Harris. Their annual meetings were a huge success, and the energy and enthusiasm of our members are palpable.

I feel very strongly that great things are ahead of us in the fields of pulmonary medicine and critical care. The CHEST organization will continue to focus on our mission to crush lung disease and stay true to our values of community, inclusivity, innovation, advocacy, and integrity. With 2025 marking the 90th anniversary of the college, I very much look forward to sharing the impact of the organization and showcasing what is yet to come. 

We will continue to collaborate with sister societies and like-minded industry partners to improve the quality of patient care and support clinicians in our field. Specifically, I look forward to continuing the momentum we’ve seen in early identification of lung cancer and increasing cure rates. Working as a team of interventional pulmonologists, respiratory therapists, advanced practice providers, thoracic surgeons, and more, we can make a real impact on what it means to be diagnosed with lung cancer. 



What do you consider to be CHEST’s greatest strength, and how will you build upon this during your presidency? 

CHEST’s greatest strength is the people involved with the organization. There is such a wonderful culture of inclusivity and innovation cultivated by the outstanding staff, committed volunteers, and expert faculty leaders. We have focused on continuous board development for the last eight years and are seeing the benefits in the strategic and innovative steps the Board of Regents have taken to better serve our members and patients. It’s an honor to step into the role of leading such an extraordinary group. 



What are some of the challenges facing CHEST, and how will you address them? 

While not unique to CHEST, stress and burnout remain an issue in the field of health care. Clinicians are asked to do more with limited resources to provide high-quality care to an increasing number of patients with widely varying needs. We will continue to focus on providing guidance on best practices in the field of chest medicine and sharing innovations that reduce the burdens of health care delivery. To help alleviate the stress put on clinicians, we want to do our part to help remove anything that stands between a clinician and their ability to provide the best care for patients. 



What do you ask of members to support you during your presidency? 

What I would ask of our members is that they reach out to connect. I want to both celebrate your wins in the field and work with your suggestions to improve CHEST. Making the organization stronger is a collaborative effort, and every voice matters. My email starting January 1 is president@chestnet.org, and if you need some writing inspiration, I’ve got some suggested prompts:

• Share with me a recent personal success or that of a colleague; we want to help spread the word.
• What do you find most rewarding in your practice?
• What’s a recurring challenge you face in practice?
• What is CHEST getting right? Where can we improve?

I look forward to hearing from you.

Warmest regards, 

John A. Howington, MD, MBA, FCCP

In the high-stakes environment of the intensive care unit (ICU), red blood cell (RBC) transfusions are a common intervention. With approximately 25% of critically ill patients in the US receiving RBC transfusions, optimizing the approach to transfusion is vital not only for patient safety but also for resource management. A recent guideline from CHEST emphasizes the importance of a restrictive RBC transfusion approach in critically ill adults, aligning with growing evidence that restrictive transfusion thresholds do not compromise survival or recovery and may reduce adverse events in many cases. For the bedside clinician and health care systems, this presents both an opportunity and a challenge: to recalibrate transfusion practices while maintaining the highest standards of patient care.

Why a restrictive strategy?

Historically, transfusions were administered to optimize oxygen delivery to organs in the presence of anemia. However, studies have highlighted the risks associated with transfusions, such as transfusion-related lung injury, circulatory overload, and increased nosocomial infections. These risks are particularly pronounced in critically ill patients, who are often more vulnerable to complications from any additional physiological burden.

The restrictive approach—typically recommended at a hemoglobin threshold of 7 to 8 g/dL—has been shown to be the safer alternative for most ICU patients, as highlighted in recently published clinical guidelines. The data supporting this approach suggest that a restrictive transfusion strategy not only spares patients unnecessary transfusions but also aligns with cost-effective and resource-efficient health care practices.

Key recommendations

For ICU providers, this guideline presents specific recommendations based on a patient’s condition:

• General critical illness: The restrictive approach is preferred over a permissive one, with no adverse effect on ICU mortality, one-year survival, or adverse events. In other words, lower Hgb thresholds do not correlate with poorer outcomes in most critically ill patients.

• Acute gastrointestinal bleeding: Evidence favors a restrictive approach, associated with reduced rebleeding risk and short-term mortality. Studies show a significantly lower incidence of transfusion reactions and costs without compromising patient safety.

• Acute coronary syndrome (ACS): A more cautious approach is advised here. In cases of ACS, a restrictive RBC transfusion strategy could potentially increase the risk of cardiac death. It is recommended to avoid a restrictive approach, as it remains unclear whether there is a gradient effect—where risk progressively increases below a hemoglobin level of 10 g/dL—or a threshold effect at 10 g/dL. In other words, the data does not clarify if a hemoglobin level of 9 g/dL is as safe as 10 g/dL. An individualized transfusion approach, considering patient symptoms and other physiological markers, is recommended.

• Post-cardiac surgery: For postoperative patients, a restrictive strategy is suggested, as it conserves RBCs without impacting outcomes such as mortality or length of hospital stay.

• Isolated troponin elevation: In cases of elevated troponin without evidence of cardiac ischemia, transfusion decisions should consider additional patient-specific variables, with a restrictive approach as the baseline.

• Septic shock: RBC transfusions as part of a resuscitation bundle were not analyzed, as isolating the impact of RBC transfusions from other bundle elements was not feasible. However, with no clear benefit and similar adverse effects, neither strategy proved clinically superior. Nonetheless, a restrictive approach conserves RBC units, thereby saving resources and reducing costs.

The economics of restriction

Beyond clinical benefits, a restrictive approach conserves precious health care resources. With the cost of a single RBC unit hovering around $200—and significantly higher once administrative and logistic expenses are accounted for—reducing unnecessary transfusions translates into substantial savings. For a health care system already strained by limited blood supply and rising demand, a 40% reduction in transfusions across ICUs could alleviate supply pressures and contribute to more equitable resource distribution.

Easier said than done

Adopting a restrictive transfusion policy is not without challenges. Clinicians are trained to act decisively in critical situations, and, often, the instinct is to do more rather than less. However, studies indicate that with proper education, awareness, and decision-support systems, a restrictive policy is both feasible and effective. Institutions may consider behavior modification strategies, such as standardized transfusion order sets and decision-support tools within electronic medical records, to aid in adjusting transfusion practices.

Call to action

The message is clear: For most critically ill patients, a restrictive RBC transfusion strategy is not only safe but optimal. For ICU teams, this calls for a proactive shift in approach. It is a call to scrutinize transfusion triggers and lean toward a judicious, evidence-based approach.

While cases like ACS may require a different approach, the evidence strongly supports that, under most circumstances, less is more. Embracing this approach requires careful consideration, yet the potential benefits for patient safety and health care sustainability are compelling.

As critical care professionals, let us lead the way in refining transfusion practices to uphold patient safety, optimize resources, and adapt to evidence-based guidelines.



ACCESS THE FULL GUIDELINE

In the high-stakes environment of the intensive care unit (ICU), red blood cell (RBC) transfusions are a common intervention. With approximately 25% of critically ill patients in the US receiving RBC transfusions, optimizing the approach to transfusion is vital not only for patient safety but also for resource management. A recent guideline from CHEST emphasizes the importance of a restrictive RBC transfusion approach in critically ill adults, aligning with growing evidence that restrictive transfusion thresholds do not compromise survival or recovery and may reduce adverse events in many cases. For the bedside clinician and health care systems, this presents both an opportunity and a challenge: to recalibrate transfusion practices while maintaining the highest standards of patient care.

Why a restrictive strategy?

Historically, transfusions were administered to optimize oxygen delivery to organs in the presence of anemia. However, studies have highlighted the risks associated with transfusions, such as transfusion-related lung injury, circulatory overload, and increased nosocomial infections. These risks are particularly pronounced in critically ill patients, who are often more vulnerable to complications from any additional physiological burden.

The restrictive approach—typically recommended at a hemoglobin threshold of 7 to 8 g/dL—has been shown to be the safer alternative for most ICU patients, as highlighted in recently published clinical guidelines. The data supporting this approach suggest that a restrictive transfusion strategy not only spares patients unnecessary transfusions but also aligns with cost-effective and resource-efficient health care practices.

Key recommendations

For ICU providers, this guideline presents specific recommendations based on a patient’s condition:

• General critical illness: The restrictive approach is preferred over a permissive one, with no adverse effect on ICU mortality, one-year survival, or adverse events. In other words, lower Hgb thresholds do not correlate with poorer outcomes in most critically ill patients.

• Acute gastrointestinal bleeding: Evidence favors a restrictive approach, associated with reduced rebleeding risk and short-term mortality. Studies show a significantly lower incidence of transfusion reactions and costs without compromising patient safety.

• Acute coronary syndrome (ACS): A more cautious approach is advised here. In cases of ACS, a restrictive RBC transfusion strategy could potentially increase the risk of cardiac death. It is recommended to avoid a restrictive approach, as it remains unclear whether there is a gradient effect—where risk progressively increases below a hemoglobin level of 10 g/dL—or a threshold effect at 10 g/dL. In other words, the data does not clarify if a hemoglobin level of 9 g/dL is as safe as 10 g/dL. An individualized transfusion approach, considering patient symptoms and other physiological markers, is recommended.

• Post-cardiac surgery: For postoperative patients, a restrictive strategy is suggested, as it conserves RBCs without impacting outcomes such as mortality or length of hospital stay.

• Isolated troponin elevation: In cases of elevated troponin without evidence of cardiac ischemia, transfusion decisions should consider additional patient-specific variables, with a restrictive approach as the baseline.

• Septic shock: RBC transfusions as part of a resuscitation bundle were not analyzed, as isolating the impact of RBC transfusions from other bundle elements was not feasible. However, with no clear benefit and similar adverse effects, neither strategy proved clinically superior. Nonetheless, a restrictive approach conserves RBC units, thereby saving resources and reducing costs.

The economics of restriction

Beyond clinical benefits, a restrictive approach conserves precious health care resources. With the cost of a single RBC unit hovering around $200—and significantly higher once administrative and logistic expenses are accounted for—reducing unnecessary transfusions translates into substantial savings. For a health care system already strained by limited blood supply and rising demand, a 40% reduction in transfusions across ICUs could alleviate supply pressures and contribute to more equitable resource distribution.

Easier said than done

Adopting a restrictive transfusion policy is not without challenges. Clinicians are trained to act decisively in critical situations, and, often, the instinct is to do more rather than less. However, studies indicate that with proper education, awareness, and decision-support systems, a restrictive policy is both feasible and effective. Institutions may consider behavior modification strategies, such as standardized transfusion order sets and decision-support tools within electronic medical records, to aid in adjusting transfusion practices.

Call to action

The message is clear: For most critically ill patients, a restrictive RBC transfusion strategy is not only safe but optimal. For ICU teams, this calls for a proactive shift in approach. It is a call to scrutinize transfusion triggers and lean toward a judicious, evidence-based approach.

While cases like ACS may require a different approach, the evidence strongly supports that, under most circumstances, less is more. Embracing this approach requires careful consideration, yet the potential benefits for patient safety and health care sustainability are compelling.

As critical care professionals, let us lead the way in refining transfusion practices to uphold patient safety, optimize resources, and adapt to evidence-based guidelines.



ACCESS THE FULL GUIDELINE

In the high-stakes environment of the intensive care unit (ICU), red blood cell (RBC) transfusions are a common intervention. With approximately 25% of critically ill patients in the US receiving RBC transfusions, optimizing the approach to transfusion is vital not only for patient safety but also for resource management. A recent guideline from CHEST emphasizes the importance of a restrictive RBC transfusion approach in critically ill adults, aligning with growing evidence that restrictive transfusion thresholds do not compromise survival or recovery and may reduce adverse events in many cases. For the bedside clinician and health care systems, this presents both an opportunity and a challenge: to recalibrate transfusion practices while maintaining the highest standards of patient care.

Why a restrictive strategy?

Historically, transfusions were administered to optimize oxygen delivery to organs in the presence of anemia. However, studies have highlighted the risks associated with transfusions, such as transfusion-related lung injury, circulatory overload, and increased nosocomial infections. These risks are particularly pronounced in critically ill patients, who are often more vulnerable to complications from any additional physiological burden.

The restrictive approach—typically recommended at a hemoglobin threshold of 7 to 8 g/dL—has been shown to be the safer alternative for most ICU patients, as highlighted in recently published clinical guidelines. The data supporting this approach suggest that a restrictive transfusion strategy not only spares patients unnecessary transfusions but also aligns with cost-effective and resource-efficient health care practices.

Key recommendations

For ICU providers, this guideline presents specific recommendations based on a patient’s condition:

• General critical illness: The restrictive approach is preferred over a permissive one, with no adverse effect on ICU mortality, one-year survival, or adverse events. In other words, lower Hgb thresholds do not correlate with poorer outcomes in most critically ill patients.

• Acute gastrointestinal bleeding: Evidence favors a restrictive approach, associated with reduced rebleeding risk and short-term mortality. Studies show a significantly lower incidence of transfusion reactions and costs without compromising patient safety.

• Acute coronary syndrome (ACS): A more cautious approach is advised here. In cases of ACS, a restrictive RBC transfusion strategy could potentially increase the risk of cardiac death. It is recommended to avoid a restrictive approach, as it remains unclear whether there is a gradient effect—where risk progressively increases below a hemoglobin level of 10 g/dL—or a threshold effect at 10 g/dL. In other words, the data does not clarify if a hemoglobin level of 9 g/dL is as safe as 10 g/dL. An individualized transfusion approach, considering patient symptoms and other physiological markers, is recommended.

• Post-cardiac surgery: For postoperative patients, a restrictive strategy is suggested, as it conserves RBCs without impacting outcomes such as mortality or length of hospital stay.

• Isolated troponin elevation: In cases of elevated troponin without evidence of cardiac ischemia, transfusion decisions should consider additional patient-specific variables, with a restrictive approach as the baseline.

• Septic shock: RBC transfusions as part of a resuscitation bundle were not analyzed, as isolating the impact of RBC transfusions from other bundle elements was not feasible. However, with no clear benefit and similar adverse effects, neither strategy proved clinically superior. Nonetheless, a restrictive approach conserves RBC units, thereby saving resources and reducing costs.

The economics of restriction

Beyond clinical benefits, a restrictive approach conserves precious health care resources. With the cost of a single RBC unit hovering around $200—and significantly higher once administrative and logistic expenses are accounted for—reducing unnecessary transfusions translates into substantial savings. For a health care system already strained by limited blood supply and rising demand, a 40% reduction in transfusions across ICUs could alleviate supply pressures and contribute to more equitable resource distribution.

Easier said than done

Adopting a restrictive transfusion policy is not without challenges. Clinicians are trained to act decisively in critical situations, and, often, the instinct is to do more rather than less. However, studies indicate that with proper education, awareness, and decision-support systems, a restrictive policy is both feasible and effective. Institutions may consider behavior modification strategies, such as standardized transfusion order sets and decision-support tools within electronic medical records, to aid in adjusting transfusion practices.

Call to action

The message is clear: For most critically ill patients, a restrictive RBC transfusion strategy is not only safe but optimal. For ICU teams, this calls for a proactive shift in approach. It is a call to scrutinize transfusion triggers and lean toward a judicious, evidence-based approach.

While cases like ACS may require a different approach, the evidence strongly supports that, under most circumstances, less is more. Embracing this approach requires careful consideration, yet the potential benefits for patient safety and health care sustainability are compelling.

As critical care professionals, let us lead the way in refining transfusion practices to uphold patient safety, optimize resources, and adapt to evidence-based guidelines.



ACCESS THE FULL GUIDELINE

WASHINGTON — Investigational treatments aimed specifically at reducing pain in knee osteoarthritis (OA) are moving forward in parallel with disease-modifying approaches.

“We still have very few treatments for the pain of osteoarthritis…It worries me that people think the only way forward is structure modification. I think while we’re waiting for some drugs to be structure modifying, we still need more pain relief. About 70% of people can’t tolerate or shouldn’t be on a [nonsteroidal anti-inflammatory drug], and that leaves a large number of people with pain,” Philip Conaghan, MBBS, PhD, Chair of Musculoskeletal Medicine at the University of Leeds in England, said in an interview.

At the annual meeting of the American College of Rheumatology, Conaghan, who is also honorary consultant rheumatologist for the Leeds Teaching Hospitals NHS Trust, presented new data for two novel approaches, both targeting peripheral nociceptive pain signaling.

In a late-breaking poster, he presented phase 2 trial data on RTX-GRT7039 (resiniferatoxin [RTX]), an agonist of the transient receptor potential vanilloid 1 that is a driver of OA pain. The trial investigated the efficacy and safety of a single intra-articular injection of RTX-GRT7039 in people with knee OA.

And separately, in a late-breaking oral abstract session, Conaghan presented phase 2 trial safety and efficacy data for another investigational agent called LEVI-04, a first-in-class neurotrophin receptor fusion protein (p75NTR-Fc) that supplements the endogenous protein and provides analgesia via inhibition of NT-3 activity.

“I think both have potential to provide good pain relief, through slightly different mechanisms,” Conaghan said in an interview.

Asked to comment, session moderator Gregory C. Gardner, MD, emeritus professor in the Division of Rheumatology at the University of Washington, Seattle, said in an interview: “I think the results are really exciting terms of the ability to control pain to a significant degree in patients with osteoarthritis.”

However, Gardner also said, “The molecules can be very expensive ... so who do we give them to? Will insurance companies pay for this simply for OA pain? They improve function ... so clearly, [they] will be a boon to treating osteoarthritis, but do we give them to people with only more advanced forms of osteoarthritis or earlier on?”

Moreover, Gardner said, “One of my concerns about treating osteoarthritis is I don’t want to do too good of a job treating pain in somebody who has a biomechanically abnormal joint. ... You’ve got a knee that’s worn out some of the cartilage, and now you feel like you can go out and play soccer again. That’s not a good thing. That joint will wear out very quickly, even though it doesn’t feel pain.”

Another OA expert, Matlock Jeffries, MD, director of the Arthritis Research Unit at the Oklahoma Medical Research Foundation, Oklahoma City, said in an interview, “I think we don’t focus nearly enough on pain, and that’s [partly] because the [Food and Drug Administration] has defined endpoints for knee OA trials that are radiographic. ... Patients do not care what their joint space narrowing is. They care what their pain is. And joint space changes and pain do not correlate in knee OA. ... About 20% or 30% of patients who have completely normal x-rays have a lot of pain…I hope that we’ll have some new OA pain therapeutics in the future because that’s what patients actually care about.”

But Jeffries noted that it will be very important to ensure that these agents don’t produce significant side effects, as had been seen previously in several large industry-sponsored trials of drugs targeting nerve growth factors.

“The big concern that we have in the field ... is that the nerve growth factor antibody trials were all stopped because there was a low but persistent risk of rapidly progressive OA in a small percent of patients. I think one of the questions in the field is whether targeting other things having to do with OA pain is going to result in similar bad outcomes. I think the answer is probably not, but that’s one thing that people do worry about, and they never really figured out why the [rapidly progressive OA] was happening.”

 

‘Potential to Provide Meaningful and Sustained Analgesia’

The phase 2 trial of RTX-GRT7039, funded by manufacturer Grünenthal, enrolled 40 patients with a baseline visual analog pain score (VAS) of > 40 mm on motion for average joint pain in the target knee over the past 2 days with or without analgesic medication and Kellgren-Lawrence grades 2-4.

They were randomized to receive a single intra-articular injection of 2 mg or 4 mg RTX-GRT7039 within 1 minute after receiving 5 mL ropivacaine (0.5%) or 4 mg or 8 mg RTX-GRT7039 administered 15 minutes after 5 mL ropivacaine pretreatment, or equivalent placebo treatments plus ropivacaine.

Plasma samples were collected for up to 2 hours, and VAS pain scores were collected for up to 3 hours post injection.

Reductions in VAS scores from baseline in the treated knee were seen in all RTX treatment groups as early as day 8 post injection and were maintained up to 6 months, while no reductions in VAS pain on motion scores were seen in the placebo group.

At 3 months, the absolute baseline-adjusted reductions in VAS scores were similar for RTX 2 mg (–39.75), RTX 4 mg (–40.20), and RTX 8 mg (–30.25), while the reduction in the placebo group was just –8.50. At 6 months, the mean absolute reduction in VAS score was numerically greater in the RTX 2-mg (–46.49), RTX 4-mg (–43.40), and RTX 8-mg (–38.60) groups vs the group that received RTX 4 mg within 1 minute after receiving ropivacaine (–22.00).

At both 3 and 6 months, a higher proportion of patients receiving any dose of RTX-GRT7039 achieved ≥ 50% and ≥ 70% reduction in pain on motion, compared with those who received placebo. All RTX-GRT7039 treatment groups reported a greater improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score than the placebo group at both 3 and 6 months.

Rates of treatment-emergent adverse events were similar between the RTX groups (85.7%-90.9%) and placebo (85.7%) and slightly lower in the group that received RTX 4 mg within 1 minute of receiving ropivacaine (60.0%).

There was a trend toward greater procedural/injection site pain in the RTX treatment groups, compared with placebo, most commonly arthralgia (37.5%), headache (17.5%), and back pain (10%). This tended to peak around 0.5 hours post injection and resolve by 1.5-3.0 hours.

No treatment-related serious adverse events occurred, and no treatment-emergent adverse events led to discontinuation or death.

“This early-phase trial indicates that RTX-GRT7039 has the potential to provide meaningful and sustained analgesia for patients with knee OA pain,” Conaghan and colleagues wrote in their poster.

The drug is now being evaluated in three phase 3 trials (NCT05248386, NCT05449132, and NCT05377489).

 

LEVI-04: Modulation of NT-3 Appears to Work Safely

LEVI-04 was evaluated in a phase 2, 20-week, 13-center (Europe and Hong Kong) randomized, double-blind, placebo-controlled trial in 518 people with knee OA who had WOMAC pain subscale scores ≥ 20, mean average daily pain numeric rating scale score of 4-9, and radiographic Kellgren-Lawrence grade ≥ 2.

They were randomized to a total of five infusions of placebo or 0.3 mg/kg, 0.1 mg/kg, or 2 mg/kg LEVI-04 from baseline through week 16, with safety follow-up to week 30.

The primary endpoint, change in WOMAC pain from baseline to weeks 5 and 17, was met for all three doses. At 17 weeks, those were –2.79, –2.89, and –3.08 for 0.3 mg, 1.0 mg, and 2 mg, respectively, vs –2.28 for placebo (all P < .05).

Secondary endpoints, including WOMAC physical function, WOMAC stiffness, and Patient Global Assessment, and > 50% pain responders, were also all met at weeks 5 and 17. More than 50% of the LEVI-04–treated patients reported ≥ 50% reduction in pain, and > 25% reported ≥ 75% reduction at weeks 5 and 17.

“So, this modulation of NT-3 is working,” Conaghan commented.

There were no increased incidences of severe adverse events, treatment-emergent adverse events, or joint pathologies, including rapidly progressive OA, compared with placebo.

There were more paresthesias reported with the active drug, 2-4 vs 1 with placebo. “That says to me that the drug is working and that it’s having an effect on peripheral nerves, but luckily these were all mild or moderate and didn’t lead to any study withdrawal or discontinuation,” Conaghan said.

Phase 3 trials are in the planning stages, he noted.

 

Other Approaches to Treating OA Pain

Other approaches to treating OA pain have included methotrexate, for which Conaghan was also a coauthor on one paper that came out earlier in 2024. “This presumably works by treating inflammation, but it’s not clear if that is within-joint inflammation or systemic inflammation,” he said in an interview.

Another approach, using the weight loss drug semaglutide, was presented in April 2024 at the 2024 World Congress on Osteoarthritis annual meeting and published in October 2024 in The New England Journal of Medicine

The trial involving RTX-GRT7039 was funded by Grünenthal, and some study coauthors are employees of the company. The trial involving LEVI-04 was funded by Levicept, and some study coauthors are employees of the company. Conaghan is a consultant and/or speaker for Eli Lilly, Eupraxia Pharmaceuticals, Formation Bio, Galapagos, Genascence, GlaxoSmithKline, Grünenthal, Janssen Pharmaceuticals, Kolon TissueGene, Levicept, Medipost, Moebius, Novartis, Pacira, Sandoz, Stryker Corporation, and Takeda. Gardner and Jeffries had no disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — Investigational treatments aimed specifically at reducing pain in knee osteoarthritis (OA) are moving forward in parallel with disease-modifying approaches.

“We still have very few treatments for the pain of osteoarthritis…It worries me that people think the only way forward is structure modification. I think while we’re waiting for some drugs to be structure modifying, we still need more pain relief. About 70% of people can’t tolerate or shouldn’t be on a [nonsteroidal anti-inflammatory drug], and that leaves a large number of people with pain,” Philip Conaghan, MBBS, PhD, Chair of Musculoskeletal Medicine at the University of Leeds in England, said in an interview.

At the annual meeting of the American College of Rheumatology, Conaghan, who is also honorary consultant rheumatologist for the Leeds Teaching Hospitals NHS Trust, presented new data for two novel approaches, both targeting peripheral nociceptive pain signaling.

In a late-breaking poster, he presented phase 2 trial data on RTX-GRT7039 (resiniferatoxin [RTX]), an agonist of the transient receptor potential vanilloid 1 that is a driver of OA pain. The trial investigated the efficacy and safety of a single intra-articular injection of RTX-GRT7039 in people with knee OA.

And separately, in a late-breaking oral abstract session, Conaghan presented phase 2 trial safety and efficacy data for another investigational agent called LEVI-04, a first-in-class neurotrophin receptor fusion protein (p75NTR-Fc) that supplements the endogenous protein and provides analgesia via inhibition of NT-3 activity.

“I think both have potential to provide good pain relief, through slightly different mechanisms,” Conaghan said in an interview.

Asked to comment, session moderator Gregory C. Gardner, MD, emeritus professor in the Division of Rheumatology at the University of Washington, Seattle, said in an interview: “I think the results are really exciting terms of the ability to control pain to a significant degree in patients with osteoarthritis.”

However, Gardner also said, “The molecules can be very expensive ... so who do we give them to? Will insurance companies pay for this simply for OA pain? They improve function ... so clearly, [they] will be a boon to treating osteoarthritis, but do we give them to people with only more advanced forms of osteoarthritis or earlier on?”

Moreover, Gardner said, “One of my concerns about treating osteoarthritis is I don’t want to do too good of a job treating pain in somebody who has a biomechanically abnormal joint. ... You’ve got a knee that’s worn out some of the cartilage, and now you feel like you can go out and play soccer again. That’s not a good thing. That joint will wear out very quickly, even though it doesn’t feel pain.”

Another OA expert, Matlock Jeffries, MD, director of the Arthritis Research Unit at the Oklahoma Medical Research Foundation, Oklahoma City, said in an interview, “I think we don’t focus nearly enough on pain, and that’s [partly] because the [Food and Drug Administration] has defined endpoints for knee OA trials that are radiographic. ... Patients do not care what their joint space narrowing is. They care what their pain is. And joint space changes and pain do not correlate in knee OA. ... About 20% or 30% of patients who have completely normal x-rays have a lot of pain…I hope that we’ll have some new OA pain therapeutics in the future because that’s what patients actually care about.”

But Jeffries noted that it will be very important to ensure that these agents don’t produce significant side effects, as had been seen previously in several large industry-sponsored trials of drugs targeting nerve growth factors.

“The big concern that we have in the field ... is that the nerve growth factor antibody trials were all stopped because there was a low but persistent risk of rapidly progressive OA in a small percent of patients. I think one of the questions in the field is whether targeting other things having to do with OA pain is going to result in similar bad outcomes. I think the answer is probably not, but that’s one thing that people do worry about, and they never really figured out why the [rapidly progressive OA] was happening.”

 

‘Potential to Provide Meaningful and Sustained Analgesia’

The phase 2 trial of RTX-GRT7039, funded by manufacturer Grünenthal, enrolled 40 patients with a baseline visual analog pain score (VAS) of > 40 mm on motion for average joint pain in the target knee over the past 2 days with or without analgesic medication and Kellgren-Lawrence grades 2-4.

They were randomized to receive a single intra-articular injection of 2 mg or 4 mg RTX-GRT7039 within 1 minute after receiving 5 mL ropivacaine (0.5%) or 4 mg or 8 mg RTX-GRT7039 administered 15 minutes after 5 mL ropivacaine pretreatment, or equivalent placebo treatments plus ropivacaine.

Plasma samples were collected for up to 2 hours, and VAS pain scores were collected for up to 3 hours post injection.

Reductions in VAS scores from baseline in the treated knee were seen in all RTX treatment groups as early as day 8 post injection and were maintained up to 6 months, while no reductions in VAS pain on motion scores were seen in the placebo group.

At 3 months, the absolute baseline-adjusted reductions in VAS scores were similar for RTX 2 mg (–39.75), RTX 4 mg (–40.20), and RTX 8 mg (–30.25), while the reduction in the placebo group was just –8.50. At 6 months, the mean absolute reduction in VAS score was numerically greater in the RTX 2-mg (–46.49), RTX 4-mg (–43.40), and RTX 8-mg (–38.60) groups vs the group that received RTX 4 mg within 1 minute after receiving ropivacaine (–22.00).

At both 3 and 6 months, a higher proportion of patients receiving any dose of RTX-GRT7039 achieved ≥ 50% and ≥ 70% reduction in pain on motion, compared with those who received placebo. All RTX-GRT7039 treatment groups reported a greater improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score than the placebo group at both 3 and 6 months.

Rates of treatment-emergent adverse events were similar between the RTX groups (85.7%-90.9%) and placebo (85.7%) and slightly lower in the group that received RTX 4 mg within 1 minute of receiving ropivacaine (60.0%).

There was a trend toward greater procedural/injection site pain in the RTX treatment groups, compared with placebo, most commonly arthralgia (37.5%), headache (17.5%), and back pain (10%). This tended to peak around 0.5 hours post injection and resolve by 1.5-3.0 hours.

No treatment-related serious adverse events occurred, and no treatment-emergent adverse events led to discontinuation or death.

“This early-phase trial indicates that RTX-GRT7039 has the potential to provide meaningful and sustained analgesia for patients with knee OA pain,” Conaghan and colleagues wrote in their poster.

The drug is now being evaluated in three phase 3 trials (NCT05248386, NCT05449132, and NCT05377489).

 

LEVI-04: Modulation of NT-3 Appears to Work Safely

LEVI-04 was evaluated in a phase 2, 20-week, 13-center (Europe and Hong Kong) randomized, double-blind, placebo-controlled trial in 518 people with knee OA who had WOMAC pain subscale scores ≥ 20, mean average daily pain numeric rating scale score of 4-9, and radiographic Kellgren-Lawrence grade ≥ 2.

They were randomized to a total of five infusions of placebo or 0.3 mg/kg, 0.1 mg/kg, or 2 mg/kg LEVI-04 from baseline through week 16, with safety follow-up to week 30.

The primary endpoint, change in WOMAC pain from baseline to weeks 5 and 17, was met for all three doses. At 17 weeks, those were –2.79, –2.89, and –3.08 for 0.3 mg, 1.0 mg, and 2 mg, respectively, vs –2.28 for placebo (all P < .05).

Secondary endpoints, including WOMAC physical function, WOMAC stiffness, and Patient Global Assessment, and > 50% pain responders, were also all met at weeks 5 and 17. More than 50% of the LEVI-04–treated patients reported ≥ 50% reduction in pain, and > 25% reported ≥ 75% reduction at weeks 5 and 17.

“So, this modulation of NT-3 is working,” Conaghan commented.

There were no increased incidences of severe adverse events, treatment-emergent adverse events, or joint pathologies, including rapidly progressive OA, compared with placebo.

There were more paresthesias reported with the active drug, 2-4 vs 1 with placebo. “That says to me that the drug is working and that it’s having an effect on peripheral nerves, but luckily these were all mild or moderate and didn’t lead to any study withdrawal or discontinuation,” Conaghan said.

Phase 3 trials are in the planning stages, he noted.

 

Other Approaches to Treating OA Pain

Other approaches to treating OA pain have included methotrexate, for which Conaghan was also a coauthor on one paper that came out earlier in 2024. “This presumably works by treating inflammation, but it’s not clear if that is within-joint inflammation or systemic inflammation,” he said in an interview.

Another approach, using the weight loss drug semaglutide, was presented in April 2024 at the 2024 World Congress on Osteoarthritis annual meeting and published in October 2024 in The New England Journal of Medicine

The trial involving RTX-GRT7039 was funded by Grünenthal, and some study coauthors are employees of the company. The trial involving LEVI-04 was funded by Levicept, and some study coauthors are employees of the company. Conaghan is a consultant and/or speaker for Eli Lilly, Eupraxia Pharmaceuticals, Formation Bio, Galapagos, Genascence, GlaxoSmithKline, Grünenthal, Janssen Pharmaceuticals, Kolon TissueGene, Levicept, Medipost, Moebius, Novartis, Pacira, Sandoz, Stryker Corporation, and Takeda. Gardner and Jeffries had no disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — Investigational treatments aimed specifically at reducing pain in knee osteoarthritis (OA) are moving forward in parallel with disease-modifying approaches.

“We still have very few treatments for the pain of osteoarthritis…It worries me that people think the only way forward is structure modification. I think while we’re waiting for some drugs to be structure modifying, we still need more pain relief. About 70% of people can’t tolerate or shouldn’t be on a [nonsteroidal anti-inflammatory drug], and that leaves a large number of people with pain,” Philip Conaghan, MBBS, PhD, Chair of Musculoskeletal Medicine at the University of Leeds in England, said in an interview.

At the annual meeting of the American College of Rheumatology, Conaghan, who is also honorary consultant rheumatologist for the Leeds Teaching Hospitals NHS Trust, presented new data for two novel approaches, both targeting peripheral nociceptive pain signaling.

In a late-breaking poster, he presented phase 2 trial data on RTX-GRT7039 (resiniferatoxin [RTX]), an agonist of the transient receptor potential vanilloid 1 that is a driver of OA pain. The trial investigated the efficacy and safety of a single intra-articular injection of RTX-GRT7039 in people with knee OA.

And separately, in a late-breaking oral abstract session, Conaghan presented phase 2 trial safety and efficacy data for another investigational agent called LEVI-04, a first-in-class neurotrophin receptor fusion protein (p75NTR-Fc) that supplements the endogenous protein and provides analgesia via inhibition of NT-3 activity.

“I think both have potential to provide good pain relief, through slightly different mechanisms,” Conaghan said in an interview.

Asked to comment, session moderator Gregory C. Gardner, MD, emeritus professor in the Division of Rheumatology at the University of Washington, Seattle, said in an interview: “I think the results are really exciting terms of the ability to control pain to a significant degree in patients with osteoarthritis.”

However, Gardner also said, “The molecules can be very expensive ... so who do we give them to? Will insurance companies pay for this simply for OA pain? They improve function ... so clearly, [they] will be a boon to treating osteoarthritis, but do we give them to people with only more advanced forms of osteoarthritis or earlier on?”

Moreover, Gardner said, “One of my concerns about treating osteoarthritis is I don’t want to do too good of a job treating pain in somebody who has a biomechanically abnormal joint. ... You’ve got a knee that’s worn out some of the cartilage, and now you feel like you can go out and play soccer again. That’s not a good thing. That joint will wear out very quickly, even though it doesn’t feel pain.”

Another OA expert, Matlock Jeffries, MD, director of the Arthritis Research Unit at the Oklahoma Medical Research Foundation, Oklahoma City, said in an interview, “I think we don’t focus nearly enough on pain, and that’s [partly] because the [Food and Drug Administration] has defined endpoints for knee OA trials that are radiographic. ... Patients do not care what their joint space narrowing is. They care what their pain is. And joint space changes and pain do not correlate in knee OA. ... About 20% or 30% of patients who have completely normal x-rays have a lot of pain…I hope that we’ll have some new OA pain therapeutics in the future because that’s what patients actually care about.”

But Jeffries noted that it will be very important to ensure that these agents don’t produce significant side effects, as had been seen previously in several large industry-sponsored trials of drugs targeting nerve growth factors.

“The big concern that we have in the field ... is that the nerve growth factor antibody trials were all stopped because there was a low but persistent risk of rapidly progressive OA in a small percent of patients. I think one of the questions in the field is whether targeting other things having to do with OA pain is going to result in similar bad outcomes. I think the answer is probably not, but that’s one thing that people do worry about, and they never really figured out why the [rapidly progressive OA] was happening.”

 

‘Potential to Provide Meaningful and Sustained Analgesia’

The phase 2 trial of RTX-GRT7039, funded by manufacturer Grünenthal, enrolled 40 patients with a baseline visual analog pain score (VAS) of > 40 mm on motion for average joint pain in the target knee over the past 2 days with or without analgesic medication and Kellgren-Lawrence grades 2-4.

They were randomized to receive a single intra-articular injection of 2 mg or 4 mg RTX-GRT7039 within 1 minute after receiving 5 mL ropivacaine (0.5%) or 4 mg or 8 mg RTX-GRT7039 administered 15 minutes after 5 mL ropivacaine pretreatment, or equivalent placebo treatments plus ropivacaine.

Plasma samples were collected for up to 2 hours, and VAS pain scores were collected for up to 3 hours post injection.

Reductions in VAS scores from baseline in the treated knee were seen in all RTX treatment groups as early as day 8 post injection and were maintained up to 6 months, while no reductions in VAS pain on motion scores were seen in the placebo group.

At 3 months, the absolute baseline-adjusted reductions in VAS scores were similar for RTX 2 mg (–39.75), RTX 4 mg (–40.20), and RTX 8 mg (–30.25), while the reduction in the placebo group was just –8.50. At 6 months, the mean absolute reduction in VAS score was numerically greater in the RTX 2-mg (–46.49), RTX 4-mg (–43.40), and RTX 8-mg (–38.60) groups vs the group that received RTX 4 mg within 1 minute after receiving ropivacaine (–22.00).

At both 3 and 6 months, a higher proportion of patients receiving any dose of RTX-GRT7039 achieved ≥ 50% and ≥ 70% reduction in pain on motion, compared with those who received placebo. All RTX-GRT7039 treatment groups reported a greater improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score than the placebo group at both 3 and 6 months.

Rates of treatment-emergent adverse events were similar between the RTX groups (85.7%-90.9%) and placebo (85.7%) and slightly lower in the group that received RTX 4 mg within 1 minute of receiving ropivacaine (60.0%).

There was a trend toward greater procedural/injection site pain in the RTX treatment groups, compared with placebo, most commonly arthralgia (37.5%), headache (17.5%), and back pain (10%). This tended to peak around 0.5 hours post injection and resolve by 1.5-3.0 hours.

No treatment-related serious adverse events occurred, and no treatment-emergent adverse events led to discontinuation or death.

“This early-phase trial indicates that RTX-GRT7039 has the potential to provide meaningful and sustained analgesia for patients with knee OA pain,” Conaghan and colleagues wrote in their poster.

The drug is now being evaluated in three phase 3 trials (NCT05248386, NCT05449132, and NCT05377489).

 

LEVI-04: Modulation of NT-3 Appears to Work Safely

LEVI-04 was evaluated in a phase 2, 20-week, 13-center (Europe and Hong Kong) randomized, double-blind, placebo-controlled trial in 518 people with knee OA who had WOMAC pain subscale scores ≥ 20, mean average daily pain numeric rating scale score of 4-9, and radiographic Kellgren-Lawrence grade ≥ 2.

They were randomized to a total of five infusions of placebo or 0.3 mg/kg, 0.1 mg/kg, or 2 mg/kg LEVI-04 from baseline through week 16, with safety follow-up to week 30.

The primary endpoint, change in WOMAC pain from baseline to weeks 5 and 17, was met for all three doses. At 17 weeks, those were –2.79, –2.89, and –3.08 for 0.3 mg, 1.0 mg, and 2 mg, respectively, vs –2.28 for placebo (all P < .05).

Secondary endpoints, including WOMAC physical function, WOMAC stiffness, and Patient Global Assessment, and > 50% pain responders, were also all met at weeks 5 and 17. More than 50% of the LEVI-04–treated patients reported ≥ 50% reduction in pain, and > 25% reported ≥ 75% reduction at weeks 5 and 17.

“So, this modulation of NT-3 is working,” Conaghan commented.

There were no increased incidences of severe adverse events, treatment-emergent adverse events, or joint pathologies, including rapidly progressive OA, compared with placebo.

There were more paresthesias reported with the active drug, 2-4 vs 1 with placebo. “That says to me that the drug is working and that it’s having an effect on peripheral nerves, but luckily these were all mild or moderate and didn’t lead to any study withdrawal or discontinuation,” Conaghan said.

Phase 3 trials are in the planning stages, he noted.

 

Other Approaches to Treating OA Pain

Other approaches to treating OA pain have included methotrexate, for which Conaghan was also a coauthor on one paper that came out earlier in 2024. “This presumably works by treating inflammation, but it’s not clear if that is within-joint inflammation or systemic inflammation,” he said in an interview.

Another approach, using the weight loss drug semaglutide, was presented in April 2024 at the 2024 World Congress on Osteoarthritis annual meeting and published in October 2024 in The New England Journal of Medicine

The trial involving RTX-GRT7039 was funded by Grünenthal, and some study coauthors are employees of the company. The trial involving LEVI-04 was funded by Levicept, and some study coauthors are employees of the company. Conaghan is a consultant and/or speaker for Eli Lilly, Eupraxia Pharmaceuticals, Formation Bio, Galapagos, Genascence, GlaxoSmithKline, Grünenthal, Janssen Pharmaceuticals, Kolon TissueGene, Levicept, Medipost, Moebius, Novartis, Pacira, Sandoz, Stryker Corporation, and Takeda. Gardner and Jeffries had no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with serum ferritin levels higher than 1000 μg/L show a 91% increased risk for any fracture, with a doubled risk for vertebral and humerus fractures compared with those without iron overload.

 

METHODOLOGY:

• Iron overload’s association with decreased bone mineral density is established, but its relationship to osteoporotic fracture risk has remained understudied and inconsistent across fracture sites.
• Researchers conducted a population-based cohort study using a UK general practice database to evaluate the fracture risk in 20,264 patients with iron overload and 192,956 matched controls without elevated ferritin (mean age, 57 years; about 40% women).
• Patients with iron overload were identified as those with laboratory-confirmed iron overload (serum ferritin levels > 1000 μg/L; n = 13,510) or a diagnosis of an iron overloading disorder, such as thalassemia major, sickle cell disease, or hemochromatosis (n = 6754).
• The primary outcome of interest was the first occurrence of an osteoporotic fracture after the diagnosis of iron overload or first record of high ferritin.
• A sensitivity analysis was conducted to check the impact of laboratory-confirmed iron overload on the risk for osteoporotic fracture compared with a diagnosis code without elevated ferritin.

TAKEAWAY:

• In the overall cohort, patients with iron overload had a 55% higher risk for any osteoporotic fracture than control individuals (adjusted hazard ratio [aHR], 1.55; 95% CI, 1.42-1.68), with the highest risk observed for vertebral fractures (aHR, 1.97; 95% CI, 1.63-2.37) and humerus fractures (aHR, 1.91; 95% CI, 1.61-2.26).
• Patients with laboratory-confirmed iron overload showed a 91% increased risk for any fracture (aHR, 1.91; 95% CI, 1.73-2.10), with a 2.5-fold higher risk observed for vertebral fractures (aHR, 2.51; 95% CI, 2.01-3.12), followed by humerus fractures (aHR, 2.41; 95% CI, 1.96-2.95).
• There was no increased risk for fracture at any site in patients with a diagnosis of an iron overloading disorder but no laboratory-confirmed iron overload.
• No sex-specific differences were identified in the association between iron overload and fracture risk.

IN PRACTICE:

“The main clinical message from our findings is that clinicians should consider iron overloading as a risk factor for fracture. Importantly, among high-risk patients presenting with serum ferritin values exceeding 1000 μg/L, osteoporosis screening and treatment strategies should be initiated in accordance with the guidelines for patients with hepatic disease,” the authors wrote.

 

SOURCE:

The study was led by Andrea Michelle Burden, PhD, Institute of Pharmaceutical Sciences, Department of Chemistry and Applied Biosciences, ETH Zürich in Switzerland, and was published online in The Journal of Clinical Endocrinology & Metabolism.

 

LIMITATIONS:

The study could not assess the duration of iron overload on fracture risk, and thus, patients could enter the cohort with a single elevated serum ferritin value that may not have reflected systemic iron overload. The authors also acknowledged potential exposure misclassification among matched control individuals because only 2.9% had a serum ferritin value available at baseline. Also, researchers were unable to adjust for inflammation status due to the limited availability of C-reactive protein measurements and the lack of leukocyte count data in primary care settings.

 

DISCLOSURES:

This study received support through grants from the German Research Foundation. The authors declared no conflicts of interest.

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

TOPLINE:

Patients with serum ferritin levels higher than 1000 μg/L show a 91% increased risk for any fracture, with a doubled risk for vertebral and humerus fractures compared with those without iron overload.

 

METHODOLOGY:

• Iron overload’s association with decreased bone mineral density is established, but its relationship to osteoporotic fracture risk has remained understudied and inconsistent across fracture sites.
• Researchers conducted a population-based cohort study using a UK general practice database to evaluate the fracture risk in 20,264 patients with iron overload and 192,956 matched controls without elevated ferritin (mean age, 57 years; about 40% women).
• Patients with iron overload were identified as those with laboratory-confirmed iron overload (serum ferritin levels > 1000 μg/L; n = 13,510) or a diagnosis of an iron overloading disorder, such as thalassemia major, sickle cell disease, or hemochromatosis (n = 6754).
• The primary outcome of interest was the first occurrence of an osteoporotic fracture after the diagnosis of iron overload or first record of high ferritin.
• A sensitivity analysis was conducted to check the impact of laboratory-confirmed iron overload on the risk for osteoporotic fracture compared with a diagnosis code without elevated ferritin.

TAKEAWAY:

• In the overall cohort, patients with iron overload had a 55% higher risk for any osteoporotic fracture than control individuals (adjusted hazard ratio [aHR], 1.55; 95% CI, 1.42-1.68), with the highest risk observed for vertebral fractures (aHR, 1.97; 95% CI, 1.63-2.37) and humerus fractures (aHR, 1.91; 95% CI, 1.61-2.26).
• Patients with laboratory-confirmed iron overload showed a 91% increased risk for any fracture (aHR, 1.91; 95% CI, 1.73-2.10), with a 2.5-fold higher risk observed for vertebral fractures (aHR, 2.51; 95% CI, 2.01-3.12), followed by humerus fractures (aHR, 2.41; 95% CI, 1.96-2.95).
• There was no increased risk for fracture at any site in patients with a diagnosis of an iron overloading disorder but no laboratory-confirmed iron overload.
• No sex-specific differences were identified in the association between iron overload and fracture risk.

IN PRACTICE:

“The main clinical message from our findings is that clinicians should consider iron overloading as a risk factor for fracture. Importantly, among high-risk patients presenting with serum ferritin values exceeding 1000 μg/L, osteoporosis screening and treatment strategies should be initiated in accordance with the guidelines for patients with hepatic disease,” the authors wrote.

 

SOURCE:

The study was led by Andrea Michelle Burden, PhD, Institute of Pharmaceutical Sciences, Department of Chemistry and Applied Biosciences, ETH Zürich in Switzerland, and was published online in The Journal of Clinical Endocrinology & Metabolism.

 

LIMITATIONS:

The study could not assess the duration of iron overload on fracture risk, and thus, patients could enter the cohort with a single elevated serum ferritin value that may not have reflected systemic iron overload. The authors also acknowledged potential exposure misclassification among matched control individuals because only 2.9% had a serum ferritin value available at baseline. Also, researchers were unable to adjust for inflammation status due to the limited availability of C-reactive protein measurements and the lack of leukocyte count data in primary care settings.

 

DISCLOSURES:

This study received support through grants from the German Research Foundation. The authors declared no conflicts of interest.

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

TOPLINE:

Patients with serum ferritin levels higher than 1000 μg/L show a 91% increased risk for any fracture, with a doubled risk for vertebral and humerus fractures compared with those without iron overload.

 

METHODOLOGY:

• Iron overload’s association with decreased bone mineral density is established, but its relationship to osteoporotic fracture risk has remained understudied and inconsistent across fracture sites.
• Researchers conducted a population-based cohort study using a UK general practice database to evaluate the fracture risk in 20,264 patients with iron overload and 192,956 matched controls without elevated ferritin (mean age, 57 years; about 40% women).
• Patients with iron overload were identified as those with laboratory-confirmed iron overload (serum ferritin levels > 1000 μg/L; n = 13,510) or a diagnosis of an iron overloading disorder, such as thalassemia major, sickle cell disease, or hemochromatosis (n = 6754).
• The primary outcome of interest was the first occurrence of an osteoporotic fracture after the diagnosis of iron overload or first record of high ferritin.
• A sensitivity analysis was conducted to check the impact of laboratory-confirmed iron overload on the risk for osteoporotic fracture compared with a diagnosis code without elevated ferritin.

TAKEAWAY:

• In the overall cohort, patients with iron overload had a 55% higher risk for any osteoporotic fracture than control individuals (adjusted hazard ratio [aHR], 1.55; 95% CI, 1.42-1.68), with the highest risk observed for vertebral fractures (aHR, 1.97; 95% CI, 1.63-2.37) and humerus fractures (aHR, 1.91; 95% CI, 1.61-2.26).
• Patients with laboratory-confirmed iron overload showed a 91% increased risk for any fracture (aHR, 1.91; 95% CI, 1.73-2.10), with a 2.5-fold higher risk observed for vertebral fractures (aHR, 2.51; 95% CI, 2.01-3.12), followed by humerus fractures (aHR, 2.41; 95% CI, 1.96-2.95).
• There was no increased risk for fracture at any site in patients with a diagnosis of an iron overloading disorder but no laboratory-confirmed iron overload.
• No sex-specific differences were identified in the association between iron overload and fracture risk.

IN PRACTICE:

“The main clinical message from our findings is that clinicians should consider iron overloading as a risk factor for fracture. Importantly, among high-risk patients presenting with serum ferritin values exceeding 1000 μg/L, osteoporosis screening and treatment strategies should be initiated in accordance with the guidelines for patients with hepatic disease,” the authors wrote.

 

SOURCE:

The study was led by Andrea Michelle Burden, PhD, Institute of Pharmaceutical Sciences, Department of Chemistry and Applied Biosciences, ETH Zürich in Switzerland, and was published online in The Journal of Clinical Endocrinology & Metabolism.

 

LIMITATIONS:

The study could not assess the duration of iron overload on fracture risk, and thus, patients could enter the cohort with a single elevated serum ferritin value that may not have reflected systemic iron overload. The authors also acknowledged potential exposure misclassification among matched control individuals because only 2.9% had a serum ferritin value available at baseline. Also, researchers were unable to adjust for inflammation status due to the limited availability of C-reactive protein measurements and the lack of leukocyte count data in primary care settings.

 

DISCLOSURES:

This study received support through grants from the German Research Foundation. The authors declared no conflicts of interest.

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

TOPLINE:

Exposure to individual or mixed per- and polyfluoroalkyl substances (PFASs) is associated with changes in peripheral rather than central thyroid hormone sensitivity.

METHODOLOGY:

• PFASs are widely recognized for their persistence in the environment and potential endocrine-disrupting effects.
• A cross-sectional study investigated associations between PFAS exposures and thyroid homeostasis parameters in adult participants in two National Health and Nutrition Examination Survey cycles (2007-2008 and 2011-2012).
• Participants were required to have complete thyroid hormone profiles and measurements of PFAS concentration, not be pregnant, and not have thyroid disease or a history of using thyroid drugs such as thyroxine, methimazole, and propylthiouracil.
• Levels of six PFASs were measured in the serum: Perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), perfluorodecanoic acid, perfluorohexane sulfonic acid (PFHxS), and 2-(N-methyl-perfluorooctane sulfonamido) acetic acid.
• Thyroid homeostasis parameters were assessed using serum concentrations of thyroid hormones.
• Peripheral sensitivity was calculated using the ratio of free triiodothyronine to free thyroxine (FT3/FT4) and the sum activity of peripheral deiodinases (SPINA-GD).
• Central sensitivity was assessed with thyrotroph thyroxine resistance index, thyroid-stimulating hormone index, thyroid feedback quantile–based index (TFQI), and parametric TFQI.

TAKEAWAY:

• Researchers included 2386 adults (mean age, 47.59 years; 53.94% men; 42.88% White).
• FT3/FT4 and SPINA-GD were positively associated with PFOA, PFOS, PFNA, and PFHxS (P < .05 for all) in an adjusted analysis; however, no link was found between central thyroid sensitivity parameters and PFAS exposures.
• Specifically, higher quartiles of PFOA and PFOS concentrations were associated with an increased FT3/FT4 and SPINA-GD, indicating an increased conversion efficiency of FT4 to FT3 or peripheral deiodinase.
• Exposure to a mixture of different PFASs was also positively correlated with FT3/FT4 (beta, 0.013; P < .001) and SPINA-GD (beta, 1.230; P < .001), with PFOA showing the highest contribution.
• Men and smokers showed higher correlations of PFOA with peripheral thyroid hormone sensitivity indicators than women and nonsmokers, respectively.

IN PRACTICE:

“PFAS exposure, especially PFOA and PFOS, mainly impacted peripheral sensitivity to thyroid hormones, instead of central sensitivity,” the authors wrote, adding that their results may support, “taking more steps to prevent and reduce” the harmful effects of PFASs.

SOURCE:

This study was led by Xinwen Yu and Yufei Liu, Department of Endocrinology, The Second Affiliated Hospital of Air Force Medical University, Xi’an, China. It was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The cross-sectional design of this study limited the ability to establish causal relationships between PFAS exposure and thyroid function. The assessment of thyroid homeostasis parameters was conducted indirectly by measuring thyroid hormone levels. Inaccuracies in self-reported data on long-term exposure to PFASs and the exclusion of other endocrine-disrupting chemicals may have affected the study’s conclusions.

DISCLOSURES:

This study was supported by grants from the Natural Science Foundation of Shaanxi Province, China; the Key Research and Development Project of Shaanxi Province; and the Clinical Research Program of Air Force Medical University. The authors reported having no relevant conflicts of interest.

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

TOPLINE:

Exposure to individual or mixed per- and polyfluoroalkyl substances (PFASs) is associated with changes in peripheral rather than central thyroid hormone sensitivity.

METHODOLOGY:

• PFASs are widely recognized for their persistence in the environment and potential endocrine-disrupting effects.
• A cross-sectional study investigated associations between PFAS exposures and thyroid homeostasis parameters in adult participants in two National Health and Nutrition Examination Survey cycles (2007-2008 and 2011-2012).
• Participants were required to have complete thyroid hormone profiles and measurements of PFAS concentration, not be pregnant, and not have thyroid disease or a history of using thyroid drugs such as thyroxine, methimazole, and propylthiouracil.
• Levels of six PFASs were measured in the serum: Perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), perfluorodecanoic acid, perfluorohexane sulfonic acid (PFHxS), and 2-(N-methyl-perfluorooctane sulfonamido) acetic acid.
• Thyroid homeostasis parameters were assessed using serum concentrations of thyroid hormones.
• Peripheral sensitivity was calculated using the ratio of free triiodothyronine to free thyroxine (FT3/FT4) and the sum activity of peripheral deiodinases (SPINA-GD).
• Central sensitivity was assessed with thyrotroph thyroxine resistance index, thyroid-stimulating hormone index, thyroid feedback quantile–based index (TFQI), and parametric TFQI.

TAKEAWAY:

• Researchers included 2386 adults (mean age, 47.59 years; 53.94% men; 42.88% White).
• FT3/FT4 and SPINA-GD were positively associated with PFOA, PFOS, PFNA, and PFHxS (P < .05 for all) in an adjusted analysis; however, no link was found between central thyroid sensitivity parameters and PFAS exposures.
• Specifically, higher quartiles of PFOA and PFOS concentrations were associated with an increased FT3/FT4 and SPINA-GD, indicating an increased conversion efficiency of FT4 to FT3 or peripheral deiodinase.
• Exposure to a mixture of different PFASs was also positively correlated with FT3/FT4 (beta, 0.013; P < .001) and SPINA-GD (beta, 1.230; P < .001), with PFOA showing the highest contribution.
• Men and smokers showed higher correlations of PFOA with peripheral thyroid hormone sensitivity indicators than women and nonsmokers, respectively.

IN PRACTICE:

“PFAS exposure, especially PFOA and PFOS, mainly impacted peripheral sensitivity to thyroid hormones, instead of central sensitivity,” the authors wrote, adding that their results may support, “taking more steps to prevent and reduce” the harmful effects of PFASs.

SOURCE:

This study was led by Xinwen Yu and Yufei Liu, Department of Endocrinology, The Second Affiliated Hospital of Air Force Medical University, Xi’an, China. It was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The cross-sectional design of this study limited the ability to establish causal relationships between PFAS exposure and thyroid function. The assessment of thyroid homeostasis parameters was conducted indirectly by measuring thyroid hormone levels. Inaccuracies in self-reported data on long-term exposure to PFASs and the exclusion of other endocrine-disrupting chemicals may have affected the study’s conclusions.

DISCLOSURES:

This study was supported by grants from the Natural Science Foundation of Shaanxi Province, China; the Key Research and Development Project of Shaanxi Province; and the Clinical Research Program of Air Force Medical University. The authors reported having no relevant conflicts of interest.

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

TOPLINE:

Exposure to individual or mixed per- and polyfluoroalkyl substances (PFASs) is associated with changes in peripheral rather than central thyroid hormone sensitivity.

METHODOLOGY:

• PFASs are widely recognized for their persistence in the environment and potential endocrine-disrupting effects.
• A cross-sectional study investigated associations between PFAS exposures and thyroid homeostasis parameters in adult participants in two National Health and Nutrition Examination Survey cycles (2007-2008 and 2011-2012).
• Participants were required to have complete thyroid hormone profiles and measurements of PFAS concentration, not be pregnant, and not have thyroid disease or a history of using thyroid drugs such as thyroxine, methimazole, and propylthiouracil.
• Levels of six PFASs were measured in the serum: Perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), perfluorodecanoic acid, perfluorohexane sulfonic acid (PFHxS), and 2-(N-methyl-perfluorooctane sulfonamido) acetic acid.
• Thyroid homeostasis parameters were assessed using serum concentrations of thyroid hormones.
• Peripheral sensitivity was calculated using the ratio of free triiodothyronine to free thyroxine (FT3/FT4) and the sum activity of peripheral deiodinases (SPINA-GD).
• Central sensitivity was assessed with thyrotroph thyroxine resistance index, thyroid-stimulating hormone index, thyroid feedback quantile–based index (TFQI), and parametric TFQI.

TAKEAWAY:

• Researchers included 2386 adults (mean age, 47.59 years; 53.94% men; 42.88% White).
• FT3/FT4 and SPINA-GD were positively associated with PFOA, PFOS, PFNA, and PFHxS (P < .05 for all) in an adjusted analysis; however, no link was found between central thyroid sensitivity parameters and PFAS exposures.
• Specifically, higher quartiles of PFOA and PFOS concentrations were associated with an increased FT3/FT4 and SPINA-GD, indicating an increased conversion efficiency of FT4 to FT3 or peripheral deiodinase.
• Exposure to a mixture of different PFASs was also positively correlated with FT3/FT4 (beta, 0.013; P < .001) and SPINA-GD (beta, 1.230; P < .001), with PFOA showing the highest contribution.
• Men and smokers showed higher correlations of PFOA with peripheral thyroid hormone sensitivity indicators than women and nonsmokers, respectively.

IN PRACTICE:

“PFAS exposure, especially PFOA and PFOS, mainly impacted peripheral sensitivity to thyroid hormones, instead of central sensitivity,” the authors wrote, adding that their results may support, “taking more steps to prevent and reduce” the harmful effects of PFASs.

SOURCE:

This study was led by Xinwen Yu and Yufei Liu, Department of Endocrinology, The Second Affiliated Hospital of Air Force Medical University, Xi’an, China. It was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The cross-sectional design of this study limited the ability to establish causal relationships between PFAS exposure and thyroid function. The assessment of thyroid homeostasis parameters was conducted indirectly by measuring thyroid hormone levels. Inaccuracies in self-reported data on long-term exposure to PFASs and the exclusion of other endocrine-disrupting chemicals may have affected the study’s conclusions.

DISCLOSURES:

This study was supported by grants from the Natural Science Foundation of Shaanxi Province, China; the Key Research and Development Project of Shaanxi Province; and the Clinical Research Program of Air Force Medical University. The authors reported having no relevant conflicts of interest.

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

Most US adults continue to plan on skipping an annual COVID vaccine.

About 6 in 10 people say they probably won’t get an updated shot this year, despite the Centers for Disease Control and Prevention’s (CDC) recommendation that everyone do so, according to results of a new survey from the Pew Research Center.

When asked why people wouldn’t get an updated COVID vaccine, 61% said a major reason was that they don’t think they need it, and 60% said a major reason is that they are concerned about side effects. Cost was a factor for 14% of people, and 46% of people said they don’t get vaccines in general.

There were some differences in intention to get vaccinated based on a person’s age. Among people ages 65 and older, 27% said they had already gotten the vaccine, and another 27% said they probably will get the shot, leaving 45% who said they probably won’t roll up their sleeves. People ages 30-49 years old were the least likely to plan on getting a COVID shot – 66% said they probably won’t get one.

Public health officials say everyone should get an annual COVID vaccine, just as they should get a flu shot, because the vaccines are formulated each year to target virus strains predicted to be in wide circulation. Also, immunity – either from past vaccination or past infection – wanes over time. 

Research shows that the vaccines reduce the likelihood of hospitalization or death caused by severe illness, particularly among people who have risk factors, like being over age 65 or having health issues that are becoming increasingly common in the United States, like diabetes, heart problems, and lung conditions.

The survey included 9,593 adults who were asked about their COVID vaccine intentions with this question: “Public health officials recently recommended an updated vaccine for COVID-19. Do you think you will probably get an updated vaccine, probably not get an updated vaccine, or have you already received an updated vaccine?” The survey was done online and by telephone from October 21 to October 27.

So far in 2024, the CDC’s ongoing immunization survey shows that 17% of adults say that, as of November 2, they have gotten vaccinated for COVID-19 this season, and 14% said they will definitely get vaccinated. The Pew Research Center survey found that 15% of people said they’ve already gotten the shot this season.

Reports of positive COVID tests, emergency room visits, and hospitalizations remain very low. About 3.6% of test results shared with the CDC were positive for COVID the week ending November 9. Less than 1% of ER visits involve a COVID diagnosis, and hospitalizations are well below the rate seen at this time last year. Last year, COVID activity in the United States began rising around Thanksgiving and continued upward, peaking in early January.

The protection from a COVID-19 vaccination usually fully kicks in about 2 weeks after you get the shot, and the vaccines are most effective for the following 3 months.

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

Most US adults continue to plan on skipping an annual COVID vaccine.

About 6 in 10 people say they probably won’t get an updated shot this year, despite the Centers for Disease Control and Prevention’s (CDC) recommendation that everyone do so, according to results of a new survey from the Pew Research Center.

When asked why people wouldn’t get an updated COVID vaccine, 61% said a major reason was that they don’t think they need it, and 60% said a major reason is that they are concerned about side effects. Cost was a factor for 14% of people, and 46% of people said they don’t get vaccines in general.

There were some differences in intention to get vaccinated based on a person’s age. Among people ages 65 and older, 27% said they had already gotten the vaccine, and another 27% said they probably will get the shot, leaving 45% who said they probably won’t roll up their sleeves. People ages 30-49 years old were the least likely to plan on getting a COVID shot – 66% said they probably won’t get one.

Public health officials say everyone should get an annual COVID vaccine, just as they should get a flu shot, because the vaccines are formulated each year to target virus strains predicted to be in wide circulation. Also, immunity – either from past vaccination or past infection – wanes over time. 

Research shows that the vaccines reduce the likelihood of hospitalization or death caused by severe illness, particularly among people who have risk factors, like being over age 65 or having health issues that are becoming increasingly common in the United States, like diabetes, heart problems, and lung conditions.

The survey included 9,593 adults who were asked about their COVID vaccine intentions with this question: “Public health officials recently recommended an updated vaccine for COVID-19. Do you think you will probably get an updated vaccine, probably not get an updated vaccine, or have you already received an updated vaccine?” The survey was done online and by telephone from October 21 to October 27.

So far in 2024, the CDC’s ongoing immunization survey shows that 17% of adults say that, as of November 2, they have gotten vaccinated for COVID-19 this season, and 14% said they will definitely get vaccinated. The Pew Research Center survey found that 15% of people said they’ve already gotten the shot this season.

Reports of positive COVID tests, emergency room visits, and hospitalizations remain very low. About 3.6% of test results shared with the CDC were positive for COVID the week ending November 9. Less than 1% of ER visits involve a COVID diagnosis, and hospitalizations are well below the rate seen at this time last year. Last year, COVID activity in the United States began rising around Thanksgiving and continued upward, peaking in early January.

The protection from a COVID-19 vaccination usually fully kicks in about 2 weeks after you get the shot, and the vaccines are most effective for the following 3 months.

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

Most US adults continue to plan on skipping an annual COVID vaccine.

About 6 in 10 people say they probably won’t get an updated shot this year, despite the Centers for Disease Control and Prevention’s (CDC) recommendation that everyone do so, according to results of a new survey from the Pew Research Center.

When asked why people wouldn’t get an updated COVID vaccine, 61% said a major reason was that they don’t think they need it, and 60% said a major reason is that they are concerned about side effects. Cost was a factor for 14% of people, and 46% of people said they don’t get vaccines in general.

There were some differences in intention to get vaccinated based on a person’s age. Among people ages 65 and older, 27% said they had already gotten the vaccine, and another 27% said they probably will get the shot, leaving 45% who said they probably won’t roll up their sleeves. People ages 30-49 years old were the least likely to plan on getting a COVID shot – 66% said they probably won’t get one.

Public health officials say everyone should get an annual COVID vaccine, just as they should get a flu shot, because the vaccines are formulated each year to target virus strains predicted to be in wide circulation. Also, immunity – either from past vaccination or past infection – wanes over time. 

Research shows that the vaccines reduce the likelihood of hospitalization or death caused by severe illness, particularly among people who have risk factors, like being over age 65 or having health issues that are becoming increasingly common in the United States, like diabetes, heart problems, and lung conditions.

The survey included 9,593 adults who were asked about their COVID vaccine intentions with this question: “Public health officials recently recommended an updated vaccine for COVID-19. Do you think you will probably get an updated vaccine, probably not get an updated vaccine, or have you already received an updated vaccine?” The survey was done online and by telephone from October 21 to October 27.

So far in 2024, the CDC’s ongoing immunization survey shows that 17% of adults say that, as of November 2, they have gotten vaccinated for COVID-19 this season, and 14% said they will definitely get vaccinated. The Pew Research Center survey found that 15% of people said they’ve already gotten the shot this season.

Reports of positive COVID tests, emergency room visits, and hospitalizations remain very low. About 3.6% of test results shared with the CDC were positive for COVID the week ending November 9. Less than 1% of ER visits involve a COVID diagnosis, and hospitalizations are well below the rate seen at this time last year. Last year, COVID activity in the United States began rising around Thanksgiving and continued upward, peaking in early January.

The protection from a COVID-19 vaccination usually fully kicks in about 2 weeks after you get the shot, and the vaccines are most effective for the following 3 months.

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

Six times as many cases of pertussis were reported in the United States for the week ending November 16, 2024, as the same week in 2023, according to new data from the Centers for Disease Control and Prevention (CDC).

The numbers reflect a return to prepandemic trends, but overall, pertussis cases for 2024 so far have surpassed those seen prior to the pandemic in 2019, according to the CDC.

Of the 434 cases reported for the week ending November 16, 2024, a majority (109) occurred in the East North Central region, mostly in Ohio (93). Another 70 cases occurred in the West North Central region, with 32 cases and 37 cases in Missouri and Nebraska, respectively.

None of the 75 cases in the Middle Atlantic region occurred in New Jersey or New York City; 38 were reported elsewhere in New York, and 37 in Pennsylvania. The South Atlantic region reported 55 cases, including 29 in Florida. The East South Central and West South Central regions reported 11 and 20 cases, respectively. The Mountain and Pacific regions reported 31 (20 in Arizona) and 47 (20 in Washington State) cases, respectively.

The CDC tracks pertussis cases through a national surveillance system, but many cases are likely unrecognized and unreported, according to the CDC.

Although vaccines for pertussis (whooping cough) provide protection, their effectiveness decreases over time, and the CDC expects rates to increase in vaccinated and unvaccinated populations as case levels rebound with the lifting of pandemic mitigation strategies such as masking and remote learning.

Recent CDC data reported by Medscape Medical News showed an association between lower vaccination rates and 2024’s uptick in pertussis cases.

 

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

Six times as many cases of pertussis were reported in the United States for the week ending November 16, 2024, as the same week in 2023, according to new data from the Centers for Disease Control and Prevention (CDC).

The numbers reflect a return to prepandemic trends, but overall, pertussis cases for 2024 so far have surpassed those seen prior to the pandemic in 2019, according to the CDC.

Of the 434 cases reported for the week ending November 16, 2024, a majority (109) occurred in the East North Central region, mostly in Ohio (93). Another 70 cases occurred in the West North Central region, with 32 cases and 37 cases in Missouri and Nebraska, respectively.

None of the 75 cases in the Middle Atlantic region occurred in New Jersey or New York City; 38 were reported elsewhere in New York, and 37 in Pennsylvania. The South Atlantic region reported 55 cases, including 29 in Florida. The East South Central and West South Central regions reported 11 and 20 cases, respectively. The Mountain and Pacific regions reported 31 (20 in Arizona) and 47 (20 in Washington State) cases, respectively.

The CDC tracks pertussis cases through a national surveillance system, but many cases are likely unrecognized and unreported, according to the CDC.

Although vaccines for pertussis (whooping cough) provide protection, their effectiveness decreases over time, and the CDC expects rates to increase in vaccinated and unvaccinated populations as case levels rebound with the lifting of pandemic mitigation strategies such as masking and remote learning.

Recent CDC data reported by Medscape Medical News showed an association between lower vaccination rates and 2024’s uptick in pertussis cases.

 

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

Six times as many cases of pertussis were reported in the United States for the week ending November 16, 2024, as the same week in 2023, according to new data from the Centers for Disease Control and Prevention (CDC).

The numbers reflect a return to prepandemic trends, but overall, pertussis cases for 2024 so far have surpassed those seen prior to the pandemic in 2019, according to the CDC.

Of the 434 cases reported for the week ending November 16, 2024, a majority (109) occurred in the East North Central region, mostly in Ohio (93). Another 70 cases occurred in the West North Central region, with 32 cases and 37 cases in Missouri and Nebraska, respectively.

None of the 75 cases in the Middle Atlantic region occurred in New Jersey or New York City; 38 were reported elsewhere in New York, and 37 in Pennsylvania. The South Atlantic region reported 55 cases, including 29 in Florida. The East South Central and West South Central regions reported 11 and 20 cases, respectively. The Mountain and Pacific regions reported 31 (20 in Arizona) and 47 (20 in Washington State) cases, respectively.

The CDC tracks pertussis cases through a national surveillance system, but many cases are likely unrecognized and unreported, according to the CDC.

Although vaccines for pertussis (whooping cough) provide protection, their effectiveness decreases over time, and the CDC expects rates to increase in vaccinated and unvaccinated populations as case levels rebound with the lifting of pandemic mitigation strategies such as masking and remote learning.

Recent CDC data reported by Medscape Medical News showed an association between lower vaccination rates and 2024’s uptick in pertussis cases.

 

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

TOPLINE:

Administering the Bacillus Calmette-Guérin (BCG) vaccine during the active phase of COVID-19 may help protect against the development of long COVID.

METHODOLOGY:

• A phase 3 clinical trial initiated in early 2020 investigated the effect of the BCG vaccine injected during active infection on COVID-19 progression in adults with mild or moderate COVID-19. The current study summarizes the 6- and 12-month follow-up data with a focus on long-COVID symptoms.
• Patients who tested positive for severe acute respiratory syndrome coronavirus 2 were randomly assigned to receive either 0.1 mL of intradermal BCG (n = 191) or 0.9% saline placebo (n = 202) within 14 days of symptom onset and were followed up at 7, 14, 21, and 45 days and at 6 and 12 months postinjection.
• Overall, 157 BCG (median age, 40 years; 54.1% women) and 142 placebo (median age, 41 years; 65.5% women) recipients completed the 6-month follow-up, and 97 BCG (median age, 37 years; 49.5% women) and 95 placebo (median age, 40 years; 67.4% women) recipients completed the 12-month follow-up.
• The researchers primarily assessed the effect of the BCG vaccine on the development of the symptoms of long COVID at 6 and 12 months.

TAKEAWAY:

• Hearing problems were less frequent among BCG recipients at 6 months compared with those who received placebo (odds ratio [OR], 0.26; 95% CI, 0.045-1.0; P = .044).
• At 12 months, participants who received the BCG vaccine exhibited fewer issues with sleeping (P = .027), concentration (P = .009), memory (P = .009), and vision (P = .022) along with a lower long-COVID score (one-sided Wilcoxon test, P = .002) than those who received placebo.
• At 6 months, BCG demonstrated a sex-specific paradoxical effect on hair loss, decreasing it in men (P = .031), while causing a slight, though statistically nonsignificant, increase in women.
• Male sex was the strongest predictive factor for long COVID, cognitive dysfunction, and cardiopulmonary scores at both follow-up assessments.

IN PRACTICE:

“[The study] findings suggest that BCG immunotherapy for an existing ailment may be superior to prophylaxis in healthy individuals,” the authors wrote.

SOURCE:

The study was led by Mehrsa Jalalizadeh and Keini Buosi, UroScience, State University of Campinas, Unicamp, São Paulo, Brazil. It was published online on November 19, 2024, in the Journal of Internal Medicine.

LIMITATIONS:

Previous mycobacterial exposure was not tested among the study participants. A notable loss to follow-up, particularly at 12 months, may have introduced bias into the results.

DISCLOSURES:

The study was supported by the Coordination for the Improvement of Higher Education Personnel, Federal Government of Brazil, the General Coordination of the National Immunization Program, Ministry of Health (Brazil), and the National Council for Scientific and Technological Development-Research Productivity. The authors declared no conflicts of interest.

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

TOPLINE:

Administering the Bacillus Calmette-Guérin (BCG) vaccine during the active phase of COVID-19 may help protect against the development of long COVID.

METHODOLOGY:

• A phase 3 clinical trial initiated in early 2020 investigated the effect of the BCG vaccine injected during active infection on COVID-19 progression in adults with mild or moderate COVID-19. The current study summarizes the 6- and 12-month follow-up data with a focus on long-COVID symptoms.
• Patients who tested positive for severe acute respiratory syndrome coronavirus 2 were randomly assigned to receive either 0.1 mL of intradermal BCG (n = 191) or 0.9% saline placebo (n = 202) within 14 days of symptom onset and were followed up at 7, 14, 21, and 45 days and at 6 and 12 months postinjection.
• Overall, 157 BCG (median age, 40 years; 54.1% women) and 142 placebo (median age, 41 years; 65.5% women) recipients completed the 6-month follow-up, and 97 BCG (median age, 37 years; 49.5% women) and 95 placebo (median age, 40 years; 67.4% women) recipients completed the 12-month follow-up.
• The researchers primarily assessed the effect of the BCG vaccine on the development of the symptoms of long COVID at 6 and 12 months.

TAKEAWAY:

• Hearing problems were less frequent among BCG recipients at 6 months compared with those who received placebo (odds ratio [OR], 0.26; 95% CI, 0.045-1.0; P = .044).
• At 12 months, participants who received the BCG vaccine exhibited fewer issues with sleeping (P = .027), concentration (P = .009), memory (P = .009), and vision (P = .022) along with a lower long-COVID score (one-sided Wilcoxon test, P = .002) than those who received placebo.
• At 6 months, BCG demonstrated a sex-specific paradoxical effect on hair loss, decreasing it in men (P = .031), while causing a slight, though statistically nonsignificant, increase in women.
• Male sex was the strongest predictive factor for long COVID, cognitive dysfunction, and cardiopulmonary scores at both follow-up assessments.

IN PRACTICE:

“[The study] findings suggest that BCG immunotherapy for an existing ailment may be superior to prophylaxis in healthy individuals,” the authors wrote.

SOURCE:

The study was led by Mehrsa Jalalizadeh and Keini Buosi, UroScience, State University of Campinas, Unicamp, São Paulo, Brazil. It was published online on November 19, 2024, in the Journal of Internal Medicine.

LIMITATIONS:

Previous mycobacterial exposure was not tested among the study participants. A notable loss to follow-up, particularly at 12 months, may have introduced bias into the results.

DISCLOSURES:

The study was supported by the Coordination for the Improvement of Higher Education Personnel, Federal Government of Brazil, the General Coordination of the National Immunization Program, Ministry of Health (Brazil), and the National Council for Scientific and Technological Development-Research Productivity. The authors declared no conflicts of interest.

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

TOPLINE:

Administering the Bacillus Calmette-Guérin (BCG) vaccine during the active phase of COVID-19 may help protect against the development of long COVID.

METHODOLOGY:

• A phase 3 clinical trial initiated in early 2020 investigated the effect of the BCG vaccine injected during active infection on COVID-19 progression in adults with mild or moderate COVID-19. The current study summarizes the 6- and 12-month follow-up data with a focus on long-COVID symptoms.
• Patients who tested positive for severe acute respiratory syndrome coronavirus 2 were randomly assigned to receive either 0.1 mL of intradermal BCG (n = 191) or 0.9% saline placebo (n = 202) within 14 days of symptom onset and were followed up at 7, 14, 21, and 45 days and at 6 and 12 months postinjection.
• Overall, 157 BCG (median age, 40 years; 54.1% women) and 142 placebo (median age, 41 years; 65.5% women) recipients completed the 6-month follow-up, and 97 BCG (median age, 37 years; 49.5% women) and 95 placebo (median age, 40 years; 67.4% women) recipients completed the 12-month follow-up.
• The researchers primarily assessed the effect of the BCG vaccine on the development of the symptoms of long COVID at 6 and 12 months.

TAKEAWAY:

• Hearing problems were less frequent among BCG recipients at 6 months compared with those who received placebo (odds ratio [OR], 0.26; 95% CI, 0.045-1.0; P = .044).
• At 12 months, participants who received the BCG vaccine exhibited fewer issues with sleeping (P = .027), concentration (P = .009), memory (P = .009), and vision (P = .022) along with a lower long-COVID score (one-sided Wilcoxon test, P = .002) than those who received placebo.
• At 6 months, BCG demonstrated a sex-specific paradoxical effect on hair loss, decreasing it in men (P = .031), while causing a slight, though statistically nonsignificant, increase in women.
• Male sex was the strongest predictive factor for long COVID, cognitive dysfunction, and cardiopulmonary scores at both follow-up assessments.

IN PRACTICE:

“[The study] findings suggest that BCG immunotherapy for an existing ailment may be superior to prophylaxis in healthy individuals,” the authors wrote.

SOURCE:

The study was led by Mehrsa Jalalizadeh and Keini Buosi, UroScience, State University of Campinas, Unicamp, São Paulo, Brazil. It was published online on November 19, 2024, in the Journal of Internal Medicine.

LIMITATIONS:

Previous mycobacterial exposure was not tested among the study participants. A notable loss to follow-up, particularly at 12 months, may have introduced bias into the results.

DISCLOSURES:

The study was supported by the Coordination for the Improvement of Higher Education Personnel, Federal Government of Brazil, the General Coordination of the National Immunization Program, Ministry of Health (Brazil), and the National Council for Scientific and Technological Development-Research Productivity. The authors declared no conflicts of interest.

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

LAS VEGAS — For clinicians who rely on generic tretinoin 0.5% as their go-to treatment for patients with acne, Shanna Miranti, MPAS, PA-C, offers some straightforward advice: You can do better.

“Friends don’t let friends write generic tretinoin only because there are so many better options out there,” Miranti, who practices dermatology in Naples, Florida, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Don’t get lazy; your patients deserve better.”

 

In her wide-ranging presentation, Miranti described the four pillars of acne pathogenesis as increased sebum production caused by androgens, follicular hyperkeratinization in the pilosebaceous unit, colonization by Cutibacterium acnes (formerly Proprionibacterium acnes), and inflammation. Acne “starts with androgens, but this is a cascade, so you have to find treatment options that hit as many of these four pillars as possible,” Miranti explained. “If you’re only using generic tretinoin, you’re only hitting maybe two of the four pillars at best.”

She then discussed the best treatment options for each pillar:

Follicular plugging and hyperkeratinization. Topical retinoids, including tretinoin, adapalene, tazarotene, and trifarotene, are highly effective for this issue. Systemic isotretinoin is also a strong option. For patients who are pregnant or trying to conceive, azelaic acid is a helpful alternative.

Excessive sebum production and androgens. “This may be the genesis of when acne begins — during puberty,” Miranti said. “With rising androgens comes rising amounts of sebum.” The only topical treatment that specifically targets this is clascoterone (Winlevi), which should be applied twice daily. For systemic management of excessive sebum, isotretinoin is highly effective. In women, spironolactone (50 mg daily, or split into two doses) and oral contraceptives are also options.

Inflammation. Topical options include retinoids, antibiotics, benzoyl peroxide (BPO), topical dapsone, azelaic acid, and clascoterone. Systemic options include isotretinoin; the antibiotics doxycycline, minocycline, and sarecycline; spironolactone; and oral contraceptives. “So, when you see patients with intense inflammation, and they’re starting to get post-inflammatory erythema or post-inflammatory hyperpigmentation, you need something to address this inflammatory problem,” she noted.

C acnes. Topical treatment options include BPO and antibiotics. However, topical antibiotics should never be used alone, Miranti said; they must always be combined with BPO to prevent bacterial resistance. Oral options include sarecycline, “which has a low propensity for antibiotic resistance and spares the gut microbiome to some degree,” and the “old-school” antibiotics doxycycline, minocycline, and tetracycline. “But all oral antibiotics should be used concomitantly with BPO,” she added.

Regardless of which treatment is chosen for any pillar, Miranti emphasized that monotherapy with a single agent is often insufficient. “Historically, we have combined therapies to treat the multiple causes of acne,” she said. “The average number of acne products used per patient is 2.53, but that’s also the average number of copays. We have to be conscious of that. If you are a mom with four kids who are on acne medication, you want to minimize your copay burden. So, if you can find a topical medication that hits three out of the four pillars of acne pathogenesis, that would be fantastic.” The only topical that targets excess sebum is clascoterone, she noted, and the only medication that hits all four pillars is isotretinoin.

In October 2023, the Food and Drug Administration approved a once-daily topical gel for patients aged 12 years or older that contains clindamycin 1.2%, adapalene 0.15%, and BPO 3.1%. The first-ever triple combination therapy, known as Cabtreo, was released to pharmacies in March 2024. In a phase 2 trial, researchers randomized 394 patients aged 9 years or older with moderate to severe acne to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. Patients in the Cabtreo arm achieved significantly greater lesion reductions than those in the vehicle arm (inflammatory: 78.3% vs 45.1%; noninflammatory: 70.0% vs 37.6%; P < .001 for both). They also experienced lesion reductions that were 9.2%-16.6% greater than those observed with any of the dyad combination gels. Miranti characterized the study results as “pretty phenomenal,” noting that the ease of use makes Cabtreo stand out as a treatment option. “Simplicity drives compliance, and compliance drives results,” she said. “This is one product to apply once a day. Any of you who have a teenage son like me, you know it is hard to get them to brush their teeth twice a day, let alone take medicine before they leave the house in the morning. This can be a home run for a lot of patients, and not just our teenagers. Adult females have done very well with this medication.”

In a network meta-analysis, researchers reviewed 221 randomized controlled trials to compare the efficacy of pharmacologic treatment for acne. The most effective treatment in reducing inflammatory and noninflammatory lesions was oral isotretinoin, followed by Cabtreo.

Miranti disclosed being a speaker, consultant, and/or an advisory board member for Arcutis Biotherapeutics, Bausch Health, Dermavant Sciences, Galderma, Incyte, LEO Pharma, Eli Lilly, Sun Pharma, Swift USA, and Verrica Pharmaceuticals.

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

LAS VEGAS — For clinicians who rely on generic tretinoin 0.5% as their go-to treatment for patients with acne, Shanna Miranti, MPAS, PA-C, offers some straightforward advice: You can do better.

“Friends don’t let friends write generic tretinoin only because there are so many better options out there,” Miranti, who practices dermatology in Naples, Florida, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Don’t get lazy; your patients deserve better.”

 

In her wide-ranging presentation, Miranti described the four pillars of acne pathogenesis as increased sebum production caused by androgens, follicular hyperkeratinization in the pilosebaceous unit, colonization by Cutibacterium acnes (formerly Proprionibacterium acnes), and inflammation. Acne “starts with androgens, but this is a cascade, so you have to find treatment options that hit as many of these four pillars as possible,” Miranti explained. “If you’re only using generic tretinoin, you’re only hitting maybe two of the four pillars at best.”

She then discussed the best treatment options for each pillar:

Follicular plugging and hyperkeratinization. Topical retinoids, including tretinoin, adapalene, tazarotene, and trifarotene, are highly effective for this issue. Systemic isotretinoin is also a strong option. For patients who are pregnant or trying to conceive, azelaic acid is a helpful alternative.

Excessive sebum production and androgens. “This may be the genesis of when acne begins — during puberty,” Miranti said. “With rising androgens comes rising amounts of sebum.” The only topical treatment that specifically targets this is clascoterone (Winlevi), which should be applied twice daily. For systemic management of excessive sebum, isotretinoin is highly effective. In women, spironolactone (50 mg daily, or split into two doses) and oral contraceptives are also options.

Inflammation. Topical options include retinoids, antibiotics, benzoyl peroxide (BPO), topical dapsone, azelaic acid, and clascoterone. Systemic options include isotretinoin; the antibiotics doxycycline, minocycline, and sarecycline; spironolactone; and oral contraceptives. “So, when you see patients with intense inflammation, and they’re starting to get post-inflammatory erythema or post-inflammatory hyperpigmentation, you need something to address this inflammatory problem,” she noted.

C acnes. Topical treatment options include BPO and antibiotics. However, topical antibiotics should never be used alone, Miranti said; they must always be combined with BPO to prevent bacterial resistance. Oral options include sarecycline, “which has a low propensity for antibiotic resistance and spares the gut microbiome to some degree,” and the “old-school” antibiotics doxycycline, minocycline, and tetracycline. “But all oral antibiotics should be used concomitantly with BPO,” she added.

Regardless of which treatment is chosen for any pillar, Miranti emphasized that monotherapy with a single agent is often insufficient. “Historically, we have combined therapies to treat the multiple causes of acne,” she said. “The average number of acne products used per patient is 2.53, but that’s also the average number of copays. We have to be conscious of that. If you are a mom with four kids who are on acne medication, you want to minimize your copay burden. So, if you can find a topical medication that hits three out of the four pillars of acne pathogenesis, that would be fantastic.” The only topical that targets excess sebum is clascoterone, she noted, and the only medication that hits all four pillars is isotretinoin.

In October 2023, the Food and Drug Administration approved a once-daily topical gel for patients aged 12 years or older that contains clindamycin 1.2%, adapalene 0.15%, and BPO 3.1%. The first-ever triple combination therapy, known as Cabtreo, was released to pharmacies in March 2024. In a phase 2 trial, researchers randomized 394 patients aged 9 years or older with moderate to severe acne to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. Patients in the Cabtreo arm achieved significantly greater lesion reductions than those in the vehicle arm (inflammatory: 78.3% vs 45.1%; noninflammatory: 70.0% vs 37.6%; P < .001 for both). They also experienced lesion reductions that were 9.2%-16.6% greater than those observed with any of the dyad combination gels. Miranti characterized the study results as “pretty phenomenal,” noting that the ease of use makes Cabtreo stand out as a treatment option. “Simplicity drives compliance, and compliance drives results,” she said. “This is one product to apply once a day. Any of you who have a teenage son like me, you know it is hard to get them to brush their teeth twice a day, let alone take medicine before they leave the house in the morning. This can be a home run for a lot of patients, and not just our teenagers. Adult females have done very well with this medication.”

In a network meta-analysis, researchers reviewed 221 randomized controlled trials to compare the efficacy of pharmacologic treatment for acne. The most effective treatment in reducing inflammatory and noninflammatory lesions was oral isotretinoin, followed by Cabtreo.

Miranti disclosed being a speaker, consultant, and/or an advisory board member for Arcutis Biotherapeutics, Bausch Health, Dermavant Sciences, Galderma, Incyte, LEO Pharma, Eli Lilly, Sun Pharma, Swift USA, and Verrica Pharmaceuticals.

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

LAS VEGAS — For clinicians who rely on generic tretinoin 0.5% as their go-to treatment for patients with acne, Shanna Miranti, MPAS, PA-C, offers some straightforward advice: You can do better.

“Friends don’t let friends write generic tretinoin only because there are so many better options out there,” Miranti, who practices dermatology in Naples, Florida, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Don’t get lazy; your patients deserve better.”

 

In her wide-ranging presentation, Miranti described the four pillars of acne pathogenesis as increased sebum production caused by androgens, follicular hyperkeratinization in the pilosebaceous unit, colonization by Cutibacterium acnes (formerly Proprionibacterium acnes), and inflammation. Acne “starts with androgens, but this is a cascade, so you have to find treatment options that hit as many of these four pillars as possible,” Miranti explained. “If you’re only using generic tretinoin, you’re only hitting maybe two of the four pillars at best.”

She then discussed the best treatment options for each pillar:

Follicular plugging and hyperkeratinization. Topical retinoids, including tretinoin, adapalene, tazarotene, and trifarotene, are highly effective for this issue. Systemic isotretinoin is also a strong option. For patients who are pregnant or trying to conceive, azelaic acid is a helpful alternative.

Excessive sebum production and androgens. “This may be the genesis of when acne begins — during puberty,” Miranti said. “With rising androgens comes rising amounts of sebum.” The only topical treatment that specifically targets this is clascoterone (Winlevi), which should be applied twice daily. For systemic management of excessive sebum, isotretinoin is highly effective. In women, spironolactone (50 mg daily, or split into two doses) and oral contraceptives are also options.

Inflammation. Topical options include retinoids, antibiotics, benzoyl peroxide (BPO), topical dapsone, azelaic acid, and clascoterone. Systemic options include isotretinoin; the antibiotics doxycycline, minocycline, and sarecycline; spironolactone; and oral contraceptives. “So, when you see patients with intense inflammation, and they’re starting to get post-inflammatory erythema or post-inflammatory hyperpigmentation, you need something to address this inflammatory problem,” she noted.

C acnes. Topical treatment options include BPO and antibiotics. However, topical antibiotics should never be used alone, Miranti said; they must always be combined with BPO to prevent bacterial resistance. Oral options include sarecycline, “which has a low propensity for antibiotic resistance and spares the gut microbiome to some degree,” and the “old-school” antibiotics doxycycline, minocycline, and tetracycline. “But all oral antibiotics should be used concomitantly with BPO,” she added.

Regardless of which treatment is chosen for any pillar, Miranti emphasized that monotherapy with a single agent is often insufficient. “Historically, we have combined therapies to treat the multiple causes of acne,” she said. “The average number of acne products used per patient is 2.53, but that’s also the average number of copays. We have to be conscious of that. If you are a mom with four kids who are on acne medication, you want to minimize your copay burden. So, if you can find a topical medication that hits three out of the four pillars of acne pathogenesis, that would be fantastic.” The only topical that targets excess sebum is clascoterone, she noted, and the only medication that hits all four pillars is isotretinoin.

In October 2023, the Food and Drug Administration approved a once-daily topical gel for patients aged 12 years or older that contains clindamycin 1.2%, adapalene 0.15%, and BPO 3.1%. The first-ever triple combination therapy, known as Cabtreo, was released to pharmacies in March 2024. In a phase 2 trial, researchers randomized 394 patients aged 9 years or older with moderate to severe acne to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. Patients in the Cabtreo arm achieved significantly greater lesion reductions than those in the vehicle arm (inflammatory: 78.3% vs 45.1%; noninflammatory: 70.0% vs 37.6%; P < .001 for both). They also experienced lesion reductions that were 9.2%-16.6% greater than those observed with any of the dyad combination gels. Miranti characterized the study results as “pretty phenomenal,” noting that the ease of use makes Cabtreo stand out as a treatment option. “Simplicity drives compliance, and compliance drives results,” she said. “This is one product to apply once a day. Any of you who have a teenage son like me, you know it is hard to get them to brush their teeth twice a day, let alone take medicine before they leave the house in the morning. This can be a home run for a lot of patients, and not just our teenagers. Adult females have done very well with this medication.”

In a network meta-analysis, researchers reviewed 221 randomized controlled trials to compare the efficacy of pharmacologic treatment for acne. The most effective treatment in reducing inflammatory and noninflammatory lesions was oral isotretinoin, followed by Cabtreo.

Miranti disclosed being a speaker, consultant, and/or an advisory board member for Arcutis Biotherapeutics, Bausch Health, Dermavant Sciences, Galderma, Incyte, LEO Pharma, Eli Lilly, Sun Pharma, Swift USA, and Verrica Pharmaceuticals.

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