Federal Practitioner

TOPLINE:

The extended-release fluticasone propionate injection (EP-104IAR) significantly reduces knee osteoarthritis (OA) pain over 12 weeks, compared with a vehicle control, with no serious treatment-related adverse events.

METHODOLOGY:

• EP-104IAR utilizes a novel diffusion-based extended-release technology to optimize the action of fluticasone propionate.
• The researchers conducted a phase 2 trial at 12 research sites in Denmark, Poland, and the Czech Republic to assess the clinical efficacy, pharmacokinetics, and safety of EP-104IAR in 318 participants (58% women; 99% White) with a diagnosis of primary knee OA.
• Eligible patients, with a score of at least 4 out of 10 on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain rating scale, were randomly assigned to receive either 25 mg EP-104IAR (n = 163; mean age, 64 years) or a vehicle control (n = 155; mean age, 63.2 years).
• The primary outcome was the between-group difference in the change in the WOMAC pain score from baseline to week 12.

TAKEAWAY:

• The reduction in WOMAC pain scores from baseline to week 12 was significantly higher with EP-104IAR than with a vehicle control (between-group difference, −0.66; P = .0044), with the difference maintained through week 14.
• The treatment resulted in a significant improvement in WOMAC function scores (P = .014) and the area under the curve for changes in the WOMAC pain score (P < .0001) over 12 weeks.
• Treatment-emergent adverse events were noted in 9% of participants in the EP-104IAR group and 7% of participants in the vehicle control group. No serious treatment-related adverse events or discontinuations related to EP-104IAR were reported.
• Fluticasone propionate levels were maintained at around 66% to 33% of peak values between weeks 2 and 24 at near-constant levels. The effects on glucose and cortisol levels were minimal and transient.

IN PRACTICE:

“The results of this trial show that EP-104IAR has the potential for clinically meaningful benefit in reducing knee osteoarthritis pain, addressing a substantial unmet medical need,” the authors wrote. “Additionally, the stable delivery of fluticasone propionate over an extended period with fewer systemic and local side effects than other corticosteroid treatments for knee osteoarthritis support the possibility of bilateral and repeat dosing.”

SOURCE:

The study was led by Amanda Malone, PhD, Eupraxia Pharmaceuticals, Victoria, British Columbia, Canada. It was published online in The Lancet Rheumatology.

LIMITATIONS:

The study’s generalizability may be limited because of the predominantly White participant population. The success of masking was not evaluated, and the treatment was administered by an unmasked injector. Efficacy outcomes were patient-reported, with no objective measurement of knee function.

DISCLOSURES:

This study was supported by Eupraxia Pharmaceuticals. Some authors disclosed their employment with Eupraxia Pharmaceuticals or with companies contracted by Eupraxia Pharmaceuticals for clinical research and trial and data management. One author reported serving as a consultant or participating in a speakers’ bureau. Another reported being on the board of directors for Eupraxia Pharmaceuticals and receiving royalties from a medical technology company.

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

TOPLINE:

The extended-release fluticasone propionate injection (EP-104IAR) significantly reduces knee osteoarthritis (OA) pain over 12 weeks, compared with a vehicle control, with no serious treatment-related adverse events.

METHODOLOGY:

• EP-104IAR utilizes a novel diffusion-based extended-release technology to optimize the action of fluticasone propionate.
• The researchers conducted a phase 2 trial at 12 research sites in Denmark, Poland, and the Czech Republic to assess the clinical efficacy, pharmacokinetics, and safety of EP-104IAR in 318 participants (58% women; 99% White) with a diagnosis of primary knee OA.
• Eligible patients, with a score of at least 4 out of 10 on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain rating scale, were randomly assigned to receive either 25 mg EP-104IAR (n = 163; mean age, 64 years) or a vehicle control (n = 155; mean age, 63.2 years).
• The primary outcome was the between-group difference in the change in the WOMAC pain score from baseline to week 12.

TAKEAWAY:

• The reduction in WOMAC pain scores from baseline to week 12 was significantly higher with EP-104IAR than with a vehicle control (between-group difference, −0.66; P = .0044), with the difference maintained through week 14.
• The treatment resulted in a significant improvement in WOMAC function scores (P = .014) and the area under the curve for changes in the WOMAC pain score (P < .0001) over 12 weeks.
• Treatment-emergent adverse events were noted in 9% of participants in the EP-104IAR group and 7% of participants in the vehicle control group. No serious treatment-related adverse events or discontinuations related to EP-104IAR were reported.
• Fluticasone propionate levels were maintained at around 66% to 33% of peak values between weeks 2 and 24 at near-constant levels. The effects on glucose and cortisol levels were minimal and transient.

IN PRACTICE:

“The results of this trial show that EP-104IAR has the potential for clinically meaningful benefit in reducing knee osteoarthritis pain, addressing a substantial unmet medical need,” the authors wrote. “Additionally, the stable delivery of fluticasone propionate over an extended period with fewer systemic and local side effects than other corticosteroid treatments for knee osteoarthritis support the possibility of bilateral and repeat dosing.”

SOURCE:

The study was led by Amanda Malone, PhD, Eupraxia Pharmaceuticals, Victoria, British Columbia, Canada. It was published online in The Lancet Rheumatology.

LIMITATIONS:

The study’s generalizability may be limited because of the predominantly White participant population. The success of masking was not evaluated, and the treatment was administered by an unmasked injector. Efficacy outcomes were patient-reported, with no objective measurement of knee function.

DISCLOSURES:

This study was supported by Eupraxia Pharmaceuticals. Some authors disclosed their employment with Eupraxia Pharmaceuticals or with companies contracted by Eupraxia Pharmaceuticals for clinical research and trial and data management. One author reported serving as a consultant or participating in a speakers’ bureau. Another reported being on the board of directors for Eupraxia Pharmaceuticals and receiving royalties from a medical technology company.

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

TOPLINE:

The extended-release fluticasone propionate injection (EP-104IAR) significantly reduces knee osteoarthritis (OA) pain over 12 weeks, compared with a vehicle control, with no serious treatment-related adverse events.

METHODOLOGY:

• EP-104IAR utilizes a novel diffusion-based extended-release technology to optimize the action of fluticasone propionate.
• The researchers conducted a phase 2 trial at 12 research sites in Denmark, Poland, and the Czech Republic to assess the clinical efficacy, pharmacokinetics, and safety of EP-104IAR in 318 participants (58% women; 99% White) with a diagnosis of primary knee OA.
• Eligible patients, with a score of at least 4 out of 10 on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain rating scale, were randomly assigned to receive either 25 mg EP-104IAR (n = 163; mean age, 64 years) or a vehicle control (n = 155; mean age, 63.2 years).
• The primary outcome was the between-group difference in the change in the WOMAC pain score from baseline to week 12.

TAKEAWAY:

• The reduction in WOMAC pain scores from baseline to week 12 was significantly higher with EP-104IAR than with a vehicle control (between-group difference, −0.66; P = .0044), with the difference maintained through week 14.
• The treatment resulted in a significant improvement in WOMAC function scores (P = .014) and the area under the curve for changes in the WOMAC pain score (P < .0001) over 12 weeks.
• Treatment-emergent adverse events were noted in 9% of participants in the EP-104IAR group and 7% of participants in the vehicle control group. No serious treatment-related adverse events or discontinuations related to EP-104IAR were reported.
• Fluticasone propionate levels were maintained at around 66% to 33% of peak values between weeks 2 and 24 at near-constant levels. The effects on glucose and cortisol levels were minimal and transient.

IN PRACTICE:

“The results of this trial show that EP-104IAR has the potential for clinically meaningful benefit in reducing knee osteoarthritis pain, addressing a substantial unmet medical need,” the authors wrote. “Additionally, the stable delivery of fluticasone propionate over an extended period with fewer systemic and local side effects than other corticosteroid treatments for knee osteoarthritis support the possibility of bilateral and repeat dosing.”

SOURCE:

The study was led by Amanda Malone, PhD, Eupraxia Pharmaceuticals, Victoria, British Columbia, Canada. It was published online in The Lancet Rheumatology.

LIMITATIONS:

The study’s generalizability may be limited because of the predominantly White participant population. The success of masking was not evaluated, and the treatment was administered by an unmasked injector. Efficacy outcomes were patient-reported, with no objective measurement of knee function.

DISCLOSURES:

This study was supported by Eupraxia Pharmaceuticals. Some authors disclosed their employment with Eupraxia Pharmaceuticals or with companies contracted by Eupraxia Pharmaceuticals for clinical research and trial and data management. One author reported serving as a consultant or participating in a speakers’ bureau. Another reported being on the board of directors for Eupraxia Pharmaceuticals and receiving royalties from a medical technology company.

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

TOPLINE:

Allogeneic bone marrow–derived mesenchymal stromal cells (BM-MSCs) are safe but do not show efficacy in treating intervertebral disc degeneration (IDD) in patients with chronic low back pain.

METHODOLOGY:

• The RESPINE trial assessed the efficacy and safety of a single intradiscal injection of allogeneic BM-MSCs in the treatment of chronic low back pain caused by single-level IDD.
• Overall, 114 patients (mean age, 40.9 years; 35% women) with IDD-associated chronic low back pain that was persistent for 3 months or more despite conventional medical therapy and without previous surgery, were recruited across four European countries from April 2018 to April 2021 and randomly assigned to receive either intradiscal injections of allogeneic BM-MSCs (n = 58) or sham injections (n = 56).
• The first co-primary endpoint was the rate of response to BM-MSC injections at 12 months after treatment, defined as improvement of at least 20% or 20 mm in the Visual Analog Scale for pain or improvement of at least 20% in the Oswestry Disability Index for functional status.
• The secondary co-primary endpoint was structural efficacy, based on disc fluid content measured by quantitative T2 MRI between baseline and month 12.

TAKEAWAY:

• At 12 months post-intervention, 74% of patients in the BM-MSC group were classified as responders compared with 68.8% in the placebo group. However, the difference between the groups was not statistically significant.
• The probability of being a responder was higher in the BM-MSC group than in the sham group; however, the findings did not reach statistical significance.
• The average change in disc fluid content, indicative of disc regeneration, from baseline to 12 months was 37.9% in the BM-MSC group and 41.7% in the placebo group, with no significant difference between the groups.
• The incidence of adverse events and serious adverse events was not significantly different between the treatment groups.

IN PRACTICE:

“BM-MSC represents a promising opportunity for the biological treatment of IDD, but only high-quality randomized controlled trials, comparing it to standard care, can determine whether it is a truly effective alternative to spine fusion or disc replacement,” the authors wrote.

SOURCE:

The study was led by Yves-Marie Pers, MD, PhD, Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France. It was published online on October 11, 2024, in Annals of the Rheumatic Diseases.

LIMITATIONS:

MRI results were collected from only 55 patients across both trial arms, which may have affected the statistical power of the findings. Although patients were monitored for up to 24 months, the long-term efficacy and safety of BM-MSC therapy for IDD may not have been fully captured. Selection bias could not be excluded because of the difficulty in accurately identifying patients with chronic low back pain caused by single-level IDD.

DISCLOSURES:

The study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. 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:

Allogeneic bone marrow–derived mesenchymal stromal cells (BM-MSCs) are safe but do not show efficacy in treating intervertebral disc degeneration (IDD) in patients with chronic low back pain.

METHODOLOGY:

• The RESPINE trial assessed the efficacy and safety of a single intradiscal injection of allogeneic BM-MSCs in the treatment of chronic low back pain caused by single-level IDD.
• Overall, 114 patients (mean age, 40.9 years; 35% women) with IDD-associated chronic low back pain that was persistent for 3 months or more despite conventional medical therapy and without previous surgery, were recruited across four European countries from April 2018 to April 2021 and randomly assigned to receive either intradiscal injections of allogeneic BM-MSCs (n = 58) or sham injections (n = 56).
• The first co-primary endpoint was the rate of response to BM-MSC injections at 12 months after treatment, defined as improvement of at least 20% or 20 mm in the Visual Analog Scale for pain or improvement of at least 20% in the Oswestry Disability Index for functional status.
• The secondary co-primary endpoint was structural efficacy, based on disc fluid content measured by quantitative T2 MRI between baseline and month 12.

TAKEAWAY:

• At 12 months post-intervention, 74% of patients in the BM-MSC group were classified as responders compared with 68.8% in the placebo group. However, the difference between the groups was not statistically significant.
• The probability of being a responder was higher in the BM-MSC group than in the sham group; however, the findings did not reach statistical significance.
• The average change in disc fluid content, indicative of disc regeneration, from baseline to 12 months was 37.9% in the BM-MSC group and 41.7% in the placebo group, with no significant difference between the groups.
• The incidence of adverse events and serious adverse events was not significantly different between the treatment groups.

IN PRACTICE:

“BM-MSC represents a promising opportunity for the biological treatment of IDD, but only high-quality randomized controlled trials, comparing it to standard care, can determine whether it is a truly effective alternative to spine fusion or disc replacement,” the authors wrote.

SOURCE:

The study was led by Yves-Marie Pers, MD, PhD, Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France. It was published online on October 11, 2024, in Annals of the Rheumatic Diseases.

LIMITATIONS:

MRI results were collected from only 55 patients across both trial arms, which may have affected the statistical power of the findings. Although patients were monitored for up to 24 months, the long-term efficacy and safety of BM-MSC therapy for IDD may not have been fully captured. Selection bias could not be excluded because of the difficulty in accurately identifying patients with chronic low back pain caused by single-level IDD.

DISCLOSURES:

The study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. 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:

Allogeneic bone marrow–derived mesenchymal stromal cells (BM-MSCs) are safe but do not show efficacy in treating intervertebral disc degeneration (IDD) in patients with chronic low back pain.

METHODOLOGY:

• The RESPINE trial assessed the efficacy and safety of a single intradiscal injection of allogeneic BM-MSCs in the treatment of chronic low back pain caused by single-level IDD.
• Overall, 114 patients (mean age, 40.9 years; 35% women) with IDD-associated chronic low back pain that was persistent for 3 months or more despite conventional medical therapy and without previous surgery, were recruited across four European countries from April 2018 to April 2021 and randomly assigned to receive either intradiscal injections of allogeneic BM-MSCs (n = 58) or sham injections (n = 56).
• The first co-primary endpoint was the rate of response to BM-MSC injections at 12 months after treatment, defined as improvement of at least 20% or 20 mm in the Visual Analog Scale for pain or improvement of at least 20% in the Oswestry Disability Index for functional status.
• The secondary co-primary endpoint was structural efficacy, based on disc fluid content measured by quantitative T2 MRI between baseline and month 12.

TAKEAWAY:

• At 12 months post-intervention, 74% of patients in the BM-MSC group were classified as responders compared with 68.8% in the placebo group. However, the difference between the groups was not statistically significant.
• The probability of being a responder was higher in the BM-MSC group than in the sham group; however, the findings did not reach statistical significance.
• The average change in disc fluid content, indicative of disc regeneration, from baseline to 12 months was 37.9% in the BM-MSC group and 41.7% in the placebo group, with no significant difference between the groups.
• The incidence of adverse events and serious adverse events was not significantly different between the treatment groups.

IN PRACTICE:

“BM-MSC represents a promising opportunity for the biological treatment of IDD, but only high-quality randomized controlled trials, comparing it to standard care, can determine whether it is a truly effective alternative to spine fusion or disc replacement,” the authors wrote.

SOURCE:

The study was led by Yves-Marie Pers, MD, PhD, Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France. It was published online on October 11, 2024, in Annals of the Rheumatic Diseases.

LIMITATIONS:

MRI results were collected from only 55 patients across both trial arms, which may have affected the statistical power of the findings. Although patients were monitored for up to 24 months, the long-term efficacy and safety of BM-MSC therapy for IDD may not have been fully captured. Selection bias could not be excluded because of the difficulty in accurately identifying patients with chronic low back pain caused by single-level IDD.

DISCLOSURES:

The study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. 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.

PHILADELPHIA — The mortality rate of early-onset colorectal cancer (EO-CRC) has increased considerably across the United States over the past 2 decades, with the effects most pronounced in those aged 20-44 years, according to a new analysis of the two largest US mortality databases. 

Data from the Centers for Disease Control and Prevention’s National Center of Health Statistics (NCHS) and the Surveillance, Epidemiology, and End Results (SEER) databases provide yet more evidence of the increasing prevalence of EO-CRC, which is defined as a diagnosis of CRC in patients younger than age 50 years. 

Furthermore, the researchers reported that increased mortality occurred across all patients included in the study (aged 20-54) regardless of tumor stage at diagnosis.

These findings “prompt tailoring further efforts toward raising awareness of colorectal cancer symptoms and keeping a low clinical suspicion in younger patients presenting with anemia, gastrointestinal bleeding, or change in bowel habits,” Yazan Abboud, MD, internal medicine PGY-3, assistant chief resident, and chair of resident research at Rutgers New Jersey Medical School, Newark, said in an interview.

Abboud presented the findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 
 

Analyzing NCHS and SEER 

Rising rates of EO-CRC had prompted US medical societies to recommend reducing the screening age to 45 years. The US Preventive Services Task Force officially lowered it to this age in 2021. This shift is supported by real-world evidence, which shows that earlier screening leads to a significantly reduced risk for colorectal cancer. However, because colorectal cancer cases are decreasing overall in older adults, there is considerable interest in discovering why young adults are experiencing a paradoxical uptick in EO-CRC, and what impact this is having on associated mortality.

Abboud and colleagues collected age-adjusted mortality rates for EO-CRC between 2000 and 2022 from the NCHS database. In addition, stage-specific incidence-based mortality rates between 2004-2020 were obtained from the SEER 22 database. The NCHS database covers approximately 100% of the US population, whereas the SEER 22 database, which is included within the NCHS, covers 42%. 

The researchers divided patients into two cohorts based on age (20-44 years and 45-54 years) and tumor stage at diagnosis (early stage and late stage), and compared the annual percentage change (APC) and the average APC between the two groups. They also assessed trends for the entire cohort of patients aged 20-54 years. 

In the NCHS database, there were 147,026 deaths in total across all ages studied resulting from EO-CRC, of which 27% (39,746) occurred in those 20-44 years of age. Although associated mortality rates decreased between 2000-2005 in all ages studied (APC, –1.56), they increased from 2005-2022 (APC, 0.87). 

In the cohort aged 45-54 years, mortality decreased between 2000-2005 and increased thereafter, whereas in the cohort aged 20-44 years mortality increased steadily for the entire follow-up duration of 2000 to 2022 (APC, 0.93). A comparison of the age cohorts confirmed that those aged 20-44 years had a greater increase in mortality (average APC, 0.85; P < .001).

In the SEER 22 database, there were 4652 deaths in those with early-stage tumors across all age groups studied (average APC, 12.17). Mortality increased in patients aged 45-54 years (average APC, 11.52) with early-stage tumors, but there were insufficient numbers in those aged 20-44 years to determine this outcome. 

There were 42,120 deaths in those with late-stage tumors across all age groups (average APC, 10.05) in the SEER 22 database. And increased mortality was observed in those with late-stage tumors in both age cohorts: 45-54 years (average APC, 9.58) and 20-44 years (average APC, 11.06).

“When evaluating the SEER database and stratifying the tumors by stage at diagnosis, we demonstrated increasing mortality of early-onset colorectal cancer in both early- and late-stage tumors on average over the study period,” Abboud said. 
 

Identifying At-Risk Patients

In a comment, David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia School of Medicine in Norfolk, said the findings speak to the need for evidence-based means of identifying younger individuals at a higher risk of EO-CRC.

“I suspect many of younger patients with CRC had their cancer detected when it was more advanced due to delayed presentation and diagnostic testing,” said Johnson, who was not involved in the study. 

But it would be interesting to evaluate if the cancers in the cohort aged 20-44 years were more aggressive biologically or if these patients were dismissive of early signs or symptoms, he said. 

Younger patients may dismiss “alarm” features that indicate CRC testing, said Johnson. “In particular, overt bleeding and iron deficiency need a focused evaluation in these younger cohorts.”

“Future research is needed to investigate the role of neoadjuvant chemotherapy in younger patients with early-stage colorectal cancer and evaluate patients’ outcomes,” Abboud added. 

The study had no specific funding. Abboud reported no relevant financial relationships. Johnson reported serving as an adviser to ISOTHRIVE. He is also on the Medscape Gastroenterology editorial board.

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

PHILADELPHIA — The mortality rate of early-onset colorectal cancer (EO-CRC) has increased considerably across the United States over the past 2 decades, with the effects most pronounced in those aged 20-44 years, according to a new analysis of the two largest US mortality databases. 

Data from the Centers for Disease Control and Prevention’s National Center of Health Statistics (NCHS) and the Surveillance, Epidemiology, and End Results (SEER) databases provide yet more evidence of the increasing prevalence of EO-CRC, which is defined as a diagnosis of CRC in patients younger than age 50 years. 

Furthermore, the researchers reported that increased mortality occurred across all patients included in the study (aged 20-54) regardless of tumor stage at diagnosis.

These findings “prompt tailoring further efforts toward raising awareness of colorectal cancer symptoms and keeping a low clinical suspicion in younger patients presenting with anemia, gastrointestinal bleeding, or change in bowel habits,” Yazan Abboud, MD, internal medicine PGY-3, assistant chief resident, and chair of resident research at Rutgers New Jersey Medical School, Newark, said in an interview.

Abboud presented the findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 
 

Analyzing NCHS and SEER 

Rising rates of EO-CRC had prompted US medical societies to recommend reducing the screening age to 45 years. The US Preventive Services Task Force officially lowered it to this age in 2021. This shift is supported by real-world evidence, which shows that earlier screening leads to a significantly reduced risk for colorectal cancer. However, because colorectal cancer cases are decreasing overall in older adults, there is considerable interest in discovering why young adults are experiencing a paradoxical uptick in EO-CRC, and what impact this is having on associated mortality.

Abboud and colleagues collected age-adjusted mortality rates for EO-CRC between 2000 and 2022 from the NCHS database. In addition, stage-specific incidence-based mortality rates between 2004-2020 were obtained from the SEER 22 database. The NCHS database covers approximately 100% of the US population, whereas the SEER 22 database, which is included within the NCHS, covers 42%. 

The researchers divided patients into two cohorts based on age (20-44 years and 45-54 years) and tumor stage at diagnosis (early stage and late stage), and compared the annual percentage change (APC) and the average APC between the two groups. They also assessed trends for the entire cohort of patients aged 20-54 years. 

In the NCHS database, there were 147,026 deaths in total across all ages studied resulting from EO-CRC, of which 27% (39,746) occurred in those 20-44 years of age. Although associated mortality rates decreased between 2000-2005 in all ages studied (APC, –1.56), they increased from 2005-2022 (APC, 0.87). 

In the cohort aged 45-54 years, mortality decreased between 2000-2005 and increased thereafter, whereas in the cohort aged 20-44 years mortality increased steadily for the entire follow-up duration of 2000 to 2022 (APC, 0.93). A comparison of the age cohorts confirmed that those aged 20-44 years had a greater increase in mortality (average APC, 0.85; P < .001).

In the SEER 22 database, there were 4652 deaths in those with early-stage tumors across all age groups studied (average APC, 12.17). Mortality increased in patients aged 45-54 years (average APC, 11.52) with early-stage tumors, but there were insufficient numbers in those aged 20-44 years to determine this outcome. 

There were 42,120 deaths in those with late-stage tumors across all age groups (average APC, 10.05) in the SEER 22 database. And increased mortality was observed in those with late-stage tumors in both age cohorts: 45-54 years (average APC, 9.58) and 20-44 years (average APC, 11.06).

“When evaluating the SEER database and stratifying the tumors by stage at diagnosis, we demonstrated increasing mortality of early-onset colorectal cancer in both early- and late-stage tumors on average over the study period,” Abboud said. 
 

Identifying At-Risk Patients

In a comment, David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia School of Medicine in Norfolk, said the findings speak to the need for evidence-based means of identifying younger individuals at a higher risk of EO-CRC.

“I suspect many of younger patients with CRC had their cancer detected when it was more advanced due to delayed presentation and diagnostic testing,” said Johnson, who was not involved in the study. 

But it would be interesting to evaluate if the cancers in the cohort aged 20-44 years were more aggressive biologically or if these patients were dismissive of early signs or symptoms, he said. 

Younger patients may dismiss “alarm” features that indicate CRC testing, said Johnson. “In particular, overt bleeding and iron deficiency need a focused evaluation in these younger cohorts.”

“Future research is needed to investigate the role of neoadjuvant chemotherapy in younger patients with early-stage colorectal cancer and evaluate patients’ outcomes,” Abboud added. 

The study had no specific funding. Abboud reported no relevant financial relationships. Johnson reported serving as an adviser to ISOTHRIVE. He is also on the Medscape Gastroenterology editorial board.

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

PHILADELPHIA — The mortality rate of early-onset colorectal cancer (EO-CRC) has increased considerably across the United States over the past 2 decades, with the effects most pronounced in those aged 20-44 years, according to a new analysis of the two largest US mortality databases. 

Data from the Centers for Disease Control and Prevention’s National Center of Health Statistics (NCHS) and the Surveillance, Epidemiology, and End Results (SEER) databases provide yet more evidence of the increasing prevalence of EO-CRC, which is defined as a diagnosis of CRC in patients younger than age 50 years. 

Furthermore, the researchers reported that increased mortality occurred across all patients included in the study (aged 20-54) regardless of tumor stage at diagnosis.

These findings “prompt tailoring further efforts toward raising awareness of colorectal cancer symptoms and keeping a low clinical suspicion in younger patients presenting with anemia, gastrointestinal bleeding, or change in bowel habits,” Yazan Abboud, MD, internal medicine PGY-3, assistant chief resident, and chair of resident research at Rutgers New Jersey Medical School, Newark, said in an interview.

Abboud presented the findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 
 

Analyzing NCHS and SEER 

Rising rates of EO-CRC had prompted US medical societies to recommend reducing the screening age to 45 years. The US Preventive Services Task Force officially lowered it to this age in 2021. This shift is supported by real-world evidence, which shows that earlier screening leads to a significantly reduced risk for colorectal cancer. However, because colorectal cancer cases are decreasing overall in older adults, there is considerable interest in discovering why young adults are experiencing a paradoxical uptick in EO-CRC, and what impact this is having on associated mortality.

Abboud and colleagues collected age-adjusted mortality rates for EO-CRC between 2000 and 2022 from the NCHS database. In addition, stage-specific incidence-based mortality rates between 2004-2020 were obtained from the SEER 22 database. The NCHS database covers approximately 100% of the US population, whereas the SEER 22 database, which is included within the NCHS, covers 42%. 

The researchers divided patients into two cohorts based on age (20-44 years and 45-54 years) and tumor stage at diagnosis (early stage and late stage), and compared the annual percentage change (APC) and the average APC between the two groups. They also assessed trends for the entire cohort of patients aged 20-54 years. 

In the NCHS database, there were 147,026 deaths in total across all ages studied resulting from EO-CRC, of which 27% (39,746) occurred in those 20-44 years of age. Although associated mortality rates decreased between 2000-2005 in all ages studied (APC, –1.56), they increased from 2005-2022 (APC, 0.87). 

In the cohort aged 45-54 years, mortality decreased between 2000-2005 and increased thereafter, whereas in the cohort aged 20-44 years mortality increased steadily for the entire follow-up duration of 2000 to 2022 (APC, 0.93). A comparison of the age cohorts confirmed that those aged 20-44 years had a greater increase in mortality (average APC, 0.85; P < .001).

In the SEER 22 database, there were 4652 deaths in those with early-stage tumors across all age groups studied (average APC, 12.17). Mortality increased in patients aged 45-54 years (average APC, 11.52) with early-stage tumors, but there were insufficient numbers in those aged 20-44 years to determine this outcome. 

There were 42,120 deaths in those with late-stage tumors across all age groups (average APC, 10.05) in the SEER 22 database. And increased mortality was observed in those with late-stage tumors in both age cohorts: 45-54 years (average APC, 9.58) and 20-44 years (average APC, 11.06).

“When evaluating the SEER database and stratifying the tumors by stage at diagnosis, we demonstrated increasing mortality of early-onset colorectal cancer in both early- and late-stage tumors on average over the study period,” Abboud said. 
 

Identifying At-Risk Patients

In a comment, David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia School of Medicine in Norfolk, said the findings speak to the need for evidence-based means of identifying younger individuals at a higher risk of EO-CRC.

“I suspect many of younger patients with CRC had their cancer detected when it was more advanced due to delayed presentation and diagnostic testing,” said Johnson, who was not involved in the study. 

But it would be interesting to evaluate if the cancers in the cohort aged 20-44 years were more aggressive biologically or if these patients were dismissive of early signs or symptoms, he said. 

Younger patients may dismiss “alarm” features that indicate CRC testing, said Johnson. “In particular, overt bleeding and iron deficiency need a focused evaluation in these younger cohorts.”

“Future research is needed to investigate the role of neoadjuvant chemotherapy in younger patients with early-stage colorectal cancer and evaluate patients’ outcomes,” Abboud added. 

The study had no specific funding. Abboud reported no relevant financial relationships. Johnson reported serving as an adviser to ISOTHRIVE. He is also on the Medscape Gastroenterology editorial board.

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

About 7 of every 10 veterans who die by suicide involve the use of a firearm. A reason for this high rate is access, as half of veterans report owning ≥ 1 personal firearms. Of those individuals, more than half report storing firearms loaded and/or unsecured and one-third of veterans who store their firearms loaded and unlocked do not own a lockbox or safe. 

Suicide death prevention has improved as firearms have become more difficult to obtain. That’s why Navy veteran Rep. Chris Deluzio (D-PA), former FBI Special Agent and federal prosecutor Rep. Brian Fitzpatrick (R-PA), and Rep. Greg Landsman (D-OH) have teamed up to introduce the Saving Our Veterans Lives Act of 2024. Under the proposed act, any veteran would be able to get a free lockbox from the US Department of Veterans Affairs (VA).

Suicidal crises can be brief. According to the VA, if a person experiencing a suicidal crisis can’t access the method they planned to use, they generally do not seek out other lethal means. Lockboxes are a way of “putting space between thought and trigger,” the VA said.

The VA Suicide Prevention Program distributes free firearm cable locks to any veteran who requests one. However, many veterans favor lockboxes and safes to secure their guns. A VA pilot program offers free lockboxes to veterans enrolled in the Veterans Health Administration who are at an elevated risk for suicide. The program is set to launch in late 2024 and is a collaboration between the Rocky Mountain Mental Illness Research, Education, and Clinical Center for Suicide Prevention, VA National Prosthetics Service, and VA Office of Suicide Prevention.

The proposed bill would make the lockboxes (which typically cost between $25 and $350) free to any veteran, regardless of VA enrollment status or diagnosis. It ensures “sufficient funding for many tens of thousands of lockboxes to be distributed.” The bill would also direct the VA to create a public education campaign on the availability of lockboxes and the importance of secure firearm storage in suicide prevention.

“The alarming and tragic reality is that our veterans face a suicide rate 57% higher than that of civilians,” Rep. Fitzpatrick said. “This commonsense, bipartisan initiative is more than a solution—it's a lifeline.”

The representatives report that the bill has been endorsed by an “unprecedented” number of organizations, including the National Shooting Sports Foundation, Disabled American Veterans, The American Legion, GIFFORDS, Everytown for Gun Safety, Brady, American Psychological Association, American Foundation for Suicide Prevention, and Association of VA Psychologist Leaders.

“Did you know that in some cases only 10 minutes elapse between an individual having suicidal ideation and acting?” American Legion National Commander James LaCoursiere said in the representatives’ press release. “The Saving Our Veterans Lives Act is an important part of preventing suicide as it will provide veterans with the information and means to securely store their firearms to prevent suicide, while still protecting their Second Amendment rights. The Legion commends Rep. Deluzio and his team for bringing this bill forward and for their continued dedication to the welfare of our nation’s veterans.” 

"I hear colleagues all the time talk about veteran suicide," Rep. Deluzio said in an interview with Military.com. "It is a problem in my community. It's a problem across the country. Let's take action. This is a chance where we can do it that I think can cut through the politics that normally divide us on these [gun] issues. And I think the coalition supporting the bill tells you, we've got a path to pass it."

About 7 of every 10 veterans who die by suicide involve the use of a firearm. A reason for this high rate is access, as half of veterans report owning ≥ 1 personal firearms. Of those individuals, more than half report storing firearms loaded and/or unsecured and one-third of veterans who store their firearms loaded and unlocked do not own a lockbox or safe. 

Suicide death prevention has improved as firearms have become more difficult to obtain. That’s why Navy veteran Rep. Chris Deluzio (D-PA), former FBI Special Agent and federal prosecutor Rep. Brian Fitzpatrick (R-PA), and Rep. Greg Landsman (D-OH) have teamed up to introduce the Saving Our Veterans Lives Act of 2024. Under the proposed act, any veteran would be able to get a free lockbox from the US Department of Veterans Affairs (VA).

Suicidal crises can be brief. According to the VA, if a person experiencing a suicidal crisis can’t access the method they planned to use, they generally do not seek out other lethal means. Lockboxes are a way of “putting space between thought and trigger,” the VA said.

The VA Suicide Prevention Program distributes free firearm cable locks to any veteran who requests one. However, many veterans favor lockboxes and safes to secure their guns. A VA pilot program offers free lockboxes to veterans enrolled in the Veterans Health Administration who are at an elevated risk for suicide. The program is set to launch in late 2024 and is a collaboration between the Rocky Mountain Mental Illness Research, Education, and Clinical Center for Suicide Prevention, VA National Prosthetics Service, and VA Office of Suicide Prevention.

The proposed bill would make the lockboxes (which typically cost between $25 and $350) free to any veteran, regardless of VA enrollment status or diagnosis. It ensures “sufficient funding for many tens of thousands of lockboxes to be distributed.” The bill would also direct the VA to create a public education campaign on the availability of lockboxes and the importance of secure firearm storage in suicide prevention.

“The alarming and tragic reality is that our veterans face a suicide rate 57% higher than that of civilians,” Rep. Fitzpatrick said. “This commonsense, bipartisan initiative is more than a solution—it's a lifeline.”

The representatives report that the bill has been endorsed by an “unprecedented” number of organizations, including the National Shooting Sports Foundation, Disabled American Veterans, The American Legion, GIFFORDS, Everytown for Gun Safety, Brady, American Psychological Association, American Foundation for Suicide Prevention, and Association of VA Psychologist Leaders.

“Did you know that in some cases only 10 minutes elapse between an individual having suicidal ideation and acting?” American Legion National Commander James LaCoursiere said in the representatives’ press release. “The Saving Our Veterans Lives Act is an important part of preventing suicide as it will provide veterans with the information and means to securely store their firearms to prevent suicide, while still protecting their Second Amendment rights. The Legion commends Rep. Deluzio and his team for bringing this bill forward and for their continued dedication to the welfare of our nation’s veterans.” 

"I hear colleagues all the time talk about veteran suicide," Rep. Deluzio said in an interview with Military.com. "It is a problem in my community. It's a problem across the country. Let's take action. This is a chance where we can do it that I think can cut through the politics that normally divide us on these [gun] issues. And I think the coalition supporting the bill tells you, we've got a path to pass it."

About 7 of every 10 veterans who die by suicide involve the use of a firearm. A reason for this high rate is access, as half of veterans report owning ≥ 1 personal firearms. Of those individuals, more than half report storing firearms loaded and/or unsecured and one-third of veterans who store their firearms loaded and unlocked do not own a lockbox or safe. 

Suicide death prevention has improved as firearms have become more difficult to obtain. That’s why Navy veteran Rep. Chris Deluzio (D-PA), former FBI Special Agent and federal prosecutor Rep. Brian Fitzpatrick (R-PA), and Rep. Greg Landsman (D-OH) have teamed up to introduce the Saving Our Veterans Lives Act of 2024. Under the proposed act, any veteran would be able to get a free lockbox from the US Department of Veterans Affairs (VA).

Suicidal crises can be brief. According to the VA, if a person experiencing a suicidal crisis can’t access the method they planned to use, they generally do not seek out other lethal means. Lockboxes are a way of “putting space between thought and trigger,” the VA said.

The VA Suicide Prevention Program distributes free firearm cable locks to any veteran who requests one. However, many veterans favor lockboxes and safes to secure their guns. A VA pilot program offers free lockboxes to veterans enrolled in the Veterans Health Administration who are at an elevated risk for suicide. The program is set to launch in late 2024 and is a collaboration between the Rocky Mountain Mental Illness Research, Education, and Clinical Center for Suicide Prevention, VA National Prosthetics Service, and VA Office of Suicide Prevention.

The proposed bill would make the lockboxes (which typically cost between $25 and $350) free to any veteran, regardless of VA enrollment status or diagnosis. It ensures “sufficient funding for many tens of thousands of lockboxes to be distributed.” The bill would also direct the VA to create a public education campaign on the availability of lockboxes and the importance of secure firearm storage in suicide prevention.

“The alarming and tragic reality is that our veterans face a suicide rate 57% higher than that of civilians,” Rep. Fitzpatrick said. “This commonsense, bipartisan initiative is more than a solution—it's a lifeline.”

The representatives report that the bill has been endorsed by an “unprecedented” number of organizations, including the National Shooting Sports Foundation, Disabled American Veterans, The American Legion, GIFFORDS, Everytown for Gun Safety, Brady, American Psychological Association, American Foundation for Suicide Prevention, and Association of VA Psychologist Leaders.

“Did you know that in some cases only 10 minutes elapse between an individual having suicidal ideation and acting?” American Legion National Commander James LaCoursiere said in the representatives’ press release. “The Saving Our Veterans Lives Act is an important part of preventing suicide as it will provide veterans with the information and means to securely store their firearms to prevent suicide, while still protecting their Second Amendment rights. The Legion commends Rep. Deluzio and his team for bringing this bill forward and for their continued dedication to the welfare of our nation’s veterans.” 

"I hear colleagues all the time talk about veteran suicide," Rep. Deluzio said in an interview with Military.com. "It is a problem in my community. It's a problem across the country. Let's take action. This is a chance where we can do it that I think can cut through the politics that normally divide us on these [gun] issues. And I think the coalition supporting the bill tells you, we've got a path to pass it."

SAVANNAH, GEORGIA — Teamwork and transdisciplinary collaboration create an effective system of care for amyotrophic lateral sclerosis (ALS), ensuring improved health both for patients and clinicians alike, said one expert.

In a plenary address at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2024, Ileana Howard, MD, medical co-director of the ALS Center of Excellence at VA Puget Sound in Seattle, said the recently released National Academies report “Living with ALS” cited the Veterans Administration as “a bright spot in the landscape of ALS care due to its interdisciplinary, holistic, and proactive approach to care.”

Since the early 2000s and the publication of several studies linking active military service with ALS, the US Department of Veterans Affairs (VA) has opened an ALS registry, a tissue and brain biobank, and in 2008, granted 100% presumptive service connection to any individual who served more than 90 days of active duty and was later diagnosed with ALS, she said.

“We now serve approximately 4000 veterans with ALS across the system, and we count 47 full interdisciplinary clinics within VA across the nation, with ALS coordinators designated for all 170 VA facilities, regardless of whether they had an ALS clinic or not, to serve as a navigator for patients and their families, to identify the closest ALS clinic that could meet their needs.” 
 

Multidisciplinary vs Interdisciplinary

Howard emphasized that transdisciplinary collaboration is essential for maintaining an effective system. She pointed out that the term “multidisciplinary” is outdated, referring to teams that work independently but in parallel on the same issue.

In contrast, interdisciplinary teams integrate their assessments into a cohesive plan of care, whereas transdisciplinary teams take it further by combining both their assessments and care plans, allowing for greater intentional overlap.

The VA’s ALS handbook lists approximately 20 essential clinicians for a VA ALS clinic, including recreation therapists, assistive technology specialists, and veteran benefit service officers to assist with disability benefits application, among others, she said.

Essential to this collaboration is “role release,” which deliberately blurs the boundaries between disciplines. “The future of our specialty hinges on effective and selfless collaboration,” she said.

Howard encouraged ALS healthcare providers to move away from outdated terminology rooted in hierarchical team models and to break down silos that no longer benefit either the patients or the care teams.

She noted that while teamwork can enhance patient outcomes and overall health, it has also been associated with better health among healthcare providers. It’s well-known, she said, that neurologists and physiatrists are among the specialties with the highest burnout rates, and ALS teams, in particular, experience significant stress and burnout.
 

Better Together

A recent Canadian study on resiliency and burnout in ALS clinics surveyed a wide range of practitioners within ALS centers and found respondents drew resiliency through relationships with patients and colleagues, and that there was a strongly expressed desire for increased resources, team building/debriefing, and formal training in emotional exhaustion and burnout.

“A consistent theme was the lack of adequate allied health support (nursing, social work, occupational therapy) to address the complex needs of patients,” said the report’s senior author Kerri Lynn Schellenberg, MD, medical director of the ALS/Motor Neuron Diseases clinic and associate professor at the University of Saskatchewan College of Medicine in Saskatoon, Saskatchewan, Canada.

“The majority of participants felt they would benefit from more consistent team building exercises and debriefing,” noted the authors.

Schellenberg agreed, emphasizing that care teams perform best when there is mutual appreciation and support among members. By learning from one another and reaching consensus together, the care plan benefits from the collective expertise of the team. “We are stronger together,” she said.

Howard and Schellenberg reported no disclosures.
 

A version of this article appeared on Medscape.com.

SAVANNAH, GEORGIA — Teamwork and transdisciplinary collaboration create an effective system of care for amyotrophic lateral sclerosis (ALS), ensuring improved health both for patients and clinicians alike, said one expert.

In a plenary address at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2024, Ileana Howard, MD, medical co-director of the ALS Center of Excellence at VA Puget Sound in Seattle, said the recently released National Academies report “Living with ALS” cited the Veterans Administration as “a bright spot in the landscape of ALS care due to its interdisciplinary, holistic, and proactive approach to care.”

Since the early 2000s and the publication of several studies linking active military service with ALS, the US Department of Veterans Affairs (VA) has opened an ALS registry, a tissue and brain biobank, and in 2008, granted 100% presumptive service connection to any individual who served more than 90 days of active duty and was later diagnosed with ALS, she said.

“We now serve approximately 4000 veterans with ALS across the system, and we count 47 full interdisciplinary clinics within VA across the nation, with ALS coordinators designated for all 170 VA facilities, regardless of whether they had an ALS clinic or not, to serve as a navigator for patients and their families, to identify the closest ALS clinic that could meet their needs.” 
 

Multidisciplinary vs Interdisciplinary

Howard emphasized that transdisciplinary collaboration is essential for maintaining an effective system. She pointed out that the term “multidisciplinary” is outdated, referring to teams that work independently but in parallel on the same issue.

In contrast, interdisciplinary teams integrate their assessments into a cohesive plan of care, whereas transdisciplinary teams take it further by combining both their assessments and care plans, allowing for greater intentional overlap.

The VA’s ALS handbook lists approximately 20 essential clinicians for a VA ALS clinic, including recreation therapists, assistive technology specialists, and veteran benefit service officers to assist with disability benefits application, among others, she said.

Essential to this collaboration is “role release,” which deliberately blurs the boundaries between disciplines. “The future of our specialty hinges on effective and selfless collaboration,” she said.

Howard encouraged ALS healthcare providers to move away from outdated terminology rooted in hierarchical team models and to break down silos that no longer benefit either the patients or the care teams.

She noted that while teamwork can enhance patient outcomes and overall health, it has also been associated with better health among healthcare providers. It’s well-known, she said, that neurologists and physiatrists are among the specialties with the highest burnout rates, and ALS teams, in particular, experience significant stress and burnout.
 

Better Together

A recent Canadian study on resiliency and burnout in ALS clinics surveyed a wide range of practitioners within ALS centers and found respondents drew resiliency through relationships with patients and colleagues, and that there was a strongly expressed desire for increased resources, team building/debriefing, and formal training in emotional exhaustion and burnout.

“A consistent theme was the lack of adequate allied health support (nursing, social work, occupational therapy) to address the complex needs of patients,” said the report’s senior author Kerri Lynn Schellenberg, MD, medical director of the ALS/Motor Neuron Diseases clinic and associate professor at the University of Saskatchewan College of Medicine in Saskatoon, Saskatchewan, Canada.

“The majority of participants felt they would benefit from more consistent team building exercises and debriefing,” noted the authors.

Schellenberg agreed, emphasizing that care teams perform best when there is mutual appreciation and support among members. By learning from one another and reaching consensus together, the care plan benefits from the collective expertise of the team. “We are stronger together,” she said.

Howard and Schellenberg reported no disclosures.
 

A version of this article appeared on Medscape.com.

SAVANNAH, GEORGIA — Teamwork and transdisciplinary collaboration create an effective system of care for amyotrophic lateral sclerosis (ALS), ensuring improved health both for patients and clinicians alike, said one expert.

In a plenary address at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2024, Ileana Howard, MD, medical co-director of the ALS Center of Excellence at VA Puget Sound in Seattle, said the recently released National Academies report “Living with ALS” cited the Veterans Administration as “a bright spot in the landscape of ALS care due to its interdisciplinary, holistic, and proactive approach to care.”

Since the early 2000s and the publication of several studies linking active military service with ALS, the US Department of Veterans Affairs (VA) has opened an ALS registry, a tissue and brain biobank, and in 2008, granted 100% presumptive service connection to any individual who served more than 90 days of active duty and was later diagnosed with ALS, she said.

“We now serve approximately 4000 veterans with ALS across the system, and we count 47 full interdisciplinary clinics within VA across the nation, with ALS coordinators designated for all 170 VA facilities, regardless of whether they had an ALS clinic or not, to serve as a navigator for patients and their families, to identify the closest ALS clinic that could meet their needs.” 
 

Multidisciplinary vs Interdisciplinary

Howard emphasized that transdisciplinary collaboration is essential for maintaining an effective system. She pointed out that the term “multidisciplinary” is outdated, referring to teams that work independently but in parallel on the same issue.

In contrast, interdisciplinary teams integrate their assessments into a cohesive plan of care, whereas transdisciplinary teams take it further by combining both their assessments and care plans, allowing for greater intentional overlap.

The VA’s ALS handbook lists approximately 20 essential clinicians for a VA ALS clinic, including recreation therapists, assistive technology specialists, and veteran benefit service officers to assist with disability benefits application, among others, she said.

Essential to this collaboration is “role release,” which deliberately blurs the boundaries between disciplines. “The future of our specialty hinges on effective and selfless collaboration,” she said.

Howard encouraged ALS healthcare providers to move away from outdated terminology rooted in hierarchical team models and to break down silos that no longer benefit either the patients or the care teams.

She noted that while teamwork can enhance patient outcomes and overall health, it has also been associated with better health among healthcare providers. It’s well-known, she said, that neurologists and physiatrists are among the specialties with the highest burnout rates, and ALS teams, in particular, experience significant stress and burnout.
 

Better Together

A recent Canadian study on resiliency and burnout in ALS clinics surveyed a wide range of practitioners within ALS centers and found respondents drew resiliency through relationships with patients and colleagues, and that there was a strongly expressed desire for increased resources, team building/debriefing, and formal training in emotional exhaustion and burnout.

“A consistent theme was the lack of adequate allied health support (nursing, social work, occupational therapy) to address the complex needs of patients,” said the report’s senior author Kerri Lynn Schellenberg, MD, medical director of the ALS/Motor Neuron Diseases clinic and associate professor at the University of Saskatchewan College of Medicine in Saskatoon, Saskatchewan, Canada.

“The majority of participants felt they would benefit from more consistent team building exercises and debriefing,” noted the authors.

Schellenberg agreed, emphasizing that care teams perform best when there is mutual appreciation and support among members. By learning from one another and reaching consensus together, the care plan benefits from the collective expertise of the team. “We are stronger together,” she said.

Howard and Schellenberg reported no disclosures.
 

A version of this article appeared on Medscape.com.

The US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) now recommends a pneumococcal conjugate vaccine (PCV) for all PCV-naive adults aged 50 years or older. The new recommendation, which passed with an ACIP member vote of 14 for and one against, expands the current age-based recommendations, which include children younger than 5 years and adults older than 65 years, as well as adults aged 19-64 years with underlying conditions or risk factors who have not received a PCV and certain adults who have received PCV13 but not PCV20.

The recommendation would leave the choice of PCV up to the clinician. The updated language calls for a single dose of PCV (which could be PCV15, PCV20, or PCV21) for all adults aged 50 years or older; adults aged 19-64 years with underlying conditions (for whom PCV is already recommended) could receive the newly approved PCV21 as an option.

The decision was based in part on economic analyses of the use of PCV in adults aged 50-64 years in the United States. Miwako Kobayashi, MD, presented the summary of the Pneumococcal Vaccines Work Group’s interpretation of the evidence and the proposed recommendation in a meeting of the ACIP on October 23, 2024, when the ACIP voting occurred.

Data from the CDC show an increase in the relative burden of pneumococcal disease in adults aged 50-64 years based in part on the success of the pediatric PCV program, she said.

Health equity was another main factor in the Work Group’s decision to recommend vaccination for adults aged 50 years or older. “Disparities in pneumococcal vaccine coverage by race and ethnicity exist for both age-based and risk-based indications,” Kobayashi noted in her presentation. The Work Group acknowledged that the overall effect of a vaccine recommendation on health equity is complex, but the majority agreed that the update would improve health equity by increasing vaccine coverage for those with known or unknown risk factors and providing protection at an earlier age when some populations already experience elevated disease rates, she said.

As for safety, the Work Group concluded that the undesirable anticipated effects of PCVs are minimal, despite the potential signal for Guillain-Barré Syndrome, and the CDC and US Food and Drug Administration will continue to monitor post-licensure safety of PCVs.

Support Not Universal

A majority of the ACIP Pneumococcal Vaccines Work Group supported the approved option, but agreed that a future booster dose may be needed, Work Group Chair James Loehr, MD, said in his introductory presentation.

Overall, key uncertainties remain, including indirect effects of new pediatric pneumococcal vaccines on adults, data on the duration of protection with adult vaccinations, and the impact new higher-valency vaccines have on adults, several of which are in development, Loehr said.

A new 21-valent PCV, known as PCV 21, was approved by the FDA for adults aged 18 years or older in June 2024, said Loehr. “PCV21 is not PCV20 with one additional serotype” and provides additional protection, he emphasized. The Work Group examined models involving PCV21 and the existing PCV20. However, a majority of the Work Group agreed that having age-based recommendations based on vaccine product would be more challenging to implement and that insurance coverage may be a factor given the recent approval of PCV21. Therefore, the proposal submitted to the full ACIP was not for a specific PCV.

Notably, Loehr said that, although as Work Group Chair he was tasked with making the motion in favor of the recommendation, he voted against it as a voting member because of his strong opinion that only the PCV21 vaccine is needed for vaccine-naive adults aged 50 or older. “I think that PCV21 is a better vaccine that targets more serotypes,” he said during the discussion. Data presented at the February 2024 ACIP meeting showed more than 80% coverage vs less than 60% coverage for invasive pneumococcal disease with PCV21 vs PCV20 among adults aged 65 years or older and those aged 19-64 years with a risk-based indication, Loehr said.

A version of this article appeared on Medscape.com.

The US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) now recommends a pneumococcal conjugate vaccine (PCV) for all PCV-naive adults aged 50 years or older. The new recommendation, which passed with an ACIP member vote of 14 for and one against, expands the current age-based recommendations, which include children younger than 5 years and adults older than 65 years, as well as adults aged 19-64 years with underlying conditions or risk factors who have not received a PCV and certain adults who have received PCV13 but not PCV20.

The recommendation would leave the choice of PCV up to the clinician. The updated language calls for a single dose of PCV (which could be PCV15, PCV20, or PCV21) for all adults aged 50 years or older; adults aged 19-64 years with underlying conditions (for whom PCV is already recommended) could receive the newly approved PCV21 as an option.

The decision was based in part on economic analyses of the use of PCV in adults aged 50-64 years in the United States. Miwako Kobayashi, MD, presented the summary of the Pneumococcal Vaccines Work Group’s interpretation of the evidence and the proposed recommendation in a meeting of the ACIP on October 23, 2024, when the ACIP voting occurred.

Data from the CDC show an increase in the relative burden of pneumococcal disease in adults aged 50-64 years based in part on the success of the pediatric PCV program, she said.

Health equity was another main factor in the Work Group’s decision to recommend vaccination for adults aged 50 years or older. “Disparities in pneumococcal vaccine coverage by race and ethnicity exist for both age-based and risk-based indications,” Kobayashi noted in her presentation. The Work Group acknowledged that the overall effect of a vaccine recommendation on health equity is complex, but the majority agreed that the update would improve health equity by increasing vaccine coverage for those with known or unknown risk factors and providing protection at an earlier age when some populations already experience elevated disease rates, she said.

As for safety, the Work Group concluded that the undesirable anticipated effects of PCVs are minimal, despite the potential signal for Guillain-Barré Syndrome, and the CDC and US Food and Drug Administration will continue to monitor post-licensure safety of PCVs.

Support Not Universal

A majority of the ACIP Pneumococcal Vaccines Work Group supported the approved option, but agreed that a future booster dose may be needed, Work Group Chair James Loehr, MD, said in his introductory presentation.

Overall, key uncertainties remain, including indirect effects of new pediatric pneumococcal vaccines on adults, data on the duration of protection with adult vaccinations, and the impact new higher-valency vaccines have on adults, several of which are in development, Loehr said.

A new 21-valent PCV, known as PCV 21, was approved by the FDA for adults aged 18 years or older in June 2024, said Loehr. “PCV21 is not PCV20 with one additional serotype” and provides additional protection, he emphasized. The Work Group examined models involving PCV21 and the existing PCV20. However, a majority of the Work Group agreed that having age-based recommendations based on vaccine product would be more challenging to implement and that insurance coverage may be a factor given the recent approval of PCV21. Therefore, the proposal submitted to the full ACIP was not for a specific PCV.

Notably, Loehr said that, although as Work Group Chair he was tasked with making the motion in favor of the recommendation, he voted against it as a voting member because of his strong opinion that only the PCV21 vaccine is needed for vaccine-naive adults aged 50 or older. “I think that PCV21 is a better vaccine that targets more serotypes,” he said during the discussion. Data presented at the February 2024 ACIP meeting showed more than 80% coverage vs less than 60% coverage for invasive pneumococcal disease with PCV21 vs PCV20 among adults aged 65 years or older and those aged 19-64 years with a risk-based indication, Loehr said.

A version of this article appeared on Medscape.com.

The US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) now recommends a pneumococcal conjugate vaccine (PCV) for all PCV-naive adults aged 50 years or older. The new recommendation, which passed with an ACIP member vote of 14 for and one against, expands the current age-based recommendations, which include children younger than 5 years and adults older than 65 years, as well as adults aged 19-64 years with underlying conditions or risk factors who have not received a PCV and certain adults who have received PCV13 but not PCV20.

The recommendation would leave the choice of PCV up to the clinician. The updated language calls for a single dose of PCV (which could be PCV15, PCV20, or PCV21) for all adults aged 50 years or older; adults aged 19-64 years with underlying conditions (for whom PCV is already recommended) could receive the newly approved PCV21 as an option.

The decision was based in part on economic analyses of the use of PCV in adults aged 50-64 years in the United States. Miwako Kobayashi, MD, presented the summary of the Pneumococcal Vaccines Work Group’s interpretation of the evidence and the proposed recommendation in a meeting of the ACIP on October 23, 2024, when the ACIP voting occurred.

Data from the CDC show an increase in the relative burden of pneumococcal disease in adults aged 50-64 years based in part on the success of the pediatric PCV program, she said.

Health equity was another main factor in the Work Group’s decision to recommend vaccination for adults aged 50 years or older. “Disparities in pneumococcal vaccine coverage by race and ethnicity exist for both age-based and risk-based indications,” Kobayashi noted in her presentation. The Work Group acknowledged that the overall effect of a vaccine recommendation on health equity is complex, but the majority agreed that the update would improve health equity by increasing vaccine coverage for those with known or unknown risk factors and providing protection at an earlier age when some populations already experience elevated disease rates, she said.

As for safety, the Work Group concluded that the undesirable anticipated effects of PCVs are minimal, despite the potential signal for Guillain-Barré Syndrome, and the CDC and US Food and Drug Administration will continue to monitor post-licensure safety of PCVs.

Support Not Universal

A majority of the ACIP Pneumococcal Vaccines Work Group supported the approved option, but agreed that a future booster dose may be needed, Work Group Chair James Loehr, MD, said in his introductory presentation.

Overall, key uncertainties remain, including indirect effects of new pediatric pneumococcal vaccines on adults, data on the duration of protection with adult vaccinations, and the impact new higher-valency vaccines have on adults, several of which are in development, Loehr said.

A new 21-valent PCV, known as PCV 21, was approved by the FDA for adults aged 18 years or older in June 2024, said Loehr. “PCV21 is not PCV20 with one additional serotype” and provides additional protection, he emphasized. The Work Group examined models involving PCV21 and the existing PCV20. However, a majority of the Work Group agreed that having age-based recommendations based on vaccine product would be more challenging to implement and that insurance coverage may be a factor given the recent approval of PCV21. Therefore, the proposal submitted to the full ACIP was not for a specific PCV.

Notably, Loehr said that, although as Work Group Chair he was tasked with making the motion in favor of the recommendation, he voted against it as a voting member because of his strong opinion that only the PCV21 vaccine is needed for vaccine-naive adults aged 50 or older. “I think that PCV21 is a better vaccine that targets more serotypes,” he said during the discussion. Data presented at the February 2024 ACIP meeting showed more than 80% coverage vs less than 60% coverage for invasive pneumococcal disease with PCV21 vs PCV20 among adults aged 65 years or older and those aged 19-64 years with a risk-based indication, Loehr said.

A version of this article appeared on Medscape.com.

LOS ANGELES — Use of preexposure prophylaxis (PrEP) to prevent HIV is increasing overall, but both the rate of increase for starting PrEP and the rate of unmet need differ widely by demographic group, according to new data from a large study.

An analysis by Li Tao, MD, MS, PhD, director of real-world evidence at Gilead Sciences, and colleagues looked at statistical trends from 2019 to 2023 and found that Black, Hispanic, and Medicaid-insured populations continue to lack equitable access to PrEP.

Among the findings were that most new PrEP users were men with HIV risk factors who are commercially insured and live in predominantly non-Hispanic White areas (53% in 2019 and 43% in 2023). For comparison, men living in predominantly Black or Hispanic neighborhoods, or who are insured by Medicaid, saw lower proportions of PrEP use (16% in 2019 and 17% in 2023) despite higher annual increases in PrEP use (11% per year) and higher unmet needs.
 

Half a Million Real-World Participants

Tao presented her team’s findings at the Infectious Disease Week (IDWeek) 2024 Annual Meeting. The study included “more than half a million real-world PrEP users over the past 5 years,” she said.

The group with the lowest growth in initiation of PrEP in the study period (an annual percentage increase of 2%) and the lowest unmet need included men with HIV risk factors, who were using commercial insurance and living in White-dominant neighborhoods.

HIV risk factors included diagnosis of any sexually transmitted disease, contact with and exposure to communicable diseases, high-risk sexual behavior, contact with a hypodermic needle, long-term prophylaxis, HIV prevention counseling, and HIV screening.

Other men with HIV risk factors (those who were commercially insured, living in Black/Hispanic neighborhoods, or those on Medicaid across all neighborhoods) had a moderate increase in PrEP initiation (an annual percentage increase of 11%-16%) and higher unmet needs.

Researchers gathered data on PrEP prescriptions and new HIV diagnoses (from 2019 to 2023) through the IQVIA pharmacy claims database. PrEP-to-need ratio (PNR) is the number of individuals using PrEP in a year divided by new HIV diagnoses in the previous year. It was calculated for subgroups defined by five PNR-associated factors: Sex, insurance, recorded HIV risk factors (identified by diagnosis or procedure codes), “Ending the HIV Epidemic” jurisdictions, and neighborhood race/ethnicity mix.
 

Disparities Persist

While PrEP use improved across all the groups studied in the 5 years, “disparities still persist and the need remains very significant,” Tao said. “It’s very crucial for guiding the future HIV prevention options.”

“Long-acting PrEP options may help to address some social determinants structural factors in HIV acquisition,” she added.
 

What Programs Are Helping?

Some guidelines and programs are helping increase uptake, Tao said.

The United States Preventive Services Task Force (USPSTF) guidelines “reinforce more accessible PrEP programs to individuals like zero-cost sharing or same-day dispensing,” Tao said in a press briefing. “Those kinds of policies are really effective. We can see that after the implementation of the USPSTF guidelines, the copay sharing is really decreasing and is coinciding with the HIV rates declining.”

The Medicaid coverage expansion in 40 states “has been really effective” in PrEP uptake, she added.

Colleen Kelley, MD, MPH, with the Division of Infectious Diseases at the Rollins School of Public Health, Emory University, in Atlanta, who was not part of the research, said there has been a slow but improving uptake of PrEP across the board in the United States, “but the issue is that the uptake has been inequitable.”
 

Large Study With Recent Data

“This is an extremely large study with very recent data,” Kelley said. “Additionally, they were able to couple (the uptake) with unmet need. People who are at higher risk of acquiring HIV or who live in high-risk areas for HIV should have greater access to PrEP. They have a greater need for PrEP. What we really need to do from an equity perspective is match the PrEP use with the PrEP need and we have not been successful in doing that.”

Kelley added that the finding that the group that had the highest unmet need for PrEP in the study also had no recorded HIV risk factors. “It’s an interesting time to start thinking about beyond risk factor coverage for PrEP,” she said.

Another issue, Kelley said, is that “people are using (PrEP) but they’re also stopping it. People will need to take PrEP many years for protection, but about half discontinue in the first 6-12 months.

“We need to look at how people will persist on PrEP over the long term. That’s the next frontier,” she said. “We hope the long-acting injectables will help overcome some of the PrEP fatigue. But some may just tire of taking medication repeatedly for an infection they don’t have,” she said.

The study was funded by Gilead Sciences. Tao is employed by and is a shareholder of Gilead Sciences. All relevant financial disclosures have been mitigated, according to the paper. Kelley has research grants to her institution from Gilead, Moderna, Novavax, ViiV, and Humanigen.
 

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

LOS ANGELES — Use of preexposure prophylaxis (PrEP) to prevent HIV is increasing overall, but both the rate of increase for starting PrEP and the rate of unmet need differ widely by demographic group, according to new data from a large study.

An analysis by Li Tao, MD, MS, PhD, director of real-world evidence at Gilead Sciences, and colleagues looked at statistical trends from 2019 to 2023 and found that Black, Hispanic, and Medicaid-insured populations continue to lack equitable access to PrEP.

Among the findings were that most new PrEP users were men with HIV risk factors who are commercially insured and live in predominantly non-Hispanic White areas (53% in 2019 and 43% in 2023). For comparison, men living in predominantly Black or Hispanic neighborhoods, or who are insured by Medicaid, saw lower proportions of PrEP use (16% in 2019 and 17% in 2023) despite higher annual increases in PrEP use (11% per year) and higher unmet needs.
 

Half a Million Real-World Participants

Tao presented her team’s findings at the Infectious Disease Week (IDWeek) 2024 Annual Meeting. The study included “more than half a million real-world PrEP users over the past 5 years,” she said.

The group with the lowest growth in initiation of PrEP in the study period (an annual percentage increase of 2%) and the lowest unmet need included men with HIV risk factors, who were using commercial insurance and living in White-dominant neighborhoods.

HIV risk factors included diagnosis of any sexually transmitted disease, contact with and exposure to communicable diseases, high-risk sexual behavior, contact with a hypodermic needle, long-term prophylaxis, HIV prevention counseling, and HIV screening.

Other men with HIV risk factors (those who were commercially insured, living in Black/Hispanic neighborhoods, or those on Medicaid across all neighborhoods) had a moderate increase in PrEP initiation (an annual percentage increase of 11%-16%) and higher unmet needs.

Researchers gathered data on PrEP prescriptions and new HIV diagnoses (from 2019 to 2023) through the IQVIA pharmacy claims database. PrEP-to-need ratio (PNR) is the number of individuals using PrEP in a year divided by new HIV diagnoses in the previous year. It was calculated for subgroups defined by five PNR-associated factors: Sex, insurance, recorded HIV risk factors (identified by diagnosis or procedure codes), “Ending the HIV Epidemic” jurisdictions, and neighborhood race/ethnicity mix.
 

Disparities Persist

While PrEP use improved across all the groups studied in the 5 years, “disparities still persist and the need remains very significant,” Tao said. “It’s very crucial for guiding the future HIV prevention options.”

“Long-acting PrEP options may help to address some social determinants structural factors in HIV acquisition,” she added.
 

What Programs Are Helping?

Some guidelines and programs are helping increase uptake, Tao said.

The United States Preventive Services Task Force (USPSTF) guidelines “reinforce more accessible PrEP programs to individuals like zero-cost sharing or same-day dispensing,” Tao said in a press briefing. “Those kinds of policies are really effective. We can see that after the implementation of the USPSTF guidelines, the copay sharing is really decreasing and is coinciding with the HIV rates declining.”

The Medicaid coverage expansion in 40 states “has been really effective” in PrEP uptake, she added.

Colleen Kelley, MD, MPH, with the Division of Infectious Diseases at the Rollins School of Public Health, Emory University, in Atlanta, who was not part of the research, said there has been a slow but improving uptake of PrEP across the board in the United States, “but the issue is that the uptake has been inequitable.”
 

Large Study With Recent Data

“This is an extremely large study with very recent data,” Kelley said. “Additionally, they were able to couple (the uptake) with unmet need. People who are at higher risk of acquiring HIV or who live in high-risk areas for HIV should have greater access to PrEP. They have a greater need for PrEP. What we really need to do from an equity perspective is match the PrEP use with the PrEP need and we have not been successful in doing that.”

Kelley added that the finding that the group that had the highest unmet need for PrEP in the study also had no recorded HIV risk factors. “It’s an interesting time to start thinking about beyond risk factor coverage for PrEP,” she said.

Another issue, Kelley said, is that “people are using (PrEP) but they’re also stopping it. People will need to take PrEP many years for protection, but about half discontinue in the first 6-12 months.

“We need to look at how people will persist on PrEP over the long term. That’s the next frontier,” she said. “We hope the long-acting injectables will help overcome some of the PrEP fatigue. But some may just tire of taking medication repeatedly for an infection they don’t have,” she said.

The study was funded by Gilead Sciences. Tao is employed by and is a shareholder of Gilead Sciences. All relevant financial disclosures have been mitigated, according to the paper. Kelley has research grants to her institution from Gilead, Moderna, Novavax, ViiV, and Humanigen.
 

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

LOS ANGELES — Use of preexposure prophylaxis (PrEP) to prevent HIV is increasing overall, but both the rate of increase for starting PrEP and the rate of unmet need differ widely by demographic group, according to new data from a large study.

An analysis by Li Tao, MD, MS, PhD, director of real-world evidence at Gilead Sciences, and colleagues looked at statistical trends from 2019 to 2023 and found that Black, Hispanic, and Medicaid-insured populations continue to lack equitable access to PrEP.

Among the findings were that most new PrEP users were men with HIV risk factors who are commercially insured and live in predominantly non-Hispanic White areas (53% in 2019 and 43% in 2023). For comparison, men living in predominantly Black or Hispanic neighborhoods, or who are insured by Medicaid, saw lower proportions of PrEP use (16% in 2019 and 17% in 2023) despite higher annual increases in PrEP use (11% per year) and higher unmet needs.
 

Half a Million Real-World Participants

Tao presented her team’s findings at the Infectious Disease Week (IDWeek) 2024 Annual Meeting. The study included “more than half a million real-world PrEP users over the past 5 years,” she said.

The group with the lowest growth in initiation of PrEP in the study period (an annual percentage increase of 2%) and the lowest unmet need included men with HIV risk factors, who were using commercial insurance and living in White-dominant neighborhoods.

HIV risk factors included diagnosis of any sexually transmitted disease, contact with and exposure to communicable diseases, high-risk sexual behavior, contact with a hypodermic needle, long-term prophylaxis, HIV prevention counseling, and HIV screening.

Other men with HIV risk factors (those who were commercially insured, living in Black/Hispanic neighborhoods, or those on Medicaid across all neighborhoods) had a moderate increase in PrEP initiation (an annual percentage increase of 11%-16%) and higher unmet needs.

Researchers gathered data on PrEP prescriptions and new HIV diagnoses (from 2019 to 2023) through the IQVIA pharmacy claims database. PrEP-to-need ratio (PNR) is the number of individuals using PrEP in a year divided by new HIV diagnoses in the previous year. It was calculated for subgroups defined by five PNR-associated factors: Sex, insurance, recorded HIV risk factors (identified by diagnosis or procedure codes), “Ending the HIV Epidemic” jurisdictions, and neighborhood race/ethnicity mix.
 

Disparities Persist

While PrEP use improved across all the groups studied in the 5 years, “disparities still persist and the need remains very significant,” Tao said. “It’s very crucial for guiding the future HIV prevention options.”

“Long-acting PrEP options may help to address some social determinants structural factors in HIV acquisition,” she added.
 

What Programs Are Helping?

Some guidelines and programs are helping increase uptake, Tao said.

The United States Preventive Services Task Force (USPSTF) guidelines “reinforce more accessible PrEP programs to individuals like zero-cost sharing or same-day dispensing,” Tao said in a press briefing. “Those kinds of policies are really effective. We can see that after the implementation of the USPSTF guidelines, the copay sharing is really decreasing and is coinciding with the HIV rates declining.”

The Medicaid coverage expansion in 40 states “has been really effective” in PrEP uptake, she added.

Colleen Kelley, MD, MPH, with the Division of Infectious Diseases at the Rollins School of Public Health, Emory University, in Atlanta, who was not part of the research, said there has been a slow but improving uptake of PrEP across the board in the United States, “but the issue is that the uptake has been inequitable.”
 

Large Study With Recent Data

“This is an extremely large study with very recent data,” Kelley said. “Additionally, they were able to couple (the uptake) with unmet need. People who are at higher risk of acquiring HIV or who live in high-risk areas for HIV should have greater access to PrEP. They have a greater need for PrEP. What we really need to do from an equity perspective is match the PrEP use with the PrEP need and we have not been successful in doing that.”

Kelley added that the finding that the group that had the highest unmet need for PrEP in the study also had no recorded HIV risk factors. “It’s an interesting time to start thinking about beyond risk factor coverage for PrEP,” she said.

Another issue, Kelley said, is that “people are using (PrEP) but they’re also stopping it. People will need to take PrEP many years for protection, but about half discontinue in the first 6-12 months.

“We need to look at how people will persist on PrEP over the long term. That’s the next frontier,” she said. “We hope the long-acting injectables will help overcome some of the PrEP fatigue. But some may just tire of taking medication repeatedly for an infection they don’t have,” she said.

The study was funded by Gilead Sciences. Tao is employed by and is a shareholder of Gilead Sciences. All relevant financial disclosures have been mitigated, according to the paper. Kelley has research grants to her institution from Gilead, Moderna, Novavax, ViiV, and Humanigen.
 

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

How can the immunogenicity and effectiveness of flu vaccines be improved in older adults? Several strategies are available, one being the addition of an adjuvant. For example, the MF59-adjuvanted vaccine has shown superior immunogenicity. However, “we do not have data from controlled and randomized clinical trials showing superior clinical effectiveness versus the standard dose,” Professor Odile Launay, an infectious disease specialist at Cochin Hospital in Paris, France, noted during a press conference. Another option is to increase the antigen dose in the vaccine, creating a high-dose (HD) flu vaccine.

Why is there a need for an HD vaccine? “The elderly population bears the greatest burden from the flu,” explained Launay. “This is due to three factors: An aging immune system, a higher number of comorbidities, and increased frailty.” Standard-dose flu vaccines are seen as offering suboptimal protection for those older than 65 years, which led to the development of a quadrivalent vaccine with four times the antigen dose of standard flu vaccines. This HD vaccine was introduced in France during the 2021/2022 flu season. A real-world cohort study has since been conducted to evaluate its effectiveness in the target population — those aged 65 years or older. The results were recently published in Clinical Microbiology and Infection.

Cohort Study

The study included 405,385 noninstitutionalized people aged 65 years or older matched with 1,621,540 individuals in a 1:4 ratio. The first group received the HD vaccine, while the second group received the standard-dose vaccine. Both the groups had an average age of 77 years, with 56% women, and 51% vaccinated in pharmacies. The majority had been previously vaccinated against flu (91%), and 97% had completed a full COVID-19 vaccination schedule. More than half had at least one chronic illness.

Hospitalization rates for flu — the study’s primary outcome — were 69.5 vs 90.5 per 100,000 person-years in the HD vs standard-dose group. This represented a 23.3% reduction (95% CI, 8.4-35.8; P = .003).
 

Strengths and Limitations

Among the strengths of the study, Launay highlighted the large number of vaccinated participants older than 65 years — more than 7 million — and the widespread use of polymerase chain reaction flu tests in cases of hospitalization for respiratory infections, which improved flu coding in the database used. Additionally, the results were consistent with those of previous studies.

However, limitations included the retrospective design, which did not randomize participants and introduced potential bias. For example, the HD vaccine may have been prioritized for the oldest people or those with multiple comorbidities. Additionally, the 2021/2022 flu season was atypical, with the simultaneous circulation of the flu virus and SARS-CoV-2, as noted by Launay.
 

Conclusion

In conclusion, this first evaluation of the HD flu vaccine’s effectiveness in France showed a 25% reduction in hospitalizations, consistent with existing data covering 12 flu seasons. The vaccine has been available for a longer period in the United States and Northern Europe.

“The latest unpublished data from the 2022/23 season show a 27% reduction in hospitalizations with the HD vaccine in people over 65,” added Launay.

Note: Due to a pricing disagreement with the French government, Sanofi’s HD flu vaccine Efluelda, intended for people older than 65 years, will not be available this year. (See: Withdrawal of the Efluelda Influenza Vaccine: The Academy of Medicine Reacts). However, the company has submitted a dossier for a trivalent form for a return in the 2025/2026 season and is working on developing mRNA vaccines. Additionally, a combined flu/COVID-19 vaccine is currently in development.

The study was funded by Sanofi. Several authors are Sanofi employees. Odile Launay reported conflicts of interest with Sanofi, MSD, Pfizer, GSK, and Moderna.
 

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

How can the immunogenicity and effectiveness of flu vaccines be improved in older adults? Several strategies are available, one being the addition of an adjuvant. For example, the MF59-adjuvanted vaccine has shown superior immunogenicity. However, “we do not have data from controlled and randomized clinical trials showing superior clinical effectiveness versus the standard dose,” Professor Odile Launay, an infectious disease specialist at Cochin Hospital in Paris, France, noted during a press conference. Another option is to increase the antigen dose in the vaccine, creating a high-dose (HD) flu vaccine.

Why is there a need for an HD vaccine? “The elderly population bears the greatest burden from the flu,” explained Launay. “This is due to three factors: An aging immune system, a higher number of comorbidities, and increased frailty.” Standard-dose flu vaccines are seen as offering suboptimal protection for those older than 65 years, which led to the development of a quadrivalent vaccine with four times the antigen dose of standard flu vaccines. This HD vaccine was introduced in France during the 2021/2022 flu season. A real-world cohort study has since been conducted to evaluate its effectiveness in the target population — those aged 65 years or older. The results were recently published in Clinical Microbiology and Infection.

Cohort Study

The study included 405,385 noninstitutionalized people aged 65 years or older matched with 1,621,540 individuals in a 1:4 ratio. The first group received the HD vaccine, while the second group received the standard-dose vaccine. Both the groups had an average age of 77 years, with 56% women, and 51% vaccinated in pharmacies. The majority had been previously vaccinated against flu (91%), and 97% had completed a full COVID-19 vaccination schedule. More than half had at least one chronic illness.

Hospitalization rates for flu — the study’s primary outcome — were 69.5 vs 90.5 per 100,000 person-years in the HD vs standard-dose group. This represented a 23.3% reduction (95% CI, 8.4-35.8; P = .003).
 

Strengths and Limitations

Among the strengths of the study, Launay highlighted the large number of vaccinated participants older than 65 years — more than 7 million — and the widespread use of polymerase chain reaction flu tests in cases of hospitalization for respiratory infections, which improved flu coding in the database used. Additionally, the results were consistent with those of previous studies.

However, limitations included the retrospective design, which did not randomize participants and introduced potential bias. For example, the HD vaccine may have been prioritized for the oldest people or those with multiple comorbidities. Additionally, the 2021/2022 flu season was atypical, with the simultaneous circulation of the flu virus and SARS-CoV-2, as noted by Launay.
 

Conclusion

In conclusion, this first evaluation of the HD flu vaccine’s effectiveness in France showed a 25% reduction in hospitalizations, consistent with existing data covering 12 flu seasons. The vaccine has been available for a longer period in the United States and Northern Europe.

“The latest unpublished data from the 2022/23 season show a 27% reduction in hospitalizations with the HD vaccine in people over 65,” added Launay.

Note: Due to a pricing disagreement with the French government, Sanofi’s HD flu vaccine Efluelda, intended for people older than 65 years, will not be available this year. (See: Withdrawal of the Efluelda Influenza Vaccine: The Academy of Medicine Reacts). However, the company has submitted a dossier for a trivalent form for a return in the 2025/2026 season and is working on developing mRNA vaccines. Additionally, a combined flu/COVID-19 vaccine is currently in development.

The study was funded by Sanofi. Several authors are Sanofi employees. Odile Launay reported conflicts of interest with Sanofi, MSD, Pfizer, GSK, and Moderna.
 

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

How can the immunogenicity and effectiveness of flu vaccines be improved in older adults? Several strategies are available, one being the addition of an adjuvant. For example, the MF59-adjuvanted vaccine has shown superior immunogenicity. However, “we do not have data from controlled and randomized clinical trials showing superior clinical effectiveness versus the standard dose,” Professor Odile Launay, an infectious disease specialist at Cochin Hospital in Paris, France, noted during a press conference. Another option is to increase the antigen dose in the vaccine, creating a high-dose (HD) flu vaccine.

Why is there a need for an HD vaccine? “The elderly population bears the greatest burden from the flu,” explained Launay. “This is due to three factors: An aging immune system, a higher number of comorbidities, and increased frailty.” Standard-dose flu vaccines are seen as offering suboptimal protection for those older than 65 years, which led to the development of a quadrivalent vaccine with four times the antigen dose of standard flu vaccines. This HD vaccine was introduced in France during the 2021/2022 flu season. A real-world cohort study has since been conducted to evaluate its effectiveness in the target population — those aged 65 years or older. The results were recently published in Clinical Microbiology and Infection.

Cohort Study

The study included 405,385 noninstitutionalized people aged 65 years or older matched with 1,621,540 individuals in a 1:4 ratio. The first group received the HD vaccine, while the second group received the standard-dose vaccine. Both the groups had an average age of 77 years, with 56% women, and 51% vaccinated in pharmacies. The majority had been previously vaccinated against flu (91%), and 97% had completed a full COVID-19 vaccination schedule. More than half had at least one chronic illness.

Hospitalization rates for flu — the study’s primary outcome — were 69.5 vs 90.5 per 100,000 person-years in the HD vs standard-dose group. This represented a 23.3% reduction (95% CI, 8.4-35.8; P = .003).
 

Strengths and Limitations

Among the strengths of the study, Launay highlighted the large number of vaccinated participants older than 65 years — more than 7 million — and the widespread use of polymerase chain reaction flu tests in cases of hospitalization for respiratory infections, which improved flu coding in the database used. Additionally, the results were consistent with those of previous studies.

However, limitations included the retrospective design, which did not randomize participants and introduced potential bias. For example, the HD vaccine may have been prioritized for the oldest people or those with multiple comorbidities. Additionally, the 2021/2022 flu season was atypical, with the simultaneous circulation of the flu virus and SARS-CoV-2, as noted by Launay.
 

Conclusion

In conclusion, this first evaluation of the HD flu vaccine’s effectiveness in France showed a 25% reduction in hospitalizations, consistent with existing data covering 12 flu seasons. The vaccine has been available for a longer period in the United States and Northern Europe.

“The latest unpublished data from the 2022/23 season show a 27% reduction in hospitalizations with the HD vaccine in people over 65,” added Launay.

Note: Due to a pricing disagreement with the French government, Sanofi’s HD flu vaccine Efluelda, intended for people older than 65 years, will not be available this year. (See: Withdrawal of the Efluelda Influenza Vaccine: The Academy of Medicine Reacts). However, the company has submitted a dossier for a trivalent form for a return in the 2025/2026 season and is working on developing mRNA vaccines. Additionally, a combined flu/COVID-19 vaccine is currently in development.

The study was funded by Sanofi. Several authors are Sanofi employees. Odile Launay reported conflicts of interest with Sanofi, MSD, Pfizer, GSK, and Moderna.
 

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

TOPLINE:

Patients with dry eye disease are more than three times as likely to have mental health conditions, such as depression and anxiety, as those without the condition.

METHODOLOGY:

• Researchers used a database from the National Institutes of Health to investigate the association between dry eye disease and mental health disorders in a large and diverse nationwide population of American adults.
• They identified 18,257 patients (mean age, 64.9 years; 67% women) with dry eye disease who were propensity score–matched with 54,765 participants without the condition.
• The cases of dry eye disease were identified using Systematized Nomenclature of Medicine codes for dry eyes, meibomian gland dysfunction, and tear film insufficiency.
• The outcome measures for mental health conditions were clinical diagnoses of depressive disorders, anxiety-related disorders, bipolar disorder, and schizophrenia spectrum disorders.

TAKEAWAY:

• Patients with dry eye disease had more than triple the risk for mental health conditions than participants without the condition (adjusted odds ratio [aOR], 3.21; P < .001).
• Patients with dry eye disease had a higher risk for a depressive disorder (aOR, 3.47), anxiety-related disorder (aOR, 2.74), bipolar disorder (aOR, 2.23), and schizophrenia spectrum disorder (aOR, 2.48; P < .001 for all) than participants without the condition.
• The associations between dry eye disease and mental health conditions were significantly stronger among Black individuals than among White individuals, except for bipolar disorder.
• Dry eye disease was associated with two- to threefold higher odds of depressive disorders, anxiety-related disorders, bipolar disorder, and schizophrenia spectrum disorders even in participants who never used medications for mental health (P < .001 for all).

IN PRACTICE:

“Greater efforts should be undertaken to screen patients with DED [dry eye disease] for mental health conditions, particularly in historically medically underserved populations,” the authors of the study wrote.

SOURCE:

This study was led by Aaron T. Zhao, of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, and was published online on October 15, 2024, in the American Journal of Ophthalmology.

LIMITATIONS:

This study relied on electronic health record data, which may have led to the inclusion of participants with undiagnosed dry eye disease as control participants. Moreover, the study did not evaluate the severity of dry eye disease or the severity and duration of mental health conditions, which may have affected the results. The database analyzed in this study may not have fully captured the complete demographic profile of the nationwide population, which may have affected the generalizability of the findings.

DISCLOSURES:

This study was supported by funding from the National Institutes of Health and Research to Prevent Blindness. The authors declared having 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 first appeared on Medscape.com.

TOPLINE:

Patients with dry eye disease are more than three times as likely to have mental health conditions, such as depression and anxiety, as those without the condition.

METHODOLOGY:

• Researchers used a database from the National Institutes of Health to investigate the association between dry eye disease and mental health disorders in a large and diverse nationwide population of American adults.
• They identified 18,257 patients (mean age, 64.9 years; 67% women) with dry eye disease who were propensity score–matched with 54,765 participants without the condition.
• The cases of dry eye disease were identified using Systematized Nomenclature of Medicine codes for dry eyes, meibomian gland dysfunction, and tear film insufficiency.
• The outcome measures for mental health conditions were clinical diagnoses of depressive disorders, anxiety-related disorders, bipolar disorder, and schizophrenia spectrum disorders.

TAKEAWAY:

• Patients with dry eye disease had more than triple the risk for mental health conditions than participants without the condition (adjusted odds ratio [aOR], 3.21; P < .001).
• Patients with dry eye disease had a higher risk for a depressive disorder (aOR, 3.47), anxiety-related disorder (aOR, 2.74), bipolar disorder (aOR, 2.23), and schizophrenia spectrum disorder (aOR, 2.48; P < .001 for all) than participants without the condition.
• The associations between dry eye disease and mental health conditions were significantly stronger among Black individuals than among White individuals, except for bipolar disorder.
• Dry eye disease was associated with two- to threefold higher odds of depressive disorders, anxiety-related disorders, bipolar disorder, and schizophrenia spectrum disorders even in participants who never used medications for mental health (P < .001 for all).

IN PRACTICE:

“Greater efforts should be undertaken to screen patients with DED [dry eye disease] for mental health conditions, particularly in historically medically underserved populations,” the authors of the study wrote.

SOURCE:

This study was led by Aaron T. Zhao, of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, and was published online on October 15, 2024, in the American Journal of Ophthalmology.

LIMITATIONS:

This study relied on electronic health record data, which may have led to the inclusion of participants with undiagnosed dry eye disease as control participants. Moreover, the study did not evaluate the severity of dry eye disease or the severity and duration of mental health conditions, which may have affected the results. The database analyzed in this study may not have fully captured the complete demographic profile of the nationwide population, which may have affected the generalizability of the findings.

DISCLOSURES:

This study was supported by funding from the National Institutes of Health and Research to Prevent Blindness. The authors declared having 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 first appeared on Medscape.com.

TOPLINE:

Patients with dry eye disease are more than three times as likely to have mental health conditions, such as depression and anxiety, as those without the condition.

METHODOLOGY:

• Researchers used a database from the National Institutes of Health to investigate the association between dry eye disease and mental health disorders in a large and diverse nationwide population of American adults.
• They identified 18,257 patients (mean age, 64.9 years; 67% women) with dry eye disease who were propensity score–matched with 54,765 participants without the condition.
• The cases of dry eye disease were identified using Systematized Nomenclature of Medicine codes for dry eyes, meibomian gland dysfunction, and tear film insufficiency.
• The outcome measures for mental health conditions were clinical diagnoses of depressive disorders, anxiety-related disorders, bipolar disorder, and schizophrenia spectrum disorders.

TAKEAWAY:

• Patients with dry eye disease had more than triple the risk for mental health conditions than participants without the condition (adjusted odds ratio [aOR], 3.21; P < .001).
• Patients with dry eye disease had a higher risk for a depressive disorder (aOR, 3.47), anxiety-related disorder (aOR, 2.74), bipolar disorder (aOR, 2.23), and schizophrenia spectrum disorder (aOR, 2.48; P < .001 for all) than participants without the condition.
• The associations between dry eye disease and mental health conditions were significantly stronger among Black individuals than among White individuals, except for bipolar disorder.
• Dry eye disease was associated with two- to threefold higher odds of depressive disorders, anxiety-related disorders, bipolar disorder, and schizophrenia spectrum disorders even in participants who never used medications for mental health (P < .001 for all).

IN PRACTICE:

“Greater efforts should be undertaken to screen patients with DED [dry eye disease] for mental health conditions, particularly in historically medically underserved populations,” the authors of the study wrote.

SOURCE:

This study was led by Aaron T. Zhao, of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, and was published online on October 15, 2024, in the American Journal of Ophthalmology.

LIMITATIONS:

This study relied on electronic health record data, which may have led to the inclusion of participants with undiagnosed dry eye disease as control participants. Moreover, the study did not evaluate the severity of dry eye disease or the severity and duration of mental health conditions, which may have affected the results. The database analyzed in this study may not have fully captured the complete demographic profile of the nationwide population, which may have affected the generalizability of the findings.

DISCLOSURES:

This study was supported by funding from the National Institutes of Health and Research to Prevent Blindness. The authors declared having 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 first appeared on Medscape.com.

The US Department of Veterans Affairs (VA) has announced that tele-emergency care (tele-EC) is now available nationwide. According to the VA, the expansion has already helped > 61,000 callers with a 59.4% case resolution rate, meaning veterans’ needs were resolved without them having to travel to urgent care or an emergency department.

Tele-EC does not replace the need for in-person emergency evaluation, but offers quick, virtual triage assessments for veterans in rural areas or those with mobility and transportation challenges when in-person immediate care can be difficult to access. The program is a part of VA Health Connect, which connects the caller to a clinical triage nurse, who connects the veteran to tele-emergency care when clinically appropriate. Tele-EC practitioners evaluate the veteran over the phone or on video and recommend treatment or follow-up, including in-person care if needed. In life-threatening emergencies, the clinical triage nurse will call 911 and stay on the phone with the veteran until help arrives. The VA however, says the best step for a veteran experiencing a life-threatening emergency is to immediately contact 911 as opposed to seeking support via tele-EC.

The program can save time not only through on-the-spot evaluation, but by avoiding drive and wait times. “Sometimes, you’re not sure whether what you’re experiencing is a minor emergency or not — and tele-emergency care can help you resolve those questions,” VA Under Secretary for Health Shereef Elnahal, MD, says. “Veterans can get immediate, virtual triage with a VA medical provider who has direct access to their medical records. This avoids having to potentially drive to the nearest emergency department and wait to be evaluated, if appropriate.”

Veterans enrolled in VA health care can now access tele-EC nationwide by calling VA Health Connect and through the VA Health Chat app. Veterans can find their local VA Health Connect number by searching for their facility.

The US Department of Veterans Affairs (VA) has announced that tele-emergency care (tele-EC) is now available nationwide. According to the VA, the expansion has already helped > 61,000 callers with a 59.4% case resolution rate, meaning veterans’ needs were resolved without them having to travel to urgent care or an emergency department.

Tele-EC does not replace the need for in-person emergency evaluation, but offers quick, virtual triage assessments for veterans in rural areas or those with mobility and transportation challenges when in-person immediate care can be difficult to access. The program is a part of VA Health Connect, which connects the caller to a clinical triage nurse, who connects the veteran to tele-emergency care when clinically appropriate. Tele-EC practitioners evaluate the veteran over the phone or on video and recommend treatment or follow-up, including in-person care if needed. In life-threatening emergencies, the clinical triage nurse will call 911 and stay on the phone with the veteran until help arrives. The VA however, says the best step for a veteran experiencing a life-threatening emergency is to immediately contact 911 as opposed to seeking support via tele-EC.

The program can save time not only through on-the-spot evaluation, but by avoiding drive and wait times. “Sometimes, you’re not sure whether what you’re experiencing is a minor emergency or not — and tele-emergency care can help you resolve those questions,” VA Under Secretary for Health Shereef Elnahal, MD, says. “Veterans can get immediate, virtual triage with a VA medical provider who has direct access to their medical records. This avoids having to potentially drive to the nearest emergency department and wait to be evaluated, if appropriate.”

Veterans enrolled in VA health care can now access tele-EC nationwide by calling VA Health Connect and through the VA Health Chat app. Veterans can find their local VA Health Connect number by searching for their facility.

The US Department of Veterans Affairs (VA) has announced that tele-emergency care (tele-EC) is now available nationwide. According to the VA, the expansion has already helped > 61,000 callers with a 59.4% case resolution rate, meaning veterans’ needs were resolved without them having to travel to urgent care or an emergency department.

Tele-EC does not replace the need for in-person emergency evaluation, but offers quick, virtual triage assessments for veterans in rural areas or those with mobility and transportation challenges when in-person immediate care can be difficult to access. The program is a part of VA Health Connect, which connects the caller to a clinical triage nurse, who connects the veteran to tele-emergency care when clinically appropriate. Tele-EC practitioners evaluate the veteran over the phone or on video and recommend treatment or follow-up, including in-person care if needed. In life-threatening emergencies, the clinical triage nurse will call 911 and stay on the phone with the veteran until help arrives. The VA however, says the best step for a veteran experiencing a life-threatening emergency is to immediately contact 911 as opposed to seeking support via tele-EC.

The program can save time not only through on-the-spot evaluation, but by avoiding drive and wait times. “Sometimes, you’re not sure whether what you’re experiencing is a minor emergency or not — and tele-emergency care can help you resolve those questions,” VA Under Secretary for Health Shereef Elnahal, MD, says. “Veterans can get immediate, virtual triage with a VA medical provider who has direct access to their medical records. This avoids having to potentially drive to the nearest emergency department and wait to be evaluated, if appropriate.”

Veterans enrolled in VA health care can now access tele-EC nationwide by calling VA Health Connect and through the VA Health Chat app. Veterans can find their local VA Health Connect number by searching for their facility.