Heidi Splete

The Food and Drug Administration (FDA) has accepted an application for Priority Review for dupilumab as an add-on therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD), according to a press release from manufacturer Regeneron.

If approved, dupilumab would be the only biologic option for COPD and the first new treatment option in approximately 10 years, according to the company.

Dupilumab works by blocking signaling by the interleukin (IL) 4 and IL-13 pathways, and Regeneron’s development program focuses on a population of COPD patients who also have type 2 inflammation.

The supplemental Biologics License Application was based on data from a pair of clinical trials in the company’s phase 3 COPD clinical research program.

In the studies, known as BOREAS and NOTUS, adults with uncontrolled COPD and type 2 inflammation who were current or former smokers were randomized to 300 mg of subcutaneous dupilumab or placebo once every 2 weeks. Type 2 inflammation was defined as blood eosinophil counts of at least 300 cells per microliter.

All patients received standard-of-care therapy. The primary endpoint of reduced annualized moderate or severe acute COPD exacerbations was 30% and 34% greater in the dupilumab groups in the two studies, respectively, compared with the placebo groups, and the significant differences in improvement persisted at 52 weeks.

Safety data were similar to previous studies of dupilumab for its approved indications. The most common adverse events seen in 5% or more of dupilumab patients compared with placebo patients across the two studies included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.

Priority Review status is granted to applications for approval for therapies that may offer significant improvements, although the therapies are still in clinical development. The target action date for the FDA decision is June 27, 2024, and regulatory submissions for dupilumab for COPD are under consideration in China and Europe in addition to the United States, according to the company.
 

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) has accepted an application for Priority Review for dupilumab as an add-on therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD), according to a press release from manufacturer Regeneron.

If approved, dupilumab would be the only biologic option for COPD and the first new treatment option in approximately 10 years, according to the company.

Dupilumab works by blocking signaling by the interleukin (IL) 4 and IL-13 pathways, and Regeneron’s development program focuses on a population of COPD patients who also have type 2 inflammation.

The supplemental Biologics License Application was based on data from a pair of clinical trials in the company’s phase 3 COPD clinical research program.

In the studies, known as BOREAS and NOTUS, adults with uncontrolled COPD and type 2 inflammation who were current or former smokers were randomized to 300 mg of subcutaneous dupilumab or placebo once every 2 weeks. Type 2 inflammation was defined as blood eosinophil counts of at least 300 cells per microliter.

All patients received standard-of-care therapy. The primary endpoint of reduced annualized moderate or severe acute COPD exacerbations was 30% and 34% greater in the dupilumab groups in the two studies, respectively, compared with the placebo groups, and the significant differences in improvement persisted at 52 weeks.

Safety data were similar to previous studies of dupilumab for its approved indications. The most common adverse events seen in 5% or more of dupilumab patients compared with placebo patients across the two studies included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.

Priority Review status is granted to applications for approval for therapies that may offer significant improvements, although the therapies are still in clinical development. The target action date for the FDA decision is June 27, 2024, and regulatory submissions for dupilumab for COPD are under consideration in China and Europe in addition to the United States, according to the company.
 

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) has accepted an application for Priority Review for dupilumab as an add-on therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD), according to a press release from manufacturer Regeneron.

If approved, dupilumab would be the only biologic option for COPD and the first new treatment option in approximately 10 years, according to the company.

Dupilumab works by blocking signaling by the interleukin (IL) 4 and IL-13 pathways, and Regeneron’s development program focuses on a population of COPD patients who also have type 2 inflammation.

The supplemental Biologics License Application was based on data from a pair of clinical trials in the company’s phase 3 COPD clinical research program.

In the studies, known as BOREAS and NOTUS, adults with uncontrolled COPD and type 2 inflammation who were current or former smokers were randomized to 300 mg of subcutaneous dupilumab or placebo once every 2 weeks. Type 2 inflammation was defined as blood eosinophil counts of at least 300 cells per microliter.

All patients received standard-of-care therapy. The primary endpoint of reduced annualized moderate or severe acute COPD exacerbations was 30% and 34% greater in the dupilumab groups in the two studies, respectively, compared with the placebo groups, and the significant differences in improvement persisted at 52 weeks.

Safety data were similar to previous studies of dupilumab for its approved indications. The most common adverse events seen in 5% or more of dupilumab patients compared with placebo patients across the two studies included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.

Priority Review status is granted to applications for approval for therapies that may offer significant improvements, although the therapies are still in clinical development. The target action date for the FDA decision is June 27, 2024, and regulatory submissions for dupilumab for COPD are under consideration in China and Europe in addition to the United States, according to the company.
 

A version of this article appeared on Medscape.com.

The MightySat Medical, an over-the-counter medical fingertip pulse oximeter, has received clearance from the US Food and Drug Administration (FDA) for use without a prescription, according to a press release from manufacturer Masimo.

The device is the first medical fingertip pulse oximeter available directly to consumers without a prescription that includes the same technology used by many hospitals, according to the company.

According to the FDA, home pulse oximeters are currently generally of two classes: hospital-grade prescription devices which have been vetted for accuracy through clinical trials, and over-the-counter devices which are sold direct to consumers but often estimate oxygen saturation. FDA communication on pulse oximeter accuracy states "OTC oximeters that are sold as either general wellness or sporting/aviation products are not intended for medical purposes, so they do not undergo FDA review."

Pulse oximeter use is important for patients diagnosed with breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, flu, pneumonia, or COVID-19 to collect accurate data on arterial blood oxygen saturation that they can share with their healthcare providers, according to the company. Patients with cardiac conditions, including pulmonary hypertension and heart failure may also benefit from pulse oximeter monitoring.

However, challenges of pulse oximeter use include measuring accuracy when patients are moving, measuring patients with poor circulation, and measuring patients with cool, thick, or darker skin. The MightySat Medical is designed to provide reliable measures of oxygen saturation and pulse rate across all patient groups, the manufacturers wrote in the press release.

Asked for additional comment, Diego J. Maselli, MD, FCCP, Professor and Chief in the division of Pulmonary Diseases and Critical Care at UT Health at San Antonio, noted, "Over the past decades, there has been an increased interest in home monitoring of medical conditions, particulrly with the development of more portable and accessible technology."

"This was heightended by the COVID-19 pandemic where telemedicine was frequently required as a means of delivering care," Dr. Maselli continued. "One of the important characteristics to monitor was the oxgen saturation in patients that had an active COVID-19 infection as it would dictate management and was part of the protocol for monitoring the clinical course of infection. Because of this need, many companies developed portable pulse oximeters for home use. This resulted in widespread use of pulse oximeters at home and other places outside clinic or hospital."

Other over-the-counter pulse oximeters that are not cleared by the FDA may create confusion among patients about the accuracy of their measurements, according to the company.

Dr. Maselli also commented that pulse oximeters' value can vary. "Unfortunately, these devices vary in quality and reliability and patients may not be fully aware of this. Most recently, the FDA approved a hospital-grade pulse oximeter that requires no prescription. This device may provide a more accurate reading in a wide range of clinical situations outside the healthcare setting. Patients should be aware that there are different grades of pulse oximeter before selecting one for home use. In addition, patients should work closely with their providers to better select the monitoring modaility that best fits their clinical situation," he said.

MightySat Medical is indicated for individuals aged 18 years and older who are well or poorly perfused under no motion conditions and is not intended as a diagnostic or screening tool for lung disease, according to the release. Treatment decisions based on data from the device should be made only in consultation with a healthcare provider, the company said. Dr. Maselli serves as a member of the CHEST Physician editorial board.

The FDA’s website offers further guidance related to at-home pulse oximeter use, with recommendations and limitations, as well as information on initiatives to ensure accurate and equitable pulse oximetry for all patients.

A version of this article appeared on Medscape.com.

The MightySat Medical, an over-the-counter medical fingertip pulse oximeter, has received clearance from the US Food and Drug Administration (FDA) for use without a prescription, according to a press release from manufacturer Masimo.

The device is the first medical fingertip pulse oximeter available directly to consumers without a prescription that includes the same technology used by many hospitals, according to the company.

According to the FDA, home pulse oximeters are currently generally of two classes: hospital-grade prescription devices which have been vetted for accuracy through clinical trials, and over-the-counter devices which are sold direct to consumers but often estimate oxygen saturation. FDA communication on pulse oximeter accuracy states "OTC oximeters that are sold as either general wellness or sporting/aviation products are not intended for medical purposes, so they do not undergo FDA review."

Pulse oximeter use is important for patients diagnosed with breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, flu, pneumonia, or COVID-19 to collect accurate data on arterial blood oxygen saturation that they can share with their healthcare providers, according to the company. Patients with cardiac conditions, including pulmonary hypertension and heart failure may also benefit from pulse oximeter monitoring.

However, challenges of pulse oximeter use include measuring accuracy when patients are moving, measuring patients with poor circulation, and measuring patients with cool, thick, or darker skin. The MightySat Medical is designed to provide reliable measures of oxygen saturation and pulse rate across all patient groups, the manufacturers wrote in the press release.

Asked for additional comment, Diego J. Maselli, MD, FCCP, Professor and Chief in the division of Pulmonary Diseases and Critical Care at UT Health at San Antonio, noted, "Over the past decades, there has been an increased interest in home monitoring of medical conditions, particulrly with the development of more portable and accessible technology."

"This was heightended by the COVID-19 pandemic where telemedicine was frequently required as a means of delivering care," Dr. Maselli continued. "One of the important characteristics to monitor was the oxgen saturation in patients that had an active COVID-19 infection as it would dictate management and was part of the protocol for monitoring the clinical course of infection. Because of this need, many companies developed portable pulse oximeters for home use. This resulted in widespread use of pulse oximeters at home and other places outside clinic or hospital."

Other over-the-counter pulse oximeters that are not cleared by the FDA may create confusion among patients about the accuracy of their measurements, according to the company.

Dr. Maselli also commented that pulse oximeters' value can vary. "Unfortunately, these devices vary in quality and reliability and patients may not be fully aware of this. Most recently, the FDA approved a hospital-grade pulse oximeter that requires no prescription. This device may provide a more accurate reading in a wide range of clinical situations outside the healthcare setting. Patients should be aware that there are different grades of pulse oximeter before selecting one for home use. In addition, patients should work closely with their providers to better select the monitoring modaility that best fits their clinical situation," he said.

MightySat Medical is indicated for individuals aged 18 years and older who are well or poorly perfused under no motion conditions and is not intended as a diagnostic or screening tool for lung disease, according to the release. Treatment decisions based on data from the device should be made only in consultation with a healthcare provider, the company said. Dr. Maselli serves as a member of the CHEST Physician editorial board.

The FDA’s website offers further guidance related to at-home pulse oximeter use, with recommendations and limitations, as well as information on initiatives to ensure accurate and equitable pulse oximetry for all patients.

A version of this article appeared on Medscape.com.

The MightySat Medical, an over-the-counter medical fingertip pulse oximeter, has received clearance from the US Food and Drug Administration (FDA) for use without a prescription, according to a press release from manufacturer Masimo.

The device is the first medical fingertip pulse oximeter available directly to consumers without a prescription that includes the same technology used by many hospitals, according to the company.

According to the FDA, home pulse oximeters are currently generally of two classes: hospital-grade prescription devices which have been vetted for accuracy through clinical trials, and over-the-counter devices which are sold direct to consumers but often estimate oxygen saturation. FDA communication on pulse oximeter accuracy states "OTC oximeters that are sold as either general wellness or sporting/aviation products are not intended for medical purposes, so they do not undergo FDA review."

Pulse oximeter use is important for patients diagnosed with breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, flu, pneumonia, or COVID-19 to collect accurate data on arterial blood oxygen saturation that they can share with their healthcare providers, according to the company. Patients with cardiac conditions, including pulmonary hypertension and heart failure may also benefit from pulse oximeter monitoring.

However, challenges of pulse oximeter use include measuring accuracy when patients are moving, measuring patients with poor circulation, and measuring patients with cool, thick, or darker skin. The MightySat Medical is designed to provide reliable measures of oxygen saturation and pulse rate across all patient groups, the manufacturers wrote in the press release.

Asked for additional comment, Diego J. Maselli, MD, FCCP, Professor and Chief in the division of Pulmonary Diseases and Critical Care at UT Health at San Antonio, noted, "Over the past decades, there has been an increased interest in home monitoring of medical conditions, particulrly with the development of more portable and accessible technology."

"This was heightended by the COVID-19 pandemic where telemedicine was frequently required as a means of delivering care," Dr. Maselli continued. "One of the important characteristics to monitor was the oxgen saturation in patients that had an active COVID-19 infection as it would dictate management and was part of the protocol for monitoring the clinical course of infection. Because of this need, many companies developed portable pulse oximeters for home use. This resulted in widespread use of pulse oximeters at home and other places outside clinic or hospital."

Other over-the-counter pulse oximeters that are not cleared by the FDA may create confusion among patients about the accuracy of their measurements, according to the company.

Dr. Maselli also commented that pulse oximeters' value can vary. "Unfortunately, these devices vary in quality and reliability and patients may not be fully aware of this. Most recently, the FDA approved a hospital-grade pulse oximeter that requires no prescription. This device may provide a more accurate reading in a wide range of clinical situations outside the healthcare setting. Patients should be aware that there are different grades of pulse oximeter before selecting one for home use. In addition, patients should work closely with their providers to better select the monitoring modaility that best fits their clinical situation," he said.

MightySat Medical is indicated for individuals aged 18 years and older who are well or poorly perfused under no motion conditions and is not intended as a diagnostic or screening tool for lung disease, according to the release. Treatment decisions based on data from the device should be made only in consultation with a healthcare provider, the company said. Dr. Maselli serves as a member of the CHEST Physician editorial board.

The FDA’s website offers further guidance related to at-home pulse oximeter use, with recommendations and limitations, as well as information on initiatives to ensure accurate and equitable pulse oximetry for all patients.

A version of this article appeared on Medscape.com.

TOPLINE:

Pooled data from 9225 adults with psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) showed no new safety signals with extended exposure to ixekizumab (Taltz).

METHODOLOGY:

• Researchers combined patient data from 25 randomized, controlled trials of the safety and effectiveness of at least one dose of ixekizumab in adults with PsO (n = 6892), PsA (n = 1401), and axSpA (n = 932).
• The study population included patients with a mean age of approximately 43-49 years; at least 49% were male and at least 74% were White across the three conditions.
• Patients’ median duration of ixekizumab exposure was 1.3 years for PsO, 1.4 years for PsA, and 2.7 years for axSpA, with data up to 6 years for PsO and up to 3 years for PsA and axSpA.
• The primary outcomes were exposure-adjusted incidence rates per 100 patient-years overall and at successive year intervals for treatment-emergent adverse events, serious adverse events, and selected adverse events of interest.

TAKEAWAY:

• The incidence rate per 100 person-years for any treatment-emergent adverse event was 32.5 for PsO, 50.3 for PsA, and 38.0 for axSpA; these did not increase with lengthier exposure.
• The incidence rates for serious adverse events for patients with PsO, PsA, or axSpA were 5.4, 6.0, and 4.8 per 100 person-years, respectively.
• A total of 45 deaths were reported across the studies, including 36 in patients with PsO, six with PsA, and three with axSpA.
• Infections were the most common treatment-emergent adverse events across all patient groups, reported in patients at rates of 62.5% with PsO, 52.4% with PsA, and 57.9% with axSpA; incidence of infections did not increase over time.

IN PRACTICE:

“These final, end-of-study program results surrounding the long-term use of [ixekizumab] in patients with PsO, PsA, and axSpA should serve as an important point of reference for physicians considering [ixekizumab],” the researchers wrote.

SOURCE:

The lead author on the study was Atul Deodhar, MD, of Oregon Health & Science University, Portland. The study was published online on February 12 in Arthritis Research & Therapy.

LIMITATIONS:

Study limitations included the small sample sizes and short treatment durations in some studies, the primarily White study population, the inability to stratify risk, the lack of a long-term comparator, and potential survivor bias.

DISCLOSURES:

The studies in the review were supported by Eli Lilly. Lead author Dr. Deodhar disclosed an honorarium and serving on advisory boards at AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, as well as research grants from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, and UCB.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Pooled data from 9225 adults with psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) showed no new safety signals with extended exposure to ixekizumab (Taltz).

METHODOLOGY:

• Researchers combined patient data from 25 randomized, controlled trials of the safety and effectiveness of at least one dose of ixekizumab in adults with PsO (n = 6892), PsA (n = 1401), and axSpA (n = 932).
• The study population included patients with a mean age of approximately 43-49 years; at least 49% were male and at least 74% were White across the three conditions.
• Patients’ median duration of ixekizumab exposure was 1.3 years for PsO, 1.4 years for PsA, and 2.7 years for axSpA, with data up to 6 years for PsO and up to 3 years for PsA and axSpA.
• The primary outcomes were exposure-adjusted incidence rates per 100 patient-years overall and at successive year intervals for treatment-emergent adverse events, serious adverse events, and selected adverse events of interest.

TAKEAWAY:

• The incidence rate per 100 person-years for any treatment-emergent adverse event was 32.5 for PsO, 50.3 for PsA, and 38.0 for axSpA; these did not increase with lengthier exposure.
• The incidence rates for serious adverse events for patients with PsO, PsA, or axSpA were 5.4, 6.0, and 4.8 per 100 person-years, respectively.
• A total of 45 deaths were reported across the studies, including 36 in patients with PsO, six with PsA, and three with axSpA.
• Infections were the most common treatment-emergent adverse events across all patient groups, reported in patients at rates of 62.5% with PsO, 52.4% with PsA, and 57.9% with axSpA; incidence of infections did not increase over time.

IN PRACTICE:

“These final, end-of-study program results surrounding the long-term use of [ixekizumab] in patients with PsO, PsA, and axSpA should serve as an important point of reference for physicians considering [ixekizumab],” the researchers wrote.

SOURCE:

The lead author on the study was Atul Deodhar, MD, of Oregon Health & Science University, Portland. The study was published online on February 12 in Arthritis Research & Therapy.

LIMITATIONS:

Study limitations included the small sample sizes and short treatment durations in some studies, the primarily White study population, the inability to stratify risk, the lack of a long-term comparator, and potential survivor bias.

DISCLOSURES:

The studies in the review were supported by Eli Lilly. Lead author Dr. Deodhar disclosed an honorarium and serving on advisory boards at AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, as well as research grants from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, and UCB.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Pooled data from 9225 adults with psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) showed no new safety signals with extended exposure to ixekizumab (Taltz).

METHODOLOGY:

• Researchers combined patient data from 25 randomized, controlled trials of the safety and effectiveness of at least one dose of ixekizumab in adults with PsO (n = 6892), PsA (n = 1401), and axSpA (n = 932).
• The study population included patients with a mean age of approximately 43-49 years; at least 49% were male and at least 74% were White across the three conditions.
• Patients’ median duration of ixekizumab exposure was 1.3 years for PsO, 1.4 years for PsA, and 2.7 years for axSpA, with data up to 6 years for PsO and up to 3 years for PsA and axSpA.
• The primary outcomes were exposure-adjusted incidence rates per 100 patient-years overall and at successive year intervals for treatment-emergent adverse events, serious adverse events, and selected adverse events of interest.

TAKEAWAY:

• The incidence rate per 100 person-years for any treatment-emergent adverse event was 32.5 for PsO, 50.3 for PsA, and 38.0 for axSpA; these did not increase with lengthier exposure.
• The incidence rates for serious adverse events for patients with PsO, PsA, or axSpA were 5.4, 6.0, and 4.8 per 100 person-years, respectively.
• A total of 45 deaths were reported across the studies, including 36 in patients with PsO, six with PsA, and three with axSpA.
• Infections were the most common treatment-emergent adverse events across all patient groups, reported in patients at rates of 62.5% with PsO, 52.4% with PsA, and 57.9% with axSpA; incidence of infections did not increase over time.

IN PRACTICE:

“These final, end-of-study program results surrounding the long-term use of [ixekizumab] in patients with PsO, PsA, and axSpA should serve as an important point of reference for physicians considering [ixekizumab],” the researchers wrote.

SOURCE:

The lead author on the study was Atul Deodhar, MD, of Oregon Health & Science University, Portland. The study was published online on February 12 in Arthritis Research & Therapy.

LIMITATIONS:

Study limitations included the small sample sizes and short treatment durations in some studies, the primarily White study population, the inability to stratify risk, the lack of a long-term comparator, and potential survivor bias.

DISCLOSURES:

The studies in the review were supported by Eli Lilly. Lead author Dr. Deodhar disclosed an honorarium and serving on advisory boards at AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, as well as research grants from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, and UCB.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Intermittent hypoxemia prompted higher postprandial plasma triglyceride levels in men than in women compared with normoxia.

METHODOLOGY:

• Potential gender differences in the impact of intermittent hypoxemia on triglycerides have not been well studied, despite the increased risk for metabolic comorbidities in obstructive sleep apnea (OSA).
• The researchers recruited 24 healthy young adults with a mean age of 23.3 years for the 12 men and 21.3 years for the 12 women.
• Participants consumed a high-fat meal followed by 6 hours of exposure to intermittent hypoxemia or ambient air; the primary outcome was changes in postprandial plasma triglyceride levels.

TAKEAWAY:

• Intermittent hypoxemia was associated with significantly higher postprandial triglycerides in men but not in women.
• Women had lower levels of total triglycerides as well as denser triglyceride-rich lipoprotein triglycerides (TRL-TG) and buoyant TRL-TG in both normoxia and hypoxemia conditions compared with men.
• Glucose levels were significantly higher in men and significantly lower in women during intermittent hypoxemia compared with normoxia (P < .001 for both sexes).

IN PRACTICE:

“Although there is a need for larger confirmatory studies in individuals living with obstructive sleep apnea, this study demonstrates that intermittent hypoxemia alters triglyceride metabolism differently between men and women,” the researchers wrote.

SOURCE:

The lead author of the study was Nicholas Goulet, MD, of the University of Ottawa, Ottawa, Ontario, Canada. The study was published online in The Journal of Physiology on January 29, 2024.

LIMITATIONS:

Limitations of the study included the experimental design with simulated OSA, the small and homogeneous study population, the use of a specific profile for intermittent hypoxemia, and the use of a specific high-fat meal.

DISCLOSURES:

The study was supported by the Natural Sciences and Engineering Research Council of Canada and the Association Médicale Universitaire de l’Hôpital Montfort. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Intermittent hypoxemia prompted higher postprandial plasma triglyceride levels in men than in women compared with normoxia.

METHODOLOGY:

• Potential gender differences in the impact of intermittent hypoxemia on triglycerides have not been well studied, despite the increased risk for metabolic comorbidities in obstructive sleep apnea (OSA).
• The researchers recruited 24 healthy young adults with a mean age of 23.3 years for the 12 men and 21.3 years for the 12 women.
• Participants consumed a high-fat meal followed by 6 hours of exposure to intermittent hypoxemia or ambient air; the primary outcome was changes in postprandial plasma triglyceride levels.

TAKEAWAY:

• Intermittent hypoxemia was associated with significantly higher postprandial triglycerides in men but not in women.
• Women had lower levels of total triglycerides as well as denser triglyceride-rich lipoprotein triglycerides (TRL-TG) and buoyant TRL-TG in both normoxia and hypoxemia conditions compared with men.
• Glucose levels were significantly higher in men and significantly lower in women during intermittent hypoxemia compared with normoxia (P < .001 for both sexes).

IN PRACTICE:

“Although there is a need for larger confirmatory studies in individuals living with obstructive sleep apnea, this study demonstrates that intermittent hypoxemia alters triglyceride metabolism differently between men and women,” the researchers wrote.

SOURCE:

The lead author of the study was Nicholas Goulet, MD, of the University of Ottawa, Ottawa, Ontario, Canada. The study was published online in The Journal of Physiology on January 29, 2024.

LIMITATIONS:

Limitations of the study included the experimental design with simulated OSA, the small and homogeneous study population, the use of a specific profile for intermittent hypoxemia, and the use of a specific high-fat meal.

DISCLOSURES:

The study was supported by the Natural Sciences and Engineering Research Council of Canada and the Association Médicale Universitaire de l’Hôpital Montfort. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Intermittent hypoxemia prompted higher postprandial plasma triglyceride levels in men than in women compared with normoxia.

METHODOLOGY:

• Potential gender differences in the impact of intermittent hypoxemia on triglycerides have not been well studied, despite the increased risk for metabolic comorbidities in obstructive sleep apnea (OSA).
• The researchers recruited 24 healthy young adults with a mean age of 23.3 years for the 12 men and 21.3 years for the 12 women.
• Participants consumed a high-fat meal followed by 6 hours of exposure to intermittent hypoxemia or ambient air; the primary outcome was changes in postprandial plasma triglyceride levels.

TAKEAWAY:

• Intermittent hypoxemia was associated with significantly higher postprandial triglycerides in men but not in women.
• Women had lower levels of total triglycerides as well as denser triglyceride-rich lipoprotein triglycerides (TRL-TG) and buoyant TRL-TG in both normoxia and hypoxemia conditions compared with men.
• Glucose levels were significantly higher in men and significantly lower in women during intermittent hypoxemia compared with normoxia (P < .001 for both sexes).

IN PRACTICE:

“Although there is a need for larger confirmatory studies in individuals living with obstructive sleep apnea, this study demonstrates that intermittent hypoxemia alters triglyceride metabolism differently between men and women,” the researchers wrote.

SOURCE:

The lead author of the study was Nicholas Goulet, MD, of the University of Ottawa, Ottawa, Ontario, Canada. The study was published online in The Journal of Physiology on January 29, 2024.

LIMITATIONS:

Limitations of the study included the experimental design with simulated OSA, the small and homogeneous study population, the use of a specific profile for intermittent hypoxemia, and the use of a specific high-fat meal.

DISCLOSURES:

The study was supported by the Natural Sciences and Engineering Research Council of Canada and the Association Médicale Universitaire de l’Hôpital Montfort. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Eosinopenia and low ratio between eosinophil count (EC) and neutrophil count (NC) are potential indicators of infection for patients with inflammatory disease who are treated with tocilizumab.

METHODOLOGY:

• The researchers reviewed data from 163 patients treated for an inflammatory disease (mostly rheumatoid arthritis) with tocilizumab at a single center between 2009 and 2020.
• The study population included 41 patients with unscheduled hospitalizations for suspected infections. Patients’ median age was 59 years, and 83% were female.
• The researchers assessed the association in tocilizumab-treated patients between infections and eosinopenia (defined as EC < 0.05 g/L) and a low ratio between EC and NC, defined as EC/NC × 1000 < 11.8.

TAKEAWAY:

• Infectious diseases were diagnosed in 20 of the hospitalized patients (49%); the most common diseases were pneumonia (30%), joint or bone infections (25%), and gastrointestinal tract infections (15%).
• The median absolute EC at hospital admission was significantly lower for patients with infections than for those without infections (0.06 g/L vs 0.20 g/L).
• The median EC/NC × 1000 ratios were significantly lower in infected patients vs noninfected patients (6.54 vs 48.50).
• No differences appeared between patients with and without infections in age, sex, type of inflammatory disease, and steroid treatment.

IN PRACTICE:

“This original study suggests that all those easily available parameters should be used to maximize [sensitivity] in the screening of infection in patients undergoing treatment with IL-6 pathway antagonists,” the researchers wrote.

SOURCE:

The lead author on the study was Audrey Glatre, MD, of University Hospital Centre Reims, France. The study was published online in RMD Open on February 9.

LIMITATIONS:

The retrospective, observational design; relatively small study population; and use of data from a single center were potential limitations of the findings.

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

TOPLINE:

Eosinopenia and low ratio between eosinophil count (EC) and neutrophil count (NC) are potential indicators of infection for patients with inflammatory disease who are treated with tocilizumab.

METHODOLOGY:

• The researchers reviewed data from 163 patients treated for an inflammatory disease (mostly rheumatoid arthritis) with tocilizumab at a single center between 2009 and 2020.
• The study population included 41 patients with unscheduled hospitalizations for suspected infections. Patients’ median age was 59 years, and 83% were female.
• The researchers assessed the association in tocilizumab-treated patients between infections and eosinopenia (defined as EC < 0.05 g/L) and a low ratio between EC and NC, defined as EC/NC × 1000 < 11.8.

TAKEAWAY:

• Infectious diseases were diagnosed in 20 of the hospitalized patients (49%); the most common diseases were pneumonia (30%), joint or bone infections (25%), and gastrointestinal tract infections (15%).
• The median absolute EC at hospital admission was significantly lower for patients with infections than for those without infections (0.06 g/L vs 0.20 g/L).
• The median EC/NC × 1000 ratios were significantly lower in infected patients vs noninfected patients (6.54 vs 48.50).
• No differences appeared between patients with and without infections in age, sex, type of inflammatory disease, and steroid treatment.

IN PRACTICE:

“This original study suggests that all those easily available parameters should be used to maximize [sensitivity] in the screening of infection in patients undergoing treatment with IL-6 pathway antagonists,” the researchers wrote.

SOURCE:

The lead author on the study was Audrey Glatre, MD, of University Hospital Centre Reims, France. The study was published online in RMD Open on February 9.

LIMITATIONS:

The retrospective, observational design; relatively small study population; and use of data from a single center were potential limitations of the findings.

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

TOPLINE:

Eosinopenia and low ratio between eosinophil count (EC) and neutrophil count (NC) are potential indicators of infection for patients with inflammatory disease who are treated with tocilizumab.

METHODOLOGY:

• The researchers reviewed data from 163 patients treated for an inflammatory disease (mostly rheumatoid arthritis) with tocilizumab at a single center between 2009 and 2020.
• The study population included 41 patients with unscheduled hospitalizations for suspected infections. Patients’ median age was 59 years, and 83% were female.
• The researchers assessed the association in tocilizumab-treated patients between infections and eosinopenia (defined as EC < 0.05 g/L) and a low ratio between EC and NC, defined as EC/NC × 1000 < 11.8.

TAKEAWAY:

• Infectious diseases were diagnosed in 20 of the hospitalized patients (49%); the most common diseases were pneumonia (30%), joint or bone infections (25%), and gastrointestinal tract infections (15%).
• The median absolute EC at hospital admission was significantly lower for patients with infections than for those without infections (0.06 g/L vs 0.20 g/L).
• The median EC/NC × 1000 ratios were significantly lower in infected patients vs noninfected patients (6.54 vs 48.50).
• No differences appeared between patients with and without infections in age, sex, type of inflammatory disease, and steroid treatment.

IN PRACTICE:

“This original study suggests that all those easily available parameters should be used to maximize [sensitivity] in the screening of infection in patients undergoing treatment with IL-6 pathway antagonists,” the researchers wrote.

SOURCE:

The lead author on the study was Audrey Glatre, MD, of University Hospital Centre Reims, France. The study was published online in RMD Open on February 9.

LIMITATIONS:

The retrospective, observational design; relatively small study population; and use of data from a single center were potential limitations of the findings.

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

The Food and Drug Administration has granted De Novo classification to a sleep apnea feature developed by Samsung for use via the Health Monitor app, according to a company press release.

The sleep apnea feature will be available on watches in Samsung’s Galaxy series in the third quarter of 2024, according to the press release.

The new feature on the app is designed to help users with no previous diagnosis of sleep apnea to detect moderate to severe symptoms over a 2-night period.

The sleep apnea feature allows individuals older than 22 years to track their sleep twice for more than 4 hours within a 10-day period. The feature identifies breathing disruptions.

The feature “is expected to help more people proactively detect moderate or severe forms of OSA and, as a result of the detection, seek medical care to reduce the possibility of health-related complications,” according to the company.

Health-related complications associated with poor sleep include increased risk for hypertension, coronary artery disease, heart failure, and stroke, as well as fatigue, decreased mental and emotional well-being, and problems in personal relationships, according to the release.

The feature is not meant for use by individuals with a sleep apnea diagnosis, nor should it replace traditional sleep apnea assessment and diagnosis by qualified clinicians, the company noted.

The feature on the app was approved by Korea’s Ministry of Food and Drug Safety in October 2023.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has granted De Novo classification to a sleep apnea feature developed by Samsung for use via the Health Monitor app, according to a company press release.

The sleep apnea feature will be available on watches in Samsung’s Galaxy series in the third quarter of 2024, according to the press release.

The new feature on the app is designed to help users with no previous diagnosis of sleep apnea to detect moderate to severe symptoms over a 2-night period.

The sleep apnea feature allows individuals older than 22 years to track their sleep twice for more than 4 hours within a 10-day period. The feature identifies breathing disruptions.

The feature “is expected to help more people proactively detect moderate or severe forms of OSA and, as a result of the detection, seek medical care to reduce the possibility of health-related complications,” according to the company.

Health-related complications associated with poor sleep include increased risk for hypertension, coronary artery disease, heart failure, and stroke, as well as fatigue, decreased mental and emotional well-being, and problems in personal relationships, according to the release.

The feature is not meant for use by individuals with a sleep apnea diagnosis, nor should it replace traditional sleep apnea assessment and diagnosis by qualified clinicians, the company noted.

The feature on the app was approved by Korea’s Ministry of Food and Drug Safety in October 2023.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has granted De Novo classification to a sleep apnea feature developed by Samsung for use via the Health Monitor app, according to a company press release.

The sleep apnea feature will be available on watches in Samsung’s Galaxy series in the third quarter of 2024, according to the press release.

The new feature on the app is designed to help users with no previous diagnosis of sleep apnea to detect moderate to severe symptoms over a 2-night period.

The sleep apnea feature allows individuals older than 22 years to track their sleep twice for more than 4 hours within a 10-day period. The feature identifies breathing disruptions.

The feature “is expected to help more people proactively detect moderate or severe forms of OSA and, as a result of the detection, seek medical care to reduce the possibility of health-related complications,” according to the company.

Health-related complications associated with poor sleep include increased risk for hypertension, coronary artery disease, heart failure, and stroke, as well as fatigue, decreased mental and emotional well-being, and problems in personal relationships, according to the release.

The feature is not meant for use by individuals with a sleep apnea diagnosis, nor should it replace traditional sleep apnea assessment and diagnosis by qualified clinicians, the company noted.

The feature on the app was approved by Korea’s Ministry of Food and Drug Safety in October 2023.

A version of this article appeared on Medscape.com.

TOPLINE:

Age older than 65 years and serum creatinine greater than 140 micromol/L at the time of systemic polyarteritis nodosa (PAN) diagnosis were significant predictors of mortality.

METHODOLOGY:

• A total of 358 patients diagnosed with PAN between 1990 and 2020 were identified from retrospective chart reviews and prospective cohorts from nine countries as a part of GLOBAL-PAN, a collaboration of the European Vasculitis Society, the Vasculitis Clinical Research Consortium, and other networks.
• The goal of the retrospective chart review was to characterize the nature, presentation, and survival rates of patients with PAN.
• The study population included 174 female and 184 male patients; 282 had systemic PAN (sPAN) and 76 had cutaneous PAN (cPAN); the mean age at diagnosis was 44.3 years.

TAKEAWAY:

• Overall survival rates at 1, 5, and 10 years for patients with sPAN were 97.1%, 94.0%, and 89.0%, respectively.
• Significant independent predictors of mortality were age ≥ 65 years at the time of sPAN diagnosis (hazard ratio [HR], 3.85), serum creatinine > 140 micromol/L at the time of diagnosis (HR, 4.93), gastrointestinal involvement (HR, 3.51), and central nervous system involvement (HR, 3.56).
• Constitutional symptoms were significantly more common in patients with sPAN vs cPAN (78.8% vs 44.7%), while patients with cPAN were significantly more likely to be female and have more skin nodules than patients with sPAN.
• Relapse over a median disease duration of 59.6 months was slightly higher for cPAN vs sPAN (38.8% vs 32.1%).

IN PRACTICE:

“This study helps better define the demographic and clinical characteristics of patients with PAN and differentiates sPAN from cPAN,” the researchers wrote.

SOURCE:

The lead author of the study was Omer Karadag, MD, of Hacettepe University, Ankara, Turkey. The study was published online on February 12 in Arthritis & Rheumatology.

LIMITATIONS:

Study limitations included the combination of prospective and retrospective data, varying approaches to patient assessment, and lack of data on treatment effects.

DISCLOSURES:

The study was supported by the Vasculitis Clinical Research Consortium, which received funding from the National Center for Advancing Translational Science, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the National Center for Research Resources. Dr. Karadag disclosed research grants from AbbVie, Novartis, Viela-Bio, and TR-Pharma, and consulting fees from AbbVie, Abdi Ibrahim, Celltrion, Novartis, Pfizer, Sandoz, and UCB.

A version of this article appeared on Medscape.com.

TOPLINE:

Age older than 65 years and serum creatinine greater than 140 micromol/L at the time of systemic polyarteritis nodosa (PAN) diagnosis were significant predictors of mortality.

METHODOLOGY:

• A total of 358 patients diagnosed with PAN between 1990 and 2020 were identified from retrospective chart reviews and prospective cohorts from nine countries as a part of GLOBAL-PAN, a collaboration of the European Vasculitis Society, the Vasculitis Clinical Research Consortium, and other networks.
• The goal of the retrospective chart review was to characterize the nature, presentation, and survival rates of patients with PAN.
• The study population included 174 female and 184 male patients; 282 had systemic PAN (sPAN) and 76 had cutaneous PAN (cPAN); the mean age at diagnosis was 44.3 years.

TAKEAWAY:

• Overall survival rates at 1, 5, and 10 years for patients with sPAN were 97.1%, 94.0%, and 89.0%, respectively.
• Significant independent predictors of mortality were age ≥ 65 years at the time of sPAN diagnosis (hazard ratio [HR], 3.85), serum creatinine > 140 micromol/L at the time of diagnosis (HR, 4.93), gastrointestinal involvement (HR, 3.51), and central nervous system involvement (HR, 3.56).
• Constitutional symptoms were significantly more common in patients with sPAN vs cPAN (78.8% vs 44.7%), while patients with cPAN were significantly more likely to be female and have more skin nodules than patients with sPAN.
• Relapse over a median disease duration of 59.6 months was slightly higher for cPAN vs sPAN (38.8% vs 32.1%).

IN PRACTICE:

“This study helps better define the demographic and clinical characteristics of patients with PAN and differentiates sPAN from cPAN,” the researchers wrote.

SOURCE:

The lead author of the study was Omer Karadag, MD, of Hacettepe University, Ankara, Turkey. The study was published online on February 12 in Arthritis & Rheumatology.

LIMITATIONS:

Study limitations included the combination of prospective and retrospective data, varying approaches to patient assessment, and lack of data on treatment effects.

DISCLOSURES:

The study was supported by the Vasculitis Clinical Research Consortium, which received funding from the National Center for Advancing Translational Science, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the National Center for Research Resources. Dr. Karadag disclosed research grants from AbbVie, Novartis, Viela-Bio, and TR-Pharma, and consulting fees from AbbVie, Abdi Ibrahim, Celltrion, Novartis, Pfizer, Sandoz, and UCB.

A version of this article appeared on Medscape.com.

TOPLINE:

Age older than 65 years and serum creatinine greater than 140 micromol/L at the time of systemic polyarteritis nodosa (PAN) diagnosis were significant predictors of mortality.

METHODOLOGY:

• A total of 358 patients diagnosed with PAN between 1990 and 2020 were identified from retrospective chart reviews and prospective cohorts from nine countries as a part of GLOBAL-PAN, a collaboration of the European Vasculitis Society, the Vasculitis Clinical Research Consortium, and other networks.
• The goal of the retrospective chart review was to characterize the nature, presentation, and survival rates of patients with PAN.
• The study population included 174 female and 184 male patients; 282 had systemic PAN (sPAN) and 76 had cutaneous PAN (cPAN); the mean age at diagnosis was 44.3 years.

TAKEAWAY:

• Overall survival rates at 1, 5, and 10 years for patients with sPAN were 97.1%, 94.0%, and 89.0%, respectively.
• Significant independent predictors of mortality were age ≥ 65 years at the time of sPAN diagnosis (hazard ratio [HR], 3.85), serum creatinine > 140 micromol/L at the time of diagnosis (HR, 4.93), gastrointestinal involvement (HR, 3.51), and central nervous system involvement (HR, 3.56).
• Constitutional symptoms were significantly more common in patients with sPAN vs cPAN (78.8% vs 44.7%), while patients with cPAN were significantly more likely to be female and have more skin nodules than patients with sPAN.
• Relapse over a median disease duration of 59.6 months was slightly higher for cPAN vs sPAN (38.8% vs 32.1%).

IN PRACTICE:

“This study helps better define the demographic and clinical characteristics of patients with PAN and differentiates sPAN from cPAN,” the researchers wrote.

SOURCE:

The lead author of the study was Omer Karadag, MD, of Hacettepe University, Ankara, Turkey. The study was published online on February 12 in Arthritis & Rheumatology.

LIMITATIONS:

Study limitations included the combination of prospective and retrospective data, varying approaches to patient assessment, and lack of data on treatment effects.

DISCLOSURES:

The study was supported by the Vasculitis Clinical Research Consortium, which received funding from the National Center for Advancing Translational Science, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the National Center for Research Resources. Dr. Karadag disclosed research grants from AbbVie, Novartis, Viela-Bio, and TR-Pharma, and consulting fees from AbbVie, Abdi Ibrahim, Celltrion, Novartis, Pfizer, Sandoz, and UCB.

A version of this article appeared on Medscape.com.

NATIONAL HARBOR, MARYLAND — Rates of maternal morbidity in individuals with placenta accreta were similar with alternative strategies to cesarean hysterectomy regardless of the severity of the condition, based on data from 60 individuals.

Currently, the recommended management strategy for placenta accreta spectrum (PAS) is a cesarean hysterectomy, but data are lacking on alternative strategies, especially for individuals wishing to keep their uterus and potentially preserve fertility, Farah H. Amro, MD, of the University of Texas Health Science Center at Houston McGovern Medical School said in a presentation at the Pregnancy Meeting (abstract 70).

Alternative options are being studied worldwide, including delayed hysterectomy (typically performed at 4-6 weeks postpartum), Dr. Amro said at the meeting, which was sponsored by the Society for Maternal-Fetal Medicine.

At UT Houston, delayed hysterectomy is performed for more aggressive PAS that involves parametrial invasion, and the placenta left in situ until resorption/passage for those wishing to keep their uterus, Dr. Amro said in an interview.

In a cohort study at UT Houston, a level IV academic center, Dr. Amro and colleagues evaluated outcomes in 60 individuals with suspected PAS who were given three management options after extensive counseling. Of these, 29 opted for a cesarean hysterectomy (CH); 16 opted for delayed interval hysterectomy (IH) performed 4-6 weeks after delivery; and 15 individuals with a preference for uterine preservation were assigned to conservative management.

The study occurred between January 2020 and July 2023. The primary outcome was composite maternal morbidity, which was further divided into composite acute morbidity (within 24 hours from cesarean delivery or hysterectomy) and composite delayed morbidity (24 hours or more postoperatively). Secondary outcomes included total estimated blood loss, need for blood transfusion, unplanned hospital readmission, and pathology diagnosis.

Overall maternal morbidity rates were 55%, 56%, and 53% in the CH, IH, and CM groups, respectively, although those who were planned for IH and CM had more severe PAS.

The planned procedure was performed in 90% of the CH patients. Approximately 20% of patients in the IH and CM groups underwent unplanned procedures. No cases of sepsis or maternal death occurred, and uterine infection rates were 0%, 6%, and 13% in the CH, IH, and CM groups, respectively.

Patients in the CM and IH groups were significantly less likely to require blood transfusions than those in the CH group. In addition, composite delayed morbidity (24 hours or more after surgery) was similar among the groups, with rates of 31%, 38%, and 33% for CH, IH, and CM, respectively (P = .94). These results are important, given the concerns regarding leaving a placenta in situ after cesarean delivery, said Dr. Amro.

The findings were limited by several factors including the use of data from a single site, the lack of randomization, patient compliance, and cost effectiveness. However, the results were strengthened by the diverse population and comparison of novel approaches that aren’t frequently utilized In the United States, as well as the large volume of PAS cases treated in a relatively short time frame, Dr. Amro said.
 

More Options Empower Mothers

Overall, the results support the use of delayed hysterectomy and conservative management as safe alternatives to cesarean hysterectomy, especially in those with severe PAS (opting for IH Instead of CH) and those seeking to preserve the uterus (CM), Dr. Amro said. However, these alternative options can be offered only to patients who can engage in frequent postpartum follow-up and live close to the hospital; with the CM group, resorption/passage of the placenta may take as long as 6 months in some cases, she explained.

The greatest concerns with leaving the placenta in place in PAS patients are the risk of infection or subsequent hemorrhage, Dr. Amro said in an interview. However, the current study showed that the infection rate was not as high as anticipated, and the frequency of unplanned procedures occurred in only 20%, which should alleviate some of these concerns, she said.

“We have completed 28 cases of conservative management since 2015, four have gone on to successful pregnancy with no cases of PAS in the subsequent pregnancies,” Dr. Amro said. Conservative management gives mothers another option, she added. “Moms feel empowered by being given a choice, especially for those that want to keep their uterus for fertility or religious/cultural considerations, and many opt for CM.”

The next step is to take the conservative management strategy to larger groups at other centers to replicate the results in other locations, said Dr. Amro. “Also, we are looking at the utility of other interventions such as uterine artery embolization and performing delayed dilation and curettage to help with passage of the placenta in those opting for CM.”
 

Study Supports Safety of Conservative Management

“There are patients that may want to preserve their reproductive organs in the face of an accreta (such as for religious, cultural, and personal reasons), and this study helps address some of the safety considerations with conservative approaches,” Corrina M. Oxford-Horrey, MD, a maternal-fetal medicine specialist at Weill Cornell Medicine, New York, said in an interview.

“I was surprised that there was not a lot of infectious morbidity (such as sepsis) in the cohorts; that was helpful to see,” said Dr. Oxford-Horrey, who served as a moderator for the session in which the study was presented.

Based on the study findings, “nontraditional approaches to placenta accreta spectrum management may be reasonable, given similar overall postoperative composite morbidity between the groups,” she said.

As for additional research, replicating the study in a multicenter fashion would add to the generalizability of the findings, Dr. Oxford-Horrey said.

The study received no outside funding. The researchers and Dr. Oxford-Horrey had no financial conflicts to disclose.

NATIONAL HARBOR, MARYLAND — Rates of maternal morbidity in individuals with placenta accreta were similar with alternative strategies to cesarean hysterectomy regardless of the severity of the condition, based on data from 60 individuals.

Currently, the recommended management strategy for placenta accreta spectrum (PAS) is a cesarean hysterectomy, but data are lacking on alternative strategies, especially for individuals wishing to keep their uterus and potentially preserve fertility, Farah H. Amro, MD, of the University of Texas Health Science Center at Houston McGovern Medical School said in a presentation at the Pregnancy Meeting (abstract 70).

Alternative options are being studied worldwide, including delayed hysterectomy (typically performed at 4-6 weeks postpartum), Dr. Amro said at the meeting, which was sponsored by the Society for Maternal-Fetal Medicine.

At UT Houston, delayed hysterectomy is performed for more aggressive PAS that involves parametrial invasion, and the placenta left in situ until resorption/passage for those wishing to keep their uterus, Dr. Amro said in an interview.

In a cohort study at UT Houston, a level IV academic center, Dr. Amro and colleagues evaluated outcomes in 60 individuals with suspected PAS who were given three management options after extensive counseling. Of these, 29 opted for a cesarean hysterectomy (CH); 16 opted for delayed interval hysterectomy (IH) performed 4-6 weeks after delivery; and 15 individuals with a preference for uterine preservation were assigned to conservative management.

The study occurred between January 2020 and July 2023. The primary outcome was composite maternal morbidity, which was further divided into composite acute morbidity (within 24 hours from cesarean delivery or hysterectomy) and composite delayed morbidity (24 hours or more postoperatively). Secondary outcomes included total estimated blood loss, need for blood transfusion, unplanned hospital readmission, and pathology diagnosis.

Overall maternal morbidity rates were 55%, 56%, and 53% in the CH, IH, and CM groups, respectively, although those who were planned for IH and CM had more severe PAS.

The planned procedure was performed in 90% of the CH patients. Approximately 20% of patients in the IH and CM groups underwent unplanned procedures. No cases of sepsis or maternal death occurred, and uterine infection rates were 0%, 6%, and 13% in the CH, IH, and CM groups, respectively.

Patients in the CM and IH groups were significantly less likely to require blood transfusions than those in the CH group. In addition, composite delayed morbidity (24 hours or more after surgery) was similar among the groups, with rates of 31%, 38%, and 33% for CH, IH, and CM, respectively (P = .94). These results are important, given the concerns regarding leaving a placenta in situ after cesarean delivery, said Dr. Amro.

The findings were limited by several factors including the use of data from a single site, the lack of randomization, patient compliance, and cost effectiveness. However, the results were strengthened by the diverse population and comparison of novel approaches that aren’t frequently utilized In the United States, as well as the large volume of PAS cases treated in a relatively short time frame, Dr. Amro said.
 

More Options Empower Mothers

Overall, the results support the use of delayed hysterectomy and conservative management as safe alternatives to cesarean hysterectomy, especially in those with severe PAS (opting for IH Instead of CH) and those seeking to preserve the uterus (CM), Dr. Amro said. However, these alternative options can be offered only to patients who can engage in frequent postpartum follow-up and live close to the hospital; with the CM group, resorption/passage of the placenta may take as long as 6 months in some cases, she explained.

The greatest concerns with leaving the placenta in place in PAS patients are the risk of infection or subsequent hemorrhage, Dr. Amro said in an interview. However, the current study showed that the infection rate was not as high as anticipated, and the frequency of unplanned procedures occurred in only 20%, which should alleviate some of these concerns, she said.

“We have completed 28 cases of conservative management since 2015, four have gone on to successful pregnancy with no cases of PAS in the subsequent pregnancies,” Dr. Amro said. Conservative management gives mothers another option, she added. “Moms feel empowered by being given a choice, especially for those that want to keep their uterus for fertility or religious/cultural considerations, and many opt for CM.”

The next step is to take the conservative management strategy to larger groups at other centers to replicate the results in other locations, said Dr. Amro. “Also, we are looking at the utility of other interventions such as uterine artery embolization and performing delayed dilation and curettage to help with passage of the placenta in those opting for CM.”
 

Study Supports Safety of Conservative Management

“There are patients that may want to preserve their reproductive organs in the face of an accreta (such as for religious, cultural, and personal reasons), and this study helps address some of the safety considerations with conservative approaches,” Corrina M. Oxford-Horrey, MD, a maternal-fetal medicine specialist at Weill Cornell Medicine, New York, said in an interview.

“I was surprised that there was not a lot of infectious morbidity (such as sepsis) in the cohorts; that was helpful to see,” said Dr. Oxford-Horrey, who served as a moderator for the session in which the study was presented.

Based on the study findings, “nontraditional approaches to placenta accreta spectrum management may be reasonable, given similar overall postoperative composite morbidity between the groups,” she said.

As for additional research, replicating the study in a multicenter fashion would add to the generalizability of the findings, Dr. Oxford-Horrey said.

The study received no outside funding. The researchers and Dr. Oxford-Horrey had no financial conflicts to disclose.

NATIONAL HARBOR, MARYLAND — Rates of maternal morbidity in individuals with placenta accreta were similar with alternative strategies to cesarean hysterectomy regardless of the severity of the condition, based on data from 60 individuals.

Currently, the recommended management strategy for placenta accreta spectrum (PAS) is a cesarean hysterectomy, but data are lacking on alternative strategies, especially for individuals wishing to keep their uterus and potentially preserve fertility, Farah H. Amro, MD, of the University of Texas Health Science Center at Houston McGovern Medical School said in a presentation at the Pregnancy Meeting (abstract 70).

Alternative options are being studied worldwide, including delayed hysterectomy (typically performed at 4-6 weeks postpartum), Dr. Amro said at the meeting, which was sponsored by the Society for Maternal-Fetal Medicine.

At UT Houston, delayed hysterectomy is performed for more aggressive PAS that involves parametrial invasion, and the placenta left in situ until resorption/passage for those wishing to keep their uterus, Dr. Amro said in an interview.

In a cohort study at UT Houston, a level IV academic center, Dr. Amro and colleagues evaluated outcomes in 60 individuals with suspected PAS who were given three management options after extensive counseling. Of these, 29 opted for a cesarean hysterectomy (CH); 16 opted for delayed interval hysterectomy (IH) performed 4-6 weeks after delivery; and 15 individuals with a preference for uterine preservation were assigned to conservative management.

The study occurred between January 2020 and July 2023. The primary outcome was composite maternal morbidity, which was further divided into composite acute morbidity (within 24 hours from cesarean delivery or hysterectomy) and composite delayed morbidity (24 hours or more postoperatively). Secondary outcomes included total estimated blood loss, need for blood transfusion, unplanned hospital readmission, and pathology diagnosis.

Overall maternal morbidity rates were 55%, 56%, and 53% in the CH, IH, and CM groups, respectively, although those who were planned for IH and CM had more severe PAS.

The planned procedure was performed in 90% of the CH patients. Approximately 20% of patients in the IH and CM groups underwent unplanned procedures. No cases of sepsis or maternal death occurred, and uterine infection rates were 0%, 6%, and 13% in the CH, IH, and CM groups, respectively.

Patients in the CM and IH groups were significantly less likely to require blood transfusions than those in the CH group. In addition, composite delayed morbidity (24 hours or more after surgery) was similar among the groups, with rates of 31%, 38%, and 33% for CH, IH, and CM, respectively (P = .94). These results are important, given the concerns regarding leaving a placenta in situ after cesarean delivery, said Dr. Amro.

The findings were limited by several factors including the use of data from a single site, the lack of randomization, patient compliance, and cost effectiveness. However, the results were strengthened by the diverse population and comparison of novel approaches that aren’t frequently utilized In the United States, as well as the large volume of PAS cases treated in a relatively short time frame, Dr. Amro said.
 

More Options Empower Mothers

Overall, the results support the use of delayed hysterectomy and conservative management as safe alternatives to cesarean hysterectomy, especially in those with severe PAS (opting for IH Instead of CH) and those seeking to preserve the uterus (CM), Dr. Amro said. However, these alternative options can be offered only to patients who can engage in frequent postpartum follow-up and live close to the hospital; with the CM group, resorption/passage of the placenta may take as long as 6 months in some cases, she explained.

The greatest concerns with leaving the placenta in place in PAS patients are the risk of infection or subsequent hemorrhage, Dr. Amro said in an interview. However, the current study showed that the infection rate was not as high as anticipated, and the frequency of unplanned procedures occurred in only 20%, which should alleviate some of these concerns, she said.

“We have completed 28 cases of conservative management since 2015, four have gone on to successful pregnancy with no cases of PAS in the subsequent pregnancies,” Dr. Amro said. Conservative management gives mothers another option, she added. “Moms feel empowered by being given a choice, especially for those that want to keep their uterus for fertility or religious/cultural considerations, and many opt for CM.”

The next step is to take the conservative management strategy to larger groups at other centers to replicate the results in other locations, said Dr. Amro. “Also, we are looking at the utility of other interventions such as uterine artery embolization and performing delayed dilation and curettage to help with passage of the placenta in those opting for CM.”
 

Study Supports Safety of Conservative Management

“There are patients that may want to preserve their reproductive organs in the face of an accreta (such as for religious, cultural, and personal reasons), and this study helps address some of the safety considerations with conservative approaches,” Corrina M. Oxford-Horrey, MD, a maternal-fetal medicine specialist at Weill Cornell Medicine, New York, said in an interview.

“I was surprised that there was not a lot of infectious morbidity (such as sepsis) in the cohorts; that was helpful to see,” said Dr. Oxford-Horrey, who served as a moderator for the session in which the study was presented.

Based on the study findings, “nontraditional approaches to placenta accreta spectrum management may be reasonable, given similar overall postoperative composite morbidity between the groups,” she said.

As for additional research, replicating the study in a multicenter fashion would add to the generalizability of the findings, Dr. Oxford-Horrey said.

The study received no outside funding. The researchers and Dr. Oxford-Horrey had no financial conflicts to disclose.

TOPLINE:

Several female reproductive factors across the life cycle were significantly associated with increased COPD risk, including age at menarche, number of children, infertility, pregnancy outcomes, and age at menopause.

METHODOLOGY:

• The researchers reviewed data from women in the International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events (InterLACE) consortium, which includes 27 observational studies involving more than 850,000 women in 12 countries.
• The current study included 283,070 women, 3.8% of whom developed COPD over a median of 11 years.
• The researchers examined the association between COPD and age at menarche, number of children, infertility, miscarriage, stillbirth, and age at natural menopause.

TAKEAWAY: 

• Higher risk of COPD was significantly associated with menarche at age 11 years or younger (hazard ratio [HR], 1.17), and at 16 years and older (HR, 1.24), as well as having three or more children.
• Higher risk of COPD was significantly associated with a history of infertility, and with miscarriage, or stillbirth compared with no miscarriages or stillbirths; the risk increased with the number of miscarriages or stillbirths (HR, 1.36 for ≥ 3 miscarriages and 1.67 for ≥ 2 stillbirths). 
• COPD risk was significantly increased with earlier age at the time of natural menopause (HR, 1.69 for those aged < 40 years and 1.42 for those aged 40-44 years compared with those aged 50-51 years). 

IN PRACTICE:

“Further research is needed to understand the mechanisms linking multiple female reproductive histories and COPD,” which could include autoimmune components and social/environmental factors, the researchers wrote. 

SOURCE:

The lead author on the study was Chen Liang, MD, of the University of Queensland, Australia. The study was published online in BMJ Thorax). 

LIMITATIONS: 

Study limitations included volunteer bias, underreporting of COPD, potential confounders such as childhood respiratory infections and smoking history, and the inability to assess the effects of medications including contraceptives and hormone replacement therapy on COPD. 

DISCLOSURES:

The InterLACE project is supported by the Australian National Health and Medical Research Council and Centres of Research Excellence. Corresponding author Gita D. Mishra disclosed support from the Australian National Health and Medical Research Council Leadership Fellowship. 

A version of this article appeared on Medscape.com.

TOPLINE:

Several female reproductive factors across the life cycle were significantly associated with increased COPD risk, including age at menarche, number of children, infertility, pregnancy outcomes, and age at menopause.

METHODOLOGY:

• The researchers reviewed data from women in the International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events (InterLACE) consortium, which includes 27 observational studies involving more than 850,000 women in 12 countries.
• The current study included 283,070 women, 3.8% of whom developed COPD over a median of 11 years.
• The researchers examined the association between COPD and age at menarche, number of children, infertility, miscarriage, stillbirth, and age at natural menopause.

TAKEAWAY: 

• Higher risk of COPD was significantly associated with menarche at age 11 years or younger (hazard ratio [HR], 1.17), and at 16 years and older (HR, 1.24), as well as having three or more children.
• Higher risk of COPD was significantly associated with a history of infertility, and with miscarriage, or stillbirth compared with no miscarriages or stillbirths; the risk increased with the number of miscarriages or stillbirths (HR, 1.36 for ≥ 3 miscarriages and 1.67 for ≥ 2 stillbirths). 
• COPD risk was significantly increased with earlier age at the time of natural menopause (HR, 1.69 for those aged < 40 years and 1.42 for those aged 40-44 years compared with those aged 50-51 years). 

IN PRACTICE:

“Further research is needed to understand the mechanisms linking multiple female reproductive histories and COPD,” which could include autoimmune components and social/environmental factors, the researchers wrote. 

SOURCE:

The lead author on the study was Chen Liang, MD, of the University of Queensland, Australia. The study was published online in BMJ Thorax). 

LIMITATIONS: 

Study limitations included volunteer bias, underreporting of COPD, potential confounders such as childhood respiratory infections and smoking history, and the inability to assess the effects of medications including contraceptives and hormone replacement therapy on COPD. 

DISCLOSURES:

The InterLACE project is supported by the Australian National Health and Medical Research Council and Centres of Research Excellence. Corresponding author Gita D. Mishra disclosed support from the Australian National Health and Medical Research Council Leadership Fellowship. 

A version of this article appeared on Medscape.com.

TOPLINE:

Several female reproductive factors across the life cycle were significantly associated with increased COPD risk, including age at menarche, number of children, infertility, pregnancy outcomes, and age at menopause.

METHODOLOGY:

• The researchers reviewed data from women in the International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events (InterLACE) consortium, which includes 27 observational studies involving more than 850,000 women in 12 countries.
• The current study included 283,070 women, 3.8% of whom developed COPD over a median of 11 years.
• The researchers examined the association between COPD and age at menarche, number of children, infertility, miscarriage, stillbirth, and age at natural menopause.

TAKEAWAY: 

• Higher risk of COPD was significantly associated with menarche at age 11 years or younger (hazard ratio [HR], 1.17), and at 16 years and older (HR, 1.24), as well as having three or more children.
• Higher risk of COPD was significantly associated with a history of infertility, and with miscarriage, or stillbirth compared with no miscarriages or stillbirths; the risk increased with the number of miscarriages or stillbirths (HR, 1.36 for ≥ 3 miscarriages and 1.67 for ≥ 2 stillbirths). 
• COPD risk was significantly increased with earlier age at the time of natural menopause (HR, 1.69 for those aged < 40 years and 1.42 for those aged 40-44 years compared with those aged 50-51 years). 

IN PRACTICE:

“Further research is needed to understand the mechanisms linking multiple female reproductive histories and COPD,” which could include autoimmune components and social/environmental factors, the researchers wrote. 

SOURCE:

The lead author on the study was Chen Liang, MD, of the University of Queensland, Australia. The study was published online in BMJ Thorax). 

LIMITATIONS: 

Study limitations included volunteer bias, underreporting of COPD, potential confounders such as childhood respiratory infections and smoking history, and the inability to assess the effects of medications including contraceptives and hormone replacement therapy on COPD. 

DISCLOSURES:

The InterLACE project is supported by the Australian National Health and Medical Research Council and Centres of Research Excellence. Corresponding author Gita D. Mishra disclosed support from the Australian National Health and Medical Research Council Leadership Fellowship. 

A version of this article appeared on Medscape.com.

TOPLINE:

Inflammatory arthritis (IA) occurred in one-third of patients with systemic sclerosis (SSc) in a large observational study and was significantly associated with poor quality of life and physical function, as well as diffuse disease, musculoskeletal manifestations, myositis, and sicca.

METHODOLOGY:

• Researchers reviewed data from 1717 adults with SSc who were enrolled in the Australian  Cohort Study to identify those with IA, defined as the presence of synovitis in one or more joints on clinical examination documented by the treating physician.
• The primary outcome was health-related quality of life (HRQoL) based on patient reports using the Medical Outcomes Short Form 36 and Patient-Reported Outcomes Measurement Information System, and physical function measured with the Health Assessment Questionnaire.

TAKEAWAY:

• IA was identified in 33.3% of the study participants over a median of 4.3 years’ follow-up. IA occurred at a median age of about 60 years and after a median SSc disease duration of 7.9 years. No significant differences in baseline demographics appeared between patients with and without IA.
• Patients with IA had significantly increased risk for diffuse cutaneous SSc (odds ratio [OR], 1.33), concurrent musculoskeletal manifestations such as tendon friction rubs and joint contractures (OR, 1.70), myositis (OR, 2.11), and sicca symptoms (OR, 1.57), compared with those without.
• Patients with IA reported significantly lower HRQoL scores and significantly greater physical disability, compared with those who did not have IA (P < .001 for both).
• IA was significantly less common among patients with , compared with those without pulmonary arterial hypertension (7.2% vs 11.3%; P = .007).

IN PRACTICE:

“Recognizing the presence of IA in SSc is an important first step, as its treatment and monitoring may alleviate some of the associated morbidity,” the researchers wrote.

SOURCE:

The lead author of the study was Eric Schwender, a medical student at the Royal College of Surgeons in Ireland, Dublin, Ireland. The study was published online in Arthritis Care & Research.

LIMITATIONS:

The inability to assess distribution and severity of IA limited the results, as did the inability to assess the impact of disease-modifying antirheumatic drugs in patients with IA.

DISCLOSURES:

The study was supported by Scleroderma Australia, Arthritis Australia, Actelion Australia, Bayer, CSL Biotherapies, GlaxoSmithKline Australia, and Pfizer, as well as grants to several researchers from the National Health and Medical Research Council of Australia. Lead author Mr. Schwender had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Inflammatory arthritis (IA) occurred in one-third of patients with systemic sclerosis (SSc) in a large observational study and was significantly associated with poor quality of life and physical function, as well as diffuse disease, musculoskeletal manifestations, myositis, and sicca.

METHODOLOGY:

• Researchers reviewed data from 1717 adults with SSc who were enrolled in the Australian  Cohort Study to identify those with IA, defined as the presence of synovitis in one or more joints on clinical examination documented by the treating physician.
• The primary outcome was health-related quality of life (HRQoL) based on patient reports using the Medical Outcomes Short Form 36 and Patient-Reported Outcomes Measurement Information System, and physical function measured with the Health Assessment Questionnaire.

TAKEAWAY:

• IA was identified in 33.3% of the study participants over a median of 4.3 years’ follow-up. IA occurred at a median age of about 60 years and after a median SSc disease duration of 7.9 years. No significant differences in baseline demographics appeared between patients with and without IA.
• Patients with IA had significantly increased risk for diffuse cutaneous SSc (odds ratio [OR], 1.33), concurrent musculoskeletal manifestations such as tendon friction rubs and joint contractures (OR, 1.70), myositis (OR, 2.11), and sicca symptoms (OR, 1.57), compared with those without.
• Patients with IA reported significantly lower HRQoL scores and significantly greater physical disability, compared with those who did not have IA (P < .001 for both).
• IA was significantly less common among patients with , compared with those without pulmonary arterial hypertension (7.2% vs 11.3%; P = .007).

IN PRACTICE:

“Recognizing the presence of IA in SSc is an important first step, as its treatment and monitoring may alleviate some of the associated morbidity,” the researchers wrote.

SOURCE:

The lead author of the study was Eric Schwender, a medical student at the Royal College of Surgeons in Ireland, Dublin, Ireland. The study was published online in Arthritis Care & Research.

LIMITATIONS:

The inability to assess distribution and severity of IA limited the results, as did the inability to assess the impact of disease-modifying antirheumatic drugs in patients with IA.

DISCLOSURES:

The study was supported by Scleroderma Australia, Arthritis Australia, Actelion Australia, Bayer, CSL Biotherapies, GlaxoSmithKline Australia, and Pfizer, as well as grants to several researchers from the National Health and Medical Research Council of Australia. Lead author Mr. Schwender had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Inflammatory arthritis (IA) occurred in one-third of patients with systemic sclerosis (SSc) in a large observational study and was significantly associated with poor quality of life and physical function, as well as diffuse disease, musculoskeletal manifestations, myositis, and sicca.

METHODOLOGY:

• Researchers reviewed data from 1717 adults with SSc who were enrolled in the Australian  Cohort Study to identify those with IA, defined as the presence of synovitis in one or more joints on clinical examination documented by the treating physician.
• The primary outcome was health-related quality of life (HRQoL) based on patient reports using the Medical Outcomes Short Form 36 and Patient-Reported Outcomes Measurement Information System, and physical function measured with the Health Assessment Questionnaire.

TAKEAWAY:

• IA was identified in 33.3% of the study participants over a median of 4.3 years’ follow-up. IA occurred at a median age of about 60 years and after a median SSc disease duration of 7.9 years. No significant differences in baseline demographics appeared between patients with and without IA.
• Patients with IA had significantly increased risk for diffuse cutaneous SSc (odds ratio [OR], 1.33), concurrent musculoskeletal manifestations such as tendon friction rubs and joint contractures (OR, 1.70), myositis (OR, 2.11), and sicca symptoms (OR, 1.57), compared with those without.
• Patients with IA reported significantly lower HRQoL scores and significantly greater physical disability, compared with those who did not have IA (P < .001 for both).
• IA was significantly less common among patients with , compared with those without pulmonary arterial hypertension (7.2% vs 11.3%; P = .007).

IN PRACTICE:

“Recognizing the presence of IA in SSc is an important first step, as its treatment and monitoring may alleviate some of the associated morbidity,” the researchers wrote.

SOURCE:

The lead author of the study was Eric Schwender, a medical student at the Royal College of Surgeons in Ireland, Dublin, Ireland. The study was published online in Arthritis Care & Research.

LIMITATIONS:

The inability to assess distribution and severity of IA limited the results, as did the inability to assess the impact of disease-modifying antirheumatic drugs in patients with IA.

DISCLOSURES:

The study was supported by Scleroderma Australia, Arthritis Australia, Actelion Australia, Bayer, CSL Biotherapies, GlaxoSmithKline Australia, and Pfizer, as well as grants to several researchers from the National Health and Medical Research Council of Australia. Lead author Mr. Schwender had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.