ASTRO Releases New EBRT Guideline for Symptomatic Bone Mets

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A new clinical practice guideline by the American Society for Radiation Oncology (ASTRO) steers use of external beam radiation therapy (EBRT) for the palliation of symptomatic bone metastases, including recommendations concerning pain management and quality of life.

The guideline was needed to update previous recommendations and incorporate new high-quality evidence for the management of symptomatic bone metastases, Sara Alcorn, MD, PhD, of the University of Minnesota, Minneapolis, and colleagues wrote in Practical Radiation Oncology.

The focus was on the efficacy of EBRT in reducing pain, improving skeletal function, and enhancing quality of life, they wrote in the clinical practice guideline.

In developing their recommendations, the ASTRO task force reviewed evidence from 53 randomized controlled trials (RCTs) and 31 nonrandomized studies, and considered clinical experience.
 

Indications for Palliative Radiation

EBRT is strongly recommended for reducing pain from osseous metastasis and improving ambulatory status, sphincter function, and reducing pain in patients with spinal metastases causing compression of the spinal cord or cauda equina.

For patients with symptomatic bone metastases and an anticipated life expectancy of at least 4 weeks, EBRT is conditionally recommended to improve quality of life.

Implementation of other Treatments Alongside Palliative Radiation

Instead of RT alone, surgery with postoperative RT is conditionally recommended for patients with compression of the spinal cord or cauda equina.

Postoperative RT is strongly recommended for patients who have undergone surgery for non-spine bone metastases or spine metastases without involving spinal cord or cauda equina compression.

For patients with spinal bone metastases compressing the spinal cord or cauda equina, combining RT with dexamethasone is strongly recommended over RT alone.

Techniques, Dose-Fractionation, and Dose-Constraints for Initial Palliative Radiation

For patients with symptomatic bone metastases undergoing conventional palliative RT, strongly recommended doses are 800 cGy in 1 fraction, 2000 cGy in 5 fractions, 2400 cGy in 6 fractions, or 3000 cGy in 10 fractions.

For patients with spinal bone metastases causing compression of the spinal cord or cauda equina who are not candidates for initial surgical decompression and are treated with conventional palliative RT, strongly recommended doses are 800 cGy in 1 fraction, 1600 cGy in 2 fractions, 2000 cGy in 5 fractions, or 3000 cGy in 10 fractions.

When selecting dose-fractionation, consider patient and disease factors such as prognosis and radiosensitivity, the authors wrote.

Highly conformal planning and delivery techniques, such as intensity-modulated radiation therapy, are conditionally recommended for patients with spinal bone metastases compressing the spinal cord or cauda equina who are receiving dose-escalated palliative RT.

The strongly recommended stereotactic body radiotherapy (SBRT) doses for patients with symptomatic bone metastases are 1200 to 1600 cGy in 1 fraction for non-spine metastases and 2400 cGy in 2 fractions for spine metastases. Other established SBRT dose and fractionation regimens with similar biologically effective doses may be considered based on patient tumor characteristics, normal tissue factors, and physician experience.

For patients with symptomatic bone metastases who have an ECOG PS of 0-2, are not undergoing surgical intervention, and have no neurological symptoms, SBRT is conditionally recommended over conventional palliative RT. Other factors to consider include life expectancy, tumor radiosensitivity, and metastatic disease burden, the guideline says.
 

 

 

Techniques, Dose-Fractionation, and Dose-Constraints for Palliative Reirradiation

For patients with spinal bone metastases requiring reirradiation to the same site, the strongly recommended conventional palliative RT regimens are 800 cGy in 1 fraction, 2000 cGy in 5 fractions, 2400 cGy in 6 fractions, or 2000 cGy in 8 fractions. When determining the RT dose-fractionation, consider the prior RT dose, time interval, and total spinal cord tolerance, the guideline says.

Treatment with SBRT is conditionally recommended for patients with spinal bone metastases needing reirradiation at the same site. When determining if SBRT is appropriate, consider patient factors such as urgency of treatment, prognosis, and radio-resistance. In addition, consider the prior RT dose, time interval, and total spinal cord tolerance when determining the RT dose-fractionation, the authors say.

The strongly recommended options for patients with symptomatic non-spine bone metastases needing reirradiation at the same site are single-fraction RT (800 cGy in 1 fraction) or multifraction conventional palliative RT (2000 cGy in 5 fractions or 2400 cGy in 6 fractions).
 

Impact of Techniques and Dose-fractionation on Quality of Life and Toxicity

For patients with bone metastases undergoing palliative radiation, it is strongly recommended to use a shared decision-making approach to determine the dose, fractionation, and supportive measures to optimize quality of life.

“Based on published data, the ASTRO task force’s recommendations inform best clinical practices on palliative RT for symptomatic bone metastases,” the guideline panelists said.

Limitations

While the guideline provides comprehensive recommendations, the panelists underscored the importance of individualized treatment approaches. Future research is needed to address gaps in evidence, particularly regarding advanced RT techniques and reirradiation strategies.

Guideline development was funded by ASTRO, with the systematic evidence review funded by the Patient-Centered Outcomes Research Institute. The panelists disclosed relationships with AstraZeneca, Elekta, Teladoc, and others.

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A new clinical practice guideline by the American Society for Radiation Oncology (ASTRO) steers use of external beam radiation therapy (EBRT) for the palliation of symptomatic bone metastases, including recommendations concerning pain management and quality of life.

The guideline was needed to update previous recommendations and incorporate new high-quality evidence for the management of symptomatic bone metastases, Sara Alcorn, MD, PhD, of the University of Minnesota, Minneapolis, and colleagues wrote in Practical Radiation Oncology.

The focus was on the efficacy of EBRT in reducing pain, improving skeletal function, and enhancing quality of life, they wrote in the clinical practice guideline.

In developing their recommendations, the ASTRO task force reviewed evidence from 53 randomized controlled trials (RCTs) and 31 nonrandomized studies, and considered clinical experience.
 

Indications for Palliative Radiation

EBRT is strongly recommended for reducing pain from osseous metastasis and improving ambulatory status, sphincter function, and reducing pain in patients with spinal metastases causing compression of the spinal cord or cauda equina.

For patients with symptomatic bone metastases and an anticipated life expectancy of at least 4 weeks, EBRT is conditionally recommended to improve quality of life.

Implementation of other Treatments Alongside Palliative Radiation

Instead of RT alone, surgery with postoperative RT is conditionally recommended for patients with compression of the spinal cord or cauda equina.

Postoperative RT is strongly recommended for patients who have undergone surgery for non-spine bone metastases or spine metastases without involving spinal cord or cauda equina compression.

For patients with spinal bone metastases compressing the spinal cord or cauda equina, combining RT with dexamethasone is strongly recommended over RT alone.

Techniques, Dose-Fractionation, and Dose-Constraints for Initial Palliative Radiation

For patients with symptomatic bone metastases undergoing conventional palliative RT, strongly recommended doses are 800 cGy in 1 fraction, 2000 cGy in 5 fractions, 2400 cGy in 6 fractions, or 3000 cGy in 10 fractions.

For patients with spinal bone metastases causing compression of the spinal cord or cauda equina who are not candidates for initial surgical decompression and are treated with conventional palliative RT, strongly recommended doses are 800 cGy in 1 fraction, 1600 cGy in 2 fractions, 2000 cGy in 5 fractions, or 3000 cGy in 10 fractions.

When selecting dose-fractionation, consider patient and disease factors such as prognosis and radiosensitivity, the authors wrote.

Highly conformal planning and delivery techniques, such as intensity-modulated radiation therapy, are conditionally recommended for patients with spinal bone metastases compressing the spinal cord or cauda equina who are receiving dose-escalated palliative RT.

The strongly recommended stereotactic body radiotherapy (SBRT) doses for patients with symptomatic bone metastases are 1200 to 1600 cGy in 1 fraction for non-spine metastases and 2400 cGy in 2 fractions for spine metastases. Other established SBRT dose and fractionation regimens with similar biologically effective doses may be considered based on patient tumor characteristics, normal tissue factors, and physician experience.

For patients with symptomatic bone metastases who have an ECOG PS of 0-2, are not undergoing surgical intervention, and have no neurological symptoms, SBRT is conditionally recommended over conventional palliative RT. Other factors to consider include life expectancy, tumor radiosensitivity, and metastatic disease burden, the guideline says.
 

 

 

Techniques, Dose-Fractionation, and Dose-Constraints for Palliative Reirradiation

For patients with spinal bone metastases requiring reirradiation to the same site, the strongly recommended conventional palliative RT regimens are 800 cGy in 1 fraction, 2000 cGy in 5 fractions, 2400 cGy in 6 fractions, or 2000 cGy in 8 fractions. When determining the RT dose-fractionation, consider the prior RT dose, time interval, and total spinal cord tolerance, the guideline says.

Treatment with SBRT is conditionally recommended for patients with spinal bone metastases needing reirradiation at the same site. When determining if SBRT is appropriate, consider patient factors such as urgency of treatment, prognosis, and radio-resistance. In addition, consider the prior RT dose, time interval, and total spinal cord tolerance when determining the RT dose-fractionation, the authors say.

The strongly recommended options for patients with symptomatic non-spine bone metastases needing reirradiation at the same site are single-fraction RT (800 cGy in 1 fraction) or multifraction conventional palliative RT (2000 cGy in 5 fractions or 2400 cGy in 6 fractions).
 

Impact of Techniques and Dose-fractionation on Quality of Life and Toxicity

For patients with bone metastases undergoing palliative radiation, it is strongly recommended to use a shared decision-making approach to determine the dose, fractionation, and supportive measures to optimize quality of life.

“Based on published data, the ASTRO task force’s recommendations inform best clinical practices on palliative RT for symptomatic bone metastases,” the guideline panelists said.

Limitations

While the guideline provides comprehensive recommendations, the panelists underscored the importance of individualized treatment approaches. Future research is needed to address gaps in evidence, particularly regarding advanced RT techniques and reirradiation strategies.

Guideline development was funded by ASTRO, with the systematic evidence review funded by the Patient-Centered Outcomes Research Institute. The panelists disclosed relationships with AstraZeneca, Elekta, Teladoc, and others.

A new clinical practice guideline by the American Society for Radiation Oncology (ASTRO) steers use of external beam radiation therapy (EBRT) for the palliation of symptomatic bone metastases, including recommendations concerning pain management and quality of life.

The guideline was needed to update previous recommendations and incorporate new high-quality evidence for the management of symptomatic bone metastases, Sara Alcorn, MD, PhD, of the University of Minnesota, Minneapolis, and colleagues wrote in Practical Radiation Oncology.

The focus was on the efficacy of EBRT in reducing pain, improving skeletal function, and enhancing quality of life, they wrote in the clinical practice guideline.

In developing their recommendations, the ASTRO task force reviewed evidence from 53 randomized controlled trials (RCTs) and 31 nonrandomized studies, and considered clinical experience.
 

Indications for Palliative Radiation

EBRT is strongly recommended for reducing pain from osseous metastasis and improving ambulatory status, sphincter function, and reducing pain in patients with spinal metastases causing compression of the spinal cord or cauda equina.

For patients with symptomatic bone metastases and an anticipated life expectancy of at least 4 weeks, EBRT is conditionally recommended to improve quality of life.

Implementation of other Treatments Alongside Palliative Radiation

Instead of RT alone, surgery with postoperative RT is conditionally recommended for patients with compression of the spinal cord or cauda equina.

Postoperative RT is strongly recommended for patients who have undergone surgery for non-spine bone metastases or spine metastases without involving spinal cord or cauda equina compression.

For patients with spinal bone metastases compressing the spinal cord or cauda equina, combining RT with dexamethasone is strongly recommended over RT alone.

Techniques, Dose-Fractionation, and Dose-Constraints for Initial Palliative Radiation

For patients with symptomatic bone metastases undergoing conventional palliative RT, strongly recommended doses are 800 cGy in 1 fraction, 2000 cGy in 5 fractions, 2400 cGy in 6 fractions, or 3000 cGy in 10 fractions.

For patients with spinal bone metastases causing compression of the spinal cord or cauda equina who are not candidates for initial surgical decompression and are treated with conventional palliative RT, strongly recommended doses are 800 cGy in 1 fraction, 1600 cGy in 2 fractions, 2000 cGy in 5 fractions, or 3000 cGy in 10 fractions.

When selecting dose-fractionation, consider patient and disease factors such as prognosis and radiosensitivity, the authors wrote.

Highly conformal planning and delivery techniques, such as intensity-modulated radiation therapy, are conditionally recommended for patients with spinal bone metastases compressing the spinal cord or cauda equina who are receiving dose-escalated palliative RT.

The strongly recommended stereotactic body radiotherapy (SBRT) doses for patients with symptomatic bone metastases are 1200 to 1600 cGy in 1 fraction for non-spine metastases and 2400 cGy in 2 fractions for spine metastases. Other established SBRT dose and fractionation regimens with similar biologically effective doses may be considered based on patient tumor characteristics, normal tissue factors, and physician experience.

For patients with symptomatic bone metastases who have an ECOG PS of 0-2, are not undergoing surgical intervention, and have no neurological symptoms, SBRT is conditionally recommended over conventional palliative RT. Other factors to consider include life expectancy, tumor radiosensitivity, and metastatic disease burden, the guideline says.
 

 

 

Techniques, Dose-Fractionation, and Dose-Constraints for Palliative Reirradiation

For patients with spinal bone metastases requiring reirradiation to the same site, the strongly recommended conventional palliative RT regimens are 800 cGy in 1 fraction, 2000 cGy in 5 fractions, 2400 cGy in 6 fractions, or 2000 cGy in 8 fractions. When determining the RT dose-fractionation, consider the prior RT dose, time interval, and total spinal cord tolerance, the guideline says.

Treatment with SBRT is conditionally recommended for patients with spinal bone metastases needing reirradiation at the same site. When determining if SBRT is appropriate, consider patient factors such as urgency of treatment, prognosis, and radio-resistance. In addition, consider the prior RT dose, time interval, and total spinal cord tolerance when determining the RT dose-fractionation, the authors say.

The strongly recommended options for patients with symptomatic non-spine bone metastases needing reirradiation at the same site are single-fraction RT (800 cGy in 1 fraction) or multifraction conventional palliative RT (2000 cGy in 5 fractions or 2400 cGy in 6 fractions).
 

Impact of Techniques and Dose-fractionation on Quality of Life and Toxicity

For patients with bone metastases undergoing palliative radiation, it is strongly recommended to use a shared decision-making approach to determine the dose, fractionation, and supportive measures to optimize quality of life.

“Based on published data, the ASTRO task force’s recommendations inform best clinical practices on palliative RT for symptomatic bone metastases,” the guideline panelists said.

Limitations

While the guideline provides comprehensive recommendations, the panelists underscored the importance of individualized treatment approaches. Future research is needed to address gaps in evidence, particularly regarding advanced RT techniques and reirradiation strategies.

Guideline development was funded by ASTRO, with the systematic evidence review funded by the Patient-Centered Outcomes Research Institute. The panelists disclosed relationships with AstraZeneca, Elekta, Teladoc, and others.

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High NSAID Use in Patients With Axial Spondyloarthritis May Not Raise Risk for Hypertension

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TOPLINE:

Patients with axial spondyloarthritis (axSpA) who reported high nonsteroidal anti-inflammatory drug (NSAID) use did not have a higher risk for hypertension than those who reported low NSAID use.

METHODOLOGY:

  • NSAIDs are first-line therapy for axSpA and are associated with a high risk for hypertension in the general population, but it’s unknown whether NSAID use increases the risk for hypertension in patients with axSpA, who are already at higher risk for cardiovascular disease and hypertension than the general population
  • This study used the DESIR cohort, a multicenter cohort of patients with recent-onset axSpA in France, including 631 individuals aged 18-50 years who did not have hypertension at baseline and had 6 years of follow-up.
  • NSAID use was evaluated at each follow-up visit, using the Assessment of Spondyloarthritis International Society NSAID index.
  • A score ≥ 50 was categorized as high use, and a score < 50 was considered low use.
  • The primary outcome was hypertension, defined by the use of antihypertensive medication, self-reported hypertension, and/or systolic blood pressure (BP) ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg on at least two visits.

TAKEAWAY:

  • A total of 39% of patients were categorized as high NSAID users.
  • Over 6 years of follow-up, 70 patients (11%) developed hypertension.
  • There was no significant association between high NSAID use and the risk for hypertension.

IN PRACTICE:

The study is too preliminary to have practice application.

SOURCE:

The research was led and presented by Jose Meade-Aguilar, MD, of Boston University School of Medicine, at the Spondyloarthritis Research and Treatment Network (SPARTAN) 2024 annual meeting in Cleveland.

LIMITATIONS:

The study had a low number of hypertension events, which could be due to the younger age of participants and earlier disease stage. The study was observational, so residual or unmeasured confounding is possible.

DISCLOSURES:

The DESIR cohort study is financially supported by unrestricted grants from both the French Society for Rheumatology and Pfizer France. One coauthor reported receiving research grants and/or consultancy fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, UCB, and Sanofi. Another coauthor reported receiving research grants from UCB and consulting fees from Eli Lilly, Novartis, Pfizer, and UCB. The remaining authors had no financial, relational, or commercial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

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TOPLINE:

Patients with axial spondyloarthritis (axSpA) who reported high nonsteroidal anti-inflammatory drug (NSAID) use did not have a higher risk for hypertension than those who reported low NSAID use.

METHODOLOGY:

  • NSAIDs are first-line therapy for axSpA and are associated with a high risk for hypertension in the general population, but it’s unknown whether NSAID use increases the risk for hypertension in patients with axSpA, who are already at higher risk for cardiovascular disease and hypertension than the general population
  • This study used the DESIR cohort, a multicenter cohort of patients with recent-onset axSpA in France, including 631 individuals aged 18-50 years who did not have hypertension at baseline and had 6 years of follow-up.
  • NSAID use was evaluated at each follow-up visit, using the Assessment of Spondyloarthritis International Society NSAID index.
  • A score ≥ 50 was categorized as high use, and a score < 50 was considered low use.
  • The primary outcome was hypertension, defined by the use of antihypertensive medication, self-reported hypertension, and/or systolic blood pressure (BP) ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg on at least two visits.

TAKEAWAY:

  • A total of 39% of patients were categorized as high NSAID users.
  • Over 6 years of follow-up, 70 patients (11%) developed hypertension.
  • There was no significant association between high NSAID use and the risk for hypertension.

IN PRACTICE:

The study is too preliminary to have practice application.

SOURCE:

The research was led and presented by Jose Meade-Aguilar, MD, of Boston University School of Medicine, at the Spondyloarthritis Research and Treatment Network (SPARTAN) 2024 annual meeting in Cleveland.

LIMITATIONS:

The study had a low number of hypertension events, which could be due to the younger age of participants and earlier disease stage. The study was observational, so residual or unmeasured confounding is possible.

DISCLOSURES:

The DESIR cohort study is financially supported by unrestricted grants from both the French Society for Rheumatology and Pfizer France. One coauthor reported receiving research grants and/or consultancy fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, UCB, and Sanofi. Another coauthor reported receiving research grants from UCB and consulting fees from Eli Lilly, Novartis, Pfizer, and UCB. The remaining authors had no financial, relational, or commercial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

 

TOPLINE:

Patients with axial spondyloarthritis (axSpA) who reported high nonsteroidal anti-inflammatory drug (NSAID) use did not have a higher risk for hypertension than those who reported low NSAID use.

METHODOLOGY:

  • NSAIDs are first-line therapy for axSpA and are associated with a high risk for hypertension in the general population, but it’s unknown whether NSAID use increases the risk for hypertension in patients with axSpA, who are already at higher risk for cardiovascular disease and hypertension than the general population
  • This study used the DESIR cohort, a multicenter cohort of patients with recent-onset axSpA in France, including 631 individuals aged 18-50 years who did not have hypertension at baseline and had 6 years of follow-up.
  • NSAID use was evaluated at each follow-up visit, using the Assessment of Spondyloarthritis International Society NSAID index.
  • A score ≥ 50 was categorized as high use, and a score < 50 was considered low use.
  • The primary outcome was hypertension, defined by the use of antihypertensive medication, self-reported hypertension, and/or systolic blood pressure (BP) ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg on at least two visits.

TAKEAWAY:

  • A total of 39% of patients were categorized as high NSAID users.
  • Over 6 years of follow-up, 70 patients (11%) developed hypertension.
  • There was no significant association between high NSAID use and the risk for hypertension.

IN PRACTICE:

The study is too preliminary to have practice application.

SOURCE:

The research was led and presented by Jose Meade-Aguilar, MD, of Boston University School of Medicine, at the Spondyloarthritis Research and Treatment Network (SPARTAN) 2024 annual meeting in Cleveland.

LIMITATIONS:

The study had a low number of hypertension events, which could be due to the younger age of participants and earlier disease stage. The study was observational, so residual or unmeasured confounding is possible.

DISCLOSURES:

The DESIR cohort study is financially supported by unrestricted grants from both the French Society for Rheumatology and Pfizer France. One coauthor reported receiving research grants and/or consultancy fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, UCB, and Sanofi. Another coauthor reported receiving research grants from UCB and consulting fees from Eli Lilly, Novartis, Pfizer, and UCB. The remaining authors had no financial, relational, or commercial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

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ASCO Provides Guidance on CDK4/6 Inhibitors for Early Breast Cancer

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TOPLINE:

A rapid recommendation update from the American Society of Clinical Oncology (ASCO) offers guidance on use of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors, abemaciclib and ribociclib, for the adjuvant treatment of stage II and III breast cancer.

METHODOLOGY:

  • The guideline update was needed to incorporate new high-quality evidence for the adjuvant use of CDK4/6 inhibitors in early breast cancer.
  • The ASCO guideline expert panel reviewed evidence from phase 3 trials, including the monarchE and NATALEE studies, focusing on the efficacy of abemaciclib and ribociclib in improving invasive disease-free survival (IDFS) and distant disease-free survival (DDFS).

TAKEAWAY:

  • Abemaciclib for 2 years plus endocrine therapy (ET) for at least 5 years is recommended for patients with resected, hormone receptor–positive, HER2-negative, node-positive early breast cancer at high risk of recurrence, including those with at least four positive axillary lymph nodes (ALNs) or one to three positive ALNs plus additional high-risk features.
  • Ribociclib (400 mg once daily, 3 weeks on, 1 week off) for 3 years plus ET is recommended for patients with stage II or III breast cancer who have a high risk of recurrence, based on the NATALEE trial.
  • For patients meeting both monarchE and NATALEE criteria, abemaciclib is preferred due to longer follow-up, a deepening benefit over time, and FDA approval in the adjuvant setting.
  • Ribociclib is recommended for patients who cannot tolerate abemaciclib due to contraindications such as high-grade diarrhea.
  • Benefits, risks, costs, and individual patient preferences should be considered when deciding on adjuvant CDK4/6 inhibitor therapy.

IN PRACTICE:

This rapid recommendation update addresses the adjuvant use of CDK4/6 inhibitors abemaciclib and ribociclib in patients with stage II and III breast cancer.

SOURCE:

The clinical practice guideline update, led by Rachel A. Freedman, from Dana-Farber Cancer Institute, Boston, was published in the Journal of Clinical Oncology.

LIMITATIONS:

The guideline panelists noted that the clinical benefits of adjuvant CDK4/6 inhibitor therapy may not extend to all patients eligible for the trials, particularly those at lower risk. There are insufficient data to specify which subgroups of patients may not warrant therapy, emphasizing the need for individualized treatment decisions. More data are needed to provide long-term efficacy data and more detailed guidance on which specific patient populations will benefit most from adjuvant CDK4/6 inhibitor therapy.

DISCLOSURES:

Guideline development was funded by the American Society of Clinical Oncology (ASCO). The panelists disclosed relationships with Firefly Health, Eisai, Novartis, and others.

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TOPLINE:

A rapid recommendation update from the American Society of Clinical Oncology (ASCO) offers guidance on use of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors, abemaciclib and ribociclib, for the adjuvant treatment of stage II and III breast cancer.

METHODOLOGY:

  • The guideline update was needed to incorporate new high-quality evidence for the adjuvant use of CDK4/6 inhibitors in early breast cancer.
  • The ASCO guideline expert panel reviewed evidence from phase 3 trials, including the monarchE and NATALEE studies, focusing on the efficacy of abemaciclib and ribociclib in improving invasive disease-free survival (IDFS) and distant disease-free survival (DDFS).

TAKEAWAY:

  • Abemaciclib for 2 years plus endocrine therapy (ET) for at least 5 years is recommended for patients with resected, hormone receptor–positive, HER2-negative, node-positive early breast cancer at high risk of recurrence, including those with at least four positive axillary lymph nodes (ALNs) or one to three positive ALNs plus additional high-risk features.
  • Ribociclib (400 mg once daily, 3 weeks on, 1 week off) for 3 years plus ET is recommended for patients with stage II or III breast cancer who have a high risk of recurrence, based on the NATALEE trial.
  • For patients meeting both monarchE and NATALEE criteria, abemaciclib is preferred due to longer follow-up, a deepening benefit over time, and FDA approval in the adjuvant setting.
  • Ribociclib is recommended for patients who cannot tolerate abemaciclib due to contraindications such as high-grade diarrhea.
  • Benefits, risks, costs, and individual patient preferences should be considered when deciding on adjuvant CDK4/6 inhibitor therapy.

IN PRACTICE:

This rapid recommendation update addresses the adjuvant use of CDK4/6 inhibitors abemaciclib and ribociclib in patients with stage II and III breast cancer.

SOURCE:

The clinical practice guideline update, led by Rachel A. Freedman, from Dana-Farber Cancer Institute, Boston, was published in the Journal of Clinical Oncology.

LIMITATIONS:

The guideline panelists noted that the clinical benefits of adjuvant CDK4/6 inhibitor therapy may not extend to all patients eligible for the trials, particularly those at lower risk. There are insufficient data to specify which subgroups of patients may not warrant therapy, emphasizing the need for individualized treatment decisions. More data are needed to provide long-term efficacy data and more detailed guidance on which specific patient populations will benefit most from adjuvant CDK4/6 inhibitor therapy.

DISCLOSURES:

Guideline development was funded by the American Society of Clinical Oncology (ASCO). The panelists disclosed relationships with Firefly Health, Eisai, Novartis, and others.

 

TOPLINE:

A rapid recommendation update from the American Society of Clinical Oncology (ASCO) offers guidance on use of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors, abemaciclib and ribociclib, for the adjuvant treatment of stage II and III breast cancer.

METHODOLOGY:

  • The guideline update was needed to incorporate new high-quality evidence for the adjuvant use of CDK4/6 inhibitors in early breast cancer.
  • The ASCO guideline expert panel reviewed evidence from phase 3 trials, including the monarchE and NATALEE studies, focusing on the efficacy of abemaciclib and ribociclib in improving invasive disease-free survival (IDFS) and distant disease-free survival (DDFS).

TAKEAWAY:

  • Abemaciclib for 2 years plus endocrine therapy (ET) for at least 5 years is recommended for patients with resected, hormone receptor–positive, HER2-negative, node-positive early breast cancer at high risk of recurrence, including those with at least four positive axillary lymph nodes (ALNs) or one to three positive ALNs plus additional high-risk features.
  • Ribociclib (400 mg once daily, 3 weeks on, 1 week off) for 3 years plus ET is recommended for patients with stage II or III breast cancer who have a high risk of recurrence, based on the NATALEE trial.
  • For patients meeting both monarchE and NATALEE criteria, abemaciclib is preferred due to longer follow-up, a deepening benefit over time, and FDA approval in the adjuvant setting.
  • Ribociclib is recommended for patients who cannot tolerate abemaciclib due to contraindications such as high-grade diarrhea.
  • Benefits, risks, costs, and individual patient preferences should be considered when deciding on adjuvant CDK4/6 inhibitor therapy.

IN PRACTICE:

This rapid recommendation update addresses the adjuvant use of CDK4/6 inhibitors abemaciclib and ribociclib in patients with stage II and III breast cancer.

SOURCE:

The clinical practice guideline update, led by Rachel A. Freedman, from Dana-Farber Cancer Institute, Boston, was published in the Journal of Clinical Oncology.

LIMITATIONS:

The guideline panelists noted that the clinical benefits of adjuvant CDK4/6 inhibitor therapy may not extend to all patients eligible for the trials, particularly those at lower risk. There are insufficient data to specify which subgroups of patients may not warrant therapy, emphasizing the need for individualized treatment decisions. More data are needed to provide long-term efficacy data and more detailed guidance on which specific patient populations will benefit most from adjuvant CDK4/6 inhibitor therapy.

DISCLOSURES:

Guideline development was funded by the American Society of Clinical Oncology (ASCO). The panelists disclosed relationships with Firefly Health, Eisai, Novartis, and others.

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Add-On to GLP-1s Yields Greater Weight Loss

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TOPLINE:

The addition of bupropion/naltrexone to glucagon-like peptide 1 (GLP-1) receptor agonists leads to a further 4%-5% total body weight loss (TBWL) in patients with obesity, including those who show a poor response to initial GLP-1 monotherapy.

METHODOLOGY:

  • Some patients with obesity experience suboptimal weight loss with GLP-1 monotherapy; however, adding treatments targeting multiple pathways may offer synergistic effects and improve outcomes.
  • Researchers retrospectively evaluated adult patients with body mass index (BMI) ≥ 30 who attended an obesity clinic in Vancouver, Canada, and received a GLP-1 receptor agonist (liraglutide or semaglutide) for at least 6 months.
  • They compared patients who continued receiving GLP-1 monotherapy with those who received add-on bupropion/naltrexone (combination therapy).
  • The percent TBWL was compared between the groups from the initiation of the GLP-1 or the addition of bupropion/naltrexone over a period of 6 and 12 months.
  • Patients prescribed combination therapy were stratified into responders (≥ 5% TBWL) and nonresponders (< 5% TBWL) based on their initial response to GLP-1 monotherapy.

TAKEAWAY:

  • Researchers included 415 patients with BMI ≥ 30 (mean age, 47.3 years; 75.6% women), of whom 320 continued receiving GLP-1 monotherapy and 95 received add-on bupropion/naltrexone (combination therapy); the mean follow-up period was 510.9 days.
  • At 12 months, there was no significant difference in the percent TBWL among patients receiving the GLP-1 monotherapy or combination therapy (9.6% TBWL in both).
  • However, when patients were stratified by their initial GLP-1 response, combination therapy led to a greater percent TBWL than monotherapy in both responders (P = .002) and nonresponders (P < .0001).
  • After the addition of bupropion/naltrexone, the mean percent TBWL was 4.3% (P < .001) and 5.3% (P = .009) at 6 and 12 months, respectively, among the responders, and 3.7% (P = .009) and 4.0% (P = .02) at 6 and 12 months, respectively, among the nonresponders.

IN PRACTICE:

“Specific characteristics of individuals who benefit from the bupropion/naltrexone augmentation should be examined to identify patient populations wherein this may be of greatest benefit,” the authors wrote.

SOURCE:

This study, led by James Naude, Faculty of Medicine, University of British Columbia, Vancouver, Canada, was published in the International Journal of Obesity.

LIMITATIONS:

Virtual care and self-reported weights by patients owing to the COVID-19 pandemic could have introduced bias. Some of the data on weight and medication adherence were missing. Moreover, there was no placebo control; hence, there may be confounding by indication.

DISCLOSURES:

The study was not supported by any specific funding. Two of the authors reported receiving educational grants and speaker fees, with one currently being an advisory board member to various pharma companies and the other an advisory board member to a pharma company in the past.

A version of this article appeared on Medscape.com.

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TOPLINE:

The addition of bupropion/naltrexone to glucagon-like peptide 1 (GLP-1) receptor agonists leads to a further 4%-5% total body weight loss (TBWL) in patients with obesity, including those who show a poor response to initial GLP-1 monotherapy.

METHODOLOGY:

  • Some patients with obesity experience suboptimal weight loss with GLP-1 monotherapy; however, adding treatments targeting multiple pathways may offer synergistic effects and improve outcomes.
  • Researchers retrospectively evaluated adult patients with body mass index (BMI) ≥ 30 who attended an obesity clinic in Vancouver, Canada, and received a GLP-1 receptor agonist (liraglutide or semaglutide) for at least 6 months.
  • They compared patients who continued receiving GLP-1 monotherapy with those who received add-on bupropion/naltrexone (combination therapy).
  • The percent TBWL was compared between the groups from the initiation of the GLP-1 or the addition of bupropion/naltrexone over a period of 6 and 12 months.
  • Patients prescribed combination therapy were stratified into responders (≥ 5% TBWL) and nonresponders (< 5% TBWL) based on their initial response to GLP-1 monotherapy.

TAKEAWAY:

  • Researchers included 415 patients with BMI ≥ 30 (mean age, 47.3 years; 75.6% women), of whom 320 continued receiving GLP-1 monotherapy and 95 received add-on bupropion/naltrexone (combination therapy); the mean follow-up period was 510.9 days.
  • At 12 months, there was no significant difference in the percent TBWL among patients receiving the GLP-1 monotherapy or combination therapy (9.6% TBWL in both).
  • However, when patients were stratified by their initial GLP-1 response, combination therapy led to a greater percent TBWL than monotherapy in both responders (P = .002) and nonresponders (P < .0001).
  • After the addition of bupropion/naltrexone, the mean percent TBWL was 4.3% (P < .001) and 5.3% (P = .009) at 6 and 12 months, respectively, among the responders, and 3.7% (P = .009) and 4.0% (P = .02) at 6 and 12 months, respectively, among the nonresponders.

IN PRACTICE:

“Specific characteristics of individuals who benefit from the bupropion/naltrexone augmentation should be examined to identify patient populations wherein this may be of greatest benefit,” the authors wrote.

SOURCE:

This study, led by James Naude, Faculty of Medicine, University of British Columbia, Vancouver, Canada, was published in the International Journal of Obesity.

LIMITATIONS:

Virtual care and self-reported weights by patients owing to the COVID-19 pandemic could have introduced bias. Some of the data on weight and medication adherence were missing. Moreover, there was no placebo control; hence, there may be confounding by indication.

DISCLOSURES:

The study was not supported by any specific funding. Two of the authors reported receiving educational grants and speaker fees, with one currently being an advisory board member to various pharma companies and the other an advisory board member to a pharma company in the past.

A version of this article appeared on Medscape.com.

 

TOPLINE:

The addition of bupropion/naltrexone to glucagon-like peptide 1 (GLP-1) receptor agonists leads to a further 4%-5% total body weight loss (TBWL) in patients with obesity, including those who show a poor response to initial GLP-1 monotherapy.

METHODOLOGY:

  • Some patients with obesity experience suboptimal weight loss with GLP-1 monotherapy; however, adding treatments targeting multiple pathways may offer synergistic effects and improve outcomes.
  • Researchers retrospectively evaluated adult patients with body mass index (BMI) ≥ 30 who attended an obesity clinic in Vancouver, Canada, and received a GLP-1 receptor agonist (liraglutide or semaglutide) for at least 6 months.
  • They compared patients who continued receiving GLP-1 monotherapy with those who received add-on bupropion/naltrexone (combination therapy).
  • The percent TBWL was compared between the groups from the initiation of the GLP-1 or the addition of bupropion/naltrexone over a period of 6 and 12 months.
  • Patients prescribed combination therapy were stratified into responders (≥ 5% TBWL) and nonresponders (< 5% TBWL) based on their initial response to GLP-1 monotherapy.

TAKEAWAY:

  • Researchers included 415 patients with BMI ≥ 30 (mean age, 47.3 years; 75.6% women), of whom 320 continued receiving GLP-1 monotherapy and 95 received add-on bupropion/naltrexone (combination therapy); the mean follow-up period was 510.9 days.
  • At 12 months, there was no significant difference in the percent TBWL among patients receiving the GLP-1 monotherapy or combination therapy (9.6% TBWL in both).
  • However, when patients were stratified by their initial GLP-1 response, combination therapy led to a greater percent TBWL than monotherapy in both responders (P = .002) and nonresponders (P < .0001).
  • After the addition of bupropion/naltrexone, the mean percent TBWL was 4.3% (P < .001) and 5.3% (P = .009) at 6 and 12 months, respectively, among the responders, and 3.7% (P = .009) and 4.0% (P = .02) at 6 and 12 months, respectively, among the nonresponders.

IN PRACTICE:

“Specific characteristics of individuals who benefit from the bupropion/naltrexone augmentation should be examined to identify patient populations wherein this may be of greatest benefit,” the authors wrote.

SOURCE:

This study, led by James Naude, Faculty of Medicine, University of British Columbia, Vancouver, Canada, was published in the International Journal of Obesity.

LIMITATIONS:

Virtual care and self-reported weights by patients owing to the COVID-19 pandemic could have introduced bias. Some of the data on weight and medication adherence were missing. Moreover, there was no placebo control; hence, there may be confounding by indication.

DISCLOSURES:

The study was not supported by any specific funding. Two of the authors reported receiving educational grants and speaker fees, with one currently being an advisory board member to various pharma companies and the other an advisory board member to a pharma company in the past.

A version of this article appeared on Medscape.com.

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Diet and exercise improve cardiac function, QoL in PAH

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— A lifestyle intervention focused on diet and exercise can improve cardiac function and the quality of life for patients with pulmonary arterial hypertension (PAH), results of a randomized clinical trial show.

At 12 weeks of follow-up, patients with PAH who were randomized to undergo a diet and cardiovascular exercise program had improved right ventricular function, better exercise capacity, and improved quality of life compared with patients randomized to the standard of care.

In addition, for those participants in the diet and exercise group who lost weight, right ventricular glucose uptake improved, reported Gustavo A. Heresi, MD, MS of the division of pulmonary medicine at the Cleveland Clinic.

Neil Osterweil/MDedge News
Dr. Gustavo A. Heresi

The intervention did not, however, have an effect on insulin sensitivity, suggesting that insulin resistance is not a significant pathological mechanism in PAH, he said in an oral abstract session at the American Thoracic Society’s international conference.

“With these data, in the context of prior studies showing the benefits of exercise interventions, we believe that diet and exercise should be incorporated and thought of as part of the treatment armamentarium for pulmonary arterial hypertension,” he said.

Despite the availability of 14 FDA-approved medications for PAH, the disease is incurable. It is marked by progressive pulmonary vasoconstriction, pulmonary vascular remodeling, fibrosis and inflammation, in situ thrombosis, and right ventricular failure.

Because abnormalities in both glucose and insulin metabolism are prevalent and associated with decreased survival in patients with PAH, Dr. Heresi and colleagues designed a randomized trial to test the hypothesis that a diet and exercise intervention could improve insulin sensitivity and right ventricular function.
 

PHINE details

In the study, dubbed Pulmonary Arterial Hypertension Improvement with Nutrition and Exercise (PHINE), the investigators enrolled adults with group 1 PAH who were stable on PAH medications for at least 2 months. Patients with portopulmonary hypertension, New York Heart Association (NYHA) class IV heart failure, syncope, or on supplemental oxygen greater than 4 liters per minute were excluded.

The patients were screened with a graded exercise test, intravenous glucose tolerance test, and other measures at baseline, and after stratification by NYHA class and tricuspid annular plane systolic excursion (TAPSE) score were randomized to the intervention arm (16 patients) or standard of care control arm (14 patients).

The intervention consisted of supervised exercise training for 50-60 minutes on a treadmill at 80%-85% of the patient’s maximum heart rate 5 days per week, plus weekly counseling on a combination low glycemic index/Mediterranean dietary pattern. The diet portion included olive oil as the primary fat source, three 1-ounce servings of nuts and peanuts weekly, fish and legumes at a minimum of 3 servings weekly, and no sugar-sweetened beverage, commercial bakery products, pastries, white breads, white rice, or white potatoes.
 

Results

At the conclusion of the study at 12 weeks there were no statistically significant differences between the groups in either insulin sensitivity or right ventricular strain.

However, patients in the intervention arm had significant improvements compared with controls in mean RV function as measured by TAPSE, improved exercise capacity as measured by peak oxygen uptake and 6-minute walking distance, quality of life as measured by EmPHasis-10 health-related quality of life score, and NYHA functional class.

As noted, right ventricular glucose uptake was improved among those patients in the intervention group who lost weight over the study period.
 

 

 

Worth trying

Ravi Kalhan, MD, MS, of Northwestern University Feinberg School of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the study results show promise.

“We’re so centered on what’s the next big pharmacotherapy you can give to fix the disease, but sometimes maybe we should be pushing lifestyle interventions that are impactful, and they have biologic mechanisms — it’s not just that you got in better shape, but right ventricular function also improves. I’m pretty drawn to that sort of thing,” he said.

“That’s a pretty major effect over a 3-month intervention,” agreed co-moderator Nuala J. Meyer, MD, MS, ATSF, of the Hospital of the University of Pennsylvania.

The PHINE trial was supported by National Institute of Health grants. Dr. Heresi, Dr. Kalhan, and Dr. Meyer reported no conflicts of interest.

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— A lifestyle intervention focused on diet and exercise can improve cardiac function and the quality of life for patients with pulmonary arterial hypertension (PAH), results of a randomized clinical trial show.

At 12 weeks of follow-up, patients with PAH who were randomized to undergo a diet and cardiovascular exercise program had improved right ventricular function, better exercise capacity, and improved quality of life compared with patients randomized to the standard of care.

In addition, for those participants in the diet and exercise group who lost weight, right ventricular glucose uptake improved, reported Gustavo A. Heresi, MD, MS of the division of pulmonary medicine at the Cleveland Clinic.

Neil Osterweil/MDedge News
Dr. Gustavo A. Heresi

The intervention did not, however, have an effect on insulin sensitivity, suggesting that insulin resistance is not a significant pathological mechanism in PAH, he said in an oral abstract session at the American Thoracic Society’s international conference.

“With these data, in the context of prior studies showing the benefits of exercise interventions, we believe that diet and exercise should be incorporated and thought of as part of the treatment armamentarium for pulmonary arterial hypertension,” he said.

Despite the availability of 14 FDA-approved medications for PAH, the disease is incurable. It is marked by progressive pulmonary vasoconstriction, pulmonary vascular remodeling, fibrosis and inflammation, in situ thrombosis, and right ventricular failure.

Because abnormalities in both glucose and insulin metabolism are prevalent and associated with decreased survival in patients with PAH, Dr. Heresi and colleagues designed a randomized trial to test the hypothesis that a diet and exercise intervention could improve insulin sensitivity and right ventricular function.
 

PHINE details

In the study, dubbed Pulmonary Arterial Hypertension Improvement with Nutrition and Exercise (PHINE), the investigators enrolled adults with group 1 PAH who were stable on PAH medications for at least 2 months. Patients with portopulmonary hypertension, New York Heart Association (NYHA) class IV heart failure, syncope, or on supplemental oxygen greater than 4 liters per minute were excluded.

The patients were screened with a graded exercise test, intravenous glucose tolerance test, and other measures at baseline, and after stratification by NYHA class and tricuspid annular plane systolic excursion (TAPSE) score were randomized to the intervention arm (16 patients) or standard of care control arm (14 patients).

The intervention consisted of supervised exercise training for 50-60 minutes on a treadmill at 80%-85% of the patient’s maximum heart rate 5 days per week, plus weekly counseling on a combination low glycemic index/Mediterranean dietary pattern. The diet portion included olive oil as the primary fat source, three 1-ounce servings of nuts and peanuts weekly, fish and legumes at a minimum of 3 servings weekly, and no sugar-sweetened beverage, commercial bakery products, pastries, white breads, white rice, or white potatoes.
 

Results

At the conclusion of the study at 12 weeks there were no statistically significant differences between the groups in either insulin sensitivity or right ventricular strain.

However, patients in the intervention arm had significant improvements compared with controls in mean RV function as measured by TAPSE, improved exercise capacity as measured by peak oxygen uptake and 6-minute walking distance, quality of life as measured by EmPHasis-10 health-related quality of life score, and NYHA functional class.

As noted, right ventricular glucose uptake was improved among those patients in the intervention group who lost weight over the study period.
 

 

 

Worth trying

Ravi Kalhan, MD, MS, of Northwestern University Feinberg School of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the study results show promise.

“We’re so centered on what’s the next big pharmacotherapy you can give to fix the disease, but sometimes maybe we should be pushing lifestyle interventions that are impactful, and they have biologic mechanisms — it’s not just that you got in better shape, but right ventricular function also improves. I’m pretty drawn to that sort of thing,” he said.

“That’s a pretty major effect over a 3-month intervention,” agreed co-moderator Nuala J. Meyer, MD, MS, ATSF, of the Hospital of the University of Pennsylvania.

The PHINE trial was supported by National Institute of Health grants. Dr. Heresi, Dr. Kalhan, and Dr. Meyer reported no conflicts of interest.

— A lifestyle intervention focused on diet and exercise can improve cardiac function and the quality of life for patients with pulmonary arterial hypertension (PAH), results of a randomized clinical trial show.

At 12 weeks of follow-up, patients with PAH who were randomized to undergo a diet and cardiovascular exercise program had improved right ventricular function, better exercise capacity, and improved quality of life compared with patients randomized to the standard of care.

In addition, for those participants in the diet and exercise group who lost weight, right ventricular glucose uptake improved, reported Gustavo A. Heresi, MD, MS of the division of pulmonary medicine at the Cleveland Clinic.

Neil Osterweil/MDedge News
Dr. Gustavo A. Heresi

The intervention did not, however, have an effect on insulin sensitivity, suggesting that insulin resistance is not a significant pathological mechanism in PAH, he said in an oral abstract session at the American Thoracic Society’s international conference.

“With these data, in the context of prior studies showing the benefits of exercise interventions, we believe that diet and exercise should be incorporated and thought of as part of the treatment armamentarium for pulmonary arterial hypertension,” he said.

Despite the availability of 14 FDA-approved medications for PAH, the disease is incurable. It is marked by progressive pulmonary vasoconstriction, pulmonary vascular remodeling, fibrosis and inflammation, in situ thrombosis, and right ventricular failure.

Because abnormalities in both glucose and insulin metabolism are prevalent and associated with decreased survival in patients with PAH, Dr. Heresi and colleagues designed a randomized trial to test the hypothesis that a diet and exercise intervention could improve insulin sensitivity and right ventricular function.
 

PHINE details

In the study, dubbed Pulmonary Arterial Hypertension Improvement with Nutrition and Exercise (PHINE), the investigators enrolled adults with group 1 PAH who were stable on PAH medications for at least 2 months. Patients with portopulmonary hypertension, New York Heart Association (NYHA) class IV heart failure, syncope, or on supplemental oxygen greater than 4 liters per minute were excluded.

The patients were screened with a graded exercise test, intravenous glucose tolerance test, and other measures at baseline, and after stratification by NYHA class and tricuspid annular plane systolic excursion (TAPSE) score were randomized to the intervention arm (16 patients) or standard of care control arm (14 patients).

The intervention consisted of supervised exercise training for 50-60 minutes on a treadmill at 80%-85% of the patient’s maximum heart rate 5 days per week, plus weekly counseling on a combination low glycemic index/Mediterranean dietary pattern. The diet portion included olive oil as the primary fat source, three 1-ounce servings of nuts and peanuts weekly, fish and legumes at a minimum of 3 servings weekly, and no sugar-sweetened beverage, commercial bakery products, pastries, white breads, white rice, or white potatoes.
 

Results

At the conclusion of the study at 12 weeks there were no statistically significant differences between the groups in either insulin sensitivity or right ventricular strain.

However, patients in the intervention arm had significant improvements compared with controls in mean RV function as measured by TAPSE, improved exercise capacity as measured by peak oxygen uptake and 6-minute walking distance, quality of life as measured by EmPHasis-10 health-related quality of life score, and NYHA functional class.

As noted, right ventricular glucose uptake was improved among those patients in the intervention group who lost weight over the study period.
 

 

 

Worth trying

Ravi Kalhan, MD, MS, of Northwestern University Feinberg School of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the study results show promise.

“We’re so centered on what’s the next big pharmacotherapy you can give to fix the disease, but sometimes maybe we should be pushing lifestyle interventions that are impactful, and they have biologic mechanisms — it’s not just that you got in better shape, but right ventricular function also improves. I’m pretty drawn to that sort of thing,” he said.

“That’s a pretty major effect over a 3-month intervention,” agreed co-moderator Nuala J. Meyer, MD, MS, ATSF, of the Hospital of the University of Pennsylvania.

The PHINE trial was supported by National Institute of Health grants. Dr. Heresi, Dr. Kalhan, and Dr. Meyer reported no conflicts of interest.

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Risk Screening Tool Helped Identify Pregnant Patients Previously Undiagnosed With CVD

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— More than a quarter of pregnant or postpartum patients who screened positive for cardiovascular disease ended up with a cardiovascular disease diagnosis when providers used a risk screening tool built into the electronic medical records system for all patients, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Timely diagnosis of cardiovascular disease is critical, though challenging, since pregnancy is a state of hemodynamic stress with symptoms that are like those of cardiovascular disease, and healthcare providers may not suspect cardiovascular disease in pregnant patients with symptoms of it,” Kevin Flatley, MD, a resident ob.gyn. at Montefiore Health System and the Albert Einstein College of Medicine in New York City, told attendees at the conference. “The cardiovascular risk assessment tool proved valuable for identifying and providing individualized care for cardio-obstetric patients.”

The study senior author, Diana S. Wolfe, MD, MPH, associate division director of Maternal Fetal Medicine at Montefiore Health System and associate professor of medicine in cardiology at Albert Einstein College of Medicine, said in an interview that cardiovascular risk in Montefiore’s urban population is significant.

“Cardiovascular disease risk screening identifies true cardiac disease in this population and can change the medical management and outcome of pregnant and postpartum patients,” Dr. Wolfe said. Screening has the potential to decrease maternal morbidity and mortality in our country, she said.

Dawnette Lewis, MD, MPH, director of the Center for Maternal Health at Northwell Health and an ob.gyn. and maternal fetal medicine specialist who was not involved in the study, was impressed with the research.

“We know that cardiovascular disease is one of the leading causes of maternal mortality,” Dr. Lewis said in an interview. “It is important to have an accurate risk assessment score, so I think what is being presented in this abstract is great.” She said she’s aware that other cardio-obstetric programs across the country are also implementing cardiovascular risk assessment tools during pregnancy.

The researchers built into their electronic health records a screening algorithm developed by the California Maternal Quality Care Initiative that had been based on a retrospective review of cardiovascular maternal deaths in California from 2002 to 2006. Their study aimed to identify the true positives — those who actually had cardiovascular disease — of those determined to be at risk by the screening toolkit.

The institution’s goal was for all patients to undergo a screening risk assessment at least once during prenatal and/or postpartum visits. Patients were considered to screen positive if they had at least one symptom, at least one vital sign abnormality, and at least one risk factor, or any combination of these that added up to 4.

Symptoms in the screening tool included shortness of breath, shortness of breath while lying flat, a rapid heart rate, asthma that was unresponsive to therapy, palpitations, fainting or other loss of consciousness, and chest pain. Abnormal vital signs included a resting heart rate of 110 bpm or greater, systolic blood pressure of 140 mm Hg or higher, a respiratory rate of 24 or higher, and an oxygen saturation of 96% or lower.

Risk factors included being 40 or older, being Black, having a pre-pregnancy BMI of 35 or greater, preexisting diabetes, hypertension, substance use, and a history of cancer, chemotherapy, or chest radiation. “Current practice acknowledges that the risk factor currently included in the algorithm of self-identified as Black actually represents racism, bias, and social determinants of health, known risk factors for CVD,” Wolfe said.

Patients who screened positive underwent an echocardiogram, a cardio-obstetric consultation, and an additional work-up.

During the June 2022–September 2023 study period, 148 out of 1877 screened patients (7.9%) had a positive screen. Of these, 108 were false positives and 40 (27%) were true positives. The number of true false positives is not known because many women did not come for their workups.* The true positives mostly included patients with mild valvular disease, but about a quarter had mild, moderate, or severe ventricular dilation or hypertrophy and a little less than a quarter were positive for systolic or diastolic dysfunction.

Most (72.5%) of the 40 true-positive cases needed a multidisciplinary cardio-obstetrics team plan, and 11 patients (27.5%) needed follow-up and had multiple visits with the cardio-obstetrics team. Six of the true-positive cases (15%) “were deemed to be of higher risk for decompensation during labor and required detailed plans for intrapartum and postpartum management,” the researchers reported. Nine patients (22.5%) began new cardiovascular medications.

This research is a validation study of the current algorithm, Wolfe said, and the algorithm will be revised based on the results of the completed validation study.

“The objective is universal cardiovascular risk screening for all pregnant and postpartum persons in the US,” Wolfe said. “Once the data collection from this validation study is concluded, our goal is to disseminate a revised CVD risk screening tool that can be implemented into the electronic medical records of all institutions in our country.”

*The study partially funded by the National Institute of Child Health and Human Development award #5R21HD101783. All the authors and Dr. Lewis had no disclosures. Dr. Afshan B. Hameed of the University of California at Irvine was a partner in the study.

*This study was updated on May 30, 2024.

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— More than a quarter of pregnant or postpartum patients who screened positive for cardiovascular disease ended up with a cardiovascular disease diagnosis when providers used a risk screening tool built into the electronic medical records system for all patients, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Timely diagnosis of cardiovascular disease is critical, though challenging, since pregnancy is a state of hemodynamic stress with symptoms that are like those of cardiovascular disease, and healthcare providers may not suspect cardiovascular disease in pregnant patients with symptoms of it,” Kevin Flatley, MD, a resident ob.gyn. at Montefiore Health System and the Albert Einstein College of Medicine in New York City, told attendees at the conference. “The cardiovascular risk assessment tool proved valuable for identifying and providing individualized care for cardio-obstetric patients.”

The study senior author, Diana S. Wolfe, MD, MPH, associate division director of Maternal Fetal Medicine at Montefiore Health System and associate professor of medicine in cardiology at Albert Einstein College of Medicine, said in an interview that cardiovascular risk in Montefiore’s urban population is significant.

“Cardiovascular disease risk screening identifies true cardiac disease in this population and can change the medical management and outcome of pregnant and postpartum patients,” Dr. Wolfe said. Screening has the potential to decrease maternal morbidity and mortality in our country, she said.

Dawnette Lewis, MD, MPH, director of the Center for Maternal Health at Northwell Health and an ob.gyn. and maternal fetal medicine specialist who was not involved in the study, was impressed with the research.

“We know that cardiovascular disease is one of the leading causes of maternal mortality,” Dr. Lewis said in an interview. “It is important to have an accurate risk assessment score, so I think what is being presented in this abstract is great.” She said she’s aware that other cardio-obstetric programs across the country are also implementing cardiovascular risk assessment tools during pregnancy.

The researchers built into their electronic health records a screening algorithm developed by the California Maternal Quality Care Initiative that had been based on a retrospective review of cardiovascular maternal deaths in California from 2002 to 2006. Their study aimed to identify the true positives — those who actually had cardiovascular disease — of those determined to be at risk by the screening toolkit.

The institution’s goal was for all patients to undergo a screening risk assessment at least once during prenatal and/or postpartum visits. Patients were considered to screen positive if they had at least one symptom, at least one vital sign abnormality, and at least one risk factor, or any combination of these that added up to 4.

Symptoms in the screening tool included shortness of breath, shortness of breath while lying flat, a rapid heart rate, asthma that was unresponsive to therapy, palpitations, fainting or other loss of consciousness, and chest pain. Abnormal vital signs included a resting heart rate of 110 bpm or greater, systolic blood pressure of 140 mm Hg or higher, a respiratory rate of 24 or higher, and an oxygen saturation of 96% or lower.

Risk factors included being 40 or older, being Black, having a pre-pregnancy BMI of 35 or greater, preexisting diabetes, hypertension, substance use, and a history of cancer, chemotherapy, or chest radiation. “Current practice acknowledges that the risk factor currently included in the algorithm of self-identified as Black actually represents racism, bias, and social determinants of health, known risk factors for CVD,” Wolfe said.

Patients who screened positive underwent an echocardiogram, a cardio-obstetric consultation, and an additional work-up.

During the June 2022–September 2023 study period, 148 out of 1877 screened patients (7.9%) had a positive screen. Of these, 108 were false positives and 40 (27%) were true positives. The number of true false positives is not known because many women did not come for their workups.* The true positives mostly included patients with mild valvular disease, but about a quarter had mild, moderate, or severe ventricular dilation or hypertrophy and a little less than a quarter were positive for systolic or diastolic dysfunction.

Most (72.5%) of the 40 true-positive cases needed a multidisciplinary cardio-obstetrics team plan, and 11 patients (27.5%) needed follow-up and had multiple visits with the cardio-obstetrics team. Six of the true-positive cases (15%) “were deemed to be of higher risk for decompensation during labor and required detailed plans for intrapartum and postpartum management,” the researchers reported. Nine patients (22.5%) began new cardiovascular medications.

This research is a validation study of the current algorithm, Wolfe said, and the algorithm will be revised based on the results of the completed validation study.

“The objective is universal cardiovascular risk screening for all pregnant and postpartum persons in the US,” Wolfe said. “Once the data collection from this validation study is concluded, our goal is to disseminate a revised CVD risk screening tool that can be implemented into the electronic medical records of all institutions in our country.”

*The study partially funded by the National Institute of Child Health and Human Development award #5R21HD101783. All the authors and Dr. Lewis had no disclosures. Dr. Afshan B. Hameed of the University of California at Irvine was a partner in the study.

*This study was updated on May 30, 2024.

— More than a quarter of pregnant or postpartum patients who screened positive for cardiovascular disease ended up with a cardiovascular disease diagnosis when providers used a risk screening tool built into the electronic medical records system for all patients, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Timely diagnosis of cardiovascular disease is critical, though challenging, since pregnancy is a state of hemodynamic stress with symptoms that are like those of cardiovascular disease, and healthcare providers may not suspect cardiovascular disease in pregnant patients with symptoms of it,” Kevin Flatley, MD, a resident ob.gyn. at Montefiore Health System and the Albert Einstein College of Medicine in New York City, told attendees at the conference. “The cardiovascular risk assessment tool proved valuable for identifying and providing individualized care for cardio-obstetric patients.”

The study senior author, Diana S. Wolfe, MD, MPH, associate division director of Maternal Fetal Medicine at Montefiore Health System and associate professor of medicine in cardiology at Albert Einstein College of Medicine, said in an interview that cardiovascular risk in Montefiore’s urban population is significant.

“Cardiovascular disease risk screening identifies true cardiac disease in this population and can change the medical management and outcome of pregnant and postpartum patients,” Dr. Wolfe said. Screening has the potential to decrease maternal morbidity and mortality in our country, she said.

Dawnette Lewis, MD, MPH, director of the Center for Maternal Health at Northwell Health and an ob.gyn. and maternal fetal medicine specialist who was not involved in the study, was impressed with the research.

“We know that cardiovascular disease is one of the leading causes of maternal mortality,” Dr. Lewis said in an interview. “It is important to have an accurate risk assessment score, so I think what is being presented in this abstract is great.” She said she’s aware that other cardio-obstetric programs across the country are also implementing cardiovascular risk assessment tools during pregnancy.

The researchers built into their electronic health records a screening algorithm developed by the California Maternal Quality Care Initiative that had been based on a retrospective review of cardiovascular maternal deaths in California from 2002 to 2006. Their study aimed to identify the true positives — those who actually had cardiovascular disease — of those determined to be at risk by the screening toolkit.

The institution’s goal was for all patients to undergo a screening risk assessment at least once during prenatal and/or postpartum visits. Patients were considered to screen positive if they had at least one symptom, at least one vital sign abnormality, and at least one risk factor, or any combination of these that added up to 4.

Symptoms in the screening tool included shortness of breath, shortness of breath while lying flat, a rapid heart rate, asthma that was unresponsive to therapy, palpitations, fainting or other loss of consciousness, and chest pain. Abnormal vital signs included a resting heart rate of 110 bpm or greater, systolic blood pressure of 140 mm Hg or higher, a respiratory rate of 24 or higher, and an oxygen saturation of 96% or lower.

Risk factors included being 40 or older, being Black, having a pre-pregnancy BMI of 35 or greater, preexisting diabetes, hypertension, substance use, and a history of cancer, chemotherapy, or chest radiation. “Current practice acknowledges that the risk factor currently included in the algorithm of self-identified as Black actually represents racism, bias, and social determinants of health, known risk factors for CVD,” Wolfe said.

Patients who screened positive underwent an echocardiogram, a cardio-obstetric consultation, and an additional work-up.

During the June 2022–September 2023 study period, 148 out of 1877 screened patients (7.9%) had a positive screen. Of these, 108 were false positives and 40 (27%) were true positives. The number of true false positives is not known because many women did not come for their workups.* The true positives mostly included patients with mild valvular disease, but about a quarter had mild, moderate, or severe ventricular dilation or hypertrophy and a little less than a quarter were positive for systolic or diastolic dysfunction.

Most (72.5%) of the 40 true-positive cases needed a multidisciplinary cardio-obstetrics team plan, and 11 patients (27.5%) needed follow-up and had multiple visits with the cardio-obstetrics team. Six of the true-positive cases (15%) “were deemed to be of higher risk for decompensation during labor and required detailed plans for intrapartum and postpartum management,” the researchers reported. Nine patients (22.5%) began new cardiovascular medications.

This research is a validation study of the current algorithm, Wolfe said, and the algorithm will be revised based on the results of the completed validation study.

“The objective is universal cardiovascular risk screening for all pregnant and postpartum persons in the US,” Wolfe said. “Once the data collection from this validation study is concluded, our goal is to disseminate a revised CVD risk screening tool that can be implemented into the electronic medical records of all institutions in our country.”

*The study partially funded by the National Institute of Child Health and Human Development award #5R21HD101783. All the authors and Dr. Lewis had no disclosures. Dr. Afshan B. Hameed of the University of California at Irvine was a partner in the study.

*This study was updated on May 30, 2024.

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Commentary: Transition from Psoriasis to PsA and New Drug Analyses, June 2024

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Dr. Chandran scans the journals, so you don't have to!

Vinod Chandran, MBBS, MD, DM, PhD
Recent studies in psoriatic arthritis (PsA) have focused on transition from psoriasis to PsA. Patients with PsA are likely go through preclinical, subclinical, prodromal, and finally overt PsA. Zabotti and colleagues aimed to estimate the probability of developing PsA in patients with subclinical PsA defined as psoriasis and arthralgia. Of the 384 psoriasis patients from two European cohorts included in the study, 311 (80.9%) had subclinical PsA. The incidence rate of new-onset PsA was 7.7 per 100 patients-years in this group; the most predominant presentation was peripheral arthritis (82.1%). The risk for PsA was significantly higher in patients with subclinical PsA vs psoriasis (hazard ratio 11.7; 95% CI 1.57-86.7). In another cross-sectional study, Yao and colleagues compared 75 patients diagnosed with clinical PsA with 345 patients with psoriasis and without PsA, all of whom were aged 18-65 years. The authors demonstrated that at age 40 years or older, nail involvement, increased erythrocyte sedimentation rate (ESR), and high-sensitivity C-reactive protein (CRP) levels were associated with PsA. Moreover, MRI-detected enthesitis and tenosynovitis combined with these risk factors vs the risk factors alone showed better specificity (94.3% vs 69.0%) and similar sensitivity (89.0% vs 84.6%) in distinguishing PsA from psoriasis alone. Thus, psoriasis patients with arthralgia as well as those with nail disease and elevated ESR/CRP levels are at high risk for PsA. These patients should be carefully monitored to detect PsA early. These patients may also be ideal candidates to study interventions intended to prevent transition from psoriasis to PsA.

 

In regard to treatment, bimekizumab is a new monoclonal antibody that dually targets interleukin (IL)-17A and IL-17F and is highly efficacious for the treatment of psoriasis. In a meta-analysis of four placebo-controlled randomized clinical trials that included 1323 patients with PsA (age 18 years or older), of whom 853 received bimekizumab, Su and colleagues demonstrated that bimekizumab led to a significantly higher response rate for minimal disease activity (risk ratio [RR] 4.188; P < .001) and a 70% or greater improvement in the American College of Rheumatology (ACR) criteria (RR 7.932; P < .0001) when compared with placebo. Bimekizumab was superior to placebo in achieving ACR20/50/70 response at a dose of 160 mg. The risk for treatment-emergent adverse events was modestly higher with bimekizumab vs placebo (RR 1.423; P = .023), whereas the risk for serious cancers, upper respiratory tract infection, injection site reactions, and pharyngitis was similar for both. Thus, bimekizumab is an efficacious agent for the treatment of PsA. Future head-to-head studies will help clinicians determine the role of this drug in the management of PsA.

 

Not all patients respond equally well to targeted therapies, and the so-called challenging-to-treat patients are being increasingly described. Kivitz and colleagues recently described the efficacy of secukinumab, a monoclonal antibody targeting IL-17A, in these challenging-to-treat patients from the United States. In a post hoc subgroup analysis of four phase 3 studies that included 279 patients, they demonstrated that patients receiving 300 mg secukinumab and 150 mg  with a loading dose had a higher rate of achieving the ACR20 response (59.7% and 43.4%, respectively) vs 15.6% for placebo (both P < .0001). The Psoriasis Area and Severity Index 90 response was 47.1% and 22.2%, respectively, vs 5.3% (both P < .05). Thus, secukinumab is efficacious in more challenging-to-treat patients. However, such patients need to be better characterized so that effective treatment strategies to achieve a state of low disease activity may be implemented.

Author and Disclosure Information

Vinod Chandran MBBS, MD, DM, PhD, FRCPC

Staff Physician, Department of Medicine/Rheumatology, University Health Network, Toronto, ON, Canada

Vinod Chandran, MBBS, MD, DM, PhD, has disclosed the following relevant financial relationships: Member of the board of directors of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). Received research grant from: Amgen; AbbVie; Bristol-Myers Squibb; Eli Lilly. Received income in an amount equal to or greater than $250 from: Amgen; AbbVie; Bristol-Myers Squibb; Eli Lilly; Janssen; Novartis; UCB.
Spousal employment: AstraZeneca

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Vinod Chandran MBBS, MD, DM, PhD, FRCPC

Staff Physician, Department of Medicine/Rheumatology, University Health Network, Toronto, ON, Canada

Vinod Chandran, MBBS, MD, DM, PhD, has disclosed the following relevant financial relationships: Member of the board of directors of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). Received research grant from: Amgen; AbbVie; Bristol-Myers Squibb; Eli Lilly. Received income in an amount equal to or greater than $250 from: Amgen; AbbVie; Bristol-Myers Squibb; Eli Lilly; Janssen; Novartis; UCB.
Spousal employment: AstraZeneca

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Vinod Chandran MBBS, MD, DM, PhD, FRCPC

Staff Physician, Department of Medicine/Rheumatology, University Health Network, Toronto, ON, Canada

Vinod Chandran, MBBS, MD, DM, PhD, has disclosed the following relevant financial relationships: Member of the board of directors of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). Received research grant from: Amgen; AbbVie; Bristol-Myers Squibb; Eli Lilly. Received income in an amount equal to or greater than $250 from: Amgen; AbbVie; Bristol-Myers Squibb; Eli Lilly; Janssen; Novartis; UCB.
Spousal employment: AstraZeneca

Dr. Chandran scans the journals, so you don't have to!
Dr. Chandran scans the journals, so you don't have to!

Vinod Chandran, MBBS, MD, DM, PhD
Recent studies in psoriatic arthritis (PsA) have focused on transition from psoriasis to PsA. Patients with PsA are likely go through preclinical, subclinical, prodromal, and finally overt PsA. Zabotti and colleagues aimed to estimate the probability of developing PsA in patients with subclinical PsA defined as psoriasis and arthralgia. Of the 384 psoriasis patients from two European cohorts included in the study, 311 (80.9%) had subclinical PsA. The incidence rate of new-onset PsA was 7.7 per 100 patients-years in this group; the most predominant presentation was peripheral arthritis (82.1%). The risk for PsA was significantly higher in patients with subclinical PsA vs psoriasis (hazard ratio 11.7; 95% CI 1.57-86.7). In another cross-sectional study, Yao and colleagues compared 75 patients diagnosed with clinical PsA with 345 patients with psoriasis and without PsA, all of whom were aged 18-65 years. The authors demonstrated that at age 40 years or older, nail involvement, increased erythrocyte sedimentation rate (ESR), and high-sensitivity C-reactive protein (CRP) levels were associated with PsA. Moreover, MRI-detected enthesitis and tenosynovitis combined with these risk factors vs the risk factors alone showed better specificity (94.3% vs 69.0%) and similar sensitivity (89.0% vs 84.6%) in distinguishing PsA from psoriasis alone. Thus, psoriasis patients with arthralgia as well as those with nail disease and elevated ESR/CRP levels are at high risk for PsA. These patients should be carefully monitored to detect PsA early. These patients may also be ideal candidates to study interventions intended to prevent transition from psoriasis to PsA.

 

In regard to treatment, bimekizumab is a new monoclonal antibody that dually targets interleukin (IL)-17A and IL-17F and is highly efficacious for the treatment of psoriasis. In a meta-analysis of four placebo-controlled randomized clinical trials that included 1323 patients with PsA (age 18 years or older), of whom 853 received bimekizumab, Su and colleagues demonstrated that bimekizumab led to a significantly higher response rate for minimal disease activity (risk ratio [RR] 4.188; P < .001) and a 70% or greater improvement in the American College of Rheumatology (ACR) criteria (RR 7.932; P < .0001) when compared with placebo. Bimekizumab was superior to placebo in achieving ACR20/50/70 response at a dose of 160 mg. The risk for treatment-emergent adverse events was modestly higher with bimekizumab vs placebo (RR 1.423; P = .023), whereas the risk for serious cancers, upper respiratory tract infection, injection site reactions, and pharyngitis was similar for both. Thus, bimekizumab is an efficacious agent for the treatment of PsA. Future head-to-head studies will help clinicians determine the role of this drug in the management of PsA.

 

Not all patients respond equally well to targeted therapies, and the so-called challenging-to-treat patients are being increasingly described. Kivitz and colleagues recently described the efficacy of secukinumab, a monoclonal antibody targeting IL-17A, in these challenging-to-treat patients from the United States. In a post hoc subgroup analysis of four phase 3 studies that included 279 patients, they demonstrated that patients receiving 300 mg secukinumab and 150 mg  with a loading dose had a higher rate of achieving the ACR20 response (59.7% and 43.4%, respectively) vs 15.6% for placebo (both P < .0001). The Psoriasis Area and Severity Index 90 response was 47.1% and 22.2%, respectively, vs 5.3% (both P < .05). Thus, secukinumab is efficacious in more challenging-to-treat patients. However, such patients need to be better characterized so that effective treatment strategies to achieve a state of low disease activity may be implemented.

Vinod Chandran, MBBS, MD, DM, PhD
Recent studies in psoriatic arthritis (PsA) have focused on transition from psoriasis to PsA. Patients with PsA are likely go through preclinical, subclinical, prodromal, and finally overt PsA. Zabotti and colleagues aimed to estimate the probability of developing PsA in patients with subclinical PsA defined as psoriasis and arthralgia. Of the 384 psoriasis patients from two European cohorts included in the study, 311 (80.9%) had subclinical PsA. The incidence rate of new-onset PsA was 7.7 per 100 patients-years in this group; the most predominant presentation was peripheral arthritis (82.1%). The risk for PsA was significantly higher in patients with subclinical PsA vs psoriasis (hazard ratio 11.7; 95% CI 1.57-86.7). In another cross-sectional study, Yao and colleagues compared 75 patients diagnosed with clinical PsA with 345 patients with psoriasis and without PsA, all of whom were aged 18-65 years. The authors demonstrated that at age 40 years or older, nail involvement, increased erythrocyte sedimentation rate (ESR), and high-sensitivity C-reactive protein (CRP) levels were associated with PsA. Moreover, MRI-detected enthesitis and tenosynovitis combined with these risk factors vs the risk factors alone showed better specificity (94.3% vs 69.0%) and similar sensitivity (89.0% vs 84.6%) in distinguishing PsA from psoriasis alone. Thus, psoriasis patients with arthralgia as well as those with nail disease and elevated ESR/CRP levels are at high risk for PsA. These patients should be carefully monitored to detect PsA early. These patients may also be ideal candidates to study interventions intended to prevent transition from psoriasis to PsA.

 

In regard to treatment, bimekizumab is a new monoclonal antibody that dually targets interleukin (IL)-17A and IL-17F and is highly efficacious for the treatment of psoriasis. In a meta-analysis of four placebo-controlled randomized clinical trials that included 1323 patients with PsA (age 18 years or older), of whom 853 received bimekizumab, Su and colleagues demonstrated that bimekizumab led to a significantly higher response rate for minimal disease activity (risk ratio [RR] 4.188; P < .001) and a 70% or greater improvement in the American College of Rheumatology (ACR) criteria (RR 7.932; P < .0001) when compared with placebo. Bimekizumab was superior to placebo in achieving ACR20/50/70 response at a dose of 160 mg. The risk for treatment-emergent adverse events was modestly higher with bimekizumab vs placebo (RR 1.423; P = .023), whereas the risk for serious cancers, upper respiratory tract infection, injection site reactions, and pharyngitis was similar for both. Thus, bimekizumab is an efficacious agent for the treatment of PsA. Future head-to-head studies will help clinicians determine the role of this drug in the management of PsA.

 

Not all patients respond equally well to targeted therapies, and the so-called challenging-to-treat patients are being increasingly described. Kivitz and colleagues recently described the efficacy of secukinumab, a monoclonal antibody targeting IL-17A, in these challenging-to-treat patients from the United States. In a post hoc subgroup analysis of four phase 3 studies that included 279 patients, they demonstrated that patients receiving 300 mg secukinumab and 150 mg  with a loading dose had a higher rate of achieving the ACR20 response (59.7% and 43.4%, respectively) vs 15.6% for placebo (both P < .0001). The Psoriasis Area and Severity Index 90 response was 47.1% and 22.2%, respectively, vs 5.3% (both P < .05). Thus, secukinumab is efficacious in more challenging-to-treat patients. However, such patients need to be better characterized so that effective treatment strategies to achieve a state of low disease activity may be implemented.

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CGM Aids in Detecting Early Gestational Diabetes

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TOPLINE:

In women with gestational diabetes (GD), continuous glucose monitoring (CGM) shows elevated glycemic metrics earlier in pregnancy compared with the standard oral glucose tolerance test (OGTT).

METHODOLOGY:

  • Earlier diagnosis and treatment of GDM may mitigate some perinatal risks, but the traditional OGTT at 24-28 weeks’ gestation delivers inconsistent results in early pregnancy, potentially leading to missed cases or overdiagnosis.
  • This prospective noninterventional observational study conducted at two US academic-based clinical sites from June 2020 to December 2021 assessed CGM-derived glycemic patterns in 768 participants (mean age, 33 years; 77% White) enrolled prior to 17 weeks’ gestation with singleton pregnancy and an initial A1c level < 6.5%.
  • Participants were encouraged to wear a blinded Dexcom G6 Pro CGM System sensor continuously until the day of delivery, with a median CGM wear duration of 67 days prior to OGTT.
  • GDM was diagnosed using an OGTT conducted between 24 and 34 weeks’ gestation, which sorted women into those with GDM (n = 58) or without GDM (n = 710).
  • CGM-derived glycemic patterns were compared between the participants with and without GDM.

TAKEAWAY:

  • Women with GDM had a higher mean glucose (109 ± 13 vs 100 ± 8 mg/dL; P < .001) and greater glucose SD (23 ± 4 vs 19 ± 3; P < .001) than those without GDM throughout the gestational period prior to OGTT.
  • Women with GDM spent lesser time in glycemic ranges of 63-140 mg/dL (87% ± 11% vs 94% ± 4%; < .001) and 63-120 mg/dL (70% ± 17% vs 84% ± 8%; P < .001) throughout gestation than those without GDM prior to OGTT.
  • The daytime and overnight mean glucose levels were higher in those with vs without GDM and attributed to increased hyperglycemia rather than decreased hypoglycemia, with those with GDM spending more time > 120 mg/dL and > 140 mg/dL and less time < 63 mg/dL and < 54 mg/dL.
  • Mean glucose and percent time in the > 120 mg/dL and > 140 mg/dL ranges were higher in those with GDM as early as 13-14 weeks of gestation, which persisted at each 2-week period prior to OGTT.

IN PRACTICE:

“CGM could be used in addition to or instead of OGTT to screen individuals at risk for hyperglycemia during pregnancy, even as early as the first trimester,” the authors wrote, adding that “CGM could potentially play a pivotal role in providing timely identification of distinct glycemic patterns indicative of early dysglycemia.”

SOURCE:

The study, led by Celeste Durnwald, MD, Maternal-Fetal Medicine Research Program, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, was published online in Diabetes Care.

LIMITATIONS:

To include participants with possible early GDM, the study allowed the inclusion of up to 14 days of CGM data after OGTT in the overall gestational period and up to 10 days in the first and second trimesters. A detailed analysis of glycemia at the earliest timepoint of pregnancy could not be conducted as the first trimester data were limited. The findings may not be generalizable to a population with gestational hyperglycemia, as only 58 participants were identified with GDM using OGTT.

DISCLOSURES:

The study was supported by the Leona M. and Harry B. Helmsley Charitable Trust and UnitedHealth Group. Some authors reported performing advisory work, receiving research support and consultancy fees, and being on scientific advisory boards through their employer, while several authors reported that their institution received funds on their behalf from various pharmaceutical, healthcare, and medical device companies.

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

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TOPLINE:

In women with gestational diabetes (GD), continuous glucose monitoring (CGM) shows elevated glycemic metrics earlier in pregnancy compared with the standard oral glucose tolerance test (OGTT).

METHODOLOGY:

  • Earlier diagnosis and treatment of GDM may mitigate some perinatal risks, but the traditional OGTT at 24-28 weeks’ gestation delivers inconsistent results in early pregnancy, potentially leading to missed cases or overdiagnosis.
  • This prospective noninterventional observational study conducted at two US academic-based clinical sites from June 2020 to December 2021 assessed CGM-derived glycemic patterns in 768 participants (mean age, 33 years; 77% White) enrolled prior to 17 weeks’ gestation with singleton pregnancy and an initial A1c level < 6.5%.
  • Participants were encouraged to wear a blinded Dexcom G6 Pro CGM System sensor continuously until the day of delivery, with a median CGM wear duration of 67 days prior to OGTT.
  • GDM was diagnosed using an OGTT conducted between 24 and 34 weeks’ gestation, which sorted women into those with GDM (n = 58) or without GDM (n = 710).
  • CGM-derived glycemic patterns were compared between the participants with and without GDM.

TAKEAWAY:

  • Women with GDM had a higher mean glucose (109 ± 13 vs 100 ± 8 mg/dL; P < .001) and greater glucose SD (23 ± 4 vs 19 ± 3; P < .001) than those without GDM throughout the gestational period prior to OGTT.
  • Women with GDM spent lesser time in glycemic ranges of 63-140 mg/dL (87% ± 11% vs 94% ± 4%; < .001) and 63-120 mg/dL (70% ± 17% vs 84% ± 8%; P < .001) throughout gestation than those without GDM prior to OGTT.
  • The daytime and overnight mean glucose levels were higher in those with vs without GDM and attributed to increased hyperglycemia rather than decreased hypoglycemia, with those with GDM spending more time > 120 mg/dL and > 140 mg/dL and less time < 63 mg/dL and < 54 mg/dL.
  • Mean glucose and percent time in the > 120 mg/dL and > 140 mg/dL ranges were higher in those with GDM as early as 13-14 weeks of gestation, which persisted at each 2-week period prior to OGTT.

IN PRACTICE:

“CGM could be used in addition to or instead of OGTT to screen individuals at risk for hyperglycemia during pregnancy, even as early as the first trimester,” the authors wrote, adding that “CGM could potentially play a pivotal role in providing timely identification of distinct glycemic patterns indicative of early dysglycemia.”

SOURCE:

The study, led by Celeste Durnwald, MD, Maternal-Fetal Medicine Research Program, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, was published online in Diabetes Care.

LIMITATIONS:

To include participants with possible early GDM, the study allowed the inclusion of up to 14 days of CGM data after OGTT in the overall gestational period and up to 10 days in the first and second trimesters. A detailed analysis of glycemia at the earliest timepoint of pregnancy could not be conducted as the first trimester data were limited. The findings may not be generalizable to a population with gestational hyperglycemia, as only 58 participants were identified with GDM using OGTT.

DISCLOSURES:

The study was supported by the Leona M. and Harry B. Helmsley Charitable Trust and UnitedHealth Group. Some authors reported performing advisory work, receiving research support and consultancy fees, and being on scientific advisory boards through their employer, while several authors reported that their institution received funds on their behalf from various pharmaceutical, healthcare, and medical device companies.

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

 

TOPLINE:

In women with gestational diabetes (GD), continuous glucose monitoring (CGM) shows elevated glycemic metrics earlier in pregnancy compared with the standard oral glucose tolerance test (OGTT).

METHODOLOGY:

  • Earlier diagnosis and treatment of GDM may mitigate some perinatal risks, but the traditional OGTT at 24-28 weeks’ gestation delivers inconsistent results in early pregnancy, potentially leading to missed cases or overdiagnosis.
  • This prospective noninterventional observational study conducted at two US academic-based clinical sites from June 2020 to December 2021 assessed CGM-derived glycemic patterns in 768 participants (mean age, 33 years; 77% White) enrolled prior to 17 weeks’ gestation with singleton pregnancy and an initial A1c level < 6.5%.
  • Participants were encouraged to wear a blinded Dexcom G6 Pro CGM System sensor continuously until the day of delivery, with a median CGM wear duration of 67 days prior to OGTT.
  • GDM was diagnosed using an OGTT conducted between 24 and 34 weeks’ gestation, which sorted women into those with GDM (n = 58) or without GDM (n = 710).
  • CGM-derived glycemic patterns were compared between the participants with and without GDM.

TAKEAWAY:

  • Women with GDM had a higher mean glucose (109 ± 13 vs 100 ± 8 mg/dL; P < .001) and greater glucose SD (23 ± 4 vs 19 ± 3; P < .001) than those without GDM throughout the gestational period prior to OGTT.
  • Women with GDM spent lesser time in glycemic ranges of 63-140 mg/dL (87% ± 11% vs 94% ± 4%; < .001) and 63-120 mg/dL (70% ± 17% vs 84% ± 8%; P < .001) throughout gestation than those without GDM prior to OGTT.
  • The daytime and overnight mean glucose levels were higher in those with vs without GDM and attributed to increased hyperglycemia rather than decreased hypoglycemia, with those with GDM spending more time > 120 mg/dL and > 140 mg/dL and less time < 63 mg/dL and < 54 mg/dL.
  • Mean glucose and percent time in the > 120 mg/dL and > 140 mg/dL ranges were higher in those with GDM as early as 13-14 weeks of gestation, which persisted at each 2-week period prior to OGTT.

IN PRACTICE:

“CGM could be used in addition to or instead of OGTT to screen individuals at risk for hyperglycemia during pregnancy, even as early as the first trimester,” the authors wrote, adding that “CGM could potentially play a pivotal role in providing timely identification of distinct glycemic patterns indicative of early dysglycemia.”

SOURCE:

The study, led by Celeste Durnwald, MD, Maternal-Fetal Medicine Research Program, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, was published online in Diabetes Care.

LIMITATIONS:

To include participants with possible early GDM, the study allowed the inclusion of up to 14 days of CGM data after OGTT in the overall gestational period and up to 10 days in the first and second trimesters. A detailed analysis of glycemia at the earliest timepoint of pregnancy could not be conducted as the first trimester data were limited. The findings may not be generalizable to a population with gestational hyperglycemia, as only 58 participants were identified with GDM using OGTT.

DISCLOSURES:

The study was supported by the Leona M. and Harry B. Helmsley Charitable Trust and UnitedHealth Group. Some authors reported performing advisory work, receiving research support and consultancy fees, and being on scientific advisory boards through their employer, while several authors reported that their institution received funds on their behalf from various pharmaceutical, healthcare, and medical device companies.

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

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Clinicians Face Hurdles in Caring for the Growing Number of Cancer Survivors

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— Primary care clinicians face challenges in knowledge and care coordination as they care for a rising number of cancer survivors in the United States, according to panelists who spoke during a workshop at the 2024 annual meeting of the Society of General Internal Medicine.

By the year 2040, an estimated 26 million people will have lived ≥ 5 years after their initial cancer diagnosis, an increase of eight million from 2022, according to the National Cancer Institute. Primary care clinicians must help patients with new health problems that emerge as the result of previous cancer treatments and with side effects that can last for decades.

“It’s a good thing that more people are living longer and living better after cancer, but now that means we have to train an army of primary care doctors to feel empowered to take care of these patients in a general setting,” said Ilana Yurkiewicz, MD, an oncologist, internal medicine physician, and clinical assistant professor at Stanford University, Stanford, California, who co-moderated the workshop.

Dr. Yurkiewicz and her fellow panelists emphasized the high likelihood that every primary care clinician is currently caring for a survivor of cancer.

One of the greatest barriers these clinicians face in caring for survivors is the difficulty in getting screening tests paid for by insurers, according to Regina Jacob, MD, associate professor at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, who co-moderated the session.

“We have a tough time getting surveillance tests [for cancer] covered through insurance” because in some cases physician groups do not provide consensus on which surveillance tools to use or how often people should be screened, Dr. Jacob said.

For instance, the American Gastroenterological Association and the US Preventive Services Task Force — which many insurers use as basis for coverage determinations — offer differing recommendations.

Primary care physicians also face challenges in understanding the complexity of conditions patients may face during and after cancer treatment since conditions that emerge from cancer or treatment may vary among patients.

“Cancer survivorship starts the day of the diagnosis,” said Dr. Yurkiewicz. “It doesn’t necessarily mean someone who has completed cancer treatment.”

During the workshop, participants offered their own recommendations for care based on case studies, which included issues such as long-term effects of cancer and its therapies, which may arise immediately after or even years or decades after treatment.

A common situation for cancer survivors involves new health issues that occur after treatment has ended.

“Who do they turn to in cases where they don’t know if it’s related to the cancer or the cancer treatment or are separate issues? Do they turn to their oncologist? Do they turn to their primary care doctor?” Dr. Yurkiewicz said. “How should I, the primary care doctor, be thinking about the issue?”

She proposed that primary care clinicians give patients a 2-week waiting period at the onset of a symptom before intervening.

Participants also suggested establishing rapport with the treating oncologist and other specialists so that if a question arises, the primary care clinician can ask for advice.

The method physicians choose to communicate and coordinate care should be tailored to the health system in which they work, participants suggested.

“Some people have the luxury of having a unified electronic health record; some people don’t have that luxury,” said Dr. Jacob. “Recognize the institution in which you work, recognize the context in which you work, and develop a communication strategy that closes the gap.”

The moderators reported no relevant disclosures.

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

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— Primary care clinicians face challenges in knowledge and care coordination as they care for a rising number of cancer survivors in the United States, according to panelists who spoke during a workshop at the 2024 annual meeting of the Society of General Internal Medicine.

By the year 2040, an estimated 26 million people will have lived ≥ 5 years after their initial cancer diagnosis, an increase of eight million from 2022, according to the National Cancer Institute. Primary care clinicians must help patients with new health problems that emerge as the result of previous cancer treatments and with side effects that can last for decades.

“It’s a good thing that more people are living longer and living better after cancer, but now that means we have to train an army of primary care doctors to feel empowered to take care of these patients in a general setting,” said Ilana Yurkiewicz, MD, an oncologist, internal medicine physician, and clinical assistant professor at Stanford University, Stanford, California, who co-moderated the workshop.

Dr. Yurkiewicz and her fellow panelists emphasized the high likelihood that every primary care clinician is currently caring for a survivor of cancer.

One of the greatest barriers these clinicians face in caring for survivors is the difficulty in getting screening tests paid for by insurers, according to Regina Jacob, MD, associate professor at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, who co-moderated the session.

“We have a tough time getting surveillance tests [for cancer] covered through insurance” because in some cases physician groups do not provide consensus on which surveillance tools to use or how often people should be screened, Dr. Jacob said.

For instance, the American Gastroenterological Association and the US Preventive Services Task Force — which many insurers use as basis for coverage determinations — offer differing recommendations.

Primary care physicians also face challenges in understanding the complexity of conditions patients may face during and after cancer treatment since conditions that emerge from cancer or treatment may vary among patients.

“Cancer survivorship starts the day of the diagnosis,” said Dr. Yurkiewicz. “It doesn’t necessarily mean someone who has completed cancer treatment.”

During the workshop, participants offered their own recommendations for care based on case studies, which included issues such as long-term effects of cancer and its therapies, which may arise immediately after or even years or decades after treatment.

A common situation for cancer survivors involves new health issues that occur after treatment has ended.

“Who do they turn to in cases where they don’t know if it’s related to the cancer or the cancer treatment or are separate issues? Do they turn to their oncologist? Do they turn to their primary care doctor?” Dr. Yurkiewicz said. “How should I, the primary care doctor, be thinking about the issue?”

She proposed that primary care clinicians give patients a 2-week waiting period at the onset of a symptom before intervening.

Participants also suggested establishing rapport with the treating oncologist and other specialists so that if a question arises, the primary care clinician can ask for advice.

The method physicians choose to communicate and coordinate care should be tailored to the health system in which they work, participants suggested.

“Some people have the luxury of having a unified electronic health record; some people don’t have that luxury,” said Dr. Jacob. “Recognize the institution in which you work, recognize the context in which you work, and develop a communication strategy that closes the gap.”

The moderators reported no relevant disclosures.

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

— Primary care clinicians face challenges in knowledge and care coordination as they care for a rising number of cancer survivors in the United States, according to panelists who spoke during a workshop at the 2024 annual meeting of the Society of General Internal Medicine.

By the year 2040, an estimated 26 million people will have lived ≥ 5 years after their initial cancer diagnosis, an increase of eight million from 2022, according to the National Cancer Institute. Primary care clinicians must help patients with new health problems that emerge as the result of previous cancer treatments and with side effects that can last for decades.

“It’s a good thing that more people are living longer and living better after cancer, but now that means we have to train an army of primary care doctors to feel empowered to take care of these patients in a general setting,” said Ilana Yurkiewicz, MD, an oncologist, internal medicine physician, and clinical assistant professor at Stanford University, Stanford, California, who co-moderated the workshop.

Dr. Yurkiewicz and her fellow panelists emphasized the high likelihood that every primary care clinician is currently caring for a survivor of cancer.

One of the greatest barriers these clinicians face in caring for survivors is the difficulty in getting screening tests paid for by insurers, according to Regina Jacob, MD, associate professor at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, who co-moderated the session.

“We have a tough time getting surveillance tests [for cancer] covered through insurance” because in some cases physician groups do not provide consensus on which surveillance tools to use or how often people should be screened, Dr. Jacob said.

For instance, the American Gastroenterological Association and the US Preventive Services Task Force — which many insurers use as basis for coverage determinations — offer differing recommendations.

Primary care physicians also face challenges in understanding the complexity of conditions patients may face during and after cancer treatment since conditions that emerge from cancer or treatment may vary among patients.

“Cancer survivorship starts the day of the diagnosis,” said Dr. Yurkiewicz. “It doesn’t necessarily mean someone who has completed cancer treatment.”

During the workshop, participants offered their own recommendations for care based on case studies, which included issues such as long-term effects of cancer and its therapies, which may arise immediately after or even years or decades after treatment.

A common situation for cancer survivors involves new health issues that occur after treatment has ended.

“Who do they turn to in cases where they don’t know if it’s related to the cancer or the cancer treatment or are separate issues? Do they turn to their oncologist? Do they turn to their primary care doctor?” Dr. Yurkiewicz said. “How should I, the primary care doctor, be thinking about the issue?”

She proposed that primary care clinicians give patients a 2-week waiting period at the onset of a symptom before intervening.

Participants also suggested establishing rapport with the treating oncologist and other specialists so that if a question arises, the primary care clinician can ask for advice.

The method physicians choose to communicate and coordinate care should be tailored to the health system in which they work, participants suggested.

“Some people have the luxury of having a unified electronic health record; some people don’t have that luxury,” said Dr. Jacob. “Recognize the institution in which you work, recognize the context in which you work, and develop a communication strategy that closes the gap.”

The moderators reported no relevant disclosures.

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

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Is Mental Illness ‘Transmissible’?

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Teens with classmates who have a mental illness have a significantly greater risk for a psychiatric diagnosis later in life, even after controlling for parents’ mental health history and other factors, a new study suggested.

The research provides new evidence that adolescents within a specific peer network may possibly “transmit” mental disorders such as depression and anxiety to each other, the investigators noted.

Having a classmate with a mental illness was associated with a 3% higher risk for subsequent psychiatric diagnosis, researchers found. The risk was highest — 13% — in the first year of follow-up and was strongest for mood, anxiety, and eating disorders.

The study is said to the be the largest to date on the topic, including data on more than 700,000 ninth graders in Finland who were followed for up to 18 years.

At least one expert noted that the numbers are higher than he would have expected, but the investigators were quick to caution the study doesn’t prove having a classmate with a mental illness leads to later psychiatric diagnosis among peers.

“The associations observed in the study are not necessarily causal,” lead investigator Jussi Alho, PhD, a postdoctoral researcher at the University of Helsinki, Finland, told this news organization. “The study did not investigate the mechanisms that explain the observed associations.”

The results were published online on May 22 in JAMA Psychiatry.
 

Few Data

Previous studies have reported a clustering of mood symptoms, eating disorders, and other psychiatric illnesses among adolescent and adult social networks. But most involve self-selected peer groups.

“Investigating the transmission of mental disorders is especially important in childhood and adolescence,” the authors noted. “Yet, despite a few survey studies reporting that adolescents may experience increased mental health symptoms when exposed to friends or peers with mental health problems, large-scale studies on the potential peer influences of mental disorders in youth are lacking,” the authors wrote.

Researchers used a database of 713,809 students in the ninth grade, about half boys and half girls. All were born between January 1, 1985, and December 31, 1997. About 47,000 were excluded as they had a mental disorder diagnosis before the study began.

Some 666,000 students in 860 schools were followed from ninth grade until the first diagnosed mental disorder, death, emigration, or the end of the study in 2019. Median follow-up was 11.4 years.

Diagnoses were gathered from Finnish registries for inpatient, outpatient, and primary care and included ICD-9 and ICD-10 diagnoses for substance misuse disorders, schizophrenia spectrum disorders, mood disorders, anxiety disorders, eating disorders, emotional and social-functioning disorders, and hyperkinetic and conduct disorders.

The authors adjusted for sex, birth year, school and ninth-grade class size, area-level urbanicity, area-level morbidity, area-level education, area-level employment rate, parental educational level, and parental mental health, with a random intercept per school.
 

Dose-Response Relationship

Overall, a quarter (167,227) of the students were diagnosed with a mental disorder.

The risk of being diagnosed with any mental disorder was 3% higher during the entire follow-up period (hazard ratio [HR], 1.03; 95% CI, 1.02-1.04). Risk was highest in the first year of follow-up (HR, 1.13; 95% CI, 1.08-1.18) and then rose again in years 4 and 5, when the risk was 5% higher with one diagnosed classmate and 10% higher with more than one diagnosed classmate.

The risk was significantly increased for mood, anxiety, and eating disorders in each follow-up time window. Investigators also noted a dose-response relationship: The more classmates with a psychiatric illness, the greater the risk for later mental illness.

“These findings suggest that mental disorders may be transmitted within adolescent peer networks,” the authors wrote.

The researchers chose to describe the spread of mental disorders among peer classmates as “transmission” in part because it has been previously used in the literature, Dr. Alho said.

Alho said the researchers also believe that transmission is an accurate term to describe the potential mechanisms by which mental disorders may spread.

The authors hypothesized that more students might be diagnosed when disorders are normalized, through increased awareness and receptivity to diagnosis and treatment.

Conversely, the rate of disorders might also have increased — especially in the first year of follow-up — if there were no students in the peer network who had been diagnosed, the authors added. Without an example, it might discourage a student to seek help.

The authors also noted that it’s “conceivable that long-term exposure to a depressive individual could lead to gradual development of depressive symptoms through the well-established neural mechanisms of emotional contagion.”
 

 

 

New Direction for Treatment?

Commenting on the findings, Madhukar H. Trivedi, MD, the Betty Jo Hay Distinguished Chair in Mental Health at UT Southwestern Medical School, Dallas, said that the theory that having classmates with psychiatric illness could normalize these conditions has merit.

Once someone is diagnosed or receives treatment, “their peers kind of get implicit permission to be able to then express their own symptoms or express their own problems, which they may have been hiding or not recognized,” he said.

However, Dr. Trivedi disagreed with the authors’ suggestion that the rate of disorders might also have increased if no classmates had received a psychiatric diagnosis, noting that it was unlikely that a student would not have been exposed to depression, anxiety, or another mood disorder — through a peer or family member — given how common those illnesses are.

“The numbers are slightly higher than I would have expected,” Dr. Trivedi said, adding that peer influence having that type of impact “is something that has not been shown before.”

The study is notable for its use of comprehensive registries, which helped solidify the data integrity, Trivedi said, and the results offer some potential new directions for treatment, such as adding peer support. That has been found useful in adult treatment but has been less utilized with adolescents, he said.

The study was funded by the European Union and the Academy of Finland. The authors reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

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Teens with classmates who have a mental illness have a significantly greater risk for a psychiatric diagnosis later in life, even after controlling for parents’ mental health history and other factors, a new study suggested.

The research provides new evidence that adolescents within a specific peer network may possibly “transmit” mental disorders such as depression and anxiety to each other, the investigators noted.

Having a classmate with a mental illness was associated with a 3% higher risk for subsequent psychiatric diagnosis, researchers found. The risk was highest — 13% — in the first year of follow-up and was strongest for mood, anxiety, and eating disorders.

The study is said to the be the largest to date on the topic, including data on more than 700,000 ninth graders in Finland who were followed for up to 18 years.

At least one expert noted that the numbers are higher than he would have expected, but the investigators were quick to caution the study doesn’t prove having a classmate with a mental illness leads to later psychiatric diagnosis among peers.

“The associations observed in the study are not necessarily causal,” lead investigator Jussi Alho, PhD, a postdoctoral researcher at the University of Helsinki, Finland, told this news organization. “The study did not investigate the mechanisms that explain the observed associations.”

The results were published online on May 22 in JAMA Psychiatry.
 

Few Data

Previous studies have reported a clustering of mood symptoms, eating disorders, and other psychiatric illnesses among adolescent and adult social networks. But most involve self-selected peer groups.

“Investigating the transmission of mental disorders is especially important in childhood and adolescence,” the authors noted. “Yet, despite a few survey studies reporting that adolescents may experience increased mental health symptoms when exposed to friends or peers with mental health problems, large-scale studies on the potential peer influences of mental disorders in youth are lacking,” the authors wrote.

Researchers used a database of 713,809 students in the ninth grade, about half boys and half girls. All were born between January 1, 1985, and December 31, 1997. About 47,000 were excluded as they had a mental disorder diagnosis before the study began.

Some 666,000 students in 860 schools were followed from ninth grade until the first diagnosed mental disorder, death, emigration, or the end of the study in 2019. Median follow-up was 11.4 years.

Diagnoses were gathered from Finnish registries for inpatient, outpatient, and primary care and included ICD-9 and ICD-10 diagnoses for substance misuse disorders, schizophrenia spectrum disorders, mood disorders, anxiety disorders, eating disorders, emotional and social-functioning disorders, and hyperkinetic and conduct disorders.

The authors adjusted for sex, birth year, school and ninth-grade class size, area-level urbanicity, area-level morbidity, area-level education, area-level employment rate, parental educational level, and parental mental health, with a random intercept per school.
 

Dose-Response Relationship

Overall, a quarter (167,227) of the students were diagnosed with a mental disorder.

The risk of being diagnosed with any mental disorder was 3% higher during the entire follow-up period (hazard ratio [HR], 1.03; 95% CI, 1.02-1.04). Risk was highest in the first year of follow-up (HR, 1.13; 95% CI, 1.08-1.18) and then rose again in years 4 and 5, when the risk was 5% higher with one diagnosed classmate and 10% higher with more than one diagnosed classmate.

The risk was significantly increased for mood, anxiety, and eating disorders in each follow-up time window. Investigators also noted a dose-response relationship: The more classmates with a psychiatric illness, the greater the risk for later mental illness.

“These findings suggest that mental disorders may be transmitted within adolescent peer networks,” the authors wrote.

The researchers chose to describe the spread of mental disorders among peer classmates as “transmission” in part because it has been previously used in the literature, Dr. Alho said.

Alho said the researchers also believe that transmission is an accurate term to describe the potential mechanisms by which mental disorders may spread.

The authors hypothesized that more students might be diagnosed when disorders are normalized, through increased awareness and receptivity to diagnosis and treatment.

Conversely, the rate of disorders might also have increased — especially in the first year of follow-up — if there were no students in the peer network who had been diagnosed, the authors added. Without an example, it might discourage a student to seek help.

The authors also noted that it’s “conceivable that long-term exposure to a depressive individual could lead to gradual development of depressive symptoms through the well-established neural mechanisms of emotional contagion.”
 

 

 

New Direction for Treatment?

Commenting on the findings, Madhukar H. Trivedi, MD, the Betty Jo Hay Distinguished Chair in Mental Health at UT Southwestern Medical School, Dallas, said that the theory that having classmates with psychiatric illness could normalize these conditions has merit.

Once someone is diagnosed or receives treatment, “their peers kind of get implicit permission to be able to then express their own symptoms or express their own problems, which they may have been hiding or not recognized,” he said.

However, Dr. Trivedi disagreed with the authors’ suggestion that the rate of disorders might also have increased if no classmates had received a psychiatric diagnosis, noting that it was unlikely that a student would not have been exposed to depression, anxiety, or another mood disorder — through a peer or family member — given how common those illnesses are.

“The numbers are slightly higher than I would have expected,” Dr. Trivedi said, adding that peer influence having that type of impact “is something that has not been shown before.”

The study is notable for its use of comprehensive registries, which helped solidify the data integrity, Trivedi said, and the results offer some potential new directions for treatment, such as adding peer support. That has been found useful in adult treatment but has been less utilized with adolescents, he said.

The study was funded by the European Union and the Academy of Finland. The authors reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Teens with classmates who have a mental illness have a significantly greater risk for a psychiatric diagnosis later in life, even after controlling for parents’ mental health history and other factors, a new study suggested.

The research provides new evidence that adolescents within a specific peer network may possibly “transmit” mental disorders such as depression and anxiety to each other, the investigators noted.

Having a classmate with a mental illness was associated with a 3% higher risk for subsequent psychiatric diagnosis, researchers found. The risk was highest — 13% — in the first year of follow-up and was strongest for mood, anxiety, and eating disorders.

The study is said to the be the largest to date on the topic, including data on more than 700,000 ninth graders in Finland who were followed for up to 18 years.

At least one expert noted that the numbers are higher than he would have expected, but the investigators were quick to caution the study doesn’t prove having a classmate with a mental illness leads to later psychiatric diagnosis among peers.

“The associations observed in the study are not necessarily causal,” lead investigator Jussi Alho, PhD, a postdoctoral researcher at the University of Helsinki, Finland, told this news organization. “The study did not investigate the mechanisms that explain the observed associations.”

The results were published online on May 22 in JAMA Psychiatry.
 

Few Data

Previous studies have reported a clustering of mood symptoms, eating disorders, and other psychiatric illnesses among adolescent and adult social networks. But most involve self-selected peer groups.

“Investigating the transmission of mental disorders is especially important in childhood and adolescence,” the authors noted. “Yet, despite a few survey studies reporting that adolescents may experience increased mental health symptoms when exposed to friends or peers with mental health problems, large-scale studies on the potential peer influences of mental disorders in youth are lacking,” the authors wrote.

Researchers used a database of 713,809 students in the ninth grade, about half boys and half girls. All were born between January 1, 1985, and December 31, 1997. About 47,000 were excluded as they had a mental disorder diagnosis before the study began.

Some 666,000 students in 860 schools were followed from ninth grade until the first diagnosed mental disorder, death, emigration, or the end of the study in 2019. Median follow-up was 11.4 years.

Diagnoses were gathered from Finnish registries for inpatient, outpatient, and primary care and included ICD-9 and ICD-10 diagnoses for substance misuse disorders, schizophrenia spectrum disorders, mood disorders, anxiety disorders, eating disorders, emotional and social-functioning disorders, and hyperkinetic and conduct disorders.

The authors adjusted for sex, birth year, school and ninth-grade class size, area-level urbanicity, area-level morbidity, area-level education, area-level employment rate, parental educational level, and parental mental health, with a random intercept per school.
 

Dose-Response Relationship

Overall, a quarter (167,227) of the students were diagnosed with a mental disorder.

The risk of being diagnosed with any mental disorder was 3% higher during the entire follow-up period (hazard ratio [HR], 1.03; 95% CI, 1.02-1.04). Risk was highest in the first year of follow-up (HR, 1.13; 95% CI, 1.08-1.18) and then rose again in years 4 and 5, when the risk was 5% higher with one diagnosed classmate and 10% higher with more than one diagnosed classmate.

The risk was significantly increased for mood, anxiety, and eating disorders in each follow-up time window. Investigators also noted a dose-response relationship: The more classmates with a psychiatric illness, the greater the risk for later mental illness.

“These findings suggest that mental disorders may be transmitted within adolescent peer networks,” the authors wrote.

The researchers chose to describe the spread of mental disorders among peer classmates as “transmission” in part because it has been previously used in the literature, Dr. Alho said.

Alho said the researchers also believe that transmission is an accurate term to describe the potential mechanisms by which mental disorders may spread.

The authors hypothesized that more students might be diagnosed when disorders are normalized, through increased awareness and receptivity to diagnosis and treatment.

Conversely, the rate of disorders might also have increased — especially in the first year of follow-up — if there were no students in the peer network who had been diagnosed, the authors added. Without an example, it might discourage a student to seek help.

The authors also noted that it’s “conceivable that long-term exposure to a depressive individual could lead to gradual development of depressive symptoms through the well-established neural mechanisms of emotional contagion.”
 

 

 

New Direction for Treatment?

Commenting on the findings, Madhukar H. Trivedi, MD, the Betty Jo Hay Distinguished Chair in Mental Health at UT Southwestern Medical School, Dallas, said that the theory that having classmates with psychiatric illness could normalize these conditions has merit.

Once someone is diagnosed or receives treatment, “their peers kind of get implicit permission to be able to then express their own symptoms or express their own problems, which they may have been hiding or not recognized,” he said.

However, Dr. Trivedi disagreed with the authors’ suggestion that the rate of disorders might also have increased if no classmates had received a psychiatric diagnosis, noting that it was unlikely that a student would not have been exposed to depression, anxiety, or another mood disorder — through a peer or family member — given how common those illnesses are.

“The numbers are slightly higher than I would have expected,” Dr. Trivedi said, adding that peer influence having that type of impact “is something that has not been shown before.”

The study is notable for its use of comprehensive registries, which helped solidify the data integrity, Trivedi said, and the results offer some potential new directions for treatment, such as adding peer support. That has been found useful in adult treatment but has been less utilized with adolescents, he said.

The study was funded by the European Union and the Academy of Finland. The authors reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

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