SAN ANTONIO – In previously treated patients with locally advanced unresectable or metastatic HER2-positive breast cancer, tucatinib (Tukysa, Seagen) and trastuzumab emtansine (Kadcyla, T-DM1, Genentech) improved progression-free survival (PFS) versus T-DM1 alone, according to results from the phase III HER2CLIMB-02 study. A subanalysis of patients with brain metastases at baseline also showed an improvement in this population.

Brain metastases are common HER2+ breast cancer, and this is associated with poor outcomes, according to Sara A. Hurvitz, MD, who presented the study at the San Antonio Breast Cancer Symposium. There are few treatment options available for this population.

“Adding tucatinib to TDM-1 significantly improved progression free survival in patients with previously treated HER2+ advanced disease. The types of adverse events were consistent with previous reporting, and this is the second randomized study which included patients with brain metastases to demonstrate that a tucatinib-based regimen delays disease progression in this disease setting,” said Dr. Hurvitz, professor and head of the division of hematology and oncology at the University of Washington Department of Medicine and senior vice president and director of the Clinical Research Division at Fred Hutchinson Cancer Center.

Both tucatinib and TDM-1 target the HER2 receptor. T-DM1 is an antibody-drug conjugate (ADC) of trastuzumab (Herceptin) and the drug emtansine that has received FDA approval as monotherapy for both early- and late-stage HER2-positive breast cancer. Tucatinib is a small-molecule HER2 inhibitor and has efficacy against disease progression in the central nervous system, which is unusual among HER2-targeted therapies.

The earlier HER2CLIMB trial showed improved outcomes among heavily pretreated patients — including those with brain metastases — when tucatinib was added to trastuzumab and capecitabine (Xeloda, Genentech). In 2020, the FDA approved the combination for advanced unresectable or metastatic HER2-positive breast cancer, including brain metastases.

To determine if tucatinib could also improve responses when combined with a trastuzumab-based ADC, the researchers randomized 463 patients to tucatinib plus T-DM1 or placebo plus T-DM1. Nearly half (44.1%) of patients had brain metastases at baseline. Over a median follow-up of 24.4 months, the combination group had a 24% lower risk of progression or death (hazard ratio [HR], 0.76; P = .0163) and a longer median progression-free survival (9.5 months versus 7.4 months).

The PFS benefit was also seen in patients with baseline brain metastases (HR, 0.64; 95% CI, 0.46-0.89]). An insufficient number of survival events had occurred at the interim analysis to determine OS at the time of the presentation.

There was no statistically significant difference in overall response rate in the intervention arm. Treatment-emergent adverse events (TEAEs) that were more common in the tucatinib arm included nausea (65.4% vs. 49.4%), diarrhea (56.7% vs. 26.6%), and fatigue (48.9% vs. 37.3%). Grade 3 or higher TEAEs in the tucatinib arm included alanine and aspartate aminotransferase elevations (16.5% for both), versus 2.6% in the control arm for both. TEAEs associated treatment discontinuation occurred among 22.1% in the tucatinib arm and 11.6% in the control arm. TEAEs that led to mortality occurred in 1.3% of the tucatinib group and 0.9% of the control arm.

“I think tucatinib really does contain level one evidence for use in the setting of CNS metastases. There’s not yet data that has replaced that, so I will continue to consider using it in the second line setting, as it’s currently indicated in the presence of brain metastases. Without brain metastases, based on [the DESTINY-Breast03 trial], I’d probably opt for [trastuzumab deroxtecan], which is still the standard,” said Dr. Hurvitz.

Following the talk, Valentina Guarneri, MD, PhD, served as a discussant. She underscored the clinical need for treatment of patients with brain metastases.

“Brain metastases represent a devastating event for our patients and remain an unmet need considering that all of these patients will eventually require local therapies, with potentially debilitating sequelae. Since optimal therapy for these patients should not be an afterthought, clinical trials taking the risk of including these patients must be valued,” said Dr. Guarneri, professor of oncology at the University of Padua in Italy.

She acknowledged the success of the dual HER2 inhibitor strategy, and said it opens up avenues for combinations with novel antibody-drug conjugates. “HER2CLIMB-02 is unlikely to change the current algorithm, but it reinforces the role of tucatinib in the treatment of HER2+ metastatic breast cancer. The data further support studies in the early disease setting aiming to prevent the development of brain metastases,” said Dr. Guarneri.

The study was funded by Seagen. Dr. Hurvitz has received research funding from Ambrx, Arvinas, AstraZeneca, Bayer, Celcuity, CytomX Therapeutics, Daiichi Sankyo, Dantari Inc., Dignitana, Genentech, (Roche), G1 Therapeutics, Gilead Sciences Inc., Greenwich LifeSciences Inc., GSK, Immunomedics, Eli Lilly and Company, Loxo Oncology, MacroGenics, Novartis, OBI Pharma Inc., Orinove Inc., Orum Therapeutics, Pfizer, Phoenix Molecular Designs, Pieris Pharmaceuticals Inc., Puma Biotechnology, Radius Health, Sanofi, Seagen, and Zymeworks; has received royalties from McGraw Hill, Sage Publications, Wiley, and Wolters Kluwer; has served on the data and safety monitoring board for Alliance Foundation Trials LLC, Atossa Therapeutics, and the Quantum Leap Healthcare Collaborative; and has received honoraria from the Vaniam Group and OncLive. Her husband holds stock in ROMTech. Dr. Guarneri has been a member of the advisory boards for AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly, Exact Sciences, Gilead, Merck Serono, MSD, Novartis, Pfizer, Olema Oncology, and Pierre Fabre. She has been an invited speaker for AstraZeneca, Daiichi Sankyo, Eli Lilly, Exact Sciences, Gilead, GSK Novartis, and Zentiva.

SAN ANTONIO – In previously treated patients with locally advanced unresectable or metastatic HER2-positive breast cancer, tucatinib (Tukysa, Seagen) and trastuzumab emtansine (Kadcyla, T-DM1, Genentech) improved progression-free survival (PFS) versus T-DM1 alone, according to results from the phase III HER2CLIMB-02 study. A subanalysis of patients with brain metastases at baseline also showed an improvement in this population.

Brain metastases are common HER2+ breast cancer, and this is associated with poor outcomes, according to Sara A. Hurvitz, MD, who presented the study at the San Antonio Breast Cancer Symposium. There are few treatment options available for this population.

“Adding tucatinib to TDM-1 significantly improved progression free survival in patients with previously treated HER2+ advanced disease. The types of adverse events were consistent with previous reporting, and this is the second randomized study which included patients with brain metastases to demonstrate that a tucatinib-based regimen delays disease progression in this disease setting,” said Dr. Hurvitz, professor and head of the division of hematology and oncology at the University of Washington Department of Medicine and senior vice president and director of the Clinical Research Division at Fred Hutchinson Cancer Center.

Both tucatinib and TDM-1 target the HER2 receptor. T-DM1 is an antibody-drug conjugate (ADC) of trastuzumab (Herceptin) and the drug emtansine that has received FDA approval as monotherapy for both early- and late-stage HER2-positive breast cancer. Tucatinib is a small-molecule HER2 inhibitor and has efficacy against disease progression in the central nervous system, which is unusual among HER2-targeted therapies.

The earlier HER2CLIMB trial showed improved outcomes among heavily pretreated patients — including those with brain metastases — when tucatinib was added to trastuzumab and capecitabine (Xeloda, Genentech). In 2020, the FDA approved the combination for advanced unresectable or metastatic HER2-positive breast cancer, including brain metastases.

To determine if tucatinib could also improve responses when combined with a trastuzumab-based ADC, the researchers randomized 463 patients to tucatinib plus T-DM1 or placebo plus T-DM1. Nearly half (44.1%) of patients had brain metastases at baseline. Over a median follow-up of 24.4 months, the combination group had a 24% lower risk of progression or death (hazard ratio [HR], 0.76; P = .0163) and a longer median progression-free survival (9.5 months versus 7.4 months).

The PFS benefit was also seen in patients with baseline brain metastases (HR, 0.64; 95% CI, 0.46-0.89]). An insufficient number of survival events had occurred at the interim analysis to determine OS at the time of the presentation.

There was no statistically significant difference in overall response rate in the intervention arm. Treatment-emergent adverse events (TEAEs) that were more common in the tucatinib arm included nausea (65.4% vs. 49.4%), diarrhea (56.7% vs. 26.6%), and fatigue (48.9% vs. 37.3%). Grade 3 or higher TEAEs in the tucatinib arm included alanine and aspartate aminotransferase elevations (16.5% for both), versus 2.6% in the control arm for both. TEAEs associated treatment discontinuation occurred among 22.1% in the tucatinib arm and 11.6% in the control arm. TEAEs that led to mortality occurred in 1.3% of the tucatinib group and 0.9% of the control arm.

“I think tucatinib really does contain level one evidence for use in the setting of CNS metastases. There’s not yet data that has replaced that, so I will continue to consider using it in the second line setting, as it’s currently indicated in the presence of brain metastases. Without brain metastases, based on [the DESTINY-Breast03 trial], I’d probably opt for [trastuzumab deroxtecan], which is still the standard,” said Dr. Hurvitz.

Following the talk, Valentina Guarneri, MD, PhD, served as a discussant. She underscored the clinical need for treatment of patients with brain metastases.

“Brain metastases represent a devastating event for our patients and remain an unmet need considering that all of these patients will eventually require local therapies, with potentially debilitating sequelae. Since optimal therapy for these patients should not be an afterthought, clinical trials taking the risk of including these patients must be valued,” said Dr. Guarneri, professor of oncology at the University of Padua in Italy.

She acknowledged the success of the dual HER2 inhibitor strategy, and said it opens up avenues for combinations with novel antibody-drug conjugates. “HER2CLIMB-02 is unlikely to change the current algorithm, but it reinforces the role of tucatinib in the treatment of HER2+ metastatic breast cancer. The data further support studies in the early disease setting aiming to prevent the development of brain metastases,” said Dr. Guarneri.

The study was funded by Seagen. Dr. Hurvitz has received research funding from Ambrx, Arvinas, AstraZeneca, Bayer, Celcuity, CytomX Therapeutics, Daiichi Sankyo, Dantari Inc., Dignitana, Genentech, (Roche), G1 Therapeutics, Gilead Sciences Inc., Greenwich LifeSciences Inc., GSK, Immunomedics, Eli Lilly and Company, Loxo Oncology, MacroGenics, Novartis, OBI Pharma Inc., Orinove Inc., Orum Therapeutics, Pfizer, Phoenix Molecular Designs, Pieris Pharmaceuticals Inc., Puma Biotechnology, Radius Health, Sanofi, Seagen, and Zymeworks; has received royalties from McGraw Hill, Sage Publications, Wiley, and Wolters Kluwer; has served on the data and safety monitoring board for Alliance Foundation Trials LLC, Atossa Therapeutics, and the Quantum Leap Healthcare Collaborative; and has received honoraria from the Vaniam Group and OncLive. Her husband holds stock in ROMTech. Dr. Guarneri has been a member of the advisory boards for AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly, Exact Sciences, Gilead, Merck Serono, MSD, Novartis, Pfizer, Olema Oncology, and Pierre Fabre. She has been an invited speaker for AstraZeneca, Daiichi Sankyo, Eli Lilly, Exact Sciences, Gilead, GSK Novartis, and Zentiva.

SAN ANTONIO – In previously treated patients with locally advanced unresectable or metastatic HER2-positive breast cancer, tucatinib (Tukysa, Seagen) and trastuzumab emtansine (Kadcyla, T-DM1, Genentech) improved progression-free survival (PFS) versus T-DM1 alone, according to results from the phase III HER2CLIMB-02 study. A subanalysis of patients with brain metastases at baseline also showed an improvement in this population.

Brain metastases are common HER2+ breast cancer, and this is associated with poor outcomes, according to Sara A. Hurvitz, MD, who presented the study at the San Antonio Breast Cancer Symposium. There are few treatment options available for this population.

“Adding tucatinib to TDM-1 significantly improved progression free survival in patients with previously treated HER2+ advanced disease. The types of adverse events were consistent with previous reporting, and this is the second randomized study which included patients with brain metastases to demonstrate that a tucatinib-based regimen delays disease progression in this disease setting,” said Dr. Hurvitz, professor and head of the division of hematology and oncology at the University of Washington Department of Medicine and senior vice president and director of the Clinical Research Division at Fred Hutchinson Cancer Center.

Both tucatinib and TDM-1 target the HER2 receptor. T-DM1 is an antibody-drug conjugate (ADC) of trastuzumab (Herceptin) and the drug emtansine that has received FDA approval as monotherapy for both early- and late-stage HER2-positive breast cancer. Tucatinib is a small-molecule HER2 inhibitor and has efficacy against disease progression in the central nervous system, which is unusual among HER2-targeted therapies.

The earlier HER2CLIMB trial showed improved outcomes among heavily pretreated patients — including those with brain metastases — when tucatinib was added to trastuzumab and capecitabine (Xeloda, Genentech). In 2020, the FDA approved the combination for advanced unresectable or metastatic HER2-positive breast cancer, including brain metastases.

To determine if tucatinib could also improve responses when combined with a trastuzumab-based ADC, the researchers randomized 463 patients to tucatinib plus T-DM1 or placebo plus T-DM1. Nearly half (44.1%) of patients had brain metastases at baseline. Over a median follow-up of 24.4 months, the combination group had a 24% lower risk of progression or death (hazard ratio [HR], 0.76; P = .0163) and a longer median progression-free survival (9.5 months versus 7.4 months).

The PFS benefit was also seen in patients with baseline brain metastases (HR, 0.64; 95% CI, 0.46-0.89]). An insufficient number of survival events had occurred at the interim analysis to determine OS at the time of the presentation.

There was no statistically significant difference in overall response rate in the intervention arm. Treatment-emergent adverse events (TEAEs) that were more common in the tucatinib arm included nausea (65.4% vs. 49.4%), diarrhea (56.7% vs. 26.6%), and fatigue (48.9% vs. 37.3%). Grade 3 or higher TEAEs in the tucatinib arm included alanine and aspartate aminotransferase elevations (16.5% for both), versus 2.6% in the control arm for both. TEAEs associated treatment discontinuation occurred among 22.1% in the tucatinib arm and 11.6% in the control arm. TEAEs that led to mortality occurred in 1.3% of the tucatinib group and 0.9% of the control arm.

“I think tucatinib really does contain level one evidence for use in the setting of CNS metastases. There’s not yet data that has replaced that, so I will continue to consider using it in the second line setting, as it’s currently indicated in the presence of brain metastases. Without brain metastases, based on [the DESTINY-Breast03 trial], I’d probably opt for [trastuzumab deroxtecan], which is still the standard,” said Dr. Hurvitz.

Following the talk, Valentina Guarneri, MD, PhD, served as a discussant. She underscored the clinical need for treatment of patients with brain metastases.

“Brain metastases represent a devastating event for our patients and remain an unmet need considering that all of these patients will eventually require local therapies, with potentially debilitating sequelae. Since optimal therapy for these patients should not be an afterthought, clinical trials taking the risk of including these patients must be valued,” said Dr. Guarneri, professor of oncology at the University of Padua in Italy.

She acknowledged the success of the dual HER2 inhibitor strategy, and said it opens up avenues for combinations with novel antibody-drug conjugates. “HER2CLIMB-02 is unlikely to change the current algorithm, but it reinforces the role of tucatinib in the treatment of HER2+ metastatic breast cancer. The data further support studies in the early disease setting aiming to prevent the development of brain metastases,” said Dr. Guarneri.

The study was funded by Seagen. Dr. Hurvitz has received research funding from Ambrx, Arvinas, AstraZeneca, Bayer, Celcuity, CytomX Therapeutics, Daiichi Sankyo, Dantari Inc., Dignitana, Genentech, (Roche), G1 Therapeutics, Gilead Sciences Inc., Greenwich LifeSciences Inc., GSK, Immunomedics, Eli Lilly and Company, Loxo Oncology, MacroGenics, Novartis, OBI Pharma Inc., Orinove Inc., Orum Therapeutics, Pfizer, Phoenix Molecular Designs, Pieris Pharmaceuticals Inc., Puma Biotechnology, Radius Health, Sanofi, Seagen, and Zymeworks; has received royalties from McGraw Hill, Sage Publications, Wiley, and Wolters Kluwer; has served on the data and safety monitoring board for Alliance Foundation Trials LLC, Atossa Therapeutics, and the Quantum Leap Healthcare Collaborative; and has received honoraria from the Vaniam Group and OncLive. Her husband holds stock in ROMTech. Dr. Guarneri has been a member of the advisory boards for AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly, Exact Sciences, Gilead, Merck Serono, MSD, Novartis, Pfizer, Olema Oncology, and Pierre Fabre. She has been an invited speaker for AstraZeneca, Daiichi Sankyo, Eli Lilly, Exact Sciences, Gilead, GSK Novartis, and Zentiva.

BARCELONA, SPAIN — Around half of all patients with chronic headache or migraine overuse their medication, leading to aggravated or new types of headaches. “Medication overuse headache” is the third most frequent type of headache, affecting some 60 million people or around 1% of the world’s population.

“It’s a big problem,” Sait Ashina, MD, of Beth Israel Deaconess Medical Center, Boston, Massachusetts, told the audience in an opening plenary at the 17th European Headache Congress in Barcelona. “But it’s important to distinguish between medication overuse, which is a behavior, and medication overuse headache, which is a distinct secondary order condition.”

Medication overuse headache is characterized by an increasing headache frequency and progressive use of short-term medication and is recognized as a major factor in the shift from episodic to chronic headache.

It is often underrecognized; however, educating doctors and patients is a crucial element of effective treatment. Recognition that headache medication is being overused is a crucial first step to treatment, followed by advising the patient to discontinue the medication. But this poses its own problems, as it can cause withdrawal symptoms.

According to a longitudinal population-based study published in 2008, most patients overuse acetaminophen or paracetamol, followed by nonsteroidal anti-inflammatory drugs and 5-hydroxytriptamine agonists (triptans) and, in the United States, barbiturates and opioids.
 

What’s the Best Treatment Strategy?

Medication overuse headache is often treated by complete withdrawal from medication, but the withdrawal symptoms can be severe. They include nausea and vomiting, arterial hypertension, tachycardia, sleep disturbances, anxiety, and restlessness, with their duration and severity depending solely on the type of headache medication that has been overused.

There is, however, no consensus on how best to treat medication overuse headache — withdrawal plus preventive treatment, preventive treatment without withdrawal, and withdrawal with optional preventive treatment 2 months after withdrawal. The findings showed that all three strategies were effective. But the research team concluded that withdrawal combined with preventive medication from the start of withdrawal was the recommended approach.

The electronic headache diary has proved to be very useful, as it can aid accurate diagnosis by providing clear insights into a patient’s condition. Information from the diary is more reliable than self-reports because patients often underestimate the frequency of their headaches, migraines, and use of medication.

Patients who are treated for medication overuse headache tend to have a high relapse rate. So, the electronic headache diary can also be very useful for follow-up by alerting patients and clinicians when headaches and medication overuse are increasing again.

“After diagnosing medication overuse or medication overuse headache, we advise our patients to discontinue the medication,” said Judith Pijpers of Leiden University Medical School, the Netherlands. “This provides clinically relevant improvements in headache frequency in a majority of patients and a significant reduction in headache days.”

In 2019, Dr. Pijpers and her colleagues published the results of a double-blind randomized controlled trial showing that botulinum toxin A, which is widely used to treat chronic migraine, has no additional benefit over acute withdrawal in patients with chronic migraine and medication overuse.

“We saw no difference between the groups during both the double-blind and the open label phase,” said Dr. Pijpers. “And that is why we do not give patients botulinum toxin A during withdrawal.”

A further trial within the botox study showed modest benefits for behavioral intervention by a headache nurse comprising education, motivational interviewing, and value-based activity planning during withdrawal therapy.

Patients can be stratified to some extent based on the type of headache they have and the medication they are taking for it.

“You can predict [a patient’s response] to some extent from the type of medication they overuse and the type of underlying primary headache,” Dr. Pijpers said in an interview.

“Those with underlying tension-type headache have different withdrawal symptoms than those with underlying migraine, and the withdrawal symptoms tend to be somewhat shorter if a patient overuses triptans compared to analgesics.”
 

Predicting Patients’ Responses to Migraine Medication

Dr. Pijpers and her colleagues recently published the results of a cohort study suggesting that cutaneous allodynia may predict how patients with migraine respond to withdrawal therapy. Nearly 75% of the 173 patients enrolled in the study reported experiencing allodynia — pain caused by a stimulus that does not normally cause pain. The study showed that absence of allodynia was predictive of a good outcome for patients after withdrawal therapy and of reversion from chronic to episodic migraine.

The ability to accurately predict patients’ responses could pave the way for personalized treatments of medication overuse headache.
 

A version of this article appeared in Medscape.com.

BARCELONA, SPAIN — Around half of all patients with chronic headache or migraine overuse their medication, leading to aggravated or new types of headaches. “Medication overuse headache” is the third most frequent type of headache, affecting some 60 million people or around 1% of the world’s population.

“It’s a big problem,” Sait Ashina, MD, of Beth Israel Deaconess Medical Center, Boston, Massachusetts, told the audience in an opening plenary at the 17th European Headache Congress in Barcelona. “But it’s important to distinguish between medication overuse, which is a behavior, and medication overuse headache, which is a distinct secondary order condition.”

Medication overuse headache is characterized by an increasing headache frequency and progressive use of short-term medication and is recognized as a major factor in the shift from episodic to chronic headache.

It is often underrecognized; however, educating doctors and patients is a crucial element of effective treatment. Recognition that headache medication is being overused is a crucial first step to treatment, followed by advising the patient to discontinue the medication. But this poses its own problems, as it can cause withdrawal symptoms.

According to a longitudinal population-based study published in 2008, most patients overuse acetaminophen or paracetamol, followed by nonsteroidal anti-inflammatory drugs and 5-hydroxytriptamine agonists (triptans) and, in the United States, barbiturates and opioids.
 

What’s the Best Treatment Strategy?

Medication overuse headache is often treated by complete withdrawal from medication, but the withdrawal symptoms can be severe. They include nausea and vomiting, arterial hypertension, tachycardia, sleep disturbances, anxiety, and restlessness, with their duration and severity depending solely on the type of headache medication that has been overused.

There is, however, no consensus on how best to treat medication overuse headache — withdrawal plus preventive treatment, preventive treatment without withdrawal, and withdrawal with optional preventive treatment 2 months after withdrawal. The findings showed that all three strategies were effective. But the research team concluded that withdrawal combined with preventive medication from the start of withdrawal was the recommended approach.

The electronic headache diary has proved to be very useful, as it can aid accurate diagnosis by providing clear insights into a patient’s condition. Information from the diary is more reliable than self-reports because patients often underestimate the frequency of their headaches, migraines, and use of medication.

Patients who are treated for medication overuse headache tend to have a high relapse rate. So, the electronic headache diary can also be very useful for follow-up by alerting patients and clinicians when headaches and medication overuse are increasing again.

“After diagnosing medication overuse or medication overuse headache, we advise our patients to discontinue the medication,” said Judith Pijpers of Leiden University Medical School, the Netherlands. “This provides clinically relevant improvements in headache frequency in a majority of patients and a significant reduction in headache days.”

In 2019, Dr. Pijpers and her colleagues published the results of a double-blind randomized controlled trial showing that botulinum toxin A, which is widely used to treat chronic migraine, has no additional benefit over acute withdrawal in patients with chronic migraine and medication overuse.

“We saw no difference between the groups during both the double-blind and the open label phase,” said Dr. Pijpers. “And that is why we do not give patients botulinum toxin A during withdrawal.”

A further trial within the botox study showed modest benefits for behavioral intervention by a headache nurse comprising education, motivational interviewing, and value-based activity planning during withdrawal therapy.

Patients can be stratified to some extent based on the type of headache they have and the medication they are taking for it.

“You can predict [a patient’s response] to some extent from the type of medication they overuse and the type of underlying primary headache,” Dr. Pijpers said in an interview.

“Those with underlying tension-type headache have different withdrawal symptoms than those with underlying migraine, and the withdrawal symptoms tend to be somewhat shorter if a patient overuses triptans compared to analgesics.”
 

Predicting Patients’ Responses to Migraine Medication

Dr. Pijpers and her colleagues recently published the results of a cohort study suggesting that cutaneous allodynia may predict how patients with migraine respond to withdrawal therapy. Nearly 75% of the 173 patients enrolled in the study reported experiencing allodynia — pain caused by a stimulus that does not normally cause pain. The study showed that absence of allodynia was predictive of a good outcome for patients after withdrawal therapy and of reversion from chronic to episodic migraine.

The ability to accurately predict patients’ responses could pave the way for personalized treatments of medication overuse headache.
 

A version of this article appeared in Medscape.com.

BARCELONA, SPAIN — Around half of all patients with chronic headache or migraine overuse their medication, leading to aggravated or new types of headaches. “Medication overuse headache” is the third most frequent type of headache, affecting some 60 million people or around 1% of the world’s population.

“It’s a big problem,” Sait Ashina, MD, of Beth Israel Deaconess Medical Center, Boston, Massachusetts, told the audience in an opening plenary at the 17th European Headache Congress in Barcelona. “But it’s important to distinguish between medication overuse, which is a behavior, and medication overuse headache, which is a distinct secondary order condition.”

Medication overuse headache is characterized by an increasing headache frequency and progressive use of short-term medication and is recognized as a major factor in the shift from episodic to chronic headache.

It is often underrecognized; however, educating doctors and patients is a crucial element of effective treatment. Recognition that headache medication is being overused is a crucial first step to treatment, followed by advising the patient to discontinue the medication. But this poses its own problems, as it can cause withdrawal symptoms.

According to a longitudinal population-based study published in 2008, most patients overuse acetaminophen or paracetamol, followed by nonsteroidal anti-inflammatory drugs and 5-hydroxytriptamine agonists (triptans) and, in the United States, barbiturates and opioids.
 

What’s the Best Treatment Strategy?

Medication overuse headache is often treated by complete withdrawal from medication, but the withdrawal symptoms can be severe. They include nausea and vomiting, arterial hypertension, tachycardia, sleep disturbances, anxiety, and restlessness, with their duration and severity depending solely on the type of headache medication that has been overused.

There is, however, no consensus on how best to treat medication overuse headache — withdrawal plus preventive treatment, preventive treatment without withdrawal, and withdrawal with optional preventive treatment 2 months after withdrawal. The findings showed that all three strategies were effective. But the research team concluded that withdrawal combined with preventive medication from the start of withdrawal was the recommended approach.

The electronic headache diary has proved to be very useful, as it can aid accurate diagnosis by providing clear insights into a patient’s condition. Information from the diary is more reliable than self-reports because patients often underestimate the frequency of their headaches, migraines, and use of medication.

Patients who are treated for medication overuse headache tend to have a high relapse rate. So, the electronic headache diary can also be very useful for follow-up by alerting patients and clinicians when headaches and medication overuse are increasing again.

“After diagnosing medication overuse or medication overuse headache, we advise our patients to discontinue the medication,” said Judith Pijpers of Leiden University Medical School, the Netherlands. “This provides clinically relevant improvements in headache frequency in a majority of patients and a significant reduction in headache days.”

In 2019, Dr. Pijpers and her colleagues published the results of a double-blind randomized controlled trial showing that botulinum toxin A, which is widely used to treat chronic migraine, has no additional benefit over acute withdrawal in patients with chronic migraine and medication overuse.

“We saw no difference between the groups during both the double-blind and the open label phase,” said Dr. Pijpers. “And that is why we do not give patients botulinum toxin A during withdrawal.”

A further trial within the botox study showed modest benefits for behavioral intervention by a headache nurse comprising education, motivational interviewing, and value-based activity planning during withdrawal therapy.

Patients can be stratified to some extent based on the type of headache they have and the medication they are taking for it.

“You can predict [a patient’s response] to some extent from the type of medication they overuse and the type of underlying primary headache,” Dr. Pijpers said in an interview.

“Those with underlying tension-type headache have different withdrawal symptoms than those with underlying migraine, and the withdrawal symptoms tend to be somewhat shorter if a patient overuses triptans compared to analgesics.”
 

Predicting Patients’ Responses to Migraine Medication

Dr. Pijpers and her colleagues recently published the results of a cohort study suggesting that cutaneous allodynia may predict how patients with migraine respond to withdrawal therapy. Nearly 75% of the 173 patients enrolled in the study reported experiencing allodynia — pain caused by a stimulus that does not normally cause pain. The study showed that absence of allodynia was predictive of a good outcome for patients after withdrawal therapy and of reversion from chronic to episodic migraine.

The ability to accurately predict patients’ responses could pave the way for personalized treatments of medication overuse headache.
 

A version of this article appeared in Medscape.com.

Results of the PROSPECT trial provide compelling evidence that high-quality preoperative MRI in combination with postoperative analysis of pathologic features can identify a substantial subset of women with localized early breast cancer who could safely skip radiation therapy. 

Omitting radiation therapy after breast-conserving surgery in patients with no occult malignancy and favorable pathology led to a very low local recurrence rate (1%) at 5 years, reported lead investigator Gregory Bruce Mann, MBBS, PhD, of The Royal Women’s Hospital, Melbourne, Australia, at the San Antonio Breast Cancer Symposium (abstract PS02-03). 

Additionally, women who skipped radiation had superior health-related quality of life relative to peers who underwent the treatment and, quite unexpectedly, their fear of cancer recurrence was “dramatically reduced,” Dr, Mann said in an interview.

“The hypothesis was that less treatment [would] lead to more fear of cancer recurrence” because patients would worry that they hadn’t received standard treatment, “but patients who omitted RT actually had less fear of cancer recurrence,” he said. 

This may come down to positive perceptions about tailored care and trust, he explained. “If the patient got the impression that the doctor wasn’t worried about recurrence, then the patient wasn’t worried. If they trusted you and you had that relationship with the patient, they were less likely to experience a fear of recurrence.” 

Results of the PROSPECT trial were published online on December 5 in The Lancet. 

PROSPECT was a prospective, nonrandomized study that evaluated whether preoperative bilateral contrast-enhanced 3-Tesla breast MRI and postoperative tumor pathology could identify patients with “truly localized” disease who might feasibly skip radiation therapy after breast-conserving surgery.

The researchers hypothesised that radiation therapy reduces local recurrence risk by treating occult synchronous disease that has not been identified by conventional imaging techniques. Exclusion of such occult disease using preoperative MRI, in association with low-risk pathology, could define a group of patients with early breast cancer in whom radiation can be omitted without substantially compromising local recurrence rates. 

Women aged 50 years or older with cT1N0 non–triple-negative breast cancer were eligible for the trial. Among 443 patients, preoperative MRI detected 61 malignant occult lesions separate from the index cancer in 48 patients (11%) of the total cohort. 

Patients with apparently unifocal cancer had breast-conserving surgery and, if pT1N0 or N1mi, did not undergo radiation therapy (group 1: 201 women). Standard treatment including radiation therapy was offered to the others (group 2: 242 women). All women were recommended for systemic therapy. The primary endpoint was the ipsilateral invasive recurrence rate at 5 years, with follow-up to continue to 10 years. 

At a median follow-up of 5.4 years, the ipsilateral invasive recurrence rate in group 1 was exceedingly low — just 1.0% (upper 95% CI, 5.4%) — with one local recurrence at 4.5 years and a second at 7.5 years. In group 2, local recurrence at 5 years was also low, at 1.7% (upper 95% CI, 6.1%). 

The only case of distant metastasis in the entire cohort was genetically distinct from the index cancer.

Omitting radiation therapy led to better health-related quality of life and functional and cosmetic outcomes, and the women viewed not having radiation as highly acceptable and appropriate treatment, not undertreatment.

PROSPECT has defined a role for “very high quality” preoperative MRI in identifying patients who can be considered for deintensified treatment, Dr. Mann said. 

The findings need to be replicated in multicenter, international trials, “and that’s what we are working on,” he added.

 

Risk Tolerance and Personal Preferences

Writing in a comment for The Lancet, Lior Z. Braunstein, MD, with Memorial Sloan Kettering Cancer Center in New York, says that overall, PROSPECT and comparable trials of radiation therapy omission, “rather than setting uniform clinical practice, will empower patients to delineate their individual risk tolerance and personal preferences.”

He notes, however, that “the use of preoperative MRI among patients at low risk remains somewhat controversial. Indeed, the MRI intervention in PROSPECT was not entirely benign, prompting nearly 200 biopsies and five of the nine observed mastectomies.”

Dr. Braunstein concludes that with numerous approaches to risk profiling, “informed patients might very reasonably choose differing paths. Indeed, it is precisely this individualized approach to breast cancer management that has long been the promise of personalized medicine — PROSPECT adds laudably to that tradition.”

Funding for the trial was provided by Breast Cancer Trials, National Breast Cancer Foundation, Cancer Council Victoria, the Royal Melbourne Hospital Foundation, and the Breast Cancer Research Foundation. Dr. Mann and Dr. Braunstein have no relevant disclosures.Megan Brooks has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Results of the PROSPECT trial provide compelling evidence that high-quality preoperative MRI in combination with postoperative analysis of pathologic features can identify a substantial subset of women with localized early breast cancer who could safely skip radiation therapy. 

Omitting radiation therapy after breast-conserving surgery in patients with no occult malignancy and favorable pathology led to a very low local recurrence rate (1%) at 5 years, reported lead investigator Gregory Bruce Mann, MBBS, PhD, of The Royal Women’s Hospital, Melbourne, Australia, at the San Antonio Breast Cancer Symposium (abstract PS02-03). 

Additionally, women who skipped radiation had superior health-related quality of life relative to peers who underwent the treatment and, quite unexpectedly, their fear of cancer recurrence was “dramatically reduced,” Dr, Mann said in an interview.

“The hypothesis was that less treatment [would] lead to more fear of cancer recurrence” because patients would worry that they hadn’t received standard treatment, “but patients who omitted RT actually had less fear of cancer recurrence,” he said. 

This may come down to positive perceptions about tailored care and trust, he explained. “If the patient got the impression that the doctor wasn’t worried about recurrence, then the patient wasn’t worried. If they trusted you and you had that relationship with the patient, they were less likely to experience a fear of recurrence.” 

Results of the PROSPECT trial were published online on December 5 in The Lancet. 

PROSPECT was a prospective, nonrandomized study that evaluated whether preoperative bilateral contrast-enhanced 3-Tesla breast MRI and postoperative tumor pathology could identify patients with “truly localized” disease who might feasibly skip radiation therapy after breast-conserving surgery.

The researchers hypothesised that radiation therapy reduces local recurrence risk by treating occult synchronous disease that has not been identified by conventional imaging techniques. Exclusion of such occult disease using preoperative MRI, in association with low-risk pathology, could define a group of patients with early breast cancer in whom radiation can be omitted without substantially compromising local recurrence rates. 

Women aged 50 years or older with cT1N0 non–triple-negative breast cancer were eligible for the trial. Among 443 patients, preoperative MRI detected 61 malignant occult lesions separate from the index cancer in 48 patients (11%) of the total cohort. 

Patients with apparently unifocal cancer had breast-conserving surgery and, if pT1N0 or N1mi, did not undergo radiation therapy (group 1: 201 women). Standard treatment including radiation therapy was offered to the others (group 2: 242 women). All women were recommended for systemic therapy. The primary endpoint was the ipsilateral invasive recurrence rate at 5 years, with follow-up to continue to 10 years. 

At a median follow-up of 5.4 years, the ipsilateral invasive recurrence rate in group 1 was exceedingly low — just 1.0% (upper 95% CI, 5.4%) — with one local recurrence at 4.5 years and a second at 7.5 years. In group 2, local recurrence at 5 years was also low, at 1.7% (upper 95% CI, 6.1%). 

The only case of distant metastasis in the entire cohort was genetically distinct from the index cancer.

Omitting radiation therapy led to better health-related quality of life and functional and cosmetic outcomes, and the women viewed not having radiation as highly acceptable and appropriate treatment, not undertreatment.

PROSPECT has defined a role for “very high quality” preoperative MRI in identifying patients who can be considered for deintensified treatment, Dr. Mann said. 

The findings need to be replicated in multicenter, international trials, “and that’s what we are working on,” he added.

 

Risk Tolerance and Personal Preferences

Writing in a comment for The Lancet, Lior Z. Braunstein, MD, with Memorial Sloan Kettering Cancer Center in New York, says that overall, PROSPECT and comparable trials of radiation therapy omission, “rather than setting uniform clinical practice, will empower patients to delineate their individual risk tolerance and personal preferences.”

He notes, however, that “the use of preoperative MRI among patients at low risk remains somewhat controversial. Indeed, the MRI intervention in PROSPECT was not entirely benign, prompting nearly 200 biopsies and five of the nine observed mastectomies.”

Dr. Braunstein concludes that with numerous approaches to risk profiling, “informed patients might very reasonably choose differing paths. Indeed, it is precisely this individualized approach to breast cancer management that has long been the promise of personalized medicine — PROSPECT adds laudably to that tradition.”

Funding for the trial was provided by Breast Cancer Trials, National Breast Cancer Foundation, Cancer Council Victoria, the Royal Melbourne Hospital Foundation, and the Breast Cancer Research Foundation. Dr. Mann and Dr. Braunstein have no relevant disclosures.Megan Brooks has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Results of the PROSPECT trial provide compelling evidence that high-quality preoperative MRI in combination with postoperative analysis of pathologic features can identify a substantial subset of women with localized early breast cancer who could safely skip radiation therapy. 

Omitting radiation therapy after breast-conserving surgery in patients with no occult malignancy and favorable pathology led to a very low local recurrence rate (1%) at 5 years, reported lead investigator Gregory Bruce Mann, MBBS, PhD, of The Royal Women’s Hospital, Melbourne, Australia, at the San Antonio Breast Cancer Symposium (abstract PS02-03). 

Additionally, women who skipped radiation had superior health-related quality of life relative to peers who underwent the treatment and, quite unexpectedly, their fear of cancer recurrence was “dramatically reduced,” Dr, Mann said in an interview.

“The hypothesis was that less treatment [would] lead to more fear of cancer recurrence” because patients would worry that they hadn’t received standard treatment, “but patients who omitted RT actually had less fear of cancer recurrence,” he said. 

This may come down to positive perceptions about tailored care and trust, he explained. “If the patient got the impression that the doctor wasn’t worried about recurrence, then the patient wasn’t worried. If they trusted you and you had that relationship with the patient, they were less likely to experience a fear of recurrence.” 

Results of the PROSPECT trial were published online on December 5 in The Lancet. 

PROSPECT was a prospective, nonrandomized study that evaluated whether preoperative bilateral contrast-enhanced 3-Tesla breast MRI and postoperative tumor pathology could identify patients with “truly localized” disease who might feasibly skip radiation therapy after breast-conserving surgery.

The researchers hypothesised that radiation therapy reduces local recurrence risk by treating occult synchronous disease that has not been identified by conventional imaging techniques. Exclusion of such occult disease using preoperative MRI, in association with low-risk pathology, could define a group of patients with early breast cancer in whom radiation can be omitted without substantially compromising local recurrence rates. 

Women aged 50 years or older with cT1N0 non–triple-negative breast cancer were eligible for the trial. Among 443 patients, preoperative MRI detected 61 malignant occult lesions separate from the index cancer in 48 patients (11%) of the total cohort. 

Patients with apparently unifocal cancer had breast-conserving surgery and, if pT1N0 or N1mi, did not undergo radiation therapy (group 1: 201 women). Standard treatment including radiation therapy was offered to the others (group 2: 242 women). All women were recommended for systemic therapy. The primary endpoint was the ipsilateral invasive recurrence rate at 5 years, with follow-up to continue to 10 years. 

At a median follow-up of 5.4 years, the ipsilateral invasive recurrence rate in group 1 was exceedingly low — just 1.0% (upper 95% CI, 5.4%) — with one local recurrence at 4.5 years and a second at 7.5 years. In group 2, local recurrence at 5 years was also low, at 1.7% (upper 95% CI, 6.1%). 

The only case of distant metastasis in the entire cohort was genetically distinct from the index cancer.

Omitting radiation therapy led to better health-related quality of life and functional and cosmetic outcomes, and the women viewed not having radiation as highly acceptable and appropriate treatment, not undertreatment.

PROSPECT has defined a role for “very high quality” preoperative MRI in identifying patients who can be considered for deintensified treatment, Dr. Mann said. 

The findings need to be replicated in multicenter, international trials, “and that’s what we are working on,” he added.

 

Risk Tolerance and Personal Preferences

Writing in a comment for The Lancet, Lior Z. Braunstein, MD, with Memorial Sloan Kettering Cancer Center in New York, says that overall, PROSPECT and comparable trials of radiation therapy omission, “rather than setting uniform clinical practice, will empower patients to delineate their individual risk tolerance and personal preferences.”

He notes, however, that “the use of preoperative MRI among patients at low risk remains somewhat controversial. Indeed, the MRI intervention in PROSPECT was not entirely benign, prompting nearly 200 biopsies and five of the nine observed mastectomies.”

Dr. Braunstein concludes that with numerous approaches to risk profiling, “informed patients might very reasonably choose differing paths. Indeed, it is precisely this individualized approach to breast cancer management that has long been the promise of personalized medicine — PROSPECT adds laudably to that tradition.”

Funding for the trial was provided by Breast Cancer Trials, National Breast Cancer Foundation, Cancer Council Victoria, the Royal Melbourne Hospital Foundation, and the Breast Cancer Research Foundation. Dr. Mann and Dr. Braunstein have no relevant disclosures.Megan Brooks has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

After years of declining vaccination coverage worldwide, measles deaths increased by 43% in 2022, compared with 2021. The number of total reported cases rose by 18% over the same period, accounting for approximately 9 million cases and 136,000 deaths globally, mostly among children. This information comes from a new report by the World Health Organization (WHO), published in partnership with the US Centers for Disease Control and Prevention (CDC).

More Measles Outbreaks

The report also notes an increase in the number of countries experiencing significant measles outbreaks. There were 37 such countries in 2022, compared with 22 the previous year. The most affected continents were Africa and Asia.

“The rise in measles outbreaks and deaths is impressive but, unfortunately, not surprising, given the decline in vaccination rates in recent years,” said John Vertefeuille, PhD, director of the CDC’s Global Immunization Division.

Vertefeuille emphasized that measles cases anywhere in the world pose a risk to “countries and communities where people are undervaccinated.” In recent years, several regions have fallen short of their immunization targets.

Vaccination Trends

In 2022, there was a slight increase in measles vaccination after a decline exacerbated by the COVID-19 pandemic and its impact on global healthcare systems. However, 33 million children did not receive at least one dose of the vaccine last year: 22 million missed the first dose, and 11 million missed the second.

For communities to be considered protected against outbreaks, immunization coverage with the full vaccine cycle should be at least 95%. The global coverage rate for the first dose was 83%, and for the second, it was 74%.

Nevertheless, immunization recovery has not reached the poorest countries, where the immunization rate stands at 66%. Brazil is among the top 10 countries where more children missed the first dose in 2022. These nations account for over half of the 22 million unadministered vaccines. According to the report, half a million children did not receive the vaccine in Brazil.

Measles in Brazil

Brazil’s results highlight setbacks in vaccination efforts. In 2016, the country was certified to have eliminated measles, but after experiencing outbreaks in 2018, the certification was lost in 2019. In 2018, Brazil confirmed 9325 cases. The situation worsened in 2019 with 20,901 diagnoses. Since then, numbers have been decreasing: 8100 in 2020, 676 in 2021, and 44 in 2022.

Last year, four Brazilian states reported confirmed virus cases: Rio de Janeiro, Pará, São Paulo, and Amapá. Ministry of Health data indicated no confirmed measles cases in Brazil as of June 15, 2023.

Vaccination in Brazil

Vaccination coverage in Brazil, which once reached 95%, has sharply declined in recent years. The rate of patients receiving the full immunization scheme was 59% in 2021.

Globally, although the COVID-19 pandemic affected measles vaccination, measures like social isolation and mask use potentially contributed to reducing measles cases. The incidence of the disease decreased in 2020 and 2021 but is now rising again.

“From 2021 to 2022, reported measles cases increased by 67% worldwide, and the number of countries experiencing large or disruptive outbreaks increased by 68%,” the report stated.

Because of these data, the WHO and the CDC urge increased efforts for vaccination, along with improvements in epidemiological surveillance systems, especially in developing nations. “Children everywhere have the right to be protected by the lifesaving measles vaccine, no matter where they live,” said Kate O’Brien, MD, director of immunization, vaccines, and biologicals at the WHO.

“Measles is called the virus of inequality for a good reason. It is the disease that will find and attack those who are not protected.”
 

This article was translated from the Medscape Portuguese edition.

After years of declining vaccination coverage worldwide, measles deaths increased by 43% in 2022, compared with 2021. The number of total reported cases rose by 18% over the same period, accounting for approximately 9 million cases and 136,000 deaths globally, mostly among children. This information comes from a new report by the World Health Organization (WHO), published in partnership with the US Centers for Disease Control and Prevention (CDC).

More Measles Outbreaks

The report also notes an increase in the number of countries experiencing significant measles outbreaks. There were 37 such countries in 2022, compared with 22 the previous year. The most affected continents were Africa and Asia.

“The rise in measles outbreaks and deaths is impressive but, unfortunately, not surprising, given the decline in vaccination rates in recent years,” said John Vertefeuille, PhD, director of the CDC’s Global Immunization Division.

Vertefeuille emphasized that measles cases anywhere in the world pose a risk to “countries and communities where people are undervaccinated.” In recent years, several regions have fallen short of their immunization targets.

Vaccination Trends

In 2022, there was a slight increase in measles vaccination after a decline exacerbated by the COVID-19 pandemic and its impact on global healthcare systems. However, 33 million children did not receive at least one dose of the vaccine last year: 22 million missed the first dose, and 11 million missed the second.

For communities to be considered protected against outbreaks, immunization coverage with the full vaccine cycle should be at least 95%. The global coverage rate for the first dose was 83%, and for the second, it was 74%.

Nevertheless, immunization recovery has not reached the poorest countries, where the immunization rate stands at 66%. Brazil is among the top 10 countries where more children missed the first dose in 2022. These nations account for over half of the 22 million unadministered vaccines. According to the report, half a million children did not receive the vaccine in Brazil.

Measles in Brazil

Brazil’s results highlight setbacks in vaccination efforts. In 2016, the country was certified to have eliminated measles, but after experiencing outbreaks in 2018, the certification was lost in 2019. In 2018, Brazil confirmed 9325 cases. The situation worsened in 2019 with 20,901 diagnoses. Since then, numbers have been decreasing: 8100 in 2020, 676 in 2021, and 44 in 2022.

Last year, four Brazilian states reported confirmed virus cases: Rio de Janeiro, Pará, São Paulo, and Amapá. Ministry of Health data indicated no confirmed measles cases in Brazil as of June 15, 2023.

Vaccination in Brazil

Vaccination coverage in Brazil, which once reached 95%, has sharply declined in recent years. The rate of patients receiving the full immunization scheme was 59% in 2021.

Globally, although the COVID-19 pandemic affected measles vaccination, measures like social isolation and mask use potentially contributed to reducing measles cases. The incidence of the disease decreased in 2020 and 2021 but is now rising again.

“From 2021 to 2022, reported measles cases increased by 67% worldwide, and the number of countries experiencing large or disruptive outbreaks increased by 68%,” the report stated.

Because of these data, the WHO and the CDC urge increased efforts for vaccination, along with improvements in epidemiological surveillance systems, especially in developing nations. “Children everywhere have the right to be protected by the lifesaving measles vaccine, no matter where they live,” said Kate O’Brien, MD, director of immunization, vaccines, and biologicals at the WHO.

“Measles is called the virus of inequality for a good reason. It is the disease that will find and attack those who are not protected.”
 

This article was translated from the Medscape Portuguese edition.

After years of declining vaccination coverage worldwide, measles deaths increased by 43% in 2022, compared with 2021. The number of total reported cases rose by 18% over the same period, accounting for approximately 9 million cases and 136,000 deaths globally, mostly among children. This information comes from a new report by the World Health Organization (WHO), published in partnership with the US Centers for Disease Control and Prevention (CDC).

More Measles Outbreaks

The report also notes an increase in the number of countries experiencing significant measles outbreaks. There were 37 such countries in 2022, compared with 22 the previous year. The most affected continents were Africa and Asia.

“The rise in measles outbreaks and deaths is impressive but, unfortunately, not surprising, given the decline in vaccination rates in recent years,” said John Vertefeuille, PhD, director of the CDC’s Global Immunization Division.

Vertefeuille emphasized that measles cases anywhere in the world pose a risk to “countries and communities where people are undervaccinated.” In recent years, several regions have fallen short of their immunization targets.

Vaccination Trends

In 2022, there was a slight increase in measles vaccination after a decline exacerbated by the COVID-19 pandemic and its impact on global healthcare systems. However, 33 million children did not receive at least one dose of the vaccine last year: 22 million missed the first dose, and 11 million missed the second.

For communities to be considered protected against outbreaks, immunization coverage with the full vaccine cycle should be at least 95%. The global coverage rate for the first dose was 83%, and for the second, it was 74%.

Nevertheless, immunization recovery has not reached the poorest countries, where the immunization rate stands at 66%. Brazil is among the top 10 countries where more children missed the first dose in 2022. These nations account for over half of the 22 million unadministered vaccines. According to the report, half a million children did not receive the vaccine in Brazil.

Measles in Brazil

Brazil’s results highlight setbacks in vaccination efforts. In 2016, the country was certified to have eliminated measles, but after experiencing outbreaks in 2018, the certification was lost in 2019. In 2018, Brazil confirmed 9325 cases. The situation worsened in 2019 with 20,901 diagnoses. Since then, numbers have been decreasing: 8100 in 2020, 676 in 2021, and 44 in 2022.

Last year, four Brazilian states reported confirmed virus cases: Rio de Janeiro, Pará, São Paulo, and Amapá. Ministry of Health data indicated no confirmed measles cases in Brazil as of June 15, 2023.

Vaccination in Brazil

Vaccination coverage in Brazil, which once reached 95%, has sharply declined in recent years. The rate of patients receiving the full immunization scheme was 59% in 2021.

Globally, although the COVID-19 pandemic affected measles vaccination, measures like social isolation and mask use potentially contributed to reducing measles cases. The incidence of the disease decreased in 2020 and 2021 but is now rising again.

“From 2021 to 2022, reported measles cases increased by 67% worldwide, and the number of countries experiencing large or disruptive outbreaks increased by 68%,” the report stated.

Because of these data, the WHO and the CDC urge increased efforts for vaccination, along with improvements in epidemiological surveillance systems, especially in developing nations. “Children everywhere have the right to be protected by the lifesaving measles vaccine, no matter where they live,” said Kate O’Brien, MD, director of immunization, vaccines, and biologicals at the WHO.

“Measles is called the virus of inequality for a good reason. It is the disease that will find and attack those who are not protected.”
 

This article was translated from the Medscape Portuguese edition.

Combined therapy with rituximab and omalizumab appears to be well tolerated, and improves outcomes and accelerates time to remission in patients with refractory bullous pemphigoid who do not respond to rituximab alone, results of a case series suggest.

Bullous pemphigoid (BP) is a rare, chronic, inflammatory, blistering disease that mainly occurs in people in their 50s through their 70s. BP has high morbidity and mortality, especially in people with comorbidities common to the elderly, yet no Food and Drug Administration–approved therapies for BP exist, Stephanie T. Le, MD, a dermatologist in the department of dermatology of the University of California, Davis, told this publication.

May Iosotaluno

All participants received 1000 mg intravenous rituximab on days 0 and 15. In addition to rituximab, seven patients received subcutaneous high-dose omalizumab (300 mg every 2 weeks); and three patients received low-dose omalizumab (300 mg every 4 weeks or 150 mg every 2 weeks).

After a mean of 2.1 months, all patients in the high-dose omalizumab-plus-rituximab group had achieved complete remission. By contrast, all patients in the low-dose omalizumab-plus-rituximab group improved after a mean of 13 months, and none achieved complete remission.

At 3 months, all study participants were rated as being very much improved. All four patients in the high-dose omalizumab group who tapered omalizumab dosage or frequency had flare-ups within 1-3 months that resolved when they restarted the medication. Among patients who achieved complete remission, 4 of 7 required rituximab redosing between 6 and 16 months later. Rituximab alone did not achieve remission: Three patients needed to add high-dose omalizumab. All reported adverse effects were mild.

Alternatives to Corticosteroids Are Needed

For BP, “with no FDA-approved therapies available, corticosteroids remain first line for acute flares. However, prolonged corticosteroid use is associated with multiple adverse effects, including increased susceptibility to infection, osteoporosis, and diabetes mellitus,” Dr. Le pointed out. “Patients with BP who are treated with high-dose corticosteroids have significantly increased mortality and have very poor 1-year survival.

“Rituximab and omalizumab dual therapy offers another potential treatment option for severe or treatment-refractory BP,” she added. “We are hopeful that other physicians will adopt this therapy.”

The authors acknowledged limitations of the study, including its retrospective design, small sample size, lack of standardized intervals between rituximab and omalizumab, and variation in concurrent therapies, and they recommended further related research.

No conflicts of interest were reported. No funding details were provided.

Combined therapy with rituximab and omalizumab appears to be well tolerated, and improves outcomes and accelerates time to remission in patients with refractory bullous pemphigoid who do not respond to rituximab alone, results of a case series suggest.

Bullous pemphigoid (BP) is a rare, chronic, inflammatory, blistering disease that mainly occurs in people in their 50s through their 70s. BP has high morbidity and mortality, especially in people with comorbidities common to the elderly, yet no Food and Drug Administration–approved therapies for BP exist, Stephanie T. Le, MD, a dermatologist in the department of dermatology of the University of California, Davis, told this publication.

May Iosotaluno

All participants received 1000 mg intravenous rituximab on days 0 and 15. In addition to rituximab, seven patients received subcutaneous high-dose omalizumab (300 mg every 2 weeks); and three patients received low-dose omalizumab (300 mg every 4 weeks or 150 mg every 2 weeks).

After a mean of 2.1 months, all patients in the high-dose omalizumab-plus-rituximab group had achieved complete remission. By contrast, all patients in the low-dose omalizumab-plus-rituximab group improved after a mean of 13 months, and none achieved complete remission.

At 3 months, all study participants were rated as being very much improved. All four patients in the high-dose omalizumab group who tapered omalizumab dosage or frequency had flare-ups within 1-3 months that resolved when they restarted the medication. Among patients who achieved complete remission, 4 of 7 required rituximab redosing between 6 and 16 months later. Rituximab alone did not achieve remission: Three patients needed to add high-dose omalizumab. All reported adverse effects were mild.

Alternatives to Corticosteroids Are Needed

For BP, “with no FDA-approved therapies available, corticosteroids remain first line for acute flares. However, prolonged corticosteroid use is associated with multiple adverse effects, including increased susceptibility to infection, osteoporosis, and diabetes mellitus,” Dr. Le pointed out. “Patients with BP who are treated with high-dose corticosteroids have significantly increased mortality and have very poor 1-year survival.

“Rituximab and omalizumab dual therapy offers another potential treatment option for severe or treatment-refractory BP,” she added. “We are hopeful that other physicians will adopt this therapy.”

The authors acknowledged limitations of the study, including its retrospective design, small sample size, lack of standardized intervals between rituximab and omalizumab, and variation in concurrent therapies, and they recommended further related research.

No conflicts of interest were reported. No funding details were provided.

Combined therapy with rituximab and omalizumab appears to be well tolerated, and improves outcomes and accelerates time to remission in patients with refractory bullous pemphigoid who do not respond to rituximab alone, results of a case series suggest.

Bullous pemphigoid (BP) is a rare, chronic, inflammatory, blistering disease that mainly occurs in people in their 50s through their 70s. BP has high morbidity and mortality, especially in people with comorbidities common to the elderly, yet no Food and Drug Administration–approved therapies for BP exist, Stephanie T. Le, MD, a dermatologist in the department of dermatology of the University of California, Davis, told this publication.

May Iosotaluno

All participants received 1000 mg intravenous rituximab on days 0 and 15. In addition to rituximab, seven patients received subcutaneous high-dose omalizumab (300 mg every 2 weeks); and three patients received low-dose omalizumab (300 mg every 4 weeks or 150 mg every 2 weeks).

After a mean of 2.1 months, all patients in the high-dose omalizumab-plus-rituximab group had achieved complete remission. By contrast, all patients in the low-dose omalizumab-plus-rituximab group improved after a mean of 13 months, and none achieved complete remission.

At 3 months, all study participants were rated as being very much improved. All four patients in the high-dose omalizumab group who tapered omalizumab dosage or frequency had flare-ups within 1-3 months that resolved when they restarted the medication. Among patients who achieved complete remission, 4 of 7 required rituximab redosing between 6 and 16 months later. Rituximab alone did not achieve remission: Three patients needed to add high-dose omalizumab. All reported adverse effects were mild.

Alternatives to Corticosteroids Are Needed

For BP, “with no FDA-approved therapies available, corticosteroids remain first line for acute flares. However, prolonged corticosteroid use is associated with multiple adverse effects, including increased susceptibility to infection, osteoporosis, and diabetes mellitus,” Dr. Le pointed out. “Patients with BP who are treated with high-dose corticosteroids have significantly increased mortality and have very poor 1-year survival.

“Rituximab and omalizumab dual therapy offers another potential treatment option for severe or treatment-refractory BP,” she added. “We are hopeful that other physicians will adopt this therapy.”

The authors acknowledged limitations of the study, including its retrospective design, small sample size, lack of standardized intervals between rituximab and omalizumab, and variation in concurrent therapies, and they recommended further related research.

No conflicts of interest were reported. No funding details were provided.

TOPLINE:

A 12-week low-fat vegan diet with soybeans led to significant changes in the gut microbiome that correlated with significant reductions in vasomotor symptoms in postmenopausal women.

METHODOLOGY:

• For this exploratory analysis, postmenopausal women with two or more moderate to severe hot flashes daily were randomly assigned in two successive cohorts to consume a low-fat vegan diet with cooked soybeans or their usual diet.
• Over a 12-week period, frequency and severity of hot flashes were recorded on a mobile application.
• Researchers used deep shotgun metagenomic sequencing to analyze the gut microbiome at baseline and 12 weeks in a subset of 11 women in the dietary intervention group.

TAKEAWAY:

• In the subset receiving microbiome analysis, total hot flashes decreased by 95%, moderate to severe hot flashes decreased by 96%, and severe hot flashes disappeared during the dietary intervention.
• The relative abundance of Porphyromonas and Prevotella corporis decreased in participants on the diet intervention, and this correlated with a reduction in severe daytime hot flashes.
• The relative abundance of Clostridium asparagiforme also decreased in participants on the low-fat vegan diet, and this change correlated with a reduction in total severe and severe nighttime hot flashes.
• However, after correction for multiple comparisons, these associations were no longer significant.

IN PRACTICE:

“The targeted and untargeted gut microbiome analysis was robust and revealed important changes in the gut microbiome composition in response to a low-fat vegan diet and large correlations with symptomatic changes,” the authors write. “Larger randomized clinical trials are needed to further investigate these findings.”

SOURCE:

The study, with first author Hana Kahleova, MD, PhD, with the Physicians Committee for Responsible Medicine, in Washington, DC, was published online  November 8 in Complementary Therapies in Medicine.

LIMITATIONS:

The gut microbiome analysis was only performed in a small subset of women on the diet intervention, with no control group. Although strong associations were noted between several gut bacteria and changes in hot flash frequency, and nominally statistically significant relative abundance changes were observed, robust statistical significance cannot be concluded for any of the reported gut microbiome assessments when the modestly large number of total comparisons is taken into account.

DISCLOSURES:

The study was funded by the Physicians Committee for Responsible Medicine. The authors report no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A 12-week low-fat vegan diet with soybeans led to significant changes in the gut microbiome that correlated with significant reductions in vasomotor symptoms in postmenopausal women.

METHODOLOGY:

• For this exploratory analysis, postmenopausal women with two or more moderate to severe hot flashes daily were randomly assigned in two successive cohorts to consume a low-fat vegan diet with cooked soybeans or their usual diet.
• Over a 12-week period, frequency and severity of hot flashes were recorded on a mobile application.
• Researchers used deep shotgun metagenomic sequencing to analyze the gut microbiome at baseline and 12 weeks in a subset of 11 women in the dietary intervention group.

TAKEAWAY:

• In the subset receiving microbiome analysis, total hot flashes decreased by 95%, moderate to severe hot flashes decreased by 96%, and severe hot flashes disappeared during the dietary intervention.
• The relative abundance of Porphyromonas and Prevotella corporis decreased in participants on the diet intervention, and this correlated with a reduction in severe daytime hot flashes.
• The relative abundance of Clostridium asparagiforme also decreased in participants on the low-fat vegan diet, and this change correlated with a reduction in total severe and severe nighttime hot flashes.
• However, after correction for multiple comparisons, these associations were no longer significant.

IN PRACTICE:

“The targeted and untargeted gut microbiome analysis was robust and revealed important changes in the gut microbiome composition in response to a low-fat vegan diet and large correlations with symptomatic changes,” the authors write. “Larger randomized clinical trials are needed to further investigate these findings.”

SOURCE:

The study, with first author Hana Kahleova, MD, PhD, with the Physicians Committee for Responsible Medicine, in Washington, DC, was published online  November 8 in Complementary Therapies in Medicine.

LIMITATIONS:

The gut microbiome analysis was only performed in a small subset of women on the diet intervention, with no control group. Although strong associations were noted between several gut bacteria and changes in hot flash frequency, and nominally statistically significant relative abundance changes were observed, robust statistical significance cannot be concluded for any of the reported gut microbiome assessments when the modestly large number of total comparisons is taken into account.

DISCLOSURES:

The study was funded by the Physicians Committee for Responsible Medicine. The authors report no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A 12-week low-fat vegan diet with soybeans led to significant changes in the gut microbiome that correlated with significant reductions in vasomotor symptoms in postmenopausal women.

METHODOLOGY:

• For this exploratory analysis, postmenopausal women with two or more moderate to severe hot flashes daily were randomly assigned in two successive cohorts to consume a low-fat vegan diet with cooked soybeans or their usual diet.
• Over a 12-week period, frequency and severity of hot flashes were recorded on a mobile application.
• Researchers used deep shotgun metagenomic sequencing to analyze the gut microbiome at baseline and 12 weeks in a subset of 11 women in the dietary intervention group.

TAKEAWAY:

• In the subset receiving microbiome analysis, total hot flashes decreased by 95%, moderate to severe hot flashes decreased by 96%, and severe hot flashes disappeared during the dietary intervention.
• The relative abundance of Porphyromonas and Prevotella corporis decreased in participants on the diet intervention, and this correlated with a reduction in severe daytime hot flashes.
• The relative abundance of Clostridium asparagiforme also decreased in participants on the low-fat vegan diet, and this change correlated with a reduction in total severe and severe nighttime hot flashes.
• However, after correction for multiple comparisons, these associations were no longer significant.

IN PRACTICE:

“The targeted and untargeted gut microbiome analysis was robust and revealed important changes in the gut microbiome composition in response to a low-fat vegan diet and large correlations with symptomatic changes,” the authors write. “Larger randomized clinical trials are needed to further investigate these findings.”

SOURCE:

The study, with first author Hana Kahleova, MD, PhD, with the Physicians Committee for Responsible Medicine, in Washington, DC, was published online  November 8 in Complementary Therapies in Medicine.

LIMITATIONS:

The gut microbiome analysis was only performed in a small subset of women on the diet intervention, with no control group. Although strong associations were noted between several gut bacteria and changes in hot flash frequency, and nominally statistically significant relative abundance changes were observed, robust statistical significance cannot be concluded for any of the reported gut microbiome assessments when the modestly large number of total comparisons is taken into account.

DISCLOSURES:

The study was funded by the Physicians Committee for Responsible Medicine. The authors report no conflicts of interest.

A version of this article appeared on Medscape.com.

Follicular occlusion, mast cell disease, and eczema were common presentations among patients with hypermobile Ehlers-Danlos syndrome (hEDS), in a study of nearly 500 individuals.

The genetic cause of hEDS, a common inherited connective tissue disorder, remains unknown, wrote Alan Snyder, MD, of the department of dermatology and dermatologic surgery at Medical University of South Carolina, Charleston, and colleagues.

Previous research suggests that changes in dermal mechanics predispose these patients to a range of skin conditions including mast cell activation disorder (MCAD) spectrum and chronic spontaneous urticaria, abnormal scars or wound healing, piezogenic papules, dyshidrosis, skin laxity or softness, easy bruising, local anesthesia resistance, keratosis pilaris, striae, and hidradenitis suppurativa, the researchers wrote.

However, data on these and other dermatologic manifestations of hEDS are limited, they said.

The diagnosis of hEDS will continue to be made more frequently and carefully, as the condition becomes more recognized and understood in the medical community, especially with anticipated capabilities of genetic testing, Dr. Snyder said in an interview.

“Being able to be aware of disease-specific comorbidities, such as those discovered in this study, allows providers to better stratify phenotypes and improve patient disease co-management,” he said.

In the study, published in the Journal of the American Academy of Dermatology, the researchers reviewed data on 1,364 patients with ICD-10 or ICD-9 codes for hEDS or EDS unspecified who were seen at a single institution between June 2005 and May 2022. Most of the patients were White (95.4%) and female (86.7%); the average age was 29.2 years.

Of the 1,364 patients included in the chart review, 497 (36.4%) had documented skin manifestations. Of these, 118 (24.2%) had disorders of follicular occlusion (12 had hidradenitis suppurativa, 32 had folliculitis, and 74 had acne); 112 (23%) had eczema or atopic dermatitis, 98 (19.7%) had mast cell disorder, 32 (6.4%) had psoriasis, and 32 (6.4%) had wound healing issues (16 had hypertrophic keloids/scarring, 5 had abscesses, 3 had abnormal bruising, and 8 had other would healing issues).

The study also included results of a multiple-choice patient survey from 1,354 individuals. In the survey, approximately two-thirds of patients reported abnormal scarring, abnormal wound healing, and cutaneous laxity (61.7%, 69.0%, and 71.0%, respectively).

The findings were limited by several factors including the retrospective study design, lack of testing to confirm hEDS diagnosis, and the potential interdisciplinary selection bias for diagnoses, the authors noted.

However, the results support previous studies showing increased rates of occlusive conditions in hEDS and higher rates of acne, folliculitis, and psoriasis, and highlight the need for clinician education to manage patients and promote better outcomes, the researchers concluded.

Data Enhance Clinical Awareness

“Given the increasingly understood relation between TH2-directed and mast-cell mediated diseases and hEDS, it was not necessarily a surprise to find the increased prevalence of atopy and mast cell disease, but rather an interesting confirmation, within the limitations that exist with retrospective chart review,” Dr. Snyder told this news organization. “While it may make some intuitive sense that certain cohorts with higher risk of HS may have a higher risk of acne, this had not been reported in the literature to date,” he noted. “Given the high levels of patient reported issues with scarring and wound healing, I was surprised that so few analogous diagnoses were physician-reported in the medical records.”

In clinical practice, “health care professionals and patients need to be aware hEDS is associated with high rates of eczematous, mast-cell mediated and follicular occlusive cutaneous disorders,” Dr. Snyder said in an interview. “There seems to be a discrepancy between patients and physician awareness of scarring or wound healing issues in this patient population,” he added.

Looking ahead, “we need to better research and characterize the various hEDS phenotypes to understand who is at highest risk for various TH2-mediated or follicular occlusive disorders,” said Dr. Snyder. “Moreover, a greater understanding is needed of the wound healing inadequacies that predispose these patients to poor outcomes during dermatologic surgery,” he said.

The study was supported by the Ehlers-Danlos Society and the Milton and Tamar Maltz Family Foundation. The researchers had no financial conflicts to disclose.

Follicular occlusion, mast cell disease, and eczema were common presentations among patients with hypermobile Ehlers-Danlos syndrome (hEDS), in a study of nearly 500 individuals.

The genetic cause of hEDS, a common inherited connective tissue disorder, remains unknown, wrote Alan Snyder, MD, of the department of dermatology and dermatologic surgery at Medical University of South Carolina, Charleston, and colleagues.

Previous research suggests that changes in dermal mechanics predispose these patients to a range of skin conditions including mast cell activation disorder (MCAD) spectrum and chronic spontaneous urticaria, abnormal scars or wound healing, piezogenic papules, dyshidrosis, skin laxity or softness, easy bruising, local anesthesia resistance, keratosis pilaris, striae, and hidradenitis suppurativa, the researchers wrote.

However, data on these and other dermatologic manifestations of hEDS are limited, they said.

The diagnosis of hEDS will continue to be made more frequently and carefully, as the condition becomes more recognized and understood in the medical community, especially with anticipated capabilities of genetic testing, Dr. Snyder said in an interview.

“Being able to be aware of disease-specific comorbidities, such as those discovered in this study, allows providers to better stratify phenotypes and improve patient disease co-management,” he said.

In the study, published in the Journal of the American Academy of Dermatology, the researchers reviewed data on 1,364 patients with ICD-10 or ICD-9 codes for hEDS or EDS unspecified who were seen at a single institution between June 2005 and May 2022. Most of the patients were White (95.4%) and female (86.7%); the average age was 29.2 years.

Of the 1,364 patients included in the chart review, 497 (36.4%) had documented skin manifestations. Of these, 118 (24.2%) had disorders of follicular occlusion (12 had hidradenitis suppurativa, 32 had folliculitis, and 74 had acne); 112 (23%) had eczema or atopic dermatitis, 98 (19.7%) had mast cell disorder, 32 (6.4%) had psoriasis, and 32 (6.4%) had wound healing issues (16 had hypertrophic keloids/scarring, 5 had abscesses, 3 had abnormal bruising, and 8 had other would healing issues).

The study also included results of a multiple-choice patient survey from 1,354 individuals. In the survey, approximately two-thirds of patients reported abnormal scarring, abnormal wound healing, and cutaneous laxity (61.7%, 69.0%, and 71.0%, respectively).

The findings were limited by several factors including the retrospective study design, lack of testing to confirm hEDS diagnosis, and the potential interdisciplinary selection bias for diagnoses, the authors noted.

However, the results support previous studies showing increased rates of occlusive conditions in hEDS and higher rates of acne, folliculitis, and psoriasis, and highlight the need for clinician education to manage patients and promote better outcomes, the researchers concluded.

Data Enhance Clinical Awareness

“Given the increasingly understood relation between TH2-directed and mast-cell mediated diseases and hEDS, it was not necessarily a surprise to find the increased prevalence of atopy and mast cell disease, but rather an interesting confirmation, within the limitations that exist with retrospective chart review,” Dr. Snyder told this news organization. “While it may make some intuitive sense that certain cohorts with higher risk of HS may have a higher risk of acne, this had not been reported in the literature to date,” he noted. “Given the high levels of patient reported issues with scarring and wound healing, I was surprised that so few analogous diagnoses were physician-reported in the medical records.”

In clinical practice, “health care professionals and patients need to be aware hEDS is associated with high rates of eczematous, mast-cell mediated and follicular occlusive cutaneous disorders,” Dr. Snyder said in an interview. “There seems to be a discrepancy between patients and physician awareness of scarring or wound healing issues in this patient population,” he added.

Looking ahead, “we need to better research and characterize the various hEDS phenotypes to understand who is at highest risk for various TH2-mediated or follicular occlusive disorders,” said Dr. Snyder. “Moreover, a greater understanding is needed of the wound healing inadequacies that predispose these patients to poor outcomes during dermatologic surgery,” he said.

The study was supported by the Ehlers-Danlos Society and the Milton and Tamar Maltz Family Foundation. The researchers had no financial conflicts to disclose.

Follicular occlusion, mast cell disease, and eczema were common presentations among patients with hypermobile Ehlers-Danlos syndrome (hEDS), in a study of nearly 500 individuals.

The genetic cause of hEDS, a common inherited connective tissue disorder, remains unknown, wrote Alan Snyder, MD, of the department of dermatology and dermatologic surgery at Medical University of South Carolina, Charleston, and colleagues.

Previous research suggests that changes in dermal mechanics predispose these patients to a range of skin conditions including mast cell activation disorder (MCAD) spectrum and chronic spontaneous urticaria, abnormal scars or wound healing, piezogenic papules, dyshidrosis, skin laxity or softness, easy bruising, local anesthesia resistance, keratosis pilaris, striae, and hidradenitis suppurativa, the researchers wrote.

However, data on these and other dermatologic manifestations of hEDS are limited, they said.

The diagnosis of hEDS will continue to be made more frequently and carefully, as the condition becomes more recognized and understood in the medical community, especially with anticipated capabilities of genetic testing, Dr. Snyder said in an interview.

“Being able to be aware of disease-specific comorbidities, such as those discovered in this study, allows providers to better stratify phenotypes and improve patient disease co-management,” he said.

In the study, published in the Journal of the American Academy of Dermatology, the researchers reviewed data on 1,364 patients with ICD-10 or ICD-9 codes for hEDS or EDS unspecified who were seen at a single institution between June 2005 and May 2022. Most of the patients were White (95.4%) and female (86.7%); the average age was 29.2 years.

Of the 1,364 patients included in the chart review, 497 (36.4%) had documented skin manifestations. Of these, 118 (24.2%) had disorders of follicular occlusion (12 had hidradenitis suppurativa, 32 had folliculitis, and 74 had acne); 112 (23%) had eczema or atopic dermatitis, 98 (19.7%) had mast cell disorder, 32 (6.4%) had psoriasis, and 32 (6.4%) had wound healing issues (16 had hypertrophic keloids/scarring, 5 had abscesses, 3 had abnormal bruising, and 8 had other would healing issues).

The study also included results of a multiple-choice patient survey from 1,354 individuals. In the survey, approximately two-thirds of patients reported abnormal scarring, abnormal wound healing, and cutaneous laxity (61.7%, 69.0%, and 71.0%, respectively).

The findings were limited by several factors including the retrospective study design, lack of testing to confirm hEDS diagnosis, and the potential interdisciplinary selection bias for diagnoses, the authors noted.

However, the results support previous studies showing increased rates of occlusive conditions in hEDS and higher rates of acne, folliculitis, and psoriasis, and highlight the need for clinician education to manage patients and promote better outcomes, the researchers concluded.

Data Enhance Clinical Awareness

“Given the increasingly understood relation between TH2-directed and mast-cell mediated diseases and hEDS, it was not necessarily a surprise to find the increased prevalence of atopy and mast cell disease, but rather an interesting confirmation, within the limitations that exist with retrospective chart review,” Dr. Snyder told this news organization. “While it may make some intuitive sense that certain cohorts with higher risk of HS may have a higher risk of acne, this had not been reported in the literature to date,” he noted. “Given the high levels of patient reported issues with scarring and wound healing, I was surprised that so few analogous diagnoses were physician-reported in the medical records.”

In clinical practice, “health care professionals and patients need to be aware hEDS is associated with high rates of eczematous, mast-cell mediated and follicular occlusive cutaneous disorders,” Dr. Snyder said in an interview. “There seems to be a discrepancy between patients and physician awareness of scarring or wound healing issues in this patient population,” he added.

Looking ahead, “we need to better research and characterize the various hEDS phenotypes to understand who is at highest risk for various TH2-mediated or follicular occlusive disorders,” said Dr. Snyder. “Moreover, a greater understanding is needed of the wound healing inadequacies that predispose these patients to poor outcomes during dermatologic surgery,” he said.

The study was supported by the Ehlers-Danlos Society and the Milton and Tamar Maltz Family Foundation. The researchers had no financial conflicts to disclose.

Early ileocecal resection is associated with better long-term outcomes compared with anti–tumor necrosis factor (TNF) therapy for patients with Crohn’s disease (CD), based on new real-world evidence.

These findings add weight to previously reported data from the LIR!C trial, suggesting that ileocecal resection should be considered a first-line treatment option for CD, reported principal investigator Kristine H. Allin, MD, PhD, of Aalborg University, Copenhagen.

“The LIR!C randomized clinical trial has demonstrated comparable quality of life with ileocecal resection and infliximab as a first-line treatment for limited, nonstricturing ileocecal CD at 1 year of follow-up, and improved outcomes with ileocecal resection on retrospective analysis of long-term follow-up data,” the investigators wrote in Gastroenterology. “However, in the real world, the long-term impact of early ileocecal resection for CD, compared with medical therapy, remains largely unexplored.”

To gather these real-world data, the investigators turned to the Danish National Patient Registry and the Danish National Prescription Registry, which included 1,279 individuals diagnosed with CD between 2003 and 2018 who received anti-TNF therapy or underwent ileocecal resection within 1 year of diagnosis. Within this group, slightly less than half underwent ileocecal resection (45.4%) while the remainder (54.6%) received anti-TNF therapy.

The primary outcome was a composite of one or more events: perianal CD, CD-related surgery, systemic corticosteroid exposure, and CD-related hospitalization. Secondary analyses evaluated the relative risks of these same four events as independent entities.

Multifactor-adjusted Cox proportional hazards regression analysis revealed that patients who underwent ileocecal resection had a 33% lower risk of the composite outcome compared with those who received anti-TNF therapy (adjusted hazard ratio [aHR], 0.67; 95% CI, 0.54-0.83).

In the secondary analyses, which examined risks for each component of the composite outcome, the surgery group had a significantly lower risk of CD-related surgery (aHR, 0.56; 95% CI, 0.39-0.80) and corticosteroid exposure (aHR, 0.71; 95% CI, 0.54-0.92), but not perianal CD or CD-related hospitalization.

After 5 years, half of the patients (49.7%) who underwent ileocecal resection were not receiving any treatment for CD. At the same timepoint, a slightly lower percentage of this group (46.3%) had started immunomodulator therapy, while 16.8% started anti-TNF therapy. Just 1.8% of these patients required a second intestinal resection.

Icahn School of Medicine at Mount Sinai

“To our knowledge, these are the first real-world data in a population-based cohort with long-term follow-up of early ileocecal resection compared with anti-TNF therapy for newly diagnosed ileal and ileocecal CD,” the investigators wrote. “These data suggest that ileocecal resection may have a role as first-line therapy in Crohn’s disease management and challenge the current paradigm of reserving surgery for complicated Crohn’s disease refractory or intolerant to medications.”

Corresponding author Manasi Agrawal, MD, of Icahn School of Medicine at Mount Sinai, New York, suggested that “validation of our findings in external cohorts [is needed], and understanding of factors associated with improved outcomes following ileocecal resection.”

For clinicians and patients choosing between first-line anti-TNF therapy versus ileocecal resection using currently available evidence, Dr. Agrawal suggested that a variety of factors need to be considered, including disease location, extent of terminal ileum involved, presence of complications such as stricture, fistula, comorbid conditions, access to biologics, financial considerations, and patient preferences.

Cleveland Clinic

Benjamin Cohen, MD, staff physician and co-section head and clinical director for inflammatory bowel diseases in the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic, called this “an important study” because it offers the first real-world evidence to support the findings from the LIR!C trial.

Dr. Cohen agreed with Dr. Agrawal that more work is needed to determine which patients benefit most from early ileocecal resection, although he suggested that known risk factors for worse outcomes — such as early age at diagnosis, penetrating features of disease, or perianal disease — may increase strength of surgical candidacy.

Still, based on the “fairly strong” body of data now available, he suggested that all patients should be educated about first-line ileocecal resection, as it is “reasonable” approach.

“It’s always important to present surgery as a treatment option,” Dr. Cohen said in an interview. “We don’t want to think of surgery as a last resort, or a failure, because that really colors it in a negative light, and then that ultimately impacts patients’ quality of life, and their perception of outcomes.”

The study was supported by the Danish National Research Foundation. The investigators disclosed no conflicts of interest. Dr. Cohen disclosed consulting and speaking honoraria from AbbVie.

Early ileocecal resection is associated with better long-term outcomes compared with anti–tumor necrosis factor (TNF) therapy for patients with Crohn’s disease (CD), based on new real-world evidence.

These findings add weight to previously reported data from the LIR!C trial, suggesting that ileocecal resection should be considered a first-line treatment option for CD, reported principal investigator Kristine H. Allin, MD, PhD, of Aalborg University, Copenhagen.

“The LIR!C randomized clinical trial has demonstrated comparable quality of life with ileocecal resection and infliximab as a first-line treatment for limited, nonstricturing ileocecal CD at 1 year of follow-up, and improved outcomes with ileocecal resection on retrospective analysis of long-term follow-up data,” the investigators wrote in Gastroenterology. “However, in the real world, the long-term impact of early ileocecal resection for CD, compared with medical therapy, remains largely unexplored.”

To gather these real-world data, the investigators turned to the Danish National Patient Registry and the Danish National Prescription Registry, which included 1,279 individuals diagnosed with CD between 2003 and 2018 who received anti-TNF therapy or underwent ileocecal resection within 1 year of diagnosis. Within this group, slightly less than half underwent ileocecal resection (45.4%) while the remainder (54.6%) received anti-TNF therapy.

The primary outcome was a composite of one or more events: perianal CD, CD-related surgery, systemic corticosteroid exposure, and CD-related hospitalization. Secondary analyses evaluated the relative risks of these same four events as independent entities.

Multifactor-adjusted Cox proportional hazards regression analysis revealed that patients who underwent ileocecal resection had a 33% lower risk of the composite outcome compared with those who received anti-TNF therapy (adjusted hazard ratio [aHR], 0.67; 95% CI, 0.54-0.83).

In the secondary analyses, which examined risks for each component of the composite outcome, the surgery group had a significantly lower risk of CD-related surgery (aHR, 0.56; 95% CI, 0.39-0.80) and corticosteroid exposure (aHR, 0.71; 95% CI, 0.54-0.92), but not perianal CD or CD-related hospitalization.

After 5 years, half of the patients (49.7%) who underwent ileocecal resection were not receiving any treatment for CD. At the same timepoint, a slightly lower percentage of this group (46.3%) had started immunomodulator therapy, while 16.8% started anti-TNF therapy. Just 1.8% of these patients required a second intestinal resection.

Icahn School of Medicine at Mount Sinai

“To our knowledge, these are the first real-world data in a population-based cohort with long-term follow-up of early ileocecal resection compared with anti-TNF therapy for newly diagnosed ileal and ileocecal CD,” the investigators wrote. “These data suggest that ileocecal resection may have a role as first-line therapy in Crohn’s disease management and challenge the current paradigm of reserving surgery for complicated Crohn’s disease refractory or intolerant to medications.”

Corresponding author Manasi Agrawal, MD, of Icahn School of Medicine at Mount Sinai, New York, suggested that “validation of our findings in external cohorts [is needed], and understanding of factors associated with improved outcomes following ileocecal resection.”

For clinicians and patients choosing between first-line anti-TNF therapy versus ileocecal resection using currently available evidence, Dr. Agrawal suggested that a variety of factors need to be considered, including disease location, extent of terminal ileum involved, presence of complications such as stricture, fistula, comorbid conditions, access to biologics, financial considerations, and patient preferences.

Cleveland Clinic

Benjamin Cohen, MD, staff physician and co-section head and clinical director for inflammatory bowel diseases in the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic, called this “an important study” because it offers the first real-world evidence to support the findings from the LIR!C trial.

Dr. Cohen agreed with Dr. Agrawal that more work is needed to determine which patients benefit most from early ileocecal resection, although he suggested that known risk factors for worse outcomes — such as early age at diagnosis, penetrating features of disease, or perianal disease — may increase strength of surgical candidacy.

Still, based on the “fairly strong” body of data now available, he suggested that all patients should be educated about first-line ileocecal resection, as it is “reasonable” approach.

“It’s always important to present surgery as a treatment option,” Dr. Cohen said in an interview. “We don’t want to think of surgery as a last resort, or a failure, because that really colors it in a negative light, and then that ultimately impacts patients’ quality of life, and their perception of outcomes.”

The study was supported by the Danish National Research Foundation. The investigators disclosed no conflicts of interest. Dr. Cohen disclosed consulting and speaking honoraria from AbbVie.

Early ileocecal resection is associated with better long-term outcomes compared with anti–tumor necrosis factor (TNF) therapy for patients with Crohn’s disease (CD), based on new real-world evidence.

These findings add weight to previously reported data from the LIR!C trial, suggesting that ileocecal resection should be considered a first-line treatment option for CD, reported principal investigator Kristine H. Allin, MD, PhD, of Aalborg University, Copenhagen.

“The LIR!C randomized clinical trial has demonstrated comparable quality of life with ileocecal resection and infliximab as a first-line treatment for limited, nonstricturing ileocecal CD at 1 year of follow-up, and improved outcomes with ileocecal resection on retrospective analysis of long-term follow-up data,” the investigators wrote in Gastroenterology. “However, in the real world, the long-term impact of early ileocecal resection for CD, compared with medical therapy, remains largely unexplored.”

To gather these real-world data, the investigators turned to the Danish National Patient Registry and the Danish National Prescription Registry, which included 1,279 individuals diagnosed with CD between 2003 and 2018 who received anti-TNF therapy or underwent ileocecal resection within 1 year of diagnosis. Within this group, slightly less than half underwent ileocecal resection (45.4%) while the remainder (54.6%) received anti-TNF therapy.

The primary outcome was a composite of one or more events: perianal CD, CD-related surgery, systemic corticosteroid exposure, and CD-related hospitalization. Secondary analyses evaluated the relative risks of these same four events as independent entities.

Multifactor-adjusted Cox proportional hazards regression analysis revealed that patients who underwent ileocecal resection had a 33% lower risk of the composite outcome compared with those who received anti-TNF therapy (adjusted hazard ratio [aHR], 0.67; 95% CI, 0.54-0.83).

In the secondary analyses, which examined risks for each component of the composite outcome, the surgery group had a significantly lower risk of CD-related surgery (aHR, 0.56; 95% CI, 0.39-0.80) and corticosteroid exposure (aHR, 0.71; 95% CI, 0.54-0.92), but not perianal CD or CD-related hospitalization.

After 5 years, half of the patients (49.7%) who underwent ileocecal resection were not receiving any treatment for CD. At the same timepoint, a slightly lower percentage of this group (46.3%) had started immunomodulator therapy, while 16.8% started anti-TNF therapy. Just 1.8% of these patients required a second intestinal resection.

Icahn School of Medicine at Mount Sinai

“To our knowledge, these are the first real-world data in a population-based cohort with long-term follow-up of early ileocecal resection compared with anti-TNF therapy for newly diagnosed ileal and ileocecal CD,” the investigators wrote. “These data suggest that ileocecal resection may have a role as first-line therapy in Crohn’s disease management and challenge the current paradigm of reserving surgery for complicated Crohn’s disease refractory or intolerant to medications.”

Corresponding author Manasi Agrawal, MD, of Icahn School of Medicine at Mount Sinai, New York, suggested that “validation of our findings in external cohorts [is needed], and understanding of factors associated with improved outcomes following ileocecal resection.”

For clinicians and patients choosing between first-line anti-TNF therapy versus ileocecal resection using currently available evidence, Dr. Agrawal suggested that a variety of factors need to be considered, including disease location, extent of terminal ileum involved, presence of complications such as stricture, fistula, comorbid conditions, access to biologics, financial considerations, and patient preferences.

Cleveland Clinic

Benjamin Cohen, MD, staff physician and co-section head and clinical director for inflammatory bowel diseases in the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic, called this “an important study” because it offers the first real-world evidence to support the findings from the LIR!C trial.

Dr. Cohen agreed with Dr. Agrawal that more work is needed to determine which patients benefit most from early ileocecal resection, although he suggested that known risk factors for worse outcomes — such as early age at diagnosis, penetrating features of disease, or perianal disease — may increase strength of surgical candidacy.

Still, based on the “fairly strong” body of data now available, he suggested that all patients should be educated about first-line ileocecal resection, as it is “reasonable” approach.

“It’s always important to present surgery as a treatment option,” Dr. Cohen said in an interview. “We don’t want to think of surgery as a last resort, or a failure, because that really colors it in a negative light, and then that ultimately impacts patients’ quality of life, and their perception of outcomes.”

The study was supported by the Danish National Research Foundation. The investigators disclosed no conflicts of interest. Dr. Cohen disclosed consulting and speaking honoraria from AbbVie.

ORLANDO — Sleep disorders in people with epilepsy are linked to a significantly higher risk for sudden unexplained death in epilepsy (SUDEP) and all-cause mortality, new research shows.

SUDEP is a major concern for patients with epilepsy, said study investigator Marion Lazaj, MSc, Center for Neuroscience Studies, Queen’s University, Kingston, Ontario, Canada, but she believes that SUDEP risk assessment is overly focused on seizure control.

“We want to push the idea that this mortality risk assessment needs to be widened to include sleep factors, and not just sleep disorders but even sleep disturbances,” said Ms. Lazaj.

She also believes physicians should routinely discuss SUDEP with their patients with epilepsy. Given that the incidence of SUDEP is only about 1%, many clinicians don’t want to unduly frighten their patients, she added.

The findings were presented at the annual meeting of the American Epilepsy Society (AES).

The retrospective study included chart data from 1,506 consecutive patients diagnosed with epilepsy at a single center over 4 years. The mean age of participants was about 37 years but there was a large age range, said Ms. Lazaj.

The cohort was divided into two groups. Group 1 included 1130 patients without a comorbid sleep disorder, and Group 2 had 376 patients with a primary comorbid sleep disorder, mostly obstructive sleep apnea (OSA) but also restless leg syndrome or insomnia.

They gathered demographic information including age, sex, employment status, education, and epilepsy-related data such as epilepsy type, duration, the number of anti-seizure medications and relevant information from hospital and emergency room (ER) records.
 

SUDEP Inventory

Researchers assessed SUDEP risk using the revised SUDEP-7 risk inventory. The first four items on this inventory focus on generalized tonic clonic seizure activity and occurrence while others assess the number of antiseizure medicines, epilepsy duration, and the presence of other developmental delays.

Investigators then stratified patients into high risk (score on the SUDEP-7 of 5 or greater) and low mortality risk (score less than 5).

Results showed a significant association between a high mortality risk and having a comorbid sleep disorder (P = .033). Researchers also looked at all-cause mortality, including drownings and suicides, and found a similar significant association (P = .026). There was also an association between high risk and accidents and trauma (P = .042).

The researchers had access to overnight diagnostic polysomnography data for a smaller group of patients. Here, they found decreased sleep efficiency (P =.0098), increased spontaneous arousal index (P = .034), and prolonged sleep onset latency (P = .0000052) were all significantly associated with high SUDEP risk.

From the polysomnographic data, researchers found high SUDEP risk was significantly associated with a diagnosis of OSA (P = .034).
 

Powerful Study

Commenting on the findings, Gordon F. Buchanan, MD, PhD, Beth L. Tross epilepsy associate professor, Department of Neurology, University of Iowa Carver College of Medicine, Iowa City, said he was “very excited” by the research.

“That this study attempts to look through data in a retrospective way and see if there’s additional risk with having comorbid sleep disorders is really interesting and I think really powerful,” he said.

Sleep disorders “are potentially a really simple thing that we can screen for and test for,” he added. He also noted that additional research is needed to replicate the findings.

Dr. Buchanan acknowledged that the SUDEP-7 inventory is not a particularly good tool and said there is a need for a better means of assessment that includes sleep disorders and other factors like sleep states and circadian rhythm, which he said affect SUDEP risk.

Ms. Lazaj and Dr. Buchanan report no relevant financial relationships.

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

ORLANDO — Sleep disorders in people with epilepsy are linked to a significantly higher risk for sudden unexplained death in epilepsy (SUDEP) and all-cause mortality, new research shows.

SUDEP is a major concern for patients with epilepsy, said study investigator Marion Lazaj, MSc, Center for Neuroscience Studies, Queen’s University, Kingston, Ontario, Canada, but she believes that SUDEP risk assessment is overly focused on seizure control.

“We want to push the idea that this mortality risk assessment needs to be widened to include sleep factors, and not just sleep disorders but even sleep disturbances,” said Ms. Lazaj.

She also believes physicians should routinely discuss SUDEP with their patients with epilepsy. Given that the incidence of SUDEP is only about 1%, many clinicians don’t want to unduly frighten their patients, she added.

The findings were presented at the annual meeting of the American Epilepsy Society (AES).

The retrospective study included chart data from 1,506 consecutive patients diagnosed with epilepsy at a single center over 4 years. The mean age of participants was about 37 years but there was a large age range, said Ms. Lazaj.

The cohort was divided into two groups. Group 1 included 1130 patients without a comorbid sleep disorder, and Group 2 had 376 patients with a primary comorbid sleep disorder, mostly obstructive sleep apnea (OSA) but also restless leg syndrome or insomnia.

They gathered demographic information including age, sex, employment status, education, and epilepsy-related data such as epilepsy type, duration, the number of anti-seizure medications and relevant information from hospital and emergency room (ER) records.
 

SUDEP Inventory

Researchers assessed SUDEP risk using the revised SUDEP-7 risk inventory. The first four items on this inventory focus on generalized tonic clonic seizure activity and occurrence while others assess the number of antiseizure medicines, epilepsy duration, and the presence of other developmental delays.

Investigators then stratified patients into high risk (score on the SUDEP-7 of 5 or greater) and low mortality risk (score less than 5).

Results showed a significant association between a high mortality risk and having a comorbid sleep disorder (P = .033). Researchers also looked at all-cause mortality, including drownings and suicides, and found a similar significant association (P = .026). There was also an association between high risk and accidents and trauma (P = .042).

The researchers had access to overnight diagnostic polysomnography data for a smaller group of patients. Here, they found decreased sleep efficiency (P =.0098), increased spontaneous arousal index (P = .034), and prolonged sleep onset latency (P = .0000052) were all significantly associated with high SUDEP risk.

From the polysomnographic data, researchers found high SUDEP risk was significantly associated with a diagnosis of OSA (P = .034).
 

Powerful Study

Commenting on the findings, Gordon F. Buchanan, MD, PhD, Beth L. Tross epilepsy associate professor, Department of Neurology, University of Iowa Carver College of Medicine, Iowa City, said he was “very excited” by the research.

“That this study attempts to look through data in a retrospective way and see if there’s additional risk with having comorbid sleep disorders is really interesting and I think really powerful,” he said.

Sleep disorders “are potentially a really simple thing that we can screen for and test for,” he added. He also noted that additional research is needed to replicate the findings.

Dr. Buchanan acknowledged that the SUDEP-7 inventory is not a particularly good tool and said there is a need for a better means of assessment that includes sleep disorders and other factors like sleep states and circadian rhythm, which he said affect SUDEP risk.

Ms. Lazaj and Dr. Buchanan report no relevant financial relationships.

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

ORLANDO — Sleep disorders in people with epilepsy are linked to a significantly higher risk for sudden unexplained death in epilepsy (SUDEP) and all-cause mortality, new research shows.

SUDEP is a major concern for patients with epilepsy, said study investigator Marion Lazaj, MSc, Center for Neuroscience Studies, Queen’s University, Kingston, Ontario, Canada, but she believes that SUDEP risk assessment is overly focused on seizure control.

“We want to push the idea that this mortality risk assessment needs to be widened to include sleep factors, and not just sleep disorders but even sleep disturbances,” said Ms. Lazaj.

She also believes physicians should routinely discuss SUDEP with their patients with epilepsy. Given that the incidence of SUDEP is only about 1%, many clinicians don’t want to unduly frighten their patients, she added.

The findings were presented at the annual meeting of the American Epilepsy Society (AES).

The retrospective study included chart data from 1,506 consecutive patients diagnosed with epilepsy at a single center over 4 years. The mean age of participants was about 37 years but there was a large age range, said Ms. Lazaj.

The cohort was divided into two groups. Group 1 included 1130 patients without a comorbid sleep disorder, and Group 2 had 376 patients with a primary comorbid sleep disorder, mostly obstructive sleep apnea (OSA) but also restless leg syndrome or insomnia.

They gathered demographic information including age, sex, employment status, education, and epilepsy-related data such as epilepsy type, duration, the number of anti-seizure medications and relevant information from hospital and emergency room (ER) records.
 

SUDEP Inventory

Researchers assessed SUDEP risk using the revised SUDEP-7 risk inventory. The first four items on this inventory focus on generalized tonic clonic seizure activity and occurrence while others assess the number of antiseizure medicines, epilepsy duration, and the presence of other developmental delays.

Investigators then stratified patients into high risk (score on the SUDEP-7 of 5 or greater) and low mortality risk (score less than 5).

Results showed a significant association between a high mortality risk and having a comorbid sleep disorder (P = .033). Researchers also looked at all-cause mortality, including drownings and suicides, and found a similar significant association (P = .026). There was also an association between high risk and accidents and trauma (P = .042).

The researchers had access to overnight diagnostic polysomnography data for a smaller group of patients. Here, they found decreased sleep efficiency (P =.0098), increased spontaneous arousal index (P = .034), and prolonged sleep onset latency (P = .0000052) were all significantly associated with high SUDEP risk.

From the polysomnographic data, researchers found high SUDEP risk was significantly associated with a diagnosis of OSA (P = .034).
 

Powerful Study

Commenting on the findings, Gordon F. Buchanan, MD, PhD, Beth L. Tross epilepsy associate professor, Department of Neurology, University of Iowa Carver College of Medicine, Iowa City, said he was “very excited” by the research.

“That this study attempts to look through data in a retrospective way and see if there’s additional risk with having comorbid sleep disorders is really interesting and I think really powerful,” he said.

Sleep disorders “are potentially a really simple thing that we can screen for and test for,” he added. He also noted that additional research is needed to replicate the findings.

Dr. Buchanan acknowledged that the SUDEP-7 inventory is not a particularly good tool and said there is a need for a better means of assessment that includes sleep disorders and other factors like sleep states and circadian rhythm, which he said affect SUDEP risk.

Ms. Lazaj and Dr. Buchanan report no relevant financial relationships.

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

TOPLINE: 

Compared with a healthy omnivore diet, a healthy vegan diet led to significant improvement in  low-density lipoprotein cholesterol (LDL-C) as well as fasting insulin and weight loss in a randomized controlled trial of identical twins. 

METHODOLOGY:  

• Researchers randomly assigned 22 pairs of healthy adult identical twins (34 women, mean age 39 years, mean body mass index 25.9) to a healthy vegan or omnivore diet (1 twin per pair) for 8 weeks.
• For the first 4 weeks, diet-specific meals were provided via a meal delivery service. For the final 4 weeks, participants prepared their own diet-appropriate meals/snacks.
• The primary outcome was change in LDL-C; secondary outcomes included changes in body weight and fasting insulin. 

TAKEAWAY:

• After 8 weeks, twins eating a vegan diet showed a significant mean decrease of 13.9 mg/dL in LDL-C compared with twins eating an omnivorous diet.
• The vegan diet also led to a significant mean decrease of 2.9 Times New RomanμIU/mL in fasting insulin and 1.9 kg in body weight after 8 weeks compared with the omnivore diet, although weight loss was observed in both diet groups. 
• The vegan diet group also had a larger but nonsignificant absolute median decrease in fasting HDL-C  triglycerides , vitamin B12, glucose, and trimethylamine N-oxide levels at 8 weeks.

IN PRACTICE: 

“Our results corroborate a previous finding showing that eating a vegan diet can improve cardiovascular health. Clinicians may consider recommending plant-based diets to reduce cardiometabolic risk factors, as well as aligning with environmental benefits,” the researchers concluded. 

SOURCE: 

The study, with first author Matthew J. Landry, PhD, RDN, Stanford Prevention Research Center, Stanford University School of Medicine, California, was published online November 30 in  JAMA Network Open. 

LIMITATIONS: 

The adult twin population was generally healthy and findings may not be generalizable to other populations. The sample size was small, and the duration of intervention was short and there was no follow-up period, which limits insights on stability and sustainability of the diets. 

DISCLOSURES: 

Funding was provided by the Vogt Foundation, and grants from Stanford University and the National Heart, Lung, and Blood Institute. Dr. Landry has no relevant disclosures. One author reported receiving funding from Beyond Meat outside of this study. 

A version of this article appeared on Medscape.com.

TOPLINE: 

Compared with a healthy omnivore diet, a healthy vegan diet led to significant improvement in  low-density lipoprotein cholesterol (LDL-C) as well as fasting insulin and weight loss in a randomized controlled trial of identical twins. 

METHODOLOGY:  

• Researchers randomly assigned 22 pairs of healthy adult identical twins (34 women, mean age 39 years, mean body mass index 25.9) to a healthy vegan or omnivore diet (1 twin per pair) for 8 weeks.
• For the first 4 weeks, diet-specific meals were provided via a meal delivery service. For the final 4 weeks, participants prepared their own diet-appropriate meals/snacks.
• The primary outcome was change in LDL-C; secondary outcomes included changes in body weight and fasting insulin. 

TAKEAWAY:

• After 8 weeks, twins eating a vegan diet showed a significant mean decrease of 13.9 mg/dL in LDL-C compared with twins eating an omnivorous diet.
• The vegan diet also led to a significant mean decrease of 2.9 Times New RomanμIU/mL in fasting insulin and 1.9 kg in body weight after 8 weeks compared with the omnivore diet, although weight loss was observed in both diet groups. 
• The vegan diet group also had a larger but nonsignificant absolute median decrease in fasting HDL-C  triglycerides , vitamin B12, glucose, and trimethylamine N-oxide levels at 8 weeks.

IN PRACTICE: 

“Our results corroborate a previous finding showing that eating a vegan diet can improve cardiovascular health. Clinicians may consider recommending plant-based diets to reduce cardiometabolic risk factors, as well as aligning with environmental benefits,” the researchers concluded. 

SOURCE: 

The study, with first author Matthew J. Landry, PhD, RDN, Stanford Prevention Research Center, Stanford University School of Medicine, California, was published online November 30 in  JAMA Network Open. 

LIMITATIONS: 

The adult twin population was generally healthy and findings may not be generalizable to other populations. The sample size was small, and the duration of intervention was short and there was no follow-up period, which limits insights on stability and sustainability of the diets. 

DISCLOSURES: 

Funding was provided by the Vogt Foundation, and grants from Stanford University and the National Heart, Lung, and Blood Institute. Dr. Landry has no relevant disclosures. One author reported receiving funding from Beyond Meat outside of this study. 

A version of this article appeared on Medscape.com.

TOPLINE: 

Compared with a healthy omnivore diet, a healthy vegan diet led to significant improvement in  low-density lipoprotein cholesterol (LDL-C) as well as fasting insulin and weight loss in a randomized controlled trial of identical twins. 

METHODOLOGY:  

• Researchers randomly assigned 22 pairs of healthy adult identical twins (34 women, mean age 39 years, mean body mass index 25.9) to a healthy vegan or omnivore diet (1 twin per pair) for 8 weeks.
• For the first 4 weeks, diet-specific meals were provided via a meal delivery service. For the final 4 weeks, participants prepared their own diet-appropriate meals/snacks.
• The primary outcome was change in LDL-C; secondary outcomes included changes in body weight and fasting insulin. 

TAKEAWAY:

• After 8 weeks, twins eating a vegan diet showed a significant mean decrease of 13.9 mg/dL in LDL-C compared with twins eating an omnivorous diet.
• The vegan diet also led to a significant mean decrease of 2.9 Times New RomanμIU/mL in fasting insulin and 1.9 kg in body weight after 8 weeks compared with the omnivore diet, although weight loss was observed in both diet groups. 
• The vegan diet group also had a larger but nonsignificant absolute median decrease in fasting HDL-C  triglycerides , vitamin B12, glucose, and trimethylamine N-oxide levels at 8 weeks.

IN PRACTICE: 

“Our results corroborate a previous finding showing that eating a vegan diet can improve cardiovascular health. Clinicians may consider recommending plant-based diets to reduce cardiometabolic risk factors, as well as aligning with environmental benefits,” the researchers concluded. 

SOURCE: 

The study, with first author Matthew J. Landry, PhD, RDN, Stanford Prevention Research Center, Stanford University School of Medicine, California, was published online November 30 in  JAMA Network Open. 

LIMITATIONS: 

The adult twin population was generally healthy and findings may not be generalizable to other populations. The sample size was small, and the duration of intervention was short and there was no follow-up period, which limits insights on stability and sustainability of the diets. 

DISCLOSURES: 

Funding was provided by the Vogt Foundation, and grants from Stanford University and the National Heart, Lung, and Blood Institute. Dr. Landry has no relevant disclosures. One author reported receiving funding from Beyond Meat outside of this study. 

A version of this article appeared on Medscape.com.