TOPLINE:

The anti-inflammatory shift in mid-pregnancy may be linked to changes in gut microbiota, which, in turn, may wield their influence through fecal and plasma metabolites.

METHODOLOGY:

• Midway through a normal pregnancy, the maternal immune system shifts to a more anti-inflammatory state, which may be linked to changes in the gut microbial community by unknown mechanisms.
• The study explored the associations between the gut microbiota, fecal and plasma metabolites, and cytokine levels of pregnant women and compared them with those of nonpregnant women.
• The study recruited 30 pregnant women (ages 18-34 years; prepregnancy body mass index [BMI], 18.5-21.9) who conceived naturally with a singleton pregnancy and 15 nonpregnant women of similar age and BMI from the First Affiliated Hospital of Jinan University, Guangzhou, China, between February 2019 and August 2020.
• All participants had not used probiotics or antibiotics in the 6 months prior to participating in the study.
• Fecal and blood samples were collected during or after the 37th week of pregnancy in pregnant women until their labor and on the 14th day of the menstrual cycle in nonpregnant women.

TAKEAWAY:

• Pregnant women had more Actinobacteriota than nonpregnant women (9.15% vs 2.98%, respectively; P = .002) in their gut microbiomes, and the most enriched other microbes showed a negative correlation with pro-inflammatory cytokines.
• Pregnant women had differences in 44 fecal and 53 plasma metabolites, with certain enriched metabolites negatively correlated with pro-inflammatory cytokines and certain depleted ones positively correlated.
• Levels of pro-inflammatory plasma cytokines such as interleukins (IL)-1β, IL-2, IL-6, IL-12, interferon gamma, and tumor necrosis factor alpha were reduced, while levels of the anti-inflammatory cytokine IL-4 were elevated in pregnant vs nonpregnant women.
• Researchers identified a total of 46 connections between gut microbes, metabolites, and cytokines, with details suggesting that gut microbes may alter plasma cytokine levels by interacting with host metabolites.

IN PRACTICE:

“Our study revealed complicated associations among gut microbiota, metabolites, and immune system during pregnancy and identified some specific metabolites which may act as mediators between symbiotic microorganisms and immune homeostasis,” the authors wrote.

SOURCE:

The study, led by Ting Huang, Department of Obstetrics and Gynecology, the First Affiliated Hospital of Jinan University, Guangzhou, China, was published online on February 7, 2024, in mSystems.

LIMITATIONS:

The small sample size of the study may have limited capacity to address errors resulting from individual differences. No causal relationships between gut microbiota, metabolites, and immune system response could be confirmed. Researchers were unable to account for the possible effects of confounding variables, such as diet, because of the cross-sectional nature of this study.

DISCLOSURES:

This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

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

TOPLINE:

The anti-inflammatory shift in mid-pregnancy may be linked to changes in gut microbiota, which, in turn, may wield their influence through fecal and plasma metabolites.

METHODOLOGY:

• Midway through a normal pregnancy, the maternal immune system shifts to a more anti-inflammatory state, which may be linked to changes in the gut microbial community by unknown mechanisms.
• The study explored the associations between the gut microbiota, fecal and plasma metabolites, and cytokine levels of pregnant women and compared them with those of nonpregnant women.
• The study recruited 30 pregnant women (ages 18-34 years; prepregnancy body mass index [BMI], 18.5-21.9) who conceived naturally with a singleton pregnancy and 15 nonpregnant women of similar age and BMI from the First Affiliated Hospital of Jinan University, Guangzhou, China, between February 2019 and August 2020.
• All participants had not used probiotics or antibiotics in the 6 months prior to participating in the study.
• Fecal and blood samples were collected during or after the 37th week of pregnancy in pregnant women until their labor and on the 14th day of the menstrual cycle in nonpregnant women.

TAKEAWAY:

• Pregnant women had more Actinobacteriota than nonpregnant women (9.15% vs 2.98%, respectively; P = .002) in their gut microbiomes, and the most enriched other microbes showed a negative correlation with pro-inflammatory cytokines.
• Pregnant women had differences in 44 fecal and 53 plasma metabolites, with certain enriched metabolites negatively correlated with pro-inflammatory cytokines and certain depleted ones positively correlated.
• Levels of pro-inflammatory plasma cytokines such as interleukins (IL)-1β, IL-2, IL-6, IL-12, interferon gamma, and tumor necrosis factor alpha were reduced, while levels of the anti-inflammatory cytokine IL-4 were elevated in pregnant vs nonpregnant women.
• Researchers identified a total of 46 connections between gut microbes, metabolites, and cytokines, with details suggesting that gut microbes may alter plasma cytokine levels by interacting with host metabolites.

IN PRACTICE:

“Our study revealed complicated associations among gut microbiota, metabolites, and immune system during pregnancy and identified some specific metabolites which may act as mediators between symbiotic microorganisms and immune homeostasis,” the authors wrote.

SOURCE:

The study, led by Ting Huang, Department of Obstetrics and Gynecology, the First Affiliated Hospital of Jinan University, Guangzhou, China, was published online on February 7, 2024, in mSystems.

LIMITATIONS:

The small sample size of the study may have limited capacity to address errors resulting from individual differences. No causal relationships between gut microbiota, metabolites, and immune system response could be confirmed. Researchers were unable to account for the possible effects of confounding variables, such as diet, because of the cross-sectional nature of this study.

DISCLOSURES:

This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

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

TOPLINE:

The anti-inflammatory shift in mid-pregnancy may be linked to changes in gut microbiota, which, in turn, may wield their influence through fecal and plasma metabolites.

METHODOLOGY:

• Midway through a normal pregnancy, the maternal immune system shifts to a more anti-inflammatory state, which may be linked to changes in the gut microbial community by unknown mechanisms.
• The study explored the associations between the gut microbiota, fecal and plasma metabolites, and cytokine levels of pregnant women and compared them with those of nonpregnant women.
• The study recruited 30 pregnant women (ages 18-34 years; prepregnancy body mass index [BMI], 18.5-21.9) who conceived naturally with a singleton pregnancy and 15 nonpregnant women of similar age and BMI from the First Affiliated Hospital of Jinan University, Guangzhou, China, between February 2019 and August 2020.
• All participants had not used probiotics or antibiotics in the 6 months prior to participating in the study.
• Fecal and blood samples were collected during or after the 37th week of pregnancy in pregnant women until their labor and on the 14th day of the menstrual cycle in nonpregnant women.

TAKEAWAY:

• Pregnant women had more Actinobacteriota than nonpregnant women (9.15% vs 2.98%, respectively; P = .002) in their gut microbiomes, and the most enriched other microbes showed a negative correlation with pro-inflammatory cytokines.
• Pregnant women had differences in 44 fecal and 53 plasma metabolites, with certain enriched metabolites negatively correlated with pro-inflammatory cytokines and certain depleted ones positively correlated.
• Levels of pro-inflammatory plasma cytokines such as interleukins (IL)-1β, IL-2, IL-6, IL-12, interferon gamma, and tumor necrosis factor alpha were reduced, while levels of the anti-inflammatory cytokine IL-4 were elevated in pregnant vs nonpregnant women.
• Researchers identified a total of 46 connections between gut microbes, metabolites, and cytokines, with details suggesting that gut microbes may alter plasma cytokine levels by interacting with host metabolites.

IN PRACTICE:

“Our study revealed complicated associations among gut microbiota, metabolites, and immune system during pregnancy and identified some specific metabolites which may act as mediators between symbiotic microorganisms and immune homeostasis,” the authors wrote.

SOURCE:

The study, led by Ting Huang, Department of Obstetrics and Gynecology, the First Affiliated Hospital of Jinan University, Guangzhou, China, was published online on February 7, 2024, in mSystems.

LIMITATIONS:

The small sample size of the study may have limited capacity to address errors resulting from individual differences. No causal relationships between gut microbiota, metabolites, and immune system response could be confirmed. Researchers were unable to account for the possible effects of confounding variables, such as diet, because of the cross-sectional nature of this study.

DISCLOSURES:

This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

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

An FDA advisory committee has recommended that the United States switch from a quadrivalent to trivalent influenza vaccine for the next flu season.

The flu vaccine currently in use targets two A strains and two B strains. But the Yamagata/B subtype, which was already in decline, has not been detected worldwide since March 2020, the FDA said. Social distancing and other precautions used to avoid COVID apparently finished it off. 

In response to that change, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on March 5 to recommend the three-strain flu shot.

VRBPAC recommended the egg-based flu vaccines contain an A/Victoria/4897/2022 (H1N1)pdm09-like virus, an A/Thailand/8/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The committee recommended the cell- or recombinant-based flu vaccines contain an A/Wisconsin/67/2022 (H1N1)pdm09-like virus; an A/Massachusetts/18/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The move is no surprise. The World Health Organization and FDA experts had been recommending the change since last year. 

Jerry Weir, MD, director of the FDA’s Division of Viral Products, said companies that make flu vaccines should have the trivalent shot ready for the 2024-2025  flu season.

“Each of the U.S. influenza vaccine manufacturers have submitted updated regulatory files related to a trivalent influenza vaccine, and approval of all the necessary regulatory submissions is on track for 2024-25,” he said during the advisory committee’s meeting, according to CNN.

“FDA anticipates that there will be an adequate and diverse supply of approved trivalent seasonal influenza vaccines for the United States in the coming season,” the agency said.

U.S. flu vaccine manufacturers will still make a four-strain vaccine for distribution to overseas markets, CNN said.
 

A version of this article appeared on WebMD.com.

An FDA advisory committee has recommended that the United States switch from a quadrivalent to trivalent influenza vaccine for the next flu season.

The flu vaccine currently in use targets two A strains and two B strains. But the Yamagata/B subtype, which was already in decline, has not been detected worldwide since March 2020, the FDA said. Social distancing and other precautions used to avoid COVID apparently finished it off. 

In response to that change, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on March 5 to recommend the three-strain flu shot.

VRBPAC recommended the egg-based flu vaccines contain an A/Victoria/4897/2022 (H1N1)pdm09-like virus, an A/Thailand/8/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The committee recommended the cell- or recombinant-based flu vaccines contain an A/Wisconsin/67/2022 (H1N1)pdm09-like virus; an A/Massachusetts/18/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The move is no surprise. The World Health Organization and FDA experts had been recommending the change since last year. 

Jerry Weir, MD, director of the FDA’s Division of Viral Products, said companies that make flu vaccines should have the trivalent shot ready for the 2024-2025  flu season.

“Each of the U.S. influenza vaccine manufacturers have submitted updated regulatory files related to a trivalent influenza vaccine, and approval of all the necessary regulatory submissions is on track for 2024-25,” he said during the advisory committee’s meeting, according to CNN.

“FDA anticipates that there will be an adequate and diverse supply of approved trivalent seasonal influenza vaccines for the United States in the coming season,” the agency said.

U.S. flu vaccine manufacturers will still make a four-strain vaccine for distribution to overseas markets, CNN said.
 

A version of this article appeared on WebMD.com.

An FDA advisory committee has recommended that the United States switch from a quadrivalent to trivalent influenza vaccine for the next flu season.

The flu vaccine currently in use targets two A strains and two B strains. But the Yamagata/B subtype, which was already in decline, has not been detected worldwide since March 2020, the FDA said. Social distancing and other precautions used to avoid COVID apparently finished it off. 

In response to that change, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on March 5 to recommend the three-strain flu shot.

VRBPAC recommended the egg-based flu vaccines contain an A/Victoria/4897/2022 (H1N1)pdm09-like virus, an A/Thailand/8/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The committee recommended the cell- or recombinant-based flu vaccines contain an A/Wisconsin/67/2022 (H1N1)pdm09-like virus; an A/Massachusetts/18/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The move is no surprise. The World Health Organization and FDA experts had been recommending the change since last year. 

Jerry Weir, MD, director of the FDA’s Division of Viral Products, said companies that make flu vaccines should have the trivalent shot ready for the 2024-2025  flu season.

“Each of the U.S. influenza vaccine manufacturers have submitted updated regulatory files related to a trivalent influenza vaccine, and approval of all the necessary regulatory submissions is on track for 2024-25,” he said during the advisory committee’s meeting, according to CNN.

“FDA anticipates that there will be an adequate and diverse supply of approved trivalent seasonal influenza vaccines for the United States in the coming season,” the agency said.

U.S. flu vaccine manufacturers will still make a four-strain vaccine for distribution to overseas markets, CNN said.
 

A version of this article appeared on WebMD.com.

An ongoing cyberattack, lasting more than 2 weeks, has had a substantial impact on cancer practices and their patients in the United States. Change Healthcare, a subsidiary of UnitedHealth, took its systems offline after a cyberattack by BlackCat/ALPHV ransomware group. 

The American Hospital Association said that this massive interruption is the “most significant cyberattack on the US healthcare system in American history.” 

What Is the Change Healthcare Attack? 

On February 21, Change Healthcare experienced an outside cybersecurity threat. When it became aware of the issue, the company disconnected its systems to prevent any further issues. Change Healthcare said that it has a “high level” of confidence that the cyberattack did not affect Optum, UnitedHealthcare, and UnitedHealth Group systems, stating it was an isolated attack on Change Healthcare. However, Change Healthcare has not said whether patient information has been compromised. 

Who Is Behind the Attack? 

In a statement, Change Healthcare announced that BlackCat/ALPHV identified itself to the company, claiming responsibility for the cybercrime. According to the US Department of Justice, BlackCat/ALPHV is the second most prolific ransomware-as-a-service entity in the world, with over 1000 victims of cybercrimes across the globe. 

This news organization reached out to the Cybersecurity and Infrastructure Security Agency (CISA), a component of the US Department of Homeland Security, for comment on whether CISA or other agencies had taken any previous action to stop the group after other attacks. 

“CISA is working with our partners and Change Healthcare to support remediation, assist impacted organizations, and share timely information to reduce the likelihood of similar intrusions,” Eric Goldstein, executive assistant director for cybersecurity, responded in a statement. 

How Has the Attack Affected Oncology Practices? 

Change Healthcare is a technology company that provides services to hospitals and clinics across the country, including pharmacy claims transactions, clinician claims processing, patient access and financial clearance, clinician payments, and prior authorizations. 

The Community Oncology Alliance (COA) said that the cyberattack has caused a massive disruption in claims processing. COA also said that practices have reported the disruption of benefits verification for patients, prior authorizations, and financial assistance from the attack. 

“It’s impacting pretty much every facet of the practice and practice management,” said Nicolas Ferreyros, managing director of policy, advocacy, and communications at COA. “Right now, practices are making do, they’re working around these challenges.” 

However, Ferreyros cautioned, continuing to manage these challenges “is absolutely, 100% unsustainable” for oncology practices.

“Very soon you’re going to find practices that are having to make tough decisions about what to do, how are they going to make payroll, are they going to take financial risks on filling prescriptions and treating patients?” he added.

What Are Current Workarounds for Clinicians? 

Change Healthcare recommends that clinicians use manual methods such as calling the payer’s provider service line to check patients’ claim status and complete eligibility verification and prior authorizations. 

The Department of Health & Human Services has issued guidance to Medicare Advantage organizations and Part D sponsors asking them to “remove or relax prior authorization, other utilization management, and timely filing requirements” while systems are offline. The department is also asking Medicare Advantage to offer advance funding to clinicians who have been affected the most.

How Common Are Attacks Like These? 

In 2023, a record-setting 725 healthcare security breaches were reported to the Department of Health & Human Services Office for Civil Rights, according to a report from The HIPAA Journal. The number of breachers has increased yearly. Last year, an average of 370,000 healthcare records were breached every day.

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

An ongoing cyberattack, lasting more than 2 weeks, has had a substantial impact on cancer practices and their patients in the United States. Change Healthcare, a subsidiary of UnitedHealth, took its systems offline after a cyberattack by BlackCat/ALPHV ransomware group. 

The American Hospital Association said that this massive interruption is the “most significant cyberattack on the US healthcare system in American history.” 

What Is the Change Healthcare Attack? 

On February 21, Change Healthcare experienced an outside cybersecurity threat. When it became aware of the issue, the company disconnected its systems to prevent any further issues. Change Healthcare said that it has a “high level” of confidence that the cyberattack did not affect Optum, UnitedHealthcare, and UnitedHealth Group systems, stating it was an isolated attack on Change Healthcare. However, Change Healthcare has not said whether patient information has been compromised. 

Who Is Behind the Attack? 

In a statement, Change Healthcare announced that BlackCat/ALPHV identified itself to the company, claiming responsibility for the cybercrime. According to the US Department of Justice, BlackCat/ALPHV is the second most prolific ransomware-as-a-service entity in the world, with over 1000 victims of cybercrimes across the globe. 

This news organization reached out to the Cybersecurity and Infrastructure Security Agency (CISA), a component of the US Department of Homeland Security, for comment on whether CISA or other agencies had taken any previous action to stop the group after other attacks. 

“CISA is working with our partners and Change Healthcare to support remediation, assist impacted organizations, and share timely information to reduce the likelihood of similar intrusions,” Eric Goldstein, executive assistant director for cybersecurity, responded in a statement. 

How Has the Attack Affected Oncology Practices? 

Change Healthcare is a technology company that provides services to hospitals and clinics across the country, including pharmacy claims transactions, clinician claims processing, patient access and financial clearance, clinician payments, and prior authorizations. 

The Community Oncology Alliance (COA) said that the cyberattack has caused a massive disruption in claims processing. COA also said that practices have reported the disruption of benefits verification for patients, prior authorizations, and financial assistance from the attack. 

“It’s impacting pretty much every facet of the practice and practice management,” said Nicolas Ferreyros, managing director of policy, advocacy, and communications at COA. “Right now, practices are making do, they’re working around these challenges.” 

However, Ferreyros cautioned, continuing to manage these challenges “is absolutely, 100% unsustainable” for oncology practices.

“Very soon you’re going to find practices that are having to make tough decisions about what to do, how are they going to make payroll, are they going to take financial risks on filling prescriptions and treating patients?” he added.

What Are Current Workarounds for Clinicians? 

Change Healthcare recommends that clinicians use manual methods such as calling the payer’s provider service line to check patients’ claim status and complete eligibility verification and prior authorizations. 

The Department of Health & Human Services has issued guidance to Medicare Advantage organizations and Part D sponsors asking them to “remove or relax prior authorization, other utilization management, and timely filing requirements” while systems are offline. The department is also asking Medicare Advantage to offer advance funding to clinicians who have been affected the most.

How Common Are Attacks Like These? 

In 2023, a record-setting 725 healthcare security breaches were reported to the Department of Health & Human Services Office for Civil Rights, according to a report from The HIPAA Journal. The number of breachers has increased yearly. Last year, an average of 370,000 healthcare records were breached every day.

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

An ongoing cyberattack, lasting more than 2 weeks, has had a substantial impact on cancer practices and their patients in the United States. Change Healthcare, a subsidiary of UnitedHealth, took its systems offline after a cyberattack by BlackCat/ALPHV ransomware group. 

The American Hospital Association said that this massive interruption is the “most significant cyberattack on the US healthcare system in American history.” 

What Is the Change Healthcare Attack? 

On February 21, Change Healthcare experienced an outside cybersecurity threat. When it became aware of the issue, the company disconnected its systems to prevent any further issues. Change Healthcare said that it has a “high level” of confidence that the cyberattack did not affect Optum, UnitedHealthcare, and UnitedHealth Group systems, stating it was an isolated attack on Change Healthcare. However, Change Healthcare has not said whether patient information has been compromised. 

Who Is Behind the Attack? 

In a statement, Change Healthcare announced that BlackCat/ALPHV identified itself to the company, claiming responsibility for the cybercrime. According to the US Department of Justice, BlackCat/ALPHV is the second most prolific ransomware-as-a-service entity in the world, with over 1000 victims of cybercrimes across the globe. 

This news organization reached out to the Cybersecurity and Infrastructure Security Agency (CISA), a component of the US Department of Homeland Security, for comment on whether CISA or other agencies had taken any previous action to stop the group after other attacks. 

“CISA is working with our partners and Change Healthcare to support remediation, assist impacted organizations, and share timely information to reduce the likelihood of similar intrusions,” Eric Goldstein, executive assistant director for cybersecurity, responded in a statement. 

How Has the Attack Affected Oncology Practices? 

Change Healthcare is a technology company that provides services to hospitals and clinics across the country, including pharmacy claims transactions, clinician claims processing, patient access and financial clearance, clinician payments, and prior authorizations. 

The Community Oncology Alliance (COA) said that the cyberattack has caused a massive disruption in claims processing. COA also said that practices have reported the disruption of benefits verification for patients, prior authorizations, and financial assistance from the attack. 

“It’s impacting pretty much every facet of the practice and practice management,” said Nicolas Ferreyros, managing director of policy, advocacy, and communications at COA. “Right now, practices are making do, they’re working around these challenges.” 

However, Ferreyros cautioned, continuing to manage these challenges “is absolutely, 100% unsustainable” for oncology practices.

“Very soon you’re going to find practices that are having to make tough decisions about what to do, how are they going to make payroll, are they going to take financial risks on filling prescriptions and treating patients?” he added.

What Are Current Workarounds for Clinicians? 

Change Healthcare recommends that clinicians use manual methods such as calling the payer’s provider service line to check patients’ claim status and complete eligibility verification and prior authorizations. 

The Department of Health & Human Services has issued guidance to Medicare Advantage organizations and Part D sponsors asking them to “remove or relax prior authorization, other utilization management, and timely filing requirements” while systems are offline. The department is also asking Medicare Advantage to offer advance funding to clinicians who have been affected the most.

How Common Are Attacks Like These? 

In 2023, a record-setting 725 healthcare security breaches were reported to the Department of Health & Human Services Office for Civil Rights, according to a report from The HIPAA Journal. The number of breachers has increased yearly. Last year, an average of 370,000 healthcare records were breached every day.

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

Thunderstorm asthma can strike with little warning, leaving people with the symptoms of an asthma attack during or after the dark clouds pass. 

If you’re unfamiliar, the risk for a thunderstorm asthma attack grows when heavy storms arrive on a day with very high pollen or spores. The storm uplifts these particles, adds water, and causes them to explode into smaller grains. The electrical activity in a storm can do the same. Next, strong winds sweep these particles down and across the ground. People in the path of the storm can experience shortness of breath, coughing, and wheezing.

If thunderstorms are predicted to become more frequent and more severe with climate change, will the same hold true for thunderstorm asthma?   

“Yes, if only because the amount of pollen appears to be increasing in many areas due to climate change,” said Frank S. Virant, MD, chief of the Allergy Division at Seattle Children’s Hospital in Washington.

Most cases of thunderstorm asthma occur in the spring and early summer, but that also could change. Pollen seasons “have been getting longer and more intense,” said Shaan M. Waqar, MD, an allergist at ENT and Allergy Associates in Plainview, NY. 

“Thunderstorm asthma events are rare, but our changing environment and the increase in the number of people with allergies may make such events more common and more severe into the future,” agreed Paul J. Beggs, PhD, associate professor in the School of Natural Sciences at Macquarie University in Sydney, Australia.

How to Minimize Your Risk

If your patients are sensitive to pollen, advise them to continue to monitor outdoor levels, particularly during tree, grass, and weed pollen season, Dr. Virant recommended. Also patients should pay attention to weather reports. Watch for thunderstorms that could “amplify exposure to the pollen with 40-plus mile per hour winds and often colder air downdrafts.” Cold is an additional asthma trigger, he noted. 

People with asthma should try to stay indoors with windows and doors closed during strong thunderstorms and for several hours afterward. Using air filters can also help reduce risk, said Deepti V. Manian, MD, an allergist and immunologist at Stormont Vail Health in Topeka, Kansas.

Patients should continue controller therapies -- such as longer-acting inhalers and allergy medications -- and use a rescue inhaler or nebulizer for prompt treatment of symptoms, recommended Donald J. Dvorin, MD, of The Allergy and Asthma Doctors in Mount Laurel, NJ. Ideally, people seeking shelter indoors during storms should be “accompanied by friends or family who can help them transport quickly to a hospital if needed.”

Asthma Diagnosis Not Required

Even peoples who would not consider themselves to have asthma can be seriously affected. For example, people with hay fever, or allergic rhinitis as it’s also known, are also at risk, said Ajay Kevat, MBBS, MPH, of the respiratory department at Queensland Children’s Hospital in Brisbane, Australia.

People with hay fever can also experience stronger symptoms during and after thunderstorms. Optimally treating allergic rhinitis during the pollen season with non-sedation antihistamines and nasal steroids can help, Dr. Virant said, instead of “chasing symptoms with medication after they are already severe.” 

Part of the challenge is connecting severe weather to worse asthma symptoms. “In my experience, there is a lack of awareness surrounding thunderstorm asthma,” Dr. Manian said. For example, people with non-allergic rhinitis, also known as vasomotor rhinitis, can also experience the effects. “It often surprises many of my patients when I introduce the concept of vasomotor rhinitis, which can be triggered by environmental fluctuations.”

Gathering Clouds, Gathering Evidence

Climate change could also change which Americans experience the most storms. Researchers in a June 2022 study predicted fewer storms in the Southern plains and more storms in the Midwest and the Southeastern United States in the future.

Dr. Dvorin practices in Southern New Jersey, and in this area, “we fortunate in this area not to experience thunderstorm-induced asthma exacerbations,” he said. 

But climate change means that in the future, thunderstorm asthma could strike in places it has never been seen before, said Dr. Kevat, who wrote a thunderstorm asthma review article published online June 2020 in the Journal of Asthma and Allergy.

And this is not just a concern in the United States. Major thunderstorm asthma events have been reported in Italy, the United Kingdom, the Middle East, Asia, and Australia. In  November 2016, for instance, a strong set of storms swept across Melbourne, Australia. Temperatures dropped 10C (about 18F), humidity rose above 70%, and particulate matter like pollen became more concentrated in the air. 

This event spurred a “thunderstorm asthma epidemic of unprecedented magnitude, tempo, and geographical range and severity,” Dr. Beggs and colleagues wrote in their June 2018 report in The Lancet Planetary Health. 

Large-scale events like this can affect entire communities and quickly overwhelm local health care resources. Within 30 hours of the Melbourne storms, 3,365 people more than usual came to local emergency departments with respiratory issues — and 476 with asthma were admitted to the hospital. Ten people died: five in the hospital and five who could not be resuscitated or died while waiting for emergency services.

More research is needed “so as to best prepare for this unpredictable, significant public health threat,” Dr. Kevat wrote.

People whose asthma is triggered by pollen or mold spores are particularly at risk for thunderstorm asthma, Dr. Waqar said. If you’re unsure, an allergist can help diagnose and treat your allergic risks.

More severe thunderstorms are just one asthma trigger associated with climate change. Last summer, Canadian wildfires sent smoke across the northern U.S. and triggered widespread asthma exacerbations.

A version of this article appeared on WebMD.com. 

Thunderstorm asthma can strike with little warning, leaving people with the symptoms of an asthma attack during or after the dark clouds pass. 

If you’re unfamiliar, the risk for a thunderstorm asthma attack grows when heavy storms arrive on a day with very high pollen or spores. The storm uplifts these particles, adds water, and causes them to explode into smaller grains. The electrical activity in a storm can do the same. Next, strong winds sweep these particles down and across the ground. People in the path of the storm can experience shortness of breath, coughing, and wheezing.

If thunderstorms are predicted to become more frequent and more severe with climate change, will the same hold true for thunderstorm asthma?   

“Yes, if only because the amount of pollen appears to be increasing in many areas due to climate change,” said Frank S. Virant, MD, chief of the Allergy Division at Seattle Children’s Hospital in Washington.

Most cases of thunderstorm asthma occur in the spring and early summer, but that also could change. Pollen seasons “have been getting longer and more intense,” said Shaan M. Waqar, MD, an allergist at ENT and Allergy Associates in Plainview, NY. 

“Thunderstorm asthma events are rare, but our changing environment and the increase in the number of people with allergies may make such events more common and more severe into the future,” agreed Paul J. Beggs, PhD, associate professor in the School of Natural Sciences at Macquarie University in Sydney, Australia.

How to Minimize Your Risk

If your patients are sensitive to pollen, advise them to continue to monitor outdoor levels, particularly during tree, grass, and weed pollen season, Dr. Virant recommended. Also patients should pay attention to weather reports. Watch for thunderstorms that could “amplify exposure to the pollen with 40-plus mile per hour winds and often colder air downdrafts.” Cold is an additional asthma trigger, he noted. 

People with asthma should try to stay indoors with windows and doors closed during strong thunderstorms and for several hours afterward. Using air filters can also help reduce risk, said Deepti V. Manian, MD, an allergist and immunologist at Stormont Vail Health in Topeka, Kansas.

Patients should continue controller therapies -- such as longer-acting inhalers and allergy medications -- and use a rescue inhaler or nebulizer for prompt treatment of symptoms, recommended Donald J. Dvorin, MD, of The Allergy and Asthma Doctors in Mount Laurel, NJ. Ideally, people seeking shelter indoors during storms should be “accompanied by friends or family who can help them transport quickly to a hospital if needed.”

Asthma Diagnosis Not Required

Even peoples who would not consider themselves to have asthma can be seriously affected. For example, people with hay fever, or allergic rhinitis as it’s also known, are also at risk, said Ajay Kevat, MBBS, MPH, of the respiratory department at Queensland Children’s Hospital in Brisbane, Australia.

People with hay fever can also experience stronger symptoms during and after thunderstorms. Optimally treating allergic rhinitis during the pollen season with non-sedation antihistamines and nasal steroids can help, Dr. Virant said, instead of “chasing symptoms with medication after they are already severe.” 

Part of the challenge is connecting severe weather to worse asthma symptoms. “In my experience, there is a lack of awareness surrounding thunderstorm asthma,” Dr. Manian said. For example, people with non-allergic rhinitis, also known as vasomotor rhinitis, can also experience the effects. “It often surprises many of my patients when I introduce the concept of vasomotor rhinitis, which can be triggered by environmental fluctuations.”

Gathering Clouds, Gathering Evidence

Climate change could also change which Americans experience the most storms. Researchers in a June 2022 study predicted fewer storms in the Southern plains and more storms in the Midwest and the Southeastern United States in the future.

Dr. Dvorin practices in Southern New Jersey, and in this area, “we fortunate in this area not to experience thunderstorm-induced asthma exacerbations,” he said. 

But climate change means that in the future, thunderstorm asthma could strike in places it has never been seen before, said Dr. Kevat, who wrote a thunderstorm asthma review article published online June 2020 in the Journal of Asthma and Allergy.

And this is not just a concern in the United States. Major thunderstorm asthma events have been reported in Italy, the United Kingdom, the Middle East, Asia, and Australia. In  November 2016, for instance, a strong set of storms swept across Melbourne, Australia. Temperatures dropped 10C (about 18F), humidity rose above 70%, and particulate matter like pollen became more concentrated in the air. 

This event spurred a “thunderstorm asthma epidemic of unprecedented magnitude, tempo, and geographical range and severity,” Dr. Beggs and colleagues wrote in their June 2018 report in The Lancet Planetary Health. 

Large-scale events like this can affect entire communities and quickly overwhelm local health care resources. Within 30 hours of the Melbourne storms, 3,365 people more than usual came to local emergency departments with respiratory issues — and 476 with asthma were admitted to the hospital. Ten people died: five in the hospital and five who could not be resuscitated or died while waiting for emergency services.

More research is needed “so as to best prepare for this unpredictable, significant public health threat,” Dr. Kevat wrote.

People whose asthma is triggered by pollen or mold spores are particularly at risk for thunderstorm asthma, Dr. Waqar said. If you’re unsure, an allergist can help diagnose and treat your allergic risks.

More severe thunderstorms are just one asthma trigger associated with climate change. Last summer, Canadian wildfires sent smoke across the northern U.S. and triggered widespread asthma exacerbations.

A version of this article appeared on WebMD.com. 

Thunderstorm asthma can strike with little warning, leaving people with the symptoms of an asthma attack during or after the dark clouds pass. 

If you’re unfamiliar, the risk for a thunderstorm asthma attack grows when heavy storms arrive on a day with very high pollen or spores. The storm uplifts these particles, adds water, and causes them to explode into smaller grains. The electrical activity in a storm can do the same. Next, strong winds sweep these particles down and across the ground. People in the path of the storm can experience shortness of breath, coughing, and wheezing.

If thunderstorms are predicted to become more frequent and more severe with climate change, will the same hold true for thunderstorm asthma?   

“Yes, if only because the amount of pollen appears to be increasing in many areas due to climate change,” said Frank S. Virant, MD, chief of the Allergy Division at Seattle Children’s Hospital in Washington.

Most cases of thunderstorm asthma occur in the spring and early summer, but that also could change. Pollen seasons “have been getting longer and more intense,” said Shaan M. Waqar, MD, an allergist at ENT and Allergy Associates in Plainview, NY. 

“Thunderstorm asthma events are rare, but our changing environment and the increase in the number of people with allergies may make such events more common and more severe into the future,” agreed Paul J. Beggs, PhD, associate professor in the School of Natural Sciences at Macquarie University in Sydney, Australia.

How to Minimize Your Risk

If your patients are sensitive to pollen, advise them to continue to monitor outdoor levels, particularly during tree, grass, and weed pollen season, Dr. Virant recommended. Also patients should pay attention to weather reports. Watch for thunderstorms that could “amplify exposure to the pollen with 40-plus mile per hour winds and often colder air downdrafts.” Cold is an additional asthma trigger, he noted. 

People with asthma should try to stay indoors with windows and doors closed during strong thunderstorms and for several hours afterward. Using air filters can also help reduce risk, said Deepti V. Manian, MD, an allergist and immunologist at Stormont Vail Health in Topeka, Kansas.

Patients should continue controller therapies -- such as longer-acting inhalers and allergy medications -- and use a rescue inhaler or nebulizer for prompt treatment of symptoms, recommended Donald J. Dvorin, MD, of The Allergy and Asthma Doctors in Mount Laurel, NJ. Ideally, people seeking shelter indoors during storms should be “accompanied by friends or family who can help them transport quickly to a hospital if needed.”

Asthma Diagnosis Not Required

Even peoples who would not consider themselves to have asthma can be seriously affected. For example, people with hay fever, or allergic rhinitis as it’s also known, are also at risk, said Ajay Kevat, MBBS, MPH, of the respiratory department at Queensland Children’s Hospital in Brisbane, Australia.

People with hay fever can also experience stronger symptoms during and after thunderstorms. Optimally treating allergic rhinitis during the pollen season with non-sedation antihistamines and nasal steroids can help, Dr. Virant said, instead of “chasing symptoms with medication after they are already severe.” 

Part of the challenge is connecting severe weather to worse asthma symptoms. “In my experience, there is a lack of awareness surrounding thunderstorm asthma,” Dr. Manian said. For example, people with non-allergic rhinitis, also known as vasomotor rhinitis, can also experience the effects. “It often surprises many of my patients when I introduce the concept of vasomotor rhinitis, which can be triggered by environmental fluctuations.”

Gathering Clouds, Gathering Evidence

Climate change could also change which Americans experience the most storms. Researchers in a June 2022 study predicted fewer storms in the Southern plains and more storms in the Midwest and the Southeastern United States in the future.

Dr. Dvorin practices in Southern New Jersey, and in this area, “we fortunate in this area not to experience thunderstorm-induced asthma exacerbations,” he said. 

But climate change means that in the future, thunderstorm asthma could strike in places it has never been seen before, said Dr. Kevat, who wrote a thunderstorm asthma review article published online June 2020 in the Journal of Asthma and Allergy.

And this is not just a concern in the United States. Major thunderstorm asthma events have been reported in Italy, the United Kingdom, the Middle East, Asia, and Australia. In  November 2016, for instance, a strong set of storms swept across Melbourne, Australia. Temperatures dropped 10C (about 18F), humidity rose above 70%, and particulate matter like pollen became more concentrated in the air. 

This event spurred a “thunderstorm asthma epidemic of unprecedented magnitude, tempo, and geographical range and severity,” Dr. Beggs and colleagues wrote in their June 2018 report in The Lancet Planetary Health. 

Large-scale events like this can affect entire communities and quickly overwhelm local health care resources. Within 30 hours of the Melbourne storms, 3,365 people more than usual came to local emergency departments with respiratory issues — and 476 with asthma were admitted to the hospital. Ten people died: five in the hospital and five who could not be resuscitated or died while waiting for emergency services.

More research is needed “so as to best prepare for this unpredictable, significant public health threat,” Dr. Kevat wrote.

People whose asthma is triggered by pollen or mold spores are particularly at risk for thunderstorm asthma, Dr. Waqar said. If you’re unsure, an allergist can help diagnose and treat your allergic risks.

More severe thunderstorms are just one asthma trigger associated with climate change. Last summer, Canadian wildfires sent smoke across the northern U.S. and triggered widespread asthma exacerbations.

A version of this article appeared on WebMD.com. 

The US Food and Drug Administration has expanded the indication of inotuzumab ozogamicin (Besponsa, Pfizer) to include children aged ≥ 1 year with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

The CD22-directed antibody and cytotoxic drug conjugate was previously approved only for adults with the condition. 

Pediatric approval was based on a single-arm study of 53 children, of whom 12 were treated with an initial dose of 1.4 mg/m^{2 per} cycle and the rest with an initial dose of 1.8 mg/m² per cycle for a median of two cycles and a range of one to four cycles. 

Premedications included methylprednisolone plus an antipyretic and antihistamine.

Overall, 22 children (42%) had a complete remission, defined as < 5% blasts in the bone marrow, no leukemia blasts in peripheral blood, full recovery of peripheral blood counts, and resolution of extramedullary disease. The median duration of complete remission was 8.2 months. 

All but one child who went into complete remission (95.5%) had no minimal residual disease (MRD) by flow cytometry, and 19 (86.4%) were MRD negative by real-time quantitative polymerase chain reaction.

Adverse events in ≥ 20% of participants included thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.

The antibody-drug conjugate carries a black box warning of hepatotoxicity, including hepatic veno-occlusive and post-hematopoietic stem cell transplant mortality.

The initial recommended dose is 1.8 mg/m² per cycle, divided into 0.8 mg/m² on day 1, followed by 0.5 mg/m² on day 9 and 0.5 mg/m² on day 15. The initial 3-week cycle can be extended to 4 weeks for patients who have a complete remission or a complete remission with incomplete hematologic recovery and/or to recover from toxicities. 

According to drugs.com, 0.9 mg costs $23,423.47.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration has expanded the indication of inotuzumab ozogamicin (Besponsa, Pfizer) to include children aged ≥ 1 year with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

The CD22-directed antibody and cytotoxic drug conjugate was previously approved only for adults with the condition. 

Pediatric approval was based on a single-arm study of 53 children, of whom 12 were treated with an initial dose of 1.4 mg/m^{2 per} cycle and the rest with an initial dose of 1.8 mg/m² per cycle for a median of two cycles and a range of one to four cycles. 

Premedications included methylprednisolone plus an antipyretic and antihistamine.

Overall, 22 children (42%) had a complete remission, defined as < 5% blasts in the bone marrow, no leukemia blasts in peripheral blood, full recovery of peripheral blood counts, and resolution of extramedullary disease. The median duration of complete remission was 8.2 months. 

All but one child who went into complete remission (95.5%) had no minimal residual disease (MRD) by flow cytometry, and 19 (86.4%) were MRD negative by real-time quantitative polymerase chain reaction.

Adverse events in ≥ 20% of participants included thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.

The antibody-drug conjugate carries a black box warning of hepatotoxicity, including hepatic veno-occlusive and post-hematopoietic stem cell transplant mortality.

The initial recommended dose is 1.8 mg/m² per cycle, divided into 0.8 mg/m² on day 1, followed by 0.5 mg/m² on day 9 and 0.5 mg/m² on day 15. The initial 3-week cycle can be extended to 4 weeks for patients who have a complete remission or a complete remission with incomplete hematologic recovery and/or to recover from toxicities. 

According to drugs.com, 0.9 mg costs $23,423.47.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration has expanded the indication of inotuzumab ozogamicin (Besponsa, Pfizer) to include children aged ≥ 1 year with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

The CD22-directed antibody and cytotoxic drug conjugate was previously approved only for adults with the condition. 

Pediatric approval was based on a single-arm study of 53 children, of whom 12 were treated with an initial dose of 1.4 mg/m^{2 per} cycle and the rest with an initial dose of 1.8 mg/m² per cycle for a median of two cycles and a range of one to four cycles. 

Premedications included methylprednisolone plus an antipyretic and antihistamine.

Overall, 22 children (42%) had a complete remission, defined as < 5% blasts in the bone marrow, no leukemia blasts in peripheral blood, full recovery of peripheral blood counts, and resolution of extramedullary disease. The median duration of complete remission was 8.2 months. 

All but one child who went into complete remission (95.5%) had no minimal residual disease (MRD) by flow cytometry, and 19 (86.4%) were MRD negative by real-time quantitative polymerase chain reaction.

Adverse events in ≥ 20% of participants included thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.

The antibody-drug conjugate carries a black box warning of hepatotoxicity, including hepatic veno-occlusive and post-hematopoietic stem cell transplant mortality.

The initial recommended dose is 1.8 mg/m² per cycle, divided into 0.8 mg/m² on day 1, followed by 0.5 mg/m² on day 9 and 0.5 mg/m² on day 15. The initial 3-week cycle can be extended to 4 weeks for patients who have a complete remission or a complete remission with incomplete hematologic recovery and/or to recover from toxicities. 

According to drugs.com, 0.9 mg costs $23,423.47.
 

A version of this article appeared on Medscape.com.

A new AGA white paper, published in Clinical Gastroenterology and Hepatology, highlights barriers to care and calls for collaboration among our healthcare community, insurers, pharmaceutical companies, and legislators to improve and optimize care for more than 3 million Americans living with inflammatory bowel disease (IBD).

Over the last two decades, there has been a revolution in therapeutics fueled by exciting research and development that continues to expand the treatment options for IBD, offering tools for better disease control. However, the most effective therapies are cost prohibitive and have largely become inaccessible due to insurer-mandated barriers to care, such as prior authorization and step therapy.

AGA has created a plan that addresses these barriers and proposes tangible solutions to provide patients with high quality, high value care.

1. The lived experiences and valuable insights from both patients and expert clinicians should be reflected in the data and research represented in the field.

2. AGA recognizes the powerful benefit of individually tailoring IBD therapy based on risk, comorbidities and response, and encourages all stakeholders to do the same.

3. As a field, we need to move beyond insurer-mandated step therapy and fail first policies.

4. AGA urges insurers to cover all necessary disease activity and drug level monitoring, which will ensure patients are able to achieve treat-to-target-driven outcomes.

5. Streamlined and expedited expert reviews should be guaranteed to all providers when they are mandated by an insurer.

6. To ensure transparency and accountability, AGA wants to require that payors publish their denial and appeals data.

7. AGA believes that holistic patient-centered multidisciplinary care, including psychosocial and dietary support, should be covered by insurance. Having access to such care contributes to improved patient resilience and well-being, which will lead to decreased health care utilization and better health outcomes.

8. AGA supports the creation and continuation of a variety of patient education programs to improve health literacy and awareness of complex health care systems.

9. AGA is committed to improving patients’ access to expert specialized clinical IBD care. This includes flexible delivery models to ensure that underserved populations are being reached. In addition, AGA supports training and educating specialty providers across the spectrum of medical care (advanced practice providers, nurse educators, etc.) to increase the number of qualified IBD providers.

10. Piloting innovative shared incentive partnerships between high value subspecialty care practices and payors will be a new shared goal.

11. AGA wants to engage pharmaceutical partners in developing equitable programs to address prohibitive drug costs while also expanding patient access and support.

12. AGA plans to continue to advocate for legislation to make access to therapy equitable for Medicare and Medicaid patients.

“Unaffordable drug costs, step therapy, and other insurer-mandated barriers are fixable problems,” said M. Anthony Sofia, MD, a coauthor of the AGA white paper and an IBD specialist at Oregon Health and Science University, Portland.

Oregon Health and Science University

“Every day, we see people that have been harmed by delayed and inadequate care. Solving these barriers would lift an unimaginable weight off our patient’s shoulders and allow them to lead healthier lives. We must work together to collaborate on solutions to strengthen and advance the care for all people with IBD.”

View the full white paper here.

A new AGA white paper, published in Clinical Gastroenterology and Hepatology, highlights barriers to care and calls for collaboration among our healthcare community, insurers, pharmaceutical companies, and legislators to improve and optimize care for more than 3 million Americans living with inflammatory bowel disease (IBD).

Over the last two decades, there has been a revolution in therapeutics fueled by exciting research and development that continues to expand the treatment options for IBD, offering tools for better disease control. However, the most effective therapies are cost prohibitive and have largely become inaccessible due to insurer-mandated barriers to care, such as prior authorization and step therapy.

AGA has created a plan that addresses these barriers and proposes tangible solutions to provide patients with high quality, high value care.

1. The lived experiences and valuable insights from both patients and expert clinicians should be reflected in the data and research represented in the field.

2. AGA recognizes the powerful benefit of individually tailoring IBD therapy based on risk, comorbidities and response, and encourages all stakeholders to do the same.

3. As a field, we need to move beyond insurer-mandated step therapy and fail first policies.

4. AGA urges insurers to cover all necessary disease activity and drug level monitoring, which will ensure patients are able to achieve treat-to-target-driven outcomes.

5. Streamlined and expedited expert reviews should be guaranteed to all providers when they are mandated by an insurer.

6. To ensure transparency and accountability, AGA wants to require that payors publish their denial and appeals data.

7. AGA believes that holistic patient-centered multidisciplinary care, including psychosocial and dietary support, should be covered by insurance. Having access to such care contributes to improved patient resilience and well-being, which will lead to decreased health care utilization and better health outcomes.

8. AGA supports the creation and continuation of a variety of patient education programs to improve health literacy and awareness of complex health care systems.

9. AGA is committed to improving patients’ access to expert specialized clinical IBD care. This includes flexible delivery models to ensure that underserved populations are being reached. In addition, AGA supports training and educating specialty providers across the spectrum of medical care (advanced practice providers, nurse educators, etc.) to increase the number of qualified IBD providers.

10. Piloting innovative shared incentive partnerships between high value subspecialty care practices and payors will be a new shared goal.

11. AGA wants to engage pharmaceutical partners in developing equitable programs to address prohibitive drug costs while also expanding patient access and support.

12. AGA plans to continue to advocate for legislation to make access to therapy equitable for Medicare and Medicaid patients.

“Unaffordable drug costs, step therapy, and other insurer-mandated barriers are fixable problems,” said M. Anthony Sofia, MD, a coauthor of the AGA white paper and an IBD specialist at Oregon Health and Science University, Portland.

Oregon Health and Science University

“Every day, we see people that have been harmed by delayed and inadequate care. Solving these barriers would lift an unimaginable weight off our patient’s shoulders and allow them to lead healthier lives. We must work together to collaborate on solutions to strengthen and advance the care for all people with IBD.”

View the full white paper here.

A new AGA white paper, published in Clinical Gastroenterology and Hepatology, highlights barriers to care and calls for collaboration among our healthcare community, insurers, pharmaceutical companies, and legislators to improve and optimize care for more than 3 million Americans living with inflammatory bowel disease (IBD).

Over the last two decades, there has been a revolution in therapeutics fueled by exciting research and development that continues to expand the treatment options for IBD, offering tools for better disease control. However, the most effective therapies are cost prohibitive and have largely become inaccessible due to insurer-mandated barriers to care, such as prior authorization and step therapy.

AGA has created a plan that addresses these barriers and proposes tangible solutions to provide patients with high quality, high value care.

1. The lived experiences and valuable insights from both patients and expert clinicians should be reflected in the data and research represented in the field.

2. AGA recognizes the powerful benefit of individually tailoring IBD therapy based on risk, comorbidities and response, and encourages all stakeholders to do the same.

3. As a field, we need to move beyond insurer-mandated step therapy and fail first policies.

4. AGA urges insurers to cover all necessary disease activity and drug level monitoring, which will ensure patients are able to achieve treat-to-target-driven outcomes.

5. Streamlined and expedited expert reviews should be guaranteed to all providers when they are mandated by an insurer.

6. To ensure transparency and accountability, AGA wants to require that payors publish their denial and appeals data.

7. AGA believes that holistic patient-centered multidisciplinary care, including psychosocial and dietary support, should be covered by insurance. Having access to such care contributes to improved patient resilience and well-being, which will lead to decreased health care utilization and better health outcomes.

8. AGA supports the creation and continuation of a variety of patient education programs to improve health literacy and awareness of complex health care systems.

9. AGA is committed to improving patients’ access to expert specialized clinical IBD care. This includes flexible delivery models to ensure that underserved populations are being reached. In addition, AGA supports training and educating specialty providers across the spectrum of medical care (advanced practice providers, nurse educators, etc.) to increase the number of qualified IBD providers.

10. Piloting innovative shared incentive partnerships between high value subspecialty care practices and payors will be a new shared goal.

11. AGA wants to engage pharmaceutical partners in developing equitable programs to address prohibitive drug costs while also expanding patient access and support.

12. AGA plans to continue to advocate for legislation to make access to therapy equitable for Medicare and Medicaid patients.

“Unaffordable drug costs, step therapy, and other insurer-mandated barriers are fixable problems,” said M. Anthony Sofia, MD, a coauthor of the AGA white paper and an IBD specialist at Oregon Health and Science University, Portland.

Oregon Health and Science University

“Every day, we see people that have been harmed by delayed and inadequate care. Solving these barriers would lift an unimaginable weight off our patient’s shoulders and allow them to lead healthier lives. We must work together to collaborate on solutions to strengthen and advance the care for all people with IBD.”

View the full white paper here.

TOPLINE:

The odds of having cognitive impairment may be increased among children with atopic dermatitis, primarily among those with neurodevelopmental disorders, such as attention-deficit/hyperactivity disorder (ADHD) or a learning disability.

METHODOLOGY:

It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.

To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.

Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.

The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.

TAKEAWAY:

Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).

On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41). 

When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).

Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions. 

IN PRACTICE:

“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.

SOURCE:

Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep. 

DISCLOSURES:

The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report. 

A version of this article appeared on Medscape.com.

TOPLINE:

The odds of having cognitive impairment may be increased among children with atopic dermatitis, primarily among those with neurodevelopmental disorders, such as attention-deficit/hyperactivity disorder (ADHD) or a learning disability.

METHODOLOGY:

It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.

To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.

Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.

The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.

TAKEAWAY:

Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).

On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41). 

When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).

Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions. 

IN PRACTICE:

“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.

SOURCE:

Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep. 

DISCLOSURES:

The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report. 

A version of this article appeared on Medscape.com.

TOPLINE:

The odds of having cognitive impairment may be increased among children with atopic dermatitis, primarily among those with neurodevelopmental disorders, such as attention-deficit/hyperactivity disorder (ADHD) or a learning disability.

METHODOLOGY:

It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.

To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.

Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.

The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.

TAKEAWAY:

Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).

On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41). 

When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).

Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions. 

IN PRACTICE:

“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.

SOURCE:

Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep. 

DISCLOSURES:

The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report. 

A version of this article appeared on Medscape.com.

TOPLINE:

Women with daily exposure to spironolactone for dermatologic conditions showed no higher risk of developing breast or gynecologic cancer than that of unexposed women.

METHODOLOGY:

• Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
• The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
• Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.

TAKEAWAY:

• A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
• After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
• The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).

IN PRACTICE:

“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.

SOURCE:

The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.

LIMITATIONS:

The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.

DISCLOSURES:

The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.

A version of this article appeared on Medscape.com.

TOPLINE:

Women with daily exposure to spironolactone for dermatologic conditions showed no higher risk of developing breast or gynecologic cancer than that of unexposed women.

METHODOLOGY:

• Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
• The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
• Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.

TAKEAWAY:

• A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
• After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
• The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).

IN PRACTICE:

“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.

SOURCE:

The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.

LIMITATIONS:

The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.

DISCLOSURES:

The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.

A version of this article appeared on Medscape.com.

TOPLINE:

Women with daily exposure to spironolactone for dermatologic conditions showed no higher risk of developing breast or gynecologic cancer than that of unexposed women.

METHODOLOGY:

• Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
• The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
• Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.

TAKEAWAY:

• A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
• After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
• The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).

IN PRACTICE:

“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.

SOURCE:

The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.

LIMITATIONS:

The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.

DISCLOSURES:

The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.

A version of this article appeared on Medscape.com.

Lawmakers have added a provision to raise Medicare payments to clinicians to a $460 billion bipartisan package of federal spending bills that passed in the House on March 6 and is expected to be passed in the Senate and signed by President Biden before then end of March 8, but industry groups have criticized it as paltry.

Lawmakers often tweak Medicare policy by adding provisions to other kinds of legislation, including the spending bills Congress must pass to keep the federal government running.

Physicians’ groups and some lawmakers have long pressed Congress to change Medicare payment rules with little success, even as inflation has caused physicians’ expenses to rise. Doctors now face a 3.4% cut to Medicare reimbursements in 2024, which would be only partly mitigated by the recently announced provision.

The Medical Group Management Association (MGMA) said the proposed increase would total 1.68%. The increase, part of a bipartisan package of bills released by the House and Senate Appropriations committees on March 3, would apply to the budget for fiscal 2024, which began on October 1, 2023.

“We are deeply disappointed with Congress’ half-hearted attempt to remedy the devastating blow physician practices were dealt by the 2024 Medicare Physician Fee Schedule,” Anders Gilberg, senior vice president of MGMA, said in a statement. “Anything less than a full reversal of the 3.4% cut is appallingly inadequate.”

The American Medical Association said it was “extremely disappointed” that the boost only eased, but did not fully reverse, a deeper planned cut.

The American Academy of Family Physicians (AAFP) also expressed disappointment with the proposed increase.

“The AAFP has repeatedly told Congress that the 3.4% Medicare payment reduction that went into effect on January 1 is untenable for family physicians and threatens patients’ access to primary care,” the group said in a statement.

“While we appreciate the partial relief, family physicians continue to face an annual threat of payment cuts that are detrimental to practices and patients,” AAFP said.

A version of this article appeared on Medscape.com.

Lawmakers have added a provision to raise Medicare payments to clinicians to a $460 billion bipartisan package of federal spending bills that passed in the House on March 6 and is expected to be passed in the Senate and signed by President Biden before then end of March 8, but industry groups have criticized it as paltry.

Lawmakers often tweak Medicare policy by adding provisions to other kinds of legislation, including the spending bills Congress must pass to keep the federal government running.

Physicians’ groups and some lawmakers have long pressed Congress to change Medicare payment rules with little success, even as inflation has caused physicians’ expenses to rise. Doctors now face a 3.4% cut to Medicare reimbursements in 2024, which would be only partly mitigated by the recently announced provision.

The Medical Group Management Association (MGMA) said the proposed increase would total 1.68%. The increase, part of a bipartisan package of bills released by the House and Senate Appropriations committees on March 3, would apply to the budget for fiscal 2024, which began on October 1, 2023.

“We are deeply disappointed with Congress’ half-hearted attempt to remedy the devastating blow physician practices were dealt by the 2024 Medicare Physician Fee Schedule,” Anders Gilberg, senior vice president of MGMA, said in a statement. “Anything less than a full reversal of the 3.4% cut is appallingly inadequate.”

The American Medical Association said it was “extremely disappointed” that the boost only eased, but did not fully reverse, a deeper planned cut.

The American Academy of Family Physicians (AAFP) also expressed disappointment with the proposed increase.

“The AAFP has repeatedly told Congress that the 3.4% Medicare payment reduction that went into effect on January 1 is untenable for family physicians and threatens patients’ access to primary care,” the group said in a statement.

“While we appreciate the partial relief, family physicians continue to face an annual threat of payment cuts that are detrimental to practices and patients,” AAFP said.

A version of this article appeared on Medscape.com.

Lawmakers have added a provision to raise Medicare payments to clinicians to a $460 billion bipartisan package of federal spending bills that passed in the House on March 6 and is expected to be passed in the Senate and signed by President Biden before then end of March 8, but industry groups have criticized it as paltry.

Lawmakers often tweak Medicare policy by adding provisions to other kinds of legislation, including the spending bills Congress must pass to keep the federal government running.

Physicians’ groups and some lawmakers have long pressed Congress to change Medicare payment rules with little success, even as inflation has caused physicians’ expenses to rise. Doctors now face a 3.4% cut to Medicare reimbursements in 2024, which would be only partly mitigated by the recently announced provision.

The Medical Group Management Association (MGMA) said the proposed increase would total 1.68%. The increase, part of a bipartisan package of bills released by the House and Senate Appropriations committees on March 3, would apply to the budget for fiscal 2024, which began on October 1, 2023.

“We are deeply disappointed with Congress’ half-hearted attempt to remedy the devastating blow physician practices were dealt by the 2024 Medicare Physician Fee Schedule,” Anders Gilberg, senior vice president of MGMA, said in a statement. “Anything less than a full reversal of the 3.4% cut is appallingly inadequate.”

The American Medical Association said it was “extremely disappointed” that the boost only eased, but did not fully reverse, a deeper planned cut.

The American Academy of Family Physicians (AAFP) also expressed disappointment with the proposed increase.

“The AAFP has repeatedly told Congress that the 3.4% Medicare payment reduction that went into effect on January 1 is untenable for family physicians and threatens patients’ access to primary care,” the group said in a statement.

“While we appreciate the partial relief, family physicians continue to face an annual threat of payment cuts that are detrimental to practices and patients,” AAFP said.

A version of this article appeared on Medscape.com.

TOPLINE:

A fiber supplement also found in beans and other foods may lead to weight loss and improved insulin sensitivity in people with excess body weight, partly due to changes in the gut microbiota.

METHODOLOGY:

• In animal studies, resistant starch (RS), a kind of dietary fiber, has shown a potential to reduce body fat along with other metabolic benefits, but human dietary studies of RS have been inconsistent, especially with a high-fat diet.
• Researchers conducted a crossover, randomized trial to study the effect of RS as a dietary supplement on 37 individuals with overweight or obesity (average age, 33.43 years; 15 women; body mass index > 24 or higher waist circumference).
• Participants were fed a similar background diet and either 40 g of RS (high-amylose maize) or an energy-matched placebo starch daily for 8 weeks and then switched between the two in a separate 8-week period.
• The primary outcome was body weight, and the secondary outcomes were visceral and subcutaneous fat mass, waist circumference, lipid profiles, insulin sensitivity, metabolome, and gut microbiome.
• RS’s impact on gut microbiota composition and function was assessed with metagenomics and metabolomics, and RS-modified gut microbiota’s effect on host body fat and glucose was confirmed by transferring from select average participants to mice.

TAKEAWAY:

• Participants showed a mean weight loss of 2.8 kg after consuming RS for 8 weeks (P < .001), but there was no significant change in body weight in those on placebo starch.
• RS improved insulin sensitivity in people to a greater extent than placebo starch (P = .025) and showed a greater reduction in fat mass, waist circumference, and other obesity-related outcomes.
• The abundance in the gut of the microbe Bifidobacterium adolescentis increased significantly following RS intervention, an increase that exhibited a strong correlation with decreased BMI, suggesting a role of RS in reducing obesity.
• The levels of pro-inflammatory cytokines, such as serum tumor necrosis factor-alpha and interleukin-1 beta, were significantly lower in participants who consumed RS than in those who had placebo starch.

IN PRACTICE:

“Our study provided an effective dietary recommendation using RS as a supplement (40 g/d with a balanced background diet containing 25%-30% fat), which may help to achieve significant weight loss,” the authors wrote.

SOURCE:

This study was led and corresponded by Huating Li, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China, and University of Hong Kong, Pok Fu Lam, and published online in Nature Metabolism.

LIMITATIONS:

This study was limited by the small sample size and stringent inclusion criteria for participants. The use of database-driven and taxane-based methodology might have led to difficult-to-classify sequences being discarded and strain-level functional diversity being overlooked. The authors also acknowledged the need to validate the findings of this study in larger and more diverse cohorts.

DISCLOSURES:

This work was supported by the National Key Research and Development Program of China, Shanghai Municipal Key Clinical Specialty, National Natural Science Foundation of China, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A fiber supplement also found in beans and other foods may lead to weight loss and improved insulin sensitivity in people with excess body weight, partly due to changes in the gut microbiota.

METHODOLOGY:

• In animal studies, resistant starch (RS), a kind of dietary fiber, has shown a potential to reduce body fat along with other metabolic benefits, but human dietary studies of RS have been inconsistent, especially with a high-fat diet.
• Researchers conducted a crossover, randomized trial to study the effect of RS as a dietary supplement on 37 individuals with overweight or obesity (average age, 33.43 years; 15 women; body mass index > 24 or higher waist circumference).
• Participants were fed a similar background diet and either 40 g of RS (high-amylose maize) or an energy-matched placebo starch daily for 8 weeks and then switched between the two in a separate 8-week period.
• The primary outcome was body weight, and the secondary outcomes were visceral and subcutaneous fat mass, waist circumference, lipid profiles, insulin sensitivity, metabolome, and gut microbiome.
• RS’s impact on gut microbiota composition and function was assessed with metagenomics and metabolomics, and RS-modified gut microbiota’s effect on host body fat and glucose was confirmed by transferring from select average participants to mice.

TAKEAWAY:

• Participants showed a mean weight loss of 2.8 kg after consuming RS for 8 weeks (P < .001), but there was no significant change in body weight in those on placebo starch.
• RS improved insulin sensitivity in people to a greater extent than placebo starch (P = .025) and showed a greater reduction in fat mass, waist circumference, and other obesity-related outcomes.
• The abundance in the gut of the microbe Bifidobacterium adolescentis increased significantly following RS intervention, an increase that exhibited a strong correlation with decreased BMI, suggesting a role of RS in reducing obesity.
• The levels of pro-inflammatory cytokines, such as serum tumor necrosis factor-alpha and interleukin-1 beta, were significantly lower in participants who consumed RS than in those who had placebo starch.

IN PRACTICE:

“Our study provided an effective dietary recommendation using RS as a supplement (40 g/d with a balanced background diet containing 25%-30% fat), which may help to achieve significant weight loss,” the authors wrote.

SOURCE:

This study was led and corresponded by Huating Li, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China, and University of Hong Kong, Pok Fu Lam, and published online in Nature Metabolism.

LIMITATIONS:

This study was limited by the small sample size and stringent inclusion criteria for participants. The use of database-driven and taxane-based methodology might have led to difficult-to-classify sequences being discarded and strain-level functional diversity being overlooked. The authors also acknowledged the need to validate the findings of this study in larger and more diverse cohorts.

DISCLOSURES:

This work was supported by the National Key Research and Development Program of China, Shanghai Municipal Key Clinical Specialty, National Natural Science Foundation of China, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A fiber supplement also found in beans and other foods may lead to weight loss and improved insulin sensitivity in people with excess body weight, partly due to changes in the gut microbiota.

METHODOLOGY:

• In animal studies, resistant starch (RS), a kind of dietary fiber, has shown a potential to reduce body fat along with other metabolic benefits, but human dietary studies of RS have been inconsistent, especially with a high-fat diet.
• Researchers conducted a crossover, randomized trial to study the effect of RS as a dietary supplement on 37 individuals with overweight or obesity (average age, 33.43 years; 15 women; body mass index > 24 or higher waist circumference).
• Participants were fed a similar background diet and either 40 g of RS (high-amylose maize) or an energy-matched placebo starch daily for 8 weeks and then switched between the two in a separate 8-week period.
• The primary outcome was body weight, and the secondary outcomes were visceral and subcutaneous fat mass, waist circumference, lipid profiles, insulin sensitivity, metabolome, and gut microbiome.
• RS’s impact on gut microbiota composition and function was assessed with metagenomics and metabolomics, and RS-modified gut microbiota’s effect on host body fat and glucose was confirmed by transferring from select average participants to mice.

TAKEAWAY:

• Participants showed a mean weight loss of 2.8 kg after consuming RS for 8 weeks (P < .001), but there was no significant change in body weight in those on placebo starch.
• RS improved insulin sensitivity in people to a greater extent than placebo starch (P = .025) and showed a greater reduction in fat mass, waist circumference, and other obesity-related outcomes.
• The abundance in the gut of the microbe Bifidobacterium adolescentis increased significantly following RS intervention, an increase that exhibited a strong correlation with decreased BMI, suggesting a role of RS in reducing obesity.
• The levels of pro-inflammatory cytokines, such as serum tumor necrosis factor-alpha and interleukin-1 beta, were significantly lower in participants who consumed RS than in those who had placebo starch.

IN PRACTICE:

“Our study provided an effective dietary recommendation using RS as a supplement (40 g/d with a balanced background diet containing 25%-30% fat), which may help to achieve significant weight loss,” the authors wrote.

SOURCE:

This study was led and corresponded by Huating Li, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China, and University of Hong Kong, Pok Fu Lam, and published online in Nature Metabolism.

LIMITATIONS:

This study was limited by the small sample size and stringent inclusion criteria for participants. The use of database-driven and taxane-based methodology might have led to difficult-to-classify sequences being discarded and strain-level functional diversity being overlooked. The authors also acknowledged the need to validate the findings of this study in larger and more diverse cohorts.

DISCLOSURES:

This work was supported by the National Key Research and Development Program of China, Shanghai Municipal Key Clinical Specialty, National Natural Science Foundation of China, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.