Damian McNamara

If Roe v. Wade is overturned, can criminal prosecutors or tech companies use smartphone data against someone?

Now that the future of U.S. abortion laws hangs in the balance, many women are questioning the degree of caution needed to keep their cyber activity confidential – especially period and fertility tracking apps, smartphone location data, and social media interactions.

Cybersecurity and legal experts say the answer largely boils down to one major issue: The right to privacy.

“There’s this notion of the expectation of privacy,” said Brad Malin, PhD, professor of biomedical informatics, biostatistics, and computer science at Vanderbilt University in Nashville, Tenn.

Dr. Malin said it’s directly related to bodily privacy that a person expects they have control of as part of their own environment.

According to Dr. Malin, this is “why this whole notion of Roe v. Wade at the present moment is really relevant. The right to privacy is mentioned about a dozen times within the law for the case.

“This is why we don’t know what’s going to happen with Roe v. Wade, but it worries a lot of privacy professionals,” he said. “It leads down this slippery slope of if you don’t even have control over your own body, then with electronic communications … we might as well not even start.”
 

Legal protections

The Fourth Amendment of the U.S. Constitution protects people against unreasonable searches and seizures.

To acquire cyber data that could be used as evidence in courts in states where abortion is deemed a crime, prosecutors would still have to go through standard criminal procedures, said Anthony Michael Kreis, JD, a constitutional law professor at Georgia State University, Atlanta.

But the data they do get could still be used in court against someone who is suspected of having had an abortion or who “miscarried under circumstances law enforcement officers found suspicious,” Mr. Kreis said.

And there’s another possibility, he noted: States holding women who end their pregnancies criminally or civilly responsible for “leaving their jurisdiction to obtain an abortion out-of-state.”

“That legal mechanism may abridge the constitutional right to travel, but it is not out of the realm of possibilities in a post-Roe America,” said Mr. Kreis.

But while many anti-abortion groups have said that criminalizing abortion or limiting access to contraception is not the end goal, “history is not promising here,” said Ellen Wright Clayton, MD, JD, professor of pediatrics and professor of law at Vanderbilt University.

She referred to a recent proposal from lawmakers in Louisiana to classify abortion as homicide.

The bill didn’t get far in the House of Representatives, but the concern is warranted, said Dr. Clayton.
 

Period and fertility tracking apps

Health information privacy laws, like the Health Insurance Portability and Accountability Act (HIPAA), do not protect information on period and fertility tracking apps.

Right now, there are no signs that people plan to use period and fertility tracking data to advance a prochoice agenda, according to Adam Levin, JD, a cybersecurity expert and founder of CyberScout, a global identity and data protection company.

Still, a cycle tracking app “created by a company owned by an antiabortion activist” is totally feasible, said Mr. Levin.

If you want to ensure your data is safe from such meddling, you may want to delete your app, he said, noting that using the notepad feature on your smartphone could be a safer alternative, as could using old-fashioned pen and paper.

You don’t have to stop with period and fertility tracking apps, either.

For any apps you share personal information with, set privacy settings “as tightly as possible” – and reconsider using apps if these options are unavailable, Mr. Levin advised.

“Make sure that company is not engaging in social or political activism that does not align with your politics.”

New York State Attorney General Letitia James recently spoke on the topic, noting on May 13 that “people use fertility tracking apps and location services every day, but if they’re not careful their personal information can end up in the wrong hands.

“With abortion rights in jeopardy, it’s more important than ever that everyone take their digital privacy seriously,” she said. “I urge everyone, especially those visiting abortion clinics or seeking abortion care, to follow the tips offered by my office and be more careful of the apps and websites they use.”

The New York State Attorney General’s Office recommends women use encrypted messaging when communicating about personal health information or behaviors, and to be careful about what they share on social media posts. The office also suggests turning off location and personalized advertising options on their smartphones.
 

Cellphone location data

Dr. Malin said there are several ways that location services could be used to track where a woman uses her smartphone. An app could track locations if someone grants permission through the app end user agreement, for example.

A second but less likely scenario would be the service provider tracking the pings coming off cellphone towers to find a smartphone.

So what recourse does a woman have if tracked by a third-party app?

“It’s a really tricky situation there because it depends on if the individual was put expressly in harm’s way,” Dr. Malin said. What’s more, tracking someone out in public is not prohibited in general.

“There’s a big difference between documenting what an individual does within a Planned Parenthood clinic versus what they do outside of it,” he said.

Dr. Malin said it’s better that regulations protect all smartphone users rather than requiring each person to remember to turn off the location tracker and then turn it back on again. Also, it should be more of an opt-in situation – where app developers must ask permission to track app usage or location services – versus making each woman opt out.
 

Think before you share

Vindictive or untrustworthy partners and family members of women in abusive relationships could also be a cause of concern, said Mr. Kreis.

“Individuals within a woman’s closest circles could hold abortions over their head or threaten reporting them for reproductive health care or miscarriages,” he said.

It’s not uncommon for women to experience domestic violence after having an abortion, particularly if their partners were unaware they had the procedure, according to Dr. Clayton.

She said women should also be mindful of what they share on social media.

Dr. Clayton gave the example of a woman seeking advice on where to get a safe abortion or how to order certain medications.

“If someone goes online to look for that, that’s potentially dangerous.”

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

If Roe v. Wade is overturned, can criminal prosecutors or tech companies use smartphone data against someone?

Now that the future of U.S. abortion laws hangs in the balance, many women are questioning the degree of caution needed to keep their cyber activity confidential – especially period and fertility tracking apps, smartphone location data, and social media interactions.

Cybersecurity and legal experts say the answer largely boils down to one major issue: The right to privacy.

“There’s this notion of the expectation of privacy,” said Brad Malin, PhD, professor of biomedical informatics, biostatistics, and computer science at Vanderbilt University in Nashville, Tenn.

Dr. Malin said it’s directly related to bodily privacy that a person expects they have control of as part of their own environment.

According to Dr. Malin, this is “why this whole notion of Roe v. Wade at the present moment is really relevant. The right to privacy is mentioned about a dozen times within the law for the case.

“This is why we don’t know what’s going to happen with Roe v. Wade, but it worries a lot of privacy professionals,” he said. “It leads down this slippery slope of if you don’t even have control over your own body, then with electronic communications … we might as well not even start.”
 

Legal protections

The Fourth Amendment of the U.S. Constitution protects people against unreasonable searches and seizures.

To acquire cyber data that could be used as evidence in courts in states where abortion is deemed a crime, prosecutors would still have to go through standard criminal procedures, said Anthony Michael Kreis, JD, a constitutional law professor at Georgia State University, Atlanta.

But the data they do get could still be used in court against someone who is suspected of having had an abortion or who “miscarried under circumstances law enforcement officers found suspicious,” Mr. Kreis said.

And there’s another possibility, he noted: States holding women who end their pregnancies criminally or civilly responsible for “leaving their jurisdiction to obtain an abortion out-of-state.”

“That legal mechanism may abridge the constitutional right to travel, but it is not out of the realm of possibilities in a post-Roe America,” said Mr. Kreis.

But while many anti-abortion groups have said that criminalizing abortion or limiting access to contraception is not the end goal, “history is not promising here,” said Ellen Wright Clayton, MD, JD, professor of pediatrics and professor of law at Vanderbilt University.

She referred to a recent proposal from lawmakers in Louisiana to classify abortion as homicide.

The bill didn’t get far in the House of Representatives, but the concern is warranted, said Dr. Clayton.
 

Period and fertility tracking apps

Health information privacy laws, like the Health Insurance Portability and Accountability Act (HIPAA), do not protect information on period and fertility tracking apps.

Right now, there are no signs that people plan to use period and fertility tracking data to advance a prochoice agenda, according to Adam Levin, JD, a cybersecurity expert and founder of CyberScout, a global identity and data protection company.

Still, a cycle tracking app “created by a company owned by an antiabortion activist” is totally feasible, said Mr. Levin.

If you want to ensure your data is safe from such meddling, you may want to delete your app, he said, noting that using the notepad feature on your smartphone could be a safer alternative, as could using old-fashioned pen and paper.

You don’t have to stop with period and fertility tracking apps, either.

For any apps you share personal information with, set privacy settings “as tightly as possible” – and reconsider using apps if these options are unavailable, Mr. Levin advised.

“Make sure that company is not engaging in social or political activism that does not align with your politics.”

New York State Attorney General Letitia James recently spoke on the topic, noting on May 13 that “people use fertility tracking apps and location services every day, but if they’re not careful their personal information can end up in the wrong hands.

“With abortion rights in jeopardy, it’s more important than ever that everyone take their digital privacy seriously,” she said. “I urge everyone, especially those visiting abortion clinics or seeking abortion care, to follow the tips offered by my office and be more careful of the apps and websites they use.”

The New York State Attorney General’s Office recommends women use encrypted messaging when communicating about personal health information or behaviors, and to be careful about what they share on social media posts. The office also suggests turning off location and personalized advertising options on their smartphones.
 

Cellphone location data

Dr. Malin said there are several ways that location services could be used to track where a woman uses her smartphone. An app could track locations if someone grants permission through the app end user agreement, for example.

A second but less likely scenario would be the service provider tracking the pings coming off cellphone towers to find a smartphone.

So what recourse does a woman have if tracked by a third-party app?

“It’s a really tricky situation there because it depends on if the individual was put expressly in harm’s way,” Dr. Malin said. What’s more, tracking someone out in public is not prohibited in general.

“There’s a big difference between documenting what an individual does within a Planned Parenthood clinic versus what they do outside of it,” he said.

Dr. Malin said it’s better that regulations protect all smartphone users rather than requiring each person to remember to turn off the location tracker and then turn it back on again. Also, it should be more of an opt-in situation – where app developers must ask permission to track app usage or location services – versus making each woman opt out.
 

Think before you share

Vindictive or untrustworthy partners and family members of women in abusive relationships could also be a cause of concern, said Mr. Kreis.

“Individuals within a woman’s closest circles could hold abortions over their head or threaten reporting them for reproductive health care or miscarriages,” he said.

It’s not uncommon for women to experience domestic violence after having an abortion, particularly if their partners were unaware they had the procedure, according to Dr. Clayton.

She said women should also be mindful of what they share on social media.

Dr. Clayton gave the example of a woman seeking advice on where to get a safe abortion or how to order certain medications.

“If someone goes online to look for that, that’s potentially dangerous.”

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

If Roe v. Wade is overturned, can criminal prosecutors or tech companies use smartphone data against someone?

Now that the future of U.S. abortion laws hangs in the balance, many women are questioning the degree of caution needed to keep their cyber activity confidential – especially period and fertility tracking apps, smartphone location data, and social media interactions.

Cybersecurity and legal experts say the answer largely boils down to one major issue: The right to privacy.

“There’s this notion of the expectation of privacy,” said Brad Malin, PhD, professor of biomedical informatics, biostatistics, and computer science at Vanderbilt University in Nashville, Tenn.

Dr. Malin said it’s directly related to bodily privacy that a person expects they have control of as part of their own environment.

According to Dr. Malin, this is “why this whole notion of Roe v. Wade at the present moment is really relevant. The right to privacy is mentioned about a dozen times within the law for the case.

“This is why we don’t know what’s going to happen with Roe v. Wade, but it worries a lot of privacy professionals,” he said. “It leads down this slippery slope of if you don’t even have control over your own body, then with electronic communications … we might as well not even start.”
 

Legal protections

The Fourth Amendment of the U.S. Constitution protects people against unreasonable searches and seizures.

To acquire cyber data that could be used as evidence in courts in states where abortion is deemed a crime, prosecutors would still have to go through standard criminal procedures, said Anthony Michael Kreis, JD, a constitutional law professor at Georgia State University, Atlanta.

But the data they do get could still be used in court against someone who is suspected of having had an abortion or who “miscarried under circumstances law enforcement officers found suspicious,” Mr. Kreis said.

And there’s another possibility, he noted: States holding women who end their pregnancies criminally or civilly responsible for “leaving their jurisdiction to obtain an abortion out-of-state.”

“That legal mechanism may abridge the constitutional right to travel, but it is not out of the realm of possibilities in a post-Roe America,” said Mr. Kreis.

But while many anti-abortion groups have said that criminalizing abortion or limiting access to contraception is not the end goal, “history is not promising here,” said Ellen Wright Clayton, MD, JD, professor of pediatrics and professor of law at Vanderbilt University.

She referred to a recent proposal from lawmakers in Louisiana to classify abortion as homicide.

The bill didn’t get far in the House of Representatives, but the concern is warranted, said Dr. Clayton.
 

Period and fertility tracking apps

Health information privacy laws, like the Health Insurance Portability and Accountability Act (HIPAA), do not protect information on period and fertility tracking apps.

Right now, there are no signs that people plan to use period and fertility tracking data to advance a prochoice agenda, according to Adam Levin, JD, a cybersecurity expert and founder of CyberScout, a global identity and data protection company.

Still, a cycle tracking app “created by a company owned by an antiabortion activist” is totally feasible, said Mr. Levin.

If you want to ensure your data is safe from such meddling, you may want to delete your app, he said, noting that using the notepad feature on your smartphone could be a safer alternative, as could using old-fashioned pen and paper.

You don’t have to stop with period and fertility tracking apps, either.

For any apps you share personal information with, set privacy settings “as tightly as possible” – and reconsider using apps if these options are unavailable, Mr. Levin advised.

“Make sure that company is not engaging in social or political activism that does not align with your politics.”

New York State Attorney General Letitia James recently spoke on the topic, noting on May 13 that “people use fertility tracking apps and location services every day, but if they’re not careful their personal information can end up in the wrong hands.

“With abortion rights in jeopardy, it’s more important than ever that everyone take their digital privacy seriously,” she said. “I urge everyone, especially those visiting abortion clinics or seeking abortion care, to follow the tips offered by my office and be more careful of the apps and websites they use.”

The New York State Attorney General’s Office recommends women use encrypted messaging when communicating about personal health information or behaviors, and to be careful about what they share on social media posts. The office also suggests turning off location and personalized advertising options on their smartphones.
 

Cellphone location data

Dr. Malin said there are several ways that location services could be used to track where a woman uses her smartphone. An app could track locations if someone grants permission through the app end user agreement, for example.

A second but less likely scenario would be the service provider tracking the pings coming off cellphone towers to find a smartphone.

So what recourse does a woman have if tracked by a third-party app?

“It’s a really tricky situation there because it depends on if the individual was put expressly in harm’s way,” Dr. Malin said. What’s more, tracking someone out in public is not prohibited in general.

“There’s a big difference between documenting what an individual does within a Planned Parenthood clinic versus what they do outside of it,” he said.

Dr. Malin said it’s better that regulations protect all smartphone users rather than requiring each person to remember to turn off the location tracker and then turn it back on again. Also, it should be more of an opt-in situation – where app developers must ask permission to track app usage or location services – versus making each woman opt out.
 

Think before you share

Vindictive or untrustworthy partners and family members of women in abusive relationships could also be a cause of concern, said Mr. Kreis.

“Individuals within a woman’s closest circles could hold abortions over their head or threaten reporting them for reproductive health care or miscarriages,” he said.

It’s not uncommon for women to experience domestic violence after having an abortion, particularly if their partners were unaware they had the procedure, according to Dr. Clayton.

She said women should also be mindful of what they share on social media.

Dr. Clayton gave the example of a woman seeking advice on where to get a safe abortion or how to order certain medications.

“If someone goes online to look for that, that’s potentially dangerous.”

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

People with nonalcoholic fatty liver disease (NAFLD) and a lean or healthy body mass index are at increased risk for peripheral vascular disease, stroke, and cardiovascular disease, a surprise finding from a new study reveals.

“Our team had expected to see that those with a normal BMI would have a lower prevalence of any metabolic or cardiovascular conditions,” lead researcher Karn Wijarnpreecha, MD, MPH, said during a media briefing that previewed select research for Digestive Disease Week^® (DDW) 2022. “So, we were very surprised to find this link to cardiovascular disease.”

The investigators saw this increased risk of cardiovascular disease despite this group having a lower prevalence of atherosclerotic risk factors and metabolic disease.

This first study of its kind suggests physicians should consider the risk of cardiovascular disease in all patients with NAFLD, not just in those who are overweight or living with obesity – groups traditionally thought to carry more risk.

NAFLD in lean individuals is not a benign disease.

“NAFLD patients with a normal BMI are often overlooked because we assume that the risk for more serious conditions is lower than for those who are overweight or obese. But this way of thinking may be putting these patients at risk,” added Dr. Wijarnpreecha, who is a transplant hepatology fellow at the University of Michigan, Ann Arbor.

Key findings

Approximately 25% of U.S. adults live with NAFLD, an umbrella term for liver conditions in people who drink little to no alcohol. It is characterized by too much fat stored in the liver. Although most people have no symptoms, the condition can lead to other dangerous conditions, such as diabetes, cardiovascular disease, and cirrhosis of the liver, Dr. Wijarnpreecha said.

The investigators retrospectively studied a cohort of 18,793 adults diagnosed with NAFLD at the University of Michigan Hospital from 2012-2021. One aim was to compare the prevalence of cirrhosis, cardiovascular disease, metabolic diseases, and chronic kidney disease in relation to BMI.

They also classified people into four BMI categories: lean, overweight, obesity class 1, and obesity class 2-3.

Compared with non-lean patients, lean patients had a higher prevalence of peripheral arterial disease and stroke and a similar rate of cardiovascular disease based on identification of ICD codes.

Almost 6% of lean patients had peripheral arterial disease, compared with rates of approximately 4%-5% in overweight people and people with obesity. Similarly, more than 6% of the lean group experienced a stroke compared with 5% or less of the other BMI groups.

“We found that lean patients with NAFLD also had a significant higher prevalence of cardiovascular disease, independent of age, sex, race, smoking status, diabetes, hypertension, and dyslipidemia,” Dr. Wijarnpreecha said.

At the same time, compared with non-lean patients, lean patients had a lower prevalence of cirrhosis, diabetes mellitus, hypertension, dyslipidemia, and chronic kidney disease in an analysis that adjusted for confounders.
 

Exploring the unknown

Researchers now have a mystery on their hands: What is causing this unexpected higher risk of cardiovascular disease in lean people with NAFLD?

Loren Laine, MD, chief of the section of digestive diseases at Yale University School of Medicine, New Haven, Conn., and moderator of the media briefing, asked Wijarnpreecha for his leading theory behind this connection.

“We think that could be from a difference in lifestyle, diet, exercise, genetics, or even gut microbiota,” Dr. Wijarnpreecha replied. “But these are factors that we did not capture from this current study.”

“We are preparing to conduct additional research with longitudinal data to better understand NAFLD in lean patients,” Dr. Wijarnpreecha added.

“It’s an interesting finding, but there are some questions from this retrospective study,” said Arun J. Sanyal, MD, when asked to comment on the study.

Identifying and quantifying any alcohol use, smoking, or hypertension that could also have contributed to increased cardiovascular risk would be useful. Another question relates to how the population with NAFLD was identified. Was NAFLD an incidental finding in their diagnosis, asked Dr. Sanyal, director of the Stravitz-Sanyal Institute for Liver Disease & Metabolic Health at Virginia Commonwealth University, Richmond.

“I’m not dissing the study,” he said, “But like all the observations like this, I think we have to kick the tires.”

It’s an “important new observation” that requires further study to fully understand what it means and what the therapeutic implications might be. It is also important to assess any possible confounders and any causal relationship among these factors, Dr. Sanyal added.

“There’s no question it is important to continue to do these types of studies,” he added. “Through this kind of research we find new things that lead to the science that can then significantly change how we approach these issues.”

A version of this article first appeared on Medscape.com. This article was updated on May 18, 2022.

People with nonalcoholic fatty liver disease (NAFLD) and a lean or healthy body mass index are at increased risk for peripheral vascular disease, stroke, and cardiovascular disease, a surprise finding from a new study reveals.

“Our team had expected to see that those with a normal BMI would have a lower prevalence of any metabolic or cardiovascular conditions,” lead researcher Karn Wijarnpreecha, MD, MPH, said during a media briefing that previewed select research for Digestive Disease Week^® (DDW) 2022. “So, we were very surprised to find this link to cardiovascular disease.”

The investigators saw this increased risk of cardiovascular disease despite this group having a lower prevalence of atherosclerotic risk factors and metabolic disease.

This first study of its kind suggests physicians should consider the risk of cardiovascular disease in all patients with NAFLD, not just in those who are overweight or living with obesity – groups traditionally thought to carry more risk.

NAFLD in lean individuals is not a benign disease.

“NAFLD patients with a normal BMI are often overlooked because we assume that the risk for more serious conditions is lower than for those who are overweight or obese. But this way of thinking may be putting these patients at risk,” added Dr. Wijarnpreecha, who is a transplant hepatology fellow at the University of Michigan, Ann Arbor.

Key findings

Approximately 25% of U.S. adults live with NAFLD, an umbrella term for liver conditions in people who drink little to no alcohol. It is characterized by too much fat stored in the liver. Although most people have no symptoms, the condition can lead to other dangerous conditions, such as diabetes, cardiovascular disease, and cirrhosis of the liver, Dr. Wijarnpreecha said.

The investigators retrospectively studied a cohort of 18,793 adults diagnosed with NAFLD at the University of Michigan Hospital from 2012-2021. One aim was to compare the prevalence of cirrhosis, cardiovascular disease, metabolic diseases, and chronic kidney disease in relation to BMI.

They also classified people into four BMI categories: lean, overweight, obesity class 1, and obesity class 2-3.

Compared with non-lean patients, lean patients had a higher prevalence of peripheral arterial disease and stroke and a similar rate of cardiovascular disease based on identification of ICD codes.

Almost 6% of lean patients had peripheral arterial disease, compared with rates of approximately 4%-5% in overweight people and people with obesity. Similarly, more than 6% of the lean group experienced a stroke compared with 5% or less of the other BMI groups.

“We found that lean patients with NAFLD also had a significant higher prevalence of cardiovascular disease, independent of age, sex, race, smoking status, diabetes, hypertension, and dyslipidemia,” Dr. Wijarnpreecha said.

At the same time, compared with non-lean patients, lean patients had a lower prevalence of cirrhosis, diabetes mellitus, hypertension, dyslipidemia, and chronic kidney disease in an analysis that adjusted for confounders.
 

Exploring the unknown

Researchers now have a mystery on their hands: What is causing this unexpected higher risk of cardiovascular disease in lean people with NAFLD?

Loren Laine, MD, chief of the section of digestive diseases at Yale University School of Medicine, New Haven, Conn., and moderator of the media briefing, asked Wijarnpreecha for his leading theory behind this connection.

“We think that could be from a difference in lifestyle, diet, exercise, genetics, or even gut microbiota,” Dr. Wijarnpreecha replied. “But these are factors that we did not capture from this current study.”

“We are preparing to conduct additional research with longitudinal data to better understand NAFLD in lean patients,” Dr. Wijarnpreecha added.

“It’s an interesting finding, but there are some questions from this retrospective study,” said Arun J. Sanyal, MD, when asked to comment on the study.

Identifying and quantifying any alcohol use, smoking, or hypertension that could also have contributed to increased cardiovascular risk would be useful. Another question relates to how the population with NAFLD was identified. Was NAFLD an incidental finding in their diagnosis, asked Dr. Sanyal, director of the Stravitz-Sanyal Institute for Liver Disease & Metabolic Health at Virginia Commonwealth University, Richmond.

“I’m not dissing the study,” he said, “But like all the observations like this, I think we have to kick the tires.”

It’s an “important new observation” that requires further study to fully understand what it means and what the therapeutic implications might be. It is also important to assess any possible confounders and any causal relationship among these factors, Dr. Sanyal added.

“There’s no question it is important to continue to do these types of studies,” he added. “Through this kind of research we find new things that lead to the science that can then significantly change how we approach these issues.”

A version of this article first appeared on Medscape.com. This article was updated on May 18, 2022.

People with nonalcoholic fatty liver disease (NAFLD) and a lean or healthy body mass index are at increased risk for peripheral vascular disease, stroke, and cardiovascular disease, a surprise finding from a new study reveals.

“Our team had expected to see that those with a normal BMI would have a lower prevalence of any metabolic or cardiovascular conditions,” lead researcher Karn Wijarnpreecha, MD, MPH, said during a media briefing that previewed select research for Digestive Disease Week^® (DDW) 2022. “So, we were very surprised to find this link to cardiovascular disease.”

The investigators saw this increased risk of cardiovascular disease despite this group having a lower prevalence of atherosclerotic risk factors and metabolic disease.

This first study of its kind suggests physicians should consider the risk of cardiovascular disease in all patients with NAFLD, not just in those who are overweight or living with obesity – groups traditionally thought to carry more risk.

NAFLD in lean individuals is not a benign disease.

“NAFLD patients with a normal BMI are often overlooked because we assume that the risk for more serious conditions is lower than for those who are overweight or obese. But this way of thinking may be putting these patients at risk,” added Dr. Wijarnpreecha, who is a transplant hepatology fellow at the University of Michigan, Ann Arbor.

Key findings

Approximately 25% of U.S. adults live with NAFLD, an umbrella term for liver conditions in people who drink little to no alcohol. It is characterized by too much fat stored in the liver. Although most people have no symptoms, the condition can lead to other dangerous conditions, such as diabetes, cardiovascular disease, and cirrhosis of the liver, Dr. Wijarnpreecha said.

The investigators retrospectively studied a cohort of 18,793 adults diagnosed with NAFLD at the University of Michigan Hospital from 2012-2021. One aim was to compare the prevalence of cirrhosis, cardiovascular disease, metabolic diseases, and chronic kidney disease in relation to BMI.

They also classified people into four BMI categories: lean, overweight, obesity class 1, and obesity class 2-3.

Compared with non-lean patients, lean patients had a higher prevalence of peripheral arterial disease and stroke and a similar rate of cardiovascular disease based on identification of ICD codes.

Almost 6% of lean patients had peripheral arterial disease, compared with rates of approximately 4%-5% in overweight people and people with obesity. Similarly, more than 6% of the lean group experienced a stroke compared with 5% or less of the other BMI groups.

“We found that lean patients with NAFLD also had a significant higher prevalence of cardiovascular disease, independent of age, sex, race, smoking status, diabetes, hypertension, and dyslipidemia,” Dr. Wijarnpreecha said.

At the same time, compared with non-lean patients, lean patients had a lower prevalence of cirrhosis, diabetes mellitus, hypertension, dyslipidemia, and chronic kidney disease in an analysis that adjusted for confounders.
 

Exploring the unknown

Researchers now have a mystery on their hands: What is causing this unexpected higher risk of cardiovascular disease in lean people with NAFLD?

Loren Laine, MD, chief of the section of digestive diseases at Yale University School of Medicine, New Haven, Conn., and moderator of the media briefing, asked Wijarnpreecha for his leading theory behind this connection.

“We think that could be from a difference in lifestyle, diet, exercise, genetics, or even gut microbiota,” Dr. Wijarnpreecha replied. “But these are factors that we did not capture from this current study.”

“We are preparing to conduct additional research with longitudinal data to better understand NAFLD in lean patients,” Dr. Wijarnpreecha added.

“It’s an interesting finding, but there are some questions from this retrospective study,” said Arun J. Sanyal, MD, when asked to comment on the study.

Identifying and quantifying any alcohol use, smoking, or hypertension that could also have contributed to increased cardiovascular risk would be useful. Another question relates to how the population with NAFLD was identified. Was NAFLD an incidental finding in their diagnosis, asked Dr. Sanyal, director of the Stravitz-Sanyal Institute for Liver Disease & Metabolic Health at Virginia Commonwealth University, Richmond.

“I’m not dissing the study,” he said, “But like all the observations like this, I think we have to kick the tires.”

It’s an “important new observation” that requires further study to fully understand what it means and what the therapeutic implications might be. It is also important to assess any possible confounders and any causal relationship among these factors, Dr. Sanyal added.

“There’s no question it is important to continue to do these types of studies,” he added. “Through this kind of research we find new things that lead to the science that can then significantly change how we approach these issues.”

A version of this article first appeared on Medscape.com. This article was updated on May 18, 2022.

The percentage of Americans who have been infected with COVID-19 jumped from 34% in December 2021 to 58% in February 2022, a new study from the Centers for Disease Control and Prevention reveals.

This is the first time the seroprevalence of prior infection is more than 50% in the American population.

“I definitely expected that we were going to see an increase continue ... but I didn’t expect it to increase quite this much. But we follow the data ... and this is what the evidence is showing us,” lead study researcher Kristie E. N. Clarke, MD, said during a CDC media briefing April 26.

Researchers found that presence of antinucleocapsid (anti-N) antibodies from prior infection varied by age. The rate varied from as high as 75% in children and teenagers 17 years and younger to 33% in those 65 and older, for example.  

The study showed that the anti-N antibodies were more common in age groups with the lowest vaccination numbers.

Combined with up-to-date CDC data on deaths, hospitalizations, and cases, the study provides a clearer picture of where we are now and where we might be headed in terms of the pandemic.
 

Vaccination still valuable

The fact that nearly 60% of Americans have antibodies from prior infection is not a reason to think people with a history of COVID-19 should skip vaccination, said CDC director Rochelle P. Walensky, MD.

“I can’t underscore enough that those with detectable antibodies from previous infection, we encourage them to still get vaccinated,” Dr. Walensky said.

“We do know that reinfections happen,” she said, “so that’s important in terms of thinking forward.”

The CDC continues to encourage all Americans to stay up to date with their COVID-19 vaccinations, said Dr. Clarke, colead for the CDC’s COVID-19 Epidemiology and Surveillance Taskforce Seroprevalence Team. “Having infection-induced antibodies does not necessarily mean you are protected against future infections.”

The study, published in the CDC’s Morbidity and Mortality Weekly Report (MMWR), did not evaluate antibody protection from COVID-19 vaccination.

It should also be noted that the study looked at presence or absence of anti-N antibodies, and not whether certain levels were linked to less or more protection.
 

Where are we now?

Dr. Walensky used the media briefing as an opportunity to share current COVID-19 numbers.

“Overall, we can continue to have some mixed trends. Deaths, fortunately, are continuing to trend downward with a 7-day average of about 300 per day, which represents an estimated 18% decline from the prior week,” she said.

Hospital admissions also remain low, at about 1,500 per day. “But we should note that for the second week in a row, they are slowly trending upwards,” Dr. Walensky said. There was an increase of about 9% at press time compared with the prior week.

Cases remain “comparatively low” to even where we were a month ago, at 44,000 per day,” Dr. Walensky said. “Although this too represents an increase of about 25% in the past week.”

Dr. Walensky noted that positive test numbers are not as reliable a metric as they were before the growth in use of rapid home tests. But it’s not the only measure. “We continue to believe that our PCR testing data, especially when we corroborate it with information from our other surveillance systems – like wastewater surveillance and emergency department surveillance – provide us a reliable picture of the trajectory of COVID-19 across our country.”

She recommended that people continue to consult the CDC’s COVID-19 county tracker to monitor local levels of COVID-19.

Dr. Walensky also shared recent findings from genomic sequencing that continue to show the predominance of the Omicron variant. “Essentially a hundred percent of what we’re finding now is Omicron,” she said. In terms of individual variants, the Omicron BA.1 variant is about 3% of circulating virus, the BA.2 variant is about 68%, and BA.2.12.1 makes up about 35%.

“We’re just starting to learn about the impact of BA2.121,” Dr. Walensky said. “It appears it might have a transmission advantage of about 25% over the BA2 subvariant.”

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

The percentage of Americans who have been infected with COVID-19 jumped from 34% in December 2021 to 58% in February 2022, a new study from the Centers for Disease Control and Prevention reveals.

This is the first time the seroprevalence of prior infection is more than 50% in the American population.

“I definitely expected that we were going to see an increase continue ... but I didn’t expect it to increase quite this much. But we follow the data ... and this is what the evidence is showing us,” lead study researcher Kristie E. N. Clarke, MD, said during a CDC media briefing April 26.

Researchers found that presence of antinucleocapsid (anti-N) antibodies from prior infection varied by age. The rate varied from as high as 75% in children and teenagers 17 years and younger to 33% in those 65 and older, for example.  

The study showed that the anti-N antibodies were more common in age groups with the lowest vaccination numbers.

Combined with up-to-date CDC data on deaths, hospitalizations, and cases, the study provides a clearer picture of where we are now and where we might be headed in terms of the pandemic.
 

Vaccination still valuable

The fact that nearly 60% of Americans have antibodies from prior infection is not a reason to think people with a history of COVID-19 should skip vaccination, said CDC director Rochelle P. Walensky, MD.

“I can’t underscore enough that those with detectable antibodies from previous infection, we encourage them to still get vaccinated,” Dr. Walensky said.

“We do know that reinfections happen,” she said, “so that’s important in terms of thinking forward.”

The CDC continues to encourage all Americans to stay up to date with their COVID-19 vaccinations, said Dr. Clarke, colead for the CDC’s COVID-19 Epidemiology and Surveillance Taskforce Seroprevalence Team. “Having infection-induced antibodies does not necessarily mean you are protected against future infections.”

The study, published in the CDC’s Morbidity and Mortality Weekly Report (MMWR), did not evaluate antibody protection from COVID-19 vaccination.

It should also be noted that the study looked at presence or absence of anti-N antibodies, and not whether certain levels were linked to less or more protection.
 

Where are we now?

Dr. Walensky used the media briefing as an opportunity to share current COVID-19 numbers.

“Overall, we can continue to have some mixed trends. Deaths, fortunately, are continuing to trend downward with a 7-day average of about 300 per day, which represents an estimated 18% decline from the prior week,” she said.

Hospital admissions also remain low, at about 1,500 per day. “But we should note that for the second week in a row, they are slowly trending upwards,” Dr. Walensky said. There was an increase of about 9% at press time compared with the prior week.

Cases remain “comparatively low” to even where we were a month ago, at 44,000 per day,” Dr. Walensky said. “Although this too represents an increase of about 25% in the past week.”

Dr. Walensky noted that positive test numbers are not as reliable a metric as they were before the growth in use of rapid home tests. But it’s not the only measure. “We continue to believe that our PCR testing data, especially when we corroborate it with information from our other surveillance systems – like wastewater surveillance and emergency department surveillance – provide us a reliable picture of the trajectory of COVID-19 across our country.”

She recommended that people continue to consult the CDC’s COVID-19 county tracker to monitor local levels of COVID-19.

Dr. Walensky also shared recent findings from genomic sequencing that continue to show the predominance of the Omicron variant. “Essentially a hundred percent of what we’re finding now is Omicron,” she said. In terms of individual variants, the Omicron BA.1 variant is about 3% of circulating virus, the BA.2 variant is about 68%, and BA.2.12.1 makes up about 35%.

“We’re just starting to learn about the impact of BA2.121,” Dr. Walensky said. “It appears it might have a transmission advantage of about 25% over the BA2 subvariant.”

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

The percentage of Americans who have been infected with COVID-19 jumped from 34% in December 2021 to 58% in February 2022, a new study from the Centers for Disease Control and Prevention reveals.

This is the first time the seroprevalence of prior infection is more than 50% in the American population.

“I definitely expected that we were going to see an increase continue ... but I didn’t expect it to increase quite this much. But we follow the data ... and this is what the evidence is showing us,” lead study researcher Kristie E. N. Clarke, MD, said during a CDC media briefing April 26.

Researchers found that presence of antinucleocapsid (anti-N) antibodies from prior infection varied by age. The rate varied from as high as 75% in children and teenagers 17 years and younger to 33% in those 65 and older, for example.  

The study showed that the anti-N antibodies were more common in age groups with the lowest vaccination numbers.

Combined with up-to-date CDC data on deaths, hospitalizations, and cases, the study provides a clearer picture of where we are now and where we might be headed in terms of the pandemic.
 

Vaccination still valuable

The fact that nearly 60% of Americans have antibodies from prior infection is not a reason to think people with a history of COVID-19 should skip vaccination, said CDC director Rochelle P. Walensky, MD.

“I can’t underscore enough that those with detectable antibodies from previous infection, we encourage them to still get vaccinated,” Dr. Walensky said.

“We do know that reinfections happen,” she said, “so that’s important in terms of thinking forward.”

The CDC continues to encourage all Americans to stay up to date with their COVID-19 vaccinations, said Dr. Clarke, colead for the CDC’s COVID-19 Epidemiology and Surveillance Taskforce Seroprevalence Team. “Having infection-induced antibodies does not necessarily mean you are protected against future infections.”

The study, published in the CDC’s Morbidity and Mortality Weekly Report (MMWR), did not evaluate antibody protection from COVID-19 vaccination.

It should also be noted that the study looked at presence or absence of anti-N antibodies, and not whether certain levels were linked to less or more protection.
 

Where are we now?

Dr. Walensky used the media briefing as an opportunity to share current COVID-19 numbers.

“Overall, we can continue to have some mixed trends. Deaths, fortunately, are continuing to trend downward with a 7-day average of about 300 per day, which represents an estimated 18% decline from the prior week,” she said.

Hospital admissions also remain low, at about 1,500 per day. “But we should note that for the second week in a row, they are slowly trending upwards,” Dr. Walensky said. There was an increase of about 9% at press time compared with the prior week.

Cases remain “comparatively low” to even where we were a month ago, at 44,000 per day,” Dr. Walensky said. “Although this too represents an increase of about 25% in the past week.”

Dr. Walensky noted that positive test numbers are not as reliable a metric as they were before the growth in use of rapid home tests. But it’s not the only measure. “We continue to believe that our PCR testing data, especially when we corroborate it with information from our other surveillance systems – like wastewater surveillance and emergency department surveillance – provide us a reliable picture of the trajectory of COVID-19 across our country.”

She recommended that people continue to consult the CDC’s COVID-19 county tracker to monitor local levels of COVID-19.

Dr. Walensky also shared recent findings from genomic sequencing that continue to show the predominance of the Omicron variant. “Essentially a hundred percent of what we’re finding now is Omicron,” she said. In terms of individual variants, the Omicron BA.1 variant is about 3% of circulating virus, the BA.2 variant is about 68%, and BA.2.12.1 makes up about 35%.

“We’re just starting to learn about the impact of BA2.121,” Dr. Walensky said. “It appears it might have a transmission advantage of about 25% over the BA2 subvariant.”

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

Moderna on March 23 released interim results indicating that its mRNA-1273 COVID vaccine produced “robust” neutralizing antibody titers in children aged 6 months to 6 years – levels similar to those seen in adults.

Vaccine efficacy against infection was 43.7% in children aged 6 months to 2 years and 37.5% among children aged 2-6 years, the new data from its phase 2/3 KidCOVE study show.

The company explained the lower efficacy numbers by noting that its study involving these younger children was conducted during the Omicron wave. The same decrease in efficacy against infection was reported in adults during the Omicron surge.

A majority of COVID-19 cases were mild in the approximately 6,900 children aged 6 months to 6 years in the study. No severe COVID-19 cases, hospitalizations, or deaths were reported.

The primary series of two 25-mcg doses of the vaccine given 28 days apart was generally well tolerated. Most adverse events were mild to moderate. For example, temperature greater than 38° C (>100.4° F) was reported for 17.0% of the 6-month-old to 2-year-old group and for 14.6% of the 2- to 6-year-old group. A few children, 0.2% of each group, experienced a temperature greater than 40° C (>104° F).

Moderna plans to include these response, efficacy, and safety data in an application to the Food and Drug Administration for emergency use authorization (EUA) of the vaccine in these younger children in the coming weeks.

“We now have clinical data on the performance of our vaccine from infants 6 months of age through older adults,” Moderna CEO Stephane Bancel said in a news release. He described the interim results as “good news for parents of children under 6 years of age.”
 

In other news

Moderna also announced that it began the FDA EUA submission process for a 50-μg two-dose primary series for children aged 6-12 years.

The company is also updating its EUA submission for a 100-mcg two-dose primary series for children and adolescents aged 12-18 years.

Similar to its booster research in adults, Moderna plans to evaluate the potential of a booster dose for all pediatric populations, including those aged 6 months to 6 years, 6-12 years, and adolescents. The company is evaluating both a booster dose of mRNA-1273 and its bivalent booster candidate (mRNA1273.214), which includes an Omicron variant booster and mRNA-1273.

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

Moderna on March 23 released interim results indicating that its mRNA-1273 COVID vaccine produced “robust” neutralizing antibody titers in children aged 6 months to 6 years – levels similar to those seen in adults.

Vaccine efficacy against infection was 43.7% in children aged 6 months to 2 years and 37.5% among children aged 2-6 years, the new data from its phase 2/3 KidCOVE study show.

The company explained the lower efficacy numbers by noting that its study involving these younger children was conducted during the Omicron wave. The same decrease in efficacy against infection was reported in adults during the Omicron surge.

A majority of COVID-19 cases were mild in the approximately 6,900 children aged 6 months to 6 years in the study. No severe COVID-19 cases, hospitalizations, or deaths were reported.

The primary series of two 25-mcg doses of the vaccine given 28 days apart was generally well tolerated. Most adverse events were mild to moderate. For example, temperature greater than 38° C (>100.4° F) was reported for 17.0% of the 6-month-old to 2-year-old group and for 14.6% of the 2- to 6-year-old group. A few children, 0.2% of each group, experienced a temperature greater than 40° C (>104° F).

Moderna plans to include these response, efficacy, and safety data in an application to the Food and Drug Administration for emergency use authorization (EUA) of the vaccine in these younger children in the coming weeks.

“We now have clinical data on the performance of our vaccine from infants 6 months of age through older adults,” Moderna CEO Stephane Bancel said in a news release. He described the interim results as “good news for parents of children under 6 years of age.”
 

In other news

Moderna also announced that it began the FDA EUA submission process for a 50-μg two-dose primary series for children aged 6-12 years.

The company is also updating its EUA submission for a 100-mcg two-dose primary series for children and adolescents aged 12-18 years.

Similar to its booster research in adults, Moderna plans to evaluate the potential of a booster dose for all pediatric populations, including those aged 6 months to 6 years, 6-12 years, and adolescents. The company is evaluating both a booster dose of mRNA-1273 and its bivalent booster candidate (mRNA1273.214), which includes an Omicron variant booster and mRNA-1273.

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

Moderna on March 23 released interim results indicating that its mRNA-1273 COVID vaccine produced “robust” neutralizing antibody titers in children aged 6 months to 6 years – levels similar to those seen in adults.

Vaccine efficacy against infection was 43.7% in children aged 6 months to 2 years and 37.5% among children aged 2-6 years, the new data from its phase 2/3 KidCOVE study show.

The company explained the lower efficacy numbers by noting that its study involving these younger children was conducted during the Omicron wave. The same decrease in efficacy against infection was reported in adults during the Omicron surge.

A majority of COVID-19 cases were mild in the approximately 6,900 children aged 6 months to 6 years in the study. No severe COVID-19 cases, hospitalizations, or deaths were reported.

The primary series of two 25-mcg doses of the vaccine given 28 days apart was generally well tolerated. Most adverse events were mild to moderate. For example, temperature greater than 38° C (>100.4° F) was reported for 17.0% of the 6-month-old to 2-year-old group and for 14.6% of the 2- to 6-year-old group. A few children, 0.2% of each group, experienced a temperature greater than 40° C (>104° F).

Moderna plans to include these response, efficacy, and safety data in an application to the Food and Drug Administration for emergency use authorization (EUA) of the vaccine in these younger children in the coming weeks.

“We now have clinical data on the performance of our vaccine from infants 6 months of age through older adults,” Moderna CEO Stephane Bancel said in a news release. He described the interim results as “good news for parents of children under 6 years of age.”
 

In other news

Moderna also announced that it began the FDA EUA submission process for a 50-μg two-dose primary series for children aged 6-12 years.

The company is also updating its EUA submission for a 100-mcg two-dose primary series for children and adolescents aged 12-18 years.

Similar to its booster research in adults, Moderna plans to evaluate the potential of a booster dose for all pediatric populations, including those aged 6 months to 6 years, 6-12 years, and adolescents. The company is evaluating both a booster dose of mRNA-1273 and its bivalent booster candidate (mRNA1273.214), which includes an Omicron variant booster and mRNA-1273.

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

Eat french fries every day for a month? Sure, as long as it’s for science.

That’s exactly what 107 people did in a scientific study, while 58 others ate a daily serving of almonds with the same number of calories.

At the end of the study, the researchers found no significant differences between the groups in people’s total amount of fat or their fasting glucose measures, according to the study, published Feb. 18 in the American Journal of Clinical Nutrition.

The french fry eaters gained a little more weight, but it was not statistically significant. The people who ate french fries gained 0.49 kilograms (just over a pound), vs. about a tenth of a kilogram (about one-fifth of a pound) in the group of people who ate almonds.

“The take-home is if you like almonds, eat some almonds. If you like potatoes, eat some potatoes, but don’t overeat either,” said study leader David B. Allison, PhD, a professor at Indiana University’s School of Public Health in Bloomington. ‘It’s probably good to have a little bit of each – each has some unique advantages in terms of nutrition.”

“This study confirms what registered dietitian nutritionists already know – all foods can fit. We can eat almonds, french fries, kale, and cookies,” said Melissa Majumdar, a registered dietitian and certified specialist in obesity and weight management at Emory University Hospital Midtown in Atlanta. ‘The consumption of one food or the avoidance of another does not make a healthy diet.”

At the same time, people should not interpret the results to mean it’s OK to eat french fries all day, every day. “We know that while potatoes are nutrient dense, the frying process reduces the nutritional value,” Ms. Majumdar said.

“Because french fries are often consumed alongside other nutrient-poor or high-fat foods, they should not be consumed daily but can fit into an overall balanced diet,” she added.
 

Would you like fries with that?

The researchers compared french fries to almonds because almonds are known for positive effects on energy balance, body composition, and low glycemic index. The research was partly funded by the Alliance for Potato Research and Education.

French fries are an incredibly popular food in the United States. According to an August 2021 post on the food website Mashed, Americans eat an average of 30 pounds of french fries each year.

Although consumption of almonds is increasing, Americans eat far less in volume each year than they do fries – an estimated 2.4 pounds of almonds per person, according to August 2021 figures from the Almond Board of California.

Dr. Allison and colleagues recruited 180 healthy adults for the study. Their average age was 30, and about two-thirds were women.

They randomly assigned 60 people to add about a medium serving of plain french fries (Tater Pals Ovenable Crinkle Cut Fries, Simplot Foods) to their diet. Another 60 people were assigned to the same amount of Tater Pals fries with herbs (oregano, basil, garlic, onion, and rosemary), and another 60 people ate Wonderful brand roasted and salted almonds.

Investigators told people to add either the potatoes or nuts to their diet every day for a month and gave no further instructions.

After some people dropped out of the study, results were based on 55 who ate regular french fries, 52 who ate french fries with herbs and spices, and 58 who ate the nuts.

The researchers scanned people to detect any changes in fat mass. They also measured changes in body weight, carbohydrate metabolism, and fasting blood glucose and insulin.
 

Key findings

Changes in total body fat mass and fat mass were not significantly different between the french fry groups and the almond group.

In terms of glycemic control, eating french fries for a month “is no better or worse than consuming a caloric equivalent of nuts,” the researchers noted.

Similarly, the change in total fat mass did not differ significantly among the three treatment groups.

Adding the herb and spice mix to the french fries did not make a significant difference on glycemic control, contrary to what the researchers thought might happen.

And fasting glucose, insulin, and HbA1c levels did not differ significantly between the combined french fry and almond groups. When comparisons were made among the three groups, the almond group had a lower insulin response, compared to the plain french fry group.

Many different things could be explored in future research, said study coauthor Rebecca Hanson, a registered dietitian nutritionist and research study coordinator at the University of Alabama at Birmingham. “People were not told to change their exercise or diet, so there are so many different variables,” she said. Repeating the research in people with diabetes is another possibility going forward.

The researchers acknowledged that 30 days may not have been long enough to show a significant difference. But they also noted that many previous studies were observational while they used a randomized controlled trial, considered a more robust study design.

Dr. Allison, the senior author, emphasized that this is just one study. “No one study has all the answers.

“I don’t want to tell you our results are the be all and end all or that we’ve now learned everything there is to learn about potatoes and almonds,” he said.

“Our study shows for the variables we looked at ... we did not see important, discernible differences,” he said. “That doesn’t mean if you ate 500 potatoes a day or 500 kilograms of almonds it would be the same. But at these modest levels, it doesn’t seem to make much difference.”

The study was funded by grants from the National Institutes of Health and from the Alliance for Potato Research and Education.

Asked if the industry support should be a concern, Ms. Majumdar said, “Funding from a specific food board does not necessarily dilute the results of a well-designed study. It’s not uncommon for a funding source to come from a food board that may benefit from the findings. Research money has to come from somewhere.

“This study has reputable researchers, some of the best in the field,” she said.

The U.S. produces the most almonds in the world, and California is the only state where almonds are grown commercially. Asked for the almond industry’s take on the findings, “We don’t have a comment,” said Rick Kushman, a spokesman for the Almond Board of California.

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

Eat french fries every day for a month? Sure, as long as it’s for science.

That’s exactly what 107 people did in a scientific study, while 58 others ate a daily serving of almonds with the same number of calories.

At the end of the study, the researchers found no significant differences between the groups in people’s total amount of fat or their fasting glucose measures, according to the study, published Feb. 18 in the American Journal of Clinical Nutrition.

The french fry eaters gained a little more weight, but it was not statistically significant. The people who ate french fries gained 0.49 kilograms (just over a pound), vs. about a tenth of a kilogram (about one-fifth of a pound) in the group of people who ate almonds.

“The take-home is if you like almonds, eat some almonds. If you like potatoes, eat some potatoes, but don’t overeat either,” said study leader David B. Allison, PhD, a professor at Indiana University’s School of Public Health in Bloomington. ‘It’s probably good to have a little bit of each – each has some unique advantages in terms of nutrition.”

“This study confirms what registered dietitian nutritionists already know – all foods can fit. We can eat almonds, french fries, kale, and cookies,” said Melissa Majumdar, a registered dietitian and certified specialist in obesity and weight management at Emory University Hospital Midtown in Atlanta. ‘The consumption of one food or the avoidance of another does not make a healthy diet.”

At the same time, people should not interpret the results to mean it’s OK to eat french fries all day, every day. “We know that while potatoes are nutrient dense, the frying process reduces the nutritional value,” Ms. Majumdar said.

“Because french fries are often consumed alongside other nutrient-poor or high-fat foods, they should not be consumed daily but can fit into an overall balanced diet,” she added.
 

Would you like fries with that?

The researchers compared french fries to almonds because almonds are known for positive effects on energy balance, body composition, and low glycemic index. The research was partly funded by the Alliance for Potato Research and Education.

French fries are an incredibly popular food in the United States. According to an August 2021 post on the food website Mashed, Americans eat an average of 30 pounds of french fries each year.

Although consumption of almonds is increasing, Americans eat far less in volume each year than they do fries – an estimated 2.4 pounds of almonds per person, according to August 2021 figures from the Almond Board of California.

Dr. Allison and colleagues recruited 180 healthy adults for the study. Their average age was 30, and about two-thirds were women.

They randomly assigned 60 people to add about a medium serving of plain french fries (Tater Pals Ovenable Crinkle Cut Fries, Simplot Foods) to their diet. Another 60 people were assigned to the same amount of Tater Pals fries with herbs (oregano, basil, garlic, onion, and rosemary), and another 60 people ate Wonderful brand roasted and salted almonds.

Investigators told people to add either the potatoes or nuts to their diet every day for a month and gave no further instructions.

After some people dropped out of the study, results were based on 55 who ate regular french fries, 52 who ate french fries with herbs and spices, and 58 who ate the nuts.

The researchers scanned people to detect any changes in fat mass. They also measured changes in body weight, carbohydrate metabolism, and fasting blood glucose and insulin.
 

Key findings

Changes in total body fat mass and fat mass were not significantly different between the french fry groups and the almond group.

In terms of glycemic control, eating french fries for a month “is no better or worse than consuming a caloric equivalent of nuts,” the researchers noted.

Similarly, the change in total fat mass did not differ significantly among the three treatment groups.

Adding the herb and spice mix to the french fries did not make a significant difference on glycemic control, contrary to what the researchers thought might happen.

And fasting glucose, insulin, and HbA1c levels did not differ significantly between the combined french fry and almond groups. When comparisons were made among the three groups, the almond group had a lower insulin response, compared to the plain french fry group.

Many different things could be explored in future research, said study coauthor Rebecca Hanson, a registered dietitian nutritionist and research study coordinator at the University of Alabama at Birmingham. “People were not told to change their exercise or diet, so there are so many different variables,” she said. Repeating the research in people with diabetes is another possibility going forward.

The researchers acknowledged that 30 days may not have been long enough to show a significant difference. But they also noted that many previous studies were observational while they used a randomized controlled trial, considered a more robust study design.

Dr. Allison, the senior author, emphasized that this is just one study. “No one study has all the answers.

“I don’t want to tell you our results are the be all and end all or that we’ve now learned everything there is to learn about potatoes and almonds,” he said.

“Our study shows for the variables we looked at ... we did not see important, discernible differences,” he said. “That doesn’t mean if you ate 500 potatoes a day or 500 kilograms of almonds it would be the same. But at these modest levels, it doesn’t seem to make much difference.”

The study was funded by grants from the National Institutes of Health and from the Alliance for Potato Research and Education.

Asked if the industry support should be a concern, Ms. Majumdar said, “Funding from a specific food board does not necessarily dilute the results of a well-designed study. It’s not uncommon for a funding source to come from a food board that may benefit from the findings. Research money has to come from somewhere.

“This study has reputable researchers, some of the best in the field,” she said.

The U.S. produces the most almonds in the world, and California is the only state where almonds are grown commercially. Asked for the almond industry’s take on the findings, “We don’t have a comment,” said Rick Kushman, a spokesman for the Almond Board of California.

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

Eat french fries every day for a month? Sure, as long as it’s for science.

That’s exactly what 107 people did in a scientific study, while 58 others ate a daily serving of almonds with the same number of calories.

At the end of the study, the researchers found no significant differences between the groups in people’s total amount of fat or their fasting glucose measures, according to the study, published Feb. 18 in the American Journal of Clinical Nutrition.

The french fry eaters gained a little more weight, but it was not statistically significant. The people who ate french fries gained 0.49 kilograms (just over a pound), vs. about a tenth of a kilogram (about one-fifth of a pound) in the group of people who ate almonds.

“The take-home is if you like almonds, eat some almonds. If you like potatoes, eat some potatoes, but don’t overeat either,” said study leader David B. Allison, PhD, a professor at Indiana University’s School of Public Health in Bloomington. ‘It’s probably good to have a little bit of each – each has some unique advantages in terms of nutrition.”

“This study confirms what registered dietitian nutritionists already know – all foods can fit. We can eat almonds, french fries, kale, and cookies,” said Melissa Majumdar, a registered dietitian and certified specialist in obesity and weight management at Emory University Hospital Midtown in Atlanta. ‘The consumption of one food or the avoidance of another does not make a healthy diet.”

At the same time, people should not interpret the results to mean it’s OK to eat french fries all day, every day. “We know that while potatoes are nutrient dense, the frying process reduces the nutritional value,” Ms. Majumdar said.

“Because french fries are often consumed alongside other nutrient-poor or high-fat foods, they should not be consumed daily but can fit into an overall balanced diet,” she added.
 

Would you like fries with that?

The researchers compared french fries to almonds because almonds are known for positive effects on energy balance, body composition, and low glycemic index. The research was partly funded by the Alliance for Potato Research and Education.

French fries are an incredibly popular food in the United States. According to an August 2021 post on the food website Mashed, Americans eat an average of 30 pounds of french fries each year.

Although consumption of almonds is increasing, Americans eat far less in volume each year than they do fries – an estimated 2.4 pounds of almonds per person, according to August 2021 figures from the Almond Board of California.

Dr. Allison and colleagues recruited 180 healthy adults for the study. Their average age was 30, and about two-thirds were women.

They randomly assigned 60 people to add about a medium serving of plain french fries (Tater Pals Ovenable Crinkle Cut Fries, Simplot Foods) to their diet. Another 60 people were assigned to the same amount of Tater Pals fries with herbs (oregano, basil, garlic, onion, and rosemary), and another 60 people ate Wonderful brand roasted and salted almonds.

Investigators told people to add either the potatoes or nuts to their diet every day for a month and gave no further instructions.

After some people dropped out of the study, results were based on 55 who ate regular french fries, 52 who ate french fries with herbs and spices, and 58 who ate the nuts.

The researchers scanned people to detect any changes in fat mass. They also measured changes in body weight, carbohydrate metabolism, and fasting blood glucose and insulin.
 

Key findings

Changes in total body fat mass and fat mass were not significantly different between the french fry groups and the almond group.

In terms of glycemic control, eating french fries for a month “is no better or worse than consuming a caloric equivalent of nuts,” the researchers noted.

Similarly, the change in total fat mass did not differ significantly among the three treatment groups.

Adding the herb and spice mix to the french fries did not make a significant difference on glycemic control, contrary to what the researchers thought might happen.

And fasting glucose, insulin, and HbA1c levels did not differ significantly between the combined french fry and almond groups. When comparisons were made among the three groups, the almond group had a lower insulin response, compared to the plain french fry group.

Many different things could be explored in future research, said study coauthor Rebecca Hanson, a registered dietitian nutritionist and research study coordinator at the University of Alabama at Birmingham. “People were not told to change their exercise or diet, so there are so many different variables,” she said. Repeating the research in people with diabetes is another possibility going forward.

The researchers acknowledged that 30 days may not have been long enough to show a significant difference. But they also noted that many previous studies were observational while they used a randomized controlled trial, considered a more robust study design.

Dr. Allison, the senior author, emphasized that this is just one study. “No one study has all the answers.

“I don’t want to tell you our results are the be all and end all or that we’ve now learned everything there is to learn about potatoes and almonds,” he said.

“Our study shows for the variables we looked at ... we did not see important, discernible differences,” he said. “That doesn’t mean if you ate 500 potatoes a day or 500 kilograms of almonds it would be the same. But at these modest levels, it doesn’t seem to make much difference.”

The study was funded by grants from the National Institutes of Health and from the Alliance for Potato Research and Education.

Asked if the industry support should be a concern, Ms. Majumdar said, “Funding from a specific food board does not necessarily dilute the results of a well-designed study. It’s not uncommon for a funding source to come from a food board that may benefit from the findings. Research money has to come from somewhere.

“This study has reputable researchers, some of the best in the field,” she said.

The U.S. produces the most almonds in the world, and California is the only state where almonds are grown commercially. Asked for the almond industry’s take on the findings, “We don’t have a comment,” said Rick Kushman, a spokesman for the Almond Board of California.

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

Both tofacitinib (Xeljanz) and vedolizumab (Entyvio) are effective options for people with ulcerative colitis (UC) who fail at least one antitumor necrosis factor (anti-TNF) therapy, a real-world study in France revealed.

However, response was superior with tofacitinib among people after primary failure to biologics and multiple therapeutic failure, the researchers report, including endoscopic improvement and mucosal healing.  

Anthony Buisson, MD, presented the results Feb. 18 at the 17th congress of the European Crohn’s and Colitis Organisation.
 

The French comparison

Although multiple therapeutic options are available to treat ulcerative colitis after anti-TNF failure, “there are no data comparing tofacitinib to vedolizumab in the real world,” said Dr. Buisson, a gastroenterologist at Clermont Auvergne University, Clermont-Ferrand, France.

In addition, network meta-analysis data are inconclusive, he said.

This led Dr. Buisson and colleagues to study adults with symptomatic UC with prior exposure to at least one anti-TNF treatment. They assessed 126 patients in a tofacitinib group and 178 in a vedolizumab group. The groups were comparable except for higher disease activity at baseline in the tofacitinib group.

The retrospective study was conducted at nine academic centers. Patients started either tofacitinib or vedolizumab between January 2019 and June 2021.

The primary endpoint, corticosteroid-free clinical remission at 16 weeks, was achieved by 45% of the tofacitinib group and 40% of the vedolizumab group. This difference was not statistically significant.

However, endoscopic improvement at week 16 did differ significantly and was achieved by 24% of the tofacitinib group versus 7% of the vedolizumab group (P = .0036).

“Tofacitinib and vedolizumab are effective to induce corticosteroid-free clinical remission at week 16 in patients with UC who failed at least one anti-TNF agent,” Dr. Buisson said.

“Vedolizumab seems to be less effective in cases of more severe UC and prior history of primary failure to any biologic,” he added.

Dr. Buisson said he and his colleagues plan to continue the study beyond 16 weeks to look at longterm outcomes.
 

The science from Spain

In another study presented at ECCO ‘22 Virtual, investigators from Spain compared vedolizumab to ustekinumab (Stelara) after at least one anti-TNF treatment failure, this time among people with Crohn’s disease.

Finding effective treatments after an anti-TNF failure is essential, Maria Jose Garcia, MD, said when presenting the results of the VERSUS-CD trial. “Over 20%-30% of Crohn’s disease patients are nonresponders or develop intolerance to anti-TNF therapies. Also, anti-TNF responders can experience a loss of response over time.”

Both vedolizumab and ustekinumab are effective for Crohn’s, she said. “But no clinical trial has compared both treatments, and limited data exist in real life.”

To remedy this situation, Dr. Garcia and colleagues studied 755 people from 30 medical centers in a national database in Spain who failed a previous anti-TNF agent, including 195 people switched to vedolizumab and 560 switched to ustekinumab. Luminal activity, perianal disease, or postoperative recurrence of Crohn’s were the indications for treatment.

The study’s main objective was to compare the short- and long-term treatment survival rate of vedolizumab and ustekinumab after anti-TNF therapy failure in clinical practice. Evaluating efficacy and safety were secondary aims.

“The treatment survival rate with ustekinumab was higher than with vedolizumab” over 5 years of follow-up, said Dr. Garcia, a gastroenterologist at Hospital Universitario Marqués de Valdecilla-IDIVAL, Santander, Spain. The difference was statistically significant (P < .001).

Just less than half (43%) of the 327 patients discontinued treatment over time, including 142 in the vedolizumab group and 185 in the ustekinumab group. The most frequent cause was primarily nonresponse.

Infection, arthralgia, and infusion reactions were the most common adverse events. The safety profile was similar between groups, Dr. Garcia said.

“In clinical practice, vedolizumab and ustekinumab are both effective after anti-TNF failure or intolerance in CD,” Dr. Garcia said, adding that, “the retention rate of ustekinumab was higher compared to vedolizumab.”

When asked if the results will change how she practices, Dr. Garcia responded, “This confirms the first choice is ustekinumab more than vedolizumab in clinical practice, because it seems the clinical remission and durability of the treatment is superior.”
 

More options means more questions

“Looking back almost 25 years ago, the struggle was how to work with just one biologic and how to make it last for patients who have already failed all the available therapies. All these years later, we have such riches that the question we most often deal with is ‘What’s my first treatment?’ for patients with inflammatory bowel disease,” Arun Swaminath, MD, said, when asked to comment on both studies.

“Increasingly, we are seeing industry do head-to-head trials of drugs, but this is a time-consuming and expensive process,” added Dr. Swaminath, chief of gastroenterology and director of the inflammatory bowel diseases program at Lenox Hill Hospital, New York.

The study from Dr. Buisson and colleagues in UC approaches the design of a head-to-head trial, Dr. Swaminath said. “In the end, their primary endpoint was a statistical dead heat between the two options.”

In the VERSUS-CD study, vedolizumab was compared with ustekinumab, “with more patients not discontinuing ustekinumab therapy compared to vedolizumab,” he said. “This study also seems to favor sicker patients being treated with ustekinumab.”

“In both cases, we are starting to see the ‘order’ of treatments take shape, even before the benefit of head-to-head trials,” Dr. Swaminath said.

Dr. Buisson reports receiving grant support from AbbVie, Celltrion, Pfizer, and Takeda, as well as personal fees from AbbVie, Amgen, Arena, Biogen, Celltrion, Ferring, Janssen, MSD, Nexbiome, Pfizer, Roche, sanofi-aventis, Takeda, Tillots, and Vifor Pharma. Dr. Garcia reports receiving financial support for traveling and educational activities from MSD, Janssen, AbbVie, Takeda, and Ferring. Dr. Swaminath reports receiving advanced IBD fellowship support from Janssen and Takeda and is on the advisory board for Boehringer Ingelheim.

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

Both tofacitinib (Xeljanz) and vedolizumab (Entyvio) are effective options for people with ulcerative colitis (UC) who fail at least one antitumor necrosis factor (anti-TNF) therapy, a real-world study in France revealed.

However, response was superior with tofacitinib among people after primary failure to biologics and multiple therapeutic failure, the researchers report, including endoscopic improvement and mucosal healing.  

Anthony Buisson, MD, presented the results Feb. 18 at the 17th congress of the European Crohn’s and Colitis Organisation.
 

The French comparison

Although multiple therapeutic options are available to treat ulcerative colitis after anti-TNF failure, “there are no data comparing tofacitinib to vedolizumab in the real world,” said Dr. Buisson, a gastroenterologist at Clermont Auvergne University, Clermont-Ferrand, France.

In addition, network meta-analysis data are inconclusive, he said.

This led Dr. Buisson and colleagues to study adults with symptomatic UC with prior exposure to at least one anti-TNF treatment. They assessed 126 patients in a tofacitinib group and 178 in a vedolizumab group. The groups were comparable except for higher disease activity at baseline in the tofacitinib group.

The retrospective study was conducted at nine academic centers. Patients started either tofacitinib or vedolizumab between January 2019 and June 2021.

The primary endpoint, corticosteroid-free clinical remission at 16 weeks, was achieved by 45% of the tofacitinib group and 40% of the vedolizumab group. This difference was not statistically significant.

However, endoscopic improvement at week 16 did differ significantly and was achieved by 24% of the tofacitinib group versus 7% of the vedolizumab group (P = .0036).

“Tofacitinib and vedolizumab are effective to induce corticosteroid-free clinical remission at week 16 in patients with UC who failed at least one anti-TNF agent,” Dr. Buisson said.

“Vedolizumab seems to be less effective in cases of more severe UC and prior history of primary failure to any biologic,” he added.

Dr. Buisson said he and his colleagues plan to continue the study beyond 16 weeks to look at longterm outcomes.
 

The science from Spain

In another study presented at ECCO ‘22 Virtual, investigators from Spain compared vedolizumab to ustekinumab (Stelara) after at least one anti-TNF treatment failure, this time among people with Crohn’s disease.

Finding effective treatments after an anti-TNF failure is essential, Maria Jose Garcia, MD, said when presenting the results of the VERSUS-CD trial. “Over 20%-30% of Crohn’s disease patients are nonresponders or develop intolerance to anti-TNF therapies. Also, anti-TNF responders can experience a loss of response over time.”

Both vedolizumab and ustekinumab are effective for Crohn’s, she said. “But no clinical trial has compared both treatments, and limited data exist in real life.”

To remedy this situation, Dr. Garcia and colleagues studied 755 people from 30 medical centers in a national database in Spain who failed a previous anti-TNF agent, including 195 people switched to vedolizumab and 560 switched to ustekinumab. Luminal activity, perianal disease, or postoperative recurrence of Crohn’s were the indications for treatment.

The study’s main objective was to compare the short- and long-term treatment survival rate of vedolizumab and ustekinumab after anti-TNF therapy failure in clinical practice. Evaluating efficacy and safety were secondary aims.

“The treatment survival rate with ustekinumab was higher than with vedolizumab” over 5 years of follow-up, said Dr. Garcia, a gastroenterologist at Hospital Universitario Marqués de Valdecilla-IDIVAL, Santander, Spain. The difference was statistically significant (P < .001).

Just less than half (43%) of the 327 patients discontinued treatment over time, including 142 in the vedolizumab group and 185 in the ustekinumab group. The most frequent cause was primarily nonresponse.

Infection, arthralgia, and infusion reactions were the most common adverse events. The safety profile was similar between groups, Dr. Garcia said.

“In clinical practice, vedolizumab and ustekinumab are both effective after anti-TNF failure or intolerance in CD,” Dr. Garcia said, adding that, “the retention rate of ustekinumab was higher compared to vedolizumab.”

When asked if the results will change how she practices, Dr. Garcia responded, “This confirms the first choice is ustekinumab more than vedolizumab in clinical practice, because it seems the clinical remission and durability of the treatment is superior.”
 

More options means more questions

“Looking back almost 25 years ago, the struggle was how to work with just one biologic and how to make it last for patients who have already failed all the available therapies. All these years later, we have such riches that the question we most often deal with is ‘What’s my first treatment?’ for patients with inflammatory bowel disease,” Arun Swaminath, MD, said, when asked to comment on both studies.

“Increasingly, we are seeing industry do head-to-head trials of drugs, but this is a time-consuming and expensive process,” added Dr. Swaminath, chief of gastroenterology and director of the inflammatory bowel diseases program at Lenox Hill Hospital, New York.

The study from Dr. Buisson and colleagues in UC approaches the design of a head-to-head trial, Dr. Swaminath said. “In the end, their primary endpoint was a statistical dead heat between the two options.”

In the VERSUS-CD study, vedolizumab was compared with ustekinumab, “with more patients not discontinuing ustekinumab therapy compared to vedolizumab,” he said. “This study also seems to favor sicker patients being treated with ustekinumab.”

“In both cases, we are starting to see the ‘order’ of treatments take shape, even before the benefit of head-to-head trials,” Dr. Swaminath said.

Dr. Buisson reports receiving grant support from AbbVie, Celltrion, Pfizer, and Takeda, as well as personal fees from AbbVie, Amgen, Arena, Biogen, Celltrion, Ferring, Janssen, MSD, Nexbiome, Pfizer, Roche, sanofi-aventis, Takeda, Tillots, and Vifor Pharma. Dr. Garcia reports receiving financial support for traveling and educational activities from MSD, Janssen, AbbVie, Takeda, and Ferring. Dr. Swaminath reports receiving advanced IBD fellowship support from Janssen and Takeda and is on the advisory board for Boehringer Ingelheim.

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

Both tofacitinib (Xeljanz) and vedolizumab (Entyvio) are effective options for people with ulcerative colitis (UC) who fail at least one antitumor necrosis factor (anti-TNF) therapy, a real-world study in France revealed.

However, response was superior with tofacitinib among people after primary failure to biologics and multiple therapeutic failure, the researchers report, including endoscopic improvement and mucosal healing.  

Anthony Buisson, MD, presented the results Feb. 18 at the 17th congress of the European Crohn’s and Colitis Organisation.
 

The French comparison

Although multiple therapeutic options are available to treat ulcerative colitis after anti-TNF failure, “there are no data comparing tofacitinib to vedolizumab in the real world,” said Dr. Buisson, a gastroenterologist at Clermont Auvergne University, Clermont-Ferrand, France.

In addition, network meta-analysis data are inconclusive, he said.

This led Dr. Buisson and colleagues to study adults with symptomatic UC with prior exposure to at least one anti-TNF treatment. They assessed 126 patients in a tofacitinib group and 178 in a vedolizumab group. The groups were comparable except for higher disease activity at baseline in the tofacitinib group.

The retrospective study was conducted at nine academic centers. Patients started either tofacitinib or vedolizumab between January 2019 and June 2021.

The primary endpoint, corticosteroid-free clinical remission at 16 weeks, was achieved by 45% of the tofacitinib group and 40% of the vedolizumab group. This difference was not statistically significant.

However, endoscopic improvement at week 16 did differ significantly and was achieved by 24% of the tofacitinib group versus 7% of the vedolizumab group (P = .0036).

“Tofacitinib and vedolizumab are effective to induce corticosteroid-free clinical remission at week 16 in patients with UC who failed at least one anti-TNF agent,” Dr. Buisson said.

“Vedolizumab seems to be less effective in cases of more severe UC and prior history of primary failure to any biologic,” he added.

Dr. Buisson said he and his colleagues plan to continue the study beyond 16 weeks to look at longterm outcomes.
 

The science from Spain

In another study presented at ECCO ‘22 Virtual, investigators from Spain compared vedolizumab to ustekinumab (Stelara) after at least one anti-TNF treatment failure, this time among people with Crohn’s disease.

Finding effective treatments after an anti-TNF failure is essential, Maria Jose Garcia, MD, said when presenting the results of the VERSUS-CD trial. “Over 20%-30% of Crohn’s disease patients are nonresponders or develop intolerance to anti-TNF therapies. Also, anti-TNF responders can experience a loss of response over time.”

Both vedolizumab and ustekinumab are effective for Crohn’s, she said. “But no clinical trial has compared both treatments, and limited data exist in real life.”

To remedy this situation, Dr. Garcia and colleagues studied 755 people from 30 medical centers in a national database in Spain who failed a previous anti-TNF agent, including 195 people switched to vedolizumab and 560 switched to ustekinumab. Luminal activity, perianal disease, or postoperative recurrence of Crohn’s were the indications for treatment.

The study’s main objective was to compare the short- and long-term treatment survival rate of vedolizumab and ustekinumab after anti-TNF therapy failure in clinical practice. Evaluating efficacy and safety were secondary aims.

“The treatment survival rate with ustekinumab was higher than with vedolizumab” over 5 years of follow-up, said Dr. Garcia, a gastroenterologist at Hospital Universitario Marqués de Valdecilla-IDIVAL, Santander, Spain. The difference was statistically significant (P < .001).

Just less than half (43%) of the 327 patients discontinued treatment over time, including 142 in the vedolizumab group and 185 in the ustekinumab group. The most frequent cause was primarily nonresponse.

Infection, arthralgia, and infusion reactions were the most common adverse events. The safety profile was similar between groups, Dr. Garcia said.

“In clinical practice, vedolizumab and ustekinumab are both effective after anti-TNF failure or intolerance in CD,” Dr. Garcia said, adding that, “the retention rate of ustekinumab was higher compared to vedolizumab.”

When asked if the results will change how she practices, Dr. Garcia responded, “This confirms the first choice is ustekinumab more than vedolizumab in clinical practice, because it seems the clinical remission and durability of the treatment is superior.”
 

More options means more questions

“Looking back almost 25 years ago, the struggle was how to work with just one biologic and how to make it last for patients who have already failed all the available therapies. All these years later, we have such riches that the question we most often deal with is ‘What’s my first treatment?’ for patients with inflammatory bowel disease,” Arun Swaminath, MD, said, when asked to comment on both studies.

“Increasingly, we are seeing industry do head-to-head trials of drugs, but this is a time-consuming and expensive process,” added Dr. Swaminath, chief of gastroenterology and director of the inflammatory bowel diseases program at Lenox Hill Hospital, New York.

The study from Dr. Buisson and colleagues in UC approaches the design of a head-to-head trial, Dr. Swaminath said. “In the end, their primary endpoint was a statistical dead heat between the two options.”

In the VERSUS-CD study, vedolizumab was compared with ustekinumab, “with more patients not discontinuing ustekinumab therapy compared to vedolizumab,” he said. “This study also seems to favor sicker patients being treated with ustekinumab.”

“In both cases, we are starting to see the ‘order’ of treatments take shape, even before the benefit of head-to-head trials,” Dr. Swaminath said.

Dr. Buisson reports receiving grant support from AbbVie, Celltrion, Pfizer, and Takeda, as well as personal fees from AbbVie, Amgen, Arena, Biogen, Celltrion, Ferring, Janssen, MSD, Nexbiome, Pfizer, Roche, sanofi-aventis, Takeda, Tillots, and Vifor Pharma. Dr. Garcia reports receiving financial support for traveling and educational activities from MSD, Janssen, AbbVie, Takeda, and Ferring. Dr. Swaminath reports receiving advanced IBD fellowship support from Janssen and Takeda and is on the advisory board for Boehringer Ingelheim.

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

Many people with inflammatory bowel disease (IBD) can mount a strong antibody response to a booster shot of an mRNA COVID-19 vaccine, including those who were unable to respond fully to an initial two-dose vaccine series, new evidence suggests.

Of the study participants, 93% had detectable antibodies after their initial vaccination series, which increased to 99.5% following an additional dose.

“Most IBD patients, including those who are immune suppressed and/or did not have detectable humoral immune responses following the initial mRNA COVID-19 vaccine series, demonstrate strong immune responses to additional doses of mRNA vaccines,” Michael D. Kappelman, MD, a pediatric gastroenterologist at the University of North Carolina at Chapel Hill, told this news organization.

“These data support an additional vaccine dose of mRNA vaccine in patients at risk for an inadequate response to the initial series,” he said.

Dr. Kappelman presented these findings on behalf of the PREVENT-COVID Study Group as an e-poster at the 17th congress of the European Crohn’s and Colitis Organisation.
 

A study design to measure boosters’ benefits

For people with Crohn’s disease or ulcerative colitis who are taking immunosuppressants, boosters are generally recommended, Dr. Kappelman and colleagues noted. However, “real-world data on the effectiveness and safety of additional vaccine doses are lacking.”

They studied 659 people with IBD (mean age, 45 years; 72% female), of whom 72% had Crohn’s disease and 27% had ulcerative colitis/unclassified IBD.

Of these participants, 63% received Pfizer/BioNTech vaccine and 37% received the Moderna vaccine. Five participants received the Johnson & Johnson vaccine. In 98% of cases, people who received an mRNA vaccine initially also received the same type for the additional dose.

Participants completed baseline and follow-up surveys. Their blood work was obtained and evaluated 8 weeks after completion of the initial vaccine series and 6 weeks after a booster to measure anti–receptor binding domain IgG antibody levels specific to SARS-CoV-2.

Mean increase in antibody levels was 61 µg/mL in the Pfizer vaccine group and 78 µg/mL in the Moderna vaccine group following the booster shot.

Of the 47 patients without initial antibody response, 45 (96%) had detectable antibodies following an additional dose.

Serious adverse events (AEs) associated with the booster were rare, Dr. Kappelman said. Among participants, 44% reported no AEs, 24% mild AEs, 25% moderate AEs, and 6% reported serious AEs.

“These data can be used to inform vaccine decisions in patients with a broad array of immune-medicated conditions frequently managed by immunosuppression,” the investigators note.
 

A ‘reassuring’ finding

“This abstract [gives us] an important understanding about how patients with inflammatory bowel disease respond to COVID-19 vaccination. There have been mixed reports in the prior studies regarding how well patients with IBD respond to vaccination,” Jason Ken Hou, MD, said when asked to comment on the research.

The main findings that 99.5% of patients had detectable antibodies after an additional dose “is reassuring, as prior studies have suggested some patients did not develop antibodies after the [initial series],” added Dr. Hou, associate professor of medicine-gastroenterology at Baylor College of Medicine in Houston.

The researchers conducted the study within a previously established, well-known Internet-based cohort of IBD patients, Dr. Hou said. Although the researchers collected information on the IBD medications that patients were taking at the time of vaccination, the analyses that were presented did not compare antibody response rates based on medication.

“Further study is still required, as there is more to vaccination response than detectable antibody alone,” he added.

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

Many people with inflammatory bowel disease (IBD) can mount a strong antibody response to a booster shot of an mRNA COVID-19 vaccine, including those who were unable to respond fully to an initial two-dose vaccine series, new evidence suggests.

Of the study participants, 93% had detectable antibodies after their initial vaccination series, which increased to 99.5% following an additional dose.

“Most IBD patients, including those who are immune suppressed and/or did not have detectable humoral immune responses following the initial mRNA COVID-19 vaccine series, demonstrate strong immune responses to additional doses of mRNA vaccines,” Michael D. Kappelman, MD, a pediatric gastroenterologist at the University of North Carolina at Chapel Hill, told this news organization.

“These data support an additional vaccine dose of mRNA vaccine in patients at risk for an inadequate response to the initial series,” he said.

Dr. Kappelman presented these findings on behalf of the PREVENT-COVID Study Group as an e-poster at the 17th congress of the European Crohn’s and Colitis Organisation.
 

A study design to measure boosters’ benefits

For people with Crohn’s disease or ulcerative colitis who are taking immunosuppressants, boosters are generally recommended, Dr. Kappelman and colleagues noted. However, “real-world data on the effectiveness and safety of additional vaccine doses are lacking.”

They studied 659 people with IBD (mean age, 45 years; 72% female), of whom 72% had Crohn’s disease and 27% had ulcerative colitis/unclassified IBD.

Of these participants, 63% received Pfizer/BioNTech vaccine and 37% received the Moderna vaccine. Five participants received the Johnson & Johnson vaccine. In 98% of cases, people who received an mRNA vaccine initially also received the same type for the additional dose.

Participants completed baseline and follow-up surveys. Their blood work was obtained and evaluated 8 weeks after completion of the initial vaccine series and 6 weeks after a booster to measure anti–receptor binding domain IgG antibody levels specific to SARS-CoV-2.

Mean increase in antibody levels was 61 µg/mL in the Pfizer vaccine group and 78 µg/mL in the Moderna vaccine group following the booster shot.

Of the 47 patients without initial antibody response, 45 (96%) had detectable antibodies following an additional dose.

Serious adverse events (AEs) associated with the booster were rare, Dr. Kappelman said. Among participants, 44% reported no AEs, 24% mild AEs, 25% moderate AEs, and 6% reported serious AEs.

“These data can be used to inform vaccine decisions in patients with a broad array of immune-medicated conditions frequently managed by immunosuppression,” the investigators note.
 

A ‘reassuring’ finding

“This abstract [gives us] an important understanding about how patients with inflammatory bowel disease respond to COVID-19 vaccination. There have been mixed reports in the prior studies regarding how well patients with IBD respond to vaccination,” Jason Ken Hou, MD, said when asked to comment on the research.

The main findings that 99.5% of patients had detectable antibodies after an additional dose “is reassuring, as prior studies have suggested some patients did not develop antibodies after the [initial series],” added Dr. Hou, associate professor of medicine-gastroenterology at Baylor College of Medicine in Houston.

The researchers conducted the study within a previously established, well-known Internet-based cohort of IBD patients, Dr. Hou said. Although the researchers collected information on the IBD medications that patients were taking at the time of vaccination, the analyses that were presented did not compare antibody response rates based on medication.

“Further study is still required, as there is more to vaccination response than detectable antibody alone,” he added.

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

Many people with inflammatory bowel disease (IBD) can mount a strong antibody response to a booster shot of an mRNA COVID-19 vaccine, including those who were unable to respond fully to an initial two-dose vaccine series, new evidence suggests.

Of the study participants, 93% had detectable antibodies after their initial vaccination series, which increased to 99.5% following an additional dose.

“Most IBD patients, including those who are immune suppressed and/or did not have detectable humoral immune responses following the initial mRNA COVID-19 vaccine series, demonstrate strong immune responses to additional doses of mRNA vaccines,” Michael D. Kappelman, MD, a pediatric gastroenterologist at the University of North Carolina at Chapel Hill, told this news organization.

“These data support an additional vaccine dose of mRNA vaccine in patients at risk for an inadequate response to the initial series,” he said.

Dr. Kappelman presented these findings on behalf of the PREVENT-COVID Study Group as an e-poster at the 17th congress of the European Crohn’s and Colitis Organisation.
 

A study design to measure boosters’ benefits

For people with Crohn’s disease or ulcerative colitis who are taking immunosuppressants, boosters are generally recommended, Dr. Kappelman and colleagues noted. However, “real-world data on the effectiveness and safety of additional vaccine doses are lacking.”

They studied 659 people with IBD (mean age, 45 years; 72% female), of whom 72% had Crohn’s disease and 27% had ulcerative colitis/unclassified IBD.

Of these participants, 63% received Pfizer/BioNTech vaccine and 37% received the Moderna vaccine. Five participants received the Johnson & Johnson vaccine. In 98% of cases, people who received an mRNA vaccine initially also received the same type for the additional dose.

Participants completed baseline and follow-up surveys. Their blood work was obtained and evaluated 8 weeks after completion of the initial vaccine series and 6 weeks after a booster to measure anti–receptor binding domain IgG antibody levels specific to SARS-CoV-2.

Mean increase in antibody levels was 61 µg/mL in the Pfizer vaccine group and 78 µg/mL in the Moderna vaccine group following the booster shot.

Of the 47 patients without initial antibody response, 45 (96%) had detectable antibodies following an additional dose.

Serious adverse events (AEs) associated with the booster were rare, Dr. Kappelman said. Among participants, 44% reported no AEs, 24% mild AEs, 25% moderate AEs, and 6% reported serious AEs.

“These data can be used to inform vaccine decisions in patients with a broad array of immune-medicated conditions frequently managed by immunosuppression,” the investigators note.
 

A ‘reassuring’ finding

“This abstract [gives us] an important understanding about how patients with inflammatory bowel disease respond to COVID-19 vaccination. There have been mixed reports in the prior studies regarding how well patients with IBD respond to vaccination,” Jason Ken Hou, MD, said when asked to comment on the research.

The main findings that 99.5% of patients had detectable antibodies after an additional dose “is reassuring, as prior studies have suggested some patients did not develop antibodies after the [initial series],” added Dr. Hou, associate professor of medicine-gastroenterology at Baylor College of Medicine in Houston.

The researchers conducted the study within a previously established, well-known Internet-based cohort of IBD patients, Dr. Hou said. Although the researchers collected information on the IBD medications that patients were taking at the time of vaccination, the analyses that were presented did not compare antibody response rates based on medication.

“Further study is still required, as there is more to vaccination response than detectable antibody alone,” he added.

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

An infliximab biosimilar (infliximab-axxq) delivered via subcutaneous injection was superior to intravenous vedolizumab (Entyvio) for induction and maintenance therapy of Crohn’s disease (CD), according to a systematic review and meta-analysis from French researchers.  

In contrast, the same research showed no significant differences in efficacy between these agents for people with ulcerative colitis (UC).

The subcutaneous injection formulation of infliximab-axxq, also known as CT-P13 SC, is approved by the European Medicines Agency for both CD and UC (Remsima SC). This formulation is not yet approved by the U.S. Food and Drug Administration.

“It’s kind of a small revolution, because now we have access, and in France, we are using a lot of subcutaneous infliximab,” Laurent Peyrin-Biroulet, MD, said during a digital oral presentation at ECCO ‘22 Virtual, the European Crohn’s and Colitis Organisation 2022 Congress. He is ECCO president and a gastroenterologist at University Hospital of Nancy in France.

Dr. Peyrin-Biroulet and colleagues compared the efficacy and safety of the two agents in major randomized controlled trials looking at moderate-to-severe CD or UC from January 2010 to April 2021.

Subcutaneous infliximab-axxq data came from NCT02883452, an ongoing phase 1 study started in 2016. The vedolizumab data come from GEMINI I, II, and III; VISIBLE 1 and 2; and VARSITY trials.
 

Key findings

In CD, induction efficacy was 79% for subcutaneous infliximab-axxq versus a 45% response for vedolizumab, as measured by the Crohn’s Disease Activity Index-70 (CDAI-70).

In addition, the study showed a 62% induction efficacy for subcutaneous infliximab-axxq versus 36% for vedolizumab on the CDAI-100.

The maintenance response on the CDAI-100 was achieved by 64% of the infliximab-axxq patients versus 47% of the vedolizumab patients.

“You can see better efficacy results of subcutaneous infliximab compared to vedolizumab in CD for both induction and maintenance,” Dr. Peyrin-Biroulet said, adding that what is seen here is probably what has been observed.
 

Similar results for UC

“We know vedolizumab is a good drug in UC, and there was not a difference between UC and CD,” Dr. Peyrin-Biroulet said.

There were no significant differences between subcutaneous infliximab-axxq and vedolizumab in terms of clinical response for induction (77% vs. 69%, respectively) or clinical response for maintenance (62% vs. 63%, respectively).

Similarly, no significant differences emerged in rates of clinical remission or mucosal healing.
 

Safety so far

Safety profiles for both agents in both indications were similar over 1 year.

However, Dr. Peyrin-Biroulet shared a caveat about that timeline. “It’s a 1-year follow-up, not a 10-year follow-up with 100,000 patients,” he said. “But still, what we see here is a confirmation of what we see in other analyses. There is not a significant [safety] difference between these two drugs.”

The rate of any adverse event in CD was 76% for subcutaneous infliximab-axxq versus 77% for vedolizumab, for example. Rates of any serious adverse event were 9% and 14%, respectively.

In UC studies, the rate of any adverse event was 67% for subcutaneous infliximab-axxq versus 64% for vedolizumab. Rates of serious adverse events were 12% and 11%, respectively.

Rates of discontinuation over 1 year differed between agents. Five percent of subcutaneous infliximab-axxq participants with CD discontinued treatment as because of lack of efficacy compared with 32% with vedolizumab. In UC participants, discontinuation for the same reason was reported for 3% of subcutaneous infliximab-axxq patients versus 15% of vedolizumab.

Although all participants in the subcutaneous infliximab-axxq trial were anti-tumor necrosis factor treatment naive, some in the vedolizumab may have been previously exposed to such therapy, Dr. Peyrin-Biroulet said. “Subgroup analyses would be need to further explore that.”

“It’s interesting and a clinically relevant piece of work,” said Mark Samaan, MD, session moderator and consultant gastroenterologist at Guy’s and St. Thomas’ NHS Foundation Trust in London, who was not involved in the study.

“The results are in keeping with what one might expect from IV infliximab administration. In that sense, [it is] reassuring that the two routes of administration appear to perform in a broadly similar manner,” Dr. Samaan said.

“So long as adequate exposure is achieved, I wouldn’t have expected route of administration to be a significant determinant of efficacy,” he added.

Dr. Peyrin-Biroulet reports receiving personal fees from Galapagos, AbbVie, Janssen, Genetech, Ferring, Tillots, Pharmacosmos, Celltrion, Takeda, Samsung Bioepis, Alma, Sterna, Nestle, Inotrem, Enterome, Allergen, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgene, Mylan, Lilly, Fresenius Kabi, Opplian Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, and Theravance. Dr. Samaan reports receiving advisory fees from Janssen, Takeda, Sandoz, Samsung Bioepis, Galapagos, and AbbVie and lecture fees from Bristol-Myers Squibb, Janssen, Takeda, MSD, Falk, AbbVie, and Galapagos.

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

An infliximab biosimilar (infliximab-axxq) delivered via subcutaneous injection was superior to intravenous vedolizumab (Entyvio) for induction and maintenance therapy of Crohn’s disease (CD), according to a systematic review and meta-analysis from French researchers.  

In contrast, the same research showed no significant differences in efficacy between these agents for people with ulcerative colitis (UC).

The subcutaneous injection formulation of infliximab-axxq, also known as CT-P13 SC, is approved by the European Medicines Agency for both CD and UC (Remsima SC). This formulation is not yet approved by the U.S. Food and Drug Administration.

“It’s kind of a small revolution, because now we have access, and in France, we are using a lot of subcutaneous infliximab,” Laurent Peyrin-Biroulet, MD, said during a digital oral presentation at ECCO ‘22 Virtual, the European Crohn’s and Colitis Organisation 2022 Congress. He is ECCO president and a gastroenterologist at University Hospital of Nancy in France.

Dr. Peyrin-Biroulet and colleagues compared the efficacy and safety of the two agents in major randomized controlled trials looking at moderate-to-severe CD or UC from January 2010 to April 2021.

Subcutaneous infliximab-axxq data came from NCT02883452, an ongoing phase 1 study started in 2016. The vedolizumab data come from GEMINI I, II, and III; VISIBLE 1 and 2; and VARSITY trials.
 

Key findings

In CD, induction efficacy was 79% for subcutaneous infliximab-axxq versus a 45% response for vedolizumab, as measured by the Crohn’s Disease Activity Index-70 (CDAI-70).

In addition, the study showed a 62% induction efficacy for subcutaneous infliximab-axxq versus 36% for vedolizumab on the CDAI-100.

The maintenance response on the CDAI-100 was achieved by 64% of the infliximab-axxq patients versus 47% of the vedolizumab patients.

“You can see better efficacy results of subcutaneous infliximab compared to vedolizumab in CD for both induction and maintenance,” Dr. Peyrin-Biroulet said, adding that what is seen here is probably what has been observed.
 

Similar results for UC

“We know vedolizumab is a good drug in UC, and there was not a difference between UC and CD,” Dr. Peyrin-Biroulet said.

There were no significant differences between subcutaneous infliximab-axxq and vedolizumab in terms of clinical response for induction (77% vs. 69%, respectively) or clinical response for maintenance (62% vs. 63%, respectively).

Similarly, no significant differences emerged in rates of clinical remission or mucosal healing.
 

Safety so far

Safety profiles for both agents in both indications were similar over 1 year.

However, Dr. Peyrin-Biroulet shared a caveat about that timeline. “It’s a 1-year follow-up, not a 10-year follow-up with 100,000 patients,” he said. “But still, what we see here is a confirmation of what we see in other analyses. There is not a significant [safety] difference between these two drugs.”

The rate of any adverse event in CD was 76% for subcutaneous infliximab-axxq versus 77% for vedolizumab, for example. Rates of any serious adverse event were 9% and 14%, respectively.

In UC studies, the rate of any adverse event was 67% for subcutaneous infliximab-axxq versus 64% for vedolizumab. Rates of serious adverse events were 12% and 11%, respectively.

Rates of discontinuation over 1 year differed between agents. Five percent of subcutaneous infliximab-axxq participants with CD discontinued treatment as because of lack of efficacy compared with 32% with vedolizumab. In UC participants, discontinuation for the same reason was reported for 3% of subcutaneous infliximab-axxq patients versus 15% of vedolizumab.

Although all participants in the subcutaneous infliximab-axxq trial were anti-tumor necrosis factor treatment naive, some in the vedolizumab may have been previously exposed to such therapy, Dr. Peyrin-Biroulet said. “Subgroup analyses would be need to further explore that.”

“It’s interesting and a clinically relevant piece of work,” said Mark Samaan, MD, session moderator and consultant gastroenterologist at Guy’s and St. Thomas’ NHS Foundation Trust in London, who was not involved in the study.

“The results are in keeping with what one might expect from IV infliximab administration. In that sense, [it is] reassuring that the two routes of administration appear to perform in a broadly similar manner,” Dr. Samaan said.

“So long as adequate exposure is achieved, I wouldn’t have expected route of administration to be a significant determinant of efficacy,” he added.

Dr. Peyrin-Biroulet reports receiving personal fees from Galapagos, AbbVie, Janssen, Genetech, Ferring, Tillots, Pharmacosmos, Celltrion, Takeda, Samsung Bioepis, Alma, Sterna, Nestle, Inotrem, Enterome, Allergen, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgene, Mylan, Lilly, Fresenius Kabi, Opplian Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, and Theravance. Dr. Samaan reports receiving advisory fees from Janssen, Takeda, Sandoz, Samsung Bioepis, Galapagos, and AbbVie and lecture fees from Bristol-Myers Squibb, Janssen, Takeda, MSD, Falk, AbbVie, and Galapagos.

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

An infliximab biosimilar (infliximab-axxq) delivered via subcutaneous injection was superior to intravenous vedolizumab (Entyvio) for induction and maintenance therapy of Crohn’s disease (CD), according to a systematic review and meta-analysis from French researchers.  

In contrast, the same research showed no significant differences in efficacy between these agents for people with ulcerative colitis (UC).

The subcutaneous injection formulation of infliximab-axxq, also known as CT-P13 SC, is approved by the European Medicines Agency for both CD and UC (Remsima SC). This formulation is not yet approved by the U.S. Food and Drug Administration.

“It’s kind of a small revolution, because now we have access, and in France, we are using a lot of subcutaneous infliximab,” Laurent Peyrin-Biroulet, MD, said during a digital oral presentation at ECCO ‘22 Virtual, the European Crohn’s and Colitis Organisation 2022 Congress. He is ECCO president and a gastroenterologist at University Hospital of Nancy in France.

Dr. Peyrin-Biroulet and colleagues compared the efficacy and safety of the two agents in major randomized controlled trials looking at moderate-to-severe CD or UC from January 2010 to April 2021.

Subcutaneous infliximab-axxq data came from NCT02883452, an ongoing phase 1 study started in 2016. The vedolizumab data come from GEMINI I, II, and III; VISIBLE 1 and 2; and VARSITY trials.
 

Key findings

In CD, induction efficacy was 79% for subcutaneous infliximab-axxq versus a 45% response for vedolizumab, as measured by the Crohn’s Disease Activity Index-70 (CDAI-70).

In addition, the study showed a 62% induction efficacy for subcutaneous infliximab-axxq versus 36% for vedolizumab on the CDAI-100.

The maintenance response on the CDAI-100 was achieved by 64% of the infliximab-axxq patients versus 47% of the vedolizumab patients.

“You can see better efficacy results of subcutaneous infliximab compared to vedolizumab in CD for both induction and maintenance,” Dr. Peyrin-Biroulet said, adding that what is seen here is probably what has been observed.
 

Similar results for UC

“We know vedolizumab is a good drug in UC, and there was not a difference between UC and CD,” Dr. Peyrin-Biroulet said.

There were no significant differences between subcutaneous infliximab-axxq and vedolizumab in terms of clinical response for induction (77% vs. 69%, respectively) or clinical response for maintenance (62% vs. 63%, respectively).

Similarly, no significant differences emerged in rates of clinical remission or mucosal healing.
 

Safety so far

Safety profiles for both agents in both indications were similar over 1 year.

However, Dr. Peyrin-Biroulet shared a caveat about that timeline. “It’s a 1-year follow-up, not a 10-year follow-up with 100,000 patients,” he said. “But still, what we see here is a confirmation of what we see in other analyses. There is not a significant [safety] difference between these two drugs.”

The rate of any adverse event in CD was 76% for subcutaneous infliximab-axxq versus 77% for vedolizumab, for example. Rates of any serious adverse event were 9% and 14%, respectively.

In UC studies, the rate of any adverse event was 67% for subcutaneous infliximab-axxq versus 64% for vedolizumab. Rates of serious adverse events were 12% and 11%, respectively.

Rates of discontinuation over 1 year differed between agents. Five percent of subcutaneous infliximab-axxq participants with CD discontinued treatment as because of lack of efficacy compared with 32% with vedolizumab. In UC participants, discontinuation for the same reason was reported for 3% of subcutaneous infliximab-axxq patients versus 15% of vedolizumab.

Although all participants in the subcutaneous infliximab-axxq trial were anti-tumor necrosis factor treatment naive, some in the vedolizumab may have been previously exposed to such therapy, Dr. Peyrin-Biroulet said. “Subgroup analyses would be need to further explore that.”

“It’s interesting and a clinically relevant piece of work,” said Mark Samaan, MD, session moderator and consultant gastroenterologist at Guy’s and St. Thomas’ NHS Foundation Trust in London, who was not involved in the study.

“The results are in keeping with what one might expect from IV infliximab administration. In that sense, [it is] reassuring that the two routes of administration appear to perform in a broadly similar manner,” Dr. Samaan said.

“So long as adequate exposure is achieved, I wouldn’t have expected route of administration to be a significant determinant of efficacy,” he added.

Dr. Peyrin-Biroulet reports receiving personal fees from Galapagos, AbbVie, Janssen, Genetech, Ferring, Tillots, Pharmacosmos, Celltrion, Takeda, Samsung Bioepis, Alma, Sterna, Nestle, Inotrem, Enterome, Allergen, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgene, Mylan, Lilly, Fresenius Kabi, Opplian Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, and Theravance. Dr. Samaan reports receiving advisory fees from Janssen, Takeda, Sandoz, Samsung Bioepis, Galapagos, and AbbVie and lecture fees from Bristol-Myers Squibb, Janssen, Takeda, MSD, Falk, AbbVie, and Galapagos.

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

In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.

In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.

This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.

Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.

“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.

Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.

The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.

The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
 

Some dual protection suggested

Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.

“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.

Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.

The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls. 

Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.

Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.

Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.

A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
 

Maternal vaccination trends

A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.

“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.

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

In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.

In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.

This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.

Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.

“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.

Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.

The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.

The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
 

Some dual protection suggested

Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.

“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.

Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.

The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls. 

Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.

Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.

Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.

A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
 

Maternal vaccination trends

A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.

“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.

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

In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.

In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.

This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.

Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.

“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.

Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.

The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.

The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
 

Some dual protection suggested

Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.

“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.

Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.

The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls. 

Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.

Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.

Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.

A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
 

Maternal vaccination trends

A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.

“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.

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

It’s a matter of quality, not quantity. That’s the gist of a new Israeli study that shows that unvaccinated people with a prior SARS-CoV-2 infection create antibodies that are more effective in the long run compared with others who were vaccinated but never infected.

“While the quantity of antibodies decreases with time in both COVID-19 recovered patients and vaccinated individuals, the quality of antibody performance increases following infection but not after vaccination,” lead author Carmit Cohen, PhD, said in an interview.

This difference could explain why previously infected patients appear to be better protected against a new infection than those who have only been vaccinated, according to a news release attached to the research.

One key caveat: This research does not include people from the later part of the pandemic.

This means there is a catch in terms of timing, William Schaffner, MD, Vanderbilt University School of Medicine, Nashville, Tenn., said when asked to comment on the study: “The study involved only the early COVID strains – it has no information on either the Delta or Omicron variants. Thus, the results primarily are of scientific or historical interest but are not immediately relevant to the current situation.”

The findings come from an early release of a study to be presented at the European Congress of Clinical Microbiology & Infectious Diseases in April.

An unexpected finding of the study showed that obese people had better protection – a higher and more sustained immune response – compared with overweight and normal-weight individuals.

“The results in the obese group were indeed unexpected and need further research to confirm or dispute,” Dr. Schaffner said. “Obesity does predispose to more severe disease.”
 

A focus on earlier strains

Dr. Cohen – a senior research assistant in infectious disease prevention at the Sheba Medical Center in Ramat Gan, Israel – and her colleagues recruited participants between March 25, 2020 and Nov. 25, 2020 and completed analysis in April 2021. This means they assessed people with a history of infection from the original, the Alpha, and some Beta strains of SARS-CoV-2.

Dr. Cohen indicated that the next phase of their research will examine innate and acquired immune responses to the more recent Delta and Omicron variants.

The investigators analyzed the antibody-induced immune response up to 1 year in 130 COVID-19 recovered but unvaccinated individuals versus up to 8 months among 402 others matched by age and body mass index (BMI) and without previous infection who received two doses of the Pfizer vaccine.

The numbers of antibodies a month after vaccination were higher than those in the COVID-19 recovered patients. However, these numbers also declined more steeply in the vaccinated group, they note.

To assess the antibody performance, the investigators used the avidity index. This assay measures antibody function based on the strength of the interactions between the antibody and the viral antigen.

They found that the avidity index was higher in vaccinated individuals than in recovered patients initially but changes over time. At up to 6 months, the index did not significantly change in vaccinated individuals, whereas it gradually increased in recovered patients. This increase would potentially protect them from reinfection, the authors note.

These findings stand in stark contrast to an Oct. 29, 2021, Centers for Disease Control and Prevention study that found that COVID-19 vaccines provided five times the protection of natural immunity.

Those results, published in the organization’s Morbidity and Mortality Weekly Report, suggest that vaccination helps people mount a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least 6 months.
 

Protection linked to obesity

Another finding that ran against the scientific grain was the data about obesity.

There was a higher and more persistent antibody performance among people with a BMI of 30 kg/m².

This could relate to greater disease severity and/or a more pronounced initial response to infection among the obese group.

“Our hypothesis is that patients with obesity begin with a more pronounced response – reflected also by the disease manifestation – and the trend of decline is similar, therefore the kinetics of immune response remain higher throughout the study,” Dr. Cohen said.

“The results in the obese group were indeed unexpected and need further research to confirm or dispute,” said Dr. Schaffner, who is also the current medical director of the National Foundation for Infectious Diseases. “Obesity does predispose to more severe disease.”
 

Before the boosters

Along with using participants from only the earlier part of the pandemic, another limitation of the study was that the vaccinated group had only two doses of vaccine; boosters were not given during the time of the study, Dr. Schaffner said.

“Again, not the current situation.”

“That said, the strength and duration of natural immunity provided by the early variants was solid for up to a year, confirming previous reports,” he said.

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

It’s a matter of quality, not quantity. That’s the gist of a new Israeli study that shows that unvaccinated people with a prior SARS-CoV-2 infection create antibodies that are more effective in the long run compared with others who were vaccinated but never infected.

“While the quantity of antibodies decreases with time in both COVID-19 recovered patients and vaccinated individuals, the quality of antibody performance increases following infection but not after vaccination,” lead author Carmit Cohen, PhD, said in an interview.

This difference could explain why previously infected patients appear to be better protected against a new infection than those who have only been vaccinated, according to a news release attached to the research.

One key caveat: This research does not include people from the later part of the pandemic.

This means there is a catch in terms of timing, William Schaffner, MD, Vanderbilt University School of Medicine, Nashville, Tenn., said when asked to comment on the study: “The study involved only the early COVID strains – it has no information on either the Delta or Omicron variants. Thus, the results primarily are of scientific or historical interest but are not immediately relevant to the current situation.”

The findings come from an early release of a study to be presented at the European Congress of Clinical Microbiology & Infectious Diseases in April.

An unexpected finding of the study showed that obese people had better protection – a higher and more sustained immune response – compared with overweight and normal-weight individuals.

“The results in the obese group were indeed unexpected and need further research to confirm or dispute,” Dr. Schaffner said. “Obesity does predispose to more severe disease.”
 

A focus on earlier strains

Dr. Cohen – a senior research assistant in infectious disease prevention at the Sheba Medical Center in Ramat Gan, Israel – and her colleagues recruited participants between March 25, 2020 and Nov. 25, 2020 and completed analysis in April 2021. This means they assessed people with a history of infection from the original, the Alpha, and some Beta strains of SARS-CoV-2.

Dr. Cohen indicated that the next phase of their research will examine innate and acquired immune responses to the more recent Delta and Omicron variants.

The investigators analyzed the antibody-induced immune response up to 1 year in 130 COVID-19 recovered but unvaccinated individuals versus up to 8 months among 402 others matched by age and body mass index (BMI) and without previous infection who received two doses of the Pfizer vaccine.

The numbers of antibodies a month after vaccination were higher than those in the COVID-19 recovered patients. However, these numbers also declined more steeply in the vaccinated group, they note.

To assess the antibody performance, the investigators used the avidity index. This assay measures antibody function based on the strength of the interactions between the antibody and the viral antigen.

They found that the avidity index was higher in vaccinated individuals than in recovered patients initially but changes over time. At up to 6 months, the index did not significantly change in vaccinated individuals, whereas it gradually increased in recovered patients. This increase would potentially protect them from reinfection, the authors note.

These findings stand in stark contrast to an Oct. 29, 2021, Centers for Disease Control and Prevention study that found that COVID-19 vaccines provided five times the protection of natural immunity.

Those results, published in the organization’s Morbidity and Mortality Weekly Report, suggest that vaccination helps people mount a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least 6 months.
 

Protection linked to obesity

Another finding that ran against the scientific grain was the data about obesity.

There was a higher and more persistent antibody performance among people with a BMI of 30 kg/m².

This could relate to greater disease severity and/or a more pronounced initial response to infection among the obese group.

“Our hypothesis is that patients with obesity begin with a more pronounced response – reflected also by the disease manifestation – and the trend of decline is similar, therefore the kinetics of immune response remain higher throughout the study,” Dr. Cohen said.

“The results in the obese group were indeed unexpected and need further research to confirm or dispute,” said Dr. Schaffner, who is also the current medical director of the National Foundation for Infectious Diseases. “Obesity does predispose to more severe disease.”
 

Before the boosters

Along with using participants from only the earlier part of the pandemic, another limitation of the study was that the vaccinated group had only two doses of vaccine; boosters were not given during the time of the study, Dr. Schaffner said.

“Again, not the current situation.”

“That said, the strength and duration of natural immunity provided by the early variants was solid for up to a year, confirming previous reports,” he said.

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

It’s a matter of quality, not quantity. That’s the gist of a new Israeli study that shows that unvaccinated people with a prior SARS-CoV-2 infection create antibodies that are more effective in the long run compared with others who were vaccinated but never infected.

“While the quantity of antibodies decreases with time in both COVID-19 recovered patients and vaccinated individuals, the quality of antibody performance increases following infection but not after vaccination,” lead author Carmit Cohen, PhD, said in an interview.

This difference could explain why previously infected patients appear to be better protected against a new infection than those who have only been vaccinated, according to a news release attached to the research.

One key caveat: This research does not include people from the later part of the pandemic.

This means there is a catch in terms of timing, William Schaffner, MD, Vanderbilt University School of Medicine, Nashville, Tenn., said when asked to comment on the study: “The study involved only the early COVID strains – it has no information on either the Delta or Omicron variants. Thus, the results primarily are of scientific or historical interest but are not immediately relevant to the current situation.”

The findings come from an early release of a study to be presented at the European Congress of Clinical Microbiology & Infectious Diseases in April.

An unexpected finding of the study showed that obese people had better protection – a higher and more sustained immune response – compared with overweight and normal-weight individuals.

“The results in the obese group were indeed unexpected and need further research to confirm or dispute,” Dr. Schaffner said. “Obesity does predispose to more severe disease.”
 

A focus on earlier strains

Dr. Cohen – a senior research assistant in infectious disease prevention at the Sheba Medical Center in Ramat Gan, Israel – and her colleagues recruited participants between March 25, 2020 and Nov. 25, 2020 and completed analysis in April 2021. This means they assessed people with a history of infection from the original, the Alpha, and some Beta strains of SARS-CoV-2.

Dr. Cohen indicated that the next phase of their research will examine innate and acquired immune responses to the more recent Delta and Omicron variants.

The investigators analyzed the antibody-induced immune response up to 1 year in 130 COVID-19 recovered but unvaccinated individuals versus up to 8 months among 402 others matched by age and body mass index (BMI) and without previous infection who received two doses of the Pfizer vaccine.

The numbers of antibodies a month after vaccination were higher than those in the COVID-19 recovered patients. However, these numbers also declined more steeply in the vaccinated group, they note.

To assess the antibody performance, the investigators used the avidity index. This assay measures antibody function based on the strength of the interactions between the antibody and the viral antigen.

They found that the avidity index was higher in vaccinated individuals than in recovered patients initially but changes over time. At up to 6 months, the index did not significantly change in vaccinated individuals, whereas it gradually increased in recovered patients. This increase would potentially protect them from reinfection, the authors note.

These findings stand in stark contrast to an Oct. 29, 2021, Centers for Disease Control and Prevention study that found that COVID-19 vaccines provided five times the protection of natural immunity.

Those results, published in the organization’s Morbidity and Mortality Weekly Report, suggest that vaccination helps people mount a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least 6 months.
 

Protection linked to obesity

Another finding that ran against the scientific grain was the data about obesity.

There was a higher and more persistent antibody performance among people with a BMI of 30 kg/m².

This could relate to greater disease severity and/or a more pronounced initial response to infection among the obese group.

“Our hypothesis is that patients with obesity begin with a more pronounced response – reflected also by the disease manifestation – and the trend of decline is similar, therefore the kinetics of immune response remain higher throughout the study,” Dr. Cohen said.

“The results in the obese group were indeed unexpected and need further research to confirm or dispute,” said Dr. Schaffner, who is also the current medical director of the National Foundation for Infectious Diseases. “Obesity does predispose to more severe disease.”
 

Before the boosters

Along with using participants from only the earlier part of the pandemic, another limitation of the study was that the vaccinated group had only two doses of vaccine; boosters were not given during the time of the study, Dr. Schaffner said.

“Again, not the current situation.”

“That said, the strength and duration of natural immunity provided by the early variants was solid for up to a year, confirming previous reports,” he said.

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