Clinician Reviews

Are you still wearing a cloth face mask?

Amid the rapidly spreading Omicron variant, experts stress that we all should swap cloth masks for N95 respirators or 3-ply surgical masks.

For background: N95 respirators are tightly fitting masks that cover your mouth and nose and help prevent contact with droplets and tiny particles in the air from people talking, coughing, sneezing, and spreading in other ways. Usually worn by health care workers and first responders, these masks can filter up to 95% of air droplets and particles, according to the CDC.

KN95 and KN94 masks are similar but are designed to meet international standards, unlike N95s that are approved by the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health.

Meanwhile, a 3-ply surgical mask is a looser-fitting mask that can help prevent contact with infected droplets in the air.

But recommendations to opt for N95 and 3-ply surgical masks over cloth masks are nothing new, says Leana Wen, MD, an emergency doctor and public health professor at George Washington University, Washington.

In fact, public health experts have been urging stronger mask protection for months.

“It’s not just with Omicron that we need better masks, it was with Delta, it was with Alpha before that,” Dr. Wen said. “We have known for many months that COVID-19 is airborne, and therefore, a simple cloth mask is not going to cut it.”

Here’s what to know about these protective masks.
 

They’re necessary

Omicron is spreading much faster than previous COVID-19 variants. As it’s up to three times as likely to spread as the Delta variant, mask-wearing is paramount right now, says Anita Gupta, DO, an adjunct assistant professor of anesthesiology and critical care medicine and pain medicine at Johns Hopkins University, Baltimore.

The quality of a mask also matters a lot, said Dr. Wen.

“Double masking, including a well-fitting cloth mask on top of a surgical mask, adds additional protection,” she said. “Ideally, though, people should be wearing an N95, KN95, or KF94 when in indoor settings around other people with unknown vaccination status.”

If wearing an N95 mask causes extreme discomfort, wear it in high-risk settings where there are lots of people, like crowded restaurants and busy commuter trains, says Dr. Wen. “If you’re in a grocery store, there’s plenty of space and ventilation. You may not need an N95. I recommend that people obtain different masks and practice with them in low-risk settings before they go out in public in a high-risk setting.”

But people should wear a 3-ply surgical mask at the very least.
 

Three-ply surgical and N95 mask qualities

With 3-ply surgical masks, the fit of the mask is often more of an issue than its comfort, Dr. Wen said. But there are ways to adjust these masks, especially for those who have smaller heads.

“You can put a rubber band around the ear loops and make them a bit tighter,” said Dr. Wen. “Some people have found that using pins in their hair, that’s another way of keeping the loops in place.”

Another important tip on 3-ply surgical masks and N95s: These masks are reusable.

But how many times you should use them varies, Dr. Wen said. “As an example, if you are sweating a lot, and the mask is now really damp. Or putting it in your purse or backpack, and now it’s misshapen, and you cannot get it back to fit on your face, then it’s time to throw it away.”
 

Protection first

For some, cloth masks became somewhat of a statement, with people sporting logos of their favorite NFL team, or maybe even a fun animal print.

But you should always keep in mind the purpose of wearing a mask, Dr. Wen said. “Mask wearing is very functional and is about reducing your likelihood of contracting COVID. People should also use whatever methods inspire them, too, but for me, it’s purely a functional exercise.”

Mask wearing is not always enjoyable, but it remains critical in keeping people safe from COVID-19, especially the elderly and other high-risk people, Gupta says.

“There is lots of research and experts working hard to stop COVID-19,” she says. “It is important for all of us to remember that wearing a mask alone doesn’t make us safe.”

“We all need to keep washing our hands frequently and maintaining a distance from people, as well.”

For more information on where to find 3-ply surgical masks and N95s, check here or here to start.

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

Are you still wearing a cloth face mask?

Amid the rapidly spreading Omicron variant, experts stress that we all should swap cloth masks for N95 respirators or 3-ply surgical masks.

For background: N95 respirators are tightly fitting masks that cover your mouth and nose and help prevent contact with droplets and tiny particles in the air from people talking, coughing, sneezing, and spreading in other ways. Usually worn by health care workers and first responders, these masks can filter up to 95% of air droplets and particles, according to the CDC.

KN95 and KN94 masks are similar but are designed to meet international standards, unlike N95s that are approved by the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health.

Meanwhile, a 3-ply surgical mask is a looser-fitting mask that can help prevent contact with infected droplets in the air.

But recommendations to opt for N95 and 3-ply surgical masks over cloth masks are nothing new, says Leana Wen, MD, an emergency doctor and public health professor at George Washington University, Washington.

In fact, public health experts have been urging stronger mask protection for months.

“It’s not just with Omicron that we need better masks, it was with Delta, it was with Alpha before that,” Dr. Wen said. “We have known for many months that COVID-19 is airborne, and therefore, a simple cloth mask is not going to cut it.”

Here’s what to know about these protective masks.
 

They’re necessary

Omicron is spreading much faster than previous COVID-19 variants. As it’s up to three times as likely to spread as the Delta variant, mask-wearing is paramount right now, says Anita Gupta, DO, an adjunct assistant professor of anesthesiology and critical care medicine and pain medicine at Johns Hopkins University, Baltimore.

The quality of a mask also matters a lot, said Dr. Wen.

“Double masking, including a well-fitting cloth mask on top of a surgical mask, adds additional protection,” she said. “Ideally, though, people should be wearing an N95, KN95, or KF94 when in indoor settings around other people with unknown vaccination status.”

If wearing an N95 mask causes extreme discomfort, wear it in high-risk settings where there are lots of people, like crowded restaurants and busy commuter trains, says Dr. Wen. “If you’re in a grocery store, there’s plenty of space and ventilation. You may not need an N95. I recommend that people obtain different masks and practice with them in low-risk settings before they go out in public in a high-risk setting.”

But people should wear a 3-ply surgical mask at the very least.
 

Three-ply surgical and N95 mask qualities

With 3-ply surgical masks, the fit of the mask is often more of an issue than its comfort, Dr. Wen said. But there are ways to adjust these masks, especially for those who have smaller heads.

“You can put a rubber band around the ear loops and make them a bit tighter,” said Dr. Wen. “Some people have found that using pins in their hair, that’s another way of keeping the loops in place.”

Another important tip on 3-ply surgical masks and N95s: These masks are reusable.

But how many times you should use them varies, Dr. Wen said. “As an example, if you are sweating a lot, and the mask is now really damp. Or putting it in your purse or backpack, and now it’s misshapen, and you cannot get it back to fit on your face, then it’s time to throw it away.”
 

Protection first

For some, cloth masks became somewhat of a statement, with people sporting logos of their favorite NFL team, or maybe even a fun animal print.

But you should always keep in mind the purpose of wearing a mask, Dr. Wen said. “Mask wearing is very functional and is about reducing your likelihood of contracting COVID. People should also use whatever methods inspire them, too, but for me, it’s purely a functional exercise.”

Mask wearing is not always enjoyable, but it remains critical in keeping people safe from COVID-19, especially the elderly and other high-risk people, Gupta says.

“There is lots of research and experts working hard to stop COVID-19,” she says. “It is important for all of us to remember that wearing a mask alone doesn’t make us safe.”

“We all need to keep washing our hands frequently and maintaining a distance from people, as well.”

For more information on where to find 3-ply surgical masks and N95s, check here or here to start.

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

Are you still wearing a cloth face mask?

Amid the rapidly spreading Omicron variant, experts stress that we all should swap cloth masks for N95 respirators or 3-ply surgical masks.

For background: N95 respirators are tightly fitting masks that cover your mouth and nose and help prevent contact with droplets and tiny particles in the air from people talking, coughing, sneezing, and spreading in other ways. Usually worn by health care workers and first responders, these masks can filter up to 95% of air droplets and particles, according to the CDC.

KN95 and KN94 masks are similar but are designed to meet international standards, unlike N95s that are approved by the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health.

Meanwhile, a 3-ply surgical mask is a looser-fitting mask that can help prevent contact with infected droplets in the air.

But recommendations to opt for N95 and 3-ply surgical masks over cloth masks are nothing new, says Leana Wen, MD, an emergency doctor and public health professor at George Washington University, Washington.

In fact, public health experts have been urging stronger mask protection for months.

“It’s not just with Omicron that we need better masks, it was with Delta, it was with Alpha before that,” Dr. Wen said. “We have known for many months that COVID-19 is airborne, and therefore, a simple cloth mask is not going to cut it.”

Here’s what to know about these protective masks.
 

They’re necessary

Omicron is spreading much faster than previous COVID-19 variants. As it’s up to three times as likely to spread as the Delta variant, mask-wearing is paramount right now, says Anita Gupta, DO, an adjunct assistant professor of anesthesiology and critical care medicine and pain medicine at Johns Hopkins University, Baltimore.

The quality of a mask also matters a lot, said Dr. Wen.

“Double masking, including a well-fitting cloth mask on top of a surgical mask, adds additional protection,” she said. “Ideally, though, people should be wearing an N95, KN95, or KF94 when in indoor settings around other people with unknown vaccination status.”

If wearing an N95 mask causes extreme discomfort, wear it in high-risk settings where there are lots of people, like crowded restaurants and busy commuter trains, says Dr. Wen. “If you’re in a grocery store, there’s plenty of space and ventilation. You may not need an N95. I recommend that people obtain different masks and practice with them in low-risk settings before they go out in public in a high-risk setting.”

But people should wear a 3-ply surgical mask at the very least.
 

Three-ply surgical and N95 mask qualities

With 3-ply surgical masks, the fit of the mask is often more of an issue than its comfort, Dr. Wen said. But there are ways to adjust these masks, especially for those who have smaller heads.

“You can put a rubber band around the ear loops and make them a bit tighter,” said Dr. Wen. “Some people have found that using pins in their hair, that’s another way of keeping the loops in place.”

Another important tip on 3-ply surgical masks and N95s: These masks are reusable.

But how many times you should use them varies, Dr. Wen said. “As an example, if you are sweating a lot, and the mask is now really damp. Or putting it in your purse or backpack, and now it’s misshapen, and you cannot get it back to fit on your face, then it’s time to throw it away.”
 

Protection first

For some, cloth masks became somewhat of a statement, with people sporting logos of their favorite NFL team, or maybe even a fun animal print.

But you should always keep in mind the purpose of wearing a mask, Dr. Wen said. “Mask wearing is very functional and is about reducing your likelihood of contracting COVID. People should also use whatever methods inspire them, too, but for me, it’s purely a functional exercise.”

Mask wearing is not always enjoyable, but it remains critical in keeping people safe from COVID-19, especially the elderly and other high-risk people, Gupta says.

“There is lots of research and experts working hard to stop COVID-19,” she says. “It is important for all of us to remember that wearing a mask alone doesn’t make us safe.”

“We all need to keep washing our hands frequently and maintaining a distance from people, as well.”

For more information on where to find 3-ply surgical masks and N95s, check here or here to start.

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

With new cases of COVID-19 skyrocketing to more than 240,000 a day recently in the U.S., many people are facing the same situation: A family member or friend tests positive or was exposed to someone who did, and the holiday gathering, visit, or return to work is just days or hours away. Now what?

New guidance issued Dec. 27 by the Centers for Disease Control and Prevention shortens the recommended isolation and quarantine period for the general population, coming after the agency shortened the isolation period for health care workers.

This news organization reached out to two infectious disease specialists to get answers to questions that are frequently asked in these situations.
 

If you have tested positive for COVID-19, what do you do next?

“If you have tested positive, you are infected. At the moment, you are [either] symptomatically affected or presymptomatically infected,’’ said Paul A. Offit, MD, director of the Vaccine Education Center and professor of pediatrics at Children’s Hospital of Philadelphia. At that point, you need to isolate for 5 days, according to the new CDC guidance. (That period has been shortened from 10 days.)

Isolation means separating the infected person from others. Quarantine refers to things you should do if you’re exposed to the virus or you have a close contact infected with COVID-19.

Under the new CDC guidelines, after the 5-day isolation, if the infected person then has no symptoms, he or she can leave isolation and then wear a mask for 5  days.

Those who test positive also need to tell their close contacts they are positive, said Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security.  

According to the CDC, the change to a shortened quarantine time is motivated by science ‘’demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of the illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after.”
 

If you have been exposed to someone with COVID-19, what do you do next?

“If they are vaccinated and boosted, the guidance says there is no need to quarantine,” Dr. Adalja said. But the CDC guidance does recommend these people wear a well-fitting mask at all times when around others for 10 days after exposure.

For everyone else, including the unvaccinated and those who are more than 6 months out from their second Pfizer or Moderna vaccine dose, or more than 2 months from their J&J dose, the CDC recommends a quarantine for 5 days – and wearing a mask for the 5 days after that.

On a practical level, Dr. Adalja said he thinks those who are vaccinated but not boosted could also skip the quarantine and wear a mask for 10 days. Dr. Offit agrees. Because many people exposed have trouble quarantining, Dr. Offit advises those exposed who can’t follow that guidance to be sure to wear a mask for 10 days when indoors. The CDC guidance also offers that as another strategy – that if a 5-day quarantine is not feasible, the exposed person should wear a mask for 10 days when around others.

But if  someone who was exposed gets symptoms, that person then enters the infected category and follows that guidance, Dr. Offit said.
 

When should the person who has been exposed get tested?

After the exposure, ‘’you should probably wait 2-3 days,” Dr. Offit said. “The virus has to reproduce itself.”

Testing should be done by those exposed at least once, Dr. Adalja said.

“But there’s data to support daily testing to guide their activities, but this is not CDC guidance. Home tests are sufficient for this purpose.”
 

At what point can the infected person mingle safely with others?

“Technically, if asymptomatic, 10 days without a mask, 5 days with a mask,” said Dr. Adalja. “I think this could also be guided with home test negativity being a gauge [as to whether to mingle].”

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

With new cases of COVID-19 skyrocketing to more than 240,000 a day recently in the U.S., many people are facing the same situation: A family member or friend tests positive or was exposed to someone who did, and the holiday gathering, visit, or return to work is just days or hours away. Now what?

New guidance issued Dec. 27 by the Centers for Disease Control and Prevention shortens the recommended isolation and quarantine period for the general population, coming after the agency shortened the isolation period for health care workers.

This news organization reached out to two infectious disease specialists to get answers to questions that are frequently asked in these situations.
 

If you have tested positive for COVID-19, what do you do next?

“If you have tested positive, you are infected. At the moment, you are [either] symptomatically affected or presymptomatically infected,’’ said Paul A. Offit, MD, director of the Vaccine Education Center and professor of pediatrics at Children’s Hospital of Philadelphia. At that point, you need to isolate for 5 days, according to the new CDC guidance. (That period has been shortened from 10 days.)

Isolation means separating the infected person from others. Quarantine refers to things you should do if you’re exposed to the virus or you have a close contact infected with COVID-19.

Under the new CDC guidelines, after the 5-day isolation, if the infected person then has no symptoms, he or she can leave isolation and then wear a mask for 5  days.

Those who test positive also need to tell their close contacts they are positive, said Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security.  

According to the CDC, the change to a shortened quarantine time is motivated by science ‘’demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of the illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after.”
 

If you have been exposed to someone with COVID-19, what do you do next?

“If they are vaccinated and boosted, the guidance says there is no need to quarantine,” Dr. Adalja said. But the CDC guidance does recommend these people wear a well-fitting mask at all times when around others for 10 days after exposure.

For everyone else, including the unvaccinated and those who are more than 6 months out from their second Pfizer or Moderna vaccine dose, or more than 2 months from their J&J dose, the CDC recommends a quarantine for 5 days – and wearing a mask for the 5 days after that.

On a practical level, Dr. Adalja said he thinks those who are vaccinated but not boosted could also skip the quarantine and wear a mask for 10 days. Dr. Offit agrees. Because many people exposed have trouble quarantining, Dr. Offit advises those exposed who can’t follow that guidance to be sure to wear a mask for 10 days when indoors. The CDC guidance also offers that as another strategy – that if a 5-day quarantine is not feasible, the exposed person should wear a mask for 10 days when around others.

But if  someone who was exposed gets symptoms, that person then enters the infected category and follows that guidance, Dr. Offit said.
 

When should the person who has been exposed get tested?

After the exposure, ‘’you should probably wait 2-3 days,” Dr. Offit said. “The virus has to reproduce itself.”

Testing should be done by those exposed at least once, Dr. Adalja said.

“But there’s data to support daily testing to guide their activities, but this is not CDC guidance. Home tests are sufficient for this purpose.”
 

At what point can the infected person mingle safely with others?

“Technically, if asymptomatic, 10 days without a mask, 5 days with a mask,” said Dr. Adalja. “I think this could also be guided with home test negativity being a gauge [as to whether to mingle].”

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

With new cases of COVID-19 skyrocketing to more than 240,000 a day recently in the U.S., many people are facing the same situation: A family member or friend tests positive or was exposed to someone who did, and the holiday gathering, visit, or return to work is just days or hours away. Now what?

New guidance issued Dec. 27 by the Centers for Disease Control and Prevention shortens the recommended isolation and quarantine period for the general population, coming after the agency shortened the isolation period for health care workers.

This news organization reached out to two infectious disease specialists to get answers to questions that are frequently asked in these situations.
 

If you have tested positive for COVID-19, what do you do next?

“If you have tested positive, you are infected. At the moment, you are [either] symptomatically affected or presymptomatically infected,’’ said Paul A. Offit, MD, director of the Vaccine Education Center and professor of pediatrics at Children’s Hospital of Philadelphia. At that point, you need to isolate for 5 days, according to the new CDC guidance. (That period has been shortened from 10 days.)

Isolation means separating the infected person from others. Quarantine refers to things you should do if you’re exposed to the virus or you have a close contact infected with COVID-19.

Under the new CDC guidelines, after the 5-day isolation, if the infected person then has no symptoms, he or she can leave isolation and then wear a mask for 5  days.

Those who test positive also need to tell their close contacts they are positive, said Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security.  

According to the CDC, the change to a shortened quarantine time is motivated by science ‘’demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of the illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after.”
 

If you have been exposed to someone with COVID-19, what do you do next?

“If they are vaccinated and boosted, the guidance says there is no need to quarantine,” Dr. Adalja said. But the CDC guidance does recommend these people wear a well-fitting mask at all times when around others for 10 days after exposure.

For everyone else, including the unvaccinated and those who are more than 6 months out from their second Pfizer or Moderna vaccine dose, or more than 2 months from their J&J dose, the CDC recommends a quarantine for 5 days – and wearing a mask for the 5 days after that.

On a practical level, Dr. Adalja said he thinks those who are vaccinated but not boosted could also skip the quarantine and wear a mask for 10 days. Dr. Offit agrees. Because many people exposed have trouble quarantining, Dr. Offit advises those exposed who can’t follow that guidance to be sure to wear a mask for 10 days when indoors. The CDC guidance also offers that as another strategy – that if a 5-day quarantine is not feasible, the exposed person should wear a mask for 10 days when around others.

But if  someone who was exposed gets symptoms, that person then enters the infected category and follows that guidance, Dr. Offit said.
 

When should the person who has been exposed get tested?

After the exposure, ‘’you should probably wait 2-3 days,” Dr. Offit said. “The virus has to reproduce itself.”

Testing should be done by those exposed at least once, Dr. Adalja said.

“But there’s data to support daily testing to guide their activities, but this is not CDC guidance. Home tests are sufficient for this purpose.”
 

At what point can the infected person mingle safely with others?

“Technically, if asymptomatic, 10 days without a mask, 5 days with a mask,” said Dr. Adalja. “I think this could also be guided with home test negativity being a gauge [as to whether to mingle].”

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

Rapid antigen tests for COVID-19 might be less effective at detecting the Omicron variant that is spreading rapidly across the United States, according to the Food and Drug Administration.

Early data suggest that COVID-19 antigen tests “do detect the Omicron variant but may have reduced sensitivity,” the FDA said in a statement posted Dec. 28 on its website.

The FDA is working with the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative to assess the performance of antigen tests with patient samples that have the Omicron variant.

The potential for antigen tests to be less sensitive for the Omicron variant emerged in tests using patient samples containing live virus, “which represents the best way to evaluate true test performance in the short term,” the FDA said.

Initial laboratory tests using heat-activated (killed) virus samples found that antigen tests were able to detect the Omicron variant.

“It is important to note that these laboratory data are not a replacement for clinical study evaluations using patient samples with live virus, which are ongoing. The FDA and RADx are continuing to further evaluate the performance of antigen tests using patient samples with live virus,” the FDA said.
 

Testing still important

The agency continues to recommend use of antigen tests as directed in the authorized labeling and in accordance with the instructions included with the tests.

They note that antigen tests are generally less sensitive and less likely to pick up very early infections, compared with molecular tests.

The FDA continues to recommend that an individual with a negative antigen test who has symptoms or a high likelihood of infection because of exposure follow-up with a molecular test to determine if they have COVID-19.

An individual with a positive antigen test should self-isolate and seek follow-up care with a health care provider to determine the next steps.

The FDA, with partners and test developers, are continuing to evaluate test sensitivity, as well as the best timing and frequency of antigen testing.

The agency said that it will provide updated information and any needed recommendations when appropriate.

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

Rapid antigen tests for COVID-19 might be less effective at detecting the Omicron variant that is spreading rapidly across the United States, according to the Food and Drug Administration.

Early data suggest that COVID-19 antigen tests “do detect the Omicron variant but may have reduced sensitivity,” the FDA said in a statement posted Dec. 28 on its website.

The FDA is working with the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative to assess the performance of antigen tests with patient samples that have the Omicron variant.

The potential for antigen tests to be less sensitive for the Omicron variant emerged in tests using patient samples containing live virus, “which represents the best way to evaluate true test performance in the short term,” the FDA said.

Initial laboratory tests using heat-activated (killed) virus samples found that antigen tests were able to detect the Omicron variant.

“It is important to note that these laboratory data are not a replacement for clinical study evaluations using patient samples with live virus, which are ongoing. The FDA and RADx are continuing to further evaluate the performance of antigen tests using patient samples with live virus,” the FDA said.
 

Testing still important

The agency continues to recommend use of antigen tests as directed in the authorized labeling and in accordance with the instructions included with the tests.

They note that antigen tests are generally less sensitive and less likely to pick up very early infections, compared with molecular tests.

The FDA continues to recommend that an individual with a negative antigen test who has symptoms or a high likelihood of infection because of exposure follow-up with a molecular test to determine if they have COVID-19.

An individual with a positive antigen test should self-isolate and seek follow-up care with a health care provider to determine the next steps.

The FDA, with partners and test developers, are continuing to evaluate test sensitivity, as well as the best timing and frequency of antigen testing.

The agency said that it will provide updated information and any needed recommendations when appropriate.

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

Rapid antigen tests for COVID-19 might be less effective at detecting the Omicron variant that is spreading rapidly across the United States, according to the Food and Drug Administration.

Early data suggest that COVID-19 antigen tests “do detect the Omicron variant but may have reduced sensitivity,” the FDA said in a statement posted Dec. 28 on its website.

The FDA is working with the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative to assess the performance of antigen tests with patient samples that have the Omicron variant.

The potential for antigen tests to be less sensitive for the Omicron variant emerged in tests using patient samples containing live virus, “which represents the best way to evaluate true test performance in the short term,” the FDA said.

Initial laboratory tests using heat-activated (killed) virus samples found that antigen tests were able to detect the Omicron variant.

“It is important to note that these laboratory data are not a replacement for clinical study evaluations using patient samples with live virus, which are ongoing. The FDA and RADx are continuing to further evaluate the performance of antigen tests using patient samples with live virus,” the FDA said.
 

Testing still important

The agency continues to recommend use of antigen tests as directed in the authorized labeling and in accordance with the instructions included with the tests.

They note that antigen tests are generally less sensitive and less likely to pick up very early infections, compared with molecular tests.

The FDA continues to recommend that an individual with a negative antigen test who has symptoms or a high likelihood of infection because of exposure follow-up with a molecular test to determine if they have COVID-19.

An individual with a positive antigen test should self-isolate and seek follow-up care with a health care provider to determine the next steps.

The FDA, with partners and test developers, are continuing to evaluate test sensitivity, as well as the best timing and frequency of antigen testing.

The agency said that it will provide updated information and any needed recommendations when appropriate.

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

As new COVID-19 cases mount in New York City, Mayor Bill de Blasio began his final week in office watching a sweeping vaccine mandate for private employers take effect.

Business owners were supposed to require all workers to have at least one dose of vaccine by Monday, Dec. 27. Workers won’t be able to opt out of vaccinations, as a proposed federal mandate for private sector employees would allow. Municipal workers were already under a vaccine mandate.

Mayor De Blasio called it the strongest private sector vaccine mandate in the world – and insists it’s absolutely necessary.

“I am 110 percent convinced this was the right thing to do, remains the right thing to do, particularly with the ferocity of Omicron,” the mayor told reporters on Dec. 27. “I don’t know if there’s going to be another variant behind it, but I do know our best defense is to get everyone vaccinated and mandates have worked.”

It’s unclear if Mayor de Blasio’s successor, Mayor-Elect Eric Adams, will continue the vaccine mandate. The New York Times reported that Mr. Adams’ spokesman, Evan Thies, said in a text: “The mayor-elect will make announcements on his administration’s Covid policy this week.”

Mayor De Blasio said enforcement would be light in the first week. Not every business owner is following the law.

The New York Post said Stratis Morfogen, owner of the Brooklyn Dumpling Shop and executive managing director of Brooklyn Chop House, went on Instagram and dared the mayor and Gov. Kathy Hochul to come and arrest him.

“Not going to follow your mandate on threatening my family of employees to get the jab or lose your job!” he said.

Mr. Morfogen said he’s not against vaccines but thinks the mandate violates his employees’ constitutional rights. He said he’s taking more steps toward safety, such as frequent testing of employees.

Union Square Hospitality Group CEO Danny Meyer, who oversees restaurants such as Union Square Cafe and Blue Smoke, requires employees not only to get vaccinated, but to get the booster, too.

“Hospitality is a team sport – it’s kind of like putting on a play on Broadway or playing a basketball game,” Mr. Meyer told CNBC. “If you can’t field a full healthy team, you’re going to have to hit pause.”

Customers at Union Square Hospitality Group restaurants will soon be required to show proof of having received a booster shot.

Also starting Dec. 27, all New Yorkers 12 and up must show they’ve received two doses of vaccine to enter indoor dining, fitness, entertainment, and performance venues unless they’ve gotten the one-dose Johnson & Johnson vaccine.

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

As new COVID-19 cases mount in New York City, Mayor Bill de Blasio began his final week in office watching a sweeping vaccine mandate for private employers take effect.

Business owners were supposed to require all workers to have at least one dose of vaccine by Monday, Dec. 27. Workers won’t be able to opt out of vaccinations, as a proposed federal mandate for private sector employees would allow. Municipal workers were already under a vaccine mandate.

Mayor De Blasio called it the strongest private sector vaccine mandate in the world – and insists it’s absolutely necessary.

“I am 110 percent convinced this was the right thing to do, remains the right thing to do, particularly with the ferocity of Omicron,” the mayor told reporters on Dec. 27. “I don’t know if there’s going to be another variant behind it, but I do know our best defense is to get everyone vaccinated and mandates have worked.”

It’s unclear if Mayor de Blasio’s successor, Mayor-Elect Eric Adams, will continue the vaccine mandate. The New York Times reported that Mr. Adams’ spokesman, Evan Thies, said in a text: “The mayor-elect will make announcements on his administration’s Covid policy this week.”

Mayor De Blasio said enforcement would be light in the first week. Not every business owner is following the law.

The New York Post said Stratis Morfogen, owner of the Brooklyn Dumpling Shop and executive managing director of Brooklyn Chop House, went on Instagram and dared the mayor and Gov. Kathy Hochul to come and arrest him.

“Not going to follow your mandate on threatening my family of employees to get the jab or lose your job!” he said.

Mr. Morfogen said he’s not against vaccines but thinks the mandate violates his employees’ constitutional rights. He said he’s taking more steps toward safety, such as frequent testing of employees.

Union Square Hospitality Group CEO Danny Meyer, who oversees restaurants such as Union Square Cafe and Blue Smoke, requires employees not only to get vaccinated, but to get the booster, too.

“Hospitality is a team sport – it’s kind of like putting on a play on Broadway or playing a basketball game,” Mr. Meyer told CNBC. “If you can’t field a full healthy team, you’re going to have to hit pause.”

Customers at Union Square Hospitality Group restaurants will soon be required to show proof of having received a booster shot.

Also starting Dec. 27, all New Yorkers 12 and up must show they’ve received two doses of vaccine to enter indoor dining, fitness, entertainment, and performance venues unless they’ve gotten the one-dose Johnson & Johnson vaccine.

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

As new COVID-19 cases mount in New York City, Mayor Bill de Blasio began his final week in office watching a sweeping vaccine mandate for private employers take effect.

Business owners were supposed to require all workers to have at least one dose of vaccine by Monday, Dec. 27. Workers won’t be able to opt out of vaccinations, as a proposed federal mandate for private sector employees would allow. Municipal workers were already under a vaccine mandate.

Mayor De Blasio called it the strongest private sector vaccine mandate in the world – and insists it’s absolutely necessary.

“I am 110 percent convinced this was the right thing to do, remains the right thing to do, particularly with the ferocity of Omicron,” the mayor told reporters on Dec. 27. “I don’t know if there’s going to be another variant behind it, but I do know our best defense is to get everyone vaccinated and mandates have worked.”

It’s unclear if Mayor de Blasio’s successor, Mayor-Elect Eric Adams, will continue the vaccine mandate. The New York Times reported that Mr. Adams’ spokesman, Evan Thies, said in a text: “The mayor-elect will make announcements on his administration’s Covid policy this week.”

Mayor De Blasio said enforcement would be light in the first week. Not every business owner is following the law.

The New York Post said Stratis Morfogen, owner of the Brooklyn Dumpling Shop and executive managing director of Brooklyn Chop House, went on Instagram and dared the mayor and Gov. Kathy Hochul to come and arrest him.

“Not going to follow your mandate on threatening my family of employees to get the jab or lose your job!” he said.

Mr. Morfogen said he’s not against vaccines but thinks the mandate violates his employees’ constitutional rights. He said he’s taking more steps toward safety, such as frequent testing of employees.

Union Square Hospitality Group CEO Danny Meyer, who oversees restaurants such as Union Square Cafe and Blue Smoke, requires employees not only to get vaccinated, but to get the booster, too.

“Hospitality is a team sport – it’s kind of like putting on a play on Broadway or playing a basketball game,” Mr. Meyer told CNBC. “If you can’t field a full healthy team, you’re going to have to hit pause.”

Customers at Union Square Hospitality Group restaurants will soon be required to show proof of having received a booster shot.

Also starting Dec. 27, all New Yorkers 12 and up must show they’ve received two doses of vaccine to enter indoor dining, fitness, entertainment, and performance venues unless they’ve gotten the one-dose Johnson & Johnson vaccine.

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

The coronavirus that causes COVID-19 can spread to the heart and brain within days of infection and can survive for months in organs, according to a new study by the National Institutes of Health.

The virus can spread to almost every organ system in the body, which could contribute to the ongoing symptoms seen in “long COVID” patients, the study authors wrote. The study is considered one of the most comprehensive reviews of how the virus replicates in human cells and persists in the human body. It is under review for publication in the journal Nature.

“This is remarkably important work,” Ziyad Al-Aly, MD, director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, told Bloomberg News. Dr. Al-Aly wasn’t involved with the NIH study but has researched the long-term effects of COVID-19.

“For a long time now, we have been scratching our heads and asking why long COVID seems to affect so many organ systems,” he said. “This paper sheds some light and may help explain why long COVID can occur even in people who had mild or asymptomatic acute disease.”

The NIH researchers sampled and analyzed tissues from autopsies on 44 patients who died after contracting the coronavirus during the first year of the pandemic. They found persistent virus particles in multiple parts of the body, including the heart and brain, for as long as 230 days after symptoms began. This could represent infection with defective virus particles, they said, which has also been seen in persistent infections among measles patients.

“We don’t yet know what burden of chronic illness will result in years to come,” Raina MacIntyre, PhD, a professor of global biosecurity at the University of New South Wales, Sydney, told Bloomberg News.

“Will we see young-onset cardiac failure in survivors or early-onset dementia?” she asked. “These are unanswered questions which call for a precautionary public health approach to mitigation of the spread of this virus.”

Unlike other COVID-19 autopsy research, the NIH team had a more comprehensive postmortem tissue collection process, which typically occurred within a day of the patient’s death, Bloomberg News reported. The researchers also used a variety of ways to preserve tissue to figure out viral levels. They were able to grow the virus collected from several tissues, including the heart, lungs, small intestine, and adrenal glands.

“Our results collectively show that, while the highest burden of SARS-CoV-2 is in the airways and lung, the virus can disseminate early during infection and infect cells throughout the entire body, including widely throughout the brain,” the study authors wrote.

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

The coronavirus that causes COVID-19 can spread to the heart and brain within days of infection and can survive for months in organs, according to a new study by the National Institutes of Health.

The virus can spread to almost every organ system in the body, which could contribute to the ongoing symptoms seen in “long COVID” patients, the study authors wrote. The study is considered one of the most comprehensive reviews of how the virus replicates in human cells and persists in the human body. It is under review for publication in the journal Nature.

“This is remarkably important work,” Ziyad Al-Aly, MD, director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, told Bloomberg News. Dr. Al-Aly wasn’t involved with the NIH study but has researched the long-term effects of COVID-19.

“For a long time now, we have been scratching our heads and asking why long COVID seems to affect so many organ systems,” he said. “This paper sheds some light and may help explain why long COVID can occur even in people who had mild or asymptomatic acute disease.”

The NIH researchers sampled and analyzed tissues from autopsies on 44 patients who died after contracting the coronavirus during the first year of the pandemic. They found persistent virus particles in multiple parts of the body, including the heart and brain, for as long as 230 days after symptoms began. This could represent infection with defective virus particles, they said, which has also been seen in persistent infections among measles patients.

“We don’t yet know what burden of chronic illness will result in years to come,” Raina MacIntyre, PhD, a professor of global biosecurity at the University of New South Wales, Sydney, told Bloomberg News.

“Will we see young-onset cardiac failure in survivors or early-onset dementia?” she asked. “These are unanswered questions which call for a precautionary public health approach to mitigation of the spread of this virus.”

Unlike other COVID-19 autopsy research, the NIH team had a more comprehensive postmortem tissue collection process, which typically occurred within a day of the patient’s death, Bloomberg News reported. The researchers also used a variety of ways to preserve tissue to figure out viral levels. They were able to grow the virus collected from several tissues, including the heart, lungs, small intestine, and adrenal glands.

“Our results collectively show that, while the highest burden of SARS-CoV-2 is in the airways and lung, the virus can disseminate early during infection and infect cells throughout the entire body, including widely throughout the brain,” the study authors wrote.

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

The coronavirus that causes COVID-19 can spread to the heart and brain within days of infection and can survive for months in organs, according to a new study by the National Institutes of Health.

The virus can spread to almost every organ system in the body, which could contribute to the ongoing symptoms seen in “long COVID” patients, the study authors wrote. The study is considered one of the most comprehensive reviews of how the virus replicates in human cells and persists in the human body. It is under review for publication in the journal Nature.

“This is remarkably important work,” Ziyad Al-Aly, MD, director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, told Bloomberg News. Dr. Al-Aly wasn’t involved with the NIH study but has researched the long-term effects of COVID-19.

“For a long time now, we have been scratching our heads and asking why long COVID seems to affect so many organ systems,” he said. “This paper sheds some light and may help explain why long COVID can occur even in people who had mild or asymptomatic acute disease.”

The NIH researchers sampled and analyzed tissues from autopsies on 44 patients who died after contracting the coronavirus during the first year of the pandemic. They found persistent virus particles in multiple parts of the body, including the heart and brain, for as long as 230 days after symptoms began. This could represent infection with defective virus particles, they said, which has also been seen in persistent infections among measles patients.

“We don’t yet know what burden of chronic illness will result in years to come,” Raina MacIntyre, PhD, a professor of global biosecurity at the University of New South Wales, Sydney, told Bloomberg News.

“Will we see young-onset cardiac failure in survivors or early-onset dementia?” she asked. “These are unanswered questions which call for a precautionary public health approach to mitigation of the spread of this virus.”

Unlike other COVID-19 autopsy research, the NIH team had a more comprehensive postmortem tissue collection process, which typically occurred within a day of the patient’s death, Bloomberg News reported. The researchers also used a variety of ways to preserve tissue to figure out viral levels. They were able to grow the virus collected from several tissues, including the heart, lungs, small intestine, and adrenal glands.

“Our results collectively show that, while the highest burden of SARS-CoV-2 is in the airways and lung, the virus can disseminate early during infection and infect cells throughout the entire body, including widely throughout the brain,” the study authors wrote.

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

The Food and Drug Administration has approved tralokinumab for the treatment of moderate to severe atopic dermatitis (AD) in adults whose disease is not well controlled with topical prescription therapies or when those therapies are not advisable.

Olivier Le Moal/Getty Images

Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. The drug, which has been developed by LEO Pharma, comes as a single-dose (150 mg) prefilled syringe with needle guard.

In two pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints. For example, at week 16, for the ECZTRA 1 and 2 monotherapy trials, respectively, 16% and 21% of patients treated with tralokinumab 300 mg every other week achieved clear or almost clear skin (IGA 0/1) versus 7% and 9% with placebo.

In addition, 25% and 33% of patients treated with tralokinumab 300 mg every other week achieved an improvement of 75% or more in the Eczema Area and Severity Index score (EASI-75) versus 13% and 10% with placebo. At 52 weeks, 51% and 60% of patients who responded at week 16 maintained IGA 0/1 response with tralokinumab 300 mg every other week in ECZTRA 1 and 2, respectively.

Finally, 60% and 57% of patients who responded at week 16 maintained EASI-75 response with tralokinumab 300 mg every other week.

In the drug’s third pivotal trial, ECZTRA 3, researchers evaluated the efficacy and safety of tralokinumab 300 mg in combination with topical corticosteroids (TCS) as needed in adults with moderate to severe atopic dermatitis who are candidates for systemic therapy. At week 16, 38% of patients treated with tralokinumab 300 mg every other week plus TCS achieved clear or almost clear skin (IGA 0/1) versus 27% with placebo plus TCS. In addition, 56% of patients treated with tralokinumab 300 mg every other week plus TCS achieved an improvement of 75% or more in the EASI-75 versus 37% with placebo plus TCS. At 32 weeks, 89% and 92% of patients who responded at week 16 maintained response (IGA 0/1 and EASI-75, respectively) with tralokinumab 300 mg every other week.

A link to prescribing information can be found here. Tralokinumab is expected to be available by February 2022.

[email protected]

The Food and Drug Administration has approved tralokinumab for the treatment of moderate to severe atopic dermatitis (AD) in adults whose disease is not well controlled with topical prescription therapies or when those therapies are not advisable.

Olivier Le Moal/Getty Images

Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. The drug, which has been developed by LEO Pharma, comes as a single-dose (150 mg) prefilled syringe with needle guard.

In two pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints. For example, at week 16, for the ECZTRA 1 and 2 monotherapy trials, respectively, 16% and 21% of patients treated with tralokinumab 300 mg every other week achieved clear or almost clear skin (IGA 0/1) versus 7% and 9% with placebo.

In addition, 25% and 33% of patients treated with tralokinumab 300 mg every other week achieved an improvement of 75% or more in the Eczema Area and Severity Index score (EASI-75) versus 13% and 10% with placebo. At 52 weeks, 51% and 60% of patients who responded at week 16 maintained IGA 0/1 response with tralokinumab 300 mg every other week in ECZTRA 1 and 2, respectively.

Finally, 60% and 57% of patients who responded at week 16 maintained EASI-75 response with tralokinumab 300 mg every other week.

In the drug’s third pivotal trial, ECZTRA 3, researchers evaluated the efficacy and safety of tralokinumab 300 mg in combination with topical corticosteroids (TCS) as needed in adults with moderate to severe atopic dermatitis who are candidates for systemic therapy. At week 16, 38% of patients treated with tralokinumab 300 mg every other week plus TCS achieved clear or almost clear skin (IGA 0/1) versus 27% with placebo plus TCS. In addition, 56% of patients treated with tralokinumab 300 mg every other week plus TCS achieved an improvement of 75% or more in the EASI-75 versus 37% with placebo plus TCS. At 32 weeks, 89% and 92% of patients who responded at week 16 maintained response (IGA 0/1 and EASI-75, respectively) with tralokinumab 300 mg every other week.

A link to prescribing information can be found here. Tralokinumab is expected to be available by February 2022.

[email protected]

The Food and Drug Administration has approved tralokinumab for the treatment of moderate to severe atopic dermatitis (AD) in adults whose disease is not well controlled with topical prescription therapies or when those therapies are not advisable.

Olivier Le Moal/Getty Images

Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. The drug, which has been developed by LEO Pharma, comes as a single-dose (150 mg) prefilled syringe with needle guard.

In two pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints. For example, at week 16, for the ECZTRA 1 and 2 monotherapy trials, respectively, 16% and 21% of patients treated with tralokinumab 300 mg every other week achieved clear or almost clear skin (IGA 0/1) versus 7% and 9% with placebo.

In addition, 25% and 33% of patients treated with tralokinumab 300 mg every other week achieved an improvement of 75% or more in the Eczema Area and Severity Index score (EASI-75) versus 13% and 10% with placebo. At 52 weeks, 51% and 60% of patients who responded at week 16 maintained IGA 0/1 response with tralokinumab 300 mg every other week in ECZTRA 1 and 2, respectively.

Finally, 60% and 57% of patients who responded at week 16 maintained EASI-75 response with tralokinumab 300 mg every other week.

In the drug’s third pivotal trial, ECZTRA 3, researchers evaluated the efficacy and safety of tralokinumab 300 mg in combination with topical corticosteroids (TCS) as needed in adults with moderate to severe atopic dermatitis who are candidates for systemic therapy. At week 16, 38% of patients treated with tralokinumab 300 mg every other week plus TCS achieved clear or almost clear skin (IGA 0/1) versus 27% with placebo plus TCS. In addition, 56% of patients treated with tralokinumab 300 mg every other week plus TCS achieved an improvement of 75% or more in the EASI-75 versus 37% with placebo plus TCS. At 32 weeks, 89% and 92% of patients who responded at week 16 maintained response (IGA 0/1 and EASI-75, respectively) with tralokinumab 300 mg every other week.

A link to prescribing information can be found here. Tralokinumab is expected to be available by February 2022.

[email protected]

Earlier this year, hospitals in India were dealing not only with the coronavirus pandemic but also with a surge in a potentially lethal fungal infection in patients previously treated for COVID-19. Mucormycosis, also known as black fungus, is typically a rare infection, but India had recorded more than 45,000 cases as of July 2021.

Now, a recent report suggests that patients with COVID-19–associated rhino-orbital cerebral mucormycosis (CAM) may have a higher mortality rate than previously estimated. At highest risk, CAM patients with severe COVID-19 or orbital disease are more likely to die within 10 days of admission. The study was published Dec. 9 in JAMA Ophthalmology.

“The mortality indicators we observed, such as assisted ventilation and presence of severe orbital manifestations, can help physicians triage patients for emergency procedures, such as functional endoscopic sinus surgery (FESS), and administer systemic antifungal agents when in short supply,” the study authors wrote.

Mucormycosis usually infects immunocompromised patients. Previous research has found that poorly controlled diabetes – an epidemic in India – and use of high-dose systemic corticosteroids are two main risk factors for developing CAM. Even before COVID-19, India had a high incidence of mucormycosis compared to other countries, but cases exist around the world. In fact, on Dec. 17, the Centers for Disease Control and Prevention reported 10 isolated cases of COVID-19–associated mucormycosis identified in Arkansas hospitals between July and September 2021.

The disease can cause blurred vision, black lesions on the nose or inside of the mouth, and facial swelling. In rhino-orbital cerebral mucormycosis, extensive infection can necessitate orbital exenteration surgery, a disfiguring procedure that typically involves removal of the entire contents of the bony eye socket, as well as removal of the sinuses. Estimates for the mortality rate for this disease range from 14% to nearly 80%.

To better understand the cumulative morality rates for CAM and to identify additional risk factors, researchers reviewed the medical records of patients diagnosed and treated for CAM at a tertiary care multispecialty government hospital in Maharashtra, a state in the west-central region of India. The analysis included patients who died after admission or who had at minimum 30 days of documented follow-up. All diagnoses occurred between March 1 and May 30, 2021. All patients underwent comprehensive ophthalmic exams and routine blood workups.

Seventy-three patients were included in the study, with the average age of 53.5 years; 66% of the patients were male, and 74% of all patients had diabetes. Of the 47 individuals with available COVID-19 vaccination information, 89% had not had either shot of the vaccine, and 11% had the first dose. No patients in the cohort had received both doses of the vaccine; 87% of the patients were previously hospitalized for COVID-19, with 43 needing supplemental oxygen, 14 receiving noninvasive ventilation and ventilator support (NIV), and three requiring mechanical ventilation.

Patients developed CAM a median of 28 days after being discharged from the hospital for COVID-19 treatment; 26 patients died, 18 patients underwent FESS, and five underwent orbital exenteration. While 36% of patients died overall, the researchers found the cumulative probability of death from CAM rose from 26% at day 7 to 53% at day 21. They also found that the patients who died had more severe COVID-19, indicated by more days spent on supplemental oxygen (P = .003) and increased need for NIV or mechanical ventilation (P = .02) compared to patients who survived CAM. Those who died also had poorer visual acuity, with 35% of the group having no light perception during examination compared to 6% of surviving CAM patients (P = .02).

These findings are largely “confirmatory to what we previously knew, which is that [CAM] is a very bad disease with high morbidity and high mortality,” Ilan Schwartz, MD, PHD, an infectious disease physician at the University of Alberta, Edmonton, who researches emerging fungal infections, said in an interview. He was not involved with the research.

While larger studies looking at similar questions have been published, the new report has longer patient follow-up and is “better positioned to be able to estimate the mortality rate,” Dr. Schwartz noted. Even with 30 days of follow-up, “patients can have ongoing problems for many months, and so it’s possible that the true mortality rate is even higher, once you get beyond that period,” he added.

But Santosh G. Honavar, MD, the director of medical services at the Centre for Sight Eye Hospital in Hyderabad, India, also unaffiliated with the study, noted that the subset of patients included in the latest report may have had much more severe infection – and subsequently higher mortality rates – than a more generalized study in a broader patient population.

For example, a study by Mrittika Sen, PhD, Dr. Honavar, and their coauthors, published in the Indian Journal of Ophthalmology earlier this year, found a mortality rate of 14% when they examined the records of more than 2,800 patients across 102 treatment centers.

Taking that into account, “we believe that the actual mortality may be somewhere between the 14% reported by Sen et al. from the large Indian series and the 53% that we report at 3 weeks,” the JAMA Ophthalmology authors wrote.

Dr. Honavar also noted that the new report of severe infection outcomes identifies subgroups at higher risk of death due to CAM: those with severe COVID-19 infection or orbital disease. These groups “would need higher surveillance for mucormycosis, thus enabling early diagnosis and prompt initiation of amphotericin B upon diagnosis of mucormycosis,” he said in an interview. “These measures can possibly minimize the risk of death.”

Ongoing research on CAM cases will continue to inform knowledge and treatment of the disease, but there are still unanswered questions. “We still have a fairly unsatisfactory understanding of exactly why this [CAM] epidemic occurred and why it was so bad,” Dr. Schwartz noted. And while mucormycosis cases have seemed to drop off since the surge earlier this year, “I don’t think we’re out of the woods,” he added. “There’s a lot more awareness in India and around the world about this disease now, but we’re still quite vulnerable to seeing it again.”

Dr. Honavar is the editor-in-chief of the Indian Journal of Ophthalmology. Dr. Schwartz reports no relevant financial relationships.

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

Earlier this year, hospitals in India were dealing not only with the coronavirus pandemic but also with a surge in a potentially lethal fungal infection in patients previously treated for COVID-19. Mucormycosis, also known as black fungus, is typically a rare infection, but India had recorded more than 45,000 cases as of July 2021.

Now, a recent report suggests that patients with COVID-19–associated rhino-orbital cerebral mucormycosis (CAM) may have a higher mortality rate than previously estimated. At highest risk, CAM patients with severe COVID-19 or orbital disease are more likely to die within 10 days of admission. The study was published Dec. 9 in JAMA Ophthalmology.

“The mortality indicators we observed, such as assisted ventilation and presence of severe orbital manifestations, can help physicians triage patients for emergency procedures, such as functional endoscopic sinus surgery (FESS), and administer systemic antifungal agents when in short supply,” the study authors wrote.

Mucormycosis usually infects immunocompromised patients. Previous research has found that poorly controlled diabetes – an epidemic in India – and use of high-dose systemic corticosteroids are two main risk factors for developing CAM. Even before COVID-19, India had a high incidence of mucormycosis compared to other countries, but cases exist around the world. In fact, on Dec. 17, the Centers for Disease Control and Prevention reported 10 isolated cases of COVID-19–associated mucormycosis identified in Arkansas hospitals between July and September 2021.

The disease can cause blurred vision, black lesions on the nose or inside of the mouth, and facial swelling. In rhino-orbital cerebral mucormycosis, extensive infection can necessitate orbital exenteration surgery, a disfiguring procedure that typically involves removal of the entire contents of the bony eye socket, as well as removal of the sinuses. Estimates for the mortality rate for this disease range from 14% to nearly 80%.

To better understand the cumulative morality rates for CAM and to identify additional risk factors, researchers reviewed the medical records of patients diagnosed and treated for CAM at a tertiary care multispecialty government hospital in Maharashtra, a state in the west-central region of India. The analysis included patients who died after admission or who had at minimum 30 days of documented follow-up. All diagnoses occurred between March 1 and May 30, 2021. All patients underwent comprehensive ophthalmic exams and routine blood workups.

Seventy-three patients were included in the study, with the average age of 53.5 years; 66% of the patients were male, and 74% of all patients had diabetes. Of the 47 individuals with available COVID-19 vaccination information, 89% had not had either shot of the vaccine, and 11% had the first dose. No patients in the cohort had received both doses of the vaccine; 87% of the patients were previously hospitalized for COVID-19, with 43 needing supplemental oxygen, 14 receiving noninvasive ventilation and ventilator support (NIV), and three requiring mechanical ventilation.

Patients developed CAM a median of 28 days after being discharged from the hospital for COVID-19 treatment; 26 patients died, 18 patients underwent FESS, and five underwent orbital exenteration. While 36% of patients died overall, the researchers found the cumulative probability of death from CAM rose from 26% at day 7 to 53% at day 21. They also found that the patients who died had more severe COVID-19, indicated by more days spent on supplemental oxygen (P = .003) and increased need for NIV or mechanical ventilation (P = .02) compared to patients who survived CAM. Those who died also had poorer visual acuity, with 35% of the group having no light perception during examination compared to 6% of surviving CAM patients (P = .02).

These findings are largely “confirmatory to what we previously knew, which is that [CAM] is a very bad disease with high morbidity and high mortality,” Ilan Schwartz, MD, PHD, an infectious disease physician at the University of Alberta, Edmonton, who researches emerging fungal infections, said in an interview. He was not involved with the research.

While larger studies looking at similar questions have been published, the new report has longer patient follow-up and is “better positioned to be able to estimate the mortality rate,” Dr. Schwartz noted. Even with 30 days of follow-up, “patients can have ongoing problems for many months, and so it’s possible that the true mortality rate is even higher, once you get beyond that period,” he added.

But Santosh G. Honavar, MD, the director of medical services at the Centre for Sight Eye Hospital in Hyderabad, India, also unaffiliated with the study, noted that the subset of patients included in the latest report may have had much more severe infection – and subsequently higher mortality rates – than a more generalized study in a broader patient population.

For example, a study by Mrittika Sen, PhD, Dr. Honavar, and their coauthors, published in the Indian Journal of Ophthalmology earlier this year, found a mortality rate of 14% when they examined the records of more than 2,800 patients across 102 treatment centers.

Taking that into account, “we believe that the actual mortality may be somewhere between the 14% reported by Sen et al. from the large Indian series and the 53% that we report at 3 weeks,” the JAMA Ophthalmology authors wrote.

Dr. Honavar also noted that the new report of severe infection outcomes identifies subgroups at higher risk of death due to CAM: those with severe COVID-19 infection or orbital disease. These groups “would need higher surveillance for mucormycosis, thus enabling early diagnosis and prompt initiation of amphotericin B upon diagnosis of mucormycosis,” he said in an interview. “These measures can possibly minimize the risk of death.”

Ongoing research on CAM cases will continue to inform knowledge and treatment of the disease, but there are still unanswered questions. “We still have a fairly unsatisfactory understanding of exactly why this [CAM] epidemic occurred and why it was so bad,” Dr. Schwartz noted. And while mucormycosis cases have seemed to drop off since the surge earlier this year, “I don’t think we’re out of the woods,” he added. “There’s a lot more awareness in India and around the world about this disease now, but we’re still quite vulnerable to seeing it again.”

Dr. Honavar is the editor-in-chief of the Indian Journal of Ophthalmology. Dr. Schwartz reports no relevant financial relationships.

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

Earlier this year, hospitals in India were dealing not only with the coronavirus pandemic but also with a surge in a potentially lethal fungal infection in patients previously treated for COVID-19. Mucormycosis, also known as black fungus, is typically a rare infection, but India had recorded more than 45,000 cases as of July 2021.

Now, a recent report suggests that patients with COVID-19–associated rhino-orbital cerebral mucormycosis (CAM) may have a higher mortality rate than previously estimated. At highest risk, CAM patients with severe COVID-19 or orbital disease are more likely to die within 10 days of admission. The study was published Dec. 9 in JAMA Ophthalmology.

“The mortality indicators we observed, such as assisted ventilation and presence of severe orbital manifestations, can help physicians triage patients for emergency procedures, such as functional endoscopic sinus surgery (FESS), and administer systemic antifungal agents when in short supply,” the study authors wrote.

Mucormycosis usually infects immunocompromised patients. Previous research has found that poorly controlled diabetes – an epidemic in India – and use of high-dose systemic corticosteroids are two main risk factors for developing CAM. Even before COVID-19, India had a high incidence of mucormycosis compared to other countries, but cases exist around the world. In fact, on Dec. 17, the Centers for Disease Control and Prevention reported 10 isolated cases of COVID-19–associated mucormycosis identified in Arkansas hospitals between July and September 2021.

The disease can cause blurred vision, black lesions on the nose or inside of the mouth, and facial swelling. In rhino-orbital cerebral mucormycosis, extensive infection can necessitate orbital exenteration surgery, a disfiguring procedure that typically involves removal of the entire contents of the bony eye socket, as well as removal of the sinuses. Estimates for the mortality rate for this disease range from 14% to nearly 80%.

To better understand the cumulative morality rates for CAM and to identify additional risk factors, researchers reviewed the medical records of patients diagnosed and treated for CAM at a tertiary care multispecialty government hospital in Maharashtra, a state in the west-central region of India. The analysis included patients who died after admission or who had at minimum 30 days of documented follow-up. All diagnoses occurred between March 1 and May 30, 2021. All patients underwent comprehensive ophthalmic exams and routine blood workups.

Seventy-three patients were included in the study, with the average age of 53.5 years; 66% of the patients were male, and 74% of all patients had diabetes. Of the 47 individuals with available COVID-19 vaccination information, 89% had not had either shot of the vaccine, and 11% had the first dose. No patients in the cohort had received both doses of the vaccine; 87% of the patients were previously hospitalized for COVID-19, with 43 needing supplemental oxygen, 14 receiving noninvasive ventilation and ventilator support (NIV), and three requiring mechanical ventilation.

Patients developed CAM a median of 28 days after being discharged from the hospital for COVID-19 treatment; 26 patients died, 18 patients underwent FESS, and five underwent orbital exenteration. While 36% of patients died overall, the researchers found the cumulative probability of death from CAM rose from 26% at day 7 to 53% at day 21. They also found that the patients who died had more severe COVID-19, indicated by more days spent on supplemental oxygen (P = .003) and increased need for NIV or mechanical ventilation (P = .02) compared to patients who survived CAM. Those who died also had poorer visual acuity, with 35% of the group having no light perception during examination compared to 6% of surviving CAM patients (P = .02).

These findings are largely “confirmatory to what we previously knew, which is that [CAM] is a very bad disease with high morbidity and high mortality,” Ilan Schwartz, MD, PHD, an infectious disease physician at the University of Alberta, Edmonton, who researches emerging fungal infections, said in an interview. He was not involved with the research.

While larger studies looking at similar questions have been published, the new report has longer patient follow-up and is “better positioned to be able to estimate the mortality rate,” Dr. Schwartz noted. Even with 30 days of follow-up, “patients can have ongoing problems for many months, and so it’s possible that the true mortality rate is even higher, once you get beyond that period,” he added.

But Santosh G. Honavar, MD, the director of medical services at the Centre for Sight Eye Hospital in Hyderabad, India, also unaffiliated with the study, noted that the subset of patients included in the latest report may have had much more severe infection – and subsequently higher mortality rates – than a more generalized study in a broader patient population.

For example, a study by Mrittika Sen, PhD, Dr. Honavar, and their coauthors, published in the Indian Journal of Ophthalmology earlier this year, found a mortality rate of 14% when they examined the records of more than 2,800 patients across 102 treatment centers.

Taking that into account, “we believe that the actual mortality may be somewhere between the 14% reported by Sen et al. from the large Indian series and the 53% that we report at 3 weeks,” the JAMA Ophthalmology authors wrote.

Dr. Honavar also noted that the new report of severe infection outcomes identifies subgroups at higher risk of death due to CAM: those with severe COVID-19 infection or orbital disease. These groups “would need higher surveillance for mucormycosis, thus enabling early diagnosis and prompt initiation of amphotericin B upon diagnosis of mucormycosis,” he said in an interview. “These measures can possibly minimize the risk of death.”

Ongoing research on CAM cases will continue to inform knowledge and treatment of the disease, but there are still unanswered questions. “We still have a fairly unsatisfactory understanding of exactly why this [CAM] epidemic occurred and why it was so bad,” Dr. Schwartz noted. And while mucormycosis cases have seemed to drop off since the surge earlier this year, “I don’t think we’re out of the woods,” he added. “There’s a lot more awareness in India and around the world about this disease now, but we’re still quite vulnerable to seeing it again.”

Dr. Honavar is the editor-in-chief of the Indian Journal of Ophthalmology. Dr. Schwartz reports no relevant financial relationships.

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

A high-fiber diet may improve treatment response among patients with advanced melanoma receiving immune checkpoint inhibitors, while probiotics may reduce treatment effectiveness, a new study shows.

Investigators found that the patients who reported consuming at least 20 g of dietary fiber daily had significantly better progression-free survival (PFS) than those who reported consuming lower amounts of dietary fiber. However, patients who took a probiotic supplement in the past month had slightly shorter PFS, but the results were not statistically significant.

And after adjusting for clinical factors, each 5-g increase in daily dietary fiber intake corresponded to a 30% lower risk of disease progression, according to the analysis, published online Dec. 23, 2021, in Science.

“Our study sheds light on the potential effects of a patient’s diet and supplement use when starting treatment with immune checkpoint blockade,” co–lead study author Jennifer Wargo, MD, professor of genomic medicine and surgical oncology at University of Texas MD Anderson Cancer Center, Houston, said in a press release. “These results provide further support for clinical trials to modulate the microbiome with the goal of improving cancer outcomes using dietary and other strategies.”

Previous research has suggested that the microbiome can influence patients’ response to immunotherapy. One recent analysis, for instance, found that fecal microbiota transplant can improve response to immunotherapy in advanced melanoma. And a small 2019 analysis from Dr. Dr. Wargo and colleagues hinted that a high-fiber diet may enhance patients’ ability to respond to immunotherapy in advanced melanoma, while probiotics appear to dampen that response.

Still, the role diet and probiotic supplements play in treatment response remains poorly understood.

In the current study, Dr. Wargo and colleagues assessed fecal microbiota profiles and dietary habits, including fiber intake and probiotic use, in 158 patients with advanced melanoma who received immune checkpoint blockade inhibitors.

In the cohort, 31% (49 of 158) of late-stage melanoma patients reported taking a commercially available probiotic in the past month. When assessing whether probiotic use influenced patient outcomes, the investigators observed a shorter but not statistically significant difference in PFS in those who took a probiotic (median, 17 months) versus those who did not (23 months).

Higher dietary fiber, however, was associated with significantly improved PFS in a subset of 128 patients. The team divided patients into a higher-fiber intake group (those consuming at least 20 g/day) and a low-fiber group (those consuming less than 20 g).

The 37 patients reporting higher fiber intake demonstrated improved PFS, compared with those in the low-intake group (median PFS not reached vs. 13 months), plus a 30% lower risk of disease progression or death for each additional 5 g consumed each day.

“The observed protective effect of dietary fiber intake in relation to PFS and response remained consistent among the subset of patients treated with anti–PD-1 monotherapy, with the exclusion of patients reporting recent antibiotic use,” the authors noted.

When assessing fiber and probiotic intake together, the researchers found that immunotherapy response rate was higher (82%) in the 22 patients who reported sufficient dietary fiber intake with no probiotic use versus 59% in 101 patients who reported either insufficient fiber intake or probiotic use.

Overall, the research suggests that “consuming a diet rich in fiber, like fruits, vegetables, and legumes, could improve your ability to respond to immunotherapy,” co–lead author Giorgio Trinchieri, MD, chief of the Laboratory of Integrative Cancer Immunology in the National Cancer Institute’s Center for Cancer Research, Bethesda, Md., said in a press statement. “The data also suggest that it’s probably better for people with cancer receiving immunotherapy not to use commercially available probiotics.”

The investigators also explored whether dietary fiber intake enhanced treatment response in preclinical mouse models of melanoma. In this instance, mice receiving a fiber-rich diet showed delayed tumor growth after anti–PD-1 treatment, compared with mice given a low-fiber diet or probiotics.

According to the authors, “our preclinical models support the hypothesis that dietary fiber and probiotics modulate the microbiome and that antitumor immunity is impaired in mice receiving a low-fiber diet and in those receiving probiotics – with suppression of intratumoral [interferon-gamma] T-cell responses in both cases.”

Dietary fiber may exert beneficial effect by increasing specific types of bacteria in the gut, such as Ruminococcaceae, which “produce high levels of certain short-chain fatty acids that have an antitumor effect,” Dr. Trinchieri explained.

However, “the impact of dietary fiber and probiotics on the gut microbiota is only part of the bigger picture,” Dr. Trinchieri said in a press release. “Many factors can affect the ability of a patient with melanoma to respond to immunotherapy” but, according to this analysis, “the microbiota seems to be one of the dominant factors.”

While Jeffrey S. Weber, MD, PhD, applauded the “innovative and interesting” research, he believes the patient population is too small to confirm that a high-fiber diet does indeed contribute to improved immunotherapy response and PFS in patients with advanced melanoma.

Additional data are needed to clarify these findings. “I will believe it if I could see it replicated in a larger study,” Dr. Weber, professor and deputy director of the Laura and Isaac Perlmutter Cancer Center, New York University, said in an interview.

Dr. Wargo noted that a randomized clinical trial exploring how diets with varying fiber content affect the microbiome and immune response is currently enrolling patients with stage III and IV melanoma receiving immunotherapy.

This study was supported by the Melanoma Moon Shot, among others. Dr. Wargo is a collaborator on a U.S. patent application that covers methods to enhance immune checkpoint blockade responses by modulating the microbiome. Dr. Weber reported relationships with Bristol-Myers Squibb, GlaxoSmithKline, Genentech BioOncology, Merck, Novartis, EMD Serono, Celldex, CytomX, Nektar, Roche, Altor, Daiichi Sankyo, and Eli Lilly, and is named on patents filed for biomarkers for ipilimumab and nivolumab.

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

A high-fiber diet may improve treatment response among patients with advanced melanoma receiving immune checkpoint inhibitors, while probiotics may reduce treatment effectiveness, a new study shows.

Investigators found that the patients who reported consuming at least 20 g of dietary fiber daily had significantly better progression-free survival (PFS) than those who reported consuming lower amounts of dietary fiber. However, patients who took a probiotic supplement in the past month had slightly shorter PFS, but the results were not statistically significant.

And after adjusting for clinical factors, each 5-g increase in daily dietary fiber intake corresponded to a 30% lower risk of disease progression, according to the analysis, published online Dec. 23, 2021, in Science.

“Our study sheds light on the potential effects of a patient’s diet and supplement use when starting treatment with immune checkpoint blockade,” co–lead study author Jennifer Wargo, MD, professor of genomic medicine and surgical oncology at University of Texas MD Anderson Cancer Center, Houston, said in a press release. “These results provide further support for clinical trials to modulate the microbiome with the goal of improving cancer outcomes using dietary and other strategies.”

Previous research has suggested that the microbiome can influence patients’ response to immunotherapy. One recent analysis, for instance, found that fecal microbiota transplant can improve response to immunotherapy in advanced melanoma. And a small 2019 analysis from Dr. Dr. Wargo and colleagues hinted that a high-fiber diet may enhance patients’ ability to respond to immunotherapy in advanced melanoma, while probiotics appear to dampen that response.

Still, the role diet and probiotic supplements play in treatment response remains poorly understood.

In the current study, Dr. Wargo and colleagues assessed fecal microbiota profiles and dietary habits, including fiber intake and probiotic use, in 158 patients with advanced melanoma who received immune checkpoint blockade inhibitors.

In the cohort, 31% (49 of 158) of late-stage melanoma patients reported taking a commercially available probiotic in the past month. When assessing whether probiotic use influenced patient outcomes, the investigators observed a shorter but not statistically significant difference in PFS in those who took a probiotic (median, 17 months) versus those who did not (23 months).

Higher dietary fiber, however, was associated with significantly improved PFS in a subset of 128 patients. The team divided patients into a higher-fiber intake group (those consuming at least 20 g/day) and a low-fiber group (those consuming less than 20 g).

The 37 patients reporting higher fiber intake demonstrated improved PFS, compared with those in the low-intake group (median PFS not reached vs. 13 months), plus a 30% lower risk of disease progression or death for each additional 5 g consumed each day.

“The observed protective effect of dietary fiber intake in relation to PFS and response remained consistent among the subset of patients treated with anti–PD-1 monotherapy, with the exclusion of patients reporting recent antibiotic use,” the authors noted.

When assessing fiber and probiotic intake together, the researchers found that immunotherapy response rate was higher (82%) in the 22 patients who reported sufficient dietary fiber intake with no probiotic use versus 59% in 101 patients who reported either insufficient fiber intake or probiotic use.

Overall, the research suggests that “consuming a diet rich in fiber, like fruits, vegetables, and legumes, could improve your ability to respond to immunotherapy,” co–lead author Giorgio Trinchieri, MD, chief of the Laboratory of Integrative Cancer Immunology in the National Cancer Institute’s Center for Cancer Research, Bethesda, Md., said in a press statement. “The data also suggest that it’s probably better for people with cancer receiving immunotherapy not to use commercially available probiotics.”

The investigators also explored whether dietary fiber intake enhanced treatment response in preclinical mouse models of melanoma. In this instance, mice receiving a fiber-rich diet showed delayed tumor growth after anti–PD-1 treatment, compared with mice given a low-fiber diet or probiotics.

According to the authors, “our preclinical models support the hypothesis that dietary fiber and probiotics modulate the microbiome and that antitumor immunity is impaired in mice receiving a low-fiber diet and in those receiving probiotics – with suppression of intratumoral [interferon-gamma] T-cell responses in both cases.”

Dietary fiber may exert beneficial effect by increasing specific types of bacteria in the gut, such as Ruminococcaceae, which “produce high levels of certain short-chain fatty acids that have an antitumor effect,” Dr. Trinchieri explained.

However, “the impact of dietary fiber and probiotics on the gut microbiota is only part of the bigger picture,” Dr. Trinchieri said in a press release. “Many factors can affect the ability of a patient with melanoma to respond to immunotherapy” but, according to this analysis, “the microbiota seems to be one of the dominant factors.”

While Jeffrey S. Weber, MD, PhD, applauded the “innovative and interesting” research, he believes the patient population is too small to confirm that a high-fiber diet does indeed contribute to improved immunotherapy response and PFS in patients with advanced melanoma.

Additional data are needed to clarify these findings. “I will believe it if I could see it replicated in a larger study,” Dr. Weber, professor and deputy director of the Laura and Isaac Perlmutter Cancer Center, New York University, said in an interview.

Dr. Wargo noted that a randomized clinical trial exploring how diets with varying fiber content affect the microbiome and immune response is currently enrolling patients with stage III and IV melanoma receiving immunotherapy.

This study was supported by the Melanoma Moon Shot, among others. Dr. Wargo is a collaborator on a U.S. patent application that covers methods to enhance immune checkpoint blockade responses by modulating the microbiome. Dr. Weber reported relationships with Bristol-Myers Squibb, GlaxoSmithKline, Genentech BioOncology, Merck, Novartis, EMD Serono, Celldex, CytomX, Nektar, Roche, Altor, Daiichi Sankyo, and Eli Lilly, and is named on patents filed for biomarkers for ipilimumab and nivolumab.

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

A high-fiber diet may improve treatment response among patients with advanced melanoma receiving immune checkpoint inhibitors, while probiotics may reduce treatment effectiveness, a new study shows.

Investigators found that the patients who reported consuming at least 20 g of dietary fiber daily had significantly better progression-free survival (PFS) than those who reported consuming lower amounts of dietary fiber. However, patients who took a probiotic supplement in the past month had slightly shorter PFS, but the results were not statistically significant.

And after adjusting for clinical factors, each 5-g increase in daily dietary fiber intake corresponded to a 30% lower risk of disease progression, according to the analysis, published online Dec. 23, 2021, in Science.

“Our study sheds light on the potential effects of a patient’s diet and supplement use when starting treatment with immune checkpoint blockade,” co–lead study author Jennifer Wargo, MD, professor of genomic medicine and surgical oncology at University of Texas MD Anderson Cancer Center, Houston, said in a press release. “These results provide further support for clinical trials to modulate the microbiome with the goal of improving cancer outcomes using dietary and other strategies.”

Previous research has suggested that the microbiome can influence patients’ response to immunotherapy. One recent analysis, for instance, found that fecal microbiota transplant can improve response to immunotherapy in advanced melanoma. And a small 2019 analysis from Dr. Dr. Wargo and colleagues hinted that a high-fiber diet may enhance patients’ ability to respond to immunotherapy in advanced melanoma, while probiotics appear to dampen that response.

Still, the role diet and probiotic supplements play in treatment response remains poorly understood.

In the current study, Dr. Wargo and colleagues assessed fecal microbiota profiles and dietary habits, including fiber intake and probiotic use, in 158 patients with advanced melanoma who received immune checkpoint blockade inhibitors.

In the cohort, 31% (49 of 158) of late-stage melanoma patients reported taking a commercially available probiotic in the past month. When assessing whether probiotic use influenced patient outcomes, the investigators observed a shorter but not statistically significant difference in PFS in those who took a probiotic (median, 17 months) versus those who did not (23 months).

Higher dietary fiber, however, was associated with significantly improved PFS in a subset of 128 patients. The team divided patients into a higher-fiber intake group (those consuming at least 20 g/day) and a low-fiber group (those consuming less than 20 g).

The 37 patients reporting higher fiber intake demonstrated improved PFS, compared with those in the low-intake group (median PFS not reached vs. 13 months), plus a 30% lower risk of disease progression or death for each additional 5 g consumed each day.

“The observed protective effect of dietary fiber intake in relation to PFS and response remained consistent among the subset of patients treated with anti–PD-1 monotherapy, with the exclusion of patients reporting recent antibiotic use,” the authors noted.

When assessing fiber and probiotic intake together, the researchers found that immunotherapy response rate was higher (82%) in the 22 patients who reported sufficient dietary fiber intake with no probiotic use versus 59% in 101 patients who reported either insufficient fiber intake or probiotic use.

Overall, the research suggests that “consuming a diet rich in fiber, like fruits, vegetables, and legumes, could improve your ability to respond to immunotherapy,” co–lead author Giorgio Trinchieri, MD, chief of the Laboratory of Integrative Cancer Immunology in the National Cancer Institute’s Center for Cancer Research, Bethesda, Md., said in a press statement. “The data also suggest that it’s probably better for people with cancer receiving immunotherapy not to use commercially available probiotics.”

The investigators also explored whether dietary fiber intake enhanced treatment response in preclinical mouse models of melanoma. In this instance, mice receiving a fiber-rich diet showed delayed tumor growth after anti–PD-1 treatment, compared with mice given a low-fiber diet or probiotics.

According to the authors, “our preclinical models support the hypothesis that dietary fiber and probiotics modulate the microbiome and that antitumor immunity is impaired in mice receiving a low-fiber diet and in those receiving probiotics – with suppression of intratumoral [interferon-gamma] T-cell responses in both cases.”

Dietary fiber may exert beneficial effect by increasing specific types of bacteria in the gut, such as Ruminococcaceae, which “produce high levels of certain short-chain fatty acids that have an antitumor effect,” Dr. Trinchieri explained.

However, “the impact of dietary fiber and probiotics on the gut microbiota is only part of the bigger picture,” Dr. Trinchieri said in a press release. “Many factors can affect the ability of a patient with melanoma to respond to immunotherapy” but, according to this analysis, “the microbiota seems to be one of the dominant factors.”

While Jeffrey S. Weber, MD, PhD, applauded the “innovative and interesting” research, he believes the patient population is too small to confirm that a high-fiber diet does indeed contribute to improved immunotherapy response and PFS in patients with advanced melanoma.

Additional data are needed to clarify these findings. “I will believe it if I could see it replicated in a larger study,” Dr. Weber, professor and deputy director of the Laura and Isaac Perlmutter Cancer Center, New York University, said in an interview.

Dr. Wargo noted that a randomized clinical trial exploring how diets with varying fiber content affect the microbiome and immune response is currently enrolling patients with stage III and IV melanoma receiving immunotherapy.

This study was supported by the Melanoma Moon Shot, among others. Dr. Wargo is a collaborator on a U.S. patent application that covers methods to enhance immune checkpoint blockade responses by modulating the microbiome. Dr. Weber reported relationships with Bristol-Myers Squibb, GlaxoSmithKline, Genentech BioOncology, Merck, Novartis, EMD Serono, Celldex, CytomX, Nektar, Roche, Altor, Daiichi Sankyo, and Eli Lilly, and is named on patents filed for biomarkers for ipilimumab and nivolumab.

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

Booster shot protection against symptomatic COVID-19 caused by the Omicron variant appears to fade in about 10 weeks, according to new data from Britain.

U.K. health officials shared the data just before Christmas and noted that there haven’t been enough severe cases of the Omicron variant to calculate how well boosters protect against severe disease. But they believe the extra shots provide significant protection against hospitalization and death.

“It will be a few weeks before effectiveness against severe disease with Omicron can be estimated,” U.K. Health Security Agency officials wrote in the report. “However, based on experience with previous variants, this is likely to be substantially higher than the estimates against symptomatic disease.”

Since countries began reporting Omicron cases in November, multiple studies have suggested the variant is better at escaping antibodies from vaccination and previous infection, according to the New York Times. The U.K. report adds to that, noting that both the initial vaccine series and booster doses were less effective and faded faster against the Omicron variant than the Delta variant.

Among those who received two doses of the AstraZeneca vaccine, a booster of the Pfizer or Moderna vaccine was 60% effective at preventing symptomatic disease 2 to 4 weeks after the shot. But after 10 weeks, the Pfizer booster was 35% effective, and the Moderna booster was 45% effective. (The AstraZeneca vaccine is not authorized in the United States, but the Johnson & Johnson shot uses a similar technology, the New York Times reported.)

Among those who received three Pfizer doses, vaccine effectiveness was 70% about a week after the booster but dropped to 45% after 10 weeks. At the same time, those who received an initial two-dose series of the Pfizer vaccine and then a Moderna booster seemed to have 75% effectiveness up to 9 weeks.

The report was based on an analysis of 148,000 Delta cases and 68,000 Omicron cases in the United Kingdom through Dec. 20. So far, the U.K. health officials wrote, Omicron infections appear to be less severe and less likely to lead to hospitalization than Delta infections. At that time, 132 people with lab-confirmed Omicron had been admitted to hospitals, and 14 deaths had been reported among ages 52-96.

“This analysis is preliminary because of the small numbers of Omicron cases currently in hospital and the limited spread of Omicron into older age groups as yet,” the report said.

The reinfection rate has also increased for the Omicron variant, the report found. Among the 116,000 people who had an Omicron infection, about 11,000 -- or 9.5% -- were linked to a previously confirmed infection, which is likely an undercount of reinfections. In the data analyzed, 69 Omicron cases were a third episode of COVID-19 infection, and 290 cases occurred 60-89 days after a first infection.

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

Booster shot protection against symptomatic COVID-19 caused by the Omicron variant appears to fade in about 10 weeks, according to new data from Britain.

U.K. health officials shared the data just before Christmas and noted that there haven’t been enough severe cases of the Omicron variant to calculate how well boosters protect against severe disease. But they believe the extra shots provide significant protection against hospitalization and death.

“It will be a few weeks before effectiveness against severe disease with Omicron can be estimated,” U.K. Health Security Agency officials wrote in the report. “However, based on experience with previous variants, this is likely to be substantially higher than the estimates against symptomatic disease.”

Since countries began reporting Omicron cases in November, multiple studies have suggested the variant is better at escaping antibodies from vaccination and previous infection, according to the New York Times. The U.K. report adds to that, noting that both the initial vaccine series and booster doses were less effective and faded faster against the Omicron variant than the Delta variant.

Among those who received two doses of the AstraZeneca vaccine, a booster of the Pfizer or Moderna vaccine was 60% effective at preventing symptomatic disease 2 to 4 weeks after the shot. But after 10 weeks, the Pfizer booster was 35% effective, and the Moderna booster was 45% effective. (The AstraZeneca vaccine is not authorized in the United States, but the Johnson & Johnson shot uses a similar technology, the New York Times reported.)

Among those who received three Pfizer doses, vaccine effectiveness was 70% about a week after the booster but dropped to 45% after 10 weeks. At the same time, those who received an initial two-dose series of the Pfizer vaccine and then a Moderna booster seemed to have 75% effectiveness up to 9 weeks.

The report was based on an analysis of 148,000 Delta cases and 68,000 Omicron cases in the United Kingdom through Dec. 20. So far, the U.K. health officials wrote, Omicron infections appear to be less severe and less likely to lead to hospitalization than Delta infections. At that time, 132 people with lab-confirmed Omicron had been admitted to hospitals, and 14 deaths had been reported among ages 52-96.

“This analysis is preliminary because of the small numbers of Omicron cases currently in hospital and the limited spread of Omicron into older age groups as yet,” the report said.

The reinfection rate has also increased for the Omicron variant, the report found. Among the 116,000 people who had an Omicron infection, about 11,000 -- or 9.5% -- were linked to a previously confirmed infection, which is likely an undercount of reinfections. In the data analyzed, 69 Omicron cases were a third episode of COVID-19 infection, and 290 cases occurred 60-89 days after a first infection.

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

Booster shot protection against symptomatic COVID-19 caused by the Omicron variant appears to fade in about 10 weeks, according to new data from Britain.

U.K. health officials shared the data just before Christmas and noted that there haven’t been enough severe cases of the Omicron variant to calculate how well boosters protect against severe disease. But they believe the extra shots provide significant protection against hospitalization and death.

“It will be a few weeks before effectiveness against severe disease with Omicron can be estimated,” U.K. Health Security Agency officials wrote in the report. “However, based on experience with previous variants, this is likely to be substantially higher than the estimates against symptomatic disease.”

Since countries began reporting Omicron cases in November, multiple studies have suggested the variant is better at escaping antibodies from vaccination and previous infection, according to the New York Times. The U.K. report adds to that, noting that both the initial vaccine series and booster doses were less effective and faded faster against the Omicron variant than the Delta variant.

Among those who received two doses of the AstraZeneca vaccine, a booster of the Pfizer or Moderna vaccine was 60% effective at preventing symptomatic disease 2 to 4 weeks after the shot. But after 10 weeks, the Pfizer booster was 35% effective, and the Moderna booster was 45% effective. (The AstraZeneca vaccine is not authorized in the United States, but the Johnson & Johnson shot uses a similar technology, the New York Times reported.)

Among those who received three Pfizer doses, vaccine effectiveness was 70% about a week after the booster but dropped to 45% after 10 weeks. At the same time, those who received an initial two-dose series of the Pfizer vaccine and then a Moderna booster seemed to have 75% effectiveness up to 9 weeks.

The report was based on an analysis of 148,000 Delta cases and 68,000 Omicron cases in the United Kingdom through Dec. 20. So far, the U.K. health officials wrote, Omicron infections appear to be less severe and less likely to lead to hospitalization than Delta infections. At that time, 132 people with lab-confirmed Omicron had been admitted to hospitals, and 14 deaths had been reported among ages 52-96.

“This analysis is preliminary because of the small numbers of Omicron cases currently in hospital and the limited spread of Omicron into older age groups as yet,” the report said.

The reinfection rate has also increased for the Omicron variant, the report found. Among the 116,000 people who had an Omicron infection, about 11,000 -- or 9.5% -- were linked to a previously confirmed infection, which is likely an undercount of reinfections. In the data analyzed, 69 Omicron cases were a third episode of COVID-19 infection, and 290 cases occurred 60-89 days after a first infection.

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

Involvement of the head, neck, face, and hands with atopic dermatitis was associated with a significantly higher impact on health-related quality of life and appeared to be associated with more severe AD, according to a large, cross-sectional study of patients with AD.

“While we know that head, neck, face, and hands seem to be significantly affected by patients with AD, there is a limited evidence basis regarding the prevalence and health-related quality of life impact of AD in these areas,” presenting author Lawrence F. Eichenfield, MD, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium.

For the study, Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues evaluated 533 patients from the TARGET-DERM AD cohort, an ongoing, longitudinal, observational study launched in 2019 that captures patients with AD in 44 community or academic sites in the United States.

Adult, adolescent, and pediatric patients with moderate or severe Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores at enrollment were included in the analysis. The researchers used the Patient-Oriented Scoring AD (PO-SCORAD) index to gather information on involvement of the head, neck, face, hands, or other areas, and the Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index/Children’s DLQI (CDLQI) to measure health-related quality of life outcomes.

Of the 533 study participants, 453 (85%) had AD affecting the head, neck, face, hands, and other areas, while 80 (15%) had AD located in other body regions not including the head, neck, face, or hands. About 38% of all patients were using systemic treatments; most were using topical treatments.

Comorbid immune system disorders (including allergic and hypersensitivity disorders) were noted in 44.8% of patients, infections in 32.5%, asthma in 26.5%, hypertension in 18.6%, depression in 15.8%, and anxiety in 12.4%, with similar proportions observed in those with or without head, neck, face, and hand involvement.

However, patients with head, face, neck, and hand involvement, when compared with patients without those affected areas, were more likely to have severe vIGA scores (28.5% vs. 16.3%, P = .02) and a higher median total body surface area affected (15% vs. 10%, P ≤ .01). Also, while bivariable analyses did not detect statistical differences in POEM and DLQI/CDLQI by body region involvement, multivariable-adjusted models showed that patients with head, neck, face, and hand involvement were more than twice as likely to report higher DLQI/CDLQI (odds ratio, 2.09) and POEM (OR, 2.51) scores than those without head, face, neck, and hand involvement.

“These findings highlight the importance of detailed assessment of specific areas affected by AD to personalize treatment approaches to the needs of patients,” Dr. Eichenfield concluded.

Raj Chovatiya MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that the findings confirm clinical suspicions about the unique and heightened impact of facial, head/neck, and hand dermatitis. “These data show that a detailed skin examination is necessary for a complete assessment of AD,” he said. “Future studies should focus on characterizing the optimal treatment approaches for each of these special sites.”

“This is important data,” added primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington. “We need more high-quality studies like this; we need to create long-term longitudinal data to better understand [the impact of AD on] this and other cohorts.”

TARGET-DERM is sponsored by Target RWE. Dr. Eichenfield disclosed that he has served as a consultant to or investigator for numerous pharmaceutical companies. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

Commentary by Robert Sidbury, MD, MPH

Patients with atopic dermatitis (AD) in “visible” areas such as the head, neck, and hands experience a higher impact on their quality of life than those who do not have these areas of involvement. This is a self-evident and unsurprising result but also a particularly important one to document for several reasons. First, evidence-based demonstration of quality-of-life impact is critical as we petition carriers to support the use of newer, more expensive medications. Second, from a topical therapy standpoint, we often use different medications on the head, neck, face, and hands relative to other areas. On the head and neck area we often use either weaker topical steroids to avoid side effects or nonsteroids like topical calcineurin or phosphodiesterase inhibitors; conversely, on the hands we use stronger steroids and are less likely to use nonsteroidal agents that are perceived to be less potent. These data emphasize the need to tailor therapy but ascertain whether standard approaches are satisfactory. If patients are not responding, particularly in these sensitive areas, providers should consider the outsized impact AD may be having on quality of life.

Dr. Sidbury is chief of dermatology at Seattle Children's Hospital and professor, department of pediatrics, University of Washington, Seattle. He is a site principal investigator for dupilumab trials, for which the hospital has a contract with Regeneron.

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

This article was updated 6/10/22.

Involvement of the head, neck, face, and hands with atopic dermatitis was associated with a significantly higher impact on health-related quality of life and appeared to be associated with more severe AD, according to a large, cross-sectional study of patients with AD.

“While we know that head, neck, face, and hands seem to be significantly affected by patients with AD, there is a limited evidence basis regarding the prevalence and health-related quality of life impact of AD in these areas,” presenting author Lawrence F. Eichenfield, MD, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium.

For the study, Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues evaluated 533 patients from the TARGET-DERM AD cohort, an ongoing, longitudinal, observational study launched in 2019 that captures patients with AD in 44 community or academic sites in the United States.

Adult, adolescent, and pediatric patients with moderate or severe Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores at enrollment were included in the analysis. The researchers used the Patient-Oriented Scoring AD (PO-SCORAD) index to gather information on involvement of the head, neck, face, hands, or other areas, and the Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index/Children’s DLQI (CDLQI) to measure health-related quality of life outcomes.

Of the 533 study participants, 453 (85%) had AD affecting the head, neck, face, hands, and other areas, while 80 (15%) had AD located in other body regions not including the head, neck, face, or hands. About 38% of all patients were using systemic treatments; most were using topical treatments.

Comorbid immune system disorders (including allergic and hypersensitivity disorders) were noted in 44.8% of patients, infections in 32.5%, asthma in 26.5%, hypertension in 18.6%, depression in 15.8%, and anxiety in 12.4%, with similar proportions observed in those with or without head, neck, face, and hand involvement.

However, patients with head, face, neck, and hand involvement, when compared with patients without those affected areas, were more likely to have severe vIGA scores (28.5% vs. 16.3%, P = .02) and a higher median total body surface area affected (15% vs. 10%, P ≤ .01). Also, while bivariable analyses did not detect statistical differences in POEM and DLQI/CDLQI by body region involvement, multivariable-adjusted models showed that patients with head, neck, face, and hand involvement were more than twice as likely to report higher DLQI/CDLQI (odds ratio, 2.09) and POEM (OR, 2.51) scores than those without head, face, neck, and hand involvement.

“These findings highlight the importance of detailed assessment of specific areas affected by AD to personalize treatment approaches to the needs of patients,” Dr. Eichenfield concluded.

Raj Chovatiya MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that the findings confirm clinical suspicions about the unique and heightened impact of facial, head/neck, and hand dermatitis. “These data show that a detailed skin examination is necessary for a complete assessment of AD,” he said. “Future studies should focus on characterizing the optimal treatment approaches for each of these special sites.”

“This is important data,” added primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington. “We need more high-quality studies like this; we need to create long-term longitudinal data to better understand [the impact of AD on] this and other cohorts.”

TARGET-DERM is sponsored by Target RWE. Dr. Eichenfield disclosed that he has served as a consultant to or investigator for numerous pharmaceutical companies. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

Commentary by Robert Sidbury, MD, MPH

Patients with atopic dermatitis (AD) in “visible” areas such as the head, neck, and hands experience a higher impact on their quality of life than those who do not have these areas of involvement. This is a self-evident and unsurprising result but also a particularly important one to document for several reasons. First, evidence-based demonstration of quality-of-life impact is critical as we petition carriers to support the use of newer, more expensive medications. Second, from a topical therapy standpoint, we often use different medications on the head, neck, face, and hands relative to other areas. On the head and neck area we often use either weaker topical steroids to avoid side effects or nonsteroids like topical calcineurin or phosphodiesterase inhibitors; conversely, on the hands we use stronger steroids and are less likely to use nonsteroidal agents that are perceived to be less potent. These data emphasize the need to tailor therapy but ascertain whether standard approaches are satisfactory. If patients are not responding, particularly in these sensitive areas, providers should consider the outsized impact AD may be having on quality of life.

Dr. Sidbury is chief of dermatology at Seattle Children's Hospital and professor, department of pediatrics, University of Washington, Seattle. He is a site principal investigator for dupilumab trials, for which the hospital has a contract with Regeneron.

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

This article was updated 6/10/22.

Involvement of the head, neck, face, and hands with atopic dermatitis was associated with a significantly higher impact on health-related quality of life and appeared to be associated with more severe AD, according to a large, cross-sectional study of patients with AD.

“While we know that head, neck, face, and hands seem to be significantly affected by patients with AD, there is a limited evidence basis regarding the prevalence and health-related quality of life impact of AD in these areas,” presenting author Lawrence F. Eichenfield, MD, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium.

For the study, Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues evaluated 533 patients from the TARGET-DERM AD cohort, an ongoing, longitudinal, observational study launched in 2019 that captures patients with AD in 44 community or academic sites in the United States.

Adult, adolescent, and pediatric patients with moderate or severe Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores at enrollment were included in the analysis. The researchers used the Patient-Oriented Scoring AD (PO-SCORAD) index to gather information on involvement of the head, neck, face, hands, or other areas, and the Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index/Children’s DLQI (CDLQI) to measure health-related quality of life outcomes.

Of the 533 study participants, 453 (85%) had AD affecting the head, neck, face, hands, and other areas, while 80 (15%) had AD located in other body regions not including the head, neck, face, or hands. About 38% of all patients were using systemic treatments; most were using topical treatments.

Comorbid immune system disorders (including allergic and hypersensitivity disorders) were noted in 44.8% of patients, infections in 32.5%, asthma in 26.5%, hypertension in 18.6%, depression in 15.8%, and anxiety in 12.4%, with similar proportions observed in those with or without head, neck, face, and hand involvement.

However, patients with head, face, neck, and hand involvement, when compared with patients without those affected areas, were more likely to have severe vIGA scores (28.5% vs. 16.3%, P = .02) and a higher median total body surface area affected (15% vs. 10%, P ≤ .01). Also, while bivariable analyses did not detect statistical differences in POEM and DLQI/CDLQI by body region involvement, multivariable-adjusted models showed that patients with head, neck, face, and hand involvement were more than twice as likely to report higher DLQI/CDLQI (odds ratio, 2.09) and POEM (OR, 2.51) scores than those without head, face, neck, and hand involvement.

“These findings highlight the importance of detailed assessment of specific areas affected by AD to personalize treatment approaches to the needs of patients,” Dr. Eichenfield concluded.

Raj Chovatiya MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that the findings confirm clinical suspicions about the unique and heightened impact of facial, head/neck, and hand dermatitis. “These data show that a detailed skin examination is necessary for a complete assessment of AD,” he said. “Future studies should focus on characterizing the optimal treatment approaches for each of these special sites.”

“This is important data,” added primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington. “We need more high-quality studies like this; we need to create long-term longitudinal data to better understand [the impact of AD on] this and other cohorts.”

TARGET-DERM is sponsored by Target RWE. Dr. Eichenfield disclosed that he has served as a consultant to or investigator for numerous pharmaceutical companies. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

Commentary by Robert Sidbury, MD, MPH

Patients with atopic dermatitis (AD) in “visible” areas such as the head, neck, and hands experience a higher impact on their quality of life than those who do not have these areas of involvement. This is a self-evident and unsurprising result but also a particularly important one to document for several reasons. First, evidence-based demonstration of quality-of-life impact is critical as we petition carriers to support the use of newer, more expensive medications. Second, from a topical therapy standpoint, we often use different medications on the head, neck, face, and hands relative to other areas. On the head and neck area we often use either weaker topical steroids to avoid side effects or nonsteroids like topical calcineurin or phosphodiesterase inhibitors; conversely, on the hands we use stronger steroids and are less likely to use nonsteroidal agents that are perceived to be less potent. These data emphasize the need to tailor therapy but ascertain whether standard approaches are satisfactory. If patients are not responding, particularly in these sensitive areas, providers should consider the outsized impact AD may be having on quality of life.

Dr. Sidbury is chief of dermatology at Seattle Children's Hospital and professor, department of pediatrics, University of Washington, Seattle. He is a site principal investigator for dupilumab trials, for which the hospital has a contract with Regeneron.

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

This article was updated 6/10/22.