Hospitalists across the United States have been and continue to be a critical part of our nation’s response to COVID-19. On National Hospitalist Day, Thursday, March 4, 2021, the Society of Hospital Medicine invites you to celebrate the individuals and teams that make up the hospital medicine community.

Courtesy Joseph Li

On this special day, SHM encourages you to share your story, showcase your team’s efforts to improve patient care, express your pride for the specialty, or share how you are making a difference in your hospital and in the lives of patients.

Here are just a few of the ways you can celebrate:

• Register for our live roundtable, featuring Mark Shapiro, MD, hospitalist and host of the Explore the Space podcast, and four hospitalist panelists, on March 4 at 7 p.m. ET/4 p.m. PT.
• Download shareable graphics, posters, Zoom backgrounds, and coloring book pages
• Enter our social media photo contest and follow the #HowWeHospitalist hashtag across all platforms
• Read special hospitalist profiles in the Hospitalist, including: Eric E. Howell, MD, MHM; Grace Huang, MD; Bridget McGrath, PA-C, FHM; and Harry Cho, MD, SFHM

Thank you for all you do and continue to do for hospital medicine. We hope you take some time today to celebrate you and your colleagues, as well as your commendable contributions to health care and the future of the specialty.

To learn more about National Hospitalist Day, visit hospitalmedicine.org/hospitalistday.




 

Hospitalists across the United States have been and continue to be a critical part of our nation’s response to COVID-19. On National Hospitalist Day, Thursday, March 4, 2021, the Society of Hospital Medicine invites you to celebrate the individuals and teams that make up the hospital medicine community.

Courtesy Joseph Li

On this special day, SHM encourages you to share your story, showcase your team’s efforts to improve patient care, express your pride for the specialty, or share how you are making a difference in your hospital and in the lives of patients.

Here are just a few of the ways you can celebrate:

• Register for our live roundtable, featuring Mark Shapiro, MD, hospitalist and host of the Explore the Space podcast, and four hospitalist panelists, on March 4 at 7 p.m. ET/4 p.m. PT.
• Download shareable graphics, posters, Zoom backgrounds, and coloring book pages
• Enter our social media photo contest and follow the #HowWeHospitalist hashtag across all platforms
• Read special hospitalist profiles in the Hospitalist, including: Eric E. Howell, MD, MHM; Grace Huang, MD; Bridget McGrath, PA-C, FHM; and Harry Cho, MD, SFHM

Thank you for all you do and continue to do for hospital medicine. We hope you take some time today to celebrate you and your colleagues, as well as your commendable contributions to health care and the future of the specialty.

To learn more about National Hospitalist Day, visit hospitalmedicine.org/hospitalistday.




 

Hospitalists across the United States have been and continue to be a critical part of our nation’s response to COVID-19. On National Hospitalist Day, Thursday, March 4, 2021, the Society of Hospital Medicine invites you to celebrate the individuals and teams that make up the hospital medicine community.

Courtesy Joseph Li

On this special day, SHM encourages you to share your story, showcase your team’s efforts to improve patient care, express your pride for the specialty, or share how you are making a difference in your hospital and in the lives of patients.

Here are just a few of the ways you can celebrate:

• Register for our live roundtable, featuring Mark Shapiro, MD, hospitalist and host of the Explore the Space podcast, and four hospitalist panelists, on March 4 at 7 p.m. ET/4 p.m. PT.
• Download shareable graphics, posters, Zoom backgrounds, and coloring book pages
• Enter our social media photo contest and follow the #HowWeHospitalist hashtag across all platforms
• Read special hospitalist profiles in the Hospitalist, including: Eric E. Howell, MD, MHM; Grace Huang, MD; Bridget McGrath, PA-C, FHM; and Harry Cho, MD, SFHM

Thank you for all you do and continue to do for hospital medicine. We hope you take some time today to celebrate you and your colleagues, as well as your commendable contributions to health care and the future of the specialty.

To learn more about National Hospitalist Day, visit hospitalmedicine.org/hospitalistday.




 

United Healthcare recently became the latest major insurer to offer a “virtual primary care service.” Initially, the service will be part of some employer-sponsored insurance plans in 11 states. United intends to expand its footprint next year.

United is using the platform and the medical group of American Well, a telehealth service, to provide virtual primary care. Besides minor acute care, United’s virtual service covers annual wellness visits, routine follow-ups for chronic conditions, lab tests, and specialist referrals with little or no cost sharing.

The giant insurer is now offering its virtual primary care plan in Arizona, Colorado, Illinois, Maryland, North Carolina, Ohio, South Carolina, Texas, Virginia, Washington, D.C., and West Virginia.

Other insurers are offering similar virtual primary care plans. For example, Humana has partnered with Doctor on Demand, and Cigna is working with MDLive to offer virtual primary care plans. Both of these plans encourage consumers to form ongoing relationships with physicians hired by the telehealth services. Similarly, Harvard Pilgrim, which has also joined with Doctor on Demand, said that consumers get “virtual PCPs” along with a full care team.

Humana has priced the premiums for its virtual service at about half the cost of Humana’s most popular traditional plan. There are no copays for telehealth visits; there are $5 copays for common lab tests and prescriptions. Cigna said that its virtual plan makes coverage “more affordable,” but doesn’t provide any specifics.

According to United spokeswoman Maria Shydlo, the insurer’s virtual primary care service is not cheaper than its traditional products.
 

Increased telehealth adoption

When the COVID-19 pandemic first struck last year, telehealth was a lifesaver for primary care practices. Physicians were able to treat half or more of their patients through telehealth, including video and phone consultations.

That initial romance with telehealth did not last. Today, telehealth represents 9% of adult primary care visits. However, that’s still a much higher percentage than before 2020, and telehealth has become a fixture of primary care.

Prior to the pandemic, telehealth services dominated the virtual care space. Some large groups experimented with having their doctors conduct virtual consults with their patients. Other physicians dabbled with telehealth or stayed out of it entirely because health plans paid much less for virtual visits than for in-person visits.

That began to change as more and more states passed laws requiring payment parity. (Today, 36 states do.) Then as the pandemic took hold, Medicare loosened its regulations, allowing coverage of telehealth everywhere and establishing parity. But it’s unclear what will happen after the public health emergency ends.

United and other insurers portray their virtual primary care plans as an effort to connect more consumers with primary care physicians. Having a relationship with a primary care doctor, United noted in a press release, increases access to care, including preventive services. Moreover, a United survey found that a quarter of respondents preferred a virtual relationship with a primary care doctor.
 

Physician have mostly positive but mixed reactions

This news organization interviewed several physicians who practice in states where United has introduced its new offering. Only one doctor had heard about it, and another, solo family physician Will Sawyer, MD, of Cincinnati no longer contracts with United. Nevertheless, they all had strong opinions about virtual primary care plans from United and other insurers.

Dr. Sawyer is a big proponent of telehealth and notes that it’s “incredibly convenient” for older people, many of whom are afraid to come to the office out of fear they might contract COVID-19. He has found that telehealth can be useful for many kinds of acute and chronic care. But he believes (although he admits he does not have evidence) that United started its virtual primary care service mainly to save money.

No to some kinds of telehealth doctors

The physicians we spoke with were unified in their opposition to virtual primary care plans that mainly use physicians hired by telehealth services. Dr. Sawyer noted that one-off consultations with telehealth doctors might be okay for urgent care. “But what we’re trying to do with patients is change their behavior for better health outcomes, and that doesn’t happen in these one-off contacts,” he said.

Even if a patient were able to develop an online relationship with a telehealth doctor, Dr. Basch said, there are any number of situations in which an in-person visit might be necessary. “Whether it’s a urologic visit, a cardiac visit, or an allergy visit, do I need to listen to you or put my hands on you to palpate your liver? Or is this just a conversation with someone I know to see how they’re doing, how they’re managing their meds? Ninety percent of a diagnosis is history.”

Although the virtual plans allow a telehealth physician to refer a patient to an in-network specialist for an office visit, this isn’t the same as their primary care physician asking them to come in to be examined.

Moreover, Dr. Basch noted, people with chronic conditions can’t be treated only virtually. “I wouldn’t say that primary care should be done predominantly through virtual visits. It may be okay for young and healthy patients, but not for older people with chronic conditions. There are times when they should see their doctor in person.”
 

What can be done via telehealth

On the other hand, Dr. Basch heartily approves of conducting routine follow-up visits virtually for patients with chronic diseases, as long as the physician knows the patient’s history. Telehealth can also be used to coach patients on exercise, nutrition, and other lifestyle changes.

Dr. Kubitschek estimates that around 40%-50% of primary care can be delivered through telehealth. But the remainder encompasses potentially serious conditions that should be diagnosed and treated in face-to-face encounters, he said. “For example, if a patient has abdominal pain, you have to examine the person to get a clue of what they’re talking about. The pains are often diffuse, but they might be painful locally, which could indicate a mass or a bladder distension.”

For that reason, he doesn’t support the idea of patients depending on telehealth doctors in virtual primary care plans. “These doctors would not be available to care for the patient in an urgent situation without sending them to a costly emergency room or urgent care clinic. In those settings, excess testing is done because of a lack of familiarity with the patient and his or her history and exam. I think a combination of in-person and telehealth visits presents the best circumstance for the patient and the physician. Having said that, I do believe that telehealth alone is better than no interaction with a health care provider.”
 

United approach can help with prevention

Donny Aga, MD, an internist with Kelsey-Seybold, a multispecialty group in Houston, has been a member of United’s virtual health advisory group for the past 2 years. In his view, United’s virtual primary care service is moving in the right direction by covering preventive and chronic care. Noting that 25%-30% of patients nationally have put off wellness and chronic care visits out of fear of COVID-19, he said that,“if health plans like United are willing to cover preventive services through telehealth, that will allow us to catch up on a lot of the needed screening tests and exams. So it’s a very positive step forward.”

On the other hand, he said, virtual plans that depend solely on telehealth doctors are not the way to manage chronic conditions. “Primary care is best done by your own primary care physician, not by someone who doesn’t know you from a distance.”

Regarding the virtual plans in which patients can establish relationships with telehealth physicians, Dr. Aga said that this approach can benefit some patients, especially those who live in rural areas and don’t have access to primary care. But there are drawbacks, including the telehealth providers’ lack of knowledge about local specialists.

“The negative is that you don’t have a [primary care physicians] who’s local, who knows you, who has examined you before, and who has a good relationship with those specialists and knows who is the right specialist to see for your problem,” Dr. Aga said. “It’s very difficult, if you don’t live and work in that area, to know the best places to send people.”
 

Virtual visits cost less

Like Dr. Basch, Dr. Aga said it’s possible that some insurance companies might begin to cover office visits only for certain conditions or services if they can be managed more cheaply via telehealth. He hopes that doesn’t happen; if it does, he predicts that patients and doctors will push back hard.

Why would a virtual primary care visit cost a health plan less than an in-person visit if it’s paying doctors the same for both? Dr. Aga said it’s because fewer prescriptions and lab tests are ordered in telehealth encounters. He bases this assertion on the quarter of a million virtual visits that Kelsey-Seybold has conducted and also alludes to published studies.

The characteristics of telehealth visits might explain this phenomenon, he said. “These visits are typically much shorter, and it’s easy to be problem-centric and problem based. Physicians use more of their intuitive skills, rather than just lab everybody up and get an x-ray, because that patient’s not there, and it’s easier to draw blood or get an x-ray if somebody is there.”
 

Cutting practice overhead

From the perspective of Kelsey-Seybold, which is now conducting about a fifth of its visits virtually, “infrastructure costs are less” for telehealth, Aga notes. Although Dr. Kubitschek and Dr. Sawyer say it doesn’t take less time to conduct a telehealth visit than an office visit, other practice costs may decrease in relationship to the percentage of a doctor’s visits that are virtual.

“If implemented appropriately, telehealth consults should cost less in terms of the ancillary costs surrounding care,” said Dr. Basch. He recalls that, some years ago, a five-doctor primary care group in Portland, Ore., began charging small monthly fees to patients for full-service care that included email access. After a while, 40% of their patients were coming in, and the rest received care by email or phone. As a result, the doctors were able to downsize to a smaller office space because they didn’t need a waiting room.

Although Dr. Basch doesn’t believe it would be appropriate for practices to do something like this in the midst of a pandemic, he sees the possibility of it happening in the future. “Eventually, a group might be able to say: ‘Yes, our practice expenses can be lower if we do this smartly. We could do as well as we’ve done on whatever insurance pays for office visits, knowing that we can deliver care to the same patient panel at, say, 10% lower overhead with telehealth.’ ”

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

United Healthcare recently became the latest major insurer to offer a “virtual primary care service.” Initially, the service will be part of some employer-sponsored insurance plans in 11 states. United intends to expand its footprint next year.

United is using the platform and the medical group of American Well, a telehealth service, to provide virtual primary care. Besides minor acute care, United’s virtual service covers annual wellness visits, routine follow-ups for chronic conditions, lab tests, and specialist referrals with little or no cost sharing.

The giant insurer is now offering its virtual primary care plan in Arizona, Colorado, Illinois, Maryland, North Carolina, Ohio, South Carolina, Texas, Virginia, Washington, D.C., and West Virginia.

Other insurers are offering similar virtual primary care plans. For example, Humana has partnered with Doctor on Demand, and Cigna is working with MDLive to offer virtual primary care plans. Both of these plans encourage consumers to form ongoing relationships with physicians hired by the telehealth services. Similarly, Harvard Pilgrim, which has also joined with Doctor on Demand, said that consumers get “virtual PCPs” along with a full care team.

Humana has priced the premiums for its virtual service at about half the cost of Humana’s most popular traditional plan. There are no copays for telehealth visits; there are $5 copays for common lab tests and prescriptions. Cigna said that its virtual plan makes coverage “more affordable,” but doesn’t provide any specifics.

According to United spokeswoman Maria Shydlo, the insurer’s virtual primary care service is not cheaper than its traditional products.
 

Increased telehealth adoption

When the COVID-19 pandemic first struck last year, telehealth was a lifesaver for primary care practices. Physicians were able to treat half or more of their patients through telehealth, including video and phone consultations.

That initial romance with telehealth did not last. Today, telehealth represents 9% of adult primary care visits. However, that’s still a much higher percentage than before 2020, and telehealth has become a fixture of primary care.

Prior to the pandemic, telehealth services dominated the virtual care space. Some large groups experimented with having their doctors conduct virtual consults with their patients. Other physicians dabbled with telehealth or stayed out of it entirely because health plans paid much less for virtual visits than for in-person visits.

That began to change as more and more states passed laws requiring payment parity. (Today, 36 states do.) Then as the pandemic took hold, Medicare loosened its regulations, allowing coverage of telehealth everywhere and establishing parity. But it’s unclear what will happen after the public health emergency ends.

United and other insurers portray their virtual primary care plans as an effort to connect more consumers with primary care physicians. Having a relationship with a primary care doctor, United noted in a press release, increases access to care, including preventive services. Moreover, a United survey found that a quarter of respondents preferred a virtual relationship with a primary care doctor.
 

Physician have mostly positive but mixed reactions

This news organization interviewed several physicians who practice in states where United has introduced its new offering. Only one doctor had heard about it, and another, solo family physician Will Sawyer, MD, of Cincinnati no longer contracts with United. Nevertheless, they all had strong opinions about virtual primary care plans from United and other insurers.

Dr. Sawyer is a big proponent of telehealth and notes that it’s “incredibly convenient” for older people, many of whom are afraid to come to the office out of fear they might contract COVID-19. He has found that telehealth can be useful for many kinds of acute and chronic care. But he believes (although he admits he does not have evidence) that United started its virtual primary care service mainly to save money.

No to some kinds of telehealth doctors

The physicians we spoke with were unified in their opposition to virtual primary care plans that mainly use physicians hired by telehealth services. Dr. Sawyer noted that one-off consultations with telehealth doctors might be okay for urgent care. “But what we’re trying to do with patients is change their behavior for better health outcomes, and that doesn’t happen in these one-off contacts,” he said.

Even if a patient were able to develop an online relationship with a telehealth doctor, Dr. Basch said, there are any number of situations in which an in-person visit might be necessary. “Whether it’s a urologic visit, a cardiac visit, or an allergy visit, do I need to listen to you or put my hands on you to palpate your liver? Or is this just a conversation with someone I know to see how they’re doing, how they’re managing their meds? Ninety percent of a diagnosis is history.”

Although the virtual plans allow a telehealth physician to refer a patient to an in-network specialist for an office visit, this isn’t the same as their primary care physician asking them to come in to be examined.

Moreover, Dr. Basch noted, people with chronic conditions can’t be treated only virtually. “I wouldn’t say that primary care should be done predominantly through virtual visits. It may be okay for young and healthy patients, but not for older people with chronic conditions. There are times when they should see their doctor in person.”
 

What can be done via telehealth

On the other hand, Dr. Basch heartily approves of conducting routine follow-up visits virtually for patients with chronic diseases, as long as the physician knows the patient’s history. Telehealth can also be used to coach patients on exercise, nutrition, and other lifestyle changes.

Dr. Kubitschek estimates that around 40%-50% of primary care can be delivered through telehealth. But the remainder encompasses potentially serious conditions that should be diagnosed and treated in face-to-face encounters, he said. “For example, if a patient has abdominal pain, you have to examine the person to get a clue of what they’re talking about. The pains are often diffuse, but they might be painful locally, which could indicate a mass or a bladder distension.”

For that reason, he doesn’t support the idea of patients depending on telehealth doctors in virtual primary care plans. “These doctors would not be available to care for the patient in an urgent situation without sending them to a costly emergency room or urgent care clinic. In those settings, excess testing is done because of a lack of familiarity with the patient and his or her history and exam. I think a combination of in-person and telehealth visits presents the best circumstance for the patient and the physician. Having said that, I do believe that telehealth alone is better than no interaction with a health care provider.”
 

United approach can help with prevention

Donny Aga, MD, an internist with Kelsey-Seybold, a multispecialty group in Houston, has been a member of United’s virtual health advisory group for the past 2 years. In his view, United’s virtual primary care service is moving in the right direction by covering preventive and chronic care. Noting that 25%-30% of patients nationally have put off wellness and chronic care visits out of fear of COVID-19, he said that,“if health plans like United are willing to cover preventive services through telehealth, that will allow us to catch up on a lot of the needed screening tests and exams. So it’s a very positive step forward.”

On the other hand, he said, virtual plans that depend solely on telehealth doctors are not the way to manage chronic conditions. “Primary care is best done by your own primary care physician, not by someone who doesn’t know you from a distance.”

Regarding the virtual plans in which patients can establish relationships with telehealth physicians, Dr. Aga said that this approach can benefit some patients, especially those who live in rural areas and don’t have access to primary care. But there are drawbacks, including the telehealth providers’ lack of knowledge about local specialists.

“The negative is that you don’t have a [primary care physicians] who’s local, who knows you, who has examined you before, and who has a good relationship with those specialists and knows who is the right specialist to see for your problem,” Dr. Aga said. “It’s very difficult, if you don’t live and work in that area, to know the best places to send people.”
 

Virtual visits cost less

Like Dr. Basch, Dr. Aga said it’s possible that some insurance companies might begin to cover office visits only for certain conditions or services if they can be managed more cheaply via telehealth. He hopes that doesn’t happen; if it does, he predicts that patients and doctors will push back hard.

Why would a virtual primary care visit cost a health plan less than an in-person visit if it’s paying doctors the same for both? Dr. Aga said it’s because fewer prescriptions and lab tests are ordered in telehealth encounters. He bases this assertion on the quarter of a million virtual visits that Kelsey-Seybold has conducted and also alludes to published studies.

The characteristics of telehealth visits might explain this phenomenon, he said. “These visits are typically much shorter, and it’s easy to be problem-centric and problem based. Physicians use more of their intuitive skills, rather than just lab everybody up and get an x-ray, because that patient’s not there, and it’s easier to draw blood or get an x-ray if somebody is there.”
 

Cutting practice overhead

From the perspective of Kelsey-Seybold, which is now conducting about a fifth of its visits virtually, “infrastructure costs are less” for telehealth, Aga notes. Although Dr. Kubitschek and Dr. Sawyer say it doesn’t take less time to conduct a telehealth visit than an office visit, other practice costs may decrease in relationship to the percentage of a doctor’s visits that are virtual.

“If implemented appropriately, telehealth consults should cost less in terms of the ancillary costs surrounding care,” said Dr. Basch. He recalls that, some years ago, a five-doctor primary care group in Portland, Ore., began charging small monthly fees to patients for full-service care that included email access. After a while, 40% of their patients were coming in, and the rest received care by email or phone. As a result, the doctors were able to downsize to a smaller office space because they didn’t need a waiting room.

Although Dr. Basch doesn’t believe it would be appropriate for practices to do something like this in the midst of a pandemic, he sees the possibility of it happening in the future. “Eventually, a group might be able to say: ‘Yes, our practice expenses can be lower if we do this smartly. We could do as well as we’ve done on whatever insurance pays for office visits, knowing that we can deliver care to the same patient panel at, say, 10% lower overhead with telehealth.’ ”

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

United Healthcare recently became the latest major insurer to offer a “virtual primary care service.” Initially, the service will be part of some employer-sponsored insurance plans in 11 states. United intends to expand its footprint next year.

United is using the platform and the medical group of American Well, a telehealth service, to provide virtual primary care. Besides minor acute care, United’s virtual service covers annual wellness visits, routine follow-ups for chronic conditions, lab tests, and specialist referrals with little or no cost sharing.

The giant insurer is now offering its virtual primary care plan in Arizona, Colorado, Illinois, Maryland, North Carolina, Ohio, South Carolina, Texas, Virginia, Washington, D.C., and West Virginia.

Other insurers are offering similar virtual primary care plans. For example, Humana has partnered with Doctor on Demand, and Cigna is working with MDLive to offer virtual primary care plans. Both of these plans encourage consumers to form ongoing relationships with physicians hired by the telehealth services. Similarly, Harvard Pilgrim, which has also joined with Doctor on Demand, said that consumers get “virtual PCPs” along with a full care team.

Humana has priced the premiums for its virtual service at about half the cost of Humana’s most popular traditional plan. There are no copays for telehealth visits; there are $5 copays for common lab tests and prescriptions. Cigna said that its virtual plan makes coverage “more affordable,” but doesn’t provide any specifics.

According to United spokeswoman Maria Shydlo, the insurer’s virtual primary care service is not cheaper than its traditional products.
 

Increased telehealth adoption

When the COVID-19 pandemic first struck last year, telehealth was a lifesaver for primary care practices. Physicians were able to treat half or more of their patients through telehealth, including video and phone consultations.

That initial romance with telehealth did not last. Today, telehealth represents 9% of adult primary care visits. However, that’s still a much higher percentage than before 2020, and telehealth has become a fixture of primary care.

Prior to the pandemic, telehealth services dominated the virtual care space. Some large groups experimented with having their doctors conduct virtual consults with their patients. Other physicians dabbled with telehealth or stayed out of it entirely because health plans paid much less for virtual visits than for in-person visits.

That began to change as more and more states passed laws requiring payment parity. (Today, 36 states do.) Then as the pandemic took hold, Medicare loosened its regulations, allowing coverage of telehealth everywhere and establishing parity. But it’s unclear what will happen after the public health emergency ends.

United and other insurers portray their virtual primary care plans as an effort to connect more consumers with primary care physicians. Having a relationship with a primary care doctor, United noted in a press release, increases access to care, including preventive services. Moreover, a United survey found that a quarter of respondents preferred a virtual relationship with a primary care doctor.
 

Physician have mostly positive but mixed reactions

This news organization interviewed several physicians who practice in states where United has introduced its new offering. Only one doctor had heard about it, and another, solo family physician Will Sawyer, MD, of Cincinnati no longer contracts with United. Nevertheless, they all had strong opinions about virtual primary care plans from United and other insurers.

Dr. Sawyer is a big proponent of telehealth and notes that it’s “incredibly convenient” for older people, many of whom are afraid to come to the office out of fear they might contract COVID-19. He has found that telehealth can be useful for many kinds of acute and chronic care. But he believes (although he admits he does not have evidence) that United started its virtual primary care service mainly to save money.

No to some kinds of telehealth doctors

The physicians we spoke with were unified in their opposition to virtual primary care plans that mainly use physicians hired by telehealth services. Dr. Sawyer noted that one-off consultations with telehealth doctors might be okay for urgent care. “But what we’re trying to do with patients is change their behavior for better health outcomes, and that doesn’t happen in these one-off contacts,” he said.

Even if a patient were able to develop an online relationship with a telehealth doctor, Dr. Basch said, there are any number of situations in which an in-person visit might be necessary. “Whether it’s a urologic visit, a cardiac visit, or an allergy visit, do I need to listen to you or put my hands on you to palpate your liver? Or is this just a conversation with someone I know to see how they’re doing, how they’re managing their meds? Ninety percent of a diagnosis is history.”

Although the virtual plans allow a telehealth physician to refer a patient to an in-network specialist for an office visit, this isn’t the same as their primary care physician asking them to come in to be examined.

Moreover, Dr. Basch noted, people with chronic conditions can’t be treated only virtually. “I wouldn’t say that primary care should be done predominantly through virtual visits. It may be okay for young and healthy patients, but not for older people with chronic conditions. There are times when they should see their doctor in person.”
 

What can be done via telehealth

On the other hand, Dr. Basch heartily approves of conducting routine follow-up visits virtually for patients with chronic diseases, as long as the physician knows the patient’s history. Telehealth can also be used to coach patients on exercise, nutrition, and other lifestyle changes.

Dr. Kubitschek estimates that around 40%-50% of primary care can be delivered through telehealth. But the remainder encompasses potentially serious conditions that should be diagnosed and treated in face-to-face encounters, he said. “For example, if a patient has abdominal pain, you have to examine the person to get a clue of what they’re talking about. The pains are often diffuse, but they might be painful locally, which could indicate a mass or a bladder distension.”

For that reason, he doesn’t support the idea of patients depending on telehealth doctors in virtual primary care plans. “These doctors would not be available to care for the patient in an urgent situation without sending them to a costly emergency room or urgent care clinic. In those settings, excess testing is done because of a lack of familiarity with the patient and his or her history and exam. I think a combination of in-person and telehealth visits presents the best circumstance for the patient and the physician. Having said that, I do believe that telehealth alone is better than no interaction with a health care provider.”
 

United approach can help with prevention

Donny Aga, MD, an internist with Kelsey-Seybold, a multispecialty group in Houston, has been a member of United’s virtual health advisory group for the past 2 years. In his view, United’s virtual primary care service is moving in the right direction by covering preventive and chronic care. Noting that 25%-30% of patients nationally have put off wellness and chronic care visits out of fear of COVID-19, he said that,“if health plans like United are willing to cover preventive services through telehealth, that will allow us to catch up on a lot of the needed screening tests and exams. So it’s a very positive step forward.”

On the other hand, he said, virtual plans that depend solely on telehealth doctors are not the way to manage chronic conditions. “Primary care is best done by your own primary care physician, not by someone who doesn’t know you from a distance.”

Regarding the virtual plans in which patients can establish relationships with telehealth physicians, Dr. Aga said that this approach can benefit some patients, especially those who live in rural areas and don’t have access to primary care. But there are drawbacks, including the telehealth providers’ lack of knowledge about local specialists.

“The negative is that you don’t have a [primary care physicians] who’s local, who knows you, who has examined you before, and who has a good relationship with those specialists and knows who is the right specialist to see for your problem,” Dr. Aga said. “It’s very difficult, if you don’t live and work in that area, to know the best places to send people.”
 

Virtual visits cost less

Like Dr. Basch, Dr. Aga said it’s possible that some insurance companies might begin to cover office visits only for certain conditions or services if they can be managed more cheaply via telehealth. He hopes that doesn’t happen; if it does, he predicts that patients and doctors will push back hard.

Why would a virtual primary care visit cost a health plan less than an in-person visit if it’s paying doctors the same for both? Dr. Aga said it’s because fewer prescriptions and lab tests are ordered in telehealth encounters. He bases this assertion on the quarter of a million virtual visits that Kelsey-Seybold has conducted and also alludes to published studies.

The characteristics of telehealth visits might explain this phenomenon, he said. “These visits are typically much shorter, and it’s easy to be problem-centric and problem based. Physicians use more of their intuitive skills, rather than just lab everybody up and get an x-ray, because that patient’s not there, and it’s easier to draw blood or get an x-ray if somebody is there.”
 

Cutting practice overhead

From the perspective of Kelsey-Seybold, which is now conducting about a fifth of its visits virtually, “infrastructure costs are less” for telehealth, Aga notes. Although Dr. Kubitschek and Dr. Sawyer say it doesn’t take less time to conduct a telehealth visit than an office visit, other practice costs may decrease in relationship to the percentage of a doctor’s visits that are virtual.

“If implemented appropriately, telehealth consults should cost less in terms of the ancillary costs surrounding care,” said Dr. Basch. He recalls that, some years ago, a five-doctor primary care group in Portland, Ore., began charging small monthly fees to patients for full-service care that included email access. After a while, 40% of their patients were coming in, and the rest received care by email or phone. As a result, the doctors were able to downsize to a smaller office space because they didn’t need a waiting room.

Although Dr. Basch doesn’t believe it would be appropriate for practices to do something like this in the midst of a pandemic, he sees the possibility of it happening in the future. “Eventually, a group might be able to say: ‘Yes, our practice expenses can be lower if we do this smartly. We could do as well as we’ve done on whatever insurance pays for office visits, knowing that we can deliver care to the same patient panel at, say, 10% lower overhead with telehealth.’ ”

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

Women living in rural areas were significantly more likely than were those in urban areas to receive inappropriate antibiotic prescriptions for urinary tract infections, based on data from an observational cohort study of more than 600,000 women.

Uncomplicated urinary tract infections (UTIs) are common among otherwise healthy women in the United States, and certain antibiotics are recommended as first-line therapy, wrote Abbye W. Clark, MD, of Washington University, St. Louis, and colleagues.

“However, the majority of antibiotic prescriptions for uncomplicated UTI are suboptimal because they are written for nonrecommended agents and durations,” they said.

Addressing rural health disparities has become a focus in the United States, and previous studies of respiratory tract infections have shown differences in antibiotic prescribing based on geographic region; “however, no large-scale studies have evaluated rural-urban differences in inappropriate outpatient prescribing for UTI,” they added.

In a study published in Infection Control & Hospital Epidemiology, the researchers identified 670,450 women aged 18-44 years who received oral antibiotics for uncomplicated UTIs between 2010 to 2015, using a commercial insurance database to determine diagnosis and antibiotic prescription information. Women were defined as urban if they lived in a metropolitan statistical area of at least 50,000 inhabitants (86.2%); all other women were defined as rural (13.8%). The median age was 30 years for both groups.

Overall, 46.7% of the women received prescriptions for inappropriate antibiotics, and 76.1% received antibiotics for inappropriate durations.

Antibiotics and durations were defined as appropriate or inappropriate based on current clinical guidelines. “We classified first-line agents (nitrofurantoin, TMP-SMX, fosfomycin) as appropriate and non–first-line agents (fluoroquinolones, beta-lactams) as inappropriate,” the researchers said.

The regimens classified as appropriate duration were “nitrofurantoin 5-day regimen, TMP-SMX (including TMP monotherapy) 3-day regimen, fosfomycin 1-day regimen, fluoroquinolones 3-day regimen, and beta-lactams 3- to 7-day regimen. All other regimens were classified as inappropriate duration,” they noted.
 

More rural women receive long-duration antibiotics

In a multivariate analysis, similar percentages of antibiotics for rural and urban women consisted of inappropriate agents (45.9% vs. 46.9%) including use of fluoroquinolones (41.0% vs. 41.7%) and beta-lactams (4.8% vs. 5.0%).

However, across all antibiotics, women in rural areas were more likely than were women in urban areas to receive prescriptions for inappropriately long durations (83.9% vs. 75.9%, adjusted risk ratio 1.10).

The percentage of women who received inappropriate antibiotic agents was not significantly different based on geographic region of the country.

From 2011 to 2015, the quarterly proportion of women overall who received inappropriate agents and antibiotics for inappropriate durations decreased slightly (48.5% to 43.7% and 78.3% to 73.4%, respectively), the researchers noted.

The study findings were limited by several factors including the potentially lenient definition of antibiotic duration, a study population that disproportionately oversampled from the South and undersampled from the West, use of ZIP codes to determine rural vs. urban status, lack of data on race and income, and lack of access to urine culture results, the researchers noted.

However, “our study identified rural-urban differences in antibiotic prescribing, including an actionable disparity in the duration of antibiotics that disproportionately affects women who live in rural locations,” they said.

“Given the large quantity of inappropriate prescriptions annually in the U.S., as well as the negative patient- and society-level consequences of unnecessary exposure to antibiotics, antimicrobial stewardship interventions are needed to improve outpatient UTI antibiotic prescribing, particularly in rural settings,” they concluded.
 

Data support need for education and stewardship

“This manuscript provides valuable information to all women’s health providers regarding the importance of antibiotic stewardship,” David M. Jaspan, DO, and Natasha Abdullah, MD, Einstein Medical Center, Philadelphia, said in an interview. Whether urban or rural, over 45% of the patients received inappropriate non–first-line treatment and 76% of the prescriptions were for an inappropriate duration (98.8% for longer than recommended), they emphasized.

“The potential negative impact of antibiotic resistance, coupled with the potential for increased side effects, should prompt providers to ensure that when treating uncomplicated UTIs in women, that the choice of treatment and the duration of treatment is tailored to the patient’s needs,” the Dr. Jaspan and Dr. Abdullah said.

To improve antibiotic prescribing, especially at the local and regional level, “We encourage providers to familiarize themselves with local information as it pertains to known resistance when prescribing empiric treatment regimens for uncomplicated UTIs,” they said.

The study was supported by the National Center for Advancing Translational Sciences at the National Institutes of Health. Lead author Dr. Clark, as well as Dr. Jaspan and Dr. Abdullah, had no financial conflicts to disclose.

Women living in rural areas were significantly more likely than were those in urban areas to receive inappropriate antibiotic prescriptions for urinary tract infections, based on data from an observational cohort study of more than 600,000 women.

Uncomplicated urinary tract infections (UTIs) are common among otherwise healthy women in the United States, and certain antibiotics are recommended as first-line therapy, wrote Abbye W. Clark, MD, of Washington University, St. Louis, and colleagues.

“However, the majority of antibiotic prescriptions for uncomplicated UTI are suboptimal because they are written for nonrecommended agents and durations,” they said.

Addressing rural health disparities has become a focus in the United States, and previous studies of respiratory tract infections have shown differences in antibiotic prescribing based on geographic region; “however, no large-scale studies have evaluated rural-urban differences in inappropriate outpatient prescribing for UTI,” they added.

In a study published in Infection Control & Hospital Epidemiology, the researchers identified 670,450 women aged 18-44 years who received oral antibiotics for uncomplicated UTIs between 2010 to 2015, using a commercial insurance database to determine diagnosis and antibiotic prescription information. Women were defined as urban if they lived in a metropolitan statistical area of at least 50,000 inhabitants (86.2%); all other women were defined as rural (13.8%). The median age was 30 years for both groups.

Overall, 46.7% of the women received prescriptions for inappropriate antibiotics, and 76.1% received antibiotics for inappropriate durations.

Antibiotics and durations were defined as appropriate or inappropriate based on current clinical guidelines. “We classified first-line agents (nitrofurantoin, TMP-SMX, fosfomycin) as appropriate and non–first-line agents (fluoroquinolones, beta-lactams) as inappropriate,” the researchers said.

The regimens classified as appropriate duration were “nitrofurantoin 5-day regimen, TMP-SMX (including TMP monotherapy) 3-day regimen, fosfomycin 1-day regimen, fluoroquinolones 3-day regimen, and beta-lactams 3- to 7-day regimen. All other regimens were classified as inappropriate duration,” they noted.
 

More rural women receive long-duration antibiotics

In a multivariate analysis, similar percentages of antibiotics for rural and urban women consisted of inappropriate agents (45.9% vs. 46.9%) including use of fluoroquinolones (41.0% vs. 41.7%) and beta-lactams (4.8% vs. 5.0%).

However, across all antibiotics, women in rural areas were more likely than were women in urban areas to receive prescriptions for inappropriately long durations (83.9% vs. 75.9%, adjusted risk ratio 1.10).

The percentage of women who received inappropriate antibiotic agents was not significantly different based on geographic region of the country.

From 2011 to 2015, the quarterly proportion of women overall who received inappropriate agents and antibiotics for inappropriate durations decreased slightly (48.5% to 43.7% and 78.3% to 73.4%, respectively), the researchers noted.

The study findings were limited by several factors including the potentially lenient definition of antibiotic duration, a study population that disproportionately oversampled from the South and undersampled from the West, use of ZIP codes to determine rural vs. urban status, lack of data on race and income, and lack of access to urine culture results, the researchers noted.

However, “our study identified rural-urban differences in antibiotic prescribing, including an actionable disparity in the duration of antibiotics that disproportionately affects women who live in rural locations,” they said.

“Given the large quantity of inappropriate prescriptions annually in the U.S., as well as the negative patient- and society-level consequences of unnecessary exposure to antibiotics, antimicrobial stewardship interventions are needed to improve outpatient UTI antibiotic prescribing, particularly in rural settings,” they concluded.
 

Data support need for education and stewardship

“This manuscript provides valuable information to all women’s health providers regarding the importance of antibiotic stewardship,” David M. Jaspan, DO, and Natasha Abdullah, MD, Einstein Medical Center, Philadelphia, said in an interview. Whether urban or rural, over 45% of the patients received inappropriate non–first-line treatment and 76% of the prescriptions were for an inappropriate duration (98.8% for longer than recommended), they emphasized.

“The potential negative impact of antibiotic resistance, coupled with the potential for increased side effects, should prompt providers to ensure that when treating uncomplicated UTIs in women, that the choice of treatment and the duration of treatment is tailored to the patient’s needs,” the Dr. Jaspan and Dr. Abdullah said.

To improve antibiotic prescribing, especially at the local and regional level, “We encourage providers to familiarize themselves with local information as it pertains to known resistance when prescribing empiric treatment regimens for uncomplicated UTIs,” they said.

The study was supported by the National Center for Advancing Translational Sciences at the National Institutes of Health. Lead author Dr. Clark, as well as Dr. Jaspan and Dr. Abdullah, had no financial conflicts to disclose.

Women living in rural areas were significantly more likely than were those in urban areas to receive inappropriate antibiotic prescriptions for urinary tract infections, based on data from an observational cohort study of more than 600,000 women.

Uncomplicated urinary tract infections (UTIs) are common among otherwise healthy women in the United States, and certain antibiotics are recommended as first-line therapy, wrote Abbye W. Clark, MD, of Washington University, St. Louis, and colleagues.

“However, the majority of antibiotic prescriptions for uncomplicated UTI are suboptimal because they are written for nonrecommended agents and durations,” they said.

Addressing rural health disparities has become a focus in the United States, and previous studies of respiratory tract infections have shown differences in antibiotic prescribing based on geographic region; “however, no large-scale studies have evaluated rural-urban differences in inappropriate outpatient prescribing for UTI,” they added.

In a study published in Infection Control & Hospital Epidemiology, the researchers identified 670,450 women aged 18-44 years who received oral antibiotics for uncomplicated UTIs between 2010 to 2015, using a commercial insurance database to determine diagnosis and antibiotic prescription information. Women were defined as urban if they lived in a metropolitan statistical area of at least 50,000 inhabitants (86.2%); all other women were defined as rural (13.8%). The median age was 30 years for both groups.

Overall, 46.7% of the women received prescriptions for inappropriate antibiotics, and 76.1% received antibiotics for inappropriate durations.

Antibiotics and durations were defined as appropriate or inappropriate based on current clinical guidelines. “We classified first-line agents (nitrofurantoin, TMP-SMX, fosfomycin) as appropriate and non–first-line agents (fluoroquinolones, beta-lactams) as inappropriate,” the researchers said.

The regimens classified as appropriate duration were “nitrofurantoin 5-day regimen, TMP-SMX (including TMP monotherapy) 3-day regimen, fosfomycin 1-day regimen, fluoroquinolones 3-day regimen, and beta-lactams 3- to 7-day regimen. All other regimens were classified as inappropriate duration,” they noted.
 

More rural women receive long-duration antibiotics

In a multivariate analysis, similar percentages of antibiotics for rural and urban women consisted of inappropriate agents (45.9% vs. 46.9%) including use of fluoroquinolones (41.0% vs. 41.7%) and beta-lactams (4.8% vs. 5.0%).

However, across all antibiotics, women in rural areas were more likely than were women in urban areas to receive prescriptions for inappropriately long durations (83.9% vs. 75.9%, adjusted risk ratio 1.10).

The percentage of women who received inappropriate antibiotic agents was not significantly different based on geographic region of the country.

From 2011 to 2015, the quarterly proportion of women overall who received inappropriate agents and antibiotics for inappropriate durations decreased slightly (48.5% to 43.7% and 78.3% to 73.4%, respectively), the researchers noted.

The study findings were limited by several factors including the potentially lenient definition of antibiotic duration, a study population that disproportionately oversampled from the South and undersampled from the West, use of ZIP codes to determine rural vs. urban status, lack of data on race and income, and lack of access to urine culture results, the researchers noted.

However, “our study identified rural-urban differences in antibiotic prescribing, including an actionable disparity in the duration of antibiotics that disproportionately affects women who live in rural locations,” they said.

“Given the large quantity of inappropriate prescriptions annually in the U.S., as well as the negative patient- and society-level consequences of unnecessary exposure to antibiotics, antimicrobial stewardship interventions are needed to improve outpatient UTI antibiotic prescribing, particularly in rural settings,” they concluded.
 

Data support need for education and stewardship

“This manuscript provides valuable information to all women’s health providers regarding the importance of antibiotic stewardship,” David M. Jaspan, DO, and Natasha Abdullah, MD, Einstein Medical Center, Philadelphia, said in an interview. Whether urban or rural, over 45% of the patients received inappropriate non–first-line treatment and 76% of the prescriptions were for an inappropriate duration (98.8% for longer than recommended), they emphasized.

“The potential negative impact of antibiotic resistance, coupled with the potential for increased side effects, should prompt providers to ensure that when treating uncomplicated UTIs in women, that the choice of treatment and the duration of treatment is tailored to the patient’s needs,” the Dr. Jaspan and Dr. Abdullah said.

To improve antibiotic prescribing, especially at the local and regional level, “We encourage providers to familiarize themselves with local information as it pertains to known resistance when prescribing empiric treatment regimens for uncomplicated UTIs,” they said.

The study was supported by the National Center for Advancing Translational Sciences at the National Institutes of Health. Lead author Dr. Clark, as well as Dr. Jaspan and Dr. Abdullah, had no financial conflicts to disclose.

Patients consider the risk of cancer and menopause, as well as other factors, when making decisions about ovarian cancer prevention surgery, according to a small study.

Investigators interviewed 24 premenopausal women with BRCA mutations who were considering prophylactic surgery. Responses showed that women who prioritized cancer risk reduction opted for risk-reducing salpingo-oophorectomy (RRSO), while those who were more concerned about the effects of surgical menopause opted for risk-reducing early salpingectomy with delayed oophorectomy (RRESDO). Factors such as past surgical experience influenced patients’ decisions as well.

The women were participants in the PROTECTOR trial, which was designed to determine the impact of RRESDO on sexual function by comparing RRESDO, RRSO, and no surgery. Study participants made their own decisions regarding surgery, and the interviews with 24 participants provided insight into how patients made their decisions.

Faiza Gaba, MBBS, PhD, of Queen Mary University of London, and colleagues reviewed the results in the Journal of Medical Genetics.

“I think what is most important is that even though this is a tough decision women are being given, they are being given options that allow them to make up their own minds with support from health care providers,” said Barbara A. Goff, MD, of the University of Washington, Seattle, when asked to comment on this research.
 

Study details and results

The investigators interviewed 24 women aged 34-46 years. Fourteen patients were BRCA1 carriers, and 10 were BRCA2 carriers. Twenty-two women were White, and two were Asian. Nineteen women were married, and four were nulliparous.

The interviews lasted a mean of 55 minutes and were conducted with a predeveloped topic guide.

Eleven of the women interviewed opted for RRESDO, seven opted for RRSO, and six decided against prophylactic surgery. Four women who had previous breast cancer all opted for ovarian cancer prevention surgery.

Among the 18 women who chose surgery, 16 had completed childbearing, and 2 didn’t want children. Among the six women who decided against surgery, four had not completed childbearing, one was unsure of which procedure to choose, and the sixth had strong feelings against removing healthy tissue.

The 11 women who chose RRESDO did so because of concerns about early menopause following oophorectomy, particularly low mood, sexual dysfunction, and poorer quality of life. They were also more likely to have had a previous positive surgical experience, so they were not as concerned about a two-step surgery.

Women who chose RRSO were motivated by a strong family history of ovarian cancer, fear of dying, concurrent benign gynecological issues, lack of screening for ovarian cancer, and physician advice.

Nine women also opted for risk-reducing mastectomy (RRM), which was deemed a more difficult decision than prophylactic ovarian cancer surgery.

Women who decided against RRM did so because they hadn’t completed childbearing, they were concerned about recovery time and the psychological effects of the surgery, or they had confidence in breast cancer screening and treatment.

Among women who chose RRM, two highlighted lack of health care professional support for deciding against reconstruction. One interviewee regretted opting for flap reconstruction due to the resultant cosmetic appearance and chronic pain but did not regret RRM.

Fifteen women said they would have preferred combined RRM and ovarian cancer prevention in one surgery, due to less anxiety, less waiting, fewer appointments, less time off work, and a single surgical recovery.

The women advised fellow BRCA carriers to avoid time pressure with surgical decision-making, talk to other BRCA carriers, do personal research, and ask for second opinions if not satisfied. They also said the opportunity to ask experts questions and meet other BRCA carriers face-to-face was more helpful than online support groups. Women managed in specialist settings said they received better care, better access to hormone replacement therapy, and were more satisfied.

High-risk women need to be supported by a multidisciplinary team of geneticists, gynecologists/oncologists, oncoplastic surgeons, menopause specialists, fertility specialists, psychologists, and specialist nurses, the investigators wrote.

This study was funded by the Rosetrees Trust and Barts Charity. The authors disclosed relationships with AstraZeneca, Merck, Cancer Research UK, The Eve Appeal, Israel National Institute for Health Policy Research, and the UK National Health Service. Dr. Goff has no relevant disclosures.

aotto@mdedge.com

Patients consider the risk of cancer and menopause, as well as other factors, when making decisions about ovarian cancer prevention surgery, according to a small study.

Investigators interviewed 24 premenopausal women with BRCA mutations who were considering prophylactic surgery. Responses showed that women who prioritized cancer risk reduction opted for risk-reducing salpingo-oophorectomy (RRSO), while those who were more concerned about the effects of surgical menopause opted for risk-reducing early salpingectomy with delayed oophorectomy (RRESDO). Factors such as past surgical experience influenced patients’ decisions as well.

The women were participants in the PROTECTOR trial, which was designed to determine the impact of RRESDO on sexual function by comparing RRESDO, RRSO, and no surgery. Study participants made their own decisions regarding surgery, and the interviews with 24 participants provided insight into how patients made their decisions.

Faiza Gaba, MBBS, PhD, of Queen Mary University of London, and colleagues reviewed the results in the Journal of Medical Genetics.

“I think what is most important is that even though this is a tough decision women are being given, they are being given options that allow them to make up their own minds with support from health care providers,” said Barbara A. Goff, MD, of the University of Washington, Seattle, when asked to comment on this research.
 

Study details and results

The investigators interviewed 24 women aged 34-46 years. Fourteen patients were BRCA1 carriers, and 10 were BRCA2 carriers. Twenty-two women were White, and two were Asian. Nineteen women were married, and four were nulliparous.

The interviews lasted a mean of 55 minutes and were conducted with a predeveloped topic guide.

Eleven of the women interviewed opted for RRESDO, seven opted for RRSO, and six decided against prophylactic surgery. Four women who had previous breast cancer all opted for ovarian cancer prevention surgery.

Among the 18 women who chose surgery, 16 had completed childbearing, and 2 didn’t want children. Among the six women who decided against surgery, four had not completed childbearing, one was unsure of which procedure to choose, and the sixth had strong feelings against removing healthy tissue.

The 11 women who chose RRESDO did so because of concerns about early menopause following oophorectomy, particularly low mood, sexual dysfunction, and poorer quality of life. They were also more likely to have had a previous positive surgical experience, so they were not as concerned about a two-step surgery.

Women who chose RRSO were motivated by a strong family history of ovarian cancer, fear of dying, concurrent benign gynecological issues, lack of screening for ovarian cancer, and physician advice.

Nine women also opted for risk-reducing mastectomy (RRM), which was deemed a more difficult decision than prophylactic ovarian cancer surgery.

Women who decided against RRM did so because they hadn’t completed childbearing, they were concerned about recovery time and the psychological effects of the surgery, or they had confidence in breast cancer screening and treatment.

Among women who chose RRM, two highlighted lack of health care professional support for deciding against reconstruction. One interviewee regretted opting for flap reconstruction due to the resultant cosmetic appearance and chronic pain but did not regret RRM.

Fifteen women said they would have preferred combined RRM and ovarian cancer prevention in one surgery, due to less anxiety, less waiting, fewer appointments, less time off work, and a single surgical recovery.

The women advised fellow BRCA carriers to avoid time pressure with surgical decision-making, talk to other BRCA carriers, do personal research, and ask for second opinions if not satisfied. They also said the opportunity to ask experts questions and meet other BRCA carriers face-to-face was more helpful than online support groups. Women managed in specialist settings said they received better care, better access to hormone replacement therapy, and were more satisfied.

High-risk women need to be supported by a multidisciplinary team of geneticists, gynecologists/oncologists, oncoplastic surgeons, menopause specialists, fertility specialists, psychologists, and specialist nurses, the investigators wrote.

This study was funded by the Rosetrees Trust and Barts Charity. The authors disclosed relationships with AstraZeneca, Merck, Cancer Research UK, The Eve Appeal, Israel National Institute for Health Policy Research, and the UK National Health Service. Dr. Goff has no relevant disclosures.

aotto@mdedge.com

Patients consider the risk of cancer and menopause, as well as other factors, when making decisions about ovarian cancer prevention surgery, according to a small study.

Investigators interviewed 24 premenopausal women with BRCA mutations who were considering prophylactic surgery. Responses showed that women who prioritized cancer risk reduction opted for risk-reducing salpingo-oophorectomy (RRSO), while those who were more concerned about the effects of surgical menopause opted for risk-reducing early salpingectomy with delayed oophorectomy (RRESDO). Factors such as past surgical experience influenced patients’ decisions as well.

The women were participants in the PROTECTOR trial, which was designed to determine the impact of RRESDO on sexual function by comparing RRESDO, RRSO, and no surgery. Study participants made their own decisions regarding surgery, and the interviews with 24 participants provided insight into how patients made their decisions.

Faiza Gaba, MBBS, PhD, of Queen Mary University of London, and colleagues reviewed the results in the Journal of Medical Genetics.

“I think what is most important is that even though this is a tough decision women are being given, they are being given options that allow them to make up their own minds with support from health care providers,” said Barbara A. Goff, MD, of the University of Washington, Seattle, when asked to comment on this research.
 

Study details and results

The investigators interviewed 24 women aged 34-46 years. Fourteen patients were BRCA1 carriers, and 10 were BRCA2 carriers. Twenty-two women were White, and two were Asian. Nineteen women were married, and four were nulliparous.

The interviews lasted a mean of 55 minutes and were conducted with a predeveloped topic guide.

Eleven of the women interviewed opted for RRESDO, seven opted for RRSO, and six decided against prophylactic surgery. Four women who had previous breast cancer all opted for ovarian cancer prevention surgery.

Among the 18 women who chose surgery, 16 had completed childbearing, and 2 didn’t want children. Among the six women who decided against surgery, four had not completed childbearing, one was unsure of which procedure to choose, and the sixth had strong feelings against removing healthy tissue.

The 11 women who chose RRESDO did so because of concerns about early menopause following oophorectomy, particularly low mood, sexual dysfunction, and poorer quality of life. They were also more likely to have had a previous positive surgical experience, so they were not as concerned about a two-step surgery.

Women who chose RRSO were motivated by a strong family history of ovarian cancer, fear of dying, concurrent benign gynecological issues, lack of screening for ovarian cancer, and physician advice.

Nine women also opted for risk-reducing mastectomy (RRM), which was deemed a more difficult decision than prophylactic ovarian cancer surgery.

Women who decided against RRM did so because they hadn’t completed childbearing, they were concerned about recovery time and the psychological effects of the surgery, or they had confidence in breast cancer screening and treatment.

Among women who chose RRM, two highlighted lack of health care professional support for deciding against reconstruction. One interviewee regretted opting for flap reconstruction due to the resultant cosmetic appearance and chronic pain but did not regret RRM.

Fifteen women said they would have preferred combined RRM and ovarian cancer prevention in one surgery, due to less anxiety, less waiting, fewer appointments, less time off work, and a single surgical recovery.

The women advised fellow BRCA carriers to avoid time pressure with surgical decision-making, talk to other BRCA carriers, do personal research, and ask for second opinions if not satisfied. They also said the opportunity to ask experts questions and meet other BRCA carriers face-to-face was more helpful than online support groups. Women managed in specialist settings said they received better care, better access to hormone replacement therapy, and were more satisfied.

High-risk women need to be supported by a multidisciplinary team of geneticists, gynecologists/oncologists, oncoplastic surgeons, menopause specialists, fertility specialists, psychologists, and specialist nurses, the investigators wrote.

This study was funded by the Rosetrees Trust and Barts Charity. The authors disclosed relationships with AstraZeneca, Merck, Cancer Research UK, The Eve Appeal, Israel National Institute for Health Policy Research, and the UK National Health Service. Dr. Goff has no relevant disclosures.

aotto@mdedge.com

Editor’s note: This profile is part of the Society of Hospital Medicine’s celebration of National Hospitalist Day on March 4. National Hospitalist Day occurs the first Thursday in March annually and celebrates the fastest growing specialty in modern medicine and hospitalists’ enduring contributions to the evolving health care landscape.

Bridget McGrath, PA-C, FHM, is a physician assistant and director of the nurse practitioner/physician assistant service line for the section of hospital medicine at the University of Chicago. She is a cochair of SHM’s NP/PA Special Interest Group.

Where did you receive your PA education/training? Was your intention always to be a PA?

I graduated from the PA program at Butler University, Indianapolis, in 2014. In college, whenever I shadowed a PA, I was always impressed that each one loved their job and said they would never change it. That universal passion for the PA profession really made an impression on me.

At what point in your PA education/training did you decide to practice hospital medicine? What about it appealed to you?

That occurred during my clinical rotation year at Butler. I had always thought I wanted to practice neonatology, but during my clinical rotation I really fell in love with adult medicine. I recall that during my clinical rotation, the preceptor said to me that the goal was not to have me understand every aspect of medicine, but to learn how to exist in a hospital setting. I was exposed to the breadth of hospital medicine practice and I fell in love with the complexity, the variety, and the environment itself.

I initially accepted a job as a med-peds hospitalist PA – which brought both of my passions together at that time – at Schneck Medical Center in Seymour, Ind. During that time, Schneck was a 100-bed rural community hospital which had recently been the recipient of the Malcolm Baldrige National Quality Award. It was there that I was able to practice with a phenomenal group of physicians, nurses, and social workers who really took me under their wing and taught me how to be a hospitalist PA. I practiced at Schneck for 3 years, and then moved to the University of Chicago in 2017.

I am now the director of NP/PA services for the section of hospital medicine, overseeing a group of seven on our NP/PA team, within a larger group of about 60 physicians.
 

What are your favorite areas of clinical practice?

Like many hospitalists, I enjoy the variety of medicine that hospitalists practice. One area that I find especially rewarding is my time in our transplant comanagement services. To be able to walk with patients on their transplant journey is very rewarding, and I am very appreciative of the mentoring I have received from some of my colleagues with a deeper understanding of transplant medicine.

In my administrative role, I have the privilege of helping to expand the professional education and training of my colleagues. I have a passion for medical education, and we have been working to develop interprofessional educational opportunities within our section. I have had time to think about the imprint of NPs and PAs in academic medicine, and how we can continue to meet the professional educational needs of our section while improving the care of our patients.
 

What are the most challenging aspects of practicing hospital medicine?

The volume of diagnoses that we are expected to manage on a daily basis can be challenging. This challenges you to continue learning. The complexity of discharge planning, particularly for patients in underserved communities, can also be challenging. You have to make sure your patients are ready mentally, physically and emotionally for discharge. As a hospitalist, you are continuously thinking about how to optimize patients to leave your care. For example, patients have different insurance situations, different access to care at home – you are always managing the medical needs of your patient in the context of these other issues.

How does a hospitalist PA work differently from a PA in other care settings?

We are meant to be generalists. We serve as the main provider in owning our patients’ care. A hospitalist PA serves as a cog in the wheel, with connections to specialists, consultants, nurses, social workers, pharmacists, etc., and we are tasked with synthesizing all aspects of patient care to ensure the best outcome.

What has your experience taught you about how NPs and PAs can best fit into hospital medicine groups?

Each hospital medicine group will know how to best integrate their NPs and PAs based on the skillsets of their NPs and PAs, and the needs of the section and the hospital. I personally feel that the best way to utilize NPs and PAs is to allow them to own all aspects of patient care and work at the highest scope of practice. By doing this you empower the NP or PA to continue to develop their skill set and set a precedent of collaboration and respect for interprofessional care models within your section’s culture.

Scope of practice for an NP or PA is going to be based on a conglomeration of roles and bylaws. We are certified nationally, and our scope of practice is determined at the state level and the hospital by level. For the individual NP and PA, it really depends on the hospital medicine group, and how well a practice incorporates a sense of collegiality.
 

What kind of resources do hospitalist PAs need to succeed, either from SHM or from their own institutions?

There are a few key things that need to happen in order for hospital medicine groups to set up their NPs and PAs for success. The first is for PAs to have exposure to inpatient rotations during clinical rotations. A hospital medicine group also should have a very intentional onboarding process for NPs and PAs. They should also establish a culture of acceptance. To do this, they should utilize resources like SHM’s NP/PA Hospital Medicine Onboarding Toolkit and the SHM/American Academy of Physician Assistants Hospitalist Bootcamp On Demand.

Mentoring is also remarkably important. I have been incredibly blessed to have mentors that helped make me into the PA that I am. I could not have done what I did in the field without people taking a chance on me, and it is important to pass that on to the next generation of PAs.
 

How has COVID-19 changed the practice of hospital medicine, specifically for advanced practice providers?

The pandemic has demonstrated opportunities for teamwork and utilization of NPs and PAs. The COVID pandemic forced everyone to reflect on why they originally got into medicine – to help patients. I think there will be many doors opening for NPs and PAs, and many pathways for leadership.

The hospitalist leadership at the University of Chicago truly identified that we needed to make wellness a main priority during the beginning of the pandemic. We developed a wellness work group that I have been coleading.
 

What’s on the horizon for NPs and PAs in hospital medicine?

We are seeing significant increases in hospitalist program utilization, so this is a time where NPs and PAs can be advocates for our profession and articulate how we can use our backgrounds and training to build better care models in order to meet the needs of our patients.

I hope we will see more NPs and PAs assuming leadership roles to ensure that our voices are heard. We should also be advocating for more collaboration and teamwork with our MD and DO colleagues.
 

Do you have any advice for PA students interested in hospital medicine?

I always tell my students that they should be sponges – you are not expected to know everything as a hospitalist PA, but you are expected to continue learning in order to develop into the best PA you can be. Always be open to where your career path can take you. Hospital medicine is a relatively young field within medicine, and the diversity of our field is very exciting looking forward.

Editor’s note: This profile is part of the Society of Hospital Medicine’s celebration of National Hospitalist Day on March 4. National Hospitalist Day occurs the first Thursday in March annually and celebrates the fastest growing specialty in modern medicine and hospitalists’ enduring contributions to the evolving health care landscape.

Bridget McGrath, PA-C, FHM, is a physician assistant and director of the nurse practitioner/physician assistant service line for the section of hospital medicine at the University of Chicago. She is a cochair of SHM’s NP/PA Special Interest Group.

Where did you receive your PA education/training? Was your intention always to be a PA?

I graduated from the PA program at Butler University, Indianapolis, in 2014. In college, whenever I shadowed a PA, I was always impressed that each one loved their job and said they would never change it. That universal passion for the PA profession really made an impression on me.

At what point in your PA education/training did you decide to practice hospital medicine? What about it appealed to you?

That occurred during my clinical rotation year at Butler. I had always thought I wanted to practice neonatology, but during my clinical rotation I really fell in love with adult medicine. I recall that during my clinical rotation, the preceptor said to me that the goal was not to have me understand every aspect of medicine, but to learn how to exist in a hospital setting. I was exposed to the breadth of hospital medicine practice and I fell in love with the complexity, the variety, and the environment itself.

I initially accepted a job as a med-peds hospitalist PA – which brought both of my passions together at that time – at Schneck Medical Center in Seymour, Ind. During that time, Schneck was a 100-bed rural community hospital which had recently been the recipient of the Malcolm Baldrige National Quality Award. It was there that I was able to practice with a phenomenal group of physicians, nurses, and social workers who really took me under their wing and taught me how to be a hospitalist PA. I practiced at Schneck for 3 years, and then moved to the University of Chicago in 2017.

I am now the director of NP/PA services for the section of hospital medicine, overseeing a group of seven on our NP/PA team, within a larger group of about 60 physicians.
 

What are your favorite areas of clinical practice?

Like many hospitalists, I enjoy the variety of medicine that hospitalists practice. One area that I find especially rewarding is my time in our transplant comanagement services. To be able to walk with patients on their transplant journey is very rewarding, and I am very appreciative of the mentoring I have received from some of my colleagues with a deeper understanding of transplant medicine.

In my administrative role, I have the privilege of helping to expand the professional education and training of my colleagues. I have a passion for medical education, and we have been working to develop interprofessional educational opportunities within our section. I have had time to think about the imprint of NPs and PAs in academic medicine, and how we can continue to meet the professional educational needs of our section while improving the care of our patients.
 

What are the most challenging aspects of practicing hospital medicine?

The volume of diagnoses that we are expected to manage on a daily basis can be challenging. This challenges you to continue learning. The complexity of discharge planning, particularly for patients in underserved communities, can also be challenging. You have to make sure your patients are ready mentally, physically and emotionally for discharge. As a hospitalist, you are continuously thinking about how to optimize patients to leave your care. For example, patients have different insurance situations, different access to care at home – you are always managing the medical needs of your patient in the context of these other issues.

How does a hospitalist PA work differently from a PA in other care settings?

We are meant to be generalists. We serve as the main provider in owning our patients’ care. A hospitalist PA serves as a cog in the wheel, with connections to specialists, consultants, nurses, social workers, pharmacists, etc., and we are tasked with synthesizing all aspects of patient care to ensure the best outcome.

What has your experience taught you about how NPs and PAs can best fit into hospital medicine groups?

Each hospital medicine group will know how to best integrate their NPs and PAs based on the skillsets of their NPs and PAs, and the needs of the section and the hospital. I personally feel that the best way to utilize NPs and PAs is to allow them to own all aspects of patient care and work at the highest scope of practice. By doing this you empower the NP or PA to continue to develop their skill set and set a precedent of collaboration and respect for interprofessional care models within your section’s culture.

Scope of practice for an NP or PA is going to be based on a conglomeration of roles and bylaws. We are certified nationally, and our scope of practice is determined at the state level and the hospital by level. For the individual NP and PA, it really depends on the hospital medicine group, and how well a practice incorporates a sense of collegiality.
 

What kind of resources do hospitalist PAs need to succeed, either from SHM or from their own institutions?

There are a few key things that need to happen in order for hospital medicine groups to set up their NPs and PAs for success. The first is for PAs to have exposure to inpatient rotations during clinical rotations. A hospital medicine group also should have a very intentional onboarding process for NPs and PAs. They should also establish a culture of acceptance. To do this, they should utilize resources like SHM’s NP/PA Hospital Medicine Onboarding Toolkit and the SHM/American Academy of Physician Assistants Hospitalist Bootcamp On Demand.

Mentoring is also remarkably important. I have been incredibly blessed to have mentors that helped make me into the PA that I am. I could not have done what I did in the field without people taking a chance on me, and it is important to pass that on to the next generation of PAs.
 

How has COVID-19 changed the practice of hospital medicine, specifically for advanced practice providers?

The pandemic has demonstrated opportunities for teamwork and utilization of NPs and PAs. The COVID pandemic forced everyone to reflect on why they originally got into medicine – to help patients. I think there will be many doors opening for NPs and PAs, and many pathways for leadership.

The hospitalist leadership at the University of Chicago truly identified that we needed to make wellness a main priority during the beginning of the pandemic. We developed a wellness work group that I have been coleading.
 

What’s on the horizon for NPs and PAs in hospital medicine?

We are seeing significant increases in hospitalist program utilization, so this is a time where NPs and PAs can be advocates for our profession and articulate how we can use our backgrounds and training to build better care models in order to meet the needs of our patients.

I hope we will see more NPs and PAs assuming leadership roles to ensure that our voices are heard. We should also be advocating for more collaboration and teamwork with our MD and DO colleagues.
 

Do you have any advice for PA students interested in hospital medicine?

I always tell my students that they should be sponges – you are not expected to know everything as a hospitalist PA, but you are expected to continue learning in order to develop into the best PA you can be. Always be open to where your career path can take you. Hospital medicine is a relatively young field within medicine, and the diversity of our field is very exciting looking forward.

Editor’s note: This profile is part of the Society of Hospital Medicine’s celebration of National Hospitalist Day on March 4. National Hospitalist Day occurs the first Thursday in March annually and celebrates the fastest growing specialty in modern medicine and hospitalists’ enduring contributions to the evolving health care landscape.

Bridget McGrath, PA-C, FHM, is a physician assistant and director of the nurse practitioner/physician assistant service line for the section of hospital medicine at the University of Chicago. She is a cochair of SHM’s NP/PA Special Interest Group.

Where did you receive your PA education/training? Was your intention always to be a PA?

I graduated from the PA program at Butler University, Indianapolis, in 2014. In college, whenever I shadowed a PA, I was always impressed that each one loved their job and said they would never change it. That universal passion for the PA profession really made an impression on me.

At what point in your PA education/training did you decide to practice hospital medicine? What about it appealed to you?

That occurred during my clinical rotation year at Butler. I had always thought I wanted to practice neonatology, but during my clinical rotation I really fell in love with adult medicine. I recall that during my clinical rotation, the preceptor said to me that the goal was not to have me understand every aspect of medicine, but to learn how to exist in a hospital setting. I was exposed to the breadth of hospital medicine practice and I fell in love with the complexity, the variety, and the environment itself.

I initially accepted a job as a med-peds hospitalist PA – which brought both of my passions together at that time – at Schneck Medical Center in Seymour, Ind. During that time, Schneck was a 100-bed rural community hospital which had recently been the recipient of the Malcolm Baldrige National Quality Award. It was there that I was able to practice with a phenomenal group of physicians, nurses, and social workers who really took me under their wing and taught me how to be a hospitalist PA. I practiced at Schneck for 3 years, and then moved to the University of Chicago in 2017.

I am now the director of NP/PA services for the section of hospital medicine, overseeing a group of seven on our NP/PA team, within a larger group of about 60 physicians.
 

What are your favorite areas of clinical practice?

Like many hospitalists, I enjoy the variety of medicine that hospitalists practice. One area that I find especially rewarding is my time in our transplant comanagement services. To be able to walk with patients on their transplant journey is very rewarding, and I am very appreciative of the mentoring I have received from some of my colleagues with a deeper understanding of transplant medicine.

In my administrative role, I have the privilege of helping to expand the professional education and training of my colleagues. I have a passion for medical education, and we have been working to develop interprofessional educational opportunities within our section. I have had time to think about the imprint of NPs and PAs in academic medicine, and how we can continue to meet the professional educational needs of our section while improving the care of our patients.
 

What are the most challenging aspects of practicing hospital medicine?

The volume of diagnoses that we are expected to manage on a daily basis can be challenging. This challenges you to continue learning. The complexity of discharge planning, particularly for patients in underserved communities, can also be challenging. You have to make sure your patients are ready mentally, physically and emotionally for discharge. As a hospitalist, you are continuously thinking about how to optimize patients to leave your care. For example, patients have different insurance situations, different access to care at home – you are always managing the medical needs of your patient in the context of these other issues.

How does a hospitalist PA work differently from a PA in other care settings?

We are meant to be generalists. We serve as the main provider in owning our patients’ care. A hospitalist PA serves as a cog in the wheel, with connections to specialists, consultants, nurses, social workers, pharmacists, etc., and we are tasked with synthesizing all aspects of patient care to ensure the best outcome.

What has your experience taught you about how NPs and PAs can best fit into hospital medicine groups?

Each hospital medicine group will know how to best integrate their NPs and PAs based on the skillsets of their NPs and PAs, and the needs of the section and the hospital. I personally feel that the best way to utilize NPs and PAs is to allow them to own all aspects of patient care and work at the highest scope of practice. By doing this you empower the NP or PA to continue to develop their skill set and set a precedent of collaboration and respect for interprofessional care models within your section’s culture.

Scope of practice for an NP or PA is going to be based on a conglomeration of roles and bylaws. We are certified nationally, and our scope of practice is determined at the state level and the hospital by level. For the individual NP and PA, it really depends on the hospital medicine group, and how well a practice incorporates a sense of collegiality.
 

What kind of resources do hospitalist PAs need to succeed, either from SHM or from their own institutions?

There are a few key things that need to happen in order for hospital medicine groups to set up their NPs and PAs for success. The first is for PAs to have exposure to inpatient rotations during clinical rotations. A hospital medicine group also should have a very intentional onboarding process for NPs and PAs. They should also establish a culture of acceptance. To do this, they should utilize resources like SHM’s NP/PA Hospital Medicine Onboarding Toolkit and the SHM/American Academy of Physician Assistants Hospitalist Bootcamp On Demand.

Mentoring is also remarkably important. I have been incredibly blessed to have mentors that helped make me into the PA that I am. I could not have done what I did in the field without people taking a chance on me, and it is important to pass that on to the next generation of PAs.
 

How has COVID-19 changed the practice of hospital medicine, specifically for advanced practice providers?

The pandemic has demonstrated opportunities for teamwork and utilization of NPs and PAs. The COVID pandemic forced everyone to reflect on why they originally got into medicine – to help patients. I think there will be many doors opening for NPs and PAs, and many pathways for leadership.

The hospitalist leadership at the University of Chicago truly identified that we needed to make wellness a main priority during the beginning of the pandemic. We developed a wellness work group that I have been coleading.
 

What’s on the horizon for NPs and PAs in hospital medicine?

We are seeing significant increases in hospitalist program utilization, so this is a time where NPs and PAs can be advocates for our profession and articulate how we can use our backgrounds and training to build better care models in order to meet the needs of our patients.

I hope we will see more NPs and PAs assuming leadership roles to ensure that our voices are heard. We should also be advocating for more collaboration and teamwork with our MD and DO colleagues.
 

Do you have any advice for PA students interested in hospital medicine?

I always tell my students that they should be sponges – you are not expected to know everything as a hospitalist PA, but you are expected to continue learning in order to develop into the best PA you can be. Always be open to where your career path can take you. Hospital medicine is a relatively young field within medicine, and the diversity of our field is very exciting looking forward.

Maribavir, an investigational antiviral agent with a novel mechanism of action, was superior to other antiviral strategies at clearing cytomegalovirus (CMV) viremia and controlling symptoms in hematopoietic cell or solid-organ transplant recipients, results of a phase 3 clinical trial showed.

CDC

CMV viremia clearance at study week 8 was seen in 55.7% of all patients randomized to receive maribavir, compared with 23.9% for patients assigned to receive investigator-assigned therapy (IAT), Francisco Marty, MD, from the Dana-Farber Cancer Institute in Boston reported at the Transplant & Cellular Therapies Meetings.

“Maribavir’s benefit was driven by lower incidence of treatment-limiting toxicities, compared with IAT,” he said a late-breaking abstract session during the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

“Available anti-CMV antivirals are limited by development of resistance and toxicities, particularly myelosuppression with the use of valganciclovir and nephrotoxicity with the use of foscarnet and cidofovir. Alternative treatment options are required to address this unmet medical need,” he said.

Maribavir inhibits the CMV UL97 protein kinase and is thought to affect several critical processes in CMV replication, including viral DNA synthesis, viral gene expression, encapsidation, and egress of mature capsids from the nucleus.
 

Details of trial

In the phase 3 SHP620-30e trial (NCT02931539), Dr. Marty and colleagues enrolled patients with relapsed or refractory CMV infections after hematopoietic cell transplant (HCT) or solid-organ transplant (SOT) and after stratification by transplant type and screening CMV DNA level randomly assigned them on a 2:1 basis to receive either maribavir 400 mg twice daily (235 patients) or IAT (117 patients), consisting of either ganciclovir/valganciclovir, foscarnet, cidofovir, or combined foscarnet and val/ganciclovir.

The primary endpoint of viremia clearance at 8 weeks was defined as plasma CMV DNA less than 137 IU/mL in two consecutive tests at a central laboratory at least 5 days apart beginning at the end of week 8.

The trial met its primary endpoint, with a viremia clearance rate of 55.7% with maribavir versus 23.9% with IAT.

The viremia clearance rates were similar in each of the transplant groups: 55.9% versus 20.8%, respectively, in patients who underwent HCT, and 55.6% versus 26.1% in patients who underwent SOT (P < .001).

Clearance rates among patients with CMV DNA below 9,100 IU/mL at baseline were 62.1% with maribavir versus 24.7% with IAT. Among patients with baseline CMV DNA of 9100 IU/mL or above, the respective rates were 43.9% versus 21.9%.

CMV viremia clearance continued from week 8 to week 16 in 18.7% of patients assigned to maribavir and to 10.3% of patients randomized to IAT (P < .013).

The median time to first CMV viremia clearance as 22 days with maribavir versus 27 days with IAT (P = .039).

All-cause mortality was similar between the groups, at 11.5% versus 11.1%, respectively.

The incidences of serious and severe treatment-emergent adverse events (TEAE) were 38.5% and 32.1%, respectively, in the maribavir group, and 37.1% and 37.9% in the IAT group.

Any TEAE leading to study drug discontinuation was less common with maribavir, occurring in 13.2% of patients, compared with 31.9% of patients on IAT. Serious TEAEs leading to drug discontinuation occurred in 8.5% versus 14.7%, respectively.

Serious TEAEs leading to death occurred in 6.8% of patients on maribavir versus 5.2% of those on IAT.
 

Role of letermovir

In the question-and-answer session following the presentation, comoderator Monalisa Ghosh, MD, from the University of Michigan, Ann Arbor, asked whether any patients in the study were currently on letermovir (Prevymis) prophylaxis, and whether any patients had previously been treated with letermovir but had CMV reactivation and were then treated on study.

Dr. Marty noted that the trial was designed before letermovir was approved for CMV prophylaxis in adults who have undergone an allogeneic HCT.

“Nobody was on letermovir at the beginning of the trial,” he replied, but noted that some patients who were enrolled and had infections that were refractory or resistant to valganciclovir, foscarnet, or a combination of the two received letermovir as secondary prophylaxis.

“I haven’t got the data to tell you how often [letermovir] was used; I think part of the lack of mortality benefit [with maribavir] may be due to the fact that people jumped into secondary prophylaxis with letermovir to minimize the toxicities that we saw,” he said.

Although maribavir has not as of this writing received Food and Drug Administration approval, the drug may be available to some patients through a compassionate-use program from Takeda, Dr. Marty noted.

The study was funded by Shire ViroPharma. Dr. Marty disclosed research funding from Shire and from others. Dr. Ghosh had no relevant disclosures.

Maribavir, an investigational antiviral agent with a novel mechanism of action, was superior to other antiviral strategies at clearing cytomegalovirus (CMV) viremia and controlling symptoms in hematopoietic cell or solid-organ transplant recipients, results of a phase 3 clinical trial showed.

CDC

CMV viremia clearance at study week 8 was seen in 55.7% of all patients randomized to receive maribavir, compared with 23.9% for patients assigned to receive investigator-assigned therapy (IAT), Francisco Marty, MD, from the Dana-Farber Cancer Institute in Boston reported at the Transplant & Cellular Therapies Meetings.

“Maribavir’s benefit was driven by lower incidence of treatment-limiting toxicities, compared with IAT,” he said a late-breaking abstract session during the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

“Available anti-CMV antivirals are limited by development of resistance and toxicities, particularly myelosuppression with the use of valganciclovir and nephrotoxicity with the use of foscarnet and cidofovir. Alternative treatment options are required to address this unmet medical need,” he said.

Maribavir inhibits the CMV UL97 protein kinase and is thought to affect several critical processes in CMV replication, including viral DNA synthesis, viral gene expression, encapsidation, and egress of mature capsids from the nucleus.
 

Details of trial

In the phase 3 SHP620-30e trial (NCT02931539), Dr. Marty and colleagues enrolled patients with relapsed or refractory CMV infections after hematopoietic cell transplant (HCT) or solid-organ transplant (SOT) and after stratification by transplant type and screening CMV DNA level randomly assigned them on a 2:1 basis to receive either maribavir 400 mg twice daily (235 patients) or IAT (117 patients), consisting of either ganciclovir/valganciclovir, foscarnet, cidofovir, or combined foscarnet and val/ganciclovir.

The primary endpoint of viremia clearance at 8 weeks was defined as plasma CMV DNA less than 137 IU/mL in two consecutive tests at a central laboratory at least 5 days apart beginning at the end of week 8.

The trial met its primary endpoint, with a viremia clearance rate of 55.7% with maribavir versus 23.9% with IAT.

The viremia clearance rates were similar in each of the transplant groups: 55.9% versus 20.8%, respectively, in patients who underwent HCT, and 55.6% versus 26.1% in patients who underwent SOT (P < .001).

Clearance rates among patients with CMV DNA below 9,100 IU/mL at baseline were 62.1% with maribavir versus 24.7% with IAT. Among patients with baseline CMV DNA of 9100 IU/mL or above, the respective rates were 43.9% versus 21.9%.

CMV viremia clearance continued from week 8 to week 16 in 18.7% of patients assigned to maribavir and to 10.3% of patients randomized to IAT (P < .013).

The median time to first CMV viremia clearance as 22 days with maribavir versus 27 days with IAT (P = .039).

All-cause mortality was similar between the groups, at 11.5% versus 11.1%, respectively.

The incidences of serious and severe treatment-emergent adverse events (TEAE) were 38.5% and 32.1%, respectively, in the maribavir group, and 37.1% and 37.9% in the IAT group.

Any TEAE leading to study drug discontinuation was less common with maribavir, occurring in 13.2% of patients, compared with 31.9% of patients on IAT. Serious TEAEs leading to drug discontinuation occurred in 8.5% versus 14.7%, respectively.

Serious TEAEs leading to death occurred in 6.8% of patients on maribavir versus 5.2% of those on IAT.
 

Role of letermovir

In the question-and-answer session following the presentation, comoderator Monalisa Ghosh, MD, from the University of Michigan, Ann Arbor, asked whether any patients in the study were currently on letermovir (Prevymis) prophylaxis, and whether any patients had previously been treated with letermovir but had CMV reactivation and were then treated on study.

Dr. Marty noted that the trial was designed before letermovir was approved for CMV prophylaxis in adults who have undergone an allogeneic HCT.

“Nobody was on letermovir at the beginning of the trial,” he replied, but noted that some patients who were enrolled and had infections that were refractory or resistant to valganciclovir, foscarnet, or a combination of the two received letermovir as secondary prophylaxis.

“I haven’t got the data to tell you how often [letermovir] was used; I think part of the lack of mortality benefit [with maribavir] may be due to the fact that people jumped into secondary prophylaxis with letermovir to minimize the toxicities that we saw,” he said.

Although maribavir has not as of this writing received Food and Drug Administration approval, the drug may be available to some patients through a compassionate-use program from Takeda, Dr. Marty noted.

The study was funded by Shire ViroPharma. Dr. Marty disclosed research funding from Shire and from others. Dr. Ghosh had no relevant disclosures.

Maribavir, an investigational antiviral agent with a novel mechanism of action, was superior to other antiviral strategies at clearing cytomegalovirus (CMV) viremia and controlling symptoms in hematopoietic cell or solid-organ transplant recipients, results of a phase 3 clinical trial showed.

CDC

CMV viremia clearance at study week 8 was seen in 55.7% of all patients randomized to receive maribavir, compared with 23.9% for patients assigned to receive investigator-assigned therapy (IAT), Francisco Marty, MD, from the Dana-Farber Cancer Institute in Boston reported at the Transplant & Cellular Therapies Meetings.

“Maribavir’s benefit was driven by lower incidence of treatment-limiting toxicities, compared with IAT,” he said a late-breaking abstract session during the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

“Available anti-CMV antivirals are limited by development of resistance and toxicities, particularly myelosuppression with the use of valganciclovir and nephrotoxicity with the use of foscarnet and cidofovir. Alternative treatment options are required to address this unmet medical need,” he said.

Maribavir inhibits the CMV UL97 protein kinase and is thought to affect several critical processes in CMV replication, including viral DNA synthesis, viral gene expression, encapsidation, and egress of mature capsids from the nucleus.
 

Details of trial

In the phase 3 SHP620-30e trial (NCT02931539), Dr. Marty and colleagues enrolled patients with relapsed or refractory CMV infections after hematopoietic cell transplant (HCT) or solid-organ transplant (SOT) and after stratification by transplant type and screening CMV DNA level randomly assigned them on a 2:1 basis to receive either maribavir 400 mg twice daily (235 patients) or IAT (117 patients), consisting of either ganciclovir/valganciclovir, foscarnet, cidofovir, or combined foscarnet and val/ganciclovir.

The primary endpoint of viremia clearance at 8 weeks was defined as plasma CMV DNA less than 137 IU/mL in two consecutive tests at a central laboratory at least 5 days apart beginning at the end of week 8.

The trial met its primary endpoint, with a viremia clearance rate of 55.7% with maribavir versus 23.9% with IAT.

The viremia clearance rates were similar in each of the transplant groups: 55.9% versus 20.8%, respectively, in patients who underwent HCT, and 55.6% versus 26.1% in patients who underwent SOT (P < .001).

Clearance rates among patients with CMV DNA below 9,100 IU/mL at baseline were 62.1% with maribavir versus 24.7% with IAT. Among patients with baseline CMV DNA of 9100 IU/mL or above, the respective rates were 43.9% versus 21.9%.

CMV viremia clearance continued from week 8 to week 16 in 18.7% of patients assigned to maribavir and to 10.3% of patients randomized to IAT (P < .013).

The median time to first CMV viremia clearance as 22 days with maribavir versus 27 days with IAT (P = .039).

All-cause mortality was similar between the groups, at 11.5% versus 11.1%, respectively.

The incidences of serious and severe treatment-emergent adverse events (TEAE) were 38.5% and 32.1%, respectively, in the maribavir group, and 37.1% and 37.9% in the IAT group.

Any TEAE leading to study drug discontinuation was less common with maribavir, occurring in 13.2% of patients, compared with 31.9% of patients on IAT. Serious TEAEs leading to drug discontinuation occurred in 8.5% versus 14.7%, respectively.

Serious TEAEs leading to death occurred in 6.8% of patients on maribavir versus 5.2% of those on IAT.
 

Role of letermovir

In the question-and-answer session following the presentation, comoderator Monalisa Ghosh, MD, from the University of Michigan, Ann Arbor, asked whether any patients in the study were currently on letermovir (Prevymis) prophylaxis, and whether any patients had previously been treated with letermovir but had CMV reactivation and were then treated on study.

Dr. Marty noted that the trial was designed before letermovir was approved for CMV prophylaxis in adults who have undergone an allogeneic HCT.

“Nobody was on letermovir at the beginning of the trial,” he replied, but noted that some patients who were enrolled and had infections that were refractory or resistant to valganciclovir, foscarnet, or a combination of the two received letermovir as secondary prophylaxis.

“I haven’t got the data to tell you how often [letermovir] was used; I think part of the lack of mortality benefit [with maribavir] may be due to the fact that people jumped into secondary prophylaxis with letermovir to minimize the toxicities that we saw,” he said.

Although maribavir has not as of this writing received Food and Drug Administration approval, the drug may be available to some patients through a compassionate-use program from Takeda, Dr. Marty noted.

The study was funded by Shire ViroPharma. Dr. Marty disclosed research funding from Shire and from others. Dr. Ghosh had no relevant disclosures.

Several surprising recent insights into the pathophysiology of psoriasis may eventually lead to superior treatment strategies for this common T-cell-mediated disease, Kenneth Brian Gordon, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually.

Courtesy National Psoriasis Foundation

Among these unexpected developments was the startling finding that skin inflammation in mild psoriasis is at least as great as in severe disease; evidence that psoriasis may actually be an autoimmune disease rather than a nonspecific immune-mediated disease; and the newly appreciated importance of interleukin-19 (IL-19) in keratinocyte proliferation, according to Dr. Gordon, professor and chair of the department of dermatology at the Medical College of Wisconsin, Milwaukee.

Immunoregulatory deficits in mild vs. severe psoriasis

Conventional wisdom has held that mild psoriasis as defined by limited affected body surface area involves less skin inflammation than more extensive severe psoriasis, so less-potent topical therapies are appropriate. Not so, according to Dr. Gordon, who highlighted work by James G. Krueger, MD, PhD, head of the laboratory of investigative dermatology at Rockefeller University, New York, and coinvestigators. They demonstrated that overall skin inflammation expressed as the sum of T-cell activation and IL-19-mediated epidermal responses didn’t differ in lesions of mild as compared with severe psoriasis. Indeed, mild skin lesions featured a greater number of T-cells, stronger expression of proinflammatory cytokine IL-17A, and greater expression of the central psoriasis transcriptome. The big difference between skin lesions of mild versus severe psoriasis was that severe psoriasis was characterized by strikingly weaker expression of immunoregulatory genes, including programmed death-ligand 1 (PD-L1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA4), than that of mild lesions.

The implication is that IL-17-targeted therapies may be of benefit in a much larger segment of the psoriatic population: namely, those with mild disease, who comprise the majority of psoriasis patients by a wide margin, according to the investigators.

Dr. Gordon concurs.

“The primary problem in psoriasis is not so much the inflammatory activity, but the ability to turn off the activity,” he explained. “That implies that if a patient wants to get clear or have significant improvement in disease, you can’t use a less effective medication just because they have less amount of disease. You’re going to need to treat it just as aggressively because the great majority of our medications block the proinflammatory pathways.”

The deficit in immunoregulatory action identified by Dr. Krueger and colleagues in patients with severe disease could provide a novel therapeutic target. If the deficient immunoregulation could be boosted, it might achieve disease control without need for continuous anti-inflammatory therapy.

 

Autoimmunity in psoriasis

“When I started work in psoriasis, we always thought there would be a common antigen for the immune process in the disease. We never found it. So for that reason, we sort of put it aside and called psoriasis a nonspecific immune-mediated disease,” Dr. Gordon recalled.

That view is being reexamined. “While we’re not completely certain, there is now some evidence that there might be autoimmunity in psoriasis,” he said.

He cited work by an international team of investigators who identified the cathelicidin antimicrobial peptide LL37 as being overexpressed in psoriatic skin, where it appears to serve as a T-cell autoantigen. LL37-specific CD4+ and CD8+ T-cells are skin homing: They can infiltrate lesional skin, where they produce interferon-gamma and proinflammatory Th17 cytokines. The investigators reported that levels of circulating LL37-specific T cells correlated with disease activity such that they were found in three-quarters of patients with moderate to severe plaque psoriasis.

“As LL37 is able to activate innate immune cells and break innate tolerance to self-nucleic acids, it represents an even more appealing target to treat psoriasis. Therapeutic targeting of LL37-specific T cells may provide new avenues to prevent or treat psoriasis without inducing indiscriminate immunosuppression,” the investigators concluded.

Similarly, German investigators have identified ADAMTS-like protein 5 (ADAMTSL5) as an autoantigen specific for melanocytes in psoriasis patients who possess the central psoriasis risk gene, known as HLA-C*06:02, which is present in two-thirds of patients with psoriasis. They proposed that their newly recognized autoimmune pathway may explain how HLA-C*06.02 predisposes to psoriasis.

Growing clinical relevance of IL-19

It’s now well-established that IL-17 is the pivotal force driving the changes in keratinocytes that define the visible expressions of psoriasis, including plaque scale and thickness, which are due to abnormal keratinocyte maturation and proliferation, respectively. Less well appreciated is the fact that IL-17-activated keratinocytes produce IL-19, which feeds back and further stimulates keratinocyte proliferation.

In light of mounting evidence that IL-19 plays an important role in the pathogenesis of psoriasis and that naked eye assessment of visible psoriasis may not reflect the true extent of inflammation, Brian J. Nickoloff, MD, PhD, and coworkers at Lilly Research Laboratories have developed a novel serum IL-19 immunoassay that appears to provide a much-needed objective biomarker of disease activity in psoriasis patients. They demonstrated that serum IL-19 levels correlated with Psoriasis Area and Severity Index scores, and that treatment with the anti-IL-17A biologic ixekizumab (Taltz) led to rapid reduction of IL-19 down to a normal level.

Moreover, following withdrawal of ixekizumab, IL-19 levels rose prior to clinical relapse, then dropped again in response to retreatment. The hope is that this assay will serve as an accurate tool for assessment of response to therapy.

Dr. Gordon reported receiving research funding and/or honoraria from more than a dozen pharmaceutical companies involved in psoriasis therapy.

MedscapeLive and this news organization are owned by the same parent company.

bjancin@mdedge.com

Several surprising recent insights into the pathophysiology of psoriasis may eventually lead to superior treatment strategies for this common T-cell-mediated disease, Kenneth Brian Gordon, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually.

Courtesy National Psoriasis Foundation

Among these unexpected developments was the startling finding that skin inflammation in mild psoriasis is at least as great as in severe disease; evidence that psoriasis may actually be an autoimmune disease rather than a nonspecific immune-mediated disease; and the newly appreciated importance of interleukin-19 (IL-19) in keratinocyte proliferation, according to Dr. Gordon, professor and chair of the department of dermatology at the Medical College of Wisconsin, Milwaukee.

Immunoregulatory deficits in mild vs. severe psoriasis

Conventional wisdom has held that mild psoriasis as defined by limited affected body surface area involves less skin inflammation than more extensive severe psoriasis, so less-potent topical therapies are appropriate. Not so, according to Dr. Gordon, who highlighted work by James G. Krueger, MD, PhD, head of the laboratory of investigative dermatology at Rockefeller University, New York, and coinvestigators. They demonstrated that overall skin inflammation expressed as the sum of T-cell activation and IL-19-mediated epidermal responses didn’t differ in lesions of mild as compared with severe psoriasis. Indeed, mild skin lesions featured a greater number of T-cells, stronger expression of proinflammatory cytokine IL-17A, and greater expression of the central psoriasis transcriptome. The big difference between skin lesions of mild versus severe psoriasis was that severe psoriasis was characterized by strikingly weaker expression of immunoregulatory genes, including programmed death-ligand 1 (PD-L1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA4), than that of mild lesions.

The implication is that IL-17-targeted therapies may be of benefit in a much larger segment of the psoriatic population: namely, those with mild disease, who comprise the majority of psoriasis patients by a wide margin, according to the investigators.

Dr. Gordon concurs.

“The primary problem in psoriasis is not so much the inflammatory activity, but the ability to turn off the activity,” he explained. “That implies that if a patient wants to get clear or have significant improvement in disease, you can’t use a less effective medication just because they have less amount of disease. You’re going to need to treat it just as aggressively because the great majority of our medications block the proinflammatory pathways.”

The deficit in immunoregulatory action identified by Dr. Krueger and colleagues in patients with severe disease could provide a novel therapeutic target. If the deficient immunoregulation could be boosted, it might achieve disease control without need for continuous anti-inflammatory therapy.

 

Autoimmunity in psoriasis

“When I started work in psoriasis, we always thought there would be a common antigen for the immune process in the disease. We never found it. So for that reason, we sort of put it aside and called psoriasis a nonspecific immune-mediated disease,” Dr. Gordon recalled.

That view is being reexamined. “While we’re not completely certain, there is now some evidence that there might be autoimmunity in psoriasis,” he said.

He cited work by an international team of investigators who identified the cathelicidin antimicrobial peptide LL37 as being overexpressed in psoriatic skin, where it appears to serve as a T-cell autoantigen. LL37-specific CD4+ and CD8+ T-cells are skin homing: They can infiltrate lesional skin, where they produce interferon-gamma and proinflammatory Th17 cytokines. The investigators reported that levels of circulating LL37-specific T cells correlated with disease activity such that they were found in three-quarters of patients with moderate to severe plaque psoriasis.

“As LL37 is able to activate innate immune cells and break innate tolerance to self-nucleic acids, it represents an even more appealing target to treat psoriasis. Therapeutic targeting of LL37-specific T cells may provide new avenues to prevent or treat psoriasis without inducing indiscriminate immunosuppression,” the investigators concluded.

Similarly, German investigators have identified ADAMTS-like protein 5 (ADAMTSL5) as an autoantigen specific for melanocytes in psoriasis patients who possess the central psoriasis risk gene, known as HLA-C*06:02, which is present in two-thirds of patients with psoriasis. They proposed that their newly recognized autoimmune pathway may explain how HLA-C*06.02 predisposes to psoriasis.

Growing clinical relevance of IL-19

It’s now well-established that IL-17 is the pivotal force driving the changes in keratinocytes that define the visible expressions of psoriasis, including plaque scale and thickness, which are due to abnormal keratinocyte maturation and proliferation, respectively. Less well appreciated is the fact that IL-17-activated keratinocytes produce IL-19, which feeds back and further stimulates keratinocyte proliferation.

In light of mounting evidence that IL-19 plays an important role in the pathogenesis of psoriasis and that naked eye assessment of visible psoriasis may not reflect the true extent of inflammation, Brian J. Nickoloff, MD, PhD, and coworkers at Lilly Research Laboratories have developed a novel serum IL-19 immunoassay that appears to provide a much-needed objective biomarker of disease activity in psoriasis patients. They demonstrated that serum IL-19 levels correlated with Psoriasis Area and Severity Index scores, and that treatment with the anti-IL-17A biologic ixekizumab (Taltz) led to rapid reduction of IL-19 down to a normal level.

Moreover, following withdrawal of ixekizumab, IL-19 levels rose prior to clinical relapse, then dropped again in response to retreatment. The hope is that this assay will serve as an accurate tool for assessment of response to therapy.

Dr. Gordon reported receiving research funding and/or honoraria from more than a dozen pharmaceutical companies involved in psoriasis therapy.

MedscapeLive and this news organization are owned by the same parent company.

bjancin@mdedge.com

Several surprising recent insights into the pathophysiology of psoriasis may eventually lead to superior treatment strategies for this common T-cell-mediated disease, Kenneth Brian Gordon, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually.

Courtesy National Psoriasis Foundation

Among these unexpected developments was the startling finding that skin inflammation in mild psoriasis is at least as great as in severe disease; evidence that psoriasis may actually be an autoimmune disease rather than a nonspecific immune-mediated disease; and the newly appreciated importance of interleukin-19 (IL-19) in keratinocyte proliferation, according to Dr. Gordon, professor and chair of the department of dermatology at the Medical College of Wisconsin, Milwaukee.

Immunoregulatory deficits in mild vs. severe psoriasis

Conventional wisdom has held that mild psoriasis as defined by limited affected body surface area involves less skin inflammation than more extensive severe psoriasis, so less-potent topical therapies are appropriate. Not so, according to Dr. Gordon, who highlighted work by James G. Krueger, MD, PhD, head of the laboratory of investigative dermatology at Rockefeller University, New York, and coinvestigators. They demonstrated that overall skin inflammation expressed as the sum of T-cell activation and IL-19-mediated epidermal responses didn’t differ in lesions of mild as compared with severe psoriasis. Indeed, mild skin lesions featured a greater number of T-cells, stronger expression of proinflammatory cytokine IL-17A, and greater expression of the central psoriasis transcriptome. The big difference between skin lesions of mild versus severe psoriasis was that severe psoriasis was characterized by strikingly weaker expression of immunoregulatory genes, including programmed death-ligand 1 (PD-L1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA4), than that of mild lesions.

The implication is that IL-17-targeted therapies may be of benefit in a much larger segment of the psoriatic population: namely, those with mild disease, who comprise the majority of psoriasis patients by a wide margin, according to the investigators.

Dr. Gordon concurs.

“The primary problem in psoriasis is not so much the inflammatory activity, but the ability to turn off the activity,” he explained. “That implies that if a patient wants to get clear or have significant improvement in disease, you can’t use a less effective medication just because they have less amount of disease. You’re going to need to treat it just as aggressively because the great majority of our medications block the proinflammatory pathways.”

The deficit in immunoregulatory action identified by Dr. Krueger and colleagues in patients with severe disease could provide a novel therapeutic target. If the deficient immunoregulation could be boosted, it might achieve disease control without need for continuous anti-inflammatory therapy.

 

Autoimmunity in psoriasis

“When I started work in psoriasis, we always thought there would be a common antigen for the immune process in the disease. We never found it. So for that reason, we sort of put it aside and called psoriasis a nonspecific immune-mediated disease,” Dr. Gordon recalled.

That view is being reexamined. “While we’re not completely certain, there is now some evidence that there might be autoimmunity in psoriasis,” he said.

He cited work by an international team of investigators who identified the cathelicidin antimicrobial peptide LL37 as being overexpressed in psoriatic skin, where it appears to serve as a T-cell autoantigen. LL37-specific CD4+ and CD8+ T-cells are skin homing: They can infiltrate lesional skin, where they produce interferon-gamma and proinflammatory Th17 cytokines. The investigators reported that levels of circulating LL37-specific T cells correlated with disease activity such that they were found in three-quarters of patients with moderate to severe plaque psoriasis.

“As LL37 is able to activate innate immune cells and break innate tolerance to self-nucleic acids, it represents an even more appealing target to treat psoriasis. Therapeutic targeting of LL37-specific T cells may provide new avenues to prevent or treat psoriasis without inducing indiscriminate immunosuppression,” the investigators concluded.

Similarly, German investigators have identified ADAMTS-like protein 5 (ADAMTSL5) as an autoantigen specific for melanocytes in psoriasis patients who possess the central psoriasis risk gene, known as HLA-C*06:02, which is present in two-thirds of patients with psoriasis. They proposed that their newly recognized autoimmune pathway may explain how HLA-C*06.02 predisposes to psoriasis.

Growing clinical relevance of IL-19

It’s now well-established that IL-17 is the pivotal force driving the changes in keratinocytes that define the visible expressions of psoriasis, including plaque scale and thickness, which are due to abnormal keratinocyte maturation and proliferation, respectively. Less well appreciated is the fact that IL-17-activated keratinocytes produce IL-19, which feeds back and further stimulates keratinocyte proliferation.

In light of mounting evidence that IL-19 plays an important role in the pathogenesis of psoriasis and that naked eye assessment of visible psoriasis may not reflect the true extent of inflammation, Brian J. Nickoloff, MD, PhD, and coworkers at Lilly Research Laboratories have developed a novel serum IL-19 immunoassay that appears to provide a much-needed objective biomarker of disease activity in psoriasis patients. They demonstrated that serum IL-19 levels correlated with Psoriasis Area and Severity Index scores, and that treatment with the anti-IL-17A biologic ixekizumab (Taltz) led to rapid reduction of IL-19 down to a normal level.

Moreover, following withdrawal of ixekizumab, IL-19 levels rose prior to clinical relapse, then dropped again in response to retreatment. The hope is that this assay will serve as an accurate tool for assessment of response to therapy.

Dr. Gordon reported receiving research funding and/or honoraria from more than a dozen pharmaceutical companies involved in psoriasis therapy.

MedscapeLive and this news organization are owned by the same parent company.

bjancin@mdedge.com

Although the only pediatric indication for chimeric antigen receptor T-cell therapy currently approved by the Food and Drug Administration is B-lineage acute lymphoblastic leukemia (ALL) that is refractory to at least two frontline induction attempts or is in second or later relapse, clinical trials of CAR-T therapy for pediatric solid tumors are also currently in progress, said Gregory Yanik, MD, from the CS Mott Children’s Hospital at the University of Michigan, Ann Arbor, at the Transplant & Cellular Therapies Meetings.

In his presentation, Dr. Yanik discussed progress in solid tumor studies as well as some issues involving the current use of CAR-T therapy for ALL.

Solid tumor studies

Malignancies such as sarcomas, brain tumors, and neuroblastomas pose unique challenges, “In contrast to hematologic malignancies, the protein we’re targeting may not be present on the cell surface of all the tumor cells. There are lower-expression profiles, and this is a problem. In fact, many people have postulated that with CAR-T for pediatric solid tumors we’ll have to do repeated cycles, almost like we do with chemotherapy,” he said at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

There are currently 14 studies of CAR-T for central nervous system tumors in children, targeting either epidermal growth factor receptor (EGFR) in glioblastoma multiforme and high-grade gliomas, HER2 in a variety of CNS tumors, the GD2 antigen on pontine gliomas, and the checkpoint molecular B7H3 in medulloblastomas and pontine gliomas.

“In sarcomas in kids there are currently 12 trials in progress. Most of the targeting epitopes are targeting either HER2 or GD2. Repetitive CAR-T infusions are being used in several of these trials in sarcomas.

For neuroblastomas there are currently 13 studies in progress, nearly all of which target GD2. Some of the trials include combining CAR-T with immune checkpoint inhibitors or C7R, an engineered cytokine driver designed to prevent T-cell exhaustion.

In addition, several trials of tumor pulsed dendritic cell vaccines are underway for treatment of children with Wilms tumor, Dr. Yanik noted.
 

Unresolved procedural questions

It’s still early days in CAR-T therapy, and there are several still unanswered questions regarding optimal therapy for and management of patients undergoing CAR-T procedures, Dr. Yanik said.

For example, the optimal time to collect T cells during apheresis is still unclear, he said. Collecting prior to reinduction therapy raises the risk of transducing leukemic cells, while collecting after reinduction may result in inadequate quantity or quality of cells. Regardless of when cells are collected, apheresis should be performed only when the absolute lymphocyte count is above 500/mcL or the CD3 count is above 150/mcL at the time of apheresis.

In the case tisagenlecleucel (Kymriah), his center typically collects 1x10⁹ CD3 cells regardless of age or weight.

The number of CAR T-cells infused also appears to matter, as responses are improved at CAR-T doses above 1.5x10⁶/kg, while risk for higher-grade cytokine release syndrome (CRS) occurs at higher infusion doses.
 

Blinatumomab or inotuzumab?

Along with CAR-T, two other agents, the bispecific T-cell engager blinatumomab (Blincyto) and the antibody conjugate inotuzumab ozogamicin (Besponsa) are also approved for the treatment of patients with relapsed/refractory B-cell ALL.

Like CAR-T therapy, the primary toxicities associated with blinatumomab are CRS and neurologic adverse events, whereas at inotuzumab is largely associated with hematologic and hepatic toxicities.

The logistics of therapy differ widely, with a 28-day infusion required for blinatumomab, compared with weekly dosing of inotuzumab, and the multiple visits for apheresis and infusion required for CAR-T.

Blinatumomab is approved for both children and adults with relapsed/refractory ALL, but inotuzumab is approved only for adults, and CAR-T with tisagenlecleucel is approved only for children in this indication.
 

CD-19 expression

There is evidence to suggest that CD19 expression prior to CAR-T has an effect on outcomes, Dr. Yanik said.

“Does blinatumomab pre–CAR-T impact outcome? The answer is probably yes,” he said.

He referred to a study by investigators at the Children’s Hospital of Philadelphia showing that, “if you’re giving blinatumomab prior to CAR-T therapy, you’re potentially reducing the cell-surface expression of CD19 on your leukemic blasts, and now while you’re bringing these patients in for CAR-T therapy, you’re getting a much higher population of dim CD19 expressers, and this is associated with a higher relapse rate and lower remission rate.”
 

Predicting relapse

Dr. Yanik referred to a study, currently unpublished, which will show that next-generation sequencing (NGS) is more sensitive than flow cytometry for detection of minimal residual disease (MRD), and that MRD analysis of marrow was more sensitive than analysis of peripheral blood.

“Poor outcomes were seen post CAR-T for patients who were in morphologic remission on day 28 or day 100, but had positive MRD. This especially held true if it was next-gen sequencing MRD-positive at day 100, for which relapse rates were over 95%,” he said.

The absence of B-cells is a surrogate marker for the persistence of CAR-T, and conversely, the recovery of CD19-positive B cells may be a predictor for relapse, especially if the B-cell recovery occurs within the first 6 months following CAR-T infusion.
 

Transplant after CAR-T?

Bone marrow transplant after CAR-T is recommend for patients with high risk of relapse, including those with B-cell recovery within the first 6 months after CAR-T, patients with MRD positivity at days 28 or 100, and patients with mixed lineage leukemia.

“Should we transplant good-risk patients, meaning, if you have NGS-MRD negative patients, is there a role for transplant? You have to look at the risk versus benefit there. These patients may have a cure rate that’s in the 80%-plus range, could we potentially optimize that even more if we consolidate them with an allo[geneic] transplant,” Dr. Yank said.
 

Move CAR-T up front?

A Children’s Oncology Group study is currently examining whether giving CAR-T therapy to patients with MRD of 0.01% or greater following first consolidation could result in lower tumor burden, fewer relapse, and less CRS with CAR-T.

Dr. Yanik reported that he had no conflicts of interest to disclose.

Although the only pediatric indication for chimeric antigen receptor T-cell therapy currently approved by the Food and Drug Administration is B-lineage acute lymphoblastic leukemia (ALL) that is refractory to at least two frontline induction attempts or is in second or later relapse, clinical trials of CAR-T therapy for pediatric solid tumors are also currently in progress, said Gregory Yanik, MD, from the CS Mott Children’s Hospital at the University of Michigan, Ann Arbor, at the Transplant & Cellular Therapies Meetings.

In his presentation, Dr. Yanik discussed progress in solid tumor studies as well as some issues involving the current use of CAR-T therapy for ALL.

Solid tumor studies

Malignancies such as sarcomas, brain tumors, and neuroblastomas pose unique challenges, “In contrast to hematologic malignancies, the protein we’re targeting may not be present on the cell surface of all the tumor cells. There are lower-expression profiles, and this is a problem. In fact, many people have postulated that with CAR-T for pediatric solid tumors we’ll have to do repeated cycles, almost like we do with chemotherapy,” he said at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

There are currently 14 studies of CAR-T for central nervous system tumors in children, targeting either epidermal growth factor receptor (EGFR) in glioblastoma multiforme and high-grade gliomas, HER2 in a variety of CNS tumors, the GD2 antigen on pontine gliomas, and the checkpoint molecular B7H3 in medulloblastomas and pontine gliomas.

“In sarcomas in kids there are currently 12 trials in progress. Most of the targeting epitopes are targeting either HER2 or GD2. Repetitive CAR-T infusions are being used in several of these trials in sarcomas.

For neuroblastomas there are currently 13 studies in progress, nearly all of which target GD2. Some of the trials include combining CAR-T with immune checkpoint inhibitors or C7R, an engineered cytokine driver designed to prevent T-cell exhaustion.

In addition, several trials of tumor pulsed dendritic cell vaccines are underway for treatment of children with Wilms tumor, Dr. Yanik noted.
 

Unresolved procedural questions

It’s still early days in CAR-T therapy, and there are several still unanswered questions regarding optimal therapy for and management of patients undergoing CAR-T procedures, Dr. Yanik said.

For example, the optimal time to collect T cells during apheresis is still unclear, he said. Collecting prior to reinduction therapy raises the risk of transducing leukemic cells, while collecting after reinduction may result in inadequate quantity or quality of cells. Regardless of when cells are collected, apheresis should be performed only when the absolute lymphocyte count is above 500/mcL or the CD3 count is above 150/mcL at the time of apheresis.

In the case tisagenlecleucel (Kymriah), his center typically collects 1x10⁹ CD3 cells regardless of age or weight.

The number of CAR T-cells infused also appears to matter, as responses are improved at CAR-T doses above 1.5x10⁶/kg, while risk for higher-grade cytokine release syndrome (CRS) occurs at higher infusion doses.
 

Blinatumomab or inotuzumab?

Along with CAR-T, two other agents, the bispecific T-cell engager blinatumomab (Blincyto) and the antibody conjugate inotuzumab ozogamicin (Besponsa) are also approved for the treatment of patients with relapsed/refractory B-cell ALL.

Like CAR-T therapy, the primary toxicities associated with blinatumomab are CRS and neurologic adverse events, whereas at inotuzumab is largely associated with hematologic and hepatic toxicities.

The logistics of therapy differ widely, with a 28-day infusion required for blinatumomab, compared with weekly dosing of inotuzumab, and the multiple visits for apheresis and infusion required for CAR-T.

Blinatumomab is approved for both children and adults with relapsed/refractory ALL, but inotuzumab is approved only for adults, and CAR-T with tisagenlecleucel is approved only for children in this indication.
 

CD-19 expression

There is evidence to suggest that CD19 expression prior to CAR-T has an effect on outcomes, Dr. Yanik said.

“Does blinatumomab pre–CAR-T impact outcome? The answer is probably yes,” he said.

He referred to a study by investigators at the Children’s Hospital of Philadelphia showing that, “if you’re giving blinatumomab prior to CAR-T therapy, you’re potentially reducing the cell-surface expression of CD19 on your leukemic blasts, and now while you’re bringing these patients in for CAR-T therapy, you’re getting a much higher population of dim CD19 expressers, and this is associated with a higher relapse rate and lower remission rate.”
 

Predicting relapse

Dr. Yanik referred to a study, currently unpublished, which will show that next-generation sequencing (NGS) is more sensitive than flow cytometry for detection of minimal residual disease (MRD), and that MRD analysis of marrow was more sensitive than analysis of peripheral blood.

“Poor outcomes were seen post CAR-T for patients who were in morphologic remission on day 28 or day 100, but had positive MRD. This especially held true if it was next-gen sequencing MRD-positive at day 100, for which relapse rates were over 95%,” he said.

The absence of B-cells is a surrogate marker for the persistence of CAR-T, and conversely, the recovery of CD19-positive B cells may be a predictor for relapse, especially if the B-cell recovery occurs within the first 6 months following CAR-T infusion.
 

Transplant after CAR-T?

Bone marrow transplant after CAR-T is recommend for patients with high risk of relapse, including those with B-cell recovery within the first 6 months after CAR-T, patients with MRD positivity at days 28 or 100, and patients with mixed lineage leukemia.

“Should we transplant good-risk patients, meaning, if you have NGS-MRD negative patients, is there a role for transplant? You have to look at the risk versus benefit there. These patients may have a cure rate that’s in the 80%-plus range, could we potentially optimize that even more if we consolidate them with an allo[geneic] transplant,” Dr. Yank said.
 

Move CAR-T up front?

A Children’s Oncology Group study is currently examining whether giving CAR-T therapy to patients with MRD of 0.01% or greater following first consolidation could result in lower tumor burden, fewer relapse, and less CRS with CAR-T.

Dr. Yanik reported that he had no conflicts of interest to disclose.

Although the only pediatric indication for chimeric antigen receptor T-cell therapy currently approved by the Food and Drug Administration is B-lineage acute lymphoblastic leukemia (ALL) that is refractory to at least two frontline induction attempts or is in second or later relapse, clinical trials of CAR-T therapy for pediatric solid tumors are also currently in progress, said Gregory Yanik, MD, from the CS Mott Children’s Hospital at the University of Michigan, Ann Arbor, at the Transplant & Cellular Therapies Meetings.

In his presentation, Dr. Yanik discussed progress in solid tumor studies as well as some issues involving the current use of CAR-T therapy for ALL.

Solid tumor studies

Malignancies such as sarcomas, brain tumors, and neuroblastomas pose unique challenges, “In contrast to hematologic malignancies, the protein we’re targeting may not be present on the cell surface of all the tumor cells. There are lower-expression profiles, and this is a problem. In fact, many people have postulated that with CAR-T for pediatric solid tumors we’ll have to do repeated cycles, almost like we do with chemotherapy,” he said at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

There are currently 14 studies of CAR-T for central nervous system tumors in children, targeting either epidermal growth factor receptor (EGFR) in glioblastoma multiforme and high-grade gliomas, HER2 in a variety of CNS tumors, the GD2 antigen on pontine gliomas, and the checkpoint molecular B7H3 in medulloblastomas and pontine gliomas.

“In sarcomas in kids there are currently 12 trials in progress. Most of the targeting epitopes are targeting either HER2 or GD2. Repetitive CAR-T infusions are being used in several of these trials in sarcomas.

For neuroblastomas there are currently 13 studies in progress, nearly all of which target GD2. Some of the trials include combining CAR-T with immune checkpoint inhibitors or C7R, an engineered cytokine driver designed to prevent T-cell exhaustion.

In addition, several trials of tumor pulsed dendritic cell vaccines are underway for treatment of children with Wilms tumor, Dr. Yanik noted.
 

Unresolved procedural questions

It’s still early days in CAR-T therapy, and there are several still unanswered questions regarding optimal therapy for and management of patients undergoing CAR-T procedures, Dr. Yanik said.

For example, the optimal time to collect T cells during apheresis is still unclear, he said. Collecting prior to reinduction therapy raises the risk of transducing leukemic cells, while collecting after reinduction may result in inadequate quantity or quality of cells. Regardless of when cells are collected, apheresis should be performed only when the absolute lymphocyte count is above 500/mcL or the CD3 count is above 150/mcL at the time of apheresis.

In the case tisagenlecleucel (Kymriah), his center typically collects 1x10⁹ CD3 cells regardless of age or weight.

The number of CAR T-cells infused also appears to matter, as responses are improved at CAR-T doses above 1.5x10⁶/kg, while risk for higher-grade cytokine release syndrome (CRS) occurs at higher infusion doses.
 

Blinatumomab or inotuzumab?

Along with CAR-T, two other agents, the bispecific T-cell engager blinatumomab (Blincyto) and the antibody conjugate inotuzumab ozogamicin (Besponsa) are also approved for the treatment of patients with relapsed/refractory B-cell ALL.

Like CAR-T therapy, the primary toxicities associated with blinatumomab are CRS and neurologic adverse events, whereas at inotuzumab is largely associated with hematologic and hepatic toxicities.

The logistics of therapy differ widely, with a 28-day infusion required for blinatumomab, compared with weekly dosing of inotuzumab, and the multiple visits for apheresis and infusion required for CAR-T.

Blinatumomab is approved for both children and adults with relapsed/refractory ALL, but inotuzumab is approved only for adults, and CAR-T with tisagenlecleucel is approved only for children in this indication.
 

CD-19 expression

There is evidence to suggest that CD19 expression prior to CAR-T has an effect on outcomes, Dr. Yanik said.

“Does blinatumomab pre–CAR-T impact outcome? The answer is probably yes,” he said.

He referred to a study by investigators at the Children’s Hospital of Philadelphia showing that, “if you’re giving blinatumomab prior to CAR-T therapy, you’re potentially reducing the cell-surface expression of CD19 on your leukemic blasts, and now while you’re bringing these patients in for CAR-T therapy, you’re getting a much higher population of dim CD19 expressers, and this is associated with a higher relapse rate and lower remission rate.”
 

Predicting relapse

Dr. Yanik referred to a study, currently unpublished, which will show that next-generation sequencing (NGS) is more sensitive than flow cytometry for detection of minimal residual disease (MRD), and that MRD analysis of marrow was more sensitive than analysis of peripheral blood.

“Poor outcomes were seen post CAR-T for patients who were in morphologic remission on day 28 or day 100, but had positive MRD. This especially held true if it was next-gen sequencing MRD-positive at day 100, for which relapse rates were over 95%,” he said.

The absence of B-cells is a surrogate marker for the persistence of CAR-T, and conversely, the recovery of CD19-positive B cells may be a predictor for relapse, especially if the B-cell recovery occurs within the first 6 months following CAR-T infusion.
 

Transplant after CAR-T?

Bone marrow transplant after CAR-T is recommend for patients with high risk of relapse, including those with B-cell recovery within the first 6 months after CAR-T, patients with MRD positivity at days 28 or 100, and patients with mixed lineage leukemia.

“Should we transplant good-risk patients, meaning, if you have NGS-MRD negative patients, is there a role for transplant? You have to look at the risk versus benefit there. These patients may have a cure rate that’s in the 80%-plus range, could we potentially optimize that even more if we consolidate them with an allo[geneic] transplant,” Dr. Yank said.
 

Move CAR-T up front?

A Children’s Oncology Group study is currently examining whether giving CAR-T therapy to patients with MRD of 0.01% or greater following first consolidation could result in lower tumor burden, fewer relapse, and less CRS with CAR-T.

Dr. Yanik reported that he had no conflicts of interest to disclose.

In honor of National Hospitalist Day, the Society of Hospital Medicine and the Explore the Space podcast are teaming up to bring you a roundtable discussion, featuring a diverse group of hospitalists from all stages in their careers, on Thursday, March 4, at 7 p.m. ET / 4 p.m. PT.

Registration is required. Sign up here.

Hosted by Mark Shapiro, MD, hospitalist and founder, producer, and host of Explore the Space, the roundtable will include:

• Gurpreet Dhaliwal, MD, a clinician-educator and professor of medicine at the University of California, San Francisco. He studies, writes, and speaks about how doctors think – how they make diagnoses, how they develop diagnostic expertise, and what motivates them to improve their practice and the systems in which they work.
• Anika Kumar, MD, FHM, a clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine, and a pediatric hospitalist at Cleveland Clinic Children’s. She also serves as the pediatric editor of the Hospitalist, SHM’s monthly news magazine.
• Maylyn S. Martinez, MD, a clinician-researcher and clinical associate at the University of Chicago. Her research focuses on hospital-associated disability and she recently authored a perspectives piece in the Journal of Hospital Medicine with her mentor, Vineet Arora, MD, MHM, on why the COVID-19 pandemic might exacerbate this problem.
• Ndidi Unaka, MD, MEd, an associate professor in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center. Dr. Unaka has served as the associate program director of the pediatric residency program since 2011. She is also the medical director of an inpatient unit that serves as the primary home.

For more information about SHM, please visit hospitalmedicine.org. To learn more about Explore the Space, please visit explorethespaceshow.com.

Register now.




 

In honor of National Hospitalist Day, the Society of Hospital Medicine and the Explore the Space podcast are teaming up to bring you a roundtable discussion, featuring a diverse group of hospitalists from all stages in their careers, on Thursday, March 4, at 7 p.m. ET / 4 p.m. PT.

Registration is required. Sign up here.

Hosted by Mark Shapiro, MD, hospitalist and founder, producer, and host of Explore the Space, the roundtable will include:

• Gurpreet Dhaliwal, MD, a clinician-educator and professor of medicine at the University of California, San Francisco. He studies, writes, and speaks about how doctors think – how they make diagnoses, how they develop diagnostic expertise, and what motivates them to improve their practice and the systems in which they work.
• Anika Kumar, MD, FHM, a clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine, and a pediatric hospitalist at Cleveland Clinic Children’s. She also serves as the pediatric editor of the Hospitalist, SHM’s monthly news magazine.
• Maylyn S. Martinez, MD, a clinician-researcher and clinical associate at the University of Chicago. Her research focuses on hospital-associated disability and she recently authored a perspectives piece in the Journal of Hospital Medicine with her mentor, Vineet Arora, MD, MHM, on why the COVID-19 pandemic might exacerbate this problem.
• Ndidi Unaka, MD, MEd, an associate professor in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center. Dr. Unaka has served as the associate program director of the pediatric residency program since 2011. She is also the medical director of an inpatient unit that serves as the primary home.

For more information about SHM, please visit hospitalmedicine.org. To learn more about Explore the Space, please visit explorethespaceshow.com.

Register now.




 

In honor of National Hospitalist Day, the Society of Hospital Medicine and the Explore the Space podcast are teaming up to bring you a roundtable discussion, featuring a diverse group of hospitalists from all stages in their careers, on Thursday, March 4, at 7 p.m. ET / 4 p.m. PT.

Registration is required. Sign up here.

Hosted by Mark Shapiro, MD, hospitalist and founder, producer, and host of Explore the Space, the roundtable will include:

• Gurpreet Dhaliwal, MD, a clinician-educator and professor of medicine at the University of California, San Francisco. He studies, writes, and speaks about how doctors think – how they make diagnoses, how they develop diagnostic expertise, and what motivates them to improve their practice and the systems in which they work.
• Anika Kumar, MD, FHM, a clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine, and a pediatric hospitalist at Cleveland Clinic Children’s. She also serves as the pediatric editor of the Hospitalist, SHM’s monthly news magazine.
• Maylyn S. Martinez, MD, a clinician-researcher and clinical associate at the University of Chicago. Her research focuses on hospital-associated disability and she recently authored a perspectives piece in the Journal of Hospital Medicine with her mentor, Vineet Arora, MD, MHM, on why the COVID-19 pandemic might exacerbate this problem.
• Ndidi Unaka, MD, MEd, an associate professor in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center. Dr. Unaka has served as the associate program director of the pediatric residency program since 2011. She is also the medical director of an inpatient unit that serves as the primary home.

For more information about SHM, please visit hospitalmedicine.org. To learn more about Explore the Space, please visit explorethespaceshow.com.

Register now.




 

A shave biopsy was performed and revealed a well-differentiated, invasive squamous cell carcinoma (SCC). Complete excision was performed with a 4-mm margin.

In the United States, SCC is the most common skin cancer in Black patients, as well as the second most common skin cancer overall. A history of UV exposure from the sun or artificial tanning beds is the most significant risk factor.¹ Radiation, carcinogenic chemical exposure, longstanding inflammation caused by burns, and immunosuppression are also risk factors for SCC.

When caring for a patient with SCC, the best initial work-up is a biopsy. A punch, shave, or excisional biopsy may all be appropriate if the dermis is adequately sampled. However, with a shave or shallow punch biopsy, thick keratin debris can unintentionally lead to a superficial sampling.

Cutaneous SCC should be treated by excision with 4- to 6-mm margins or Mohs microsurgery. Tumors that are smaller than 2 cm, lack aggressive histologic features, and are located in low-risk areas (eg, trunk or extremities) may be treated with standard excision. Larger tumors, recurrent tumors, higher risk histologic subtypes, and tumors on the head, neck, genitals, hands, or feet are candidates for Mohs surgery.

This patient was counseled to practice sun protection and to schedule regular follow-up visits every 6 months for the next 2 years.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

A shave biopsy was performed and revealed a well-differentiated, invasive squamous cell carcinoma (SCC). Complete excision was performed with a 4-mm margin.

In the United States, SCC is the most common skin cancer in Black patients, as well as the second most common skin cancer overall. A history of UV exposure from the sun or artificial tanning beds is the most significant risk factor.¹ Radiation, carcinogenic chemical exposure, longstanding inflammation caused by burns, and immunosuppression are also risk factors for SCC.

When caring for a patient with SCC, the best initial work-up is a biopsy. A punch, shave, or excisional biopsy may all be appropriate if the dermis is adequately sampled. However, with a shave or shallow punch biopsy, thick keratin debris can unintentionally lead to a superficial sampling.

Cutaneous SCC should be treated by excision with 4- to 6-mm margins or Mohs microsurgery. Tumors that are smaller than 2 cm, lack aggressive histologic features, and are located in low-risk areas (eg, trunk or extremities) may be treated with standard excision. Larger tumors, recurrent tumors, higher risk histologic subtypes, and tumors on the head, neck, genitals, hands, or feet are candidates for Mohs surgery.

This patient was counseled to practice sun protection and to schedule regular follow-up visits every 6 months for the next 2 years.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

A shave biopsy was performed and revealed a well-differentiated, invasive squamous cell carcinoma (SCC). Complete excision was performed with a 4-mm margin.

In the United States, SCC is the most common skin cancer in Black patients, as well as the second most common skin cancer overall. A history of UV exposure from the sun or artificial tanning beds is the most significant risk factor.¹ Radiation, carcinogenic chemical exposure, longstanding inflammation caused by burns, and immunosuppression are also risk factors for SCC.

When caring for a patient with SCC, the best initial work-up is a biopsy. A punch, shave, or excisional biopsy may all be appropriate if the dermis is adequately sampled. However, with a shave or shallow punch biopsy, thick keratin debris can unintentionally lead to a superficial sampling.

Cutaneous SCC should be treated by excision with 4- to 6-mm margins or Mohs microsurgery. Tumors that are smaller than 2 cm, lack aggressive histologic features, and are located in low-risk areas (eg, trunk or extremities) may be treated with standard excision. Larger tumors, recurrent tumors, higher risk histologic subtypes, and tumors on the head, neck, genitals, hands, or feet are candidates for Mohs surgery.

This patient was counseled to practice sun protection and to schedule regular follow-up visits every 6 months for the next 2 years.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).