Dermatology News

As chair of the Arkansas State Medical Board, Brian T. Hyatt, MD, often sat in judgment of other physicians. Now, state officials are investigating the psychiatrist for alleged Medicaid fraud. He has stepped down as board chair, and state officials have suspended all Medicaid payments to Dr. Hyatt and his practice, Pinnacle Premier Psychiatry in Rogers, Arkansas.

Dr. Hyatt billed 99.95% of the claims for his patients’ hospital care to Medicaid at the highest severity level, according to an affidavit filed by an investigator with the Medicaid Fraud Control Unit, Arkansas Attorney General’s Office. Other Arkansas psychiatrists billed that same level in only about 39% of claims, the affidavit states.

The possible upcoding alleged in the affidavit was a red flag that prompted the state to temporarily suspend Dr. Hyatt’s Medicaid payments.

Dr. Hyatt has until this Friday to file an appeal. He did not respond to requests from this news organization for comment.

The affidavit pointed to other concerns. For example, a whistleblower who worked at the Northwest Medical Center where Dr. Hyatt admitted patients claimed that Dr. Hyatt was only on the floor a few minutes a day and that he had no contact with patients. A review of hundreds of hours of video by state investigators revealed that Dr. Hyatt did not enter patients’ rooms, nor did he have any contact with patients, according to the affidavit. Dr. Hyatt served as the hospital’s behavioral unit director from 2018 until his contract was abruptly terminated in May 2022, according to the affidavit.

However, Dr. Hyatt claimed to have conducted daily face-to-face evaluation and management with patients, according to the affidavit. In addition, the whistleblower claimed that Dr. Hyatt did not want patients to know his name and instructed staff to cover up his name on patient armbands.
 

Detaining patients

Dr. Hyatt also faces accusations that he held patients against their will, according to civil lawsuits filed in Washington County, Ark., reports the Arkansas Advocate. 

Karla Adrian-Caceres filed suit on Jan. 17. Ms. Adrian-Caceres also named Brooke Green, Northwest Arkansas Hospitals, and 25 unidentified hospital employees as defendants.

According to the complaint, Ms. Adrian-Caceres, an engineering student at the University of Arkansas, arrived at the Northwest Medical Emergency Department after accidentally taking too many Tylenol on Jan. 18, 2022. She was then taken by ambulance to a Northwest psychiatric facility in Springdale, court records show.

According to the complaint, Ms. Adrian-Caceres said that she was given a sedative and asked to sign consent for admission while on the way to Northwest. She said that she “signed some documents without being able to read or understand them at the time.”

When she asked when she could go home, Ms. Adrian-Caceres said, “more than one employee told her there was a minimum stay and that if she asked to leave, they would take her to court where a judge would give her a longer stay because the judge always sides with Dr. Hyatt and Northwest,” according to court documents. Northwest employees stripped Ms. Adrian-Caceres, searched her body, took all of her possessions from her and issued underwear and a uniform, according to the lawsuit.

Ms. Adrian-Caceres’ mother, Katty Caceres, claimed in the lawsuit that she was prohibited from seeing her daughter. Ms. Caceres spoke with five different employees, four of whom had only their first names on their badges. Each of them reportedly said that they could not help, or that the plaintiff “would be in there for some time” and that it was Dr. Hyatt’s decision regarding how long that would be, according to court documents.

Katty Caceres hired a local attorney named Aaron Cash to represent her daughter. On Jan. 20, 2022, Mr. Cash faxed a letter to the hospital demanding her release. When Ms. Caceres arrived to pick up her daughter, she claimed that staff members indicated that the daughter was there voluntarily and refused to release her “at the direction of Dr Hyatt.” During a phone call later that day, the plaintiff told her mother that her status was being changed to an involuntary hold, court documents show.

“At one point she was threatened with the longer time in there if she kept asking to leave,” Mr. Cash told this news organization. In addition, staff members reportedly told Ms. Adrian-Caceres that the “judge always sided with Dr Hyatt” and she “would get way longer there, 30-45 days if [she] went before the judge,” according to Mr. Cash.

Mr. Cash said nine other patients have contacted his firm with similar allegations against Dr. Hyatt.

“We’ve talked to many people that have experienced the same threats,” Mr. Cash said. “When they’re asking to leave, they get these threats, they get coerced … and they’re never taken to court. They’re never given opportunity to talk to a judge or to have a public defender appointed.”
 

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

As chair of the Arkansas State Medical Board, Brian T. Hyatt, MD, often sat in judgment of other physicians. Now, state officials are investigating the psychiatrist for alleged Medicaid fraud. He has stepped down as board chair, and state officials have suspended all Medicaid payments to Dr. Hyatt and his practice, Pinnacle Premier Psychiatry in Rogers, Arkansas.

Dr. Hyatt billed 99.95% of the claims for his patients’ hospital care to Medicaid at the highest severity level, according to an affidavit filed by an investigator with the Medicaid Fraud Control Unit, Arkansas Attorney General’s Office. Other Arkansas psychiatrists billed that same level in only about 39% of claims, the affidavit states.

The possible upcoding alleged in the affidavit was a red flag that prompted the state to temporarily suspend Dr. Hyatt’s Medicaid payments.

Dr. Hyatt has until this Friday to file an appeal. He did not respond to requests from this news organization for comment.

The affidavit pointed to other concerns. For example, a whistleblower who worked at the Northwest Medical Center where Dr. Hyatt admitted patients claimed that Dr. Hyatt was only on the floor a few minutes a day and that he had no contact with patients. A review of hundreds of hours of video by state investigators revealed that Dr. Hyatt did not enter patients’ rooms, nor did he have any contact with patients, according to the affidavit. Dr. Hyatt served as the hospital’s behavioral unit director from 2018 until his contract was abruptly terminated in May 2022, according to the affidavit.

However, Dr. Hyatt claimed to have conducted daily face-to-face evaluation and management with patients, according to the affidavit. In addition, the whistleblower claimed that Dr. Hyatt did not want patients to know his name and instructed staff to cover up his name on patient armbands.
 

Detaining patients

Dr. Hyatt also faces accusations that he held patients against their will, according to civil lawsuits filed in Washington County, Ark., reports the Arkansas Advocate. 

Karla Adrian-Caceres filed suit on Jan. 17. Ms. Adrian-Caceres also named Brooke Green, Northwest Arkansas Hospitals, and 25 unidentified hospital employees as defendants.

According to the complaint, Ms. Adrian-Caceres, an engineering student at the University of Arkansas, arrived at the Northwest Medical Emergency Department after accidentally taking too many Tylenol on Jan. 18, 2022. She was then taken by ambulance to a Northwest psychiatric facility in Springdale, court records show.

According to the complaint, Ms. Adrian-Caceres said that she was given a sedative and asked to sign consent for admission while on the way to Northwest. She said that she “signed some documents without being able to read or understand them at the time.”

When she asked when she could go home, Ms. Adrian-Caceres said, “more than one employee told her there was a minimum stay and that if she asked to leave, they would take her to court where a judge would give her a longer stay because the judge always sides with Dr. Hyatt and Northwest,” according to court documents. Northwest employees stripped Ms. Adrian-Caceres, searched her body, took all of her possessions from her and issued underwear and a uniform, according to the lawsuit.

Ms. Adrian-Caceres’ mother, Katty Caceres, claimed in the lawsuit that she was prohibited from seeing her daughter. Ms. Caceres spoke with five different employees, four of whom had only their first names on their badges. Each of them reportedly said that they could not help, or that the plaintiff “would be in there for some time” and that it was Dr. Hyatt’s decision regarding how long that would be, according to court documents.

Katty Caceres hired a local attorney named Aaron Cash to represent her daughter. On Jan. 20, 2022, Mr. Cash faxed a letter to the hospital demanding her release. When Ms. Caceres arrived to pick up her daughter, she claimed that staff members indicated that the daughter was there voluntarily and refused to release her “at the direction of Dr Hyatt.” During a phone call later that day, the plaintiff told her mother that her status was being changed to an involuntary hold, court documents show.

“At one point she was threatened with the longer time in there if she kept asking to leave,” Mr. Cash told this news organization. In addition, staff members reportedly told Ms. Adrian-Caceres that the “judge always sided with Dr Hyatt” and she “would get way longer there, 30-45 days if [she] went before the judge,” according to Mr. Cash.

Mr. Cash said nine other patients have contacted his firm with similar allegations against Dr. Hyatt.

“We’ve talked to many people that have experienced the same threats,” Mr. Cash said. “When they’re asking to leave, they get these threats, they get coerced … and they’re never taken to court. They’re never given opportunity to talk to a judge or to have a public defender appointed.”
 

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

As chair of the Arkansas State Medical Board, Brian T. Hyatt, MD, often sat in judgment of other physicians. Now, state officials are investigating the psychiatrist for alleged Medicaid fraud. He has stepped down as board chair, and state officials have suspended all Medicaid payments to Dr. Hyatt and his practice, Pinnacle Premier Psychiatry in Rogers, Arkansas.

Dr. Hyatt billed 99.95% of the claims for his patients’ hospital care to Medicaid at the highest severity level, according to an affidavit filed by an investigator with the Medicaid Fraud Control Unit, Arkansas Attorney General’s Office. Other Arkansas psychiatrists billed that same level in only about 39% of claims, the affidavit states.

The possible upcoding alleged in the affidavit was a red flag that prompted the state to temporarily suspend Dr. Hyatt’s Medicaid payments.

Dr. Hyatt has until this Friday to file an appeal. He did not respond to requests from this news organization for comment.

The affidavit pointed to other concerns. For example, a whistleblower who worked at the Northwest Medical Center where Dr. Hyatt admitted patients claimed that Dr. Hyatt was only on the floor a few minutes a day and that he had no contact with patients. A review of hundreds of hours of video by state investigators revealed that Dr. Hyatt did not enter patients’ rooms, nor did he have any contact with patients, according to the affidavit. Dr. Hyatt served as the hospital’s behavioral unit director from 2018 until his contract was abruptly terminated in May 2022, according to the affidavit.

However, Dr. Hyatt claimed to have conducted daily face-to-face evaluation and management with patients, according to the affidavit. In addition, the whistleblower claimed that Dr. Hyatt did not want patients to know his name and instructed staff to cover up his name on patient armbands.
 

Detaining patients

Dr. Hyatt also faces accusations that he held patients against their will, according to civil lawsuits filed in Washington County, Ark., reports the Arkansas Advocate. 

Karla Adrian-Caceres filed suit on Jan. 17. Ms. Adrian-Caceres also named Brooke Green, Northwest Arkansas Hospitals, and 25 unidentified hospital employees as defendants.

According to the complaint, Ms. Adrian-Caceres, an engineering student at the University of Arkansas, arrived at the Northwest Medical Emergency Department after accidentally taking too many Tylenol on Jan. 18, 2022. She was then taken by ambulance to a Northwest psychiatric facility in Springdale, court records show.

According to the complaint, Ms. Adrian-Caceres said that she was given a sedative and asked to sign consent for admission while on the way to Northwest. She said that she “signed some documents without being able to read or understand them at the time.”

When she asked when she could go home, Ms. Adrian-Caceres said, “more than one employee told her there was a minimum stay and that if she asked to leave, they would take her to court where a judge would give her a longer stay because the judge always sides with Dr. Hyatt and Northwest,” according to court documents. Northwest employees stripped Ms. Adrian-Caceres, searched her body, took all of her possessions from her and issued underwear and a uniform, according to the lawsuit.

Ms. Adrian-Caceres’ mother, Katty Caceres, claimed in the lawsuit that she was prohibited from seeing her daughter. Ms. Caceres spoke with five different employees, four of whom had only their first names on their badges. Each of them reportedly said that they could not help, or that the plaintiff “would be in there for some time” and that it was Dr. Hyatt’s decision regarding how long that would be, according to court documents.

Katty Caceres hired a local attorney named Aaron Cash to represent her daughter. On Jan. 20, 2022, Mr. Cash faxed a letter to the hospital demanding her release. When Ms. Caceres arrived to pick up her daughter, she claimed that staff members indicated that the daughter was there voluntarily and refused to release her “at the direction of Dr Hyatt.” During a phone call later that day, the plaintiff told her mother that her status was being changed to an involuntary hold, court documents show.

“At one point she was threatened with the longer time in there if she kept asking to leave,” Mr. Cash told this news organization. In addition, staff members reportedly told Ms. Adrian-Caceres that the “judge always sided with Dr Hyatt” and she “would get way longer there, 30-45 days if [she] went before the judge,” according to Mr. Cash.

Mr. Cash said nine other patients have contacted his firm with similar allegations against Dr. Hyatt.

“We’ve talked to many people that have experienced the same threats,” Mr. Cash said. “When they’re asking to leave, they get these threats, they get coerced … and they’re never taken to court. They’re never given opportunity to talk to a judge or to have a public defender appointed.”
 

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

Almost three-quarters of adults living in the United States report having never tested for HIV according to a newly published study from the Centers for Disease Control and Prevention. The reasons are complex and could jeopardize goals of ending the AIDS epidemic by 2030.

Patients and doctors alike face system challenges, including stigma, confidentiality concerns, racism, and inequitable access. Yet doctors, public health authorities, and even some patients agree that testing does work: In 2022, 81% of people diagnosed with HIV were linked to care within 30 days. Moreover, many patients are aware of where and how they wish to be tested. So, what would it take to achieve what ostensibly should be the lowest hanging fruit in the HIV care continuum?

“We didn’t look at the reasons for not testing,” Marc Pitasi, MPH, CDC epidemiologist and coauthor of the CDC study said in an interview. But “we found that the majority of people prefer the test in a clinical setting, so that’s a huge important piece of the puzzle,” he said.

The “never-tested” populations (4,334 of 6,072) in the study were predominantly aged 18-29 years (79.7%) and 50 years plus (78.1%). A total of 48% of never-tested adults also indicated that they had engaged in past-year risky behaviors (that is, injection drug use, treated for a sexually transmitted disease, exchanged sex/drugs for money, engaged in condomless anal sex, or had more than four sex partners). However, the difference between never-tested adults who live in EHE (Ending the HIV Epidemic in the U.S.)–designated jurisdictions (comprising 50 areas and 7 U.S. states responsible for more than 50% of new HIV infections) and those residing in non-EHE areas was only about 5 percentage points (69.1% vs. 74.5%, respectively), underscoring the need for broader engagement.

“There’s definitely a lack of testing across the board,” explained Lina Rosengren-Hovee, MD, MPH, MS, an infectious disease epidemiologist at the University of North Carolina at Chapel Hill. “There are all sorts of biases on how we make decisions and how we stratify … and these heuristics that we have in our minds to identify who is at risk and who needs testing,” she said.

“If we just look at the need for HIV testing based on who is at risk, I think that we are always going to fall short.”
 

Conflicting priorities

Seventeen years have passed since the CDC recommended that HIV testing and screening be offered at least once to all people aged 13-64 years in a routine clinical setting, with an opt-out option and without a separate written consent. People at higher risk (sexually active gay, bisexual, and other men who have sex with men) should be rescreened at least annually.

These recommendations were subsequently reinforced by numerous organizations, including the U.S. Preventive Services Task Force in 2013 and again in 2019, and the American Academy of Pediatrics in 2021.

But Dr. Rosengren-Hovee said that some clinicians remain unaware of the guidelines; for others, they’re usually not top-of-mind because of conflicting priorities.

This is especially true of pediatricians, who, despite data demonstrating that adolescents account for roughly 21% of new HIV diagnoses, rarely recognize or take advantage of HIV-testing opportunities during routine clinical visits.

“Pediatricians want to do the right thing for their patients but at the same time, they want to do the right thing on so many different fronts,” said Sarah Wood, MD, of the University of Pennsylvania, Philadelphia, and attending physician of adolescent medicine at Children’s Hospital of Philadelphia.

Dr. Wood is coauthor of a study published in Implementation Science Communicationsexamining pediatrician perspectives on implementing HIV testing and prevention. Participants identified confidentiality and time constraints as the most important challenges across every step of their workflow, which in turn, influenced perceptions about patients’ perceived risks for acquiring HIV – perceptions that Dr. Wood believes can be overcome.

“We need to really push pediatricians (through guideline-making societies like AAP and USPSTF) that screening should be universal and not linked to sexual activity or pinned to behavior, so the offer of testing is a universal opt-out,” she said. Additionally, “we need to make it easier for pediatricians to order the test,” for example, “through an office rapid test … and a redesigned workflow that moves the conversation away from physicians and nurse practitioners to medical assistants.”

Dr. Wood also pointed out that any effort would require pediatricians and other types of providers to overcome discomfort around sexual health conversations, noting that, while pediatricians are ideally positioned to work with parents to do education around sexual health, training and impetus are needed.
 

A fractured system

A fractured, often ill-funded U.S. health care system might also be at play according to Scott Harris, MD, MPH, state health officer of the Alabama Department of Public Health in Montgomery, and Association of State and Territorial Health Officials’ Infectious Disease Policy Committee chair.

“There’s a general consensus among everyone in public health that [HIV testing] is an important issue that we’re not addressing as well as we’d like to,” he said.

Dr. Harris acknowledged that, while COVID diverted attention away from HIV, some states have prioritized HIV more than others.

“We don’t have a national public health program; we have a nationwide public health program,” he said. “Everyone’s different and has different responsibilities and authorities ... depending on where their funding streams come from.”

The White House recently announced that it proposed a measure in its Fiscal Year 2023 budget to increase funding for HIV a further $313 million to accelerate efforts to end HIV by 2030, also adding a mandatory program to increase preexposure prophylaxis (PrEP) access. Without congressional approval, the measures are doomed to fail, leaving many states without the proper tools to enhance existing programs, and further painting overworked clinicians into a corner.

For patients, the ramifications are even greater.

“The majority of folks [in the CDC study] that were not tested said that if they were to get tested, they’d prefer to do that within the context of their primary care setting,” said Justin C. Smith, MS, MPH, director of the Campaign to End AIDS, Positive Impact Health Centers; a behavioral scientist at Emory University’s Rollins School of Public Health in Atlanta; and a member of the Presidential Advisory Council on HIV/AIDS.

“When you create a more responsive system that really speaks to the needs that people are expressing, that can provide better outcomes,” Dr. Smith said.

“It’s vital that we create health care and public health interventions that change the dynamics ... and make sure that we’re designing systems with the people that we’re trying to serve at the center.”

Mr. Pitasi, Dr. Rosengren-Hovee, Dr. Wood, Dr. Harris, and Dr. Smith have disclosed no relevant financial relationships.

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

Almost three-quarters of adults living in the United States report having never tested for HIV according to a newly published study from the Centers for Disease Control and Prevention. The reasons are complex and could jeopardize goals of ending the AIDS epidemic by 2030.

Patients and doctors alike face system challenges, including stigma, confidentiality concerns, racism, and inequitable access. Yet doctors, public health authorities, and even some patients agree that testing does work: In 2022, 81% of people diagnosed with HIV were linked to care within 30 days. Moreover, many patients are aware of where and how they wish to be tested. So, what would it take to achieve what ostensibly should be the lowest hanging fruit in the HIV care continuum?

“We didn’t look at the reasons for not testing,” Marc Pitasi, MPH, CDC epidemiologist and coauthor of the CDC study said in an interview. But “we found that the majority of people prefer the test in a clinical setting, so that’s a huge important piece of the puzzle,” he said.

The “never-tested” populations (4,334 of 6,072) in the study were predominantly aged 18-29 years (79.7%) and 50 years plus (78.1%). A total of 48% of never-tested adults also indicated that they had engaged in past-year risky behaviors (that is, injection drug use, treated for a sexually transmitted disease, exchanged sex/drugs for money, engaged in condomless anal sex, or had more than four sex partners). However, the difference between never-tested adults who live in EHE (Ending the HIV Epidemic in the U.S.)–designated jurisdictions (comprising 50 areas and 7 U.S. states responsible for more than 50% of new HIV infections) and those residing in non-EHE areas was only about 5 percentage points (69.1% vs. 74.5%, respectively), underscoring the need for broader engagement.

“There’s definitely a lack of testing across the board,” explained Lina Rosengren-Hovee, MD, MPH, MS, an infectious disease epidemiologist at the University of North Carolina at Chapel Hill. “There are all sorts of biases on how we make decisions and how we stratify … and these heuristics that we have in our minds to identify who is at risk and who needs testing,” she said.

“If we just look at the need for HIV testing based on who is at risk, I think that we are always going to fall short.”
 

Conflicting priorities

Seventeen years have passed since the CDC recommended that HIV testing and screening be offered at least once to all people aged 13-64 years in a routine clinical setting, with an opt-out option and without a separate written consent. People at higher risk (sexually active gay, bisexual, and other men who have sex with men) should be rescreened at least annually.

These recommendations were subsequently reinforced by numerous organizations, including the U.S. Preventive Services Task Force in 2013 and again in 2019, and the American Academy of Pediatrics in 2021.

But Dr. Rosengren-Hovee said that some clinicians remain unaware of the guidelines; for others, they’re usually not top-of-mind because of conflicting priorities.

This is especially true of pediatricians, who, despite data demonstrating that adolescents account for roughly 21% of new HIV diagnoses, rarely recognize or take advantage of HIV-testing opportunities during routine clinical visits.

“Pediatricians want to do the right thing for their patients but at the same time, they want to do the right thing on so many different fronts,” said Sarah Wood, MD, of the University of Pennsylvania, Philadelphia, and attending physician of adolescent medicine at Children’s Hospital of Philadelphia.

Dr. Wood is coauthor of a study published in Implementation Science Communicationsexamining pediatrician perspectives on implementing HIV testing and prevention. Participants identified confidentiality and time constraints as the most important challenges across every step of their workflow, which in turn, influenced perceptions about patients’ perceived risks for acquiring HIV – perceptions that Dr. Wood believes can be overcome.

“We need to really push pediatricians (through guideline-making societies like AAP and USPSTF) that screening should be universal and not linked to sexual activity or pinned to behavior, so the offer of testing is a universal opt-out,” she said. Additionally, “we need to make it easier for pediatricians to order the test,” for example, “through an office rapid test … and a redesigned workflow that moves the conversation away from physicians and nurse practitioners to medical assistants.”

Dr. Wood also pointed out that any effort would require pediatricians and other types of providers to overcome discomfort around sexual health conversations, noting that, while pediatricians are ideally positioned to work with parents to do education around sexual health, training and impetus are needed.
 

A fractured system

A fractured, often ill-funded U.S. health care system might also be at play according to Scott Harris, MD, MPH, state health officer of the Alabama Department of Public Health in Montgomery, and Association of State and Territorial Health Officials’ Infectious Disease Policy Committee chair.

“There’s a general consensus among everyone in public health that [HIV testing] is an important issue that we’re not addressing as well as we’d like to,” he said.

Dr. Harris acknowledged that, while COVID diverted attention away from HIV, some states have prioritized HIV more than others.

“We don’t have a national public health program; we have a nationwide public health program,” he said. “Everyone’s different and has different responsibilities and authorities ... depending on where their funding streams come from.”

The White House recently announced that it proposed a measure in its Fiscal Year 2023 budget to increase funding for HIV a further $313 million to accelerate efforts to end HIV by 2030, also adding a mandatory program to increase preexposure prophylaxis (PrEP) access. Without congressional approval, the measures are doomed to fail, leaving many states without the proper tools to enhance existing programs, and further painting overworked clinicians into a corner.

For patients, the ramifications are even greater.

“The majority of folks [in the CDC study] that were not tested said that if they were to get tested, they’d prefer to do that within the context of their primary care setting,” said Justin C. Smith, MS, MPH, director of the Campaign to End AIDS, Positive Impact Health Centers; a behavioral scientist at Emory University’s Rollins School of Public Health in Atlanta; and a member of the Presidential Advisory Council on HIV/AIDS.

“When you create a more responsive system that really speaks to the needs that people are expressing, that can provide better outcomes,” Dr. Smith said.

“It’s vital that we create health care and public health interventions that change the dynamics ... and make sure that we’re designing systems with the people that we’re trying to serve at the center.”

Mr. Pitasi, Dr. Rosengren-Hovee, Dr. Wood, Dr. Harris, and Dr. Smith have disclosed no relevant financial relationships.

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

Almost three-quarters of adults living in the United States report having never tested for HIV according to a newly published study from the Centers for Disease Control and Prevention. The reasons are complex and could jeopardize goals of ending the AIDS epidemic by 2030.

Patients and doctors alike face system challenges, including stigma, confidentiality concerns, racism, and inequitable access. Yet doctors, public health authorities, and even some patients agree that testing does work: In 2022, 81% of people diagnosed with HIV were linked to care within 30 days. Moreover, many patients are aware of where and how they wish to be tested. So, what would it take to achieve what ostensibly should be the lowest hanging fruit in the HIV care continuum?

“We didn’t look at the reasons for not testing,” Marc Pitasi, MPH, CDC epidemiologist and coauthor of the CDC study said in an interview. But “we found that the majority of people prefer the test in a clinical setting, so that’s a huge important piece of the puzzle,” he said.

The “never-tested” populations (4,334 of 6,072) in the study were predominantly aged 18-29 years (79.7%) and 50 years plus (78.1%). A total of 48% of never-tested adults also indicated that they had engaged in past-year risky behaviors (that is, injection drug use, treated for a sexually transmitted disease, exchanged sex/drugs for money, engaged in condomless anal sex, or had more than four sex partners). However, the difference between never-tested adults who live in EHE (Ending the HIV Epidemic in the U.S.)–designated jurisdictions (comprising 50 areas and 7 U.S. states responsible for more than 50% of new HIV infections) and those residing in non-EHE areas was only about 5 percentage points (69.1% vs. 74.5%, respectively), underscoring the need for broader engagement.

“There’s definitely a lack of testing across the board,” explained Lina Rosengren-Hovee, MD, MPH, MS, an infectious disease epidemiologist at the University of North Carolina at Chapel Hill. “There are all sorts of biases on how we make decisions and how we stratify … and these heuristics that we have in our minds to identify who is at risk and who needs testing,” she said.

“If we just look at the need for HIV testing based on who is at risk, I think that we are always going to fall short.”
 

Conflicting priorities

Seventeen years have passed since the CDC recommended that HIV testing and screening be offered at least once to all people aged 13-64 years in a routine clinical setting, with an opt-out option and without a separate written consent. People at higher risk (sexually active gay, bisexual, and other men who have sex with men) should be rescreened at least annually.

These recommendations were subsequently reinforced by numerous organizations, including the U.S. Preventive Services Task Force in 2013 and again in 2019, and the American Academy of Pediatrics in 2021.

But Dr. Rosengren-Hovee said that some clinicians remain unaware of the guidelines; for others, they’re usually not top-of-mind because of conflicting priorities.

This is especially true of pediatricians, who, despite data demonstrating that adolescents account for roughly 21% of new HIV diagnoses, rarely recognize or take advantage of HIV-testing opportunities during routine clinical visits.

“Pediatricians want to do the right thing for their patients but at the same time, they want to do the right thing on so many different fronts,” said Sarah Wood, MD, of the University of Pennsylvania, Philadelphia, and attending physician of adolescent medicine at Children’s Hospital of Philadelphia.

Dr. Wood is coauthor of a study published in Implementation Science Communicationsexamining pediatrician perspectives on implementing HIV testing and prevention. Participants identified confidentiality and time constraints as the most important challenges across every step of their workflow, which in turn, influenced perceptions about patients’ perceived risks for acquiring HIV – perceptions that Dr. Wood believes can be overcome.

“We need to really push pediatricians (through guideline-making societies like AAP and USPSTF) that screening should be universal and not linked to sexual activity or pinned to behavior, so the offer of testing is a universal opt-out,” she said. Additionally, “we need to make it easier for pediatricians to order the test,” for example, “through an office rapid test … and a redesigned workflow that moves the conversation away from physicians and nurse practitioners to medical assistants.”

Dr. Wood also pointed out that any effort would require pediatricians and other types of providers to overcome discomfort around sexual health conversations, noting that, while pediatricians are ideally positioned to work with parents to do education around sexual health, training and impetus are needed.
 

A fractured system

A fractured, often ill-funded U.S. health care system might also be at play according to Scott Harris, MD, MPH, state health officer of the Alabama Department of Public Health in Montgomery, and Association of State and Territorial Health Officials’ Infectious Disease Policy Committee chair.

“There’s a general consensus among everyone in public health that [HIV testing] is an important issue that we’re not addressing as well as we’d like to,” he said.

Dr. Harris acknowledged that, while COVID diverted attention away from HIV, some states have prioritized HIV more than others.

“We don’t have a national public health program; we have a nationwide public health program,” he said. “Everyone’s different and has different responsibilities and authorities ... depending on where their funding streams come from.”

The White House recently announced that it proposed a measure in its Fiscal Year 2023 budget to increase funding for HIV a further $313 million to accelerate efforts to end HIV by 2030, also adding a mandatory program to increase preexposure prophylaxis (PrEP) access. Without congressional approval, the measures are doomed to fail, leaving many states without the proper tools to enhance existing programs, and further painting overworked clinicians into a corner.

For patients, the ramifications are even greater.

“The majority of folks [in the CDC study] that were not tested said that if they were to get tested, they’d prefer to do that within the context of their primary care setting,” said Justin C. Smith, MS, MPH, director of the Campaign to End AIDS, Positive Impact Health Centers; a behavioral scientist at Emory University’s Rollins School of Public Health in Atlanta; and a member of the Presidential Advisory Council on HIV/AIDS.

“When you create a more responsive system that really speaks to the needs that people are expressing, that can provide better outcomes,” Dr. Smith said.

“It’s vital that we create health care and public health interventions that change the dynamics ... and make sure that we’re designing systems with the people that we’re trying to serve at the center.”

Mr. Pitasi, Dr. Rosengren-Hovee, Dr. Wood, Dr. Harris, and Dr. Smith have disclosed no relevant financial relationships.

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

NEW ORLEANS – A monoclonal antibody targeting interferon-beta (IFN-beta) provided substantial reductions in the skin lesions associated with dermatomyositis in a double-blind, placebo-controlled phase 2 trial, according to results presented as a late-breaker at the annual meeting of the American Academy of Dermatology.

“These findings support the inhibition of IFN-beta as a promising therapeutic strategy in skin-predominant disease,” said principal investigator Aaron Mangold, MD, associate professor of dermatology, Mayo Clinic, Scottsdale, Ariz.

Ted Bosworth/MDedge News

Dermatomyositis, a rare autoimmune inflammatory condition that typically involves both skeletal muscles and skin, is a challenging disease with a diverse set of potential complications.

Immunosuppressive and immunomodulatory agents are used with mixed success for myositis, but skin manifestations, which include papular eruptions, heliotrope rash, photoerythema, burning, and pruritus, are often the most troublesome and the most difficult to control. Treatment options other than immunomodulators that target cutaneous involvement – which include steroids, emollients, and photoprotection – are generally modestly effective, according to Dr. Mangold.
 

Targeting an elevated cytokine

Interest in IFN-beta, which is elevated in the blood of individuals with dermatomyositis, was triggered by evidence that this cytokine plays an important role in driving the skin inflammation, Dr. Mangold explained.

“The blood concentrations of IFN-beta are positively correlated with cutaneous disease activity and severity,” he said.

The study drug, currently known as PF-06823859 (Dazukibart), “is a potent, selective humanized IgG1-neutralizing antibody directed at IFN-beta,” Dr. Mangold said. A dose-ranging phase 1 study published 2 years ago provided evidence of acceptable pharmacokinetics and safety in healthy individuals to support treatment studies for disorders associated with elevated IFN-beta levels. In addition to dermatomyositis, this includes systemic lupus erythematosus.

In this phase 2 trial, patients whose condition was not improved by at least one standard-care therapy for skin manifestations of dermatomyositis were eligible if they had moderate to severe disease as measured with the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), according to Dr. Mangold. During the study, patients were allowed to remain on a disease modifying antirheumatic drug and/or prednisone if they had been on stable doses and did not change the dose.

Richard Usatine, MD

After a screening run-in, the trial had two blinded stages. In stage 1, 30 patients were randomly assigned either to 600 mg of PF-06823859 or to placebo, both administered intravenously every 4 weeks. A second cohort of 25 patients was randomly assigned in stage 2 to placebo, 150 mg of PF-06823859, or 600 mg of PF-06823859. The primary endpoint assessed at 12 weeks was a greater than 5-point reduction in CDASI score or greater than 40% CDASI improvement from baseline.

Both endpoints are associated with a clinically meaningful response in regard to an improved quality of life, Dr. Mangold noted.
 

Both doses better than placebo

In results from the stage 1 portion, the mean reduction in CDASI at 12 weeks after three doses of the assigned therapy was 18.8 points in the active-treatment group versus 3.9 points in the placebo group. In pooled data from stage 1 and 2, the reductions were 16.6 points, 19.2 points, and 2.9 points for the 150-mg, 600-mg, and placebo arms, respectively. Both doses achieved a highly significant advantage over placebo.

For both stages and doses, the response curves of the active-treatment groups and the placebo group diverged almost immediately. By 4 weeks, both measures of CDASI reductions on active therapy were significantly improved relative to placebo, and the response curves had a consistent downward slope through the end of the 12-week study, Dr. Mangold reported.

The majority of patients responded by either of the primary endpoint criteria. For a CDASI reduction of greater than 5 points, the response rates were 100% and 96% for the 150-mg and 600-mg doses of PF-06823859, respectively. The placebo response was 35.7%. For the CDASI reduction of greater than 40%, the rates were 80%, 82.1%, and 7.1% for the 150-mg, 600-mg, and placebo arms, respectively.

“There were no major safety concerns. Most of the treatment-emergent adverse events were mild, and adverse events did not have a relationship to dose,” Dr. Mangold said. Notably, there were no cases of herpes zoster, and infections of any kind were low in all study groups.

A phase 3 study is being planned with the 600-mg dose, according to Dr. Mangold, but he acknowledged that regulatory authorities have generally required endpoints for both cutaneous and muscle manifestations in previous trials of therapies for dermatomyositis.

It is not yet certain that “there will be a carve-out for skin,” he said in answer to a question about investigations moving forward. So far, studies have been focused on skin response. However, a meaningful degree of benefit against muscle involvement, which has not yet been well studied, has not been ruled out.

Even though this is a phase 2 trial with small numbers, it was controlled and blinded, and the potential of an inhibitor of IFN-beta to control the skin manifestations of dermatomyositis “is kind of a big deal,” said Paul Nghiem, MD, PhD, professor of dermatology, University of Washington, Seattle.

“There is definitely an unmet need for better therapies to control the skin involvement,” Dr. Nghiem said.

Hensin Tsao, MD, PhD, clinical director of the Melanoma and Pigmented Lesion Center at Massachusetts General Hospital, Boston, agreed. Like Dr. Nghiem, Dr. Tsao was a panelist during the late-breaker session where the study was presented, and he was impressed by the data.

“This is something that is definitely newsworthy,” Dr. Tsao said.

Dr. Mangold reports financial relationships with Actelion, Amgen, Corbus, Eli Lilly, Incyte, miRagen, Novartis, Regeneron, Solagenix, Sun Pharmaceuticals, Teva, and Pfizer, which provided funding for this trial. Both Dr. Nghiem and Dr. Tsao reported no relevant financial relationships.

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

NEW ORLEANS – A monoclonal antibody targeting interferon-beta (IFN-beta) provided substantial reductions in the skin lesions associated with dermatomyositis in a double-blind, placebo-controlled phase 2 trial, according to results presented as a late-breaker at the annual meeting of the American Academy of Dermatology.

“These findings support the inhibition of IFN-beta as a promising therapeutic strategy in skin-predominant disease,” said principal investigator Aaron Mangold, MD, associate professor of dermatology, Mayo Clinic, Scottsdale, Ariz.

Ted Bosworth/MDedge News

Dermatomyositis, a rare autoimmune inflammatory condition that typically involves both skeletal muscles and skin, is a challenging disease with a diverse set of potential complications.

Immunosuppressive and immunomodulatory agents are used with mixed success for myositis, but skin manifestations, which include papular eruptions, heliotrope rash, photoerythema, burning, and pruritus, are often the most troublesome and the most difficult to control. Treatment options other than immunomodulators that target cutaneous involvement – which include steroids, emollients, and photoprotection – are generally modestly effective, according to Dr. Mangold.
 

Targeting an elevated cytokine

Interest in IFN-beta, which is elevated in the blood of individuals with dermatomyositis, was triggered by evidence that this cytokine plays an important role in driving the skin inflammation, Dr. Mangold explained.

“The blood concentrations of IFN-beta are positively correlated with cutaneous disease activity and severity,” he said.

The study drug, currently known as PF-06823859 (Dazukibart), “is a potent, selective humanized IgG1-neutralizing antibody directed at IFN-beta,” Dr. Mangold said. A dose-ranging phase 1 study published 2 years ago provided evidence of acceptable pharmacokinetics and safety in healthy individuals to support treatment studies for disorders associated with elevated IFN-beta levels. In addition to dermatomyositis, this includes systemic lupus erythematosus.

In this phase 2 trial, patients whose condition was not improved by at least one standard-care therapy for skin manifestations of dermatomyositis were eligible if they had moderate to severe disease as measured with the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), according to Dr. Mangold. During the study, patients were allowed to remain on a disease modifying antirheumatic drug and/or prednisone if they had been on stable doses and did not change the dose.

Richard Usatine, MD

After a screening run-in, the trial had two blinded stages. In stage 1, 30 patients were randomly assigned either to 600 mg of PF-06823859 or to placebo, both administered intravenously every 4 weeks. A second cohort of 25 patients was randomly assigned in stage 2 to placebo, 150 mg of PF-06823859, or 600 mg of PF-06823859. The primary endpoint assessed at 12 weeks was a greater than 5-point reduction in CDASI score or greater than 40% CDASI improvement from baseline.

Both endpoints are associated with a clinically meaningful response in regard to an improved quality of life, Dr. Mangold noted.
 

Both doses better than placebo

In results from the stage 1 portion, the mean reduction in CDASI at 12 weeks after three doses of the assigned therapy was 18.8 points in the active-treatment group versus 3.9 points in the placebo group. In pooled data from stage 1 and 2, the reductions were 16.6 points, 19.2 points, and 2.9 points for the 150-mg, 600-mg, and placebo arms, respectively. Both doses achieved a highly significant advantage over placebo.

For both stages and doses, the response curves of the active-treatment groups and the placebo group diverged almost immediately. By 4 weeks, both measures of CDASI reductions on active therapy were significantly improved relative to placebo, and the response curves had a consistent downward slope through the end of the 12-week study, Dr. Mangold reported.

The majority of patients responded by either of the primary endpoint criteria. For a CDASI reduction of greater than 5 points, the response rates were 100% and 96% for the 150-mg and 600-mg doses of PF-06823859, respectively. The placebo response was 35.7%. For the CDASI reduction of greater than 40%, the rates were 80%, 82.1%, and 7.1% for the 150-mg, 600-mg, and placebo arms, respectively.

“There were no major safety concerns. Most of the treatment-emergent adverse events were mild, and adverse events did not have a relationship to dose,” Dr. Mangold said. Notably, there were no cases of herpes zoster, and infections of any kind were low in all study groups.

A phase 3 study is being planned with the 600-mg dose, according to Dr. Mangold, but he acknowledged that regulatory authorities have generally required endpoints for both cutaneous and muscle manifestations in previous trials of therapies for dermatomyositis.

It is not yet certain that “there will be a carve-out for skin,” he said in answer to a question about investigations moving forward. So far, studies have been focused on skin response. However, a meaningful degree of benefit against muscle involvement, which has not yet been well studied, has not been ruled out.

Even though this is a phase 2 trial with small numbers, it was controlled and blinded, and the potential of an inhibitor of IFN-beta to control the skin manifestations of dermatomyositis “is kind of a big deal,” said Paul Nghiem, MD, PhD, professor of dermatology, University of Washington, Seattle.

“There is definitely an unmet need for better therapies to control the skin involvement,” Dr. Nghiem said.

Hensin Tsao, MD, PhD, clinical director of the Melanoma and Pigmented Lesion Center at Massachusetts General Hospital, Boston, agreed. Like Dr. Nghiem, Dr. Tsao was a panelist during the late-breaker session where the study was presented, and he was impressed by the data.

“This is something that is definitely newsworthy,” Dr. Tsao said.

Dr. Mangold reports financial relationships with Actelion, Amgen, Corbus, Eli Lilly, Incyte, miRagen, Novartis, Regeneron, Solagenix, Sun Pharmaceuticals, Teva, and Pfizer, which provided funding for this trial. Both Dr. Nghiem and Dr. Tsao reported no relevant financial relationships.

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

NEW ORLEANS – A monoclonal antibody targeting interferon-beta (IFN-beta) provided substantial reductions in the skin lesions associated with dermatomyositis in a double-blind, placebo-controlled phase 2 trial, according to results presented as a late-breaker at the annual meeting of the American Academy of Dermatology.

“These findings support the inhibition of IFN-beta as a promising therapeutic strategy in skin-predominant disease,” said principal investigator Aaron Mangold, MD, associate professor of dermatology, Mayo Clinic, Scottsdale, Ariz.

Ted Bosworth/MDedge News

Dermatomyositis, a rare autoimmune inflammatory condition that typically involves both skeletal muscles and skin, is a challenging disease with a diverse set of potential complications.

Immunosuppressive and immunomodulatory agents are used with mixed success for myositis, but skin manifestations, which include papular eruptions, heliotrope rash, photoerythema, burning, and pruritus, are often the most troublesome and the most difficult to control. Treatment options other than immunomodulators that target cutaneous involvement – which include steroids, emollients, and photoprotection – are generally modestly effective, according to Dr. Mangold.
 

Targeting an elevated cytokine

Interest in IFN-beta, which is elevated in the blood of individuals with dermatomyositis, was triggered by evidence that this cytokine plays an important role in driving the skin inflammation, Dr. Mangold explained.

“The blood concentrations of IFN-beta are positively correlated with cutaneous disease activity and severity,” he said.

The study drug, currently known as PF-06823859 (Dazukibart), “is a potent, selective humanized IgG1-neutralizing antibody directed at IFN-beta,” Dr. Mangold said. A dose-ranging phase 1 study published 2 years ago provided evidence of acceptable pharmacokinetics and safety in healthy individuals to support treatment studies for disorders associated with elevated IFN-beta levels. In addition to dermatomyositis, this includes systemic lupus erythematosus.

In this phase 2 trial, patients whose condition was not improved by at least one standard-care therapy for skin manifestations of dermatomyositis were eligible if they had moderate to severe disease as measured with the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), according to Dr. Mangold. During the study, patients were allowed to remain on a disease modifying antirheumatic drug and/or prednisone if they had been on stable doses and did not change the dose.

Richard Usatine, MD

After a screening run-in, the trial had two blinded stages. In stage 1, 30 patients were randomly assigned either to 600 mg of PF-06823859 or to placebo, both administered intravenously every 4 weeks. A second cohort of 25 patients was randomly assigned in stage 2 to placebo, 150 mg of PF-06823859, or 600 mg of PF-06823859. The primary endpoint assessed at 12 weeks was a greater than 5-point reduction in CDASI score or greater than 40% CDASI improvement from baseline.

Both endpoints are associated with a clinically meaningful response in regard to an improved quality of life, Dr. Mangold noted.
 

Both doses better than placebo

In results from the stage 1 portion, the mean reduction in CDASI at 12 weeks after three doses of the assigned therapy was 18.8 points in the active-treatment group versus 3.9 points in the placebo group. In pooled data from stage 1 and 2, the reductions were 16.6 points, 19.2 points, and 2.9 points for the 150-mg, 600-mg, and placebo arms, respectively. Both doses achieved a highly significant advantage over placebo.

For both stages and doses, the response curves of the active-treatment groups and the placebo group diverged almost immediately. By 4 weeks, both measures of CDASI reductions on active therapy were significantly improved relative to placebo, and the response curves had a consistent downward slope through the end of the 12-week study, Dr. Mangold reported.

The majority of patients responded by either of the primary endpoint criteria. For a CDASI reduction of greater than 5 points, the response rates were 100% and 96% for the 150-mg and 600-mg doses of PF-06823859, respectively. The placebo response was 35.7%. For the CDASI reduction of greater than 40%, the rates were 80%, 82.1%, and 7.1% for the 150-mg, 600-mg, and placebo arms, respectively.

“There were no major safety concerns. Most of the treatment-emergent adverse events were mild, and adverse events did not have a relationship to dose,” Dr. Mangold said. Notably, there were no cases of herpes zoster, and infections of any kind were low in all study groups.

A phase 3 study is being planned with the 600-mg dose, according to Dr. Mangold, but he acknowledged that regulatory authorities have generally required endpoints for both cutaneous and muscle manifestations in previous trials of therapies for dermatomyositis.

It is not yet certain that “there will be a carve-out for skin,” he said in answer to a question about investigations moving forward. So far, studies have been focused on skin response. However, a meaningful degree of benefit against muscle involvement, which has not yet been well studied, has not been ruled out.

Even though this is a phase 2 trial with small numbers, it was controlled and blinded, and the potential of an inhibitor of IFN-beta to control the skin manifestations of dermatomyositis “is kind of a big deal,” said Paul Nghiem, MD, PhD, professor of dermatology, University of Washington, Seattle.

“There is definitely an unmet need for better therapies to control the skin involvement,” Dr. Nghiem said.

Hensin Tsao, MD, PhD, clinical director of the Melanoma and Pigmented Lesion Center at Massachusetts General Hospital, Boston, agreed. Like Dr. Nghiem, Dr. Tsao was a panelist during the late-breaker session where the study was presented, and he was impressed by the data.

“This is something that is definitely newsworthy,” Dr. Tsao said.

Dr. Mangold reports financial relationships with Actelion, Amgen, Corbus, Eli Lilly, Incyte, miRagen, Novartis, Regeneron, Solagenix, Sun Pharmaceuticals, Teva, and Pfizer, which provided funding for this trial. Both Dr. Nghiem and Dr. Tsao reported no relevant financial relationships.

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

Hyperhidrosis has a significant impact on a person’s physical, psychological, and social aspects of life. The lack of treatment options and associated stigma limits access to care and treatment options.

Primary hyperhidrosis does not have an underlying cause; is symmetrical; can worsen with anxiety, fear, or stress; and may have a familial component. Palmar and axillary hyperhidrosis are the most common types of hyperhidrosis. The incidence of craniofacial hyperhidrosis has not been clearly defined but it is most commonly reported on the forehead, where the concentration of eccrine sweat glands is highest.

Treatment options for craniofacial hyperhidrosis include topical aluminum chloride, which blocks the eccrine sweat duct or causes eccrine cell atrophy. Although this option is a common treatment for palmar and axillary hyperhidrosis, use on the face has not been thoroughly studied, and may also cause skin irritation.

Topical and oral glycopyrrolate can be effective for all types of hyperhidrosis, but must be used daily and can have systemic side effects, with variable efficacy and longevity. Oral oxybutynin, beta-blockers, clonidine, and benzodiazepines have also been used with some limited studies available in patients with generalized hyperhidrosis.

Surgical treatments such as videothoracoscopy sympathectomy can be used in severe or recalcitrant cases of hyperhidrosis with good efficacy. However, surgical complications and inherent surgical risks limit these treatment options unless other modalities are exhausted.

OnabotulinumtoxinA is Food and Drug Administration approved for treating severe primary axillary hyperhidrosis, but is used off label for palmar, plantar, and craniofacial hyperhidrosis with great results and few side effects. Clinical pearls and guidelines for the use of botulinum toxin A in craniofacial hyperhidrosis were outlined by Wolosker and colleagues in a review article. As with any injection of neurotoxin, knowledge of the facial anatomy is critical to avoiding muscle paralysis.

For patients with craniofacial hyperhidrosis in my practice, I treat the scalp, nose, cheeks, upper lip, and chin with small blebs of botulinum toxin injected in the superficial dermis, double diluted. Treatment effects usually last 3 months, similar to cosmetic uses. Wolosker uses a dilution of 100 U botulinum toxin in 1.0 mL saline, which I find slightly more difficult to control and more likely to have loss of toxin.

In my experience, I have found the following dosing to be most effective with the least side effects for the following (dosages vary and can be titrated up to response):

• Upper lip: 6-10 U.
• Chin: 6-10 U.
• Forehead: 15-30 U. (Avoid 1 cm above the brow unless risks of brow drop are reviewed and acceptable to the patient. In my experience patients would rather have a lower brow than obstructive sweating in their brow that can irritate the eyes, blur vision, and smudge skincare and makeup.)
• Nose: 10 U
• Cheeks: 10 U per side (staying very superficial with injections).
• Scalp: 30-50 U (using serial injections 1-2 cm apart in the area affected by hyperhidrosis).

Side effects include temporary erythema, bruising, and edema, as well as muscle paralysis and asymmetry if proper injection technique is not used, the dose is not diluted properly, or the injection is too deep.

There are scattered case studies of symbiotic techniques to help the penetration of botulinum toxin when treating craniofacial hyperhidrosis, including microneedling, radiofrequency, long-pulsed diode laser, and ultrasound. But the safety and efficacy of these procedures have not been properly evaluated.

In all of my patients with craniofacial hyperhidrosis treated with botulinum toxin, quality of life is significantly improved with almost no complications. Botulinum toxin is a safe, relatively quick in-office procedure to treat craniofacial hyperhidrosis that can be used to help patients – particularly those who experience anxiety or have social and occupational impairment related to their disease.

This procedure is cosmetic in nature, and therefore, not covered by insurance.

Dr. Talakoub is in private practice in McLean, Va. Write to her at [email protected]. She had no relevant disclosures.

References

Parashar K et al. Am J Clin Dermatol. 2023 Mar;24(2):187-98.

Doolittle J et al. Arch Dermatol Res. 2016 Dec;308(10):743-9.

Wolosker N et al. J Vasc Bras. 2020 Nov 16;19:e20190152.

Garcia-Souto F et al. Dermatol Ther. 2021 Jan;34(1):e14658.

Ebrahim H et al. J Clin Aesthet Dermatol. 2022 Sep;15(9):40-4.

Campanati A et al. Toxins (Basel). 2022 May 27;14(6):3727.

Hyperhidrosis has a significant impact on a person’s physical, psychological, and social aspects of life. The lack of treatment options and associated stigma limits access to care and treatment options.

Primary hyperhidrosis does not have an underlying cause; is symmetrical; can worsen with anxiety, fear, or stress; and may have a familial component. Palmar and axillary hyperhidrosis are the most common types of hyperhidrosis. The incidence of craniofacial hyperhidrosis has not been clearly defined but it is most commonly reported on the forehead, where the concentration of eccrine sweat glands is highest.

Treatment options for craniofacial hyperhidrosis include topical aluminum chloride, which blocks the eccrine sweat duct or causes eccrine cell atrophy. Although this option is a common treatment for palmar and axillary hyperhidrosis, use on the face has not been thoroughly studied, and may also cause skin irritation.

Topical and oral glycopyrrolate can be effective for all types of hyperhidrosis, but must be used daily and can have systemic side effects, with variable efficacy and longevity. Oral oxybutynin, beta-blockers, clonidine, and benzodiazepines have also been used with some limited studies available in patients with generalized hyperhidrosis.

Surgical treatments such as videothoracoscopy sympathectomy can be used in severe or recalcitrant cases of hyperhidrosis with good efficacy. However, surgical complications and inherent surgical risks limit these treatment options unless other modalities are exhausted.

OnabotulinumtoxinA is Food and Drug Administration approved for treating severe primary axillary hyperhidrosis, but is used off label for palmar, plantar, and craniofacial hyperhidrosis with great results and few side effects. Clinical pearls and guidelines for the use of botulinum toxin A in craniofacial hyperhidrosis were outlined by Wolosker and colleagues in a review article. As with any injection of neurotoxin, knowledge of the facial anatomy is critical to avoiding muscle paralysis.

For patients with craniofacial hyperhidrosis in my practice, I treat the scalp, nose, cheeks, upper lip, and chin with small blebs of botulinum toxin injected in the superficial dermis, double diluted. Treatment effects usually last 3 months, similar to cosmetic uses. Wolosker uses a dilution of 100 U botulinum toxin in 1.0 mL saline, which I find slightly more difficult to control and more likely to have loss of toxin.

In my experience, I have found the following dosing to be most effective with the least side effects for the following (dosages vary and can be titrated up to response):

• Upper lip: 6-10 U.
• Chin: 6-10 U.
• Forehead: 15-30 U. (Avoid 1 cm above the brow unless risks of brow drop are reviewed and acceptable to the patient. In my experience patients would rather have a lower brow than obstructive sweating in their brow that can irritate the eyes, blur vision, and smudge skincare and makeup.)
• Nose: 10 U
• Cheeks: 10 U per side (staying very superficial with injections).
• Scalp: 30-50 U (using serial injections 1-2 cm apart in the area affected by hyperhidrosis).

Side effects include temporary erythema, bruising, and edema, as well as muscle paralysis and asymmetry if proper injection technique is not used, the dose is not diluted properly, or the injection is too deep.

There are scattered case studies of symbiotic techniques to help the penetration of botulinum toxin when treating craniofacial hyperhidrosis, including microneedling, radiofrequency, long-pulsed diode laser, and ultrasound. But the safety and efficacy of these procedures have not been properly evaluated.

In all of my patients with craniofacial hyperhidrosis treated with botulinum toxin, quality of life is significantly improved with almost no complications. Botulinum toxin is a safe, relatively quick in-office procedure to treat craniofacial hyperhidrosis that can be used to help patients – particularly those who experience anxiety or have social and occupational impairment related to their disease.

This procedure is cosmetic in nature, and therefore, not covered by insurance.

Dr. Talakoub is in private practice in McLean, Va. Write to her at [email protected]. She had no relevant disclosures.

References

Parashar K et al. Am J Clin Dermatol. 2023 Mar;24(2):187-98.

Doolittle J et al. Arch Dermatol Res. 2016 Dec;308(10):743-9.

Wolosker N et al. J Vasc Bras. 2020 Nov 16;19:e20190152.

Garcia-Souto F et al. Dermatol Ther. 2021 Jan;34(1):e14658.

Ebrahim H et al. J Clin Aesthet Dermatol. 2022 Sep;15(9):40-4.

Campanati A et al. Toxins (Basel). 2022 May 27;14(6):3727.

Hyperhidrosis has a significant impact on a person’s physical, psychological, and social aspects of life. The lack of treatment options and associated stigma limits access to care and treatment options.

Primary hyperhidrosis does not have an underlying cause; is symmetrical; can worsen with anxiety, fear, or stress; and may have a familial component. Palmar and axillary hyperhidrosis are the most common types of hyperhidrosis. The incidence of craniofacial hyperhidrosis has not been clearly defined but it is most commonly reported on the forehead, where the concentration of eccrine sweat glands is highest.

Treatment options for craniofacial hyperhidrosis include topical aluminum chloride, which blocks the eccrine sweat duct or causes eccrine cell atrophy. Although this option is a common treatment for palmar and axillary hyperhidrosis, use on the face has not been thoroughly studied, and may also cause skin irritation.

Topical and oral glycopyrrolate can be effective for all types of hyperhidrosis, but must be used daily and can have systemic side effects, with variable efficacy and longevity. Oral oxybutynin, beta-blockers, clonidine, and benzodiazepines have also been used with some limited studies available in patients with generalized hyperhidrosis.

Surgical treatments such as videothoracoscopy sympathectomy can be used in severe or recalcitrant cases of hyperhidrosis with good efficacy. However, surgical complications and inherent surgical risks limit these treatment options unless other modalities are exhausted.

OnabotulinumtoxinA is Food and Drug Administration approved for treating severe primary axillary hyperhidrosis, but is used off label for palmar, plantar, and craniofacial hyperhidrosis with great results and few side effects. Clinical pearls and guidelines for the use of botulinum toxin A in craniofacial hyperhidrosis were outlined by Wolosker and colleagues in a review article. As with any injection of neurotoxin, knowledge of the facial anatomy is critical to avoiding muscle paralysis.

For patients with craniofacial hyperhidrosis in my practice, I treat the scalp, nose, cheeks, upper lip, and chin with small blebs of botulinum toxin injected in the superficial dermis, double diluted. Treatment effects usually last 3 months, similar to cosmetic uses. Wolosker uses a dilution of 100 U botulinum toxin in 1.0 mL saline, which I find slightly more difficult to control and more likely to have loss of toxin.

In my experience, I have found the following dosing to be most effective with the least side effects for the following (dosages vary and can be titrated up to response):

• Upper lip: 6-10 U.
• Chin: 6-10 U.
• Forehead: 15-30 U. (Avoid 1 cm above the brow unless risks of brow drop are reviewed and acceptable to the patient. In my experience patients would rather have a lower brow than obstructive sweating in their brow that can irritate the eyes, blur vision, and smudge skincare and makeup.)
• Nose: 10 U
• Cheeks: 10 U per side (staying very superficial with injections).
• Scalp: 30-50 U (using serial injections 1-2 cm apart in the area affected by hyperhidrosis).

Side effects include temporary erythema, bruising, and edema, as well as muscle paralysis and asymmetry if proper injection technique is not used, the dose is not diluted properly, or the injection is too deep.

There are scattered case studies of symbiotic techniques to help the penetration of botulinum toxin when treating craniofacial hyperhidrosis, including microneedling, radiofrequency, long-pulsed diode laser, and ultrasound. But the safety and efficacy of these procedures have not been properly evaluated.

In all of my patients with craniofacial hyperhidrosis treated with botulinum toxin, quality of life is significantly improved with almost no complications. Botulinum toxin is a safe, relatively quick in-office procedure to treat craniofacial hyperhidrosis that can be used to help patients – particularly those who experience anxiety or have social and occupational impairment related to their disease.

This procedure is cosmetic in nature, and therefore, not covered by insurance.

Dr. Talakoub is in private practice in McLean, Va. Write to her at [email protected]. She had no relevant disclosures.

References

Parashar K et al. Am J Clin Dermatol. 2023 Mar;24(2):187-98.

Doolittle J et al. Arch Dermatol Res. 2016 Dec;308(10):743-9.

Wolosker N et al. J Vasc Bras. 2020 Nov 16;19:e20190152.

Garcia-Souto F et al. Dermatol Ther. 2021 Jan;34(1):e14658.

Ebrahim H et al. J Clin Aesthet Dermatol. 2022 Sep;15(9):40-4.

Campanati A et al. Toxins (Basel). 2022 May 27;14(6):3727.

NEW ORLEANS – In two phase 3 trials, bimekizumab, a monoclonal antibody targeting two types of interleukin-17 — IL-17A and IL-17F — reduced the abscess and inflammatory nodule count better than placebo in the chronic inflammatory skin condition hidradenitis suppurativa (HS), according to results presented together during a late-breaker session at the annual meeting of the American Academy of Dermatology.

“We are very excited to add this data to what we already have around IL-17 inhibition. This clearly validates this target for the control of HS,” reported lead investigator Alexa B. Kimball, MD, MPH, professor of dermatology at Harvard Medical School and Beth Israel Deaconess Medical Center, both in Boston.

Ted Bosworth

The trials, called BE HEARD I and BE HEARD II, enrolled 505 and 509 patients with HS, respectively. About 50% of patients in BE HEARD I and 60% of patients in BE HEARD II had Hurley stage 3 disease, which is the most severe of the three stratifications. The remainder were in Hurley stage 2. The mean duration of HS was 8.3 and 7.1 years, respectively.

Patients in both studies were randomized to one of four groups – either to a dosing regimen of 320 mg of bimekizumab administered by subcutaneous injection or to a placebo group. Both trials comprised double-blind 16-week initial and 32-week maintenance treatment periods.

In one experimental group, bimekizumab was given once every 2 weeks for the full course of the 48-week study (Q2W/Q2W). In another, patients started on the every-2-week schedule for 16 weeks and then were switched to every-4-week dosing (Q2W/Q4W). In the third group, patients started and remained on the every-4-week schedule (Q4W/Q4W). Patients in a fourth group started on placebo and switched at 16 weeks to the every-2-week bimekizumab schedule (placebo/Q2W).
 

Results at primary endpoint

The primary endpoint was HiSCR50, signifying a 50% reduction from baseline in abscess and inflammatory nodule count on the Hidradenitis Suppurativa Clinical Response (HiSCR) assessment tool. At 16 weeks, the initial Q2W dose in two of the groups outperformed the placebo in both BE HEARD I (47.8% vs. 28.7%) and BE HEARD II (52.0% vs. 32.2%). The response rates in the Q4W arm in BE HEARD I (45.3%) and BE HEARD II (53.8%) were also higher than the placebo, but the difference was only significant in BE HEARD II.

At 48 weeks, the proportion of patients with an HiSCR50 response climbed in all groups in both trials. The patterns were generally the same with slightly higher numerical responses among the groups that received the every-2-week dosing schedule relative to the every-4-week schedule.

In BE HEARD I at 48 weeks, the HiSCR50 response rate was about 60% for those who started and remained on every-2-week bimekizumab (Q2W/Q2W) or were switched at 16 weeks to every-4-week bimekizumab (Q2W/Q4W). For those who started and remained on every-4-week bimekizumab and the group started on placebo and switched to every-2-week bimekizumab, the response rates were 52.7% and 45.3%, respectively.  

In BE HEARD II, the HiSCR50 response rates were higher in all groups, including the placebo, and the patterns of response were similar at 48 weeks. Most patients reached the HiSCR50 response – 79.8% (Q2W/Q2W), 78.4% (Q2W/Q4W), 76.7% (Q4W/Q4W), and 65.9 % (placebo/Q2W) of patients.

It is notable that, although there was rapid increase in the proportion of placebo patients reaching HiSCR50 after the switch at 16 weeks, there appeared to be an advantage at 48 weeks for starting on full-dose bimekizumab over starting on placebo.

In this trial, patients were listed as nonresponders if they received antibiotics at any time and for any reason after randomization. This might have concealed an even greater benefit of bimekizumab, Dr. Kimball said, but the study design element was considered necessary to isolate the activity of the study drug.

“In future HS trials, it will be helpful to address the difficulty of handling the impact of antibiotics and pain medications [in assessing results],” Dr. Kimball said.

Clinically meaningful secondary endpoint

For HS patients, the secondary endpoint of HiSCR75 might be considered the most meaningful, according to Dr. Kimball. She said that this higher bar not only documents a higher level of efficacy but correlates with meaningful improvement in quality of life. In the two trials combined, more than 55% of patients on continuous bimekizumab achieved HiSCR75 at week 48 in the observed case analysis, according to a news release from biopharmaceutical company UCB, developer of bimekizumab.

In BE HEARD I, the HiSCR75 rates were 33.4% and 24.7% for the every-2-week and every-4-week bimekizumab doses, respectively. The 33.4% response was statistically superior to placebo (18.4%). In BE HEARD II, both the every-2-week dose (35.7%) and the every-4-week dose (33.7%) were superior to the 15.6% response in placebo patients.

The improvements in quality of life as measured with the Dermatology Life Quality Index (DLQI), reflected the changes in disease activity. Relative to about a 3-point reduction from baseline in the placebo groups of the two trials, the 5-point reduction for either the 2-week or 4-week bimekizumab groups in each clinical trial were highly significant, Dr. Kimball said.

Bimekizumab was relatively well tolerated, although it shares the increased risk for candidiasis observed with this agent when used in psoriasis and with other IL-17 inhibitors, such as secukinumab (Cosentyx), in general. The risk of candidiasis appeared to be dose related, but cases were generally mild and easily managed, according to Dr. Kimball. She noted that only three patients discontinued treatment for this reason. Discontinuations for a treatment-related adverse event overall was less than 4% at 16 weeks.

This is only the third phase 3 trial ever completed in patients with HS. In fact, Dr. Kimball has led all of the phase 3 trials so far, including clinical studies of adalimumab (Humira), published in 2016, and of secukinumab, published earlier this year. All were positive studies.

“This is amazing news for our patients,” Dr. Kimball said. HS remains a challenging disease, even with a growing number of options showing benefit in large studies, she said, and the high rate of response, particularly at the level of HiSCR75, “is a huge milestone for what we can achieve.”
 

Multiple treatment options important

Her assessment was echoed by other experts, including Christopher J. Sayed, MD, an associate professor of dermatology at the University of North Carolina at Chapel Hill, who publishes frequently about this disease.

“It is incredibly exciting to see the strong phase 3 data on bimekizumab, particularly the deep responses at the HiSCR75 in a majority of patients after the first year,” he said.

Importantly, he does not see the growing array of treatment options as necessarily competitive for a disease with heterogeneous manifestations and variable responses to any one agent.

“While this may be a major step forward, it will still be critical to see more drugs come along for those who do not respond fully enough or have comorbidities that prevent the use of IL-17 and TNF [tumor necrosis factor] antagonists,” he said.

Bimekizumab is not approved for any indication in the United States; it is approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy in the EU/EEA, where it is marketed as Bimzelx, according to UCB. Dr. Kimball reports financial relationships with AbbVie, Janssen, Kymera, Lilly, Novartis, Pfizer, and UCB. Dr. Sayed reports financial relationships with AbbVie, InflaRx, and UCB.
 

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

NEW ORLEANS – In two phase 3 trials, bimekizumab, a monoclonal antibody targeting two types of interleukin-17 — IL-17A and IL-17F — reduced the abscess and inflammatory nodule count better than placebo in the chronic inflammatory skin condition hidradenitis suppurativa (HS), according to results presented together during a late-breaker session at the annual meeting of the American Academy of Dermatology.

“We are very excited to add this data to what we already have around IL-17 inhibition. This clearly validates this target for the control of HS,” reported lead investigator Alexa B. Kimball, MD, MPH, professor of dermatology at Harvard Medical School and Beth Israel Deaconess Medical Center, both in Boston.

Ted Bosworth

The trials, called BE HEARD I and BE HEARD II, enrolled 505 and 509 patients with HS, respectively. About 50% of patients in BE HEARD I and 60% of patients in BE HEARD II had Hurley stage 3 disease, which is the most severe of the three stratifications. The remainder were in Hurley stage 2. The mean duration of HS was 8.3 and 7.1 years, respectively.

Patients in both studies were randomized to one of four groups – either to a dosing regimen of 320 mg of bimekizumab administered by subcutaneous injection or to a placebo group. Both trials comprised double-blind 16-week initial and 32-week maintenance treatment periods.

In one experimental group, bimekizumab was given once every 2 weeks for the full course of the 48-week study (Q2W/Q2W). In another, patients started on the every-2-week schedule for 16 weeks and then were switched to every-4-week dosing (Q2W/Q4W). In the third group, patients started and remained on the every-4-week schedule (Q4W/Q4W). Patients in a fourth group started on placebo and switched at 16 weeks to the every-2-week bimekizumab schedule (placebo/Q2W).
 

Results at primary endpoint

The primary endpoint was HiSCR50, signifying a 50% reduction from baseline in abscess and inflammatory nodule count on the Hidradenitis Suppurativa Clinical Response (HiSCR) assessment tool. At 16 weeks, the initial Q2W dose in two of the groups outperformed the placebo in both BE HEARD I (47.8% vs. 28.7%) and BE HEARD II (52.0% vs. 32.2%). The response rates in the Q4W arm in BE HEARD I (45.3%) and BE HEARD II (53.8%) were also higher than the placebo, but the difference was only significant in BE HEARD II.

At 48 weeks, the proportion of patients with an HiSCR50 response climbed in all groups in both trials. The patterns were generally the same with slightly higher numerical responses among the groups that received the every-2-week dosing schedule relative to the every-4-week schedule.

In BE HEARD I at 48 weeks, the HiSCR50 response rate was about 60% for those who started and remained on every-2-week bimekizumab (Q2W/Q2W) or were switched at 16 weeks to every-4-week bimekizumab (Q2W/Q4W). For those who started and remained on every-4-week bimekizumab and the group started on placebo and switched to every-2-week bimekizumab, the response rates were 52.7% and 45.3%, respectively.  

In BE HEARD II, the HiSCR50 response rates were higher in all groups, including the placebo, and the patterns of response were similar at 48 weeks. Most patients reached the HiSCR50 response – 79.8% (Q2W/Q2W), 78.4% (Q2W/Q4W), 76.7% (Q4W/Q4W), and 65.9 % (placebo/Q2W) of patients.

It is notable that, although there was rapid increase in the proportion of placebo patients reaching HiSCR50 after the switch at 16 weeks, there appeared to be an advantage at 48 weeks for starting on full-dose bimekizumab over starting on placebo.

In this trial, patients were listed as nonresponders if they received antibiotics at any time and for any reason after randomization. This might have concealed an even greater benefit of bimekizumab, Dr. Kimball said, but the study design element was considered necessary to isolate the activity of the study drug.

“In future HS trials, it will be helpful to address the difficulty of handling the impact of antibiotics and pain medications [in assessing results],” Dr. Kimball said.

Clinically meaningful secondary endpoint

For HS patients, the secondary endpoint of HiSCR75 might be considered the most meaningful, according to Dr. Kimball. She said that this higher bar not only documents a higher level of efficacy but correlates with meaningful improvement in quality of life. In the two trials combined, more than 55% of patients on continuous bimekizumab achieved HiSCR75 at week 48 in the observed case analysis, according to a news release from biopharmaceutical company UCB, developer of bimekizumab.

In BE HEARD I, the HiSCR75 rates were 33.4% and 24.7% for the every-2-week and every-4-week bimekizumab doses, respectively. The 33.4% response was statistically superior to placebo (18.4%). In BE HEARD II, both the every-2-week dose (35.7%) and the every-4-week dose (33.7%) were superior to the 15.6% response in placebo patients.

The improvements in quality of life as measured with the Dermatology Life Quality Index (DLQI), reflected the changes in disease activity. Relative to about a 3-point reduction from baseline in the placebo groups of the two trials, the 5-point reduction for either the 2-week or 4-week bimekizumab groups in each clinical trial were highly significant, Dr. Kimball said.

Bimekizumab was relatively well tolerated, although it shares the increased risk for candidiasis observed with this agent when used in psoriasis and with other IL-17 inhibitors, such as secukinumab (Cosentyx), in general. The risk of candidiasis appeared to be dose related, but cases were generally mild and easily managed, according to Dr. Kimball. She noted that only three patients discontinued treatment for this reason. Discontinuations for a treatment-related adverse event overall was less than 4% at 16 weeks.

This is only the third phase 3 trial ever completed in patients with HS. In fact, Dr. Kimball has led all of the phase 3 trials so far, including clinical studies of adalimumab (Humira), published in 2016, and of secukinumab, published earlier this year. All were positive studies.

“This is amazing news for our patients,” Dr. Kimball said. HS remains a challenging disease, even with a growing number of options showing benefit in large studies, she said, and the high rate of response, particularly at the level of HiSCR75, “is a huge milestone for what we can achieve.”
 

Multiple treatment options important

Her assessment was echoed by other experts, including Christopher J. Sayed, MD, an associate professor of dermatology at the University of North Carolina at Chapel Hill, who publishes frequently about this disease.

“It is incredibly exciting to see the strong phase 3 data on bimekizumab, particularly the deep responses at the HiSCR75 in a majority of patients after the first year,” he said.

Importantly, he does not see the growing array of treatment options as necessarily competitive for a disease with heterogeneous manifestations and variable responses to any one agent.

“While this may be a major step forward, it will still be critical to see more drugs come along for those who do not respond fully enough or have comorbidities that prevent the use of IL-17 and TNF [tumor necrosis factor] antagonists,” he said.

Bimekizumab is not approved for any indication in the United States; it is approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy in the EU/EEA, where it is marketed as Bimzelx, according to UCB. Dr. Kimball reports financial relationships with AbbVie, Janssen, Kymera, Lilly, Novartis, Pfizer, and UCB. Dr. Sayed reports financial relationships with AbbVie, InflaRx, and UCB.
 

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

NEW ORLEANS – In two phase 3 trials, bimekizumab, a monoclonal antibody targeting two types of interleukin-17 — IL-17A and IL-17F — reduced the abscess and inflammatory nodule count better than placebo in the chronic inflammatory skin condition hidradenitis suppurativa (HS), according to results presented together during a late-breaker session at the annual meeting of the American Academy of Dermatology.

“We are very excited to add this data to what we already have around IL-17 inhibition. This clearly validates this target for the control of HS,” reported lead investigator Alexa B. Kimball, MD, MPH, professor of dermatology at Harvard Medical School and Beth Israel Deaconess Medical Center, both in Boston.

Ted Bosworth

The trials, called BE HEARD I and BE HEARD II, enrolled 505 and 509 patients with HS, respectively. About 50% of patients in BE HEARD I and 60% of patients in BE HEARD II had Hurley stage 3 disease, which is the most severe of the three stratifications. The remainder were in Hurley stage 2. The mean duration of HS was 8.3 and 7.1 years, respectively.

Patients in both studies were randomized to one of four groups – either to a dosing regimen of 320 mg of bimekizumab administered by subcutaneous injection or to a placebo group. Both trials comprised double-blind 16-week initial and 32-week maintenance treatment periods.

In one experimental group, bimekizumab was given once every 2 weeks for the full course of the 48-week study (Q2W/Q2W). In another, patients started on the every-2-week schedule for 16 weeks and then were switched to every-4-week dosing (Q2W/Q4W). In the third group, patients started and remained on the every-4-week schedule (Q4W/Q4W). Patients in a fourth group started on placebo and switched at 16 weeks to the every-2-week bimekizumab schedule (placebo/Q2W).
 

Results at primary endpoint

The primary endpoint was HiSCR50, signifying a 50% reduction from baseline in abscess and inflammatory nodule count on the Hidradenitis Suppurativa Clinical Response (HiSCR) assessment tool. At 16 weeks, the initial Q2W dose in two of the groups outperformed the placebo in both BE HEARD I (47.8% vs. 28.7%) and BE HEARD II (52.0% vs. 32.2%). The response rates in the Q4W arm in BE HEARD I (45.3%) and BE HEARD II (53.8%) were also higher than the placebo, but the difference was only significant in BE HEARD II.

At 48 weeks, the proportion of patients with an HiSCR50 response climbed in all groups in both trials. The patterns were generally the same with slightly higher numerical responses among the groups that received the every-2-week dosing schedule relative to the every-4-week schedule.

In BE HEARD I at 48 weeks, the HiSCR50 response rate was about 60% for those who started and remained on every-2-week bimekizumab (Q2W/Q2W) or were switched at 16 weeks to every-4-week bimekizumab (Q2W/Q4W). For those who started and remained on every-4-week bimekizumab and the group started on placebo and switched to every-2-week bimekizumab, the response rates were 52.7% and 45.3%, respectively.  

In BE HEARD II, the HiSCR50 response rates were higher in all groups, including the placebo, and the patterns of response were similar at 48 weeks. Most patients reached the HiSCR50 response – 79.8% (Q2W/Q2W), 78.4% (Q2W/Q4W), 76.7% (Q4W/Q4W), and 65.9 % (placebo/Q2W) of patients.

It is notable that, although there was rapid increase in the proportion of placebo patients reaching HiSCR50 after the switch at 16 weeks, there appeared to be an advantage at 48 weeks for starting on full-dose bimekizumab over starting on placebo.

In this trial, patients were listed as nonresponders if they received antibiotics at any time and for any reason after randomization. This might have concealed an even greater benefit of bimekizumab, Dr. Kimball said, but the study design element was considered necessary to isolate the activity of the study drug.

“In future HS trials, it will be helpful to address the difficulty of handling the impact of antibiotics and pain medications [in assessing results],” Dr. Kimball said.

Clinically meaningful secondary endpoint

For HS patients, the secondary endpoint of HiSCR75 might be considered the most meaningful, according to Dr. Kimball. She said that this higher bar not only documents a higher level of efficacy but correlates with meaningful improvement in quality of life. In the two trials combined, more than 55% of patients on continuous bimekizumab achieved HiSCR75 at week 48 in the observed case analysis, according to a news release from biopharmaceutical company UCB, developer of bimekizumab.

In BE HEARD I, the HiSCR75 rates were 33.4% and 24.7% for the every-2-week and every-4-week bimekizumab doses, respectively. The 33.4% response was statistically superior to placebo (18.4%). In BE HEARD II, both the every-2-week dose (35.7%) and the every-4-week dose (33.7%) were superior to the 15.6% response in placebo patients.

The improvements in quality of life as measured with the Dermatology Life Quality Index (DLQI), reflected the changes in disease activity. Relative to about a 3-point reduction from baseline in the placebo groups of the two trials, the 5-point reduction for either the 2-week or 4-week bimekizumab groups in each clinical trial were highly significant, Dr. Kimball said.

Bimekizumab was relatively well tolerated, although it shares the increased risk for candidiasis observed with this agent when used in psoriasis and with other IL-17 inhibitors, such as secukinumab (Cosentyx), in general. The risk of candidiasis appeared to be dose related, but cases were generally mild and easily managed, according to Dr. Kimball. She noted that only three patients discontinued treatment for this reason. Discontinuations for a treatment-related adverse event overall was less than 4% at 16 weeks.

This is only the third phase 3 trial ever completed in patients with HS. In fact, Dr. Kimball has led all of the phase 3 trials so far, including clinical studies of adalimumab (Humira), published in 2016, and of secukinumab, published earlier this year. All were positive studies.

“This is amazing news for our patients,” Dr. Kimball said. HS remains a challenging disease, even with a growing number of options showing benefit in large studies, she said, and the high rate of response, particularly at the level of HiSCR75, “is a huge milestone for what we can achieve.”
 

Multiple treatment options important

Her assessment was echoed by other experts, including Christopher J. Sayed, MD, an associate professor of dermatology at the University of North Carolina at Chapel Hill, who publishes frequently about this disease.

“It is incredibly exciting to see the strong phase 3 data on bimekizumab, particularly the deep responses at the HiSCR75 in a majority of patients after the first year,” he said.

Importantly, he does not see the growing array of treatment options as necessarily competitive for a disease with heterogeneous manifestations and variable responses to any one agent.

“While this may be a major step forward, it will still be critical to see more drugs come along for those who do not respond fully enough or have comorbidities that prevent the use of IL-17 and TNF [tumor necrosis factor] antagonists,” he said.

Bimekizumab is not approved for any indication in the United States; it is approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy in the EU/EEA, where it is marketed as Bimzelx, according to UCB. Dr. Kimball reports financial relationships with AbbVie, Janssen, Kymera, Lilly, Novartis, Pfizer, and UCB. Dr. Sayed reports financial relationships with AbbVie, InflaRx, and UCB.
 

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

Baily Nagle, vice president of her graduating class at Harvard Medical School, Boston, celebrated “the luck of the Irish” on St. Patrick’s Day that allowed her to match into her chosen specialty and top choice of residency programs: anesthesia at Brigham and Women’s Hospital.

“I am feeling very excited and relieved – I matched,” she said in an interview upon hearing her good fortune on Match Monday, March 13. She had a similar reaction on Match Day, March 17. “After a lot of long nights and hard work, happy to have it pay off.”

Ms. Nagle was so determined to match into her specialty that she didn’t have any other specialties in mind as a backup.

The annual process of matching medical school graduates with compatible residency programs is an emotional roller coaster for all applicants, their personal March Madness, so to speak. But Ms. Nagle was one of the more fortunate applicants. She didn’t have to confront the heartbreak other applicants felt when the National Resident Matching Program (NRMP) announced results of the main residency match and the Supplemental Offer and Acceptance Program (SOAP), which offers alternate programs for unfilled positions or unmatched applicants.

During the 2023 Match process, this news organization has been following a handful of students, checking in with them periodically for updates on their progress. Most of them matched successfully, but at least one international medical graduate (IMG) did not. What the others have in common is that their hearts were set on a chosen specialty. Like Ms. Nagle, another student banked on landing his chosen specialty without a backup plan, whereas another said that she’d continue through the SOAP if she didn’t match successfully.

Overall, Match Day resulted in a record number of residency positions offered, most notably in primary care, which “hit an all-time high,” according to NRMP President and CEO Donna L. Lamb, DHSc, MBA, BSN. The number of positions has “consistently increased over the past 5 years, and most importantly the fill rate for primary care has remained steady,” Dr.. Lamb noted in the NRMP release of Match Day results. The release coincided with students learning through emails at noon Eastern Time to which residency or supplemental programs they were matched.

Though more applicants registered for the Match in 2023 than in 2022 – driven primarily by non-U.S. IMGs – the NRMP stated that it was surprised by the decrease in U.S. MD senior applicants.

U.S. MD seniors had a nearly 94% Match rate, a small increase over 2022. U.S. citizen IMGs saw a nearly 68% Match rate, which NRMP reported as an “all-time high” and about six percentage points over in 2022, whereas non-U.S. IMGs had a nearly 60% Match rate, a 1.3 percentage point increase over 2022.

Among the specialties that filled all available positions in 2023 were orthopedic surgery, plastic surgery (integrated), and radiology – diagnostic and thoracic surgery.
 

Not everyone matches

On March 13, the American College of Emergency Physicians issued a joint statement with other emergency medicine (EM) organizations about a high rate of unfilled EM positions expected in 2023.

NRMP acknowledged March 17 that 554 positions remained unfilled, an increase of 335 more unfilled positions than 2022. NRMP attributed the increase in unfilled positions in part to a decrease in the number of U.S. MD and U.S. DO seniors who submitted ranks for the specialty, which “could reflect changing applicant interests or projections about workforce opportunities post residency.”

Applicants who didn’t match usually try to obtain an unfilled position through SOAP. In 2023, 2,685 positions were unfilled after the matching algorithm was processed, an increase of nearly 19% over 2022. The vast majority of those positions were placed in SOAP, an increase of 17.5% over 2022.

Asim Ansari was one of the unlucky ones. Mr. Ansari was trying to match for the fifth time. He was unsuccessful in doing so again in 2023 in the Match and SOAP. Still, he was offered and accepted a child and adolescent psychiatry fellowship at Kansas University Medical Center in Kansas City. Psychiatry was his chosen specialty, so he was “feeling good. It’s a nice place to go to do the next 2 years.”

Mr. Ansari, who started the #MatchMadness support group for unmatched doctors on Twitter Spaces, was quick to cheer on his fellow matching peers on March 13 while revealing his own fate: “Congratulations to everyone who matched!!! Y’all are amazing. So proud of each one of you!!! I didn’t.”

Soon after the results, #MatchMadness held a #Soap2023 support session, and Mr. Ansari sought advice for those willing to review SOAP applications. Elsewhere on Twitter Match Day threads, a few doctors offered their support to those who planned to SOAP, students announced their matches, and others either congratulated or encouraged those still trying to match.
 

Couples match

Not everyone who matched considered the alternative. Before March 13, William Boyer said that he hadn’t given much thought to what would happen if he didn’t match because he was “optimistically confident” he would match into his chosen EM specialty. But he did and got his top choice of programs: Yale New Haven (Conn.) Hospital.

“I feel great,” he said in an interview. “I was definitely nervous opening the envelope” that revealed his residency program, “but there was a rush of relief” when he saw he landed Yale.

Earlier in the match cycle, he said in an interview that he “interviewed at a few ‘reach’ programs, so I hope I don’t match lower than expected on my rank list.”

Mr. Boyer considers himself “a mature applicant,” entering the University of South Carolina, Columbia, after 4 years as an insurance broker.

“I am celebrating today by playing pickleball with a few close medical friends who also matched this morning,” Mr. Boyer said on March 13. “I definitely had periods of nervousness leading up to this morning though that quickly turned into joy and relief” after learning he matched.

Mr. Boyer believes that his professional experience in the insurance industry and health care lobbying efforts with the National Association of Health Underwriters set him apart from other applicants.

“I changed careers to pursue this aspiration, which demonstrates my full dedication to the medical profession.”

He applied to 48 programs and was offered interviews to nearly half. Mr. Boyer visited the majority of those virtually. He said he targeted programs close to where his and his partner’s families are located: Massachusetts, North Carolina, and Texas. “My partner, who I met in medical school, matched into ortho as well so the whole household is very happy,” Mr. Boyer said.

She matched into her top choice as well on March 17, though a distance away at UT Health in San Antonio, he said. “We are both ecstatic. We both got our no. 1 choice. That was the plan going into it. We will make it work. I have 4 weeks of vacation.”

In his program choices, Mr. Boyer prioritized access to nature, minimal leadership turnover, a mix of clinical training sites, and adequate elective rotations and fellowship opportunities, such as in wilderness medicine and health policy.

NRMP reported that there were 1,239 couples participating in the Match; 1,095 had both partners match, and 114 had one partner match to residency training programs for a match rate of 93%.

Like Mr. Boyer, Hannah Hedriana matched into EM, one of the more popular despite the reported unfilled positions. In the past few years, it has consistently been one of the fastest-growing specialties, according to the NRMP.

Still Ms. Hedriana had a fall-back plan. “If I don’t match, then I do plan on going through SOAP. With the number of EM spots that were unfilled in 2022, there’s a chance I could still be an EM physician, but if not, then that’s okay with me.”

Her reaction on March 13, after learning she matched? “Super excited, celebrating with my friends right now.” On Match Day, she said she was “ecstatic” to be matched into Lakeland (Fla.) Regional Health. “This was my first choice so now I can stay close to family and friends,” she said in an interview soon after the results were released.

A first-generation, Filipino American student from the University of South Florida, Tampa, Ms. Hedriana comes from a family of health care professionals. Her father is a respiratory therapist turned physical therapist; her mother a registered nurse. Her sister is a patient care technician applying to nursing school.

Ms. Hedriana applied to 70 programs and interviewed mostly online with 24. Her goal was to stay on the East Coast.

“My partner is a licensed dentist in the state of Florida, and so for his career it would be more practical to stay in state, rather than get relicensed in another state, which could take months,” she said earlier in the matching cycle. “However, when we discussed choosing a residency program, he ultimately left it up to me and wanted me to pick where I thought I’d flourish best,” Ms. Hedriana said, adding that her family lives in Florida, too.

She said she sought a residency program that values family and teamwork.

“A program gets more points in my book if they have sites at nonprofit hospitals or has residents that regularly volunteer throughout their communities or participate in DEI [diversity, equity, and inclusion] initiatives.”

Ms. Hedriana noted that some specialties exclusively offered virtual interviews in 2023, whereas other specialties favored in-person interviews. “This year, many of my classmates were able to do multiple away rotations, which they saw as a positive regarding their chances of matching.” During COVID, in-person visits were limited.

“However, I’ve noticed that many of my classmates are not fond of the signaling aspect that was present for this year’s cycle,” she said. Signaling is a relatively new process that allows applicants to indicate interest in a limited number of residency programs. Not all residencies participate, but it’s growing in popularity among specialties, according to the American Medical Association.
 

‘Extremely competitive’

Ms. Nagle, a second lieutenant in the U.S. Air Force, applied to 12 programs and interviewed with half of them online. She said that she wasn’t targeting any specific type of program through the match.

“I believe you can get phenomenal training anywhere where you mesh with the residents and leadership. My ultimate priority is to (1) be near good people, (2) be near good food (Indian and Thai are a must), and (3) be near an international airport so I can flee the country during breaks.”

Meanwhile, she said that she found the application process, in which students have to articulate their entire medical school experience, extremely competitive. “I think this process is so easy to get wound up in and the anxiety can be palpable,” Ms. Nagle said. “People around you match your energy. So if you are a ball of anxiety then so are your attendings and residents – and that doesn’t bode well for passing the ‘do I want to be on call with them’ test.”

Looking back at medical school, Ms. Nagle recalled having a baby named after her during her first anesthesia rotation and being featured on The Kelly Clarkson Show. Ms. Nagle said that she had walked into the delivery room where new parents had been debating names of babies beginning with the letter B. “And when I introduced myself, they looked at each other and said, ‘Yep, that’s the one.’”

Mr. Boyer recounted how the majority of his medical school experience involved online education. “Roughly two-thirds of my first year was in-person prior to the pandemic. However, from spring break first year to in-person clinical rotations at the beginning of third year, we were all virtual. While I missed interacting with my classmates, I benefited from the virtual learning environment as I learn more efficiently from reading and visual aids than auditory lectures.”

Ms. Hedriana cited the friends and memories she made while learning to be a doctor. “Medical school was hard, but I wouldn’t have changed a thing.”

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

Baily Nagle, vice president of her graduating class at Harvard Medical School, Boston, celebrated “the luck of the Irish” on St. Patrick’s Day that allowed her to match into her chosen specialty and top choice of residency programs: anesthesia at Brigham and Women’s Hospital.

“I am feeling very excited and relieved – I matched,” she said in an interview upon hearing her good fortune on Match Monday, March 13. She had a similar reaction on Match Day, March 17. “After a lot of long nights and hard work, happy to have it pay off.”

Ms. Nagle was so determined to match into her specialty that she didn’t have any other specialties in mind as a backup.

The annual process of matching medical school graduates with compatible residency programs is an emotional roller coaster for all applicants, their personal March Madness, so to speak. But Ms. Nagle was one of the more fortunate applicants. She didn’t have to confront the heartbreak other applicants felt when the National Resident Matching Program (NRMP) announced results of the main residency match and the Supplemental Offer and Acceptance Program (SOAP), which offers alternate programs for unfilled positions or unmatched applicants.

During the 2023 Match process, this news organization has been following a handful of students, checking in with them periodically for updates on their progress. Most of them matched successfully, but at least one international medical graduate (IMG) did not. What the others have in common is that their hearts were set on a chosen specialty. Like Ms. Nagle, another student banked on landing his chosen specialty without a backup plan, whereas another said that she’d continue through the SOAP if she didn’t match successfully.

Overall, Match Day resulted in a record number of residency positions offered, most notably in primary care, which “hit an all-time high,” according to NRMP President and CEO Donna L. Lamb, DHSc, MBA, BSN. The number of positions has “consistently increased over the past 5 years, and most importantly the fill rate for primary care has remained steady,” Dr.. Lamb noted in the NRMP release of Match Day results. The release coincided with students learning through emails at noon Eastern Time to which residency or supplemental programs they were matched.

Though more applicants registered for the Match in 2023 than in 2022 – driven primarily by non-U.S. IMGs – the NRMP stated that it was surprised by the decrease in U.S. MD senior applicants.

U.S. MD seniors had a nearly 94% Match rate, a small increase over 2022. U.S. citizen IMGs saw a nearly 68% Match rate, which NRMP reported as an “all-time high” and about six percentage points over in 2022, whereas non-U.S. IMGs had a nearly 60% Match rate, a 1.3 percentage point increase over 2022.

Among the specialties that filled all available positions in 2023 were orthopedic surgery, plastic surgery (integrated), and radiology – diagnostic and thoracic surgery.
 

Not everyone matches

On March 13, the American College of Emergency Physicians issued a joint statement with other emergency medicine (EM) organizations about a high rate of unfilled EM positions expected in 2023.

NRMP acknowledged March 17 that 554 positions remained unfilled, an increase of 335 more unfilled positions than 2022. NRMP attributed the increase in unfilled positions in part to a decrease in the number of U.S. MD and U.S. DO seniors who submitted ranks for the specialty, which “could reflect changing applicant interests or projections about workforce opportunities post residency.”

Applicants who didn’t match usually try to obtain an unfilled position through SOAP. In 2023, 2,685 positions were unfilled after the matching algorithm was processed, an increase of nearly 19% over 2022. The vast majority of those positions were placed in SOAP, an increase of 17.5% over 2022.

Asim Ansari was one of the unlucky ones. Mr. Ansari was trying to match for the fifth time. He was unsuccessful in doing so again in 2023 in the Match and SOAP. Still, he was offered and accepted a child and adolescent psychiatry fellowship at Kansas University Medical Center in Kansas City. Psychiatry was his chosen specialty, so he was “feeling good. It’s a nice place to go to do the next 2 years.”

Mr. Ansari, who started the #MatchMadness support group for unmatched doctors on Twitter Spaces, was quick to cheer on his fellow matching peers on March 13 while revealing his own fate: “Congratulations to everyone who matched!!! Y’all are amazing. So proud of each one of you!!! I didn’t.”

Soon after the results, #MatchMadness held a #Soap2023 support session, and Mr. Ansari sought advice for those willing to review SOAP applications. Elsewhere on Twitter Match Day threads, a few doctors offered their support to those who planned to SOAP, students announced their matches, and others either congratulated or encouraged those still trying to match.
 

Couples match

Not everyone who matched considered the alternative. Before March 13, William Boyer said that he hadn’t given much thought to what would happen if he didn’t match because he was “optimistically confident” he would match into his chosen EM specialty. But he did and got his top choice of programs: Yale New Haven (Conn.) Hospital.

“I feel great,” he said in an interview. “I was definitely nervous opening the envelope” that revealed his residency program, “but there was a rush of relief” when he saw he landed Yale.

Earlier in the match cycle, he said in an interview that he “interviewed at a few ‘reach’ programs, so I hope I don’t match lower than expected on my rank list.”

Mr. Boyer considers himself “a mature applicant,” entering the University of South Carolina, Columbia, after 4 years as an insurance broker.

“I am celebrating today by playing pickleball with a few close medical friends who also matched this morning,” Mr. Boyer said on March 13. “I definitely had periods of nervousness leading up to this morning though that quickly turned into joy and relief” after learning he matched.

Mr. Boyer believes that his professional experience in the insurance industry and health care lobbying efforts with the National Association of Health Underwriters set him apart from other applicants.

“I changed careers to pursue this aspiration, which demonstrates my full dedication to the medical profession.”

He applied to 48 programs and was offered interviews to nearly half. Mr. Boyer visited the majority of those virtually. He said he targeted programs close to where his and his partner’s families are located: Massachusetts, North Carolina, and Texas. “My partner, who I met in medical school, matched into ortho as well so the whole household is very happy,” Mr. Boyer said.

She matched into her top choice as well on March 17, though a distance away at UT Health in San Antonio, he said. “We are both ecstatic. We both got our no. 1 choice. That was the plan going into it. We will make it work. I have 4 weeks of vacation.”

In his program choices, Mr. Boyer prioritized access to nature, minimal leadership turnover, a mix of clinical training sites, and adequate elective rotations and fellowship opportunities, such as in wilderness medicine and health policy.

NRMP reported that there were 1,239 couples participating in the Match; 1,095 had both partners match, and 114 had one partner match to residency training programs for a match rate of 93%.

Like Mr. Boyer, Hannah Hedriana matched into EM, one of the more popular despite the reported unfilled positions. In the past few years, it has consistently been one of the fastest-growing specialties, according to the NRMP.

Still Ms. Hedriana had a fall-back plan. “If I don’t match, then I do plan on going through SOAP. With the number of EM spots that were unfilled in 2022, there’s a chance I could still be an EM physician, but if not, then that’s okay with me.”

Her reaction on March 13, after learning she matched? “Super excited, celebrating with my friends right now.” On Match Day, she said she was “ecstatic” to be matched into Lakeland (Fla.) Regional Health. “This was my first choice so now I can stay close to family and friends,” she said in an interview soon after the results were released.

A first-generation, Filipino American student from the University of South Florida, Tampa, Ms. Hedriana comes from a family of health care professionals. Her father is a respiratory therapist turned physical therapist; her mother a registered nurse. Her sister is a patient care technician applying to nursing school.

Ms. Hedriana applied to 70 programs and interviewed mostly online with 24. Her goal was to stay on the East Coast.

“My partner is a licensed dentist in the state of Florida, and so for his career it would be more practical to stay in state, rather than get relicensed in another state, which could take months,” she said earlier in the matching cycle. “However, when we discussed choosing a residency program, he ultimately left it up to me and wanted me to pick where I thought I’d flourish best,” Ms. Hedriana said, adding that her family lives in Florida, too.

She said she sought a residency program that values family and teamwork.

“A program gets more points in my book if they have sites at nonprofit hospitals or has residents that regularly volunteer throughout their communities or participate in DEI [diversity, equity, and inclusion] initiatives.”

Ms. Hedriana noted that some specialties exclusively offered virtual interviews in 2023, whereas other specialties favored in-person interviews. “This year, many of my classmates were able to do multiple away rotations, which they saw as a positive regarding their chances of matching.” During COVID, in-person visits were limited.

“However, I’ve noticed that many of my classmates are not fond of the signaling aspect that was present for this year’s cycle,” she said. Signaling is a relatively new process that allows applicants to indicate interest in a limited number of residency programs. Not all residencies participate, but it’s growing in popularity among specialties, according to the American Medical Association.
 

‘Extremely competitive’

Ms. Nagle, a second lieutenant in the U.S. Air Force, applied to 12 programs and interviewed with half of them online. She said that she wasn’t targeting any specific type of program through the match.

“I believe you can get phenomenal training anywhere where you mesh with the residents and leadership. My ultimate priority is to (1) be near good people, (2) be near good food (Indian and Thai are a must), and (3) be near an international airport so I can flee the country during breaks.”

Meanwhile, she said that she found the application process, in which students have to articulate their entire medical school experience, extremely competitive. “I think this process is so easy to get wound up in and the anxiety can be palpable,” Ms. Nagle said. “People around you match your energy. So if you are a ball of anxiety then so are your attendings and residents – and that doesn’t bode well for passing the ‘do I want to be on call with them’ test.”

Looking back at medical school, Ms. Nagle recalled having a baby named after her during her first anesthesia rotation and being featured on The Kelly Clarkson Show. Ms. Nagle said that she had walked into the delivery room where new parents had been debating names of babies beginning with the letter B. “And when I introduced myself, they looked at each other and said, ‘Yep, that’s the one.’”

Mr. Boyer recounted how the majority of his medical school experience involved online education. “Roughly two-thirds of my first year was in-person prior to the pandemic. However, from spring break first year to in-person clinical rotations at the beginning of third year, we were all virtual. While I missed interacting with my classmates, I benefited from the virtual learning environment as I learn more efficiently from reading and visual aids than auditory lectures.”

Ms. Hedriana cited the friends and memories she made while learning to be a doctor. “Medical school was hard, but I wouldn’t have changed a thing.”

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

Baily Nagle, vice president of her graduating class at Harvard Medical School, Boston, celebrated “the luck of the Irish” on St. Patrick’s Day that allowed her to match into her chosen specialty and top choice of residency programs: anesthesia at Brigham and Women’s Hospital.

“I am feeling very excited and relieved – I matched,” she said in an interview upon hearing her good fortune on Match Monday, March 13. She had a similar reaction on Match Day, March 17. “After a lot of long nights and hard work, happy to have it pay off.”

Ms. Nagle was so determined to match into her specialty that she didn’t have any other specialties in mind as a backup.

The annual process of matching medical school graduates with compatible residency programs is an emotional roller coaster for all applicants, their personal March Madness, so to speak. But Ms. Nagle was one of the more fortunate applicants. She didn’t have to confront the heartbreak other applicants felt when the National Resident Matching Program (NRMP) announced results of the main residency match and the Supplemental Offer and Acceptance Program (SOAP), which offers alternate programs for unfilled positions or unmatched applicants.

During the 2023 Match process, this news organization has been following a handful of students, checking in with them periodically for updates on their progress. Most of them matched successfully, but at least one international medical graduate (IMG) did not. What the others have in common is that their hearts were set on a chosen specialty. Like Ms. Nagle, another student banked on landing his chosen specialty without a backup plan, whereas another said that she’d continue through the SOAP if she didn’t match successfully.

Overall, Match Day resulted in a record number of residency positions offered, most notably in primary care, which “hit an all-time high,” according to NRMP President and CEO Donna L. Lamb, DHSc, MBA, BSN. The number of positions has “consistently increased over the past 5 years, and most importantly the fill rate for primary care has remained steady,” Dr.. Lamb noted in the NRMP release of Match Day results. The release coincided with students learning through emails at noon Eastern Time to which residency or supplemental programs they were matched.

Though more applicants registered for the Match in 2023 than in 2022 – driven primarily by non-U.S. IMGs – the NRMP stated that it was surprised by the decrease in U.S. MD senior applicants.

U.S. MD seniors had a nearly 94% Match rate, a small increase over 2022. U.S. citizen IMGs saw a nearly 68% Match rate, which NRMP reported as an “all-time high” and about six percentage points over in 2022, whereas non-U.S. IMGs had a nearly 60% Match rate, a 1.3 percentage point increase over 2022.

Among the specialties that filled all available positions in 2023 were orthopedic surgery, plastic surgery (integrated), and radiology – diagnostic and thoracic surgery.
 

Not everyone matches

On March 13, the American College of Emergency Physicians issued a joint statement with other emergency medicine (EM) organizations about a high rate of unfilled EM positions expected in 2023.

NRMP acknowledged March 17 that 554 positions remained unfilled, an increase of 335 more unfilled positions than 2022. NRMP attributed the increase in unfilled positions in part to a decrease in the number of U.S. MD and U.S. DO seniors who submitted ranks for the specialty, which “could reflect changing applicant interests or projections about workforce opportunities post residency.”

Applicants who didn’t match usually try to obtain an unfilled position through SOAP. In 2023, 2,685 positions were unfilled after the matching algorithm was processed, an increase of nearly 19% over 2022. The vast majority of those positions were placed in SOAP, an increase of 17.5% over 2022.

Asim Ansari was one of the unlucky ones. Mr. Ansari was trying to match for the fifth time. He was unsuccessful in doing so again in 2023 in the Match and SOAP. Still, he was offered and accepted a child and adolescent psychiatry fellowship at Kansas University Medical Center in Kansas City. Psychiatry was his chosen specialty, so he was “feeling good. It’s a nice place to go to do the next 2 years.”

Mr. Ansari, who started the #MatchMadness support group for unmatched doctors on Twitter Spaces, was quick to cheer on his fellow matching peers on March 13 while revealing his own fate: “Congratulations to everyone who matched!!! Y’all are amazing. So proud of each one of you!!! I didn’t.”

Soon after the results, #MatchMadness held a #Soap2023 support session, and Mr. Ansari sought advice for those willing to review SOAP applications. Elsewhere on Twitter Match Day threads, a few doctors offered their support to those who planned to SOAP, students announced their matches, and others either congratulated or encouraged those still trying to match.
 

Couples match

Not everyone who matched considered the alternative. Before March 13, William Boyer said that he hadn’t given much thought to what would happen if he didn’t match because he was “optimistically confident” he would match into his chosen EM specialty. But he did and got his top choice of programs: Yale New Haven (Conn.) Hospital.

“I feel great,” he said in an interview. “I was definitely nervous opening the envelope” that revealed his residency program, “but there was a rush of relief” when he saw he landed Yale.

Earlier in the match cycle, he said in an interview that he “interviewed at a few ‘reach’ programs, so I hope I don’t match lower than expected on my rank list.”

Mr. Boyer considers himself “a mature applicant,” entering the University of South Carolina, Columbia, after 4 years as an insurance broker.

“I am celebrating today by playing pickleball with a few close medical friends who also matched this morning,” Mr. Boyer said on March 13. “I definitely had periods of nervousness leading up to this morning though that quickly turned into joy and relief” after learning he matched.

Mr. Boyer believes that his professional experience in the insurance industry and health care lobbying efforts with the National Association of Health Underwriters set him apart from other applicants.

“I changed careers to pursue this aspiration, which demonstrates my full dedication to the medical profession.”

He applied to 48 programs and was offered interviews to nearly half. Mr. Boyer visited the majority of those virtually. He said he targeted programs close to where his and his partner’s families are located: Massachusetts, North Carolina, and Texas. “My partner, who I met in medical school, matched into ortho as well so the whole household is very happy,” Mr. Boyer said.

She matched into her top choice as well on March 17, though a distance away at UT Health in San Antonio, he said. “We are both ecstatic. We both got our no. 1 choice. That was the plan going into it. We will make it work. I have 4 weeks of vacation.”

In his program choices, Mr. Boyer prioritized access to nature, minimal leadership turnover, a mix of clinical training sites, and adequate elective rotations and fellowship opportunities, such as in wilderness medicine and health policy.

NRMP reported that there were 1,239 couples participating in the Match; 1,095 had both partners match, and 114 had one partner match to residency training programs for a match rate of 93%.

Like Mr. Boyer, Hannah Hedriana matched into EM, one of the more popular despite the reported unfilled positions. In the past few years, it has consistently been one of the fastest-growing specialties, according to the NRMP.

Still Ms. Hedriana had a fall-back plan. “If I don’t match, then I do plan on going through SOAP. With the number of EM spots that were unfilled in 2022, there’s a chance I could still be an EM physician, but if not, then that’s okay with me.”

Her reaction on March 13, after learning she matched? “Super excited, celebrating with my friends right now.” On Match Day, she said she was “ecstatic” to be matched into Lakeland (Fla.) Regional Health. “This was my first choice so now I can stay close to family and friends,” she said in an interview soon after the results were released.

A first-generation, Filipino American student from the University of South Florida, Tampa, Ms. Hedriana comes from a family of health care professionals. Her father is a respiratory therapist turned physical therapist; her mother a registered nurse. Her sister is a patient care technician applying to nursing school.

Ms. Hedriana applied to 70 programs and interviewed mostly online with 24. Her goal was to stay on the East Coast.

“My partner is a licensed dentist in the state of Florida, and so for his career it would be more practical to stay in state, rather than get relicensed in another state, which could take months,” she said earlier in the matching cycle. “However, when we discussed choosing a residency program, he ultimately left it up to me and wanted me to pick where I thought I’d flourish best,” Ms. Hedriana said, adding that her family lives in Florida, too.

She said she sought a residency program that values family and teamwork.

“A program gets more points in my book if they have sites at nonprofit hospitals or has residents that regularly volunteer throughout their communities or participate in DEI [diversity, equity, and inclusion] initiatives.”

Ms. Hedriana noted that some specialties exclusively offered virtual interviews in 2023, whereas other specialties favored in-person interviews. “This year, many of my classmates were able to do multiple away rotations, which they saw as a positive regarding their chances of matching.” During COVID, in-person visits were limited.

“However, I’ve noticed that many of my classmates are not fond of the signaling aspect that was present for this year’s cycle,” she said. Signaling is a relatively new process that allows applicants to indicate interest in a limited number of residency programs. Not all residencies participate, but it’s growing in popularity among specialties, according to the American Medical Association.
 

‘Extremely competitive’

Ms. Nagle, a second lieutenant in the U.S. Air Force, applied to 12 programs and interviewed with half of them online. She said that she wasn’t targeting any specific type of program through the match.

“I believe you can get phenomenal training anywhere where you mesh with the residents and leadership. My ultimate priority is to (1) be near good people, (2) be near good food (Indian and Thai are a must), and (3) be near an international airport so I can flee the country during breaks.”

Meanwhile, she said that she found the application process, in which students have to articulate their entire medical school experience, extremely competitive. “I think this process is so easy to get wound up in and the anxiety can be palpable,” Ms. Nagle said. “People around you match your energy. So if you are a ball of anxiety then so are your attendings and residents – and that doesn’t bode well for passing the ‘do I want to be on call with them’ test.”

Looking back at medical school, Ms. Nagle recalled having a baby named after her during her first anesthesia rotation and being featured on The Kelly Clarkson Show. Ms. Nagle said that she had walked into the delivery room where new parents had been debating names of babies beginning with the letter B. “And when I introduced myself, they looked at each other and said, ‘Yep, that’s the one.’”

Mr. Boyer recounted how the majority of his medical school experience involved online education. “Roughly two-thirds of my first year was in-person prior to the pandemic. However, from spring break first year to in-person clinical rotations at the beginning of third year, we were all virtual. While I missed interacting with my classmates, I benefited from the virtual learning environment as I learn more efficiently from reading and visual aids than auditory lectures.”

Ms. Hedriana cited the friends and memories she made while learning to be a doctor. “Medical school was hard, but I wouldn’t have changed a thing.”

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

New data released by the U.S. Department of Defense show that the incidence of many types of cancer is higher among military pilots and aviation support personnel in comparison with the general population.

“Military aircrew and ground crew were overall more likely to be diagnosed with cancer, but less likely to die from cancer compared to the U.S. population,” the report concludes.

The study involved 156,050 aircrew and 737,891 ground crew. Participants were followed between 1992 and 2017. Both groups were predominantly male and non-Hispanic.

Data on cancer incidence and mortality for these two groups were compared with data from groups of similar age in the general population through use of the Surveillance, Epidemiology, and End Results (SEER) Database of the National Cancer Institute.

For aircrew, the study found an 87% higher rate of melanoma, a 39% higher rate of thyroid cancer, a 16% higher rate of prostate cancer, and a 24% higher rate of cancer for all sites combined.

A higher rate of melanoma and prostate cancer among aircrew has been reported previously, but the increased rate of thyroid cancer is a new finding, the authors note.

The uptick in melanoma has also been reported in studies of civilian pilots and cabin crew. It has been attributed to exposure to hazardous ultraviolet and cosmic radiation.

For ground crew members, the analysis found a 19% higher rate of cancers of the brain and nervous system, a 15% higher rate of thyroid cancer, a 9% higher rate of melanoma and of kidney and renal pelvis cancers, and a 3% higher rate of cancer for all sites combined.

There is little to compare these findings with: This is the first time that cancer risk has been evaluated in such a large population of military ground crew.
 

Lower rates of cancer mortality

In contrast to the increase in cancer incidence, the report found a decrease in cancer mortality.

When compared with a demographically similar U.S. population, the mortality rate among aircrew was 56% lower for all cancer sites; for ground crew, the mortality rate was 35% lower.

However, the report authors emphasize that “it is important to note that the military study population was relatively young.”

The median age at the end of follow-up for the cancer incidence analysis was 41 years for aircrew and 26 years for ground crew. The median age at the end of follow-up for the cancer mortality analysis was 48 years for aircrew and 41 years for ground crew.

“Results may have differed if additional older former Service members had been included in the study, since cancer risk and mortality rates increase with age,” the authors comment.

Other studies have found an increase in deaths from melanoma as well as an increase in the incidence of melanoma. A meta-analysis published in 2019 in the British Journal of Dermatology found that airline pilots and cabin crew have about twice the risk of melanoma and other skin cancers than the general population. Pilots are also more likely to die from melanoma.
 

Further study underway

The findings on military air and ground crew come from phase 1 of a study that was required by Congress in the 2021 defense bill. Because the investigators found an increase in the incidence of cancer, phase 2 of the study is now necessary.

The report authors explain that phase 2 will consist of identifying the carcinogenic toxicants or hazardous materials associated with military flight operations; identifying operating environments that could be associated with increased amounts of ionizing and nonionizing radiation; identifying specific duties, dates of service, and types of aircraft flown that could have increased the risk for cancer; identifying duty locations associated with a higher incidence of cancers; identifying potential exposures through military service that are not related to aviation; and determining the appropriate age to begin screening military aircrew and ground crew for cancers.

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

New data released by the U.S. Department of Defense show that the incidence of many types of cancer is higher among military pilots and aviation support personnel in comparison with the general population.

“Military aircrew and ground crew were overall more likely to be diagnosed with cancer, but less likely to die from cancer compared to the U.S. population,” the report concludes.

The study involved 156,050 aircrew and 737,891 ground crew. Participants were followed between 1992 and 2017. Both groups were predominantly male and non-Hispanic.

Data on cancer incidence and mortality for these two groups were compared with data from groups of similar age in the general population through use of the Surveillance, Epidemiology, and End Results (SEER) Database of the National Cancer Institute.

For aircrew, the study found an 87% higher rate of melanoma, a 39% higher rate of thyroid cancer, a 16% higher rate of prostate cancer, and a 24% higher rate of cancer for all sites combined.

A higher rate of melanoma and prostate cancer among aircrew has been reported previously, but the increased rate of thyroid cancer is a new finding, the authors note.

The uptick in melanoma has also been reported in studies of civilian pilots and cabin crew. It has been attributed to exposure to hazardous ultraviolet and cosmic radiation.

For ground crew members, the analysis found a 19% higher rate of cancers of the brain and nervous system, a 15% higher rate of thyroid cancer, a 9% higher rate of melanoma and of kidney and renal pelvis cancers, and a 3% higher rate of cancer for all sites combined.

There is little to compare these findings with: This is the first time that cancer risk has been evaluated in such a large population of military ground crew.
 

Lower rates of cancer mortality

In contrast to the increase in cancer incidence, the report found a decrease in cancer mortality.

When compared with a demographically similar U.S. population, the mortality rate among aircrew was 56% lower for all cancer sites; for ground crew, the mortality rate was 35% lower.

However, the report authors emphasize that “it is important to note that the military study population was relatively young.”

The median age at the end of follow-up for the cancer incidence analysis was 41 years for aircrew and 26 years for ground crew. The median age at the end of follow-up for the cancer mortality analysis was 48 years for aircrew and 41 years for ground crew.

“Results may have differed if additional older former Service members had been included in the study, since cancer risk and mortality rates increase with age,” the authors comment.

Other studies have found an increase in deaths from melanoma as well as an increase in the incidence of melanoma. A meta-analysis published in 2019 in the British Journal of Dermatology found that airline pilots and cabin crew have about twice the risk of melanoma and other skin cancers than the general population. Pilots are also more likely to die from melanoma.
 

Further study underway

The findings on military air and ground crew come from phase 1 of a study that was required by Congress in the 2021 defense bill. Because the investigators found an increase in the incidence of cancer, phase 2 of the study is now necessary.

The report authors explain that phase 2 will consist of identifying the carcinogenic toxicants or hazardous materials associated with military flight operations; identifying operating environments that could be associated with increased amounts of ionizing and nonionizing radiation; identifying specific duties, dates of service, and types of aircraft flown that could have increased the risk for cancer; identifying duty locations associated with a higher incidence of cancers; identifying potential exposures through military service that are not related to aviation; and determining the appropriate age to begin screening military aircrew and ground crew for cancers.

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

New data released by the U.S. Department of Defense show that the incidence of many types of cancer is higher among military pilots and aviation support personnel in comparison with the general population.

“Military aircrew and ground crew were overall more likely to be diagnosed with cancer, but less likely to die from cancer compared to the U.S. population,” the report concludes.

The study involved 156,050 aircrew and 737,891 ground crew. Participants were followed between 1992 and 2017. Both groups were predominantly male and non-Hispanic.

Data on cancer incidence and mortality for these two groups were compared with data from groups of similar age in the general population through use of the Surveillance, Epidemiology, and End Results (SEER) Database of the National Cancer Institute.

For aircrew, the study found an 87% higher rate of melanoma, a 39% higher rate of thyroid cancer, a 16% higher rate of prostate cancer, and a 24% higher rate of cancer for all sites combined.

A higher rate of melanoma and prostate cancer among aircrew has been reported previously, but the increased rate of thyroid cancer is a new finding, the authors note.

The uptick in melanoma has also been reported in studies of civilian pilots and cabin crew. It has been attributed to exposure to hazardous ultraviolet and cosmic radiation.

For ground crew members, the analysis found a 19% higher rate of cancers of the brain and nervous system, a 15% higher rate of thyroid cancer, a 9% higher rate of melanoma and of kidney and renal pelvis cancers, and a 3% higher rate of cancer for all sites combined.

There is little to compare these findings with: This is the first time that cancer risk has been evaluated in such a large population of military ground crew.
 

Lower rates of cancer mortality

In contrast to the increase in cancer incidence, the report found a decrease in cancer mortality.

When compared with a demographically similar U.S. population, the mortality rate among aircrew was 56% lower for all cancer sites; for ground crew, the mortality rate was 35% lower.

However, the report authors emphasize that “it is important to note that the military study population was relatively young.”

The median age at the end of follow-up for the cancer incidence analysis was 41 years for aircrew and 26 years for ground crew. The median age at the end of follow-up for the cancer mortality analysis was 48 years for aircrew and 41 years for ground crew.

“Results may have differed if additional older former Service members had been included in the study, since cancer risk and mortality rates increase with age,” the authors comment.

Other studies have found an increase in deaths from melanoma as well as an increase in the incidence of melanoma. A meta-analysis published in 2019 in the British Journal of Dermatology found that airline pilots and cabin crew have about twice the risk of melanoma and other skin cancers than the general population. Pilots are also more likely to die from melanoma.
 

Further study underway

The findings on military air and ground crew come from phase 1 of a study that was required by Congress in the 2021 defense bill. Because the investigators found an increase in the incidence of cancer, phase 2 of the study is now necessary.

The report authors explain that phase 2 will consist of identifying the carcinogenic toxicants or hazardous materials associated with military flight operations; identifying operating environments that could be associated with increased amounts of ionizing and nonionizing radiation; identifying specific duties, dates of service, and types of aircraft flown that could have increased the risk for cancer; identifying duty locations associated with a higher incidence of cancers; identifying potential exposures through military service that are not related to aviation; and determining the appropriate age to begin screening military aircrew and ground crew for cancers.

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

Detecting melanoma early, when it is easier to treat, remains a “paramount goal,” but guidelines surrounding optimal melanoma screening practices and diagnostic evaluations need greater clarity, according to the authors of a new consensus statement.

That is why a group of expert panelists evaluated the existing evidence and a range of clinical scenarios to help clarify the optimal strategies for early detection and assessment of cutaneous melanoma.

Overall, the panelists agreed that a risk-stratified approach is likely the most appropriate strategy for melanoma screening and follow-up and supported the use of visual and dermoscopic examination. However, the panelists did not reach consensus on the role for gene expression profile (GEP) testing in clinical decision-making, citing the need for these assays to be validated in large randomized clinical trials.

In an accompanying editorial, two experts highlighted the importance of carefully evaluating the role of diagnostic tests.

“Diagnostic tests such as GEP must face critical scrutiny; if not, there are immediate concerns for patient care, such as the patient being erroneously informed that they do not have cancer or told that they do have cancer when they do not,” write Alan C. Geller, MPH, RN, from the Harvard T.H. Chan School of Public Health, Boston, and Marvin A. Weinstock, MD, PhD, from Brown University, Providence, R.I.

The consensus statement was published online in JAMA Dermatology.
 

The need for guidance

Although focusing melanoma screening on higher-risk populations may be cost effective, compared with population-based screening, the major guidelines lack consistent guidance to support a risk-stratified approach to skin cancer screening and best practices on diagnosing cutaneous melanoma.

In the prebiopsy setting, the appropriate use of diagnostic tools for evaluating the need for biopsy remain poorly defined, and, in the post-biopsy setting, questions remain concerning the diagnostic accuracy of molecular techniques, diagnostic GEP testing, next-generation sequencing, and immunohistochemical assessment for various markers of melanoma.

To provide consensus recommendations on optimal screening practices, prebiopsy and postbiopsy diagnostics, and prognostic assessment of cutaneous melanoma, a group of 42 panelists voted on hypothetical scenarios via an emailed survey. The panel then came together for a consensus conference, which included 51 experts who discussed their approach to the various clinical case scenarios. Most attendees (45 of the 51) answered a follow-up survey for their final recommendations.

The panelists reached a consensus, with 70% agreement, to support a risk-stratified approach to melanoma screening in clinical settings and public screening events. The experts agreed that higher-risk individuals (those with a relative risk of 5 or greater) could be appropriately screened by a general dermatologist or pigmented lesion evaluation. Higher-risk individuals included those with severe skin damage from the sun, systemic immunosuppression, or a personal history of nonmelanoma or melanoma skin cancer.

Panelists agreed that those at general or lower risk (RR < 2) could be screened by a primary care provider or through regular self- or partner examinations, whereas those at moderate risk could be screened by their primary care clinician or general dermatologist. The experts observed “a shift in acceptance” of primary care physicians screening the general population, and an acknowledgement of the importance of self- and partner examinations as screening adjuncts for all populations.

In the prebiopsy setting, panelists reached consensus that visual and dermoscopic examination was appropriate for evaluating patients with “no new, changing, or unusual skin lesions or with a new lesion that is not visually concerning.”

The panelists also reached consensus that lesions deemed clinically suspicious for cancer or showing features of cancer on reflectance confocal microscopy should be biopsied. Although most respondents (86%) did not currently use epidermal tape stripping routinely, they agreed that, in a hypothetical situation where epidermal tape stripping was used, that lesions positive for PRAME or LINC should be biopsied.

In the postbiopsy setting, views on the use of GEP scores varied. Although panelists agreed that a low-risk prognostic GEP score should not outweigh concerning histologic features when patients are selected to undergo sentinel lymph node biopsy (SLNB), they did not reach consensus for imaging recommendations in the setting of a high-risk prognostic GEP score and low-risk histology and/or negative nodal status.

“The panelists await future, well-designed prospective studies to determine if use of these and newer technologies improves the care of patients with melanoma,” the panelists write.

In the editorial, Mr. Geller and Dr. Weinstock highlighted concerns about the cost and potential access issues associated with these newer technologies, given that the current cost of GEP testing exceeds $7,000.

The editorialists also emphasize that “going forward, the field should be advanced by tackling one of the more pressing, common, potentially morbid, and costly procedures – the prognostic use of sentinel lymph node biopsy.”

Of critical importance is “whether GEP can reduce morbidity and cost by safely reducing the number of SLNBs performed,” Mr. Geller and Dr. Weinstock write.

The funding for the administration and facilitation of the consensus development conference and the development of the manuscript was provided by Dermtech, in an unrestricted award overseen by the Melanoma Research Foundation and managed and executed at UPMC by the principal investigator. Several of the coauthors disclosed relationships with industry. Mr. Geller is a contributor to UptoDate for which he receives royalties. Dr. Weinstock receives consulting fees from AbbVie.

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

Detecting melanoma early, when it is easier to treat, remains a “paramount goal,” but guidelines surrounding optimal melanoma screening practices and diagnostic evaluations need greater clarity, according to the authors of a new consensus statement.

That is why a group of expert panelists evaluated the existing evidence and a range of clinical scenarios to help clarify the optimal strategies for early detection and assessment of cutaneous melanoma.

Overall, the panelists agreed that a risk-stratified approach is likely the most appropriate strategy for melanoma screening and follow-up and supported the use of visual and dermoscopic examination. However, the panelists did not reach consensus on the role for gene expression profile (GEP) testing in clinical decision-making, citing the need for these assays to be validated in large randomized clinical trials.

In an accompanying editorial, two experts highlighted the importance of carefully evaluating the role of diagnostic tests.

“Diagnostic tests such as GEP must face critical scrutiny; if not, there are immediate concerns for patient care, such as the patient being erroneously informed that they do not have cancer or told that they do have cancer when they do not,” write Alan C. Geller, MPH, RN, from the Harvard T.H. Chan School of Public Health, Boston, and Marvin A. Weinstock, MD, PhD, from Brown University, Providence, R.I.

The consensus statement was published online in JAMA Dermatology.
 

The need for guidance

Although focusing melanoma screening on higher-risk populations may be cost effective, compared with population-based screening, the major guidelines lack consistent guidance to support a risk-stratified approach to skin cancer screening and best practices on diagnosing cutaneous melanoma.

In the prebiopsy setting, the appropriate use of diagnostic tools for evaluating the need for biopsy remain poorly defined, and, in the post-biopsy setting, questions remain concerning the diagnostic accuracy of molecular techniques, diagnostic GEP testing, next-generation sequencing, and immunohistochemical assessment for various markers of melanoma.

To provide consensus recommendations on optimal screening practices, prebiopsy and postbiopsy diagnostics, and prognostic assessment of cutaneous melanoma, a group of 42 panelists voted on hypothetical scenarios via an emailed survey. The panel then came together for a consensus conference, which included 51 experts who discussed their approach to the various clinical case scenarios. Most attendees (45 of the 51) answered a follow-up survey for their final recommendations.

The panelists reached a consensus, with 70% agreement, to support a risk-stratified approach to melanoma screening in clinical settings and public screening events. The experts agreed that higher-risk individuals (those with a relative risk of 5 or greater) could be appropriately screened by a general dermatologist or pigmented lesion evaluation. Higher-risk individuals included those with severe skin damage from the sun, systemic immunosuppression, or a personal history of nonmelanoma or melanoma skin cancer.

Panelists agreed that those at general or lower risk (RR < 2) could be screened by a primary care provider or through regular self- or partner examinations, whereas those at moderate risk could be screened by their primary care clinician or general dermatologist. The experts observed “a shift in acceptance” of primary care physicians screening the general population, and an acknowledgement of the importance of self- and partner examinations as screening adjuncts for all populations.

In the prebiopsy setting, panelists reached consensus that visual and dermoscopic examination was appropriate for evaluating patients with “no new, changing, or unusual skin lesions or with a new lesion that is not visually concerning.”

The panelists also reached consensus that lesions deemed clinically suspicious for cancer or showing features of cancer on reflectance confocal microscopy should be biopsied. Although most respondents (86%) did not currently use epidermal tape stripping routinely, they agreed that, in a hypothetical situation where epidermal tape stripping was used, that lesions positive for PRAME or LINC should be biopsied.

In the postbiopsy setting, views on the use of GEP scores varied. Although panelists agreed that a low-risk prognostic GEP score should not outweigh concerning histologic features when patients are selected to undergo sentinel lymph node biopsy (SLNB), they did not reach consensus for imaging recommendations in the setting of a high-risk prognostic GEP score and low-risk histology and/or negative nodal status.

“The panelists await future, well-designed prospective studies to determine if use of these and newer technologies improves the care of patients with melanoma,” the panelists write.

In the editorial, Mr. Geller and Dr. Weinstock highlighted concerns about the cost and potential access issues associated with these newer technologies, given that the current cost of GEP testing exceeds $7,000.

The editorialists also emphasize that “going forward, the field should be advanced by tackling one of the more pressing, common, potentially morbid, and costly procedures – the prognostic use of sentinel lymph node biopsy.”

Of critical importance is “whether GEP can reduce morbidity and cost by safely reducing the number of SLNBs performed,” Mr. Geller and Dr. Weinstock write.

The funding for the administration and facilitation of the consensus development conference and the development of the manuscript was provided by Dermtech, in an unrestricted award overseen by the Melanoma Research Foundation and managed and executed at UPMC by the principal investigator. Several of the coauthors disclosed relationships with industry. Mr. Geller is a contributor to UptoDate for which he receives royalties. Dr. Weinstock receives consulting fees from AbbVie.

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

Detecting melanoma early, when it is easier to treat, remains a “paramount goal,” but guidelines surrounding optimal melanoma screening practices and diagnostic evaluations need greater clarity, according to the authors of a new consensus statement.

That is why a group of expert panelists evaluated the existing evidence and a range of clinical scenarios to help clarify the optimal strategies for early detection and assessment of cutaneous melanoma.

Overall, the panelists agreed that a risk-stratified approach is likely the most appropriate strategy for melanoma screening and follow-up and supported the use of visual and dermoscopic examination. However, the panelists did not reach consensus on the role for gene expression profile (GEP) testing in clinical decision-making, citing the need for these assays to be validated in large randomized clinical trials.

In an accompanying editorial, two experts highlighted the importance of carefully evaluating the role of diagnostic tests.

“Diagnostic tests such as GEP must face critical scrutiny; if not, there are immediate concerns for patient care, such as the patient being erroneously informed that they do not have cancer or told that they do have cancer when they do not,” write Alan C. Geller, MPH, RN, from the Harvard T.H. Chan School of Public Health, Boston, and Marvin A. Weinstock, MD, PhD, from Brown University, Providence, R.I.

The consensus statement was published online in JAMA Dermatology.
 

The need for guidance

Although focusing melanoma screening on higher-risk populations may be cost effective, compared with population-based screening, the major guidelines lack consistent guidance to support a risk-stratified approach to skin cancer screening and best practices on diagnosing cutaneous melanoma.

In the prebiopsy setting, the appropriate use of diagnostic tools for evaluating the need for biopsy remain poorly defined, and, in the post-biopsy setting, questions remain concerning the diagnostic accuracy of molecular techniques, diagnostic GEP testing, next-generation sequencing, and immunohistochemical assessment for various markers of melanoma.

To provide consensus recommendations on optimal screening practices, prebiopsy and postbiopsy diagnostics, and prognostic assessment of cutaneous melanoma, a group of 42 panelists voted on hypothetical scenarios via an emailed survey. The panel then came together for a consensus conference, which included 51 experts who discussed their approach to the various clinical case scenarios. Most attendees (45 of the 51) answered a follow-up survey for their final recommendations.

The panelists reached a consensus, with 70% agreement, to support a risk-stratified approach to melanoma screening in clinical settings and public screening events. The experts agreed that higher-risk individuals (those with a relative risk of 5 or greater) could be appropriately screened by a general dermatologist or pigmented lesion evaluation. Higher-risk individuals included those with severe skin damage from the sun, systemic immunosuppression, or a personal history of nonmelanoma or melanoma skin cancer.

Panelists agreed that those at general or lower risk (RR < 2) could be screened by a primary care provider or through regular self- or partner examinations, whereas those at moderate risk could be screened by their primary care clinician or general dermatologist. The experts observed “a shift in acceptance” of primary care physicians screening the general population, and an acknowledgement of the importance of self- and partner examinations as screening adjuncts for all populations.

In the prebiopsy setting, panelists reached consensus that visual and dermoscopic examination was appropriate for evaluating patients with “no new, changing, or unusual skin lesions or with a new lesion that is not visually concerning.”

The panelists also reached consensus that lesions deemed clinically suspicious for cancer or showing features of cancer on reflectance confocal microscopy should be biopsied. Although most respondents (86%) did not currently use epidermal tape stripping routinely, they agreed that, in a hypothetical situation where epidermal tape stripping was used, that lesions positive for PRAME or LINC should be biopsied.

In the postbiopsy setting, views on the use of GEP scores varied. Although panelists agreed that a low-risk prognostic GEP score should not outweigh concerning histologic features when patients are selected to undergo sentinel lymph node biopsy (SLNB), they did not reach consensus for imaging recommendations in the setting of a high-risk prognostic GEP score and low-risk histology and/or negative nodal status.

“The panelists await future, well-designed prospective studies to determine if use of these and newer technologies improves the care of patients with melanoma,” the panelists write.

In the editorial, Mr. Geller and Dr. Weinstock highlighted concerns about the cost and potential access issues associated with these newer technologies, given that the current cost of GEP testing exceeds $7,000.

The editorialists also emphasize that “going forward, the field should be advanced by tackling one of the more pressing, common, potentially morbid, and costly procedures – the prognostic use of sentinel lymph node biopsy.”

Of critical importance is “whether GEP can reduce morbidity and cost by safely reducing the number of SLNBs performed,” Mr. Geller and Dr. Weinstock write.

The funding for the administration and facilitation of the consensus development conference and the development of the manuscript was provided by Dermtech, in an unrestricted award overseen by the Melanoma Research Foundation and managed and executed at UPMC by the principal investigator. Several of the coauthors disclosed relationships with industry. Mr. Geller is a contributor to UptoDate for which he receives royalties. Dr. Weinstock receives consulting fees from AbbVie.

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

NEW ORLEANS – Application of a single-use disposable patch to the axillary area for up to 3 minutes led to statistically significant and clinically meaningful benefit for patients with primary axillary hyperhidrosis, results from a pivotal randomized trial showed.

“This is a new kind of device that is going to be a nice tool to have for treating patients who have hyperhidrosis of the axilla,” the study’s lead investigator, David M. Pariser, MD, who practices dermatology in Norfolk, Va., said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.

Koldunov/Thinkstock

Adverse events

A total of 13 patients in the active patch group experienced AEs at the treatment site, including six with erythema; four with erosion; two with burning, itching or stinging; and one with underarm odor. “The two procedure-related AEs in the TAT-treated group were compensatory sweating and irritant contact dermatitis due to the adhesive,” said Dr. Pariser said.

Most adverse events resolved in fewer than 2 weeks, and all were mild to moderate. No serious adverse events occurred. Only five adverse events occurred in the sham group.

The TAT patch is currently undergoing review by the Food and Drug Administration, and according to Dr. Pariser, no other body sites have been treated with the device.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, characterized hyperhidrosis as “an exceedingly common medical condition that is commonly overlooked even though it has a tremendous burden on quality of life. I should know, as both someone who manages a large cohort of these patients but also as someone who suffers from it.”

Treatment options “have historically been limited, many of which are off-label and some which are difficult to access due to cost and/or duration/frequency of treatment,” added Dr. Friedman, who was not involved with the study. “The TAT patch offers a new, targeted, in-office, practical procedure-based approach to treat primary axillary hyperhidrosis. Innovation is certainly welcomed and needed, and I am curious to see how this technology is employed in practice once approved.”

The device is being developed by Candesant Biomedical. Dr. Pariser disclosed that he is a consultant or investigator for Bickel Biotechnology, Biofrontera AG, Bristol Myers Squibb, Celgene Corporation, Novartis Pharmaceuticals, Pfizer, Regeneron, and Sanofi.

Dr. Friedman reported having no relevant disclosures.

NEW ORLEANS – Application of a single-use disposable patch to the axillary area for up to 3 minutes led to statistically significant and clinically meaningful benefit for patients with primary axillary hyperhidrosis, results from a pivotal randomized trial showed.

“This is a new kind of device that is going to be a nice tool to have for treating patients who have hyperhidrosis of the axilla,” the study’s lead investigator, David M. Pariser, MD, who practices dermatology in Norfolk, Va., said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.

Koldunov/Thinkstock

Adverse events

A total of 13 patients in the active patch group experienced AEs at the treatment site, including six with erythema; four with erosion; two with burning, itching or stinging; and one with underarm odor. “The two procedure-related AEs in the TAT-treated group were compensatory sweating and irritant contact dermatitis due to the adhesive,” said Dr. Pariser said.

Most adverse events resolved in fewer than 2 weeks, and all were mild to moderate. No serious adverse events occurred. Only five adverse events occurred in the sham group.

The TAT patch is currently undergoing review by the Food and Drug Administration, and according to Dr. Pariser, no other body sites have been treated with the device.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, characterized hyperhidrosis as “an exceedingly common medical condition that is commonly overlooked even though it has a tremendous burden on quality of life. I should know, as both someone who manages a large cohort of these patients but also as someone who suffers from it.”

Treatment options “have historically been limited, many of which are off-label and some which are difficult to access due to cost and/or duration/frequency of treatment,” added Dr. Friedman, who was not involved with the study. “The TAT patch offers a new, targeted, in-office, practical procedure-based approach to treat primary axillary hyperhidrosis. Innovation is certainly welcomed and needed, and I am curious to see how this technology is employed in practice once approved.”

The device is being developed by Candesant Biomedical. Dr. Pariser disclosed that he is a consultant or investigator for Bickel Biotechnology, Biofrontera AG, Bristol Myers Squibb, Celgene Corporation, Novartis Pharmaceuticals, Pfizer, Regeneron, and Sanofi.

Dr. Friedman reported having no relevant disclosures.

NEW ORLEANS – Application of a single-use disposable patch to the axillary area for up to 3 minutes led to statistically significant and clinically meaningful benefit for patients with primary axillary hyperhidrosis, results from a pivotal randomized trial showed.

“This is a new kind of device that is going to be a nice tool to have for treating patients who have hyperhidrosis of the axilla,” the study’s lead investigator, David M. Pariser, MD, who practices dermatology in Norfolk, Va., said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.

Koldunov/Thinkstock

Adverse events

A total of 13 patients in the active patch group experienced AEs at the treatment site, including six with erythema; four with erosion; two with burning, itching or stinging; and one with underarm odor. “The two procedure-related AEs in the TAT-treated group were compensatory sweating and irritant contact dermatitis due to the adhesive,” said Dr. Pariser said.

Most adverse events resolved in fewer than 2 weeks, and all were mild to moderate. No serious adverse events occurred. Only five adverse events occurred in the sham group.

The TAT patch is currently undergoing review by the Food and Drug Administration, and according to Dr. Pariser, no other body sites have been treated with the device.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, characterized hyperhidrosis as “an exceedingly common medical condition that is commonly overlooked even though it has a tremendous burden on quality of life. I should know, as both someone who manages a large cohort of these patients but also as someone who suffers from it.”

Treatment options “have historically been limited, many of which are off-label and some which are difficult to access due to cost and/or duration/frequency of treatment,” added Dr. Friedman, who was not involved with the study. “The TAT patch offers a new, targeted, in-office, practical procedure-based approach to treat primary axillary hyperhidrosis. Innovation is certainly welcomed and needed, and I am curious to see how this technology is employed in practice once approved.”

The device is being developed by Candesant Biomedical. Dr. Pariser disclosed that he is a consultant or investigator for Bickel Biotechnology, Biofrontera AG, Bristol Myers Squibb, Celgene Corporation, Novartis Pharmaceuticals, Pfizer, Regeneron, and Sanofi.

Dr. Friedman reported having no relevant disclosures.

NEW ORLEANS – Assessing underlying mechanisms for the effects of age, mean platelet volume (MPV), and tryptase may help identify pediatric patients with chronic spontaneous urticaria (CSU) who will respond to different treatment options, results from a single-center prospective study showed.

“Given that the majority of CSU cases in adults are due to autoimmunity and there being very [few] studies on biomarkers for CSU in children, our study furthers our current understanding of the role of different biomarkers in treatment response,” lead study author Alex Nguyen, MsC, said in an interview at the annual meeting of the American Academy of Dermatology, where the study was presented during a poster session.

NEW ORLEANS – Assessing underlying mechanisms for the effects of age, mean platelet volume (MPV), and tryptase may help identify pediatric patients with chronic spontaneous urticaria (CSU) who will respond to different treatment options, results from a single-center prospective study showed.

“Given that the majority of CSU cases in adults are due to autoimmunity and there being very [few] studies on biomarkers for CSU in children, our study furthers our current understanding of the role of different biomarkers in treatment response,” lead study author Alex Nguyen, MsC, said in an interview at the annual meeting of the American Academy of Dermatology, where the study was presented during a poster session.

NEW ORLEANS – Assessing underlying mechanisms for the effects of age, mean platelet volume (MPV), and tryptase may help identify pediatric patients with chronic spontaneous urticaria (CSU) who will respond to different treatment options, results from a single-center prospective study showed.

“Given that the majority of CSU cases in adults are due to autoimmunity and there being very [few] studies on biomarkers for CSU in children, our study furthers our current understanding of the role of different biomarkers in treatment response,” lead study author Alex Nguyen, MsC, said in an interview at the annual meeting of the American Academy of Dermatology, where the study was presented during a poster session.