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The leading independent newspaper covering dermatology news and commentary.
National Rosacea Society adds imprimatur to skin products
, according to a press release from the NRS.
The seal is meant to be a resource to easily identify skin care products and cosmetic products that have been evaluated as unlikely to cause rosacea flares or skin irritation, according to the press release.
Surveys conducted by the NRS indicate that 92% of rosacea patients report burning, stinging, or itching on their skin, 66% identified specific skin products as triggers for their symptoms, and 84% were “very interested” in skin care guidance.
Patients and clinicians can find a searchable list of currently approved products in the Seal of Acceptance section of the NRS website. New skin care and cosmetic products will be added to the list of those with the Seal of Acceptance on an ongoing basis.
Products under consideration to earn the Seal of Acceptance must be free of ingredients that can cause skin barrier disruption, flushing, burning, itching, or other unwanted neurosensory stimulation, according to the press release.
Each accepted product also must pass clinical testing to confirm safety and low risk for irritation and sensitization for individuals with rosacea. Applications for the Seal of Acceptance are reviewed anonymously by an independent panel of dermatologists. The NRS created the program under the guidance of Zoe D. Draelos, MD, a clinical and research dermatologist in High Point, North Carolina, who also serves on the NRS board of directors.
More information about products carrying the seal and how companies can apply to have their products considered to carry the seal is available at rosacea.org/seal-of-acceptance/.
, according to a press release from the NRS.
The seal is meant to be a resource to easily identify skin care products and cosmetic products that have been evaluated as unlikely to cause rosacea flares or skin irritation, according to the press release.
Surveys conducted by the NRS indicate that 92% of rosacea patients report burning, stinging, or itching on their skin, 66% identified specific skin products as triggers for their symptoms, and 84% were “very interested” in skin care guidance.
Patients and clinicians can find a searchable list of currently approved products in the Seal of Acceptance section of the NRS website. New skin care and cosmetic products will be added to the list of those with the Seal of Acceptance on an ongoing basis.
Products under consideration to earn the Seal of Acceptance must be free of ingredients that can cause skin barrier disruption, flushing, burning, itching, or other unwanted neurosensory stimulation, according to the press release.
Each accepted product also must pass clinical testing to confirm safety and low risk for irritation and sensitization for individuals with rosacea. Applications for the Seal of Acceptance are reviewed anonymously by an independent panel of dermatologists. The NRS created the program under the guidance of Zoe D. Draelos, MD, a clinical and research dermatologist in High Point, North Carolina, who also serves on the NRS board of directors.
More information about products carrying the seal and how companies can apply to have their products considered to carry the seal is available at rosacea.org/seal-of-acceptance/.
, according to a press release from the NRS.
The seal is meant to be a resource to easily identify skin care products and cosmetic products that have been evaluated as unlikely to cause rosacea flares or skin irritation, according to the press release.
Surveys conducted by the NRS indicate that 92% of rosacea patients report burning, stinging, or itching on their skin, 66% identified specific skin products as triggers for their symptoms, and 84% were “very interested” in skin care guidance.
Patients and clinicians can find a searchable list of currently approved products in the Seal of Acceptance section of the NRS website. New skin care and cosmetic products will be added to the list of those with the Seal of Acceptance on an ongoing basis.
Products under consideration to earn the Seal of Acceptance must be free of ingredients that can cause skin barrier disruption, flushing, burning, itching, or other unwanted neurosensory stimulation, according to the press release.
Each accepted product also must pass clinical testing to confirm safety and low risk for irritation and sensitization for individuals with rosacea. Applications for the Seal of Acceptance are reviewed anonymously by an independent panel of dermatologists. The NRS created the program under the guidance of Zoe D. Draelos, MD, a clinical and research dermatologist in High Point, North Carolina, who also serves on the NRS board of directors.
More information about products carrying the seal and how companies can apply to have their products considered to carry the seal is available at rosacea.org/seal-of-acceptance/.
US Board Discloses Cheating, Grads Say Problem Is Rampant
The United States Medical Licensing Examination (USMLE) program is invalidating scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal.
In a January 31 announcement, the USMLE program said that officials are in the process of notifying examinees with results in question and that the examinees will be required to take validation exams. The program did not offer further details about its investigation or how the questionable performance was identified.
“The USMLE program regularly monitors and analyzes examinees’ test performances for unusual score patterns or variations, and other information that could raise questions about the validity of an examinee’s results,” the program said in a statement. “Highly irregular patterns can be indicative of prior unauthorized access to secure exam content.”
Some medical graduates say the action against students cheating on the USMLE is long overdue.
, particularly by groups within the international medical graduate (IMG) community, according to multiple IMGs who shared their concerns with this news organization. Sellers operate under pseudonyms across social media platforms and charge anywhere from $300 to $2000 for questions, Medscape research shows.
Facebook posts often advertise questions for sale, said Saqib Gul, MD, an IMG from Pakistan who has voiced concerns about the practice on social media.
“People make up fake profiles and tell others to [direct message] them for recalls,” he told this news organization. “There was a dedicated Facebook page that was doing this. In other cases, a couple of friends that took the exam remember a certain number of questions and write them down after the test.”
Ahmad Ozair, MD, an IMG from Lucknow, Uttar Pradesh, India, said that he has come across many groups online sharing or selling USMLE recalls. He first became suspicious when he saw several students, all from a few medical schools in Nepal, posting on social media about scoring in the 270 and 280-plus range.
“The statistical probability that you would have three or more candidates in the same year, scoring in the 99th percentile worldwide, belonging to a small geographical area is extremely low.”
Dr. Ozair, who now is studying public health at Johns Hopkins University in Baltimore, said that the issue is important for “all stakeholders” who care about patient safety: “Would you want a doctor who has cheated on the medical licensing exam to take care of you?”
In an interview, USMLE program spokesman Joe Knickrehm said that the program relies on multiple processes to detect and respond to claims that exam integrity is being compromised. The process includes monitoring performance data, an anonymous tip line for reporting suspicious behavior, and a thorough investigative process.
“The USMLE program regularly monitors social media channels for comments relating to exam security and irregular behavior and will initiate an investigation if warranted,” Mr. Knickrehm told this news organization. “ The covert nature of this activity does not lend itself to a definitive statement regarding whether the problem has increased or decreased in recent years.”
Mr. Knickrehm said that the program’s STOPit app allows people to report suspicious behavior electronically to the USMLE program. Since its launch in 2021, the program has received more than 80 tips per year through the app, according to Mr. Knickrehm. Security violations are investigated by USMLE staff and reviewed by the USMLE Committee for Individualized Review (CIR). Anyone found to have engaged in irregular behavior by the CIR for activities undermining exam integrity are typically barred from access to the USMLE for multiple years.
How Easy Is It to Buy Recalls?
Two years ago, Dr B was approached by a former study partner who had just completed Step 2 of the USMLE. She asked whether Dr B wanted to buy recalled questions to help her pass.
“She paid this guy almost $2000 for recalls and told me if I pay this money, he’ll give me the recalls,” said Dr B, who asked to remain anonymous for fear of being associated with students cheating on the USMLE. “I told her I was not interested, and she said the guy would lower the price. I broke contact with her.”
Dr B, an IMG from Pakistan, was appalled. But she said that the episode was not the first time she has come across groups selling USMLE recalls or heard peers brag about having access to exam content.
“I am baffled at how many [groups] post on social media and brazenly advertise their ‘services,’” she told this news organization. “No one arrests them, their customers go on to score abnormally high on the boards, making it unachievable for people who take the honest route, plus giving IMGs a bad rep.”
Groups offering recalls are easily findable on sites such as Telegram and Signal. Telegram is a cloud-based messaging app that focuses on security, and Signal is an encrypted messaging service.
The website recallmastery.com purports to offer a range of USMLE recall packages, from a free, unsorted version to Step 1 and Step 2 packages that include “fresh updates,” and sections with “mostly repeated topics. Prices range from the free version to the $799 VIP package.
Another site called MedPox.com boasts 2024 Step 2 recalls, advertising “ actual exam questions to get HIGH scores.” The website’s owner states that the recalls were collected “by my friends,” and to message the them to be added to the “recalls group.”
A reporter was able to easily download a free version of alleged USMLE questions and answers from recallmastery.com. The document was a combination of typed and handwritten notes about medical questions, with red circles around recalled answers.
J. Bryan Carmody, MD, who blogs about medical education, reviewed a copy of the document. He said that the content appeared “credible” and was in fact recalled USMLE questions. However, the extent of which the question stem was recalled was incomplete at best, and there was little production value to the document, said Dr. Carmody, a nephrologist and associate professor of pediatrics at the Eastern Virgina Medical School in Norfolk.
The person selling the recall packages states on the website that the free version is not organized or sorted, but it allows viewers to “see how this works before paying for premium recalls.”
Mr. Knickrehm said that the program could not comment on the document, but that “whenever the USMLE program receives or locates information about a potential security violation, we investigate and take necessary action.”
When asked about the specific websites noted above, Knickrehm said that the program routinely monitors a wide array of websites, message boards, and chat rooms for USMLE-related materials. Though many sites advertise having USMLE recalls for sale, it’s more likely they are selling non-USMLE content, he said.
Using past content to cheat on medical exams is an old problem. In 2010, for example, the American Board of Internal Medicine suspended 139 physicians after they were caught cheating on the board exams. The scandal involved a vast cheating ring that included physicians memorizing questions and reproducing them after the tests. The board later sued a gastroenterologist for her part in the scandal.
In 2012, a CNN investigation exposed doctors who were memorizing test questions and creating sophisticated recall banks to cheat on radiology boards. The Association of American Medical Colleges sued a medical student in 2017 for attempting to secretly record content on the MCAT using spyglasses.
In recent years, Dr. Carmody said that he has received multiple messages and screenshots from concerned students and residents who were offered or encountered recalls.
“One thing that’s unclear is how legitimate the claims are,” he said. “Many of these recalls may be faulty or outdated. It could be someone who took the exam yesterday and has a photographic memory or it could be some sparsely recalled or mis-recalled information. Unless you’re willing to pay these people, you can’t inspect the quality, or even if you did, you wouldn’t know if the information was current or not.”
‘As an IMG, There Is So Much at Stake’
Whether recall sellers — and those buying them — are more frequently IMGs has fostered heated debate on social media.
On a Reddit thread devoted to IMG issues, posters expressed frustration about being bombarded with recall advertisements and unwanted messages about buying USMLE questions while trying to find study materials. One poster called the practices a “huge slap to all those IMGs who are struggling day and night, just to get a good score.”
In an X thread about the same subject, however, some self-described IMGs took offense to claims that IMGs might score higher because they have access to recalls. The allegations are “incendiary” and “malign hardworking IMGs,” posters wrote.
When Dr. Gul spoke out online about the “biopsy” culture, he received multiple private messages from fellow IMGs telling him to remove his comments, he said.
“I received a lot of backlash on social media,” he told this news organization. “Some IMGs asked me to take down my posts because they thought I was making IMGs look bad, and it might prompt authorities to take action or shut down international examination centers for IMGs.”
Most of the IMGs who spoke to this news organization were afraid to be publicly identified. Several IMG advocates and IMG associations contacted for the story did not respond. One medical education expert said that his institution advised him to “steer clear” of commenting because the issue was “controversial.”
“As an IMG, there is so much at stake,” Dr B said. “Any association with shady operations like these is an absolute suicide. I’m personally afraid of any repercussions of the sort.”
USMLE officials declined to comment on whether the buying or selling of recalls appears to be more prevalent among the IMG community, saying it is “difficult to generalize this behavior as ‘prevalent’ simply due to the clandestine nature of this activity.”
Cheat-Proofing the USMLE
The USMLE program has taken several steps intended to prevent cheating, but more needs to be done, medical education advocates say.
For example, Dr. Carmody called the recent change in the attempt limit for taking USMLE exams from six to four times a good move.
“The reality is, if you’re taking a USMLE exam five-plus times, you’re far more likely to be memorizing questions and selling them for shady test prep operations than you are to be legitimately pursuing U.S. residency training or licensure,” he wrote on X.
The 2022 move to make USMLE Step 1 pass or fail is another positive change, said Dr. Gul, who added that US programs should also put less weight on test scores and focus more on clinical experience.
“Many programs in the US prioritize scores rather than clinical experiences in home countries,” he said. “If program directors would remove these criteria, probably the cheating practices would stop. Clinical practice matters. When a doctor gets matched, they have to be good at seeing and treating patients, not just good at sitting in front of a screen and taking an exam.”
Turning over questions more rapidly would help curb the practices, Dr. Carmody said. Another strategy is using math techniques to identify unusual deviations that suggest cheating, he said.
A blueprint for the strategy was created after a cheating scandal involving Canada’s Medical Council of Canada Qualifying Examination (MCCQE) in 2004. After learning which questions were circulated, MCCQE administrators evaluated exams by comparing answers of compromised questions with the answers of noncompromised questions.
“For a person who was not cheating, the error of performance should be pretty similar on those two groups of questions,” Dr. Carmody said. “But if you were given the questions in advance, you might have very poor performance on questions that had not been compromised, and very high performance on those that had been compromised. That disparity is very unlikely to occur just by chance alone.”
Based on his research, Dr. Ozair is working on an academic review paper about cheating on the USMLE and on the Medical Council of Canada Qualification Examination. He said that he hopes the paper will raise more awareness about the problem and drive more action.
He and others interviewed for this story shared that the websites they’ve reported to the USMLE program are still active and offering recalls to buyers.
“Even if they are not actually offering something tangible or true, appearance matters,” Dr. Ozair said. “I think it’s worth the USMLE sending cease and desist letters and getting these websites taken down. This would restore faith in the process and underscore that this issue is being taken seriously.”
A version of this article appeared on Medscape.com.
The United States Medical Licensing Examination (USMLE) program is invalidating scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal.
In a January 31 announcement, the USMLE program said that officials are in the process of notifying examinees with results in question and that the examinees will be required to take validation exams. The program did not offer further details about its investigation or how the questionable performance was identified.
“The USMLE program regularly monitors and analyzes examinees’ test performances for unusual score patterns or variations, and other information that could raise questions about the validity of an examinee’s results,” the program said in a statement. “Highly irregular patterns can be indicative of prior unauthorized access to secure exam content.”
Some medical graduates say the action against students cheating on the USMLE is long overdue.
, particularly by groups within the international medical graduate (IMG) community, according to multiple IMGs who shared their concerns with this news organization. Sellers operate under pseudonyms across social media platforms and charge anywhere from $300 to $2000 for questions, Medscape research shows.
Facebook posts often advertise questions for sale, said Saqib Gul, MD, an IMG from Pakistan who has voiced concerns about the practice on social media.
“People make up fake profiles and tell others to [direct message] them for recalls,” he told this news organization. “There was a dedicated Facebook page that was doing this. In other cases, a couple of friends that took the exam remember a certain number of questions and write them down after the test.”
Ahmad Ozair, MD, an IMG from Lucknow, Uttar Pradesh, India, said that he has come across many groups online sharing or selling USMLE recalls. He first became suspicious when he saw several students, all from a few medical schools in Nepal, posting on social media about scoring in the 270 and 280-plus range.
“The statistical probability that you would have three or more candidates in the same year, scoring in the 99th percentile worldwide, belonging to a small geographical area is extremely low.”
Dr. Ozair, who now is studying public health at Johns Hopkins University in Baltimore, said that the issue is important for “all stakeholders” who care about patient safety: “Would you want a doctor who has cheated on the medical licensing exam to take care of you?”
In an interview, USMLE program spokesman Joe Knickrehm said that the program relies on multiple processes to detect and respond to claims that exam integrity is being compromised. The process includes monitoring performance data, an anonymous tip line for reporting suspicious behavior, and a thorough investigative process.
“The USMLE program regularly monitors social media channels for comments relating to exam security and irregular behavior and will initiate an investigation if warranted,” Mr. Knickrehm told this news organization. “ The covert nature of this activity does not lend itself to a definitive statement regarding whether the problem has increased or decreased in recent years.”
Mr. Knickrehm said that the program’s STOPit app allows people to report suspicious behavior electronically to the USMLE program. Since its launch in 2021, the program has received more than 80 tips per year through the app, according to Mr. Knickrehm. Security violations are investigated by USMLE staff and reviewed by the USMLE Committee for Individualized Review (CIR). Anyone found to have engaged in irregular behavior by the CIR for activities undermining exam integrity are typically barred from access to the USMLE for multiple years.
How Easy Is It to Buy Recalls?
Two years ago, Dr B was approached by a former study partner who had just completed Step 2 of the USMLE. She asked whether Dr B wanted to buy recalled questions to help her pass.
“She paid this guy almost $2000 for recalls and told me if I pay this money, he’ll give me the recalls,” said Dr B, who asked to remain anonymous for fear of being associated with students cheating on the USMLE. “I told her I was not interested, and she said the guy would lower the price. I broke contact with her.”
Dr B, an IMG from Pakistan, was appalled. But she said that the episode was not the first time she has come across groups selling USMLE recalls or heard peers brag about having access to exam content.
“I am baffled at how many [groups] post on social media and brazenly advertise their ‘services,’” she told this news organization. “No one arrests them, their customers go on to score abnormally high on the boards, making it unachievable for people who take the honest route, plus giving IMGs a bad rep.”
Groups offering recalls are easily findable on sites such as Telegram and Signal. Telegram is a cloud-based messaging app that focuses on security, and Signal is an encrypted messaging service.
The website recallmastery.com purports to offer a range of USMLE recall packages, from a free, unsorted version to Step 1 and Step 2 packages that include “fresh updates,” and sections with “mostly repeated topics. Prices range from the free version to the $799 VIP package.
Another site called MedPox.com boasts 2024 Step 2 recalls, advertising “ actual exam questions to get HIGH scores.” The website’s owner states that the recalls were collected “by my friends,” and to message the them to be added to the “recalls group.”
A reporter was able to easily download a free version of alleged USMLE questions and answers from recallmastery.com. The document was a combination of typed and handwritten notes about medical questions, with red circles around recalled answers.
J. Bryan Carmody, MD, who blogs about medical education, reviewed a copy of the document. He said that the content appeared “credible” and was in fact recalled USMLE questions. However, the extent of which the question stem was recalled was incomplete at best, and there was little production value to the document, said Dr. Carmody, a nephrologist and associate professor of pediatrics at the Eastern Virgina Medical School in Norfolk.
The person selling the recall packages states on the website that the free version is not organized or sorted, but it allows viewers to “see how this works before paying for premium recalls.”
Mr. Knickrehm said that the program could not comment on the document, but that “whenever the USMLE program receives or locates information about a potential security violation, we investigate and take necessary action.”
When asked about the specific websites noted above, Knickrehm said that the program routinely monitors a wide array of websites, message boards, and chat rooms for USMLE-related materials. Though many sites advertise having USMLE recalls for sale, it’s more likely they are selling non-USMLE content, he said.
Using past content to cheat on medical exams is an old problem. In 2010, for example, the American Board of Internal Medicine suspended 139 physicians after they were caught cheating on the board exams. The scandal involved a vast cheating ring that included physicians memorizing questions and reproducing them after the tests. The board later sued a gastroenterologist for her part in the scandal.
In 2012, a CNN investigation exposed doctors who were memorizing test questions and creating sophisticated recall banks to cheat on radiology boards. The Association of American Medical Colleges sued a medical student in 2017 for attempting to secretly record content on the MCAT using spyglasses.
In recent years, Dr. Carmody said that he has received multiple messages and screenshots from concerned students and residents who were offered or encountered recalls.
“One thing that’s unclear is how legitimate the claims are,” he said. “Many of these recalls may be faulty or outdated. It could be someone who took the exam yesterday and has a photographic memory or it could be some sparsely recalled or mis-recalled information. Unless you’re willing to pay these people, you can’t inspect the quality, or even if you did, you wouldn’t know if the information was current or not.”
‘As an IMG, There Is So Much at Stake’
Whether recall sellers — and those buying them — are more frequently IMGs has fostered heated debate on social media.
On a Reddit thread devoted to IMG issues, posters expressed frustration about being bombarded with recall advertisements and unwanted messages about buying USMLE questions while trying to find study materials. One poster called the practices a “huge slap to all those IMGs who are struggling day and night, just to get a good score.”
In an X thread about the same subject, however, some self-described IMGs took offense to claims that IMGs might score higher because they have access to recalls. The allegations are “incendiary” and “malign hardworking IMGs,” posters wrote.
When Dr. Gul spoke out online about the “biopsy” culture, he received multiple private messages from fellow IMGs telling him to remove his comments, he said.
“I received a lot of backlash on social media,” he told this news organization. “Some IMGs asked me to take down my posts because they thought I was making IMGs look bad, and it might prompt authorities to take action or shut down international examination centers for IMGs.”
Most of the IMGs who spoke to this news organization were afraid to be publicly identified. Several IMG advocates and IMG associations contacted for the story did not respond. One medical education expert said that his institution advised him to “steer clear” of commenting because the issue was “controversial.”
“As an IMG, there is so much at stake,” Dr B said. “Any association with shady operations like these is an absolute suicide. I’m personally afraid of any repercussions of the sort.”
USMLE officials declined to comment on whether the buying or selling of recalls appears to be more prevalent among the IMG community, saying it is “difficult to generalize this behavior as ‘prevalent’ simply due to the clandestine nature of this activity.”
Cheat-Proofing the USMLE
The USMLE program has taken several steps intended to prevent cheating, but more needs to be done, medical education advocates say.
For example, Dr. Carmody called the recent change in the attempt limit for taking USMLE exams from six to four times a good move.
“The reality is, if you’re taking a USMLE exam five-plus times, you’re far more likely to be memorizing questions and selling them for shady test prep operations than you are to be legitimately pursuing U.S. residency training or licensure,” he wrote on X.
The 2022 move to make USMLE Step 1 pass or fail is another positive change, said Dr. Gul, who added that US programs should also put less weight on test scores and focus more on clinical experience.
“Many programs in the US prioritize scores rather than clinical experiences in home countries,” he said. “If program directors would remove these criteria, probably the cheating practices would stop. Clinical practice matters. When a doctor gets matched, they have to be good at seeing and treating patients, not just good at sitting in front of a screen and taking an exam.”
Turning over questions more rapidly would help curb the practices, Dr. Carmody said. Another strategy is using math techniques to identify unusual deviations that suggest cheating, he said.
A blueprint for the strategy was created after a cheating scandal involving Canada’s Medical Council of Canada Qualifying Examination (MCCQE) in 2004. After learning which questions were circulated, MCCQE administrators evaluated exams by comparing answers of compromised questions with the answers of noncompromised questions.
“For a person who was not cheating, the error of performance should be pretty similar on those two groups of questions,” Dr. Carmody said. “But if you were given the questions in advance, you might have very poor performance on questions that had not been compromised, and very high performance on those that had been compromised. That disparity is very unlikely to occur just by chance alone.”
Based on his research, Dr. Ozair is working on an academic review paper about cheating on the USMLE and on the Medical Council of Canada Qualification Examination. He said that he hopes the paper will raise more awareness about the problem and drive more action.
He and others interviewed for this story shared that the websites they’ve reported to the USMLE program are still active and offering recalls to buyers.
“Even if they are not actually offering something tangible or true, appearance matters,” Dr. Ozair said. “I think it’s worth the USMLE sending cease and desist letters and getting these websites taken down. This would restore faith in the process and underscore that this issue is being taken seriously.”
A version of this article appeared on Medscape.com.
The United States Medical Licensing Examination (USMLE) program is invalidating scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal.
In a January 31 announcement, the USMLE program said that officials are in the process of notifying examinees with results in question and that the examinees will be required to take validation exams. The program did not offer further details about its investigation or how the questionable performance was identified.
“The USMLE program regularly monitors and analyzes examinees’ test performances for unusual score patterns or variations, and other information that could raise questions about the validity of an examinee’s results,” the program said in a statement. “Highly irregular patterns can be indicative of prior unauthorized access to secure exam content.”
Some medical graduates say the action against students cheating on the USMLE is long overdue.
, particularly by groups within the international medical graduate (IMG) community, according to multiple IMGs who shared their concerns with this news organization. Sellers operate under pseudonyms across social media platforms and charge anywhere from $300 to $2000 for questions, Medscape research shows.
Facebook posts often advertise questions for sale, said Saqib Gul, MD, an IMG from Pakistan who has voiced concerns about the practice on social media.
“People make up fake profiles and tell others to [direct message] them for recalls,” he told this news organization. “There was a dedicated Facebook page that was doing this. In other cases, a couple of friends that took the exam remember a certain number of questions and write them down after the test.”
Ahmad Ozair, MD, an IMG from Lucknow, Uttar Pradesh, India, said that he has come across many groups online sharing or selling USMLE recalls. He first became suspicious when he saw several students, all from a few medical schools in Nepal, posting on social media about scoring in the 270 and 280-plus range.
“The statistical probability that you would have three or more candidates in the same year, scoring in the 99th percentile worldwide, belonging to a small geographical area is extremely low.”
Dr. Ozair, who now is studying public health at Johns Hopkins University in Baltimore, said that the issue is important for “all stakeholders” who care about patient safety: “Would you want a doctor who has cheated on the medical licensing exam to take care of you?”
In an interview, USMLE program spokesman Joe Knickrehm said that the program relies on multiple processes to detect and respond to claims that exam integrity is being compromised. The process includes monitoring performance data, an anonymous tip line for reporting suspicious behavior, and a thorough investigative process.
“The USMLE program regularly monitors social media channels for comments relating to exam security and irregular behavior and will initiate an investigation if warranted,” Mr. Knickrehm told this news organization. “ The covert nature of this activity does not lend itself to a definitive statement regarding whether the problem has increased or decreased in recent years.”
Mr. Knickrehm said that the program’s STOPit app allows people to report suspicious behavior electronically to the USMLE program. Since its launch in 2021, the program has received more than 80 tips per year through the app, according to Mr. Knickrehm. Security violations are investigated by USMLE staff and reviewed by the USMLE Committee for Individualized Review (CIR). Anyone found to have engaged in irregular behavior by the CIR for activities undermining exam integrity are typically barred from access to the USMLE for multiple years.
How Easy Is It to Buy Recalls?
Two years ago, Dr B was approached by a former study partner who had just completed Step 2 of the USMLE. She asked whether Dr B wanted to buy recalled questions to help her pass.
“She paid this guy almost $2000 for recalls and told me if I pay this money, he’ll give me the recalls,” said Dr B, who asked to remain anonymous for fear of being associated with students cheating on the USMLE. “I told her I was not interested, and she said the guy would lower the price. I broke contact with her.”
Dr B, an IMG from Pakistan, was appalled. But she said that the episode was not the first time she has come across groups selling USMLE recalls or heard peers brag about having access to exam content.
“I am baffled at how many [groups] post on social media and brazenly advertise their ‘services,’” she told this news organization. “No one arrests them, their customers go on to score abnormally high on the boards, making it unachievable for people who take the honest route, plus giving IMGs a bad rep.”
Groups offering recalls are easily findable on sites such as Telegram and Signal. Telegram is a cloud-based messaging app that focuses on security, and Signal is an encrypted messaging service.
The website recallmastery.com purports to offer a range of USMLE recall packages, from a free, unsorted version to Step 1 and Step 2 packages that include “fresh updates,” and sections with “mostly repeated topics. Prices range from the free version to the $799 VIP package.
Another site called MedPox.com boasts 2024 Step 2 recalls, advertising “ actual exam questions to get HIGH scores.” The website’s owner states that the recalls were collected “by my friends,” and to message the them to be added to the “recalls group.”
A reporter was able to easily download a free version of alleged USMLE questions and answers from recallmastery.com. The document was a combination of typed and handwritten notes about medical questions, with red circles around recalled answers.
J. Bryan Carmody, MD, who blogs about medical education, reviewed a copy of the document. He said that the content appeared “credible” and was in fact recalled USMLE questions. However, the extent of which the question stem was recalled was incomplete at best, and there was little production value to the document, said Dr. Carmody, a nephrologist and associate professor of pediatrics at the Eastern Virgina Medical School in Norfolk.
The person selling the recall packages states on the website that the free version is not organized or sorted, but it allows viewers to “see how this works before paying for premium recalls.”
Mr. Knickrehm said that the program could not comment on the document, but that “whenever the USMLE program receives or locates information about a potential security violation, we investigate and take necessary action.”
When asked about the specific websites noted above, Knickrehm said that the program routinely monitors a wide array of websites, message boards, and chat rooms for USMLE-related materials. Though many sites advertise having USMLE recalls for sale, it’s more likely they are selling non-USMLE content, he said.
Using past content to cheat on medical exams is an old problem. In 2010, for example, the American Board of Internal Medicine suspended 139 physicians after they were caught cheating on the board exams. The scandal involved a vast cheating ring that included physicians memorizing questions and reproducing them after the tests. The board later sued a gastroenterologist for her part in the scandal.
In 2012, a CNN investigation exposed doctors who were memorizing test questions and creating sophisticated recall banks to cheat on radiology boards. The Association of American Medical Colleges sued a medical student in 2017 for attempting to secretly record content on the MCAT using spyglasses.
In recent years, Dr. Carmody said that he has received multiple messages and screenshots from concerned students and residents who were offered or encountered recalls.
“One thing that’s unclear is how legitimate the claims are,” he said. “Many of these recalls may be faulty or outdated. It could be someone who took the exam yesterday and has a photographic memory or it could be some sparsely recalled or mis-recalled information. Unless you’re willing to pay these people, you can’t inspect the quality, or even if you did, you wouldn’t know if the information was current or not.”
‘As an IMG, There Is So Much at Stake’
Whether recall sellers — and those buying them — are more frequently IMGs has fostered heated debate on social media.
On a Reddit thread devoted to IMG issues, posters expressed frustration about being bombarded with recall advertisements and unwanted messages about buying USMLE questions while trying to find study materials. One poster called the practices a “huge slap to all those IMGs who are struggling day and night, just to get a good score.”
In an X thread about the same subject, however, some self-described IMGs took offense to claims that IMGs might score higher because they have access to recalls. The allegations are “incendiary” and “malign hardworking IMGs,” posters wrote.
When Dr. Gul spoke out online about the “biopsy” culture, he received multiple private messages from fellow IMGs telling him to remove his comments, he said.
“I received a lot of backlash on social media,” he told this news organization. “Some IMGs asked me to take down my posts because they thought I was making IMGs look bad, and it might prompt authorities to take action or shut down international examination centers for IMGs.”
Most of the IMGs who spoke to this news organization were afraid to be publicly identified. Several IMG advocates and IMG associations contacted for the story did not respond. One medical education expert said that his institution advised him to “steer clear” of commenting because the issue was “controversial.”
“As an IMG, there is so much at stake,” Dr B said. “Any association with shady operations like these is an absolute suicide. I’m personally afraid of any repercussions of the sort.”
USMLE officials declined to comment on whether the buying or selling of recalls appears to be more prevalent among the IMG community, saying it is “difficult to generalize this behavior as ‘prevalent’ simply due to the clandestine nature of this activity.”
Cheat-Proofing the USMLE
The USMLE program has taken several steps intended to prevent cheating, but more needs to be done, medical education advocates say.
For example, Dr. Carmody called the recent change in the attempt limit for taking USMLE exams from six to four times a good move.
“The reality is, if you’re taking a USMLE exam five-plus times, you’re far more likely to be memorizing questions and selling them for shady test prep operations than you are to be legitimately pursuing U.S. residency training or licensure,” he wrote on X.
The 2022 move to make USMLE Step 1 pass or fail is another positive change, said Dr. Gul, who added that US programs should also put less weight on test scores and focus more on clinical experience.
“Many programs in the US prioritize scores rather than clinical experiences in home countries,” he said. “If program directors would remove these criteria, probably the cheating practices would stop. Clinical practice matters. When a doctor gets matched, they have to be good at seeing and treating patients, not just good at sitting in front of a screen and taking an exam.”
Turning over questions more rapidly would help curb the practices, Dr. Carmody said. Another strategy is using math techniques to identify unusual deviations that suggest cheating, he said.
A blueprint for the strategy was created after a cheating scandal involving Canada’s Medical Council of Canada Qualifying Examination (MCCQE) in 2004. After learning which questions were circulated, MCCQE administrators evaluated exams by comparing answers of compromised questions with the answers of noncompromised questions.
“For a person who was not cheating, the error of performance should be pretty similar on those two groups of questions,” Dr. Carmody said. “But if you were given the questions in advance, you might have very poor performance on questions that had not been compromised, and very high performance on those that had been compromised. That disparity is very unlikely to occur just by chance alone.”
Based on his research, Dr. Ozair is working on an academic review paper about cheating on the USMLE and on the Medical Council of Canada Qualification Examination. He said that he hopes the paper will raise more awareness about the problem and drive more action.
He and others interviewed for this story shared that the websites they’ve reported to the USMLE program are still active and offering recalls to buyers.
“Even if they are not actually offering something tangible or true, appearance matters,” Dr. Ozair said. “I think it’s worth the USMLE sending cease and desist letters and getting these websites taken down. This would restore faith in the process and underscore that this issue is being taken seriously.”
A version of this article appeared on Medscape.com.
Treating Acne Scars Can Improve Aesthetics, Quality of Life
ORLANDO, FLORIDA — For some people, acne carries a one-two punch. First, they experience acne that is significant enough to decrease their quality of life, followed by scarring that can last a lifetime. For those patients, dermatologists have several options: Subcision to lift the depression of the scar, laser treatment to lower the height of scar tissue, and injections to fill scars.
“In my practice, I find that ,” Robyn Siperstein, MD, said at the annual ODAC Dermatology, Aesthetic & Surgical Conference.
Dr. Siperstein starts by identifying the type of acne scar — rolling scars, boxcar scars, or ice pick scars. Rolling scars tend to be shallower with no sharp edges; boxcar scars are deeper, more defined round or oval depressions; and ice pick scars, as the name suggests, look like someone stuck tiny ice picks into the skin, leaving a sunken or pitted appearance.
“It’s really important to categorize so that we know which ones are going to be effectively treated with different modalities and which ones aren’t, so that we can give our patients realistic expectations,” said Dr. Siperstein, a cosmetic dermatologist in private practice in Boca Raton, Florida, and a clinical affiliate associate professor of dermatology at Florida Atlantic University, Boca Raton.
“There’s not going to be one treatment that’s right for everything,” she said. Different approaches may be required even for the same patient because some people present with all three types of acne scars, she added.
Combining Treatments
When it comes to injecting dermal fillers into acne scars to lift the depressed areas, the US Food and Drug Administration approved a filler with polymethyl methacrylate filler and bovine collagen (Bellafill) for this indication (moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over age 21) in 2015. “And off-label, I use hyaluronic acid in my practice,” Dr. Siperstein said. Each filler “probably works a little bit better or differently on different types of scars.”
For rolling scars, she recommends hyaluronic acid (HA) dermal filler for everyone. “Of course, this is my opinion.” She was also a lead investigator in a randomized, placebo-controlled split-face study comparing HA filler with saline for correcting atrophic facial scars in 15 patients. The HA filler emerged superior, although there were some improvements with saline.
In her clinical experience, patients are happy with the results and ask, “Why didn’t the last four doctors do this?”
Boxcar scars are more challenging to fill with HA. In some cases, Dr. Siperstein is able to raise the depressed portion of the scar, but some of the vertical edges remain. In this scenario, she might combine treatments. Laser resurfacing, for example, might help convert boxcar scars into rolling scars, which then can be filled more successfully.
“Ice pick scars are tough,” Dr. Siperstein said. A punch removal technique can work in some cases, or she might try the “cross technique.” This involves placing acetic acid inside the scar using a Q-tip. “You have to be really careful,” she added, “because if you get it around the edges, it’s actually going to make the scar bigger.”
Choosing the Right Candidates
Selecting the right candidate for HA treatment of acne scars is essential. Dr. Siperstein shared the example of a lifeguard who had prominent acne scarring down the center of his chest. “He was embarrassed to go to the beach and take off his shirt. He said he felt like he had bullet holes in his chest.”
One month following treatment, “he had a really nice improvement, and now he feels really comfortable,” she said.
Some dermatologists might be reluctant to consider HA fillers for acne scarring because there is a misconception that HA is short-acting, lasting 6 months to 1 year before the effect wears off. That impression can persist from company-sponsored studies that limit follow-up to 6 months or 1 year “to get their drug to market,” she noted.
Also adding to this impression is that HA fillers in wrinkles may not last as long. Dr. Siperstein explained that wrinkles on the face are dynamic and constantly moving. In contrast, acne scars experience less movement, which helps the HA last longer. There is MRI evidence that shows HA fillers last over 2 years in the face, she added.
One tip to predict how well an acne scar might respond to filler injections is to squeeze it and look for the “dimple sign.” If the floor of the scar lifts up when squeezed, “we know that they’ll be a good candidate for hyaluronic acid filler.” Another tip is to inject HA in a retrograde technique high up in the skin. Inject tiny amounts — microdroplets — of the HA filler high on the dermis, she advised.
Deeper injections run the risk of raising the entire scar instead of filling it, she added.
Like many dermatologic procedures, before and after photos are essential to demonstrate improvements, Dr. Siperstein pointed out. Patients are often skeptical. “This happens a lot with acne scar patients. They’ve been to a million places that have promised results, they have not gotten them, and they are frustrated.”
Acne scars can result from picking, inflammation, or treatment. “This is what we see all day in clinic,” Dr. Siperstein said. “Somebody who had to undergo Accutane treatment but unfortunately is left with holes. This is a huge psychological burden on our patients,” she said, describing a younger patient who had scarring, which “led to depression — it was ruining his life.”
“His mom was willing to do whatever it took. And I said, You know what, I think filler will be enough,” Dr. Siperstein said. She counseled them that treatment would not make the scars disappear completely. But patients used to 10% improvements are very happy when their acne scars look 80% or 90% better, she added.
Dr. Siperstein received grant or research support and is a member of the speakers bureau for Allergan and Galderma. She is also a consultant/advisory board member for Allergan.
A version of this article appeared on Medscape.com.
ORLANDO, FLORIDA — For some people, acne carries a one-two punch. First, they experience acne that is significant enough to decrease their quality of life, followed by scarring that can last a lifetime. For those patients, dermatologists have several options: Subcision to lift the depression of the scar, laser treatment to lower the height of scar tissue, and injections to fill scars.
“In my practice, I find that ,” Robyn Siperstein, MD, said at the annual ODAC Dermatology, Aesthetic & Surgical Conference.
Dr. Siperstein starts by identifying the type of acne scar — rolling scars, boxcar scars, or ice pick scars. Rolling scars tend to be shallower with no sharp edges; boxcar scars are deeper, more defined round or oval depressions; and ice pick scars, as the name suggests, look like someone stuck tiny ice picks into the skin, leaving a sunken or pitted appearance.
“It’s really important to categorize so that we know which ones are going to be effectively treated with different modalities and which ones aren’t, so that we can give our patients realistic expectations,” said Dr. Siperstein, a cosmetic dermatologist in private practice in Boca Raton, Florida, and a clinical affiliate associate professor of dermatology at Florida Atlantic University, Boca Raton.
“There’s not going to be one treatment that’s right for everything,” she said. Different approaches may be required even for the same patient because some people present with all three types of acne scars, she added.
Combining Treatments
When it comes to injecting dermal fillers into acne scars to lift the depressed areas, the US Food and Drug Administration approved a filler with polymethyl methacrylate filler and bovine collagen (Bellafill) for this indication (moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over age 21) in 2015. “And off-label, I use hyaluronic acid in my practice,” Dr. Siperstein said. Each filler “probably works a little bit better or differently on different types of scars.”
For rolling scars, she recommends hyaluronic acid (HA) dermal filler for everyone. “Of course, this is my opinion.” She was also a lead investigator in a randomized, placebo-controlled split-face study comparing HA filler with saline for correcting atrophic facial scars in 15 patients. The HA filler emerged superior, although there were some improvements with saline.
In her clinical experience, patients are happy with the results and ask, “Why didn’t the last four doctors do this?”
Boxcar scars are more challenging to fill with HA. In some cases, Dr. Siperstein is able to raise the depressed portion of the scar, but some of the vertical edges remain. In this scenario, she might combine treatments. Laser resurfacing, for example, might help convert boxcar scars into rolling scars, which then can be filled more successfully.
“Ice pick scars are tough,” Dr. Siperstein said. A punch removal technique can work in some cases, or she might try the “cross technique.” This involves placing acetic acid inside the scar using a Q-tip. “You have to be really careful,” she added, “because if you get it around the edges, it’s actually going to make the scar bigger.”
Choosing the Right Candidates
Selecting the right candidate for HA treatment of acne scars is essential. Dr. Siperstein shared the example of a lifeguard who had prominent acne scarring down the center of his chest. “He was embarrassed to go to the beach and take off his shirt. He said he felt like he had bullet holes in his chest.”
One month following treatment, “he had a really nice improvement, and now he feels really comfortable,” she said.
Some dermatologists might be reluctant to consider HA fillers for acne scarring because there is a misconception that HA is short-acting, lasting 6 months to 1 year before the effect wears off. That impression can persist from company-sponsored studies that limit follow-up to 6 months or 1 year “to get their drug to market,” she noted.
Also adding to this impression is that HA fillers in wrinkles may not last as long. Dr. Siperstein explained that wrinkles on the face are dynamic and constantly moving. In contrast, acne scars experience less movement, which helps the HA last longer. There is MRI evidence that shows HA fillers last over 2 years in the face, she added.
One tip to predict how well an acne scar might respond to filler injections is to squeeze it and look for the “dimple sign.” If the floor of the scar lifts up when squeezed, “we know that they’ll be a good candidate for hyaluronic acid filler.” Another tip is to inject HA in a retrograde technique high up in the skin. Inject tiny amounts — microdroplets — of the HA filler high on the dermis, she advised.
Deeper injections run the risk of raising the entire scar instead of filling it, she added.
Like many dermatologic procedures, before and after photos are essential to demonstrate improvements, Dr. Siperstein pointed out. Patients are often skeptical. “This happens a lot with acne scar patients. They’ve been to a million places that have promised results, they have not gotten them, and they are frustrated.”
Acne scars can result from picking, inflammation, or treatment. “This is what we see all day in clinic,” Dr. Siperstein said. “Somebody who had to undergo Accutane treatment but unfortunately is left with holes. This is a huge psychological burden on our patients,” she said, describing a younger patient who had scarring, which “led to depression — it was ruining his life.”
“His mom was willing to do whatever it took. And I said, You know what, I think filler will be enough,” Dr. Siperstein said. She counseled them that treatment would not make the scars disappear completely. But patients used to 10% improvements are very happy when their acne scars look 80% or 90% better, she added.
Dr. Siperstein received grant or research support and is a member of the speakers bureau for Allergan and Galderma. She is also a consultant/advisory board member for Allergan.
A version of this article appeared on Medscape.com.
ORLANDO, FLORIDA — For some people, acne carries a one-two punch. First, they experience acne that is significant enough to decrease their quality of life, followed by scarring that can last a lifetime. For those patients, dermatologists have several options: Subcision to lift the depression of the scar, laser treatment to lower the height of scar tissue, and injections to fill scars.
“In my practice, I find that ,” Robyn Siperstein, MD, said at the annual ODAC Dermatology, Aesthetic & Surgical Conference.
Dr. Siperstein starts by identifying the type of acne scar — rolling scars, boxcar scars, or ice pick scars. Rolling scars tend to be shallower with no sharp edges; boxcar scars are deeper, more defined round or oval depressions; and ice pick scars, as the name suggests, look like someone stuck tiny ice picks into the skin, leaving a sunken or pitted appearance.
“It’s really important to categorize so that we know which ones are going to be effectively treated with different modalities and which ones aren’t, so that we can give our patients realistic expectations,” said Dr. Siperstein, a cosmetic dermatologist in private practice in Boca Raton, Florida, and a clinical affiliate associate professor of dermatology at Florida Atlantic University, Boca Raton.
“There’s not going to be one treatment that’s right for everything,” she said. Different approaches may be required even for the same patient because some people present with all three types of acne scars, she added.
Combining Treatments
When it comes to injecting dermal fillers into acne scars to lift the depressed areas, the US Food and Drug Administration approved a filler with polymethyl methacrylate filler and bovine collagen (Bellafill) for this indication (moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over age 21) in 2015. “And off-label, I use hyaluronic acid in my practice,” Dr. Siperstein said. Each filler “probably works a little bit better or differently on different types of scars.”
For rolling scars, she recommends hyaluronic acid (HA) dermal filler for everyone. “Of course, this is my opinion.” She was also a lead investigator in a randomized, placebo-controlled split-face study comparing HA filler with saline for correcting atrophic facial scars in 15 patients. The HA filler emerged superior, although there were some improvements with saline.
In her clinical experience, patients are happy with the results and ask, “Why didn’t the last four doctors do this?”
Boxcar scars are more challenging to fill with HA. In some cases, Dr. Siperstein is able to raise the depressed portion of the scar, but some of the vertical edges remain. In this scenario, she might combine treatments. Laser resurfacing, for example, might help convert boxcar scars into rolling scars, which then can be filled more successfully.
“Ice pick scars are tough,” Dr. Siperstein said. A punch removal technique can work in some cases, or she might try the “cross technique.” This involves placing acetic acid inside the scar using a Q-tip. “You have to be really careful,” she added, “because if you get it around the edges, it’s actually going to make the scar bigger.”
Choosing the Right Candidates
Selecting the right candidate for HA treatment of acne scars is essential. Dr. Siperstein shared the example of a lifeguard who had prominent acne scarring down the center of his chest. “He was embarrassed to go to the beach and take off his shirt. He said he felt like he had bullet holes in his chest.”
One month following treatment, “he had a really nice improvement, and now he feels really comfortable,” she said.
Some dermatologists might be reluctant to consider HA fillers for acne scarring because there is a misconception that HA is short-acting, lasting 6 months to 1 year before the effect wears off. That impression can persist from company-sponsored studies that limit follow-up to 6 months or 1 year “to get their drug to market,” she noted.
Also adding to this impression is that HA fillers in wrinkles may not last as long. Dr. Siperstein explained that wrinkles on the face are dynamic and constantly moving. In contrast, acne scars experience less movement, which helps the HA last longer. There is MRI evidence that shows HA fillers last over 2 years in the face, she added.
One tip to predict how well an acne scar might respond to filler injections is to squeeze it and look for the “dimple sign.” If the floor of the scar lifts up when squeezed, “we know that they’ll be a good candidate for hyaluronic acid filler.” Another tip is to inject HA in a retrograde technique high up in the skin. Inject tiny amounts — microdroplets — of the HA filler high on the dermis, she advised.
Deeper injections run the risk of raising the entire scar instead of filling it, she added.
Like many dermatologic procedures, before and after photos are essential to demonstrate improvements, Dr. Siperstein pointed out. Patients are often skeptical. “This happens a lot with acne scar patients. They’ve been to a million places that have promised results, they have not gotten them, and they are frustrated.”
Acne scars can result from picking, inflammation, or treatment. “This is what we see all day in clinic,” Dr. Siperstein said. “Somebody who had to undergo Accutane treatment but unfortunately is left with holes. This is a huge psychological burden on our patients,” she said, describing a younger patient who had scarring, which “led to depression — it was ruining his life.”
“His mom was willing to do whatever it took. And I said, You know what, I think filler will be enough,” Dr. Siperstein said. She counseled them that treatment would not make the scars disappear completely. But patients used to 10% improvements are very happy when their acne scars look 80% or 90% better, she added.
Dr. Siperstein received grant or research support and is a member of the speakers bureau for Allergan and Galderma. She is also a consultant/advisory board member for Allergan.
A version of this article appeared on Medscape.com.
FROM ODAC 2024
Study Evaluates Aesthetic Concerns in Asian Women
CHICAGO — presented at the annual meeting of the American Society for Dermatologic Surgery (ASDS),
“Asian Americans represent the fastest-expanding racial group in the US, underscoring the need for a comprehensive understanding of their specific aesthetic goals and needs,” said Annie Chiu, MD, a cosmetic dermatologist in Redondo Beach, California, who presented the results at the meeting. In an interview, she noted that most of this type of research has been done in White or Eurocentric populations, “so we really wanted to identify the top aesthetic concerns for Asian women as they tend to be different.”
In the study, an online survey was administered to aesthetically-inclined adults — defined as those who care about improving their appearance and are willing to go to a professional to do so — across different demographic groups in the United States. Respondents were surveyed about 41 facial and 31 body characteristics, identifying those they have and find bothersome. Maximum difference scaling was used to generate their most and least bothersome characteristics in each respective category.
Of the 3,974 women surveyed, 652 self-identified as female and Asian. The majority of Asian female respondents self-reported a Fitzpatrick skin type IV (East/Southeast [SE]Asian: 58%; Indian/Central or Southwest [CSW] Asian: 24%) or type V (East/SE Asian: 59%; Indian/CSW Asian: 30%). The findings reported at the meeting are specific to aesthetic concerns in Asian women.
Among the Asian female participants, the top three facial concerns were uneven skin color (40%), dull/dry skin (35%), and hair loss/thinning (34%). Top facial concerns in younger patients (under 30 years) were related to skin quality, such as dull skin (54%), acne scarring (51%), and large pore size (51%), whereas the most common concerns among those older than 57 years were related to under-eye bags or sagginess (60%), uneven skin tone (55%), and hair loss/thinning (47%).
Of note, acne scarring was noted as a top concern by the Indian/CSW Asian cohort. While the lines between the brows and skin sagging were top concerns in White female participants in the overall study, these concerns were not nearly as high among Asian female participants.
For all Asian female participants, the top body concerns were related to stubborn body fat in the stomach, sides, bra or back area, and arms. Stubborn body fat in the stomach area was the most frequent concern across generations (41% to 64%). East/SE Asian participants were more interested in receiving cosmetic treatments (91%) than the Indian/CSW Asian group (47%).
“Given that injectable treatments of neuromodulators and fillers are often what we focus aesthetic treatments around and thus, what we often center cosmetic consults on, it is important to remember to customize patient consultations and address specific needs with cultural sensitivity,” Dr. Chiu said. “We may not be properly recognizing and prioritizing patient discussion around concerns of dyspigmentation, skin quality, or hair thinning,” she continued, adding: “Ultimately as experts, it’s important we use this data along with what we know about structural and cutaneous differences in patients of different cultural backgrounds to optimize and prioritize treatments.”
Allergan Aesthetics, an AbbVie company, funded the study and participated in the trial design, research, analysis, data collection, interpretation of data, and the review. Dr. Chiu is a consultant, advisory board member, and investigator for Allergan, AbbVie,and Merz; and is a consultant and advisory board member for Galderma, Evolus, and Sofwave. Other authors disclosed ties with Allergan, Merz Aesthetics, Prollenium, Revance, Galderma, Alastin, Glo Pharma, and Teoxane. Two authors are AbbVie employees.
CHICAGO — presented at the annual meeting of the American Society for Dermatologic Surgery (ASDS),
“Asian Americans represent the fastest-expanding racial group in the US, underscoring the need for a comprehensive understanding of their specific aesthetic goals and needs,” said Annie Chiu, MD, a cosmetic dermatologist in Redondo Beach, California, who presented the results at the meeting. In an interview, she noted that most of this type of research has been done in White or Eurocentric populations, “so we really wanted to identify the top aesthetic concerns for Asian women as they tend to be different.”
In the study, an online survey was administered to aesthetically-inclined adults — defined as those who care about improving their appearance and are willing to go to a professional to do so — across different demographic groups in the United States. Respondents were surveyed about 41 facial and 31 body characteristics, identifying those they have and find bothersome. Maximum difference scaling was used to generate their most and least bothersome characteristics in each respective category.
Of the 3,974 women surveyed, 652 self-identified as female and Asian. The majority of Asian female respondents self-reported a Fitzpatrick skin type IV (East/Southeast [SE]Asian: 58%; Indian/Central or Southwest [CSW] Asian: 24%) or type V (East/SE Asian: 59%; Indian/CSW Asian: 30%). The findings reported at the meeting are specific to aesthetic concerns in Asian women.
Among the Asian female participants, the top three facial concerns were uneven skin color (40%), dull/dry skin (35%), and hair loss/thinning (34%). Top facial concerns in younger patients (under 30 years) were related to skin quality, such as dull skin (54%), acne scarring (51%), and large pore size (51%), whereas the most common concerns among those older than 57 years were related to under-eye bags or sagginess (60%), uneven skin tone (55%), and hair loss/thinning (47%).
Of note, acne scarring was noted as a top concern by the Indian/CSW Asian cohort. While the lines between the brows and skin sagging were top concerns in White female participants in the overall study, these concerns were not nearly as high among Asian female participants.
For all Asian female participants, the top body concerns were related to stubborn body fat in the stomach, sides, bra or back area, and arms. Stubborn body fat in the stomach area was the most frequent concern across generations (41% to 64%). East/SE Asian participants were more interested in receiving cosmetic treatments (91%) than the Indian/CSW Asian group (47%).
“Given that injectable treatments of neuromodulators and fillers are often what we focus aesthetic treatments around and thus, what we often center cosmetic consults on, it is important to remember to customize patient consultations and address specific needs with cultural sensitivity,” Dr. Chiu said. “We may not be properly recognizing and prioritizing patient discussion around concerns of dyspigmentation, skin quality, or hair thinning,” she continued, adding: “Ultimately as experts, it’s important we use this data along with what we know about structural and cutaneous differences in patients of different cultural backgrounds to optimize and prioritize treatments.”
Allergan Aesthetics, an AbbVie company, funded the study and participated in the trial design, research, analysis, data collection, interpretation of data, and the review. Dr. Chiu is a consultant, advisory board member, and investigator for Allergan, AbbVie,and Merz; and is a consultant and advisory board member for Galderma, Evolus, and Sofwave. Other authors disclosed ties with Allergan, Merz Aesthetics, Prollenium, Revance, Galderma, Alastin, Glo Pharma, and Teoxane. Two authors are AbbVie employees.
CHICAGO — presented at the annual meeting of the American Society for Dermatologic Surgery (ASDS),
“Asian Americans represent the fastest-expanding racial group in the US, underscoring the need for a comprehensive understanding of their specific aesthetic goals and needs,” said Annie Chiu, MD, a cosmetic dermatologist in Redondo Beach, California, who presented the results at the meeting. In an interview, she noted that most of this type of research has been done in White or Eurocentric populations, “so we really wanted to identify the top aesthetic concerns for Asian women as they tend to be different.”
In the study, an online survey was administered to aesthetically-inclined adults — defined as those who care about improving their appearance and are willing to go to a professional to do so — across different demographic groups in the United States. Respondents were surveyed about 41 facial and 31 body characteristics, identifying those they have and find bothersome. Maximum difference scaling was used to generate their most and least bothersome characteristics in each respective category.
Of the 3,974 women surveyed, 652 self-identified as female and Asian. The majority of Asian female respondents self-reported a Fitzpatrick skin type IV (East/Southeast [SE]Asian: 58%; Indian/Central or Southwest [CSW] Asian: 24%) or type V (East/SE Asian: 59%; Indian/CSW Asian: 30%). The findings reported at the meeting are specific to aesthetic concerns in Asian women.
Among the Asian female participants, the top three facial concerns were uneven skin color (40%), dull/dry skin (35%), and hair loss/thinning (34%). Top facial concerns in younger patients (under 30 years) were related to skin quality, such as dull skin (54%), acne scarring (51%), and large pore size (51%), whereas the most common concerns among those older than 57 years were related to under-eye bags or sagginess (60%), uneven skin tone (55%), and hair loss/thinning (47%).
Of note, acne scarring was noted as a top concern by the Indian/CSW Asian cohort. While the lines between the brows and skin sagging were top concerns in White female participants in the overall study, these concerns were not nearly as high among Asian female participants.
For all Asian female participants, the top body concerns were related to stubborn body fat in the stomach, sides, bra or back area, and arms. Stubborn body fat in the stomach area was the most frequent concern across generations (41% to 64%). East/SE Asian participants were more interested in receiving cosmetic treatments (91%) than the Indian/CSW Asian group (47%).
“Given that injectable treatments of neuromodulators and fillers are often what we focus aesthetic treatments around and thus, what we often center cosmetic consults on, it is important to remember to customize patient consultations and address specific needs with cultural sensitivity,” Dr. Chiu said. “We may not be properly recognizing and prioritizing patient discussion around concerns of dyspigmentation, skin quality, or hair thinning,” she continued, adding: “Ultimately as experts, it’s important we use this data along with what we know about structural and cutaneous differences in patients of different cultural backgrounds to optimize and prioritize treatments.”
Allergan Aesthetics, an AbbVie company, funded the study and participated in the trial design, research, analysis, data collection, interpretation of data, and the review. Dr. Chiu is a consultant, advisory board member, and investigator for Allergan, AbbVie,and Merz; and is a consultant and advisory board member for Galderma, Evolus, and Sofwave. Other authors disclosed ties with Allergan, Merz Aesthetics, Prollenium, Revance, Galderma, Alastin, Glo Pharma, and Teoxane. Two authors are AbbVie employees.
AT ASDS 2023
Study Concludes Most Melanoma Overdiagnoses Are In Situ
TOPLINE:
METHODOLOGY:
- The increase in melanoma diagnoses in the United States, while mortality has remained flat, has raised concerns about overdiagnosis of melanoma, cases that may not result in harm if left untreated. How much of the overdiagnoses can be attributed to melanoma in situ vs invasive melanoma is unknown.
- To address this question, researchers collected data from the SEER 9 registries database.
- They used DevCan software to calculate the cumulative lifetime risk of White American men and women being diagnosed with melanoma between 1975 and 2018, adjusting for changes in longevity and risk factors over the study period.
- The primary outcome was excess lifetime risk for melanoma diagnosis between 1976 and 2018, adjusted for year 2018 competing mortality and changes in risk factors.
TAKEAWAY:
- Researchers found that between 1975 and 2018, the adjusted lifetime risk of being diagnosed with melanoma in situ increased from 0.17% to 2.7% in White men and 0.08% to 2% in White women.
- An estimated 49.7% and 64.6% of melanomas diagnosed in White men and White women, respectively, were overdiagnosed in 2018.
- Among individuals diagnosed with melanoma in situ, 89.4% of White men and 85.4% of White women were likely overdiagnosed in 2018.
IN PRACTICE:
“A large proportion of overdiagnosed melanomas are in situ cancers, pointing to a potential area to focus for an intervention de-escalation of the intensity of treatment and survivorship care,” the authors wrote.
SOURCE:
Adewole S. Adamson, MD, of the Division of Dermatology at The University of Texas at Austin Dell Medical School, led the research. The study was published in BMJ Evidence-Based Medicine on January 19, 2024.
LIMITATIONS:
The analysis only involved White individuals. Other limitations include a high risk for selection bias and that the researchers assumed no melanoma diagnosis in 1975, which may not be the case.
DISCLOSURES:
Dr. Adamson disclosed that he is supported by the Robert Wood Johnson Foundation through The Harold Amos Medical Faculty Development Program. Coauthor Katy J.L. Bell, MBchB, PhD, of the University of Sydney, is supported by an Australian Government National Health and Medical Research Council Investigator Grant.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The increase in melanoma diagnoses in the United States, while mortality has remained flat, has raised concerns about overdiagnosis of melanoma, cases that may not result in harm if left untreated. How much of the overdiagnoses can be attributed to melanoma in situ vs invasive melanoma is unknown.
- To address this question, researchers collected data from the SEER 9 registries database.
- They used DevCan software to calculate the cumulative lifetime risk of White American men and women being diagnosed with melanoma between 1975 and 2018, adjusting for changes in longevity and risk factors over the study period.
- The primary outcome was excess lifetime risk for melanoma diagnosis between 1976 and 2018, adjusted for year 2018 competing mortality and changes in risk factors.
TAKEAWAY:
- Researchers found that between 1975 and 2018, the adjusted lifetime risk of being diagnosed with melanoma in situ increased from 0.17% to 2.7% in White men and 0.08% to 2% in White women.
- An estimated 49.7% and 64.6% of melanomas diagnosed in White men and White women, respectively, were overdiagnosed in 2018.
- Among individuals diagnosed with melanoma in situ, 89.4% of White men and 85.4% of White women were likely overdiagnosed in 2018.
IN PRACTICE:
“A large proportion of overdiagnosed melanomas are in situ cancers, pointing to a potential area to focus for an intervention de-escalation of the intensity of treatment and survivorship care,” the authors wrote.
SOURCE:
Adewole S. Adamson, MD, of the Division of Dermatology at The University of Texas at Austin Dell Medical School, led the research. The study was published in BMJ Evidence-Based Medicine on January 19, 2024.
LIMITATIONS:
The analysis only involved White individuals. Other limitations include a high risk for selection bias and that the researchers assumed no melanoma diagnosis in 1975, which may not be the case.
DISCLOSURES:
Dr. Adamson disclosed that he is supported by the Robert Wood Johnson Foundation through The Harold Amos Medical Faculty Development Program. Coauthor Katy J.L. Bell, MBchB, PhD, of the University of Sydney, is supported by an Australian Government National Health and Medical Research Council Investigator Grant.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The increase in melanoma diagnoses in the United States, while mortality has remained flat, has raised concerns about overdiagnosis of melanoma, cases that may not result in harm if left untreated. How much of the overdiagnoses can be attributed to melanoma in situ vs invasive melanoma is unknown.
- To address this question, researchers collected data from the SEER 9 registries database.
- They used DevCan software to calculate the cumulative lifetime risk of White American men and women being diagnosed with melanoma between 1975 and 2018, adjusting for changes in longevity and risk factors over the study period.
- The primary outcome was excess lifetime risk for melanoma diagnosis between 1976 and 2018, adjusted for year 2018 competing mortality and changes in risk factors.
TAKEAWAY:
- Researchers found that between 1975 and 2018, the adjusted lifetime risk of being diagnosed with melanoma in situ increased from 0.17% to 2.7% in White men and 0.08% to 2% in White women.
- An estimated 49.7% and 64.6% of melanomas diagnosed in White men and White women, respectively, were overdiagnosed in 2018.
- Among individuals diagnosed with melanoma in situ, 89.4% of White men and 85.4% of White women were likely overdiagnosed in 2018.
IN PRACTICE:
“A large proportion of overdiagnosed melanomas are in situ cancers, pointing to a potential area to focus for an intervention de-escalation of the intensity of treatment and survivorship care,” the authors wrote.
SOURCE:
Adewole S. Adamson, MD, of the Division of Dermatology at The University of Texas at Austin Dell Medical School, led the research. The study was published in BMJ Evidence-Based Medicine on January 19, 2024.
LIMITATIONS:
The analysis only involved White individuals. Other limitations include a high risk for selection bias and that the researchers assumed no melanoma diagnosis in 1975, which may not be the case.
DISCLOSURES:
Dr. Adamson disclosed that he is supported by the Robert Wood Johnson Foundation through The Harold Amos Medical Faculty Development Program. Coauthor Katy J.L. Bell, MBchB, PhD, of the University of Sydney, is supported by an Australian Government National Health and Medical Research Council Investigator Grant.
A version of this article first appeared on Medscape.com.
Rituximab Results in Sustained Remission for Pemphigus, Study Found
TOPLINE:
, an analysis showed.
METHODOLOGY:
- The short-term efficacy and safety of first-line treatment with rituximab for pemphigus were demonstrated in the Ritux 3 trial, but the rates of long-term remission are unknown.
- French investigators from 25 dermatology departments evaluated 83 patients from the Ritux 3 trial between January 1, 2010, and December 31, 2015.
- They used Kaplan-Meir curves to determine the 5- and 7-year rates of disease-free survival (DFS) without corticosteroids.
TAKEAWAY:
- Of the 83 patients, 44 were in the rituximab-plus-prednisone group and 39 were in the prednisone-only group, with a median follow-up of 87.3 months (7.3 years).
- Among patients in the rituximab plus prednisone group, 43 (93.5%) achieved complete remission without corticosteroids at any time during follow-up, compared with 17 patients (39%) in the prednisone-only group.
- DFS (without corticosteroid therapy) statistically favored patients in the rituximab plus prednisone group compared with patients in the prednisone-only group at follow-up times of 5 years (76.7% vs 35.3%, respectively) and 7 years (72.1% vs 35.3%; P < .001 for both associations).
- In another finding, 31 patients in the rituximab plus prednisone group reported fewer serious adverse events (SAEs) than 58 patients in the prednisone-only group, which corresponds to 0.67 and 1.32 SAEs per patient, respectively (P = .003).
IN PRACTICE:
The study findings demonstrated “the superiority of rituximab over a standard corticosteroids regimen, both in the short term and the long term,” the authors wrote.
SOURCE:
Corresponding author Billal Tedbirt, MD, of the Department of Dermatology at CHU Rouen in France, led the study, which was published online on January 24, 2024, in JAMA Dermatology.
LIMITATIONS:
Nearly 8% of patients did not attend the end of follow-up visit. Also, serum samples used to predict relapse were drawn at month 36, but the researchers said that a window of every 4-6 months might provide higher accuracy of relapses.
DISCLOSURES:
Dr. Tedbirt reported having no disclosures. Four of the study authors reported being investigators for and/or receiving personal fees from several pharmaceutical companies. The study was supported by a grant from the French Society of Dermatology.
A version of this article appeared on Medscape.com.
TOPLINE:
, an analysis showed.
METHODOLOGY:
- The short-term efficacy and safety of first-line treatment with rituximab for pemphigus were demonstrated in the Ritux 3 trial, but the rates of long-term remission are unknown.
- French investigators from 25 dermatology departments evaluated 83 patients from the Ritux 3 trial between January 1, 2010, and December 31, 2015.
- They used Kaplan-Meir curves to determine the 5- and 7-year rates of disease-free survival (DFS) without corticosteroids.
TAKEAWAY:
- Of the 83 patients, 44 were in the rituximab-plus-prednisone group and 39 were in the prednisone-only group, with a median follow-up of 87.3 months (7.3 years).
- Among patients in the rituximab plus prednisone group, 43 (93.5%) achieved complete remission without corticosteroids at any time during follow-up, compared with 17 patients (39%) in the prednisone-only group.
- DFS (without corticosteroid therapy) statistically favored patients in the rituximab plus prednisone group compared with patients in the prednisone-only group at follow-up times of 5 years (76.7% vs 35.3%, respectively) and 7 years (72.1% vs 35.3%; P < .001 for both associations).
- In another finding, 31 patients in the rituximab plus prednisone group reported fewer serious adverse events (SAEs) than 58 patients in the prednisone-only group, which corresponds to 0.67 and 1.32 SAEs per patient, respectively (P = .003).
IN PRACTICE:
The study findings demonstrated “the superiority of rituximab over a standard corticosteroids regimen, both in the short term and the long term,” the authors wrote.
SOURCE:
Corresponding author Billal Tedbirt, MD, of the Department of Dermatology at CHU Rouen in France, led the study, which was published online on January 24, 2024, in JAMA Dermatology.
LIMITATIONS:
Nearly 8% of patients did not attend the end of follow-up visit. Also, serum samples used to predict relapse were drawn at month 36, but the researchers said that a window of every 4-6 months might provide higher accuracy of relapses.
DISCLOSURES:
Dr. Tedbirt reported having no disclosures. Four of the study authors reported being investigators for and/or receiving personal fees from several pharmaceutical companies. The study was supported by a grant from the French Society of Dermatology.
A version of this article appeared on Medscape.com.
TOPLINE:
, an analysis showed.
METHODOLOGY:
- The short-term efficacy and safety of first-line treatment with rituximab for pemphigus were demonstrated in the Ritux 3 trial, but the rates of long-term remission are unknown.
- French investigators from 25 dermatology departments evaluated 83 patients from the Ritux 3 trial between January 1, 2010, and December 31, 2015.
- They used Kaplan-Meir curves to determine the 5- and 7-year rates of disease-free survival (DFS) without corticosteroids.
TAKEAWAY:
- Of the 83 patients, 44 were in the rituximab-plus-prednisone group and 39 were in the prednisone-only group, with a median follow-up of 87.3 months (7.3 years).
- Among patients in the rituximab plus prednisone group, 43 (93.5%) achieved complete remission without corticosteroids at any time during follow-up, compared with 17 patients (39%) in the prednisone-only group.
- DFS (without corticosteroid therapy) statistically favored patients in the rituximab plus prednisone group compared with patients in the prednisone-only group at follow-up times of 5 years (76.7% vs 35.3%, respectively) and 7 years (72.1% vs 35.3%; P < .001 for both associations).
- In another finding, 31 patients in the rituximab plus prednisone group reported fewer serious adverse events (SAEs) than 58 patients in the prednisone-only group, which corresponds to 0.67 and 1.32 SAEs per patient, respectively (P = .003).
IN PRACTICE:
The study findings demonstrated “the superiority of rituximab over a standard corticosteroids regimen, both in the short term and the long term,” the authors wrote.
SOURCE:
Corresponding author Billal Tedbirt, MD, of the Department of Dermatology at CHU Rouen in France, led the study, which was published online on January 24, 2024, in JAMA Dermatology.
LIMITATIONS:
Nearly 8% of patients did not attend the end of follow-up visit. Also, serum samples used to predict relapse were drawn at month 36, but the researchers said that a window of every 4-6 months might provide higher accuracy of relapses.
DISCLOSURES:
Dr. Tedbirt reported having no disclosures. Four of the study authors reported being investigators for and/or receiving personal fees from several pharmaceutical companies. The study was supported by a grant from the French Society of Dermatology.
A version of this article appeared on Medscape.com.
Medical Aid in Dying Should Be Legal, Says Ethicist
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine.
Right now, there are 10 states and the District of Columbia that have had some version of medical assistance in dying approved and on the books. That basically means that about 20% of Americans have access where they live to a physician who can prescribe a lethal dose of medication to them if they’re terminally ill and can ingest the medication themselves. That leaves many Americans not covered by this kind of access to this kind of service.
Many of you watching this may live in states where it is legal, like Oregon, Washington, New Jersey, Colorado, and Hawaii. I know many doctors say, “I’m not going to do that.” It’s not something that anyone is compelling a doctor to do. For some Americans, access is not just about where they live but whether there is a doctor willing to participate with them in bringing about their accelerated death, knowing that they’re inevitably going to die.
There’s not much we can do about that. It’s up to the conscience of each physician as to what they’re comfortable with. Certainly, there are other things that can be done to extend the possibility of having this available.
One thing that’s taking place is that, after lawsuits were filed, Vermont and Oregon have given up on their residency requirement, so you don’t have to be there 6 months or a year in order to use this opportunity. It’s legal now to move to the state or visit the state, and as soon as you get there, sign up for this kind of end-of-life intervention.
New Jersey is also being sued. I’ll predict that every state that has a residency requirement, when sued in court, is going to lose because we’ve long recognized the right of Americans to seek out healthcare in the United States, wherever they want to go.
If some states have made this a legitimate medical procedure, courts are going to say you can’t restrict it only to state residents. If someone wants to use a service, they’re entitled to show up from another state or another place and use it. I’m not sure about foreign nationals, but I’m very sure that Americans can go state to state in search of legitimate medical procedures.
The other bills that are out there, however, are basically saying they want to emulate Oregon, Washington, and the other states and say that the terminally ill, with severe restrictions, are going to be able to get this service without going anywhere.
The restrictions include a diagnosis of terminal illness and that you have to be deemed mentally competent. You can’t use this if you have Alzheimer’s or severe depression. You have to make a request twice with a week or two in between to make sure that your request is authentic. And obviously, everyone is on board to make sure that you’re not being coerced or pushed somehow into requesting a somewhat earlier death than you would have experienced without having the availability of the pills.
You also have to take the pills yourself or be able to pull a switch so that you could use a feeding tube–type administration. If you can’t do that, say due to ALS, you’re not eligible to use medical aid in dying. It’s a pretty restricted intervention.
Many people who get pills after going through these restrictions in the states that permit it don’t use it. As many as one third say they like having it there as a safety valve or a parachute, but once they know they could end their life sooner, then they’re going to stick it out.
Should states make this legal? New York, Massachusetts, Florida, and many other states have bills that are moving through. I’m going to say yes. We’ve had Oregon and Washington since the late 1990s with medical aid in dying on the books. There doesn’t seem to be any evidence of pushing people to use this, of bias against the disabled, or bigotry against particular ethnic or racial groups being used to encourage people to end their life sooner.
I think it is an option that Americans want. I think it’s an option that makes some sense. I’m well aware that we also have to make sure that people know about hospice. In some of these states, medical aid in dying is offered as a part of hospice — not all, but a few. Not everybody wants hospice once they realize that they’re dying and that it is coming relatively soon. They may want to leave with family present, with a ceremony, or with a quality of life that they desire.
Past experience says let’s continue to expand availability in each state. Let’s also realize that we have to keep the restrictions in place on how it’s used because they have protected us against abuse. Let’s understand that every doctor has an option to do this or not do this. It’s a matter of conscience and a matter of comfort.
I think legalization is the direction we’re going to be going in. Getting rid of the residency requirements that have been around, as I think courts are going to overturn them, also gives a push to the idea that once the service is in this many states, it’s something that should be available if there are doctors willing to do it.
I’m Art Caplan at the Division of Medical Ethics at NYU Grossman School of Medicine. New York, NY. Thank you for watching.
Arthur L. Caplan, PhD, has disclosed the following relevant financial relationships:
- Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position)
- Serves as a contributing author and adviser for: Medscape
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine.
Right now, there are 10 states and the District of Columbia that have had some version of medical assistance in dying approved and on the books. That basically means that about 20% of Americans have access where they live to a physician who can prescribe a lethal dose of medication to them if they’re terminally ill and can ingest the medication themselves. That leaves many Americans not covered by this kind of access to this kind of service.
Many of you watching this may live in states where it is legal, like Oregon, Washington, New Jersey, Colorado, and Hawaii. I know many doctors say, “I’m not going to do that.” It’s not something that anyone is compelling a doctor to do. For some Americans, access is not just about where they live but whether there is a doctor willing to participate with them in bringing about their accelerated death, knowing that they’re inevitably going to die.
There’s not much we can do about that. It’s up to the conscience of each physician as to what they’re comfortable with. Certainly, there are other things that can be done to extend the possibility of having this available.
One thing that’s taking place is that, after lawsuits were filed, Vermont and Oregon have given up on their residency requirement, so you don’t have to be there 6 months or a year in order to use this opportunity. It’s legal now to move to the state or visit the state, and as soon as you get there, sign up for this kind of end-of-life intervention.
New Jersey is also being sued. I’ll predict that every state that has a residency requirement, when sued in court, is going to lose because we’ve long recognized the right of Americans to seek out healthcare in the United States, wherever they want to go.
If some states have made this a legitimate medical procedure, courts are going to say you can’t restrict it only to state residents. If someone wants to use a service, they’re entitled to show up from another state or another place and use it. I’m not sure about foreign nationals, but I’m very sure that Americans can go state to state in search of legitimate medical procedures.
The other bills that are out there, however, are basically saying they want to emulate Oregon, Washington, and the other states and say that the terminally ill, with severe restrictions, are going to be able to get this service without going anywhere.
The restrictions include a diagnosis of terminal illness and that you have to be deemed mentally competent. You can’t use this if you have Alzheimer’s or severe depression. You have to make a request twice with a week or two in between to make sure that your request is authentic. And obviously, everyone is on board to make sure that you’re not being coerced or pushed somehow into requesting a somewhat earlier death than you would have experienced without having the availability of the pills.
You also have to take the pills yourself or be able to pull a switch so that you could use a feeding tube–type administration. If you can’t do that, say due to ALS, you’re not eligible to use medical aid in dying. It’s a pretty restricted intervention.
Many people who get pills after going through these restrictions in the states that permit it don’t use it. As many as one third say they like having it there as a safety valve or a parachute, but once they know they could end their life sooner, then they’re going to stick it out.
Should states make this legal? New York, Massachusetts, Florida, and many other states have bills that are moving through. I’m going to say yes. We’ve had Oregon and Washington since the late 1990s with medical aid in dying on the books. There doesn’t seem to be any evidence of pushing people to use this, of bias against the disabled, or bigotry against particular ethnic or racial groups being used to encourage people to end their life sooner.
I think it is an option that Americans want. I think it’s an option that makes some sense. I’m well aware that we also have to make sure that people know about hospice. In some of these states, medical aid in dying is offered as a part of hospice — not all, but a few. Not everybody wants hospice once they realize that they’re dying and that it is coming relatively soon. They may want to leave with family present, with a ceremony, or with a quality of life that they desire.
Past experience says let’s continue to expand availability in each state. Let’s also realize that we have to keep the restrictions in place on how it’s used because they have protected us against abuse. Let’s understand that every doctor has an option to do this or not do this. It’s a matter of conscience and a matter of comfort.
I think legalization is the direction we’re going to be going in. Getting rid of the residency requirements that have been around, as I think courts are going to overturn them, also gives a push to the idea that once the service is in this many states, it’s something that should be available if there are doctors willing to do it.
I’m Art Caplan at the Division of Medical Ethics at NYU Grossman School of Medicine. New York, NY. Thank you for watching.
Arthur L. Caplan, PhD, has disclosed the following relevant financial relationships:
- Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position)
- Serves as a contributing author and adviser for: Medscape
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine.
Right now, there are 10 states and the District of Columbia that have had some version of medical assistance in dying approved and on the books. That basically means that about 20% of Americans have access where they live to a physician who can prescribe a lethal dose of medication to them if they’re terminally ill and can ingest the medication themselves. That leaves many Americans not covered by this kind of access to this kind of service.
Many of you watching this may live in states where it is legal, like Oregon, Washington, New Jersey, Colorado, and Hawaii. I know many doctors say, “I’m not going to do that.” It’s not something that anyone is compelling a doctor to do. For some Americans, access is not just about where they live but whether there is a doctor willing to participate with them in bringing about their accelerated death, knowing that they’re inevitably going to die.
There’s not much we can do about that. It’s up to the conscience of each physician as to what they’re comfortable with. Certainly, there are other things that can be done to extend the possibility of having this available.
One thing that’s taking place is that, after lawsuits were filed, Vermont and Oregon have given up on their residency requirement, so you don’t have to be there 6 months or a year in order to use this opportunity. It’s legal now to move to the state or visit the state, and as soon as you get there, sign up for this kind of end-of-life intervention.
New Jersey is also being sued. I’ll predict that every state that has a residency requirement, when sued in court, is going to lose because we’ve long recognized the right of Americans to seek out healthcare in the United States, wherever they want to go.
If some states have made this a legitimate medical procedure, courts are going to say you can’t restrict it only to state residents. If someone wants to use a service, they’re entitled to show up from another state or another place and use it. I’m not sure about foreign nationals, but I’m very sure that Americans can go state to state in search of legitimate medical procedures.
The other bills that are out there, however, are basically saying they want to emulate Oregon, Washington, and the other states and say that the terminally ill, with severe restrictions, are going to be able to get this service without going anywhere.
The restrictions include a diagnosis of terminal illness and that you have to be deemed mentally competent. You can’t use this if you have Alzheimer’s or severe depression. You have to make a request twice with a week or two in between to make sure that your request is authentic. And obviously, everyone is on board to make sure that you’re not being coerced or pushed somehow into requesting a somewhat earlier death than you would have experienced without having the availability of the pills.
You also have to take the pills yourself or be able to pull a switch so that you could use a feeding tube–type administration. If you can’t do that, say due to ALS, you’re not eligible to use medical aid in dying. It’s a pretty restricted intervention.
Many people who get pills after going through these restrictions in the states that permit it don’t use it. As many as one third say they like having it there as a safety valve or a parachute, but once they know they could end their life sooner, then they’re going to stick it out.
Should states make this legal? New York, Massachusetts, Florida, and many other states have bills that are moving through. I’m going to say yes. We’ve had Oregon and Washington since the late 1990s with medical aid in dying on the books. There doesn’t seem to be any evidence of pushing people to use this, of bias against the disabled, or bigotry against particular ethnic or racial groups being used to encourage people to end their life sooner.
I think it is an option that Americans want. I think it’s an option that makes some sense. I’m well aware that we also have to make sure that people know about hospice. In some of these states, medical aid in dying is offered as a part of hospice — not all, but a few. Not everybody wants hospice once they realize that they’re dying and that it is coming relatively soon. They may want to leave with family present, with a ceremony, or with a quality of life that they desire.
Past experience says let’s continue to expand availability in each state. Let’s also realize that we have to keep the restrictions in place on how it’s used because they have protected us against abuse. Let’s understand that every doctor has an option to do this or not do this. It’s a matter of conscience and a matter of comfort.
I think legalization is the direction we’re going to be going in. Getting rid of the residency requirements that have been around, as I think courts are going to overturn them, also gives a push to the idea that once the service is in this many states, it’s something that should be available if there are doctors willing to do it.
I’m Art Caplan at the Division of Medical Ethics at NYU Grossman School of Medicine. New York, NY. Thank you for watching.
Arthur L. Caplan, PhD, has disclosed the following relevant financial relationships:
- Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position)
- Serves as a contributing author and adviser for: Medscape
A version of this article appeared on Medscape.com.
Five Bold Predictions for Long COVID in 2024
With a number of large-scale clinical trials underway and researchers on the hunt for new therapies, long COVID scientists are hopeful that this is the year patients — and doctors who care for them — will finally see improvements in treating their symptoms.
Here are five bold predictions — all based on encouraging research — that could happen in 2024. At the very least, they are promising signs of progress against a debilitating and frustrating disease.
#1: We’ll gain a better understanding of each long COVID phenotype
This past year, a wide breadth of research began showing that long COVID can be defined by a number of different disease phenotypes that present a range of symptoms.
Researchers identified four clinical phenotypes: Chronic fatigue-like syndrome, headache, and memory loss; respiratory syndrome, which includes cough and difficulty breathing; chronic pain; and neurosensorial syndrome, which causes an altered sense of taste and smell.
Identifying specific diagnostic criteria for each phenotype would lead to better health outcomes for patients instead of treating them as if it were a “one-size-fits-all disease,” said Nisha Viswanathan, MD, director of the long COVID program at UCLA Health, Los Angeles, California.
Ultimately, she hopes that this year her patients will receive treatments based on the type of long COVID they’re personally experiencing, and the symptoms they have, leading to improved health outcomes and more rapid relief.
“Many new medications are focused on different pathways of long COVID, and the challenge becomes which drug is the right drug for each treatment,” said Dr. Viswanathan.
#2: Monoclonal antibodies may change the game
We’re starting to have a better understanding that what’s been called “viral persistence” as a main cause of long COVID may potentially be treated with monoclonal antibodies. These are antibodies produced by cloning unique white blood cells to target the circulating spike proteins in the blood that hang out in viral reservoirs and cause the immune system to react as if it’s still fighting acute COVID-19.
Smaller-scale studies have already shown promising results. A January 2024 study published in The American Journal of Emergency Medicine followed three patients who completely recovered from long COVID after taking monoclonal antibodies. “Remission occurred despite dissimilar past histories, sex, age, and illness duration,” wrote the study authors.
Larger clinical trials are underway at the University of California, San Francisco, California, to test targeted monoclonal antibodies. If the results of the larger study show that monoclonal antibodies are beneficial, then it could be a game changer for a large swath of patients around the world, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.
“The idea is that the downstream damage caused by viral persistence will resolve itself once you wipe out the virus,” said Dr. Putrino.
#3: Paxlovid could prove effective for long COVID
The US Food and Drug Administration granted approval for Paxlovid last May for the treatment of mild to moderate COVID-19 in adults at a high risk for severe disease. The medication is made up of two drugs packaged together. The first, nirmatrelvir, works by blocking a key enzyme required for virus replication. The second, ritonavir, is an antiviral that’s been used in patients with HIV and helps boost levels of antivirals in the body.
In a large-scale trial headed up by Dr. Putrino and his team, the oral antiviral is being studied for use in the post-viral stage in patients who test negative for acute COVID-19 but have persisting symptoms of long COVID.
Similar to monoclonal antibodies, the idea is to quell viral persistence. If patients have long COVID because they can’t clear SAR-CoV-2 from their bodies, Paxlovid could help. But unlike monoclonal antibodies that quash the virus, Paxlovid stops the virus from replicating. It’s a different mechanism with the same end goal.
It’s been a controversial treatment because it’s life-changing for some patients and ineffective for others. In addition, it can cause a range of side effects such as diarrhea, nausea, vomiting, and an impaired sense of taste. The goal of the trial is to see which patients with long COVID are most likely to benefit from the treatment.
#4: Anti-inflammatories like metformin could prove useful
Many of the inflammatory markers persistent in patients with long COVID were similarly present in patients with autoimmune diseases like rheumatoid arthritis, according to a July 2023 study published in JAMA.
The hope is that anti-inflammatory medications may be used to reduce inflammation causing long COVID symptoms. But drugs used to treat rheumatoid arthritis like abatacept and infliximabcan also have serious side effects, including increased risk for infection, flu-like symptoms, and burning of the skin.
“Powerful anti-inflammatories can change a number of pathways in the immune system,” said Grace McComsey, MD, who leads the long COVID RECOVER study at University Hospitals Health System in Cleveland, Ohio. Anti-inflammatories hold promise but, Dr. McComsey said, “some are more toxic with many side effects, so even if they work, there’s still a question about who should take them.”
Still, other anti-inflammatories that could work don’t have as many side effects. For example, a study published in The Lancet Infectious Diseases found that the diabetes drug metformin reduced a patient’s risk for long COVID up to 40% when the drug was taken during the acute stage.
Metformin, compared to other anti-inflammatories (also known as immune modulators), is an inexpensive and widely available drug with relatively few side effects compared with other medications.
#5: Serotonin levels — and selective serotonin reuptake inhibitors (SSRIs) — may be keys to unlocking long COVID
One of the most groundbreaking studies of the year came last November. A study published in the journal Cell found lower circulating serotonin levels in patents with long COVID than in those who did not have the condition. The study also found that the SSRI fluoxetine improved cognitive function in rat models infected with the virus.
Researchers found that the reduction in serotonin levels was partially caused by the body’s inability to absorb tryptophan, an amino acid that’s a precursor to serotonin. Overactivated blood platelets may also have played a role.
Michael Peluso, MD, an assistant research professor of infectious medicine at the UCSF School of Medicine, San Francisco, California, hopes to take the finding a step further, investigating whether increased serotonin levels in patients with long COVID will lead to improvements in symptoms.
“What we need now is a good clinical trial to see whether altering levels of serotonin in people with long COVID will lead to symptom relief,” Dr. Peluso said last month in an interview with this news organization.
If patients show an improvement in symptoms, then the next step is looking into whether SSRIs boost serotonin levels in patients and, as a result, reduce their symptoms.
A version of this article appeared on Medscape.com.
With a number of large-scale clinical trials underway and researchers on the hunt for new therapies, long COVID scientists are hopeful that this is the year patients — and doctors who care for them — will finally see improvements in treating their symptoms.
Here are five bold predictions — all based on encouraging research — that could happen in 2024. At the very least, they are promising signs of progress against a debilitating and frustrating disease.
#1: We’ll gain a better understanding of each long COVID phenotype
This past year, a wide breadth of research began showing that long COVID can be defined by a number of different disease phenotypes that present a range of symptoms.
Researchers identified four clinical phenotypes: Chronic fatigue-like syndrome, headache, and memory loss; respiratory syndrome, which includes cough and difficulty breathing; chronic pain; and neurosensorial syndrome, which causes an altered sense of taste and smell.
Identifying specific diagnostic criteria for each phenotype would lead to better health outcomes for patients instead of treating them as if it were a “one-size-fits-all disease,” said Nisha Viswanathan, MD, director of the long COVID program at UCLA Health, Los Angeles, California.
Ultimately, she hopes that this year her patients will receive treatments based on the type of long COVID they’re personally experiencing, and the symptoms they have, leading to improved health outcomes and more rapid relief.
“Many new medications are focused on different pathways of long COVID, and the challenge becomes which drug is the right drug for each treatment,” said Dr. Viswanathan.
#2: Monoclonal antibodies may change the game
We’re starting to have a better understanding that what’s been called “viral persistence” as a main cause of long COVID may potentially be treated with monoclonal antibodies. These are antibodies produced by cloning unique white blood cells to target the circulating spike proteins in the blood that hang out in viral reservoirs and cause the immune system to react as if it’s still fighting acute COVID-19.
Smaller-scale studies have already shown promising results. A January 2024 study published in The American Journal of Emergency Medicine followed three patients who completely recovered from long COVID after taking monoclonal antibodies. “Remission occurred despite dissimilar past histories, sex, age, and illness duration,” wrote the study authors.
Larger clinical trials are underway at the University of California, San Francisco, California, to test targeted monoclonal antibodies. If the results of the larger study show that monoclonal antibodies are beneficial, then it could be a game changer for a large swath of patients around the world, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.
“The idea is that the downstream damage caused by viral persistence will resolve itself once you wipe out the virus,” said Dr. Putrino.
#3: Paxlovid could prove effective for long COVID
The US Food and Drug Administration granted approval for Paxlovid last May for the treatment of mild to moderate COVID-19 in adults at a high risk for severe disease. The medication is made up of two drugs packaged together. The first, nirmatrelvir, works by blocking a key enzyme required for virus replication. The second, ritonavir, is an antiviral that’s been used in patients with HIV and helps boost levels of antivirals in the body.
In a large-scale trial headed up by Dr. Putrino and his team, the oral antiviral is being studied for use in the post-viral stage in patients who test negative for acute COVID-19 but have persisting symptoms of long COVID.
Similar to monoclonal antibodies, the idea is to quell viral persistence. If patients have long COVID because they can’t clear SAR-CoV-2 from their bodies, Paxlovid could help. But unlike monoclonal antibodies that quash the virus, Paxlovid stops the virus from replicating. It’s a different mechanism with the same end goal.
It’s been a controversial treatment because it’s life-changing for some patients and ineffective for others. In addition, it can cause a range of side effects such as diarrhea, nausea, vomiting, and an impaired sense of taste. The goal of the trial is to see which patients with long COVID are most likely to benefit from the treatment.
#4: Anti-inflammatories like metformin could prove useful
Many of the inflammatory markers persistent in patients with long COVID were similarly present in patients with autoimmune diseases like rheumatoid arthritis, according to a July 2023 study published in JAMA.
The hope is that anti-inflammatory medications may be used to reduce inflammation causing long COVID symptoms. But drugs used to treat rheumatoid arthritis like abatacept and infliximabcan also have serious side effects, including increased risk for infection, flu-like symptoms, and burning of the skin.
“Powerful anti-inflammatories can change a number of pathways in the immune system,” said Grace McComsey, MD, who leads the long COVID RECOVER study at University Hospitals Health System in Cleveland, Ohio. Anti-inflammatories hold promise but, Dr. McComsey said, “some are more toxic with many side effects, so even if they work, there’s still a question about who should take them.”
Still, other anti-inflammatories that could work don’t have as many side effects. For example, a study published in The Lancet Infectious Diseases found that the diabetes drug metformin reduced a patient’s risk for long COVID up to 40% when the drug was taken during the acute stage.
Metformin, compared to other anti-inflammatories (also known as immune modulators), is an inexpensive and widely available drug with relatively few side effects compared with other medications.
#5: Serotonin levels — and selective serotonin reuptake inhibitors (SSRIs) — may be keys to unlocking long COVID
One of the most groundbreaking studies of the year came last November. A study published in the journal Cell found lower circulating serotonin levels in patents with long COVID than in those who did not have the condition. The study also found that the SSRI fluoxetine improved cognitive function in rat models infected with the virus.
Researchers found that the reduction in serotonin levels was partially caused by the body’s inability to absorb tryptophan, an amino acid that’s a precursor to serotonin. Overactivated blood platelets may also have played a role.
Michael Peluso, MD, an assistant research professor of infectious medicine at the UCSF School of Medicine, San Francisco, California, hopes to take the finding a step further, investigating whether increased serotonin levels in patients with long COVID will lead to improvements in symptoms.
“What we need now is a good clinical trial to see whether altering levels of serotonin in people with long COVID will lead to symptom relief,” Dr. Peluso said last month in an interview with this news organization.
If patients show an improvement in symptoms, then the next step is looking into whether SSRIs boost serotonin levels in patients and, as a result, reduce their symptoms.
A version of this article appeared on Medscape.com.
With a number of large-scale clinical trials underway and researchers on the hunt for new therapies, long COVID scientists are hopeful that this is the year patients — and doctors who care for them — will finally see improvements in treating their symptoms.
Here are five bold predictions — all based on encouraging research — that could happen in 2024. At the very least, they are promising signs of progress against a debilitating and frustrating disease.
#1: We’ll gain a better understanding of each long COVID phenotype
This past year, a wide breadth of research began showing that long COVID can be defined by a number of different disease phenotypes that present a range of symptoms.
Researchers identified four clinical phenotypes: Chronic fatigue-like syndrome, headache, and memory loss; respiratory syndrome, which includes cough and difficulty breathing; chronic pain; and neurosensorial syndrome, which causes an altered sense of taste and smell.
Identifying specific diagnostic criteria for each phenotype would lead to better health outcomes for patients instead of treating them as if it were a “one-size-fits-all disease,” said Nisha Viswanathan, MD, director of the long COVID program at UCLA Health, Los Angeles, California.
Ultimately, she hopes that this year her patients will receive treatments based on the type of long COVID they’re personally experiencing, and the symptoms they have, leading to improved health outcomes and more rapid relief.
“Many new medications are focused on different pathways of long COVID, and the challenge becomes which drug is the right drug for each treatment,” said Dr. Viswanathan.
#2: Monoclonal antibodies may change the game
We’re starting to have a better understanding that what’s been called “viral persistence” as a main cause of long COVID may potentially be treated with monoclonal antibodies. These are antibodies produced by cloning unique white blood cells to target the circulating spike proteins in the blood that hang out in viral reservoirs and cause the immune system to react as if it’s still fighting acute COVID-19.
Smaller-scale studies have already shown promising results. A January 2024 study published in The American Journal of Emergency Medicine followed three patients who completely recovered from long COVID after taking monoclonal antibodies. “Remission occurred despite dissimilar past histories, sex, age, and illness duration,” wrote the study authors.
Larger clinical trials are underway at the University of California, San Francisco, California, to test targeted monoclonal antibodies. If the results of the larger study show that monoclonal antibodies are beneficial, then it could be a game changer for a large swath of patients around the world, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.
“The idea is that the downstream damage caused by viral persistence will resolve itself once you wipe out the virus,” said Dr. Putrino.
#3: Paxlovid could prove effective for long COVID
The US Food and Drug Administration granted approval for Paxlovid last May for the treatment of mild to moderate COVID-19 in adults at a high risk for severe disease. The medication is made up of two drugs packaged together. The first, nirmatrelvir, works by blocking a key enzyme required for virus replication. The second, ritonavir, is an antiviral that’s been used in patients with HIV and helps boost levels of antivirals in the body.
In a large-scale trial headed up by Dr. Putrino and his team, the oral antiviral is being studied for use in the post-viral stage in patients who test negative for acute COVID-19 but have persisting symptoms of long COVID.
Similar to monoclonal antibodies, the idea is to quell viral persistence. If patients have long COVID because they can’t clear SAR-CoV-2 from their bodies, Paxlovid could help. But unlike monoclonal antibodies that quash the virus, Paxlovid stops the virus from replicating. It’s a different mechanism with the same end goal.
It’s been a controversial treatment because it’s life-changing for some patients and ineffective for others. In addition, it can cause a range of side effects such as diarrhea, nausea, vomiting, and an impaired sense of taste. The goal of the trial is to see which patients with long COVID are most likely to benefit from the treatment.
#4: Anti-inflammatories like metformin could prove useful
Many of the inflammatory markers persistent in patients with long COVID were similarly present in patients with autoimmune diseases like rheumatoid arthritis, according to a July 2023 study published in JAMA.
The hope is that anti-inflammatory medications may be used to reduce inflammation causing long COVID symptoms. But drugs used to treat rheumatoid arthritis like abatacept and infliximabcan also have serious side effects, including increased risk for infection, flu-like symptoms, and burning of the skin.
“Powerful anti-inflammatories can change a number of pathways in the immune system,” said Grace McComsey, MD, who leads the long COVID RECOVER study at University Hospitals Health System in Cleveland, Ohio. Anti-inflammatories hold promise but, Dr. McComsey said, “some are more toxic with many side effects, so even if they work, there’s still a question about who should take them.”
Still, other anti-inflammatories that could work don’t have as many side effects. For example, a study published in The Lancet Infectious Diseases found that the diabetes drug metformin reduced a patient’s risk for long COVID up to 40% when the drug was taken during the acute stage.
Metformin, compared to other anti-inflammatories (also known as immune modulators), is an inexpensive and widely available drug with relatively few side effects compared with other medications.
#5: Serotonin levels — and selective serotonin reuptake inhibitors (SSRIs) — may be keys to unlocking long COVID
One of the most groundbreaking studies of the year came last November. A study published in the journal Cell found lower circulating serotonin levels in patents with long COVID than in those who did not have the condition. The study also found that the SSRI fluoxetine improved cognitive function in rat models infected with the virus.
Researchers found that the reduction in serotonin levels was partially caused by the body’s inability to absorb tryptophan, an amino acid that’s a precursor to serotonin. Overactivated blood platelets may also have played a role.
Michael Peluso, MD, an assistant research professor of infectious medicine at the UCSF School of Medicine, San Francisco, California, hopes to take the finding a step further, investigating whether increased serotonin levels in patients with long COVID will lead to improvements in symptoms.
“What we need now is a good clinical trial to see whether altering levels of serotonin in people with long COVID will lead to symptom relief,” Dr. Peluso said last month in an interview with this news organization.
If patients show an improvement in symptoms, then the next step is looking into whether SSRIs boost serotonin levels in patients and, as a result, reduce their symptoms.
A version of this article appeared on Medscape.com.
Think Outside the Traditional Toolbox to Treat Itch
ORLANDO — “Itch may not be as sexy as Mohs surgery or aesthetic procedures,” but treating it is important and meaningful to patients, particularly those who’ve found little relief previously, Shawn G. Kwatra, MD, said at the annual ODAC Dermatology, Aesthetic & Surgery Conference.
In doctors’ defense, it can be highly challenging to know which approach is optimal for each individual with pruritus, added Dr. Kwatra, associate professor of dermatology at Johns Hopkins University, Baltimore, Maryland.
Cooling agents, topical capsaicin, topical anesthetics like pramoxine 1%, various forms of lidocaine, strontium, opioid modulators like naltrexone, oral Janus kinase inhibitor (JAK) inhibitors, and medical marijuana are among some of the “outside the box” tools in Dr. Kwatra’s itch toolbox.
Often a Medical Puzzle
Frequently, patients come to the dermatologist complaining of itch, “but you don’t see much on their skin.” After a trial of antihistamines, and some topical steroids, the doctor might put up their hands and think: I tried, but I don’t know what else to do. “This actually happens a lot,” said Dr. Kwatra, who is also director of the Johns Hopkins Itch Center.
This means itch can frustrate providers as well. But for patients, the impact on their quality of life can be on the same level as recovering from a stroke or living with heart failure, Dr. Kwatra said. Finding relief for their itch is where “we can make a big difference for patients.”
Consider Cooling Agents
Many of these therapies are inexpensive and widely available. Cooling agents like menthol, camphor, or calamine can reduce activity of the transient receptor potential (TRP) channels in the skin associated with itch. This ion channel also senses temperature, pressure, and other sensations.
Another option is topical capsaicin, which works through the same ion channels. It binds to the TRPV1 receptors in sensory nerve fibers and causes desensitization. Initially, four to six applications a day are required to reduce itch. After that, patients can apply the medication less frequently. “You have to tell folks we know it’s going to work, but it’s going to burn a lot initially,” Dr. Kwatra said. “In real world practice, I’m not using it often.”
A 1.8% capsaicin patch, approved for treating postherpetic neuralgia, can be used to treat pruritus as well. “You put the patch on for one hour and you can have a true clinical response,” he noted.
Another option for itch relief, the topical anesthetic pramoxine 1%, “is probably underutilized for our patients,” Dr. Kwatra said. Pramoxine 1% works fast — as quickly as 2 minutes — and lasts up to 8 hours and is well-tolerated with low toxicity, he added. The agent is applied three to four times a day and relieves itch by reducing the transmembrane permeability of sodium ions on the skin. “This is something widely available and cheap.”
Lidocaine, another topical anesthetic, is available compounded, over the counter, and as a spray or patch. “I would be careful before you use high doses, like 10%” because of tolerability issues, Dr. Kwatra cautioned. He generally starts with lower concentrations.
Topical strontium is really interesting as a strategy, Dr. Kwatra said. Strontium is a soft, white metal that competes with calcium for receptor binding. There are over-the-counter formulations available as a scalp solution or lotion, which, he said, “are ways to go with more episodic itching.”
Topical oatmeal can also relieve itch in some patients. “There is actually some good scientific evidence for topical oatmeal preparations,” he said.
Steroid-Sparing Novel Topicals
Topical ruxolitinib (a JAK inhibitor approved for atopic dermatitis and vitiligo); topical roflumilast (a phosphodiesterase-4 inhibitor) and topical tapinarof (an aryl hydrocarbon receptor agonist), both approved for treating psoriasis; and the atopic dermatitis drug crisaborole fall into this category of topicals with potential for treating itch, he said, noting that use for treating itch is off label.
Off-label use of biologic agents are also possible treatment options for itch, dupilumab and tralokinumab, both US Food and Drug Administration (FDA)–approved for treating atopic dermatitis. Emerging agents that may prove useful for treating itch include lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab, he said.
In terms of oral therapies, the FDA has approved two oral JAK inhibitors for atopic dermatitis, abrocitinib and upadacitinib, which could prove useful for itch as an off-label indication, according to Dr. Kwatra.
Naltrexone Off Label
An emerging therapeutic concept for treating itch is using an opioid antagonist like naltrexone. Morphine causes more itch, so the theory is a reversal agent might help reduce it. The challenge is that naltrexone only comes as a 50 mg tablet, “and I find the high dose makes people nauseous and vomit,” he added.
Don’t Forget Devices
He referred to a “great paper” that he said has been “totally overlooked,” published in 2001, which evaluated a device that stimulates C fibers in the skin to reduce itch. In the study, 19 patients used the device to treat local areas 20 minutes daily for 5 weeks. Punch biopsies of the affected areas were taken at baseline and after treatment. Mean itch ratings decreased from 78% to 42%, and the number of immunoreactive nerve fibers in the epidermis decreased by 40% at the end of treatment.
“Electrical neurostimulation is better for localized pruritus. There is limited case series evidence, but it’s something to think about,” Dr. Kwatra said.
He and his colleagues also have a case study in press that explored the use of injected botulinum toxin to relieve recalcitrant, chronic itch in a 65-year-old man “who failed everything.”
Dr. Kwatra is a consultant or advisory board member for AbbVie, Amgen, Arcutis Biotherapeutics, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi.
A version of this article appeared on Medscape.com.
ORLANDO — “Itch may not be as sexy as Mohs surgery or aesthetic procedures,” but treating it is important and meaningful to patients, particularly those who’ve found little relief previously, Shawn G. Kwatra, MD, said at the annual ODAC Dermatology, Aesthetic & Surgery Conference.
In doctors’ defense, it can be highly challenging to know which approach is optimal for each individual with pruritus, added Dr. Kwatra, associate professor of dermatology at Johns Hopkins University, Baltimore, Maryland.
Cooling agents, topical capsaicin, topical anesthetics like pramoxine 1%, various forms of lidocaine, strontium, opioid modulators like naltrexone, oral Janus kinase inhibitor (JAK) inhibitors, and medical marijuana are among some of the “outside the box” tools in Dr. Kwatra’s itch toolbox.
Often a Medical Puzzle
Frequently, patients come to the dermatologist complaining of itch, “but you don’t see much on their skin.” After a trial of antihistamines, and some topical steroids, the doctor might put up their hands and think: I tried, but I don’t know what else to do. “This actually happens a lot,” said Dr. Kwatra, who is also director of the Johns Hopkins Itch Center.
This means itch can frustrate providers as well. But for patients, the impact on their quality of life can be on the same level as recovering from a stroke or living with heart failure, Dr. Kwatra said. Finding relief for their itch is where “we can make a big difference for patients.”
Consider Cooling Agents
Many of these therapies are inexpensive and widely available. Cooling agents like menthol, camphor, or calamine can reduce activity of the transient receptor potential (TRP) channels in the skin associated with itch. This ion channel also senses temperature, pressure, and other sensations.
Another option is topical capsaicin, which works through the same ion channels. It binds to the TRPV1 receptors in sensory nerve fibers and causes desensitization. Initially, four to six applications a day are required to reduce itch. After that, patients can apply the medication less frequently. “You have to tell folks we know it’s going to work, but it’s going to burn a lot initially,” Dr. Kwatra said. “In real world practice, I’m not using it often.”
A 1.8% capsaicin patch, approved for treating postherpetic neuralgia, can be used to treat pruritus as well. “You put the patch on for one hour and you can have a true clinical response,” he noted.
Another option for itch relief, the topical anesthetic pramoxine 1%, “is probably underutilized for our patients,” Dr. Kwatra said. Pramoxine 1% works fast — as quickly as 2 minutes — and lasts up to 8 hours and is well-tolerated with low toxicity, he added. The agent is applied three to four times a day and relieves itch by reducing the transmembrane permeability of sodium ions on the skin. “This is something widely available and cheap.”
Lidocaine, another topical anesthetic, is available compounded, over the counter, and as a spray or patch. “I would be careful before you use high doses, like 10%” because of tolerability issues, Dr. Kwatra cautioned. He generally starts with lower concentrations.
Topical strontium is really interesting as a strategy, Dr. Kwatra said. Strontium is a soft, white metal that competes with calcium for receptor binding. There are over-the-counter formulations available as a scalp solution or lotion, which, he said, “are ways to go with more episodic itching.”
Topical oatmeal can also relieve itch in some patients. “There is actually some good scientific evidence for topical oatmeal preparations,” he said.
Steroid-Sparing Novel Topicals
Topical ruxolitinib (a JAK inhibitor approved for atopic dermatitis and vitiligo); topical roflumilast (a phosphodiesterase-4 inhibitor) and topical tapinarof (an aryl hydrocarbon receptor agonist), both approved for treating psoriasis; and the atopic dermatitis drug crisaborole fall into this category of topicals with potential for treating itch, he said, noting that use for treating itch is off label.
Off-label use of biologic agents are also possible treatment options for itch, dupilumab and tralokinumab, both US Food and Drug Administration (FDA)–approved for treating atopic dermatitis. Emerging agents that may prove useful for treating itch include lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab, he said.
In terms of oral therapies, the FDA has approved two oral JAK inhibitors for atopic dermatitis, abrocitinib and upadacitinib, which could prove useful for itch as an off-label indication, according to Dr. Kwatra.
Naltrexone Off Label
An emerging therapeutic concept for treating itch is using an opioid antagonist like naltrexone. Morphine causes more itch, so the theory is a reversal agent might help reduce it. The challenge is that naltrexone only comes as a 50 mg tablet, “and I find the high dose makes people nauseous and vomit,” he added.
Don’t Forget Devices
He referred to a “great paper” that he said has been “totally overlooked,” published in 2001, which evaluated a device that stimulates C fibers in the skin to reduce itch. In the study, 19 patients used the device to treat local areas 20 minutes daily for 5 weeks. Punch biopsies of the affected areas were taken at baseline and after treatment. Mean itch ratings decreased from 78% to 42%, and the number of immunoreactive nerve fibers in the epidermis decreased by 40% at the end of treatment.
“Electrical neurostimulation is better for localized pruritus. There is limited case series evidence, but it’s something to think about,” Dr. Kwatra said.
He and his colleagues also have a case study in press that explored the use of injected botulinum toxin to relieve recalcitrant, chronic itch in a 65-year-old man “who failed everything.”
Dr. Kwatra is a consultant or advisory board member for AbbVie, Amgen, Arcutis Biotherapeutics, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi.
A version of this article appeared on Medscape.com.
ORLANDO — “Itch may not be as sexy as Mohs surgery or aesthetic procedures,” but treating it is important and meaningful to patients, particularly those who’ve found little relief previously, Shawn G. Kwatra, MD, said at the annual ODAC Dermatology, Aesthetic & Surgery Conference.
In doctors’ defense, it can be highly challenging to know which approach is optimal for each individual with pruritus, added Dr. Kwatra, associate professor of dermatology at Johns Hopkins University, Baltimore, Maryland.
Cooling agents, topical capsaicin, topical anesthetics like pramoxine 1%, various forms of lidocaine, strontium, opioid modulators like naltrexone, oral Janus kinase inhibitor (JAK) inhibitors, and medical marijuana are among some of the “outside the box” tools in Dr. Kwatra’s itch toolbox.
Often a Medical Puzzle
Frequently, patients come to the dermatologist complaining of itch, “but you don’t see much on their skin.” After a trial of antihistamines, and some topical steroids, the doctor might put up their hands and think: I tried, but I don’t know what else to do. “This actually happens a lot,” said Dr. Kwatra, who is also director of the Johns Hopkins Itch Center.
This means itch can frustrate providers as well. But for patients, the impact on their quality of life can be on the same level as recovering from a stroke or living with heart failure, Dr. Kwatra said. Finding relief for their itch is where “we can make a big difference for patients.”
Consider Cooling Agents
Many of these therapies are inexpensive and widely available. Cooling agents like menthol, camphor, or calamine can reduce activity of the transient receptor potential (TRP) channels in the skin associated with itch. This ion channel also senses temperature, pressure, and other sensations.
Another option is topical capsaicin, which works through the same ion channels. It binds to the TRPV1 receptors in sensory nerve fibers and causes desensitization. Initially, four to six applications a day are required to reduce itch. After that, patients can apply the medication less frequently. “You have to tell folks we know it’s going to work, but it’s going to burn a lot initially,” Dr. Kwatra said. “In real world practice, I’m not using it often.”
A 1.8% capsaicin patch, approved for treating postherpetic neuralgia, can be used to treat pruritus as well. “You put the patch on for one hour and you can have a true clinical response,” he noted.
Another option for itch relief, the topical anesthetic pramoxine 1%, “is probably underutilized for our patients,” Dr. Kwatra said. Pramoxine 1% works fast — as quickly as 2 minutes — and lasts up to 8 hours and is well-tolerated with low toxicity, he added. The agent is applied three to four times a day and relieves itch by reducing the transmembrane permeability of sodium ions on the skin. “This is something widely available and cheap.”
Lidocaine, another topical anesthetic, is available compounded, over the counter, and as a spray or patch. “I would be careful before you use high doses, like 10%” because of tolerability issues, Dr. Kwatra cautioned. He generally starts with lower concentrations.
Topical strontium is really interesting as a strategy, Dr. Kwatra said. Strontium is a soft, white metal that competes with calcium for receptor binding. There are over-the-counter formulations available as a scalp solution or lotion, which, he said, “are ways to go with more episodic itching.”
Topical oatmeal can also relieve itch in some patients. “There is actually some good scientific evidence for topical oatmeal preparations,” he said.
Steroid-Sparing Novel Topicals
Topical ruxolitinib (a JAK inhibitor approved for atopic dermatitis and vitiligo); topical roflumilast (a phosphodiesterase-4 inhibitor) and topical tapinarof (an aryl hydrocarbon receptor agonist), both approved for treating psoriasis; and the atopic dermatitis drug crisaborole fall into this category of topicals with potential for treating itch, he said, noting that use for treating itch is off label.
Off-label use of biologic agents are also possible treatment options for itch, dupilumab and tralokinumab, both US Food and Drug Administration (FDA)–approved for treating atopic dermatitis. Emerging agents that may prove useful for treating itch include lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab, he said.
In terms of oral therapies, the FDA has approved two oral JAK inhibitors for atopic dermatitis, abrocitinib and upadacitinib, which could prove useful for itch as an off-label indication, according to Dr. Kwatra.
Naltrexone Off Label
An emerging therapeutic concept for treating itch is using an opioid antagonist like naltrexone. Morphine causes more itch, so the theory is a reversal agent might help reduce it. The challenge is that naltrexone only comes as a 50 mg tablet, “and I find the high dose makes people nauseous and vomit,” he added.
Don’t Forget Devices
He referred to a “great paper” that he said has been “totally overlooked,” published in 2001, which evaluated a device that stimulates C fibers in the skin to reduce itch. In the study, 19 patients used the device to treat local areas 20 minutes daily for 5 weeks. Punch biopsies of the affected areas were taken at baseline and after treatment. Mean itch ratings decreased from 78% to 42%, and the number of immunoreactive nerve fibers in the epidermis decreased by 40% at the end of treatment.
“Electrical neurostimulation is better for localized pruritus. There is limited case series evidence, but it’s something to think about,” Dr. Kwatra said.
He and his colleagues also have a case study in press that explored the use of injected botulinum toxin to relieve recalcitrant, chronic itch in a 65-year-old man “who failed everything.”
Dr. Kwatra is a consultant or advisory board member for AbbVie, Amgen, Arcutis Biotherapeutics, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi.
A version of this article appeared on Medscape.com.
FROM ODAC 2024
Cutaneous lupus, dermatomyositis: Excitement growing around emerging therapies
ORLANDO, FLORIDA — Advances in treating medical conditions rarely emerge in a straight line. Oftentimes, progress comes in fits and starts, and therapies to treat cutaneous lupus erythematosus (CLE) and dermatomyositis are no exception.
Beyond approved treatments that deserve more attention, like belimumab, approved by the Food and Drug Administration (FDA) for systemic lupus erythematosus (SLE) in 2011, and Octagam 10%, an intravenous immune globulin (IVIG) preparation approved for dermatomyositis in 2021, anticipation is growing for emerging therapies and their potential to provide relief to patients, Anthony Fernandez, MD, PhD, said at the ODAC Dermatology, Aesthetic & Surgical Conference. The tyrosine kinase 2 (TYK2) inhibitor deucravacitinib, Janus kinase (JAK) inhibitors brepocitinib and baricitinib, and the monoclonal antibody anifrolumab, he noted, are prime examples.
“ . In my opinion, this is the start of what will be the most exciting decade in the history of these two diseases,” said Dr. Fernandez, director of medical dermatology at the Cleveland Clinic.
Emerging Treatments for Cutaneous Lupus
Although SLE can involve many organ systems, the skin is one of the most affected. There are specific cutaneous lesions categorized as either acute cutaneous lupus, subacute cutaneous lupus, or chronic cutaneous lupus.
The oral TYK2 inhibitor deucravacitinib, for example, should be able to dampen interleukin responses in people with CLE, Dr. Fernandez said. Deucravacitinib was approved by the FDA to treat psoriasis in September 2022.
A phase 2 study published in 2023 focused on this agent for relief of systemic lupus. Improvements in cutaneous disease were a secondary endpoint. The trial demonstrated that the patients treated with deucravacitinib achieved a 56%-70% CLASI-50 response, depending on dosing, compared with a 17% response among those on placebo at week 48.
Based on the trial results, recruitment has begun for a phase 2 trial to evaluate deucravacitinib, compared with placebo, in patients with discoid and/or subacute cutaneous lupus. “This may be another medicine we have available to give to any of our patients with cutaneous lupus,” Dr. Fernandez said.
Anifrolumab Appears Promising
The FDA approval of anifrolumab, a type I interferon (IFN) receptor antagonist, for treating moderate to severe SLE in July 2021, for example, is good news for dermatologists and their patients, added Dr. Fernandez. “Almost immediately after approval, case studies showed marked improvement in patients with refractory cutaneous lupus.” While the therapy was approved for treating systemic lupus, it allows for off-label treatment of the cutaneous predominant form of the disease, he said.
Furthermore, the manufacturer of anifrolumab, AstraZeneca, is launching the LAVENDER clinical trial to assess the monoclonal antibody specifically for treating CLE. “This is a big deal because we may be able to prescribe anifrolumab for our cutaneous lupus patients who don’t have systemic lupus,” Dr. Fernandez said.
Phase 3 data supported use the of anifrolumab in systemic lupus, including the TULIP-2 trial, which demonstrated its superiority to placebo for reducing severity of systemic disease and lowering corticosteroid use. A study published in March 2023 of 11 patients showed that they had a “very fast response” to the agent, Dr. Fernandez said, with a 50% or greater improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score reached by all participants at week 16. Improvements of 50% or more in this scoring system are considered clinically meaningful, he added.
Upcoming Dermatomyositis Treatments
Why highlight emerging therapies for CLE and dermatomyositis in the same ODAC presentation? Although distinct conditions, these autoimmune conditions are both mediated by type 1 IFN inflammation.
Dermatomyositis is a relatively rare immune-mediated disease that most commonly affects the skin and muscle. Doctors score disease presentation, activity, and clinical improvements on a scale similar to CLASI for cutaneous lupus, the CDASI or Cutaneous Dermatomyositis Disease Area and Severity Index. Among people with CDASI activity scores of at least 14, which is the threshold for moderate to severe disease, a 20% improvement is clinically meaningful, Dr. Fernandez said. In addition, a 40% or greater improvement correlates with significant improvements in quality of life.
There is now more evidence for the use of IVIG to treat dermatomyositis. “Among those of us who treat dermatomyositis on a regular basis, we believe IVIG is the most potent treatment. We’ve known that for a long time,” Dr. Fernandez said.
Despite this tenet, for years, there was only one placebo-controlled trial, published in 1993, that evaluated IVIG treatment for dermatomyositis, and it included only 15 participants. That was until October 2022, he said, when the New England Journal of Medicine published a study comparing a specific brand of IVIG (Octagam) with placebo in 95 people with dermatomyositis.
In the study, 79% of participants treated with IVIG had a total improvement score of at least 20 (minimal improvement), the primary endpoint, at 16 weeks, compared with 44% of those receiving a placebo. Those treated with IVIG also had significant improvements in the CDASI score, a secondary endpoint, compared with those on placebo, he said.
Based on results of this trial, the FDA approved Octagam 10% for dermatomyositis in adults. Dr. Fernandez noted the approval is restricted to the brand of IVIG in the trial, not all IVIG products. However, “the FDA approval is most important to us because it gives us ammunition to fight for insurers to approve IVIG when we feel our patients with dermatomyositis need it,” regardless of the brand.
The Potential of JAK1 Inhibitors
An open-label study of the JAK inhibitor tofacitinib, published in December 2020, showed that mean changes in CDASI activity scores at 12 weeks were statistically significant compared with baseline in 10 people with dermatomyositis. “The importance of this study is that it is proof of concept that JAK inhibition can be effective for treating dermatomyositis, especially with active skin disease,” Dr. Fernandez said.
In addition, two large phase 3 trials are evaluating JAK inhibitor safety and efficacy for treating dermatomyositis. One is the VALOR trial, currently recruiting people with recalcitrant dermatomyositis to evaluate treatment with brepocitinib. Researchers in France are looking at another JAK inhibitor, baricitinib, for treating relapsing or treatment-naive dermatomyositis. Recruitment for the BIRD clinical trial is ongoing.
Monoclonal Antibody Showing Promise
“When it comes to looking specifically at dermatomyositis cutaneous disease, it’s been found that the levels of IFN beta correlate best with not only lesional skin type 1 IFN inflammatory signatures but also overall clinical disease activity,” Dr. Fernandez said. This correlation is stronger than for any other IFN-1-type cytokine active in the disorder.
“Perhaps blocking IFN beta might be best way to get control of dermatomyositis activity,” he added.
With that in mind, a phase 2 trial of dazukibart presented at the American Academy of Dermatology 2023 annual meeting highlighted the promise of this agent that targets type 1 IFN beta.
The primary endpoint was improvement in CDASI at 12 weeks. “This medication has remarkable efficacy,” Dr. Fernandez said. “We were one of the sites for this trial. Despite being blinded, there was no question about who was receiving drug and who was receiving placebo.”
“A minimal clinical improvement in disease activity was seen in more than 90%, so almost every patient who received this medication had meaningful improvement,” he added.
Based on the results, the manufacturer, Pfizer, is recruiting participants for a phase 3 trial to further assess dazukibart in dermatomyositis and polymyositis. Dr. Fernandez said, “This is a story you should pay attention to if you treat any dermatomyositis patients at all.”
Regarding these emerging therapies for CLE and dermatomyositis, “This looks very much like the early days of psoriasis, in the early 2000s, when there was a lot of activity developing treatments,” Dr. Fernandez said. “I will predict that within 10 years, we will have multiple novel agents available that will probably work better than anything we have today.”
Dr. Fernandez reported receiving grant and/or research support from Alexion, Incyte, Mallinckrodt Pharmaceuticals, Novartis, Pfizer, and Priovant Therapeutics; acting as a consultant or advisory board member for AbbVie, Biogen, Mallinckrodt Pharmaceuticals; and being a member of the speaker bureau or receiving honoraria for non-CME from AbbVie, Kyowa Kirin, and Mallinckrodt Pharmaceuticals.
A version of this article appeared on Medscape.com.
ORLANDO, FLORIDA — Advances in treating medical conditions rarely emerge in a straight line. Oftentimes, progress comes in fits and starts, and therapies to treat cutaneous lupus erythematosus (CLE) and dermatomyositis are no exception.
Beyond approved treatments that deserve more attention, like belimumab, approved by the Food and Drug Administration (FDA) for systemic lupus erythematosus (SLE) in 2011, and Octagam 10%, an intravenous immune globulin (IVIG) preparation approved for dermatomyositis in 2021, anticipation is growing for emerging therapies and their potential to provide relief to patients, Anthony Fernandez, MD, PhD, said at the ODAC Dermatology, Aesthetic & Surgical Conference. The tyrosine kinase 2 (TYK2) inhibitor deucravacitinib, Janus kinase (JAK) inhibitors brepocitinib and baricitinib, and the monoclonal antibody anifrolumab, he noted, are prime examples.
“ . In my opinion, this is the start of what will be the most exciting decade in the history of these two diseases,” said Dr. Fernandez, director of medical dermatology at the Cleveland Clinic.
Emerging Treatments for Cutaneous Lupus
Although SLE can involve many organ systems, the skin is one of the most affected. There are specific cutaneous lesions categorized as either acute cutaneous lupus, subacute cutaneous lupus, or chronic cutaneous lupus.
The oral TYK2 inhibitor deucravacitinib, for example, should be able to dampen interleukin responses in people with CLE, Dr. Fernandez said. Deucravacitinib was approved by the FDA to treat psoriasis in September 2022.
A phase 2 study published in 2023 focused on this agent for relief of systemic lupus. Improvements in cutaneous disease were a secondary endpoint. The trial demonstrated that the patients treated with deucravacitinib achieved a 56%-70% CLASI-50 response, depending on dosing, compared with a 17% response among those on placebo at week 48.
Based on the trial results, recruitment has begun for a phase 2 trial to evaluate deucravacitinib, compared with placebo, in patients with discoid and/or subacute cutaneous lupus. “This may be another medicine we have available to give to any of our patients with cutaneous lupus,” Dr. Fernandez said.
Anifrolumab Appears Promising
The FDA approval of anifrolumab, a type I interferon (IFN) receptor antagonist, for treating moderate to severe SLE in July 2021, for example, is good news for dermatologists and their patients, added Dr. Fernandez. “Almost immediately after approval, case studies showed marked improvement in patients with refractory cutaneous lupus.” While the therapy was approved for treating systemic lupus, it allows for off-label treatment of the cutaneous predominant form of the disease, he said.
Furthermore, the manufacturer of anifrolumab, AstraZeneca, is launching the LAVENDER clinical trial to assess the monoclonal antibody specifically for treating CLE. “This is a big deal because we may be able to prescribe anifrolumab for our cutaneous lupus patients who don’t have systemic lupus,” Dr. Fernandez said.
Phase 3 data supported use the of anifrolumab in systemic lupus, including the TULIP-2 trial, which demonstrated its superiority to placebo for reducing severity of systemic disease and lowering corticosteroid use. A study published in March 2023 of 11 patients showed that they had a “very fast response” to the agent, Dr. Fernandez said, with a 50% or greater improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score reached by all participants at week 16. Improvements of 50% or more in this scoring system are considered clinically meaningful, he added.
Upcoming Dermatomyositis Treatments
Why highlight emerging therapies for CLE and dermatomyositis in the same ODAC presentation? Although distinct conditions, these autoimmune conditions are both mediated by type 1 IFN inflammation.
Dermatomyositis is a relatively rare immune-mediated disease that most commonly affects the skin and muscle. Doctors score disease presentation, activity, and clinical improvements on a scale similar to CLASI for cutaneous lupus, the CDASI or Cutaneous Dermatomyositis Disease Area and Severity Index. Among people with CDASI activity scores of at least 14, which is the threshold for moderate to severe disease, a 20% improvement is clinically meaningful, Dr. Fernandez said. In addition, a 40% or greater improvement correlates with significant improvements in quality of life.
There is now more evidence for the use of IVIG to treat dermatomyositis. “Among those of us who treat dermatomyositis on a regular basis, we believe IVIG is the most potent treatment. We’ve known that for a long time,” Dr. Fernandez said.
Despite this tenet, for years, there was only one placebo-controlled trial, published in 1993, that evaluated IVIG treatment for dermatomyositis, and it included only 15 participants. That was until October 2022, he said, when the New England Journal of Medicine published a study comparing a specific brand of IVIG (Octagam) with placebo in 95 people with dermatomyositis.
In the study, 79% of participants treated with IVIG had a total improvement score of at least 20 (minimal improvement), the primary endpoint, at 16 weeks, compared with 44% of those receiving a placebo. Those treated with IVIG also had significant improvements in the CDASI score, a secondary endpoint, compared with those on placebo, he said.
Based on results of this trial, the FDA approved Octagam 10% for dermatomyositis in adults. Dr. Fernandez noted the approval is restricted to the brand of IVIG in the trial, not all IVIG products. However, “the FDA approval is most important to us because it gives us ammunition to fight for insurers to approve IVIG when we feel our patients with dermatomyositis need it,” regardless of the brand.
The Potential of JAK1 Inhibitors
An open-label study of the JAK inhibitor tofacitinib, published in December 2020, showed that mean changes in CDASI activity scores at 12 weeks were statistically significant compared with baseline in 10 people with dermatomyositis. “The importance of this study is that it is proof of concept that JAK inhibition can be effective for treating dermatomyositis, especially with active skin disease,” Dr. Fernandez said.
In addition, two large phase 3 trials are evaluating JAK inhibitor safety and efficacy for treating dermatomyositis. One is the VALOR trial, currently recruiting people with recalcitrant dermatomyositis to evaluate treatment with brepocitinib. Researchers in France are looking at another JAK inhibitor, baricitinib, for treating relapsing or treatment-naive dermatomyositis. Recruitment for the BIRD clinical trial is ongoing.
Monoclonal Antibody Showing Promise
“When it comes to looking specifically at dermatomyositis cutaneous disease, it’s been found that the levels of IFN beta correlate best with not only lesional skin type 1 IFN inflammatory signatures but also overall clinical disease activity,” Dr. Fernandez said. This correlation is stronger than for any other IFN-1-type cytokine active in the disorder.
“Perhaps blocking IFN beta might be best way to get control of dermatomyositis activity,” he added.
With that in mind, a phase 2 trial of dazukibart presented at the American Academy of Dermatology 2023 annual meeting highlighted the promise of this agent that targets type 1 IFN beta.
The primary endpoint was improvement in CDASI at 12 weeks. “This medication has remarkable efficacy,” Dr. Fernandez said. “We were one of the sites for this trial. Despite being blinded, there was no question about who was receiving drug and who was receiving placebo.”
“A minimal clinical improvement in disease activity was seen in more than 90%, so almost every patient who received this medication had meaningful improvement,” he added.
Based on the results, the manufacturer, Pfizer, is recruiting participants for a phase 3 trial to further assess dazukibart in dermatomyositis and polymyositis. Dr. Fernandez said, “This is a story you should pay attention to if you treat any dermatomyositis patients at all.”
Regarding these emerging therapies for CLE and dermatomyositis, “This looks very much like the early days of psoriasis, in the early 2000s, when there was a lot of activity developing treatments,” Dr. Fernandez said. “I will predict that within 10 years, we will have multiple novel agents available that will probably work better than anything we have today.”
Dr. Fernandez reported receiving grant and/or research support from Alexion, Incyte, Mallinckrodt Pharmaceuticals, Novartis, Pfizer, and Priovant Therapeutics; acting as a consultant or advisory board member for AbbVie, Biogen, Mallinckrodt Pharmaceuticals; and being a member of the speaker bureau or receiving honoraria for non-CME from AbbVie, Kyowa Kirin, and Mallinckrodt Pharmaceuticals.
A version of this article appeared on Medscape.com.
ORLANDO, FLORIDA — Advances in treating medical conditions rarely emerge in a straight line. Oftentimes, progress comes in fits and starts, and therapies to treat cutaneous lupus erythematosus (CLE) and dermatomyositis are no exception.
Beyond approved treatments that deserve more attention, like belimumab, approved by the Food and Drug Administration (FDA) for systemic lupus erythematosus (SLE) in 2011, and Octagam 10%, an intravenous immune globulin (IVIG) preparation approved for dermatomyositis in 2021, anticipation is growing for emerging therapies and their potential to provide relief to patients, Anthony Fernandez, MD, PhD, said at the ODAC Dermatology, Aesthetic & Surgical Conference. The tyrosine kinase 2 (TYK2) inhibitor deucravacitinib, Janus kinase (JAK) inhibitors brepocitinib and baricitinib, and the monoclonal antibody anifrolumab, he noted, are prime examples.
“ . In my opinion, this is the start of what will be the most exciting decade in the history of these two diseases,” said Dr. Fernandez, director of medical dermatology at the Cleveland Clinic.
Emerging Treatments for Cutaneous Lupus
Although SLE can involve many organ systems, the skin is one of the most affected. There are specific cutaneous lesions categorized as either acute cutaneous lupus, subacute cutaneous lupus, or chronic cutaneous lupus.
The oral TYK2 inhibitor deucravacitinib, for example, should be able to dampen interleukin responses in people with CLE, Dr. Fernandez said. Deucravacitinib was approved by the FDA to treat psoriasis in September 2022.
A phase 2 study published in 2023 focused on this agent for relief of systemic lupus. Improvements in cutaneous disease were a secondary endpoint. The trial demonstrated that the patients treated with deucravacitinib achieved a 56%-70% CLASI-50 response, depending on dosing, compared with a 17% response among those on placebo at week 48.
Based on the trial results, recruitment has begun for a phase 2 trial to evaluate deucravacitinib, compared with placebo, in patients with discoid and/or subacute cutaneous lupus. “This may be another medicine we have available to give to any of our patients with cutaneous lupus,” Dr. Fernandez said.
Anifrolumab Appears Promising
The FDA approval of anifrolumab, a type I interferon (IFN) receptor antagonist, for treating moderate to severe SLE in July 2021, for example, is good news for dermatologists and their patients, added Dr. Fernandez. “Almost immediately after approval, case studies showed marked improvement in patients with refractory cutaneous lupus.” While the therapy was approved for treating systemic lupus, it allows for off-label treatment of the cutaneous predominant form of the disease, he said.
Furthermore, the manufacturer of anifrolumab, AstraZeneca, is launching the LAVENDER clinical trial to assess the monoclonal antibody specifically for treating CLE. “This is a big deal because we may be able to prescribe anifrolumab for our cutaneous lupus patients who don’t have systemic lupus,” Dr. Fernandez said.
Phase 3 data supported use the of anifrolumab in systemic lupus, including the TULIP-2 trial, which demonstrated its superiority to placebo for reducing severity of systemic disease and lowering corticosteroid use. A study published in March 2023 of 11 patients showed that they had a “very fast response” to the agent, Dr. Fernandez said, with a 50% or greater improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score reached by all participants at week 16. Improvements of 50% or more in this scoring system are considered clinically meaningful, he added.
Upcoming Dermatomyositis Treatments
Why highlight emerging therapies for CLE and dermatomyositis in the same ODAC presentation? Although distinct conditions, these autoimmune conditions are both mediated by type 1 IFN inflammation.
Dermatomyositis is a relatively rare immune-mediated disease that most commonly affects the skin and muscle. Doctors score disease presentation, activity, and clinical improvements on a scale similar to CLASI for cutaneous lupus, the CDASI or Cutaneous Dermatomyositis Disease Area and Severity Index. Among people with CDASI activity scores of at least 14, which is the threshold for moderate to severe disease, a 20% improvement is clinically meaningful, Dr. Fernandez said. In addition, a 40% or greater improvement correlates with significant improvements in quality of life.
There is now more evidence for the use of IVIG to treat dermatomyositis. “Among those of us who treat dermatomyositis on a regular basis, we believe IVIG is the most potent treatment. We’ve known that for a long time,” Dr. Fernandez said.
Despite this tenet, for years, there was only one placebo-controlled trial, published in 1993, that evaluated IVIG treatment for dermatomyositis, and it included only 15 participants. That was until October 2022, he said, when the New England Journal of Medicine published a study comparing a specific brand of IVIG (Octagam) with placebo in 95 people with dermatomyositis.
In the study, 79% of participants treated with IVIG had a total improvement score of at least 20 (minimal improvement), the primary endpoint, at 16 weeks, compared with 44% of those receiving a placebo. Those treated with IVIG also had significant improvements in the CDASI score, a secondary endpoint, compared with those on placebo, he said.
Based on results of this trial, the FDA approved Octagam 10% for dermatomyositis in adults. Dr. Fernandez noted the approval is restricted to the brand of IVIG in the trial, not all IVIG products. However, “the FDA approval is most important to us because it gives us ammunition to fight for insurers to approve IVIG when we feel our patients with dermatomyositis need it,” regardless of the brand.
The Potential of JAK1 Inhibitors
An open-label study of the JAK inhibitor tofacitinib, published in December 2020, showed that mean changes in CDASI activity scores at 12 weeks were statistically significant compared with baseline in 10 people with dermatomyositis. “The importance of this study is that it is proof of concept that JAK inhibition can be effective for treating dermatomyositis, especially with active skin disease,” Dr. Fernandez said.
In addition, two large phase 3 trials are evaluating JAK inhibitor safety and efficacy for treating dermatomyositis. One is the VALOR trial, currently recruiting people with recalcitrant dermatomyositis to evaluate treatment with brepocitinib. Researchers in France are looking at another JAK inhibitor, baricitinib, for treating relapsing or treatment-naive dermatomyositis. Recruitment for the BIRD clinical trial is ongoing.
Monoclonal Antibody Showing Promise
“When it comes to looking specifically at dermatomyositis cutaneous disease, it’s been found that the levels of IFN beta correlate best with not only lesional skin type 1 IFN inflammatory signatures but also overall clinical disease activity,” Dr. Fernandez said. This correlation is stronger than for any other IFN-1-type cytokine active in the disorder.
“Perhaps blocking IFN beta might be best way to get control of dermatomyositis activity,” he added.
With that in mind, a phase 2 trial of dazukibart presented at the American Academy of Dermatology 2023 annual meeting highlighted the promise of this agent that targets type 1 IFN beta.
The primary endpoint was improvement in CDASI at 12 weeks. “This medication has remarkable efficacy,” Dr. Fernandez said. “We were one of the sites for this trial. Despite being blinded, there was no question about who was receiving drug and who was receiving placebo.”
“A minimal clinical improvement in disease activity was seen in more than 90%, so almost every patient who received this medication had meaningful improvement,” he added.
Based on the results, the manufacturer, Pfizer, is recruiting participants for a phase 3 trial to further assess dazukibart in dermatomyositis and polymyositis. Dr. Fernandez said, “This is a story you should pay attention to if you treat any dermatomyositis patients at all.”
Regarding these emerging therapies for CLE and dermatomyositis, “This looks very much like the early days of psoriasis, in the early 2000s, when there was a lot of activity developing treatments,” Dr. Fernandez said. “I will predict that within 10 years, we will have multiple novel agents available that will probably work better than anything we have today.”
Dr. Fernandez reported receiving grant and/or research support from Alexion, Incyte, Mallinckrodt Pharmaceuticals, Novartis, Pfizer, and Priovant Therapeutics; acting as a consultant or advisory board member for AbbVie, Biogen, Mallinckrodt Pharmaceuticals; and being a member of the speaker bureau or receiving honoraria for non-CME from AbbVie, Kyowa Kirin, and Mallinckrodt Pharmaceuticals.
A version of this article appeared on Medscape.com.
FROM ODAC 2024