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Hospitalists ‘in exactly the right place’ to move to value-based care
Hospitalists are uniquely positioned to be agents of change in the health care system, helping to care for very sick patients as well as identifying cost-efficient ways to keep them well, Marc Harrison, MD, said in his keynote presentation Monday at HM19.
“You’re in exactly the right place in exactly the right specialty to make an enormous difference for our country, which desperately needs an upgrade in terms of how we approach keeping people well and then taking care of people when they’re sick in a superefficient as well as independent fashion,” said Dr. Harrison, president and CEO of Intermountain Healthcare, based in Salt Lake City.
Hospital medicine, hospitalists, and the health care system in general are at an inflection point, and leading change in a positive fashion is the “single core competency” attendees need as health care transitions toward value-based care. This means moving away from a volume-based care model and asking hard questions about whether providers are doing the right things for patients, said Dr. Harrison at the Annual Conference of the Society of Hospital Medicine.
“It’s going to require humility, risk taking, and a desire to truly serve others if we’re going to change the paradigm for health care delivery,” he added.
About one-third of health care that providers deliver is redundant, which costs the United States approximately $1 trillion per year, Dr. Harrison noted. “There’s plenty of money in American health care; it’s just being misspent.”
Health care is “expensive, not consumer centric, and provides uneven quality,” which has spurred businesses like Google and Amazon to try to change the model. Other trends in the health care industry are an increased focus on mergers and acquisitions, negative growth outlook for hospitals, rural hospitals facing closure, and consumers increasingly demanding transparency in health care in such places as their hospital bills.
“We need to be on our front foot” to adapt to these changes, said Dr. Harrison, which means changing how money is spent in U.S. health care. There is currently a disparity: 10% of a person’s health care comes from hospitals and clinics, while 90% of money spent in U.S. health care is on that 10%. Spending should instead be inverted, focused on population-based health initiatives such as addressing social issues surrounding housing, transportation, and food security.
A crisis is coming for providers and health systems that continue to focus on volume-based care models instead of making hard changes to value-based care, said Dr. Harrison. Population-based health initiatives that should be implemented include lowering the cost of care by shifting to outpatient care models and lowering insurance premiums.
“It doesn’t matter how technically good you are if people can’t afford what you’re doing,” he said.
Population-based health initiatives also should be modernized to care upstream, fixing the cause of health problems rather than treating the symptoms. The goal, said Dr. Harrison, is a system with end-to-end seamless care, in which providers understand patients’ goals, are intentional about keeping their patients well, and can “ensure seamless handoff” to other caregivers.
Dr. Harrison said the future of hospital medicine is providing acute care in this way, and attendees are uniquely suited to take care of patients not only in the hospital but also at home, as well as providing consultations with colleagues in care environments without hospitalist programs.
“You’re in the absolute perfect place to keep patients in the least-restrictive, least-expensive environment where they can receive superb care,” he said.
Hospitalists are uniquely positioned to be agents of change in the health care system, helping to care for very sick patients as well as identifying cost-efficient ways to keep them well, Marc Harrison, MD, said in his keynote presentation Monday at HM19.
“You’re in exactly the right place in exactly the right specialty to make an enormous difference for our country, which desperately needs an upgrade in terms of how we approach keeping people well and then taking care of people when they’re sick in a superefficient as well as independent fashion,” said Dr. Harrison, president and CEO of Intermountain Healthcare, based in Salt Lake City.
Hospital medicine, hospitalists, and the health care system in general are at an inflection point, and leading change in a positive fashion is the “single core competency” attendees need as health care transitions toward value-based care. This means moving away from a volume-based care model and asking hard questions about whether providers are doing the right things for patients, said Dr. Harrison at the Annual Conference of the Society of Hospital Medicine.
“It’s going to require humility, risk taking, and a desire to truly serve others if we’re going to change the paradigm for health care delivery,” he added.
About one-third of health care that providers deliver is redundant, which costs the United States approximately $1 trillion per year, Dr. Harrison noted. “There’s plenty of money in American health care; it’s just being misspent.”
Health care is “expensive, not consumer centric, and provides uneven quality,” which has spurred businesses like Google and Amazon to try to change the model. Other trends in the health care industry are an increased focus on mergers and acquisitions, negative growth outlook for hospitals, rural hospitals facing closure, and consumers increasingly demanding transparency in health care in such places as their hospital bills.
“We need to be on our front foot” to adapt to these changes, said Dr. Harrison, which means changing how money is spent in U.S. health care. There is currently a disparity: 10% of a person’s health care comes from hospitals and clinics, while 90% of money spent in U.S. health care is on that 10%. Spending should instead be inverted, focused on population-based health initiatives such as addressing social issues surrounding housing, transportation, and food security.
A crisis is coming for providers and health systems that continue to focus on volume-based care models instead of making hard changes to value-based care, said Dr. Harrison. Population-based health initiatives that should be implemented include lowering the cost of care by shifting to outpatient care models and lowering insurance premiums.
“It doesn’t matter how technically good you are if people can’t afford what you’re doing,” he said.
Population-based health initiatives also should be modernized to care upstream, fixing the cause of health problems rather than treating the symptoms. The goal, said Dr. Harrison, is a system with end-to-end seamless care, in which providers understand patients’ goals, are intentional about keeping their patients well, and can “ensure seamless handoff” to other caregivers.
Dr. Harrison said the future of hospital medicine is providing acute care in this way, and attendees are uniquely suited to take care of patients not only in the hospital but also at home, as well as providing consultations with colleagues in care environments without hospitalist programs.
“You’re in the absolute perfect place to keep patients in the least-restrictive, least-expensive environment where they can receive superb care,” he said.
Hospitalists are uniquely positioned to be agents of change in the health care system, helping to care for very sick patients as well as identifying cost-efficient ways to keep them well, Marc Harrison, MD, said in his keynote presentation Monday at HM19.
“You’re in exactly the right place in exactly the right specialty to make an enormous difference for our country, which desperately needs an upgrade in terms of how we approach keeping people well and then taking care of people when they’re sick in a superefficient as well as independent fashion,” said Dr. Harrison, president and CEO of Intermountain Healthcare, based in Salt Lake City.
Hospital medicine, hospitalists, and the health care system in general are at an inflection point, and leading change in a positive fashion is the “single core competency” attendees need as health care transitions toward value-based care. This means moving away from a volume-based care model and asking hard questions about whether providers are doing the right things for patients, said Dr. Harrison at the Annual Conference of the Society of Hospital Medicine.
“It’s going to require humility, risk taking, and a desire to truly serve others if we’re going to change the paradigm for health care delivery,” he added.
About one-third of health care that providers deliver is redundant, which costs the United States approximately $1 trillion per year, Dr. Harrison noted. “There’s plenty of money in American health care; it’s just being misspent.”
Health care is “expensive, not consumer centric, and provides uneven quality,” which has spurred businesses like Google and Amazon to try to change the model. Other trends in the health care industry are an increased focus on mergers and acquisitions, negative growth outlook for hospitals, rural hospitals facing closure, and consumers increasingly demanding transparency in health care in such places as their hospital bills.
“We need to be on our front foot” to adapt to these changes, said Dr. Harrison, which means changing how money is spent in U.S. health care. There is currently a disparity: 10% of a person’s health care comes from hospitals and clinics, while 90% of money spent in U.S. health care is on that 10%. Spending should instead be inverted, focused on population-based health initiatives such as addressing social issues surrounding housing, transportation, and food security.
A crisis is coming for providers and health systems that continue to focus on volume-based care models instead of making hard changes to value-based care, said Dr. Harrison. Population-based health initiatives that should be implemented include lowering the cost of care by shifting to outpatient care models and lowering insurance premiums.
“It doesn’t matter how technically good you are if people can’t afford what you’re doing,” he said.
Population-based health initiatives also should be modernized to care upstream, fixing the cause of health problems rather than treating the symptoms. The goal, said Dr. Harrison, is a system with end-to-end seamless care, in which providers understand patients’ goals, are intentional about keeping their patients well, and can “ensure seamless handoff” to other caregivers.
Dr. Harrison said the future of hospital medicine is providing acute care in this way, and attendees are uniquely suited to take care of patients not only in the hospital but also at home, as well as providing consultations with colleagues in care environments without hospitalist programs.
“You’re in the absolute perfect place to keep patients in the least-restrictive, least-expensive environment where they can receive superb care,” he said.
‘Update in HM’ highlights top research
When Christopher Moriates, MD, SFHM, and Carrie Herzke, MD, SFHM, accepted the opportunity to present the “Update in Hospital Medicine” session at HM19, it was a big moment for both of them.
Not only will they headline one of the most popular sessions at the Annual Conference, but they also will be giving a talk on stage together for the first time. The possibility that it could all go wrong in front of more than 5,000 attendees at HM19 certainly crossed their minds.
“No matter what, it’ll be fun,” said Dr. Moriates, assistant dean for health care value at the University of Texas at Austin.
The aim of Tuesday afternoon’s session is to inform busy hospitalists of what they might have missed over the past year by highlighting the most important papers, from multiple specialties, that affect hospital medicine.
The two presenters may be familiar to hospitalists: Dr. Herzke, associate vice chair for clinical affairs in the department of medicine at Johns Hopkins Medicine in Baltimore, is a member of the SHM Academic Committee, the SHM Mentoring Subcommittee, and the Annual Conference Committee. Dr. Moriates is a regular contributor to The Hospital Leader, the official blog of SHM, and also has a personal connection to the “Update in Hospital Medicine” session.
“I watched with awe as my mentor, Michelle Mourad, MD, presented ‘Update in Hospital Medicine’ on the big stage at National Harbor in 2013,” Dr. Moriates said. “It is hard to imagine that I will be following her footsteps onto that same stage this year.”
Dr. Moriates and Dr. Herzke have spent months preparing for their presentation: Together, they have pored through a year’s worth of literature, narrowing down hundreds of studies to bring attendees the Top 20 papers with an impact on hospital medicine for the session. They each collected articles throughout the year, checking in regularly to outline the themes and rank papers for the session. In January, Dr. Moriates and Dr. Herzke reviewed all the articles they had collected, finalizing the major themes and highlights for the Update.
“The harder part was dropping a few of the articles we had selected in order to make it under an hour,” he said. “We tried to come up with the highlights that all hospitalists should know about, which are most likely to inform their practices over the coming year. And so, if you haven’t picked up a journal in a year, hopefully within an hour, Carrie and I can give you a quick download.”
Attendees familiar with “Update in Hospital Medicine” also will know that the exact details of what is being presented are secret. It is one of the few sessions at HM19 where slides are not published beforehand on the official Annual Conference app. The only way to know the details of the top studies is to attend the session.
“You have to be there to find out,” Dr. Moriates said.
But curiosity should not be the only reason for hospitalists to attend. Dr. Herzke said this year’s “Update in Hospital Medicine” session holds some practice pearls that may surprise attendees.
“We picked out some studies that we think should make people question common practices and consider making changes to how they practice medicine at their home institution, or their home hospital,” she said.
“It’s fair to say there were a number of studies this year that questioned conventional practices or put forth clear evidence that suggests we should be doing things differently in the hospital than the way we currently are doing them, across a number of scenarios,” Dr. Moriates said.
Attendees can expect studies in the fields of infectious disease, cardiology, and hematology to make the Top 20 list of best papers for the session. However, the challenge is always to present clinical pearls that apply to all hospitalists, regardless of where they practice.
“I think one thing about hospitalists is that our practices are very broad based, and we have to be up to date in lots of different fields,” Dr. Moriates said. “And so, we will cover the top literature across an array of fields matching the breadth and diversity of the patients that we take care of as hospitalists.”
Dr. Moriates and Dr. Herzke had no relevant financial conflicts.
Update in Hospital Medicine
Tuesday, 1:00 – 2:00 p.m.
Potomac ABCD
When Christopher Moriates, MD, SFHM, and Carrie Herzke, MD, SFHM, accepted the opportunity to present the “Update in Hospital Medicine” session at HM19, it was a big moment for both of them.
Not only will they headline one of the most popular sessions at the Annual Conference, but they also will be giving a talk on stage together for the first time. The possibility that it could all go wrong in front of more than 5,000 attendees at HM19 certainly crossed their minds.
“No matter what, it’ll be fun,” said Dr. Moriates, assistant dean for health care value at the University of Texas at Austin.
The aim of Tuesday afternoon’s session is to inform busy hospitalists of what they might have missed over the past year by highlighting the most important papers, from multiple specialties, that affect hospital medicine.
The two presenters may be familiar to hospitalists: Dr. Herzke, associate vice chair for clinical affairs in the department of medicine at Johns Hopkins Medicine in Baltimore, is a member of the SHM Academic Committee, the SHM Mentoring Subcommittee, and the Annual Conference Committee. Dr. Moriates is a regular contributor to The Hospital Leader, the official blog of SHM, and also has a personal connection to the “Update in Hospital Medicine” session.
“I watched with awe as my mentor, Michelle Mourad, MD, presented ‘Update in Hospital Medicine’ on the big stage at National Harbor in 2013,” Dr. Moriates said. “It is hard to imagine that I will be following her footsteps onto that same stage this year.”
Dr. Moriates and Dr. Herzke have spent months preparing for their presentation: Together, they have pored through a year’s worth of literature, narrowing down hundreds of studies to bring attendees the Top 20 papers with an impact on hospital medicine for the session. They each collected articles throughout the year, checking in regularly to outline the themes and rank papers for the session. In January, Dr. Moriates and Dr. Herzke reviewed all the articles they had collected, finalizing the major themes and highlights for the Update.
“The harder part was dropping a few of the articles we had selected in order to make it under an hour,” he said. “We tried to come up with the highlights that all hospitalists should know about, which are most likely to inform their practices over the coming year. And so, if you haven’t picked up a journal in a year, hopefully within an hour, Carrie and I can give you a quick download.”
Attendees familiar with “Update in Hospital Medicine” also will know that the exact details of what is being presented are secret. It is one of the few sessions at HM19 where slides are not published beforehand on the official Annual Conference app. The only way to know the details of the top studies is to attend the session.
“You have to be there to find out,” Dr. Moriates said.
But curiosity should not be the only reason for hospitalists to attend. Dr. Herzke said this year’s “Update in Hospital Medicine” session holds some practice pearls that may surprise attendees.
“We picked out some studies that we think should make people question common practices and consider making changes to how they practice medicine at their home institution, or their home hospital,” she said.
“It’s fair to say there were a number of studies this year that questioned conventional practices or put forth clear evidence that suggests we should be doing things differently in the hospital than the way we currently are doing them, across a number of scenarios,” Dr. Moriates said.
Attendees can expect studies in the fields of infectious disease, cardiology, and hematology to make the Top 20 list of best papers for the session. However, the challenge is always to present clinical pearls that apply to all hospitalists, regardless of where they practice.
“I think one thing about hospitalists is that our practices are very broad based, and we have to be up to date in lots of different fields,” Dr. Moriates said. “And so, we will cover the top literature across an array of fields matching the breadth and diversity of the patients that we take care of as hospitalists.”
Dr. Moriates and Dr. Herzke had no relevant financial conflicts.
Update in Hospital Medicine
Tuesday, 1:00 – 2:00 p.m.
Potomac ABCD
When Christopher Moriates, MD, SFHM, and Carrie Herzke, MD, SFHM, accepted the opportunity to present the “Update in Hospital Medicine” session at HM19, it was a big moment for both of them.
Not only will they headline one of the most popular sessions at the Annual Conference, but they also will be giving a talk on stage together for the first time. The possibility that it could all go wrong in front of more than 5,000 attendees at HM19 certainly crossed their minds.
“No matter what, it’ll be fun,” said Dr. Moriates, assistant dean for health care value at the University of Texas at Austin.
The aim of Tuesday afternoon’s session is to inform busy hospitalists of what they might have missed over the past year by highlighting the most important papers, from multiple specialties, that affect hospital medicine.
The two presenters may be familiar to hospitalists: Dr. Herzke, associate vice chair for clinical affairs in the department of medicine at Johns Hopkins Medicine in Baltimore, is a member of the SHM Academic Committee, the SHM Mentoring Subcommittee, and the Annual Conference Committee. Dr. Moriates is a regular contributor to The Hospital Leader, the official blog of SHM, and also has a personal connection to the “Update in Hospital Medicine” session.
“I watched with awe as my mentor, Michelle Mourad, MD, presented ‘Update in Hospital Medicine’ on the big stage at National Harbor in 2013,” Dr. Moriates said. “It is hard to imagine that I will be following her footsteps onto that same stage this year.”
Dr. Moriates and Dr. Herzke have spent months preparing for their presentation: Together, they have pored through a year’s worth of literature, narrowing down hundreds of studies to bring attendees the Top 20 papers with an impact on hospital medicine for the session. They each collected articles throughout the year, checking in regularly to outline the themes and rank papers for the session. In January, Dr. Moriates and Dr. Herzke reviewed all the articles they had collected, finalizing the major themes and highlights for the Update.
“The harder part was dropping a few of the articles we had selected in order to make it under an hour,” he said. “We tried to come up with the highlights that all hospitalists should know about, which are most likely to inform their practices over the coming year. And so, if you haven’t picked up a journal in a year, hopefully within an hour, Carrie and I can give you a quick download.”
Attendees familiar with “Update in Hospital Medicine” also will know that the exact details of what is being presented are secret. It is one of the few sessions at HM19 where slides are not published beforehand on the official Annual Conference app. The only way to know the details of the top studies is to attend the session.
“You have to be there to find out,” Dr. Moriates said.
But curiosity should not be the only reason for hospitalists to attend. Dr. Herzke said this year’s “Update in Hospital Medicine” session holds some practice pearls that may surprise attendees.
“We picked out some studies that we think should make people question common practices and consider making changes to how they practice medicine at their home institution, or their home hospital,” she said.
“It’s fair to say there were a number of studies this year that questioned conventional practices or put forth clear evidence that suggests we should be doing things differently in the hospital than the way we currently are doing them, across a number of scenarios,” Dr. Moriates said.
Attendees can expect studies in the fields of infectious disease, cardiology, and hematology to make the Top 20 list of best papers for the session. However, the challenge is always to present clinical pearls that apply to all hospitalists, regardless of where they practice.
“I think one thing about hospitalists is that our practices are very broad based, and we have to be up to date in lots of different fields,” Dr. Moriates said. “And so, we will cover the top literature across an array of fields matching the breadth and diversity of the patients that we take care of as hospitalists.”
Dr. Moriates and Dr. Herzke had no relevant financial conflicts.
Update in Hospital Medicine
Tuesday, 1:00 – 2:00 p.m.
Potomac ABCD
Planning for change in hospitalist practice management
At Sunday’s HM19 pre-course “Oh, the Places We’ll Go! Practice Management Tools for Navigating the Changing Role of Your Hospital Medicine Group,” the theme was how to anticipate and embrace changing roles as hospital medicine groups are being asked to take on more responsibility.
“The scope of hospitalist practice is evolving rapidly, both clinically and in terms of all of the other things that hospitalists are being asked to do,” said Leslie Flores, MHA, SFHM, a partner at Nelson Flores Hospital Medicine Consultants, La Quinta, Calif., and course co-director, in an interview before the pre-course. “Our goals with this program are to help leaders position their hospitalist groups for success with this changing environment that they’re living in and the changing roles of hospitalists.”
In an audience poll at the beginning of the pre-course, attendees – a majority of whom were practicing hospitalists and managers of hospitalist groups – said their biggest challenge areas were related to compensation or workflows that have not evolved to match their changing role, and disagreements over who should admit patients.
One of the goals of the session was to give hospitalist leaders ideas to address these issues, which included information on how to implement better team-based care and interdisciplinary care models within their groups, as well as how to adjust their compensation, scheduling, and staffing models to prepare for this “new world of hospitalist medicine,” said Ms. Flores.
“One of the biggest sources of contention and stress that we see in hospitalist groups is that there’s just so much change, and it’s happening so rapidly, and people are having a hard time really figuring out how to deal with all of that,” she said.
The day began with John Nelson, MD, MHM, outlining the “Trends in Scope of Practice Evolution.” Dr. Nelson, a partner at Nelson Flores Hospital Medicine Consultants, medical director of Overlake Medical Center in Bellevue, Wash., and course co-director, said hospitalists are increasingly working more in outpatient care, post-acute care, and other specialty facilities. In addition, as group size increases, the likelihood a hospitalist group will be responsible for an observation or short stay unit increases, while a larger group is less likely to have a clinical responsibility for a code blue, cardiac arrest, or rapid response team.
Other topics in the pre-course focused on how to change the culture in a group to an environment where team members are empowered to ask questions or voice concerns, improve patient flow by removing reasons for delays in discharge, recruit the right team members to a group, handle transitions of care, and anticipate change in a group. In addition, the speakers participated in discussions where they shared their biggest successes and failures in practice as leaders and participated in a lightning round where they provided “off-the-cuff” responses to questions from Ms. Flores.
Although hospitalists did not create the current environment that is expanding their role in the health care system, they can position themselves to decide what the scope of their role is, said Dr. Nelson.
“What we should do is navigate our group through these changes in the way that’s going to be most effective for ourselves, the providers in our group, and our organization,” he said. “Those groups that try to dig their heels in or resist all change, they fail. . . and they frustrate themselves. So instead, if you engage in planning for changes in the scope of your practice, you have a chance to make it go the way you’d like it to go, and you’re going to be more satisfied.”
At Sunday’s HM19 pre-course “Oh, the Places We’ll Go! Practice Management Tools for Navigating the Changing Role of Your Hospital Medicine Group,” the theme was how to anticipate and embrace changing roles as hospital medicine groups are being asked to take on more responsibility.
“The scope of hospitalist practice is evolving rapidly, both clinically and in terms of all of the other things that hospitalists are being asked to do,” said Leslie Flores, MHA, SFHM, a partner at Nelson Flores Hospital Medicine Consultants, La Quinta, Calif., and course co-director, in an interview before the pre-course. “Our goals with this program are to help leaders position their hospitalist groups for success with this changing environment that they’re living in and the changing roles of hospitalists.”
In an audience poll at the beginning of the pre-course, attendees – a majority of whom were practicing hospitalists and managers of hospitalist groups – said their biggest challenge areas were related to compensation or workflows that have not evolved to match their changing role, and disagreements over who should admit patients.
One of the goals of the session was to give hospitalist leaders ideas to address these issues, which included information on how to implement better team-based care and interdisciplinary care models within their groups, as well as how to adjust their compensation, scheduling, and staffing models to prepare for this “new world of hospitalist medicine,” said Ms. Flores.
“One of the biggest sources of contention and stress that we see in hospitalist groups is that there’s just so much change, and it’s happening so rapidly, and people are having a hard time really figuring out how to deal with all of that,” she said.
The day began with John Nelson, MD, MHM, outlining the “Trends in Scope of Practice Evolution.” Dr. Nelson, a partner at Nelson Flores Hospital Medicine Consultants, medical director of Overlake Medical Center in Bellevue, Wash., and course co-director, said hospitalists are increasingly working more in outpatient care, post-acute care, and other specialty facilities. In addition, as group size increases, the likelihood a hospitalist group will be responsible for an observation or short stay unit increases, while a larger group is less likely to have a clinical responsibility for a code blue, cardiac arrest, or rapid response team.
Other topics in the pre-course focused on how to change the culture in a group to an environment where team members are empowered to ask questions or voice concerns, improve patient flow by removing reasons for delays in discharge, recruit the right team members to a group, handle transitions of care, and anticipate change in a group. In addition, the speakers participated in discussions where they shared their biggest successes and failures in practice as leaders and participated in a lightning round where they provided “off-the-cuff” responses to questions from Ms. Flores.
Although hospitalists did not create the current environment that is expanding their role in the health care system, they can position themselves to decide what the scope of their role is, said Dr. Nelson.
“What we should do is navigate our group through these changes in the way that’s going to be most effective for ourselves, the providers in our group, and our organization,” he said. “Those groups that try to dig their heels in or resist all change, they fail. . . and they frustrate themselves. So instead, if you engage in planning for changes in the scope of your practice, you have a chance to make it go the way you’d like it to go, and you’re going to be more satisfied.”
At Sunday’s HM19 pre-course “Oh, the Places We’ll Go! Practice Management Tools for Navigating the Changing Role of Your Hospital Medicine Group,” the theme was how to anticipate and embrace changing roles as hospital medicine groups are being asked to take on more responsibility.
“The scope of hospitalist practice is evolving rapidly, both clinically and in terms of all of the other things that hospitalists are being asked to do,” said Leslie Flores, MHA, SFHM, a partner at Nelson Flores Hospital Medicine Consultants, La Quinta, Calif., and course co-director, in an interview before the pre-course. “Our goals with this program are to help leaders position their hospitalist groups for success with this changing environment that they’re living in and the changing roles of hospitalists.”
In an audience poll at the beginning of the pre-course, attendees – a majority of whom were practicing hospitalists and managers of hospitalist groups – said their biggest challenge areas were related to compensation or workflows that have not evolved to match their changing role, and disagreements over who should admit patients.
One of the goals of the session was to give hospitalist leaders ideas to address these issues, which included information on how to implement better team-based care and interdisciplinary care models within their groups, as well as how to adjust their compensation, scheduling, and staffing models to prepare for this “new world of hospitalist medicine,” said Ms. Flores.
“One of the biggest sources of contention and stress that we see in hospitalist groups is that there’s just so much change, and it’s happening so rapidly, and people are having a hard time really figuring out how to deal with all of that,” she said.
The day began with John Nelson, MD, MHM, outlining the “Trends in Scope of Practice Evolution.” Dr. Nelson, a partner at Nelson Flores Hospital Medicine Consultants, medical director of Overlake Medical Center in Bellevue, Wash., and course co-director, said hospitalists are increasingly working more in outpatient care, post-acute care, and other specialty facilities. In addition, as group size increases, the likelihood a hospitalist group will be responsible for an observation or short stay unit increases, while a larger group is less likely to have a clinical responsibility for a code blue, cardiac arrest, or rapid response team.
Other topics in the pre-course focused on how to change the culture in a group to an environment where team members are empowered to ask questions or voice concerns, improve patient flow by removing reasons for delays in discharge, recruit the right team members to a group, handle transitions of care, and anticipate change in a group. In addition, the speakers participated in discussions where they shared their biggest successes and failures in practice as leaders and participated in a lightning round where they provided “off-the-cuff” responses to questions from Ms. Flores.
Although hospitalists did not create the current environment that is expanding their role in the health care system, they can position themselves to decide what the scope of their role is, said Dr. Nelson.
“What we should do is navigate our group through these changes in the way that’s going to be most effective for ourselves, the providers in our group, and our organization,” he said. “Those groups that try to dig their heels in or resist all change, they fail. . . and they frustrate themselves. So instead, if you engage in planning for changes in the scope of your practice, you have a chance to make it go the way you’d like it to go, and you’re going to be more satisfied.”
Amphetamine tied to higher risk of new-onset psychosis than methylphenidate
Greater risk applies only to adolescents, young adults with ADHD treated in primary care
Adolescents and young adults with ADHD who start on amphetamine might have twice the risk of developing new-onset psychosis as do those who start on methylphenidate, a cohort study of more than 220,000 patients suggests.
“The percentage of patients who had a psychotic episode was 0.10% among patients who received methylphenidate and 0.21% among patients who received amphetamine, reported Lauren V. Moran, MD, of the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital in Boston and her colleagues. The study was published by the New England Journal of Medicine.
(aged 13-25 years) with ADHD between January 2004 and September 2015 who were prescribed methylphenidate or amphetamine (both 110,923 patients; 143,286 total person-years of follow-up). They looked for an ICD-9 or ICD-10 code for new-onset psychosis followed by a prescription for an antipsychotic medication the same day or within 60 days of the psychosis diagnosis. Hazard ratios were calculated by matching patients taking methylphenidate with patients taking amphetamine across both databases and calculating the incidence rate of psychosis in each group.
The researchers found 343 new cases of psychosis overall, with an incidence of 2.4 cases per 1,000 person-years. There were 106 episodes of psychosis among patients receiving methylphenidate (0.10%) and 237 new cases among patients receiving amphetamine (0.21%). There was an incidence rate of 1.78 cases per 1,000 person-years for methylphenidate patients and 2.83 cases per 1,000 person-years for amphetamine patients. Across both databases, the pooled hazard ratio for amphetamine use and new-onset psychosis, compared with matched patients, was 1.65 (95% confidence interval, 1.31-2.09).
“The attribution of the higher risk of psychosis to amphetamine use was supported by negative control outcome analyses, which showed that there was no difference in the risk of other psychiatric events between the two stimulant groups,” Dr. Moran and her colleagues reported. “The different biologic mechanisms of methylphenidate and amphetamine activity on neurotransmitters could explain our findings.”
Patients who were prescribed amphetamine by family medicine physicians, internists, and pediatricians were at a higher risk of developing psychosis. That risk, however, did not extend to patients prescribed amphetamine by psychiatrists, the researchers said.
“Psychosis may develop in these patients regardless of stimulant treatment. Alternatively, psychiatrists may prescribe amphetamine more cautiously than other providers and may screen for risk factors for psychosis,” Dr. Moran and her colleagues wrote.
The researchers said the study was limited by unmeasured confounders, such as substance or stimulant misuse; the rate of diversion for amphetamine; and lack of information on race, gender, or socioeconomic status. In addition, they noted, the results could not be generalized to patients with public insurance or no insurance, “which disproportionately applies to patients who are black or Hispanic.”
Dr. Moran reported receiving grants from National Institute of Mental Health (NIMH). The other authors reported grants, personal fees, and other relationships with several entities, including Boehringer Ingelheim, the Food and Drug Administration, the NIMH, and Takeda.
SOURCE: Moran LV et al. N Engl J Med. 2019. doi: 10.1056/NEJMoa1813751.
The findings by Moran et al. are consistent with other randomized controlled trials that suggest a better safety profile for methylphenidate over amphetamine. But the data cannot determine causality in this patient population, Samuele Cortese, MD, PhD, wrote in a related editorial.
“The findings of the current study should not be considered definitive. Observational studies such as this one can provide information on uncommon adverse events in real-world clinical practice that are challenging to assess in randomized trials performed over brief periods,” he said. “However, even sophisticated approaches, such as the ones used in this study to address possible biases, do not have the advantages of randomized trials in excluding confounding factors.”
It is still unclear why some patients developed psychosis, such as in cases of patients with stimulant use and had a “low” or “high” vulnerability to developing psychosis after exposure. The lack of association between psychosis and prescribing amphetamines among psychiatrists also might indicate that those clinicians identified risk factors in patients that predicted the development of psychosis and thus avoided prescribing amphetamines to these patients, he said.
“Currently, it is not possible to predict which patients will have psychotic episodes after stimulant treatment,” Dr. Cortese concluded. “Perhaps techniques such as machine learning applied to large data sets from randomized trials, combined with observational data, will provide predictors at the individual patient level.”
Dr. Cortese is affiliated with the Center for Innovation in Mental Health at the University of Southampton (England). These comments summarize his accompanying editorial (N Engl J Med. 2019. doi: 10.1056/NEJMe1900887 ). He reported nonfinancial relationships with the Association for Child and Adolescent Central Health and the Healthcare Convention & Exhibitors Association.
Greater risk applies only to adolescents, young adults with ADHD treated in primary care
Greater risk applies only to adolescents, young adults with ADHD treated in primary care
The findings by Moran et al. are consistent with other randomized controlled trials that suggest a better safety profile for methylphenidate over amphetamine. But the data cannot determine causality in this patient population, Samuele Cortese, MD, PhD, wrote in a related editorial.
“The findings of the current study should not be considered definitive. Observational studies such as this one can provide information on uncommon adverse events in real-world clinical practice that are challenging to assess in randomized trials performed over brief periods,” he said. “However, even sophisticated approaches, such as the ones used in this study to address possible biases, do not have the advantages of randomized trials in excluding confounding factors.”
It is still unclear why some patients developed psychosis, such as in cases of patients with stimulant use and had a “low” or “high” vulnerability to developing psychosis after exposure. The lack of association between psychosis and prescribing amphetamines among psychiatrists also might indicate that those clinicians identified risk factors in patients that predicted the development of psychosis and thus avoided prescribing amphetamines to these patients, he said.
“Currently, it is not possible to predict which patients will have psychotic episodes after stimulant treatment,” Dr. Cortese concluded. “Perhaps techniques such as machine learning applied to large data sets from randomized trials, combined with observational data, will provide predictors at the individual patient level.”
Dr. Cortese is affiliated with the Center for Innovation in Mental Health at the University of Southampton (England). These comments summarize his accompanying editorial (N Engl J Med. 2019. doi: 10.1056/NEJMe1900887 ). He reported nonfinancial relationships with the Association for Child and Adolescent Central Health and the Healthcare Convention & Exhibitors Association.
The findings by Moran et al. are consistent with other randomized controlled trials that suggest a better safety profile for methylphenidate over amphetamine. But the data cannot determine causality in this patient population, Samuele Cortese, MD, PhD, wrote in a related editorial.
“The findings of the current study should not be considered definitive. Observational studies such as this one can provide information on uncommon adverse events in real-world clinical practice that are challenging to assess in randomized trials performed over brief periods,” he said. “However, even sophisticated approaches, such as the ones used in this study to address possible biases, do not have the advantages of randomized trials in excluding confounding factors.”
It is still unclear why some patients developed psychosis, such as in cases of patients with stimulant use and had a “low” or “high” vulnerability to developing psychosis after exposure. The lack of association between psychosis and prescribing amphetamines among psychiatrists also might indicate that those clinicians identified risk factors in patients that predicted the development of psychosis and thus avoided prescribing amphetamines to these patients, he said.
“Currently, it is not possible to predict which patients will have psychotic episodes after stimulant treatment,” Dr. Cortese concluded. “Perhaps techniques such as machine learning applied to large data sets from randomized trials, combined with observational data, will provide predictors at the individual patient level.”
Dr. Cortese is affiliated with the Center for Innovation in Mental Health at the University of Southampton (England). These comments summarize his accompanying editorial (N Engl J Med. 2019. doi: 10.1056/NEJMe1900887 ). He reported nonfinancial relationships with the Association for Child and Adolescent Central Health and the Healthcare Convention & Exhibitors Association.
Adolescents and young adults with ADHD who start on amphetamine might have twice the risk of developing new-onset psychosis as do those who start on methylphenidate, a cohort study of more than 220,000 patients suggests.
“The percentage of patients who had a psychotic episode was 0.10% among patients who received methylphenidate and 0.21% among patients who received amphetamine, reported Lauren V. Moran, MD, of the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital in Boston and her colleagues. The study was published by the New England Journal of Medicine.
(aged 13-25 years) with ADHD between January 2004 and September 2015 who were prescribed methylphenidate or amphetamine (both 110,923 patients; 143,286 total person-years of follow-up). They looked for an ICD-9 or ICD-10 code for new-onset psychosis followed by a prescription for an antipsychotic medication the same day or within 60 days of the psychosis diagnosis. Hazard ratios were calculated by matching patients taking methylphenidate with patients taking amphetamine across both databases and calculating the incidence rate of psychosis in each group.
The researchers found 343 new cases of psychosis overall, with an incidence of 2.4 cases per 1,000 person-years. There were 106 episodes of psychosis among patients receiving methylphenidate (0.10%) and 237 new cases among patients receiving amphetamine (0.21%). There was an incidence rate of 1.78 cases per 1,000 person-years for methylphenidate patients and 2.83 cases per 1,000 person-years for amphetamine patients. Across both databases, the pooled hazard ratio for amphetamine use and new-onset psychosis, compared with matched patients, was 1.65 (95% confidence interval, 1.31-2.09).
“The attribution of the higher risk of psychosis to amphetamine use was supported by negative control outcome analyses, which showed that there was no difference in the risk of other psychiatric events between the two stimulant groups,” Dr. Moran and her colleagues reported. “The different biologic mechanisms of methylphenidate and amphetamine activity on neurotransmitters could explain our findings.”
Patients who were prescribed amphetamine by family medicine physicians, internists, and pediatricians were at a higher risk of developing psychosis. That risk, however, did not extend to patients prescribed amphetamine by psychiatrists, the researchers said.
“Psychosis may develop in these patients regardless of stimulant treatment. Alternatively, psychiatrists may prescribe amphetamine more cautiously than other providers and may screen for risk factors for psychosis,” Dr. Moran and her colleagues wrote.
The researchers said the study was limited by unmeasured confounders, such as substance or stimulant misuse; the rate of diversion for amphetamine; and lack of information on race, gender, or socioeconomic status. In addition, they noted, the results could not be generalized to patients with public insurance or no insurance, “which disproportionately applies to patients who are black or Hispanic.”
Dr. Moran reported receiving grants from National Institute of Mental Health (NIMH). The other authors reported grants, personal fees, and other relationships with several entities, including Boehringer Ingelheim, the Food and Drug Administration, the NIMH, and Takeda.
SOURCE: Moran LV et al. N Engl J Med. 2019. doi: 10.1056/NEJMoa1813751.
Adolescents and young adults with ADHD who start on amphetamine might have twice the risk of developing new-onset psychosis as do those who start on methylphenidate, a cohort study of more than 220,000 patients suggests.
“The percentage of patients who had a psychotic episode was 0.10% among patients who received methylphenidate and 0.21% among patients who received amphetamine, reported Lauren V. Moran, MD, of the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital in Boston and her colleagues. The study was published by the New England Journal of Medicine.
(aged 13-25 years) with ADHD between January 2004 and September 2015 who were prescribed methylphenidate or amphetamine (both 110,923 patients; 143,286 total person-years of follow-up). They looked for an ICD-9 or ICD-10 code for new-onset psychosis followed by a prescription for an antipsychotic medication the same day or within 60 days of the psychosis diagnosis. Hazard ratios were calculated by matching patients taking methylphenidate with patients taking amphetamine across both databases and calculating the incidence rate of psychosis in each group.
The researchers found 343 new cases of psychosis overall, with an incidence of 2.4 cases per 1,000 person-years. There were 106 episodes of psychosis among patients receiving methylphenidate (0.10%) and 237 new cases among patients receiving amphetamine (0.21%). There was an incidence rate of 1.78 cases per 1,000 person-years for methylphenidate patients and 2.83 cases per 1,000 person-years for amphetamine patients. Across both databases, the pooled hazard ratio for amphetamine use and new-onset psychosis, compared with matched patients, was 1.65 (95% confidence interval, 1.31-2.09).
“The attribution of the higher risk of psychosis to amphetamine use was supported by negative control outcome analyses, which showed that there was no difference in the risk of other psychiatric events between the two stimulant groups,” Dr. Moran and her colleagues reported. “The different biologic mechanisms of methylphenidate and amphetamine activity on neurotransmitters could explain our findings.”
Patients who were prescribed amphetamine by family medicine physicians, internists, and pediatricians were at a higher risk of developing psychosis. That risk, however, did not extend to patients prescribed amphetamine by psychiatrists, the researchers said.
“Psychosis may develop in these patients regardless of stimulant treatment. Alternatively, psychiatrists may prescribe amphetamine more cautiously than other providers and may screen for risk factors for psychosis,” Dr. Moran and her colleagues wrote.
The researchers said the study was limited by unmeasured confounders, such as substance or stimulant misuse; the rate of diversion for amphetamine; and lack of information on race, gender, or socioeconomic status. In addition, they noted, the results could not be generalized to patients with public insurance or no insurance, “which disproportionately applies to patients who are black or Hispanic.”
Dr. Moran reported receiving grants from National Institute of Mental Health (NIMH). The other authors reported grants, personal fees, and other relationships with several entities, including Boehringer Ingelheim, the Food and Drug Administration, the NIMH, and Takeda.
SOURCE: Moran LV et al. N Engl J Med. 2019. doi: 10.1056/NEJMoa1813751.
FDA extends Dupixent indication for 12- to 17-year-olds
The Food and Drug Administration has approved dupilumab for adolescents with moderate to severe atopic dermatitis (AD) that has been inadequately controlled with topical prescription treatments “or when those therapies are not advisable.”
Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, was initially approved in March 2017, for the same indication, becoming the first targeted biologic treatment for AD. The adolescent approval was announced by the manufacturer.
While there are several systemic medications used as second-line therapy for treatment of pediatric AD, dupilumab is the first FDA-approved biologic for treatment of the disease in adolescents aged 12-17 years, Dawn Marie R. Davis, MD, a pediatric dermatologist at the Mayo Clinic, Rochester (MN), and current president of the Society for Pediatric Dermatology, said in an interview.
FDA approval should decrease insurance barriers and the need for prior authorization, thus increasing access to the drug, she noted, adding, “I hope it will offer a successful alternative to other advanced therapies, as the medicine works through a different mechanism of action, compared to the current systemic medications available.”
With the expanded indication to include adolescents, “patients with more moderate to severe disease who aren’t well controlled with a topical therapy are going to get treatment that will change their lives for many years to come,” dupilumab investigator Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview. “On the whole, patients are likely being undertreated and suffering from the disease more than they need to be,” said Dr. Simpson, “With the advent of this new therapy and the new data, it’s going to change the risk benefit calculation for providers and for patients.”
Results from a phase 3 clinical trial of dupilumab in adolescents with moderate to severe AD were presented last fall at the European Academy of Dermatology and Venereology Congress in Paris. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo. Dr. Simpson, the first author of this study, presented the results at that meeting.
Dr. Simpson said that he hopes dupilumab approval for adolescents and the clinical trial results will help providers recognize when patients are not in good control of their AD, and which patients qualify for a step-up in therapy when treatments such as topical therapy or prednisone are not effective. “There are so many patients out there who qualify for a step-up in therapy,” he commented. “I hope that provides comfort to both patients and providers, that it’s OK to take the next step, because the results show us that, not only it can improve your skin rash, but it can have dramatic effects on all the downstream effects of the condition.”
These downstream effects include not only quality of life and comorbidities of mental health but also the patient’s emotional state. Hopefully, dupilumab can reduce stigmatization of AD and feelings of embarrassment for adolescents at a time in life when “socialization, education, and activity is so important in creating your kind of identity in yourself and your sense of self-worth,” Dr. Simpson said.
“It is important to remember atopic dermatitis is a disease that impacts not only the skin, but the patient as a whole,” said Dr. Davis. “It is an exciting time to be caring for atopic dermatitis patients with the various new medications coming to market.”
The FDA had granted a priority review for the adolescent indication; previously the FDA had granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications
The dosing for adolescents is weight based; two doses are available, 200 mg and 300 mg, administered subcutaneously, every other week after a loading dose. The updated prescribing information is available at https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.Dr. Simpson reports relationships with Sanofi and Regeneron Pharmaceuticals. Dr. Davis reports no relevant financial disclosures.
The Food and Drug Administration has approved dupilumab for adolescents with moderate to severe atopic dermatitis (AD) that has been inadequately controlled with topical prescription treatments “or when those therapies are not advisable.”
Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, was initially approved in March 2017, for the same indication, becoming the first targeted biologic treatment for AD. The adolescent approval was announced by the manufacturer.
While there are several systemic medications used as second-line therapy for treatment of pediatric AD, dupilumab is the first FDA-approved biologic for treatment of the disease in adolescents aged 12-17 years, Dawn Marie R. Davis, MD, a pediatric dermatologist at the Mayo Clinic, Rochester (MN), and current president of the Society for Pediatric Dermatology, said in an interview.
FDA approval should decrease insurance barriers and the need for prior authorization, thus increasing access to the drug, she noted, adding, “I hope it will offer a successful alternative to other advanced therapies, as the medicine works through a different mechanism of action, compared to the current systemic medications available.”
With the expanded indication to include adolescents, “patients with more moderate to severe disease who aren’t well controlled with a topical therapy are going to get treatment that will change their lives for many years to come,” dupilumab investigator Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview. “On the whole, patients are likely being undertreated and suffering from the disease more than they need to be,” said Dr. Simpson, “With the advent of this new therapy and the new data, it’s going to change the risk benefit calculation for providers and for patients.”
Results from a phase 3 clinical trial of dupilumab in adolescents with moderate to severe AD were presented last fall at the European Academy of Dermatology and Venereology Congress in Paris. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo. Dr. Simpson, the first author of this study, presented the results at that meeting.
Dr. Simpson said that he hopes dupilumab approval for adolescents and the clinical trial results will help providers recognize when patients are not in good control of their AD, and which patients qualify for a step-up in therapy when treatments such as topical therapy or prednisone are not effective. “There are so many patients out there who qualify for a step-up in therapy,” he commented. “I hope that provides comfort to both patients and providers, that it’s OK to take the next step, because the results show us that, not only it can improve your skin rash, but it can have dramatic effects on all the downstream effects of the condition.”
These downstream effects include not only quality of life and comorbidities of mental health but also the patient’s emotional state. Hopefully, dupilumab can reduce stigmatization of AD and feelings of embarrassment for adolescents at a time in life when “socialization, education, and activity is so important in creating your kind of identity in yourself and your sense of self-worth,” Dr. Simpson said.
“It is important to remember atopic dermatitis is a disease that impacts not only the skin, but the patient as a whole,” said Dr. Davis. “It is an exciting time to be caring for atopic dermatitis patients with the various new medications coming to market.”
The FDA had granted a priority review for the adolescent indication; previously the FDA had granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications
The dosing for adolescents is weight based; two doses are available, 200 mg and 300 mg, administered subcutaneously, every other week after a loading dose. The updated prescribing information is available at https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.Dr. Simpson reports relationships with Sanofi and Regeneron Pharmaceuticals. Dr. Davis reports no relevant financial disclosures.
The Food and Drug Administration has approved dupilumab for adolescents with moderate to severe atopic dermatitis (AD) that has been inadequately controlled with topical prescription treatments “or when those therapies are not advisable.”
Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, was initially approved in March 2017, for the same indication, becoming the first targeted biologic treatment for AD. The adolescent approval was announced by the manufacturer.
While there are several systemic medications used as second-line therapy for treatment of pediatric AD, dupilumab is the first FDA-approved biologic for treatment of the disease in adolescents aged 12-17 years, Dawn Marie R. Davis, MD, a pediatric dermatologist at the Mayo Clinic, Rochester (MN), and current president of the Society for Pediatric Dermatology, said in an interview.
FDA approval should decrease insurance barriers and the need for prior authorization, thus increasing access to the drug, she noted, adding, “I hope it will offer a successful alternative to other advanced therapies, as the medicine works through a different mechanism of action, compared to the current systemic medications available.”
With the expanded indication to include adolescents, “patients with more moderate to severe disease who aren’t well controlled with a topical therapy are going to get treatment that will change their lives for many years to come,” dupilumab investigator Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview. “On the whole, patients are likely being undertreated and suffering from the disease more than they need to be,” said Dr. Simpson, “With the advent of this new therapy and the new data, it’s going to change the risk benefit calculation for providers and for patients.”
Results from a phase 3 clinical trial of dupilumab in adolescents with moderate to severe AD were presented last fall at the European Academy of Dermatology and Venereology Congress in Paris. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo. Dr. Simpson, the first author of this study, presented the results at that meeting.
Dr. Simpson said that he hopes dupilumab approval for adolescents and the clinical trial results will help providers recognize when patients are not in good control of their AD, and which patients qualify for a step-up in therapy when treatments such as topical therapy or prednisone are not effective. “There are so many patients out there who qualify for a step-up in therapy,” he commented. “I hope that provides comfort to both patients and providers, that it’s OK to take the next step, because the results show us that, not only it can improve your skin rash, but it can have dramatic effects on all the downstream effects of the condition.”
These downstream effects include not only quality of life and comorbidities of mental health but also the patient’s emotional state. Hopefully, dupilumab can reduce stigmatization of AD and feelings of embarrassment for adolescents at a time in life when “socialization, education, and activity is so important in creating your kind of identity in yourself and your sense of self-worth,” Dr. Simpson said.
“It is important to remember atopic dermatitis is a disease that impacts not only the skin, but the patient as a whole,” said Dr. Davis. “It is an exciting time to be caring for atopic dermatitis patients with the various new medications coming to market.”
The FDA had granted a priority review for the adolescent indication; previously the FDA had granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications
The dosing for adolescents is weight based; two doses are available, 200 mg and 300 mg, administered subcutaneously, every other week after a loading dose. The updated prescribing information is available at https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.Dr. Simpson reports relationships with Sanofi and Regeneron Pharmaceuticals. Dr. Davis reports no relevant financial disclosures.
Understanding AD as immune-driven disease has opened the door to new therapies
WASHINGTON – The “ of the disease has grown, Emma Guttman-Yassky, MD, PhD, said during a presentation at the annual meeting of the American Academy of Dermatology.
“It’s due to the increased understanding we now have in atopic dermatitis,” Dr. Guttman-Yassky, professor and vice chair for research in the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York, said in her presentation.
According to Dr. Guttman-Yassky, therapeutic development was prevented in AD because of the abnormalities present in the disease immune responses and barrier abnormalities. “Frankly, pharma[ceutical] companies didn’t know what they should go after,” she said. “Should they go after the immune abnormalities, or should they go after the barrier? I think that’s why we’re so far behind psoriasis – but don’t worry, we are catching up quite fast because now ... we understand what we need to go after.”
It was when researchers began to look at AD in the same way as psoriasis that they realized the two were “polar” immune diseases, with psoriasis having Th17/interleukin-17 involvement while atopic dermatitis had Th2/IL-13 involvement. The same approach of “bedside-to-bench pathogenic dissection and translational testing of therapeutics” that led to successful advancements in therapies for psoriasis can also be applied to AD, Dr. Guttman-Yassky said.
To create a translational approach to AD, researchers need to have a well-defined molecular phenotype and understanding of inflammatory pathways, good baseline biomarkers of disease activity and treatment responses, and drugs that would selectively target the immune system. Th2-type cytokines such as IL-4 and IL-13 could help link the barrier and immune defects in AD. In addition, all variations of AD subtypes across white, black, Asian, and pediatric populations have “robust Th2 activation” but differ in other areas. “We’ll need to stratify biomarkers specific to different atopic dermatitis phenotypes to really develop a personalized medicine approach in atopic dermatitis,” she said.
High-level systemic immune activation shows that AD is emerging as a systemic disease that leads to atopic comorbidities such as allergy and asthma, as well as cardiovascular and infectious comorbidities. “We need to think about it when we treat our patients, because we really need to give them systemic treatment approaches when they have this moderate to severe disease,” Dr. Guttman-Yassky said. “When adult patients have moderate to severe disease, what is nonlesional today may be lesional tomorrow, and to treat them effectively, you have to offer them some systemic approaches.”
There is evidence that dupilumab, a human monoclonal antibody that targets IL-4 receptor alpha, is “proving the immune hypothesis” of AD, Dr. Guttman-Yassky said. She cited a recent study from her own group that found use of dupilumab to inhibit IL-4/IL-13 signaling improved disease activity for patients with AD, including reducing the expression of genes that caused type 2 inflammation, epidermal hyperplasia, T cells, dendritic cells, and Th17/Th22 activity (J Allergy Clin Immunol. 2019 Jan;143(1):155-72).
“We could postulate it before, but we couldn’t prove it,” she said. “Basically, this opened the door to all the therapy that we now have in atopic dermatitis.”
According to Dr. Guttman-Yassky, the future of AD will be in creating personalized treatments for patients by stratifying biomarkers specific to different AD phenotypes.
“It’s a very hopeful time in atopic dermatitis with this growing knowledge that we have of the biology of [the disease],” she said. “We have many more agents to treat our patients, and I think the future will be about personalized medicine so we really are treating the disease very well.”
Dr. Guttman-Yassky reported relationships with AbbVie, Allergan, Almirall, Anacor Pharmaceuticals, Asana BioSciences, Celgene, Dermira, Eli Lilly, Escalier Biosciences, Galderma Research & Development, Glenmark Generics, Janssen, Kyowa Hakko Kirin, Leo Pharma, Medimmune, Novartis, Pfizer, Regeneron, Sanofi-Aventis, Sanofi/Regeneron, Stiefel, Theravance Biopharma, and Vitae Pharmaceuticals.
WASHINGTON – The “ of the disease has grown, Emma Guttman-Yassky, MD, PhD, said during a presentation at the annual meeting of the American Academy of Dermatology.
“It’s due to the increased understanding we now have in atopic dermatitis,” Dr. Guttman-Yassky, professor and vice chair for research in the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York, said in her presentation.
According to Dr. Guttman-Yassky, therapeutic development was prevented in AD because of the abnormalities present in the disease immune responses and barrier abnormalities. “Frankly, pharma[ceutical] companies didn’t know what they should go after,” she said. “Should they go after the immune abnormalities, or should they go after the barrier? I think that’s why we’re so far behind psoriasis – but don’t worry, we are catching up quite fast because now ... we understand what we need to go after.”
It was when researchers began to look at AD in the same way as psoriasis that they realized the two were “polar” immune diseases, with psoriasis having Th17/interleukin-17 involvement while atopic dermatitis had Th2/IL-13 involvement. The same approach of “bedside-to-bench pathogenic dissection and translational testing of therapeutics” that led to successful advancements in therapies for psoriasis can also be applied to AD, Dr. Guttman-Yassky said.
To create a translational approach to AD, researchers need to have a well-defined molecular phenotype and understanding of inflammatory pathways, good baseline biomarkers of disease activity and treatment responses, and drugs that would selectively target the immune system. Th2-type cytokines such as IL-4 and IL-13 could help link the barrier and immune defects in AD. In addition, all variations of AD subtypes across white, black, Asian, and pediatric populations have “robust Th2 activation” but differ in other areas. “We’ll need to stratify biomarkers specific to different atopic dermatitis phenotypes to really develop a personalized medicine approach in atopic dermatitis,” she said.
High-level systemic immune activation shows that AD is emerging as a systemic disease that leads to atopic comorbidities such as allergy and asthma, as well as cardiovascular and infectious comorbidities. “We need to think about it when we treat our patients, because we really need to give them systemic treatment approaches when they have this moderate to severe disease,” Dr. Guttman-Yassky said. “When adult patients have moderate to severe disease, what is nonlesional today may be lesional tomorrow, and to treat them effectively, you have to offer them some systemic approaches.”
There is evidence that dupilumab, a human monoclonal antibody that targets IL-4 receptor alpha, is “proving the immune hypothesis” of AD, Dr. Guttman-Yassky said. She cited a recent study from her own group that found use of dupilumab to inhibit IL-4/IL-13 signaling improved disease activity for patients with AD, including reducing the expression of genes that caused type 2 inflammation, epidermal hyperplasia, T cells, dendritic cells, and Th17/Th22 activity (J Allergy Clin Immunol. 2019 Jan;143(1):155-72).
“We could postulate it before, but we couldn’t prove it,” she said. “Basically, this opened the door to all the therapy that we now have in atopic dermatitis.”
According to Dr. Guttman-Yassky, the future of AD will be in creating personalized treatments for patients by stratifying biomarkers specific to different AD phenotypes.
“It’s a very hopeful time in atopic dermatitis with this growing knowledge that we have of the biology of [the disease],” she said. “We have many more agents to treat our patients, and I think the future will be about personalized medicine so we really are treating the disease very well.”
Dr. Guttman-Yassky reported relationships with AbbVie, Allergan, Almirall, Anacor Pharmaceuticals, Asana BioSciences, Celgene, Dermira, Eli Lilly, Escalier Biosciences, Galderma Research & Development, Glenmark Generics, Janssen, Kyowa Hakko Kirin, Leo Pharma, Medimmune, Novartis, Pfizer, Regeneron, Sanofi-Aventis, Sanofi/Regeneron, Stiefel, Theravance Biopharma, and Vitae Pharmaceuticals.
WASHINGTON – The “ of the disease has grown, Emma Guttman-Yassky, MD, PhD, said during a presentation at the annual meeting of the American Academy of Dermatology.
“It’s due to the increased understanding we now have in atopic dermatitis,” Dr. Guttman-Yassky, professor and vice chair for research in the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York, said in her presentation.
According to Dr. Guttman-Yassky, therapeutic development was prevented in AD because of the abnormalities present in the disease immune responses and barrier abnormalities. “Frankly, pharma[ceutical] companies didn’t know what they should go after,” she said. “Should they go after the immune abnormalities, or should they go after the barrier? I think that’s why we’re so far behind psoriasis – but don’t worry, we are catching up quite fast because now ... we understand what we need to go after.”
It was when researchers began to look at AD in the same way as psoriasis that they realized the two were “polar” immune diseases, with psoriasis having Th17/interleukin-17 involvement while atopic dermatitis had Th2/IL-13 involvement. The same approach of “bedside-to-bench pathogenic dissection and translational testing of therapeutics” that led to successful advancements in therapies for psoriasis can also be applied to AD, Dr. Guttman-Yassky said.
To create a translational approach to AD, researchers need to have a well-defined molecular phenotype and understanding of inflammatory pathways, good baseline biomarkers of disease activity and treatment responses, and drugs that would selectively target the immune system. Th2-type cytokines such as IL-4 and IL-13 could help link the barrier and immune defects in AD. In addition, all variations of AD subtypes across white, black, Asian, and pediatric populations have “robust Th2 activation” but differ in other areas. “We’ll need to stratify biomarkers specific to different atopic dermatitis phenotypes to really develop a personalized medicine approach in atopic dermatitis,” she said.
High-level systemic immune activation shows that AD is emerging as a systemic disease that leads to atopic comorbidities such as allergy and asthma, as well as cardiovascular and infectious comorbidities. “We need to think about it when we treat our patients, because we really need to give them systemic treatment approaches when they have this moderate to severe disease,” Dr. Guttman-Yassky said. “When adult patients have moderate to severe disease, what is nonlesional today may be lesional tomorrow, and to treat them effectively, you have to offer them some systemic approaches.”
There is evidence that dupilumab, a human monoclonal antibody that targets IL-4 receptor alpha, is “proving the immune hypothesis” of AD, Dr. Guttman-Yassky said. She cited a recent study from her own group that found use of dupilumab to inhibit IL-4/IL-13 signaling improved disease activity for patients with AD, including reducing the expression of genes that caused type 2 inflammation, epidermal hyperplasia, T cells, dendritic cells, and Th17/Th22 activity (J Allergy Clin Immunol. 2019 Jan;143(1):155-72).
“We could postulate it before, but we couldn’t prove it,” she said. “Basically, this opened the door to all the therapy that we now have in atopic dermatitis.”
According to Dr. Guttman-Yassky, the future of AD will be in creating personalized treatments for patients by stratifying biomarkers specific to different AD phenotypes.
“It’s a very hopeful time in atopic dermatitis with this growing knowledge that we have of the biology of [the disease],” she said. “We have many more agents to treat our patients, and I think the future will be about personalized medicine so we really are treating the disease very well.”
Dr. Guttman-Yassky reported relationships with AbbVie, Allergan, Almirall, Anacor Pharmaceuticals, Asana BioSciences, Celgene, Dermira, Eli Lilly, Escalier Biosciences, Galderma Research & Development, Glenmark Generics, Janssen, Kyowa Hakko Kirin, Leo Pharma, Medimmune, Novartis, Pfizer, Regeneron, Sanofi-Aventis, Sanofi/Regeneron, Stiefel, Theravance Biopharma, and Vitae Pharmaceuticals.
EXPERT ANALYSIS FROM AAD 19
31-GEP test predicts likelihood of metastasis for cutaneous melanoma
WASHINGTON – The for accurately predicting recurrence-free survival and distant metastasis-free survival and melanoma-specific survival, according to results presented by Bradley N. Greenhaw, MD, at a late-breaking research session at the annual meeting of the American Academy of Dermatology.
Dr. Greenhaw, a dermatologist affiliated with the North Mississippi Medical Center-Tupelo, and his colleagues pooled together 1,268 patients from the following studies that analyzed results from melanoma patients who had their disease classified with the 31-gene expression profile (31-GEP) test.
- A single-center study, conducted by Dr. Greenhaw and his associates (Greenhaw BN et al. Dermatol Surg. 2018 Dec. doi: 10.1097/DSS.0000000000001588.
- A multicenter prospective study (J Hematol Oncol. 2017 Aug. doi: 10.1186/s13045-017-0520-1.
- A retrospective archival study (J Am Acad Dermatol. 2019 Jan. doi: 10.1016/j.jaad.2018.07.028.
The 31-GEP test stratifies an individual’s likelihood of developing metastasis within 5 years as low and high risk. In the three studies, the test was used to identify tumors with low-risk (class 1A, class 1B), higher-risk (class 2A), and highest-risk (class 2B) melanoma based on tumor gene expression. In these individual studies, class 2B melanoma independently predicted recurrence-free survival (RFS), distant metastasis–free, and melanoma-specific survival.
Dr. Greenhaw and colleagues performed a meta-analysis of 1,268 patients with stage I through stage III melanoma from those three studies, using fixed and random effects weighting to account for study differences and heterogeneity, respectively. For class 2B tumors, they found a 2.96 increased risk for recurrent metastases and a 2.88 increased risk for distant metastases. The researchers also found no heterogeneity across the studies.
Melanoma-specific survival was not included in the meta-analysis because one paper did not contain any mortality events in class 1A melanoma patients.
“The meta-analysis demonstrated that the GEP test was able to accurately identify those melanoma patients who were at higher risk of metastasis, and we saw a consistent effect across multiple studies,” Dr. Greenhaw said.
Since publication of the 2019 JAAD paper, there were an additional 211 patients who met inclusion criteria and were included in an additional meta-analysis to determine whether inclusion of these patients affected the results. Dr. Greenhaw and colleagues found a 91.4% recurrence-free survival rate and a 94.1% distant metastasis–free survival rate for class 1A melanomas, compared with 45.7% and 55.5% , respectively, for class 2B tumors.
“You can see a big divergence,” Dr. Greenhaw said at the meeting. “Just by using this one test, it’s able to separate out melanomas that otherwise may be grouped in together under current AJCC [American Joint Committee on Cancer] staging,” he added. “The class 2B designation really did confirm a higher risk for recurrence in distant metastasis.”
The researchers used the SORT method to rate the quality of the data across all three studies. Level 1 evidence under the SORT method represents a systematic review or meta-analysis of good-quality studies and/or a prospective study with good follow-up, while an A-level recommendation represents good, quality evidence. Based on the meta-analysis results, the 31-GEP test meets level 1A evidence under the SORT method, Dr. Greenhaw said.
As a prognostic tool, 31-GEP has the potential to change how dermatologists manage their patients with regard to follow-up and adjuvant therapy. “It is being used not just as this novel test that gives us more information, it’s being used clinically,” said Dr. Greenhaw, who noted he regularly uses the 31-GEP test in his practice.
This is the first time that a meta-analysis has been performed for this test, he noted.
Dr. Greenhaw reports a pending relationship with Castle Biosciences.
SOURCE: Greenhaw BN et al. AAD 19. Session F055, Abstract 11370.
WASHINGTON – The for accurately predicting recurrence-free survival and distant metastasis-free survival and melanoma-specific survival, according to results presented by Bradley N. Greenhaw, MD, at a late-breaking research session at the annual meeting of the American Academy of Dermatology.
Dr. Greenhaw, a dermatologist affiliated with the North Mississippi Medical Center-Tupelo, and his colleagues pooled together 1,268 patients from the following studies that analyzed results from melanoma patients who had their disease classified with the 31-gene expression profile (31-GEP) test.
- A single-center study, conducted by Dr. Greenhaw and his associates (Greenhaw BN et al. Dermatol Surg. 2018 Dec. doi: 10.1097/DSS.0000000000001588.
- A multicenter prospective study (J Hematol Oncol. 2017 Aug. doi: 10.1186/s13045-017-0520-1.
- A retrospective archival study (J Am Acad Dermatol. 2019 Jan. doi: 10.1016/j.jaad.2018.07.028.
The 31-GEP test stratifies an individual’s likelihood of developing metastasis within 5 years as low and high risk. In the three studies, the test was used to identify tumors with low-risk (class 1A, class 1B), higher-risk (class 2A), and highest-risk (class 2B) melanoma based on tumor gene expression. In these individual studies, class 2B melanoma independently predicted recurrence-free survival (RFS), distant metastasis–free, and melanoma-specific survival.
Dr. Greenhaw and colleagues performed a meta-analysis of 1,268 patients with stage I through stage III melanoma from those three studies, using fixed and random effects weighting to account for study differences and heterogeneity, respectively. For class 2B tumors, they found a 2.96 increased risk for recurrent metastases and a 2.88 increased risk for distant metastases. The researchers also found no heterogeneity across the studies.
Melanoma-specific survival was not included in the meta-analysis because one paper did not contain any mortality events in class 1A melanoma patients.
“The meta-analysis demonstrated that the GEP test was able to accurately identify those melanoma patients who were at higher risk of metastasis, and we saw a consistent effect across multiple studies,” Dr. Greenhaw said.
Since publication of the 2019 JAAD paper, there were an additional 211 patients who met inclusion criteria and were included in an additional meta-analysis to determine whether inclusion of these patients affected the results. Dr. Greenhaw and colleagues found a 91.4% recurrence-free survival rate and a 94.1% distant metastasis–free survival rate for class 1A melanomas, compared with 45.7% and 55.5% , respectively, for class 2B tumors.
“You can see a big divergence,” Dr. Greenhaw said at the meeting. “Just by using this one test, it’s able to separate out melanomas that otherwise may be grouped in together under current AJCC [American Joint Committee on Cancer] staging,” he added. “The class 2B designation really did confirm a higher risk for recurrence in distant metastasis.”
The researchers used the SORT method to rate the quality of the data across all three studies. Level 1 evidence under the SORT method represents a systematic review or meta-analysis of good-quality studies and/or a prospective study with good follow-up, while an A-level recommendation represents good, quality evidence. Based on the meta-analysis results, the 31-GEP test meets level 1A evidence under the SORT method, Dr. Greenhaw said.
As a prognostic tool, 31-GEP has the potential to change how dermatologists manage their patients with regard to follow-up and adjuvant therapy. “It is being used not just as this novel test that gives us more information, it’s being used clinically,” said Dr. Greenhaw, who noted he regularly uses the 31-GEP test in his practice.
This is the first time that a meta-analysis has been performed for this test, he noted.
Dr. Greenhaw reports a pending relationship with Castle Biosciences.
SOURCE: Greenhaw BN et al. AAD 19. Session F055, Abstract 11370.
WASHINGTON – The for accurately predicting recurrence-free survival and distant metastasis-free survival and melanoma-specific survival, according to results presented by Bradley N. Greenhaw, MD, at a late-breaking research session at the annual meeting of the American Academy of Dermatology.
Dr. Greenhaw, a dermatologist affiliated with the North Mississippi Medical Center-Tupelo, and his colleagues pooled together 1,268 patients from the following studies that analyzed results from melanoma patients who had their disease classified with the 31-gene expression profile (31-GEP) test.
- A single-center study, conducted by Dr. Greenhaw and his associates (Greenhaw BN et al. Dermatol Surg. 2018 Dec. doi: 10.1097/DSS.0000000000001588.
- A multicenter prospective study (J Hematol Oncol. 2017 Aug. doi: 10.1186/s13045-017-0520-1.
- A retrospective archival study (J Am Acad Dermatol. 2019 Jan. doi: 10.1016/j.jaad.2018.07.028.
The 31-GEP test stratifies an individual’s likelihood of developing metastasis within 5 years as low and high risk. In the three studies, the test was used to identify tumors with low-risk (class 1A, class 1B), higher-risk (class 2A), and highest-risk (class 2B) melanoma based on tumor gene expression. In these individual studies, class 2B melanoma independently predicted recurrence-free survival (RFS), distant metastasis–free, and melanoma-specific survival.
Dr. Greenhaw and colleagues performed a meta-analysis of 1,268 patients with stage I through stage III melanoma from those three studies, using fixed and random effects weighting to account for study differences and heterogeneity, respectively. For class 2B tumors, they found a 2.96 increased risk for recurrent metastases and a 2.88 increased risk for distant metastases. The researchers also found no heterogeneity across the studies.
Melanoma-specific survival was not included in the meta-analysis because one paper did not contain any mortality events in class 1A melanoma patients.
“The meta-analysis demonstrated that the GEP test was able to accurately identify those melanoma patients who were at higher risk of metastasis, and we saw a consistent effect across multiple studies,” Dr. Greenhaw said.
Since publication of the 2019 JAAD paper, there were an additional 211 patients who met inclusion criteria and were included in an additional meta-analysis to determine whether inclusion of these patients affected the results. Dr. Greenhaw and colleagues found a 91.4% recurrence-free survival rate and a 94.1% distant metastasis–free survival rate for class 1A melanomas, compared with 45.7% and 55.5% , respectively, for class 2B tumors.
“You can see a big divergence,” Dr. Greenhaw said at the meeting. “Just by using this one test, it’s able to separate out melanomas that otherwise may be grouped in together under current AJCC [American Joint Committee on Cancer] staging,” he added. “The class 2B designation really did confirm a higher risk for recurrence in distant metastasis.”
The researchers used the SORT method to rate the quality of the data across all three studies. Level 1 evidence under the SORT method represents a systematic review or meta-analysis of good-quality studies and/or a prospective study with good follow-up, while an A-level recommendation represents good, quality evidence. Based on the meta-analysis results, the 31-GEP test meets level 1A evidence under the SORT method, Dr. Greenhaw said.
As a prognostic tool, 31-GEP has the potential to change how dermatologists manage their patients with regard to follow-up and adjuvant therapy. “It is being used not just as this novel test that gives us more information, it’s being used clinically,” said Dr. Greenhaw, who noted he regularly uses the 31-GEP test in his practice.
This is the first time that a meta-analysis has been performed for this test, he noted.
Dr. Greenhaw reports a pending relationship with Castle Biosciences.
SOURCE: Greenhaw BN et al. AAD 19. Session F055, Abstract 11370.
REPORTING FROM AAD 19
Management of acne duration, severity can improve rate of scar repair
WASHINGTON – Jerry Tan, MD, said at the annual meeting of the American Academy of Dermatology.
A “large majority” of patients present with active acne scarring, even those with mild and moderate disease, said Dr. Tan of the University of Western Ontario, London. The stigma associated with acne and scarring is real – in one survey, 41% of respondents noted that acne was the first thing they noticed about a person’s face (Dermatol Ther. 2016;6[2]:207-18).
“Patients with scars are stigmatized because they are perceived as being less attractive,” Dr. Tan said. “They’re perceived as being less healthy, less confident, all those negative attributes because they have developed something that was not of their own making.”
Dr. Tan presented results from his own group that estimated the risk factors of scarring. They found factors such as acne severity (odds ratio, 3.68; 95% confidence interval, 2.58-5.23), a family history of acne scarring (OR, 2.14; 95% CI, 1.67-2.76), acne duration (OR, 1.63; 1.09-2.47), and manipulation (picking and squeezing) behaviors (OR, 1.70; 95% CI, 1.27-2.29) increased the risk of acne scarring (J Eur Acad Dermatol Venereol. 2017 Sep;31[9]:1547-54). However, in a separate study, they found acne scarring and repair was an ongoing process: Of 32 patients with moderate inflammatory acne studied for 6 months, 36% of scars that were discovered within the study period were not present at follow up (J Drugs Dermatol. 2017 Jun 1;16[6]:566-72).
“I came from an era where we were taught that acne scars, when they developed, were permanent. This suggests based on good evidence that it’s not,” Dr. Tan said.
Adapalene has been successful in improving the skin texture and severity of acne scars, Dr. Tan said, citing a study that showed once-daily adapalene 0.3% gel showed a moderate to complete improvement in scar severity in 77.8% of patients and a slight improvement in 22.2% of patients (Dermatol Ther. 2018;8[2]:245-57). Increasing the dose helped: 32.9% of patients using topical adapalene 0.3% combined with benzoyl peroxide 2.5% gel at 24 weeks were clear or almost clear according to Scar Global Assessment scores, compared with 16.4% of patients randomized to vehicle (Am J Clin Dermatol. 2018 Apr;19[2]:275-86).
For established scars, many treatment modalities are available, with varying levels of evidence supporting their use. Ice pick scars are commonly treated with chemical reconstruction of skin scars (CROSS), punch techniques, and radiofrequency (RF). Rolling acne scares can be treated with dermabrasion, dermal fillers, RF, skin needling, subcision as well as ablative, nonablative and fractional lasers. Shallow boxcar scars are treated with dermabrasion, dermal fillers, RF, skin needling and subcision as well as ablative, nonablative, fractional lasers; deeper boxcar scars can be treated with RF and punch techniques.
Among these techniques, Dr. Tan said there is level I evidence to use subcision and dermal fillers with rolling acne scars and CROSS with trichloroacetic acid for ice pick and boxcar scars; and for boxcar and rolling scars, ablative and nonablative lasers, microneedling in combination with platelet-rich plasma, RF microneedle or fractional bipolar therapy.
“Remarkably atrophic acne scars can repair spontaneously. Our job is to get more willing to repair spontaneously,” Dr. Tan said. “And we think we can push that to that end with topical retinoids. Topical retinoids can reduce scar formation and certainly there are lots of corrective procedures that can help our patients.”
Dr. Tan reported relationships with Abbott Laboratories, Allergan, Avene, Bayer, Boots, Cipher Pharmaceuticals, Dermira, Eli Lilly, Galderma Laboratories, Galderma Research & Development, F. Hoffman–La Roche, Janssen Pharmaceuticals, Leo Pharma, Lilly ICOS, Pfizer, Proctor & Gamble, Stiefel, and Valeant Pharmaceuticals International.
SOURCE: Tan J et al. AAD 19, Symposium 012.
WASHINGTON – Jerry Tan, MD, said at the annual meeting of the American Academy of Dermatology.
A “large majority” of patients present with active acne scarring, even those with mild and moderate disease, said Dr. Tan of the University of Western Ontario, London. The stigma associated with acne and scarring is real – in one survey, 41% of respondents noted that acne was the first thing they noticed about a person’s face (Dermatol Ther. 2016;6[2]:207-18).
“Patients with scars are stigmatized because they are perceived as being less attractive,” Dr. Tan said. “They’re perceived as being less healthy, less confident, all those negative attributes because they have developed something that was not of their own making.”
Dr. Tan presented results from his own group that estimated the risk factors of scarring. They found factors such as acne severity (odds ratio, 3.68; 95% confidence interval, 2.58-5.23), a family history of acne scarring (OR, 2.14; 95% CI, 1.67-2.76), acne duration (OR, 1.63; 1.09-2.47), and manipulation (picking and squeezing) behaviors (OR, 1.70; 95% CI, 1.27-2.29) increased the risk of acne scarring (J Eur Acad Dermatol Venereol. 2017 Sep;31[9]:1547-54). However, in a separate study, they found acne scarring and repair was an ongoing process: Of 32 patients with moderate inflammatory acne studied for 6 months, 36% of scars that were discovered within the study period were not present at follow up (J Drugs Dermatol. 2017 Jun 1;16[6]:566-72).
“I came from an era where we were taught that acne scars, when they developed, were permanent. This suggests based on good evidence that it’s not,” Dr. Tan said.
Adapalene has been successful in improving the skin texture and severity of acne scars, Dr. Tan said, citing a study that showed once-daily adapalene 0.3% gel showed a moderate to complete improvement in scar severity in 77.8% of patients and a slight improvement in 22.2% of patients (Dermatol Ther. 2018;8[2]:245-57). Increasing the dose helped: 32.9% of patients using topical adapalene 0.3% combined with benzoyl peroxide 2.5% gel at 24 weeks were clear or almost clear according to Scar Global Assessment scores, compared with 16.4% of patients randomized to vehicle (Am J Clin Dermatol. 2018 Apr;19[2]:275-86).
For established scars, many treatment modalities are available, with varying levels of evidence supporting their use. Ice pick scars are commonly treated with chemical reconstruction of skin scars (CROSS), punch techniques, and radiofrequency (RF). Rolling acne scares can be treated with dermabrasion, dermal fillers, RF, skin needling, subcision as well as ablative, nonablative and fractional lasers. Shallow boxcar scars are treated with dermabrasion, dermal fillers, RF, skin needling and subcision as well as ablative, nonablative, fractional lasers; deeper boxcar scars can be treated with RF and punch techniques.
Among these techniques, Dr. Tan said there is level I evidence to use subcision and dermal fillers with rolling acne scars and CROSS with trichloroacetic acid for ice pick and boxcar scars; and for boxcar and rolling scars, ablative and nonablative lasers, microneedling in combination with platelet-rich plasma, RF microneedle or fractional bipolar therapy.
“Remarkably atrophic acne scars can repair spontaneously. Our job is to get more willing to repair spontaneously,” Dr. Tan said. “And we think we can push that to that end with topical retinoids. Topical retinoids can reduce scar formation and certainly there are lots of corrective procedures that can help our patients.”
Dr. Tan reported relationships with Abbott Laboratories, Allergan, Avene, Bayer, Boots, Cipher Pharmaceuticals, Dermira, Eli Lilly, Galderma Laboratories, Galderma Research & Development, F. Hoffman–La Roche, Janssen Pharmaceuticals, Leo Pharma, Lilly ICOS, Pfizer, Proctor & Gamble, Stiefel, and Valeant Pharmaceuticals International.
SOURCE: Tan J et al. AAD 19, Symposium 012.
WASHINGTON – Jerry Tan, MD, said at the annual meeting of the American Academy of Dermatology.
A “large majority” of patients present with active acne scarring, even those with mild and moderate disease, said Dr. Tan of the University of Western Ontario, London. The stigma associated with acne and scarring is real – in one survey, 41% of respondents noted that acne was the first thing they noticed about a person’s face (Dermatol Ther. 2016;6[2]:207-18).
“Patients with scars are stigmatized because they are perceived as being less attractive,” Dr. Tan said. “They’re perceived as being less healthy, less confident, all those negative attributes because they have developed something that was not of their own making.”
Dr. Tan presented results from his own group that estimated the risk factors of scarring. They found factors such as acne severity (odds ratio, 3.68; 95% confidence interval, 2.58-5.23), a family history of acne scarring (OR, 2.14; 95% CI, 1.67-2.76), acne duration (OR, 1.63; 1.09-2.47), and manipulation (picking and squeezing) behaviors (OR, 1.70; 95% CI, 1.27-2.29) increased the risk of acne scarring (J Eur Acad Dermatol Venereol. 2017 Sep;31[9]:1547-54). However, in a separate study, they found acne scarring and repair was an ongoing process: Of 32 patients with moderate inflammatory acne studied for 6 months, 36% of scars that were discovered within the study period were not present at follow up (J Drugs Dermatol. 2017 Jun 1;16[6]:566-72).
“I came from an era where we were taught that acne scars, when they developed, were permanent. This suggests based on good evidence that it’s not,” Dr. Tan said.
Adapalene has been successful in improving the skin texture and severity of acne scars, Dr. Tan said, citing a study that showed once-daily adapalene 0.3% gel showed a moderate to complete improvement in scar severity in 77.8% of patients and a slight improvement in 22.2% of patients (Dermatol Ther. 2018;8[2]:245-57). Increasing the dose helped: 32.9% of patients using topical adapalene 0.3% combined with benzoyl peroxide 2.5% gel at 24 weeks were clear or almost clear according to Scar Global Assessment scores, compared with 16.4% of patients randomized to vehicle (Am J Clin Dermatol. 2018 Apr;19[2]:275-86).
For established scars, many treatment modalities are available, with varying levels of evidence supporting their use. Ice pick scars are commonly treated with chemical reconstruction of skin scars (CROSS), punch techniques, and radiofrequency (RF). Rolling acne scares can be treated with dermabrasion, dermal fillers, RF, skin needling, subcision as well as ablative, nonablative and fractional lasers. Shallow boxcar scars are treated with dermabrasion, dermal fillers, RF, skin needling and subcision as well as ablative, nonablative, fractional lasers; deeper boxcar scars can be treated with RF and punch techniques.
Among these techniques, Dr. Tan said there is level I evidence to use subcision and dermal fillers with rolling acne scars and CROSS with trichloroacetic acid for ice pick and boxcar scars; and for boxcar and rolling scars, ablative and nonablative lasers, microneedling in combination with platelet-rich plasma, RF microneedle or fractional bipolar therapy.
“Remarkably atrophic acne scars can repair spontaneously. Our job is to get more willing to repair spontaneously,” Dr. Tan said. “And we think we can push that to that end with topical retinoids. Topical retinoids can reduce scar formation and certainly there are lots of corrective procedures that can help our patients.”
Dr. Tan reported relationships with Abbott Laboratories, Allergan, Avene, Bayer, Boots, Cipher Pharmaceuticals, Dermira, Eli Lilly, Galderma Laboratories, Galderma Research & Development, F. Hoffman–La Roche, Janssen Pharmaceuticals, Leo Pharma, Lilly ICOS, Pfizer, Proctor & Gamble, Stiefel, and Valeant Pharmaceuticals International.
SOURCE: Tan J et al. AAD 19, Symposium 012.
REPORTING FROM AAD 19
Diagnostic devices may increasingly aid melanoma diagnosis
“If you incorporate the data from these devices into the biopsy decision, you can improve biopsy sensitivity and accuracy of selection. I think there’s no question with these technologies that’s a true statement,” said Dr. Rigel, of New York University Langone Health.
When considering diagnostic devices, evaluate whether they produce results that outperform dermatologists, are low cost, user-friendly, time-efficient and have a high sensitivity and specificity, Dr. Rigel advised. But since no device has a perfect sensitivity and specificity, they cannot be followed blindly. The data from these devices should be used to inform, but not replace, clinical decisions made by dermatologists.
“They’re basically additional information to integrate into the biopsy decision,” he said. “At the end of the day, if you see something with a low score but it really looks funky, the reality is you have to really consider it for biopsy.”
Dr. Rigel discussed five device types that were used to analyze a number of preselected, noninvasive melanoma lesions. The devices required little training to use and a dermatologist would be required to correctly identify the lesions in a deeper analysis.
- Multispectral digital skin lesion analysis (MDSLA) uses 10 spectral wavelengths to measure the light reflected from the tissue, generating a score from a proprietary algorithm that predicts the risk of melanoma. Use of MDSLA improved the biopsy sensitivity for melanoma from 65% to 93% among 179 dermatologists who reviewed images of 24 lesions, 5 of which were melanoma (Arch Dermatol. 2012;148(4):541-3).
- Spectrophotometric intracutaneous analysis scope uses a similar analytic method as the MDSLA device but is difficult to find in the United States; however, one recent study cited a sensitivity of 81.4% and a specificity of 86.4%, indicating it has value for diagnosing melanoma.
- Raman spectroscopy uses monochromatic laser light to analyze the vibratory patterns of cells and examines the shifts in the light to identify a “molecular fingerprint” of potentially cancerous cells, has a high sensitivity and a “relatively reasonable specificity,” Dr. Rigel said.
- Elastic scattering spectroscopy, a newer technology that uses a smartphone-sized device to measure the difference in light scattered from different cellular structures, holds promise to reduce the number of negative biopsies when differentiating between malignant and benign skin conditions. It is currently pending approval with the Food and Drug Administration.
- Electrical impedance spectroscopy (EIS), which uses an electrical alternating current to detect the electrical resistance of potentially cancerous tissue, generates a score with a high negative predictive value and a higher positive predictive value as the score increases. In a study of melanoma diagnoses made by dermatology trainees, use of EIS decreased the number of missed melanomas by 23.4% and resulted in fewer benign biopsies. (J Amer Acad Dermatol. 2019;80:285-7).
All these technologies have been proven effective, but have encountered various economic roadblocks, including delays in regulatory approval, which are partly responsible for why some are no longer on the market, Dr. Rigel said. “If you have to wait 5 years or 7 years to get approval of these devices, by the time they’re approved, the technology is already passed by.”
There are also issues with reimbursements, Dr. Rigel noted, which can further reduce the clinical implementation of these technologies.
Dr. Rigel reported relationships with Derm Tech International, Scibase (maker of EIS) and a number of dermatologic drug companies.
“If you incorporate the data from these devices into the biopsy decision, you can improve biopsy sensitivity and accuracy of selection. I think there’s no question with these technologies that’s a true statement,” said Dr. Rigel, of New York University Langone Health.
When considering diagnostic devices, evaluate whether they produce results that outperform dermatologists, are low cost, user-friendly, time-efficient and have a high sensitivity and specificity, Dr. Rigel advised. But since no device has a perfect sensitivity and specificity, they cannot be followed blindly. The data from these devices should be used to inform, but not replace, clinical decisions made by dermatologists.
“They’re basically additional information to integrate into the biopsy decision,” he said. “At the end of the day, if you see something with a low score but it really looks funky, the reality is you have to really consider it for biopsy.”
Dr. Rigel discussed five device types that were used to analyze a number of preselected, noninvasive melanoma lesions. The devices required little training to use and a dermatologist would be required to correctly identify the lesions in a deeper analysis.
- Multispectral digital skin lesion analysis (MDSLA) uses 10 spectral wavelengths to measure the light reflected from the tissue, generating a score from a proprietary algorithm that predicts the risk of melanoma. Use of MDSLA improved the biopsy sensitivity for melanoma from 65% to 93% among 179 dermatologists who reviewed images of 24 lesions, 5 of which were melanoma (Arch Dermatol. 2012;148(4):541-3).
- Spectrophotometric intracutaneous analysis scope uses a similar analytic method as the MDSLA device but is difficult to find in the United States; however, one recent study cited a sensitivity of 81.4% and a specificity of 86.4%, indicating it has value for diagnosing melanoma.
- Raman spectroscopy uses monochromatic laser light to analyze the vibratory patterns of cells and examines the shifts in the light to identify a “molecular fingerprint” of potentially cancerous cells, has a high sensitivity and a “relatively reasonable specificity,” Dr. Rigel said.
- Elastic scattering spectroscopy, a newer technology that uses a smartphone-sized device to measure the difference in light scattered from different cellular structures, holds promise to reduce the number of negative biopsies when differentiating between malignant and benign skin conditions. It is currently pending approval with the Food and Drug Administration.
- Electrical impedance spectroscopy (EIS), which uses an electrical alternating current to detect the electrical resistance of potentially cancerous tissue, generates a score with a high negative predictive value and a higher positive predictive value as the score increases. In a study of melanoma diagnoses made by dermatology trainees, use of EIS decreased the number of missed melanomas by 23.4% and resulted in fewer benign biopsies. (J Amer Acad Dermatol. 2019;80:285-7).
All these technologies have been proven effective, but have encountered various economic roadblocks, including delays in regulatory approval, which are partly responsible for why some are no longer on the market, Dr. Rigel said. “If you have to wait 5 years or 7 years to get approval of these devices, by the time they’re approved, the technology is already passed by.”
There are also issues with reimbursements, Dr. Rigel noted, which can further reduce the clinical implementation of these technologies.
Dr. Rigel reported relationships with Derm Tech International, Scibase (maker of EIS) and a number of dermatologic drug companies.
“If you incorporate the data from these devices into the biopsy decision, you can improve biopsy sensitivity and accuracy of selection. I think there’s no question with these technologies that’s a true statement,” said Dr. Rigel, of New York University Langone Health.
When considering diagnostic devices, evaluate whether they produce results that outperform dermatologists, are low cost, user-friendly, time-efficient and have a high sensitivity and specificity, Dr. Rigel advised. But since no device has a perfect sensitivity and specificity, they cannot be followed blindly. The data from these devices should be used to inform, but not replace, clinical decisions made by dermatologists.
“They’re basically additional information to integrate into the biopsy decision,” he said. “At the end of the day, if you see something with a low score but it really looks funky, the reality is you have to really consider it for biopsy.”
Dr. Rigel discussed five device types that were used to analyze a number of preselected, noninvasive melanoma lesions. The devices required little training to use and a dermatologist would be required to correctly identify the lesions in a deeper analysis.
- Multispectral digital skin lesion analysis (MDSLA) uses 10 spectral wavelengths to measure the light reflected from the tissue, generating a score from a proprietary algorithm that predicts the risk of melanoma. Use of MDSLA improved the biopsy sensitivity for melanoma from 65% to 93% among 179 dermatologists who reviewed images of 24 lesions, 5 of which were melanoma (Arch Dermatol. 2012;148(4):541-3).
- Spectrophotometric intracutaneous analysis scope uses a similar analytic method as the MDSLA device but is difficult to find in the United States; however, one recent study cited a sensitivity of 81.4% and a specificity of 86.4%, indicating it has value for diagnosing melanoma.
- Raman spectroscopy uses monochromatic laser light to analyze the vibratory patterns of cells and examines the shifts in the light to identify a “molecular fingerprint” of potentially cancerous cells, has a high sensitivity and a “relatively reasonable specificity,” Dr. Rigel said.
- Elastic scattering spectroscopy, a newer technology that uses a smartphone-sized device to measure the difference in light scattered from different cellular structures, holds promise to reduce the number of negative biopsies when differentiating between malignant and benign skin conditions. It is currently pending approval with the Food and Drug Administration.
- Electrical impedance spectroscopy (EIS), which uses an electrical alternating current to detect the electrical resistance of potentially cancerous tissue, generates a score with a high negative predictive value and a higher positive predictive value as the score increases. In a study of melanoma diagnoses made by dermatology trainees, use of EIS decreased the number of missed melanomas by 23.4% and resulted in fewer benign biopsies. (J Amer Acad Dermatol. 2019;80:285-7).
All these technologies have been proven effective, but have encountered various economic roadblocks, including delays in regulatory approval, which are partly responsible for why some are no longer on the market, Dr. Rigel said. “If you have to wait 5 years or 7 years to get approval of these devices, by the time they’re approved, the technology is already passed by.”
There are also issues with reimbursements, Dr. Rigel noted, which can further reduce the clinical implementation of these technologies.
Dr. Rigel reported relationships with Derm Tech International, Scibase (maker of EIS) and a number of dermatologic drug companies.
EXPERT ANALYSIS FROM AAD 2019
Amyloid PET may help facilitate diagnosis of inclusion body myositis
Amyloid PET imaging may help to accurately identify inclusion body myositis and distinguish it from polymyositis, which could potentially avoid misdiagnosis and unnecessary immunosuppressive medication, according to findings from a small prospective cohort study.
The study, which found significantly greater uptake of the imaging agent [18F]florbetapir (Amyvid) in muscle from patients with inclusion body myositis (IBM) than in those with polymyositis (PM), builds on previous research showing that the intramuscular beta-amyloid seen in histopathologic analysis of IBM can help distinguish it from PM, but this approach has a low sensitivity along with high diagnostic specificity. The latest diagnostic criteria for IBM have also shifted away from strict histopathologic analysis toward identifying its characteristic clinical pattern of muscle weakness, first author James B. Lilleker, PhD, of the Centre for Musculoskeletal Research at the University of Manchester (England) and his colleagues wrote in Annals of the Rheumatic Diseases.
“While this has improved sensitivity, clinically detectable weakness implies that significant and irreversible muscle damage has occurred, reducing the likelihood that novel treatments will be effective,” the researchers wrote.
Thomas E. Lloyd II, MD, PhD, codirector of the myositis center at Johns Hopkins University, Baltimore, said in an interview that IBM is difficult to diagnose because of a lack of awareness of the early clinical signs and symptoms of the disease among primary care physicians, neurologists, and rheumatologists.
“Typically, a myositis specialist can make the diagnosis based on a combination of history and exam [slowly progressive weakness affecting distal finger flexors and knee extensors] and muscle biopsy features [endomysial inflammation with rimmed vacuoles and protein aggregates],” said Dr. Lloyd, who was not involved in the current study. “However, early in the course of disease, some patients may be misdiagnosed with polymyositis due to having atypical clinical or pathological features, especially if the muscle biopsy lacks rimmed vacuoles or the patient lacks obvious finger flexor weakness.”
But amyloid PET is promising and needs further analysis comparing it with expert diagnosis, Dr. Lloyd said. “I think this imaging method has greatest potential utility to be helpful diagnostically early in the course of disease, when diagnosis of IBM can be most challenging. This approach may also have potential to identify presymptomatic patients, especially if amyloid imaging becomes used for screening for Alzheimer’s disease in the future.”
Dr. Lilleker and colleagues set out to determine whether amyloid PET with [18F]florbetapir could distinguish between IBM and PM. They identified 10 patients with IBM and 6 patients with PM and scanned each patient from shoulders to ankles with CT and PET, followed by a same-day, whole-body MRI scan. Overall, regions of interest included the left arm, right and left forearms, right and left thighs, and right and left calves. The researchers calculated the [18F]florbetapir standard uptake values (SUVs) for each region of interest while SUV ratios (SUVRs) were calculated using the lumbar fat pad reference region.
The IBM patients (9 men, 1 woman) had a mean age of 68.3 years at the time of the scan and a mean disease duration of 4 years, and they were not currently taking immunosuppressive treatments; however, patients had previously taken prednisolone (3 of 10 patients), azathioprine (1 of 10 patients), and mycophenolate (1 of 10 patients). In the PM group (4 men, 2 women), patients’ mean age was 59.7 years, with a mean disease duration of 1.5 years.
The researchers found significantly increased overall [18F]florbetapir SUVRs among all regions of interest for IBM patients (median total SUVR, 1.45; interquartile range, 1.28-2.05), compared with PM patients (total SUVR, 1.01; IQR, 0.80-1.22; P = .005). In addition, when total [18F]florbetapir SUVR was 1.28 or greater, the diagnostic sensitivity for IBM was 80% and specificity was 100%, with an area under the curve of 0.93. There were also no significant associations between total [18F]florbetapir SUVR and age at the time of the scan, disease duration, or clinical outcome measurements such as manual muscle testing of 26 muscles (MMT26), Health Assessment Questionnaire disability index, and IBM Functional Rating Scale.
Dr. Lilleker and his colleagues noted the small study size as a potential limitation, but said other factors such as age and disease severity, which differed between groups, were unlikely to affect the [18F]florbetapir SUVR.
The rarity of PM may make it difficult to determine amyloid PET imaging’s effectiveness in diagnosing IBM when compared with more traditional methods, Dr. Lloyd noted.
“Whether PET imaging is more sensitive than expert diagnosis using traditional methods [careful physical exam of individual distal interphalangeal finger flexor muscles, MRI imaging of thighs, detailed pathological analysis of muscle biopsy including immunostaining for p62/SQSTM1, detailed serum autoantibody testing, etc.] remains to be determined,” he said.
This study was supported by grants from the National Institute for Health Research Manchester Musculoskeletal Biomedical Research Centre, the Medical Research Council, and an award from the Centre for Imaging Sciences at the University of Manchester. The authors reported no conflicts of interest. Dr. Lloyd reported being a consultant for Acceleron and principal investigator for IBM clinical trials sponsored by Orphazyme and Regeneron.
SOURCE: Lilleker JB et al. Ann Rheum Dis. 2019 Feb 13. doi: 10.1136/annrheumdis-2018-214644.
Amyloid PET imaging may help to accurately identify inclusion body myositis and distinguish it from polymyositis, which could potentially avoid misdiagnosis and unnecessary immunosuppressive medication, according to findings from a small prospective cohort study.
The study, which found significantly greater uptake of the imaging agent [18F]florbetapir (Amyvid) in muscle from patients with inclusion body myositis (IBM) than in those with polymyositis (PM), builds on previous research showing that the intramuscular beta-amyloid seen in histopathologic analysis of IBM can help distinguish it from PM, but this approach has a low sensitivity along with high diagnostic specificity. The latest diagnostic criteria for IBM have also shifted away from strict histopathologic analysis toward identifying its characteristic clinical pattern of muscle weakness, first author James B. Lilleker, PhD, of the Centre for Musculoskeletal Research at the University of Manchester (England) and his colleagues wrote in Annals of the Rheumatic Diseases.
“While this has improved sensitivity, clinically detectable weakness implies that significant and irreversible muscle damage has occurred, reducing the likelihood that novel treatments will be effective,” the researchers wrote.
Thomas E. Lloyd II, MD, PhD, codirector of the myositis center at Johns Hopkins University, Baltimore, said in an interview that IBM is difficult to diagnose because of a lack of awareness of the early clinical signs and symptoms of the disease among primary care physicians, neurologists, and rheumatologists.
“Typically, a myositis specialist can make the diagnosis based on a combination of history and exam [slowly progressive weakness affecting distal finger flexors and knee extensors] and muscle biopsy features [endomysial inflammation with rimmed vacuoles and protein aggregates],” said Dr. Lloyd, who was not involved in the current study. “However, early in the course of disease, some patients may be misdiagnosed with polymyositis due to having atypical clinical or pathological features, especially if the muscle biopsy lacks rimmed vacuoles or the patient lacks obvious finger flexor weakness.”
But amyloid PET is promising and needs further analysis comparing it with expert diagnosis, Dr. Lloyd said. “I think this imaging method has greatest potential utility to be helpful diagnostically early in the course of disease, when diagnosis of IBM can be most challenging. This approach may also have potential to identify presymptomatic patients, especially if amyloid imaging becomes used for screening for Alzheimer’s disease in the future.”
Dr. Lilleker and colleagues set out to determine whether amyloid PET with [18F]florbetapir could distinguish between IBM and PM. They identified 10 patients with IBM and 6 patients with PM and scanned each patient from shoulders to ankles with CT and PET, followed by a same-day, whole-body MRI scan. Overall, regions of interest included the left arm, right and left forearms, right and left thighs, and right and left calves. The researchers calculated the [18F]florbetapir standard uptake values (SUVs) for each region of interest while SUV ratios (SUVRs) were calculated using the lumbar fat pad reference region.
The IBM patients (9 men, 1 woman) had a mean age of 68.3 years at the time of the scan and a mean disease duration of 4 years, and they were not currently taking immunosuppressive treatments; however, patients had previously taken prednisolone (3 of 10 patients), azathioprine (1 of 10 patients), and mycophenolate (1 of 10 patients). In the PM group (4 men, 2 women), patients’ mean age was 59.7 years, with a mean disease duration of 1.5 years.
The researchers found significantly increased overall [18F]florbetapir SUVRs among all regions of interest for IBM patients (median total SUVR, 1.45; interquartile range, 1.28-2.05), compared with PM patients (total SUVR, 1.01; IQR, 0.80-1.22; P = .005). In addition, when total [18F]florbetapir SUVR was 1.28 or greater, the diagnostic sensitivity for IBM was 80% and specificity was 100%, with an area under the curve of 0.93. There were also no significant associations between total [18F]florbetapir SUVR and age at the time of the scan, disease duration, or clinical outcome measurements such as manual muscle testing of 26 muscles (MMT26), Health Assessment Questionnaire disability index, and IBM Functional Rating Scale.
Dr. Lilleker and his colleagues noted the small study size as a potential limitation, but said other factors such as age and disease severity, which differed between groups, were unlikely to affect the [18F]florbetapir SUVR.
The rarity of PM may make it difficult to determine amyloid PET imaging’s effectiveness in diagnosing IBM when compared with more traditional methods, Dr. Lloyd noted.
“Whether PET imaging is more sensitive than expert diagnosis using traditional methods [careful physical exam of individual distal interphalangeal finger flexor muscles, MRI imaging of thighs, detailed pathological analysis of muscle biopsy including immunostaining for p62/SQSTM1, detailed serum autoantibody testing, etc.] remains to be determined,” he said.
This study was supported by grants from the National Institute for Health Research Manchester Musculoskeletal Biomedical Research Centre, the Medical Research Council, and an award from the Centre for Imaging Sciences at the University of Manchester. The authors reported no conflicts of interest. Dr. Lloyd reported being a consultant for Acceleron and principal investigator for IBM clinical trials sponsored by Orphazyme and Regeneron.
SOURCE: Lilleker JB et al. Ann Rheum Dis. 2019 Feb 13. doi: 10.1136/annrheumdis-2018-214644.
Amyloid PET imaging may help to accurately identify inclusion body myositis and distinguish it from polymyositis, which could potentially avoid misdiagnosis and unnecessary immunosuppressive medication, according to findings from a small prospective cohort study.
The study, which found significantly greater uptake of the imaging agent [18F]florbetapir (Amyvid) in muscle from patients with inclusion body myositis (IBM) than in those with polymyositis (PM), builds on previous research showing that the intramuscular beta-amyloid seen in histopathologic analysis of IBM can help distinguish it from PM, but this approach has a low sensitivity along with high diagnostic specificity. The latest diagnostic criteria for IBM have also shifted away from strict histopathologic analysis toward identifying its characteristic clinical pattern of muscle weakness, first author James B. Lilleker, PhD, of the Centre for Musculoskeletal Research at the University of Manchester (England) and his colleagues wrote in Annals of the Rheumatic Diseases.
“While this has improved sensitivity, clinically detectable weakness implies that significant and irreversible muscle damage has occurred, reducing the likelihood that novel treatments will be effective,” the researchers wrote.
Thomas E. Lloyd II, MD, PhD, codirector of the myositis center at Johns Hopkins University, Baltimore, said in an interview that IBM is difficult to diagnose because of a lack of awareness of the early clinical signs and symptoms of the disease among primary care physicians, neurologists, and rheumatologists.
“Typically, a myositis specialist can make the diagnosis based on a combination of history and exam [slowly progressive weakness affecting distal finger flexors and knee extensors] and muscle biopsy features [endomysial inflammation with rimmed vacuoles and protein aggregates],” said Dr. Lloyd, who was not involved in the current study. “However, early in the course of disease, some patients may be misdiagnosed with polymyositis due to having atypical clinical or pathological features, especially if the muscle biopsy lacks rimmed vacuoles or the patient lacks obvious finger flexor weakness.”
But amyloid PET is promising and needs further analysis comparing it with expert diagnosis, Dr. Lloyd said. “I think this imaging method has greatest potential utility to be helpful diagnostically early in the course of disease, when diagnosis of IBM can be most challenging. This approach may also have potential to identify presymptomatic patients, especially if amyloid imaging becomes used for screening for Alzheimer’s disease in the future.”
Dr. Lilleker and colleagues set out to determine whether amyloid PET with [18F]florbetapir could distinguish between IBM and PM. They identified 10 patients with IBM and 6 patients with PM and scanned each patient from shoulders to ankles with CT and PET, followed by a same-day, whole-body MRI scan. Overall, regions of interest included the left arm, right and left forearms, right and left thighs, and right and left calves. The researchers calculated the [18F]florbetapir standard uptake values (SUVs) for each region of interest while SUV ratios (SUVRs) were calculated using the lumbar fat pad reference region.
The IBM patients (9 men, 1 woman) had a mean age of 68.3 years at the time of the scan and a mean disease duration of 4 years, and they were not currently taking immunosuppressive treatments; however, patients had previously taken prednisolone (3 of 10 patients), azathioprine (1 of 10 patients), and mycophenolate (1 of 10 patients). In the PM group (4 men, 2 women), patients’ mean age was 59.7 years, with a mean disease duration of 1.5 years.
The researchers found significantly increased overall [18F]florbetapir SUVRs among all regions of interest for IBM patients (median total SUVR, 1.45; interquartile range, 1.28-2.05), compared with PM patients (total SUVR, 1.01; IQR, 0.80-1.22; P = .005). In addition, when total [18F]florbetapir SUVR was 1.28 or greater, the diagnostic sensitivity for IBM was 80% and specificity was 100%, with an area under the curve of 0.93. There were also no significant associations between total [18F]florbetapir SUVR and age at the time of the scan, disease duration, or clinical outcome measurements such as manual muscle testing of 26 muscles (MMT26), Health Assessment Questionnaire disability index, and IBM Functional Rating Scale.
Dr. Lilleker and his colleagues noted the small study size as a potential limitation, but said other factors such as age and disease severity, which differed between groups, were unlikely to affect the [18F]florbetapir SUVR.
The rarity of PM may make it difficult to determine amyloid PET imaging’s effectiveness in diagnosing IBM when compared with more traditional methods, Dr. Lloyd noted.
“Whether PET imaging is more sensitive than expert diagnosis using traditional methods [careful physical exam of individual distal interphalangeal finger flexor muscles, MRI imaging of thighs, detailed pathological analysis of muscle biopsy including immunostaining for p62/SQSTM1, detailed serum autoantibody testing, etc.] remains to be determined,” he said.
This study was supported by grants from the National Institute for Health Research Manchester Musculoskeletal Biomedical Research Centre, the Medical Research Council, and an award from the Centre for Imaging Sciences at the University of Manchester. The authors reported no conflicts of interest. Dr. Lloyd reported being a consultant for Acceleron and principal investigator for IBM clinical trials sponsored by Orphazyme and Regeneron.
SOURCE: Lilleker JB et al. Ann Rheum Dis. 2019 Feb 13. doi: 10.1136/annrheumdis-2018-214644.
FROM ANNALS OF THE RHEUMATIC DISEASES