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Long-acting naltrexone effective in alcohol use disorder
according to findings presented at the annual meeting of the American College of Emergency Physicians.
The results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.
“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”
The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.
Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.
The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.
“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”
On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.
Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.
She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.
“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.
Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.
“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”
Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to findings presented at the annual meeting of the American College of Emergency Physicians.
The results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.
“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”
The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.
Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.
The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.
“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”
On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.
Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.
She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.
“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.
Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.
“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”
Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to findings presented at the annual meeting of the American College of Emergency Physicians.
The results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.
“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”
The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.
Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.
The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.
“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”
On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.
Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.
She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.
“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.
Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.
“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”
Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ACEP 2022
Mouse embryo experiment could teach us about miscarriages
Miscarriages are a devastating, if natural, occurrence. Nearly 1 million pregnant people in the United States experience a miscarriage every year, according to the National Advocates for Pregnant Women. New research could lend insight into the causes of some types of early pregnancy loss and maybe one day help prevent miscarriages.
In the bioengineering breakthrough, scientists created a mouse embryo in a lab without using sperm or eggs. The experimental embryo, called a model, was grown out of stem cells and developed further than any earlier experiments, with a beating heart and the foundation of a brain within a yolk sac, according to the researchers.
The experiment, while conducted with mouse stem cells, could help explain why some human pregnancies fail. Miscarriages occur in up to 15% of pregnancies confirmed by doctors, according to some studies, and also for many pregnant people before they even knew of the pregnancy. This experiment gives researchers a glimpse of a critical developmental stage for the first time.
“We are building mouse embryo models, but they have exactly the same principle as real human embryos,” says lead researcher Magdalena Zernicka-Goetz, PhD, professor in mammalian development and stem cell biology at Cambridge (England) University. “That’s why they tell us about real pregnancy.”
With the new mouse models, the researchers can study implantation, the stage when embryos embed themselves in the mother’s body – a stage that’s often difficult for embryos to survive. The same process happens in mouse embryos, which develop very similarly to human embryos at this early stage of life.
Six years ago, researchers from the University of Cambridge and the California Institute of Technology set out to create models that would allow them to study fetal development in three-dimensional form but without the need for human embryos.
“We are trying to understand the major principles of time and space that have to be fulfilled” to form a successful pregnancy, Dr. Zernicka-Goetz explains. “If those principles are not fulfilled, the pregnancies are terminated, even before women know they’re pregnant.”
There are limits on using human embryos for research, and previous experiments have tended to replicate only one aspect of development. That led to two-dimensional experiments: flat cells on the bottom of a petri dish that lack the structural organization of real tissue.
The new models are three-dimensional with beating hearts and the yolk sacs in which embryos feed and grow. The models even progressed to forming the beginning of a brain – a research first.
The scientists used the foundational cellular “building blocks” called stem cells and managed to get the cells to communicate along a timeline that mimicked natural development, simulating those developmental stages, says Dr. Zernicka-Goetz. Those “building blocks” are actually three types of stem cells: pluripotent stem cells that build body tissue, and two other types of stem cells that build the placenta and the amniotic sac.
Completing the experiment required the right quantity of each stem cell type. The researchers also needed to understand how those cells exchange information before they can begin to grow. The researchers were able to “decipher the code” of how the cells talk to each other, Dr. Zernicka-Goetz says.
Initially, the three types of stem cells combine, almost like a soup, but when the timing is right, they have to recognize each other and sort themselves. Next, each stem cell type must start building a different structure necessary for fetal development. Dr. Zernicka-Goetz thinks of this construction as the architecture of human tissue.
With the new technique, researchers can continue investigating the implantation stage and beyond. And they did – tweaking the experiment to create a genetically flawed embryo on purpose.
Dr. Zernicka-Goetz and her team eliminated a certain gene known to regulate how cells establish their own identities. Doing so resulted in the same brain development flaws as in human embryos, providing “a proof of concept” that the experimental models can be used to study other genetic mysteries, she says.
Scientists are still in the dark about what some genes do, as well as the point when they become critical to brain development.
“Many genes have very early roles in specifying, for example, the position of the head and also how our brain will function,” Dr. Zernicka-Goetz says. “We can now use this model system to assess the function of those genes.”
A version of this article first appeared on WebMD.com.
Miscarriages are a devastating, if natural, occurrence. Nearly 1 million pregnant people in the United States experience a miscarriage every year, according to the National Advocates for Pregnant Women. New research could lend insight into the causes of some types of early pregnancy loss and maybe one day help prevent miscarriages.
In the bioengineering breakthrough, scientists created a mouse embryo in a lab without using sperm or eggs. The experimental embryo, called a model, was grown out of stem cells and developed further than any earlier experiments, with a beating heart and the foundation of a brain within a yolk sac, according to the researchers.
The experiment, while conducted with mouse stem cells, could help explain why some human pregnancies fail. Miscarriages occur in up to 15% of pregnancies confirmed by doctors, according to some studies, and also for many pregnant people before they even knew of the pregnancy. This experiment gives researchers a glimpse of a critical developmental stage for the first time.
“We are building mouse embryo models, but they have exactly the same principle as real human embryos,” says lead researcher Magdalena Zernicka-Goetz, PhD, professor in mammalian development and stem cell biology at Cambridge (England) University. “That’s why they tell us about real pregnancy.”
With the new mouse models, the researchers can study implantation, the stage when embryos embed themselves in the mother’s body – a stage that’s often difficult for embryos to survive. The same process happens in mouse embryos, which develop very similarly to human embryos at this early stage of life.
Six years ago, researchers from the University of Cambridge and the California Institute of Technology set out to create models that would allow them to study fetal development in three-dimensional form but without the need for human embryos.
“We are trying to understand the major principles of time and space that have to be fulfilled” to form a successful pregnancy, Dr. Zernicka-Goetz explains. “If those principles are not fulfilled, the pregnancies are terminated, even before women know they’re pregnant.”
There are limits on using human embryos for research, and previous experiments have tended to replicate only one aspect of development. That led to two-dimensional experiments: flat cells on the bottom of a petri dish that lack the structural organization of real tissue.
The new models are three-dimensional with beating hearts and the yolk sacs in which embryos feed and grow. The models even progressed to forming the beginning of a brain – a research first.
The scientists used the foundational cellular “building blocks” called stem cells and managed to get the cells to communicate along a timeline that mimicked natural development, simulating those developmental stages, says Dr. Zernicka-Goetz. Those “building blocks” are actually three types of stem cells: pluripotent stem cells that build body tissue, and two other types of stem cells that build the placenta and the amniotic sac.
Completing the experiment required the right quantity of each stem cell type. The researchers also needed to understand how those cells exchange information before they can begin to grow. The researchers were able to “decipher the code” of how the cells talk to each other, Dr. Zernicka-Goetz says.
Initially, the three types of stem cells combine, almost like a soup, but when the timing is right, they have to recognize each other and sort themselves. Next, each stem cell type must start building a different structure necessary for fetal development. Dr. Zernicka-Goetz thinks of this construction as the architecture of human tissue.
With the new technique, researchers can continue investigating the implantation stage and beyond. And they did – tweaking the experiment to create a genetically flawed embryo on purpose.
Dr. Zernicka-Goetz and her team eliminated a certain gene known to regulate how cells establish their own identities. Doing so resulted in the same brain development flaws as in human embryos, providing “a proof of concept” that the experimental models can be used to study other genetic mysteries, she says.
Scientists are still in the dark about what some genes do, as well as the point when they become critical to brain development.
“Many genes have very early roles in specifying, for example, the position of the head and also how our brain will function,” Dr. Zernicka-Goetz says. “We can now use this model system to assess the function of those genes.”
A version of this article first appeared on WebMD.com.
Miscarriages are a devastating, if natural, occurrence. Nearly 1 million pregnant people in the United States experience a miscarriage every year, according to the National Advocates for Pregnant Women. New research could lend insight into the causes of some types of early pregnancy loss and maybe one day help prevent miscarriages.
In the bioengineering breakthrough, scientists created a mouse embryo in a lab without using sperm or eggs. The experimental embryo, called a model, was grown out of stem cells and developed further than any earlier experiments, with a beating heart and the foundation of a brain within a yolk sac, according to the researchers.
The experiment, while conducted with mouse stem cells, could help explain why some human pregnancies fail. Miscarriages occur in up to 15% of pregnancies confirmed by doctors, according to some studies, and also for many pregnant people before they even knew of the pregnancy. This experiment gives researchers a glimpse of a critical developmental stage for the first time.
“We are building mouse embryo models, but they have exactly the same principle as real human embryos,” says lead researcher Magdalena Zernicka-Goetz, PhD, professor in mammalian development and stem cell biology at Cambridge (England) University. “That’s why they tell us about real pregnancy.”
With the new mouse models, the researchers can study implantation, the stage when embryos embed themselves in the mother’s body – a stage that’s often difficult for embryos to survive. The same process happens in mouse embryos, which develop very similarly to human embryos at this early stage of life.
Six years ago, researchers from the University of Cambridge and the California Institute of Technology set out to create models that would allow them to study fetal development in three-dimensional form but without the need for human embryos.
“We are trying to understand the major principles of time and space that have to be fulfilled” to form a successful pregnancy, Dr. Zernicka-Goetz explains. “If those principles are not fulfilled, the pregnancies are terminated, even before women know they’re pregnant.”
There are limits on using human embryos for research, and previous experiments have tended to replicate only one aspect of development. That led to two-dimensional experiments: flat cells on the bottom of a petri dish that lack the structural organization of real tissue.
The new models are three-dimensional with beating hearts and the yolk sacs in which embryos feed and grow. The models even progressed to forming the beginning of a brain – a research first.
The scientists used the foundational cellular “building blocks” called stem cells and managed to get the cells to communicate along a timeline that mimicked natural development, simulating those developmental stages, says Dr. Zernicka-Goetz. Those “building blocks” are actually three types of stem cells: pluripotent stem cells that build body tissue, and two other types of stem cells that build the placenta and the amniotic sac.
Completing the experiment required the right quantity of each stem cell type. The researchers also needed to understand how those cells exchange information before they can begin to grow. The researchers were able to “decipher the code” of how the cells talk to each other, Dr. Zernicka-Goetz says.
Initially, the three types of stem cells combine, almost like a soup, but when the timing is right, they have to recognize each other and sort themselves. Next, each stem cell type must start building a different structure necessary for fetal development. Dr. Zernicka-Goetz thinks of this construction as the architecture of human tissue.
With the new technique, researchers can continue investigating the implantation stage and beyond. And they did – tweaking the experiment to create a genetically flawed embryo on purpose.
Dr. Zernicka-Goetz and her team eliminated a certain gene known to regulate how cells establish their own identities. Doing so resulted in the same brain development flaws as in human embryos, providing “a proof of concept” that the experimental models can be used to study other genetic mysteries, she says.
Scientists are still in the dark about what some genes do, as well as the point when they become critical to brain development.
“Many genes have very early roles in specifying, for example, the position of the head and also how our brain will function,” Dr. Zernicka-Goetz says. “We can now use this model system to assess the function of those genes.”
A version of this article first appeared on WebMD.com.
FDA approves HIV-1 treatment ibalizumab for 30-second IV push
The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.
Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.
Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.
for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.
The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.
The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.
While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.
“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.
Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.
Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.
for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.
The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.
The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.
While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.
“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.
Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.
Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.
for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.
The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.
The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.
While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.
“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”
A version of this article first appeared on Medscape.com.
Is early-onset cancer an emerging global epidemic?
, according to a recent review.
While the rising incidence of early-onset colorectal cancer (CRC) is a well-documented problem, the trend appears to extend far beyond CRC. The authors traced patterns of early-onset cancer diagnoses across 14 different cancer types, including breast, prostate, and thyroid, over the past 3 decades and found increases in many countries.
Among the 14 cancers explored, eight relate to the digestive system, which highlights the potential role diet and the oral and gut microbiome may play in cancer risk, the authors noted.
And many of the factors that appear to influence cancer risk – such as diet, exercise, sleep, and vaccination against HPV and other cancer-causing microorganisms – are modifiable.
“[Our] immediate goals should be to raise awareness of the early-onset cancer epidemic and reduce exposure to [these] risk factors,” authors Tomotaka Ugai, MD, PhD, and Shuji Ogino, MD, PhD, with Harvard School of Public Health, Boston, noted in a joint email.
The paper was published in Nature Reviews Clinical Oncology.
While the rise in cancer screenings has contributed to earlier detection of cancers, a genuine increase in the incidence of some early-onset cancers also appears to be happening.
In the current review, Dr. Ugai, Dr. Ogino, and colleagues reviewed the literature and mapped trends in the incidence of 14 cancer types among 20- to 49-year-old adults in 44 countries between 2002 and 2012.
The authors found that, since the 1990s, the incidence of early-onset cancers in the breast, colorectum, endometrium, esophagus, extrahepatic bile duct, gallbladder, head/neck, kidney, liver, bone marrow, pancreas, prostate, stomach, and thyroid, has increased around the world. Looking at the United States, for instance, the average annual percent changes for kidney cancer was 3.6% in women and 4.1% in men and for multiple myeloma was 2% in women and 3% in men for 2002 to 2012.
This overall trend could reflect increased exposures to risk factors in early life and young adulthood, although “specific effects of individual exposures remain largely unknown,” the authors acknowledged.
Since the mid-20th century, substantial changes have occurred in diet, sleep, smoking, obesity, type 2 diabetes, and environmental exposures – all of which may influence the gut microbiome or interact with our genes to increase the incidence of early-onset cancers, the authors explained. For instance, obesity, smoking, and alcohol are all established risk factors for pancreatic cancer and have been linked with early-onset disease risk as well.
“Cancer is a multifactorial disease, and we are aware of the importance of genetics as a risk factor and screening for early detection, but this paper importantly brings to light the importance of correctable lifestyle habits that may slow the rise of early onset cancers,” oncologist Marleen Meyers, MD, director of the survivorship program at NYU Langone Perlmutter Cancer Center, who wasn’t involved in the review, said in an interview.
Although modifiable factors such as diet and exercise may ease the burden of these cancers, such changes are often difficult to implement, Dr. Meyers added. In addition, understanding the impact that certain factors, such as alcohol, obesity, physical activity, and delayed reproduction play in cancer risk requires more research to tease out, but “there is enough reason at this point to address these risk factors for both personal and public health benefits,” Dr. Meyers said.
Support for this research was provided in part by the U.S. National Institutes of Health, Cancer Research UK, Prevent Cancer Foundation, Japan Society for the Promotion of Science, and the Mishima Kaiun Memorial Foundation. Dr. Ugai, Dr. Ogino, and Dr. Meyers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to a recent review.
While the rising incidence of early-onset colorectal cancer (CRC) is a well-documented problem, the trend appears to extend far beyond CRC. The authors traced patterns of early-onset cancer diagnoses across 14 different cancer types, including breast, prostate, and thyroid, over the past 3 decades and found increases in many countries.
Among the 14 cancers explored, eight relate to the digestive system, which highlights the potential role diet and the oral and gut microbiome may play in cancer risk, the authors noted.
And many of the factors that appear to influence cancer risk – such as diet, exercise, sleep, and vaccination against HPV and other cancer-causing microorganisms – are modifiable.
“[Our] immediate goals should be to raise awareness of the early-onset cancer epidemic and reduce exposure to [these] risk factors,” authors Tomotaka Ugai, MD, PhD, and Shuji Ogino, MD, PhD, with Harvard School of Public Health, Boston, noted in a joint email.
The paper was published in Nature Reviews Clinical Oncology.
While the rise in cancer screenings has contributed to earlier detection of cancers, a genuine increase in the incidence of some early-onset cancers also appears to be happening.
In the current review, Dr. Ugai, Dr. Ogino, and colleagues reviewed the literature and mapped trends in the incidence of 14 cancer types among 20- to 49-year-old adults in 44 countries between 2002 and 2012.
The authors found that, since the 1990s, the incidence of early-onset cancers in the breast, colorectum, endometrium, esophagus, extrahepatic bile duct, gallbladder, head/neck, kidney, liver, bone marrow, pancreas, prostate, stomach, and thyroid, has increased around the world. Looking at the United States, for instance, the average annual percent changes for kidney cancer was 3.6% in women and 4.1% in men and for multiple myeloma was 2% in women and 3% in men for 2002 to 2012.
This overall trend could reflect increased exposures to risk factors in early life and young adulthood, although “specific effects of individual exposures remain largely unknown,” the authors acknowledged.
Since the mid-20th century, substantial changes have occurred in diet, sleep, smoking, obesity, type 2 diabetes, and environmental exposures – all of which may influence the gut microbiome or interact with our genes to increase the incidence of early-onset cancers, the authors explained. For instance, obesity, smoking, and alcohol are all established risk factors for pancreatic cancer and have been linked with early-onset disease risk as well.
“Cancer is a multifactorial disease, and we are aware of the importance of genetics as a risk factor and screening for early detection, but this paper importantly brings to light the importance of correctable lifestyle habits that may slow the rise of early onset cancers,” oncologist Marleen Meyers, MD, director of the survivorship program at NYU Langone Perlmutter Cancer Center, who wasn’t involved in the review, said in an interview.
Although modifiable factors such as diet and exercise may ease the burden of these cancers, such changes are often difficult to implement, Dr. Meyers added. In addition, understanding the impact that certain factors, such as alcohol, obesity, physical activity, and delayed reproduction play in cancer risk requires more research to tease out, but “there is enough reason at this point to address these risk factors for both personal and public health benefits,” Dr. Meyers said.
Support for this research was provided in part by the U.S. National Institutes of Health, Cancer Research UK, Prevent Cancer Foundation, Japan Society for the Promotion of Science, and the Mishima Kaiun Memorial Foundation. Dr. Ugai, Dr. Ogino, and Dr. Meyers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to a recent review.
While the rising incidence of early-onset colorectal cancer (CRC) is a well-documented problem, the trend appears to extend far beyond CRC. The authors traced patterns of early-onset cancer diagnoses across 14 different cancer types, including breast, prostate, and thyroid, over the past 3 decades and found increases in many countries.
Among the 14 cancers explored, eight relate to the digestive system, which highlights the potential role diet and the oral and gut microbiome may play in cancer risk, the authors noted.
And many of the factors that appear to influence cancer risk – such as diet, exercise, sleep, and vaccination against HPV and other cancer-causing microorganisms – are modifiable.
“[Our] immediate goals should be to raise awareness of the early-onset cancer epidemic and reduce exposure to [these] risk factors,” authors Tomotaka Ugai, MD, PhD, and Shuji Ogino, MD, PhD, with Harvard School of Public Health, Boston, noted in a joint email.
The paper was published in Nature Reviews Clinical Oncology.
While the rise in cancer screenings has contributed to earlier detection of cancers, a genuine increase in the incidence of some early-onset cancers also appears to be happening.
In the current review, Dr. Ugai, Dr. Ogino, and colleagues reviewed the literature and mapped trends in the incidence of 14 cancer types among 20- to 49-year-old adults in 44 countries between 2002 and 2012.
The authors found that, since the 1990s, the incidence of early-onset cancers in the breast, colorectum, endometrium, esophagus, extrahepatic bile duct, gallbladder, head/neck, kidney, liver, bone marrow, pancreas, prostate, stomach, and thyroid, has increased around the world. Looking at the United States, for instance, the average annual percent changes for kidney cancer was 3.6% in women and 4.1% in men and for multiple myeloma was 2% in women and 3% in men for 2002 to 2012.
This overall trend could reflect increased exposures to risk factors in early life and young adulthood, although “specific effects of individual exposures remain largely unknown,” the authors acknowledged.
Since the mid-20th century, substantial changes have occurred in diet, sleep, smoking, obesity, type 2 diabetes, and environmental exposures – all of which may influence the gut microbiome or interact with our genes to increase the incidence of early-onset cancers, the authors explained. For instance, obesity, smoking, and alcohol are all established risk factors for pancreatic cancer and have been linked with early-onset disease risk as well.
“Cancer is a multifactorial disease, and we are aware of the importance of genetics as a risk factor and screening for early detection, but this paper importantly brings to light the importance of correctable lifestyle habits that may slow the rise of early onset cancers,” oncologist Marleen Meyers, MD, director of the survivorship program at NYU Langone Perlmutter Cancer Center, who wasn’t involved in the review, said in an interview.
Although modifiable factors such as diet and exercise may ease the burden of these cancers, such changes are often difficult to implement, Dr. Meyers added. In addition, understanding the impact that certain factors, such as alcohol, obesity, physical activity, and delayed reproduction play in cancer risk requires more research to tease out, but “there is enough reason at this point to address these risk factors for both personal and public health benefits,” Dr. Meyers said.
Support for this research was provided in part by the U.S. National Institutes of Health, Cancer Research UK, Prevent Cancer Foundation, Japan Society for the Promotion of Science, and the Mishima Kaiun Memorial Foundation. Dr. Ugai, Dr. Ogino, and Dr. Meyers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Key Data on Early Non–Small Cell Lung Cancer From ESMO 2022
Dr Jack West of City of Hope Comprehensive Cancer Center in Duarte, California, discusses key presentations on early-stage non–small lung cancer (NSCLC) from the 2022 European Society for Medical Oncology Congress.
He begins by reporting on 2 years of additional follow-up from the ADAURA trial, which looked at osimertinib as adjuvant therapy in patients with resected EGFR-mutated disease. The results raise the question of whether the drug needs to be given indefinitely.
Next, he discusses an analysis of data from the ADAURA trial that looked at longitudinal monitoring of circulating tumor DNA (ctDNA) levels. This revealed that both baseline ctDNA and ctDNA clearance were predictive of later recurrence.
Dr West moves on to a large global study that demonstrated a clear link between air pollution and lung cancer. Pollution was shown to be a tumor promoter of rare driver mutations in normal lung tissue.
After discussing disappointing data from CANOPY-A indicating that adjuvant canakinumab does not improve survival outcomes, he closes with an examination of the PATHFINDER study. This involved more than 6600 patients who were screened for cancer after a single blood test. Although the study identified cancer in 1.4% of participants, the low positive predictive value raises questions over the wider application of this test.
--
Associate Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Care, Duarte, California; Medical Director, AccessHope, Los Angeles, California
Howard (Jack) West, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AstraZeneca; Eli Lilly; EQRx; Genentech/Roche; Merck; Mirati; Pfizer; Regeneron; Takeda
Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Merck
Dr Jack West of City of Hope Comprehensive Cancer Center in Duarte, California, discusses key presentations on early-stage non–small lung cancer (NSCLC) from the 2022 European Society for Medical Oncology Congress.
He begins by reporting on 2 years of additional follow-up from the ADAURA trial, which looked at osimertinib as adjuvant therapy in patients with resected EGFR-mutated disease. The results raise the question of whether the drug needs to be given indefinitely.
Next, he discusses an analysis of data from the ADAURA trial that looked at longitudinal monitoring of circulating tumor DNA (ctDNA) levels. This revealed that both baseline ctDNA and ctDNA clearance were predictive of later recurrence.
Dr West moves on to a large global study that demonstrated a clear link between air pollution and lung cancer. Pollution was shown to be a tumor promoter of rare driver mutations in normal lung tissue.
After discussing disappointing data from CANOPY-A indicating that adjuvant canakinumab does not improve survival outcomes, he closes with an examination of the PATHFINDER study. This involved more than 6600 patients who were screened for cancer after a single blood test. Although the study identified cancer in 1.4% of participants, the low positive predictive value raises questions over the wider application of this test.
--
Associate Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Care, Duarte, California; Medical Director, AccessHope, Los Angeles, California
Howard (Jack) West, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AstraZeneca; Eli Lilly; EQRx; Genentech/Roche; Merck; Mirati; Pfizer; Regeneron; Takeda
Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Merck
Dr Jack West of City of Hope Comprehensive Cancer Center in Duarte, California, discusses key presentations on early-stage non–small lung cancer (NSCLC) from the 2022 European Society for Medical Oncology Congress.
He begins by reporting on 2 years of additional follow-up from the ADAURA trial, which looked at osimertinib as adjuvant therapy in patients with resected EGFR-mutated disease. The results raise the question of whether the drug needs to be given indefinitely.
Next, he discusses an analysis of data from the ADAURA trial that looked at longitudinal monitoring of circulating tumor DNA (ctDNA) levels. This revealed that both baseline ctDNA and ctDNA clearance were predictive of later recurrence.
Dr West moves on to a large global study that demonstrated a clear link between air pollution and lung cancer. Pollution was shown to be a tumor promoter of rare driver mutations in normal lung tissue.
After discussing disappointing data from CANOPY-A indicating that adjuvant canakinumab does not improve survival outcomes, he closes with an examination of the PATHFINDER study. This involved more than 6600 patients who were screened for cancer after a single blood test. Although the study identified cancer in 1.4% of participants, the low positive predictive value raises questions over the wider application of this test.
--
Associate Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Care, Duarte, California; Medical Director, AccessHope, Los Angeles, California
Howard (Jack) West, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AstraZeneca; Eli Lilly; EQRx; Genentech/Roche; Merck; Mirati; Pfizer; Regeneron; Takeda
Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Merck
I am not fine: The heavy toll cancer takes
PARIS – “I thought I was as exhausted, and isolated, and neglected as I could get, and then he came home.”
Those were the words of Kate Washington, PhD, from Sacramento as she gave a moving account of the immense burden she felt as caregiver to her husband with cancer.
She was taking part in the session, “I am FINE: Frustrated * Isolated * Neglected * Emotional,” at the annual meeting of the European Society for Medical Oncology. In that session,
Dr. Washington, author of “Already Toast: Caregiving and Burnout in America” (Boston: Beacon Press, 2021), explained that she cared for her husband and young family while he was “suffering through two different kinds of lymphoma and really devastating stem cell transplants.”
When her husband was first diagnosed with a rare form of lymphoma in 2015, he was placed on a watch-and-wait protocol. At that point, he seemed fine, Dr. Washington said.
A few months later, he started coughing up blood. After being rushed to the emergency department, doctors found that a slow-growing lung tumor had ruptured.
Three weeks later, he came out of the hospital with a collapsed lung – an effect of his chemotherapy, Dr. Washington said.
But that was hardly the last word. He soon experienced relapse with a “very aggressive” form of his disease, and in 2016, he underwent a stem cell transplant.
“He spent 1½ months in the hospital ... in isolation, not seeing our daughters,” Dr. Washington said. He lost his vision and developed grade 4 graft-versus-host disease, among other problems.
He was alive, just barely, Dr. Washington said.
“As you might imagine, I was pulled between the hospital and the home, taking care of our daughters, who were not seeing him during that time,” she recalled.
But every time someone asked her whether she was okay, she replied: “I am fine.”
“A total lie,” she admitted.
Dr. Washington felt frustrated, not only from the financial strain of out-of-pocket health care costs and lost earnings but also from fast evolving relationships and a feeling of being “unseen and underappreciated.”
Another jarring change: When her husband was discharged from the hospital, Dr. Washington was suddenly thrust into the role of full-time caretaker.
Her husband could not be left alone, his doctor had said. And with two young children, Dr. Washington did not know how she would manage.
The demands of being a full-time caregiver are intense. Caregivers, Dr. Washington explained, can spend 32 hours a week looking after a loved one with cancer.
Like Dr. Washington, most caregivers feel they have no choice but to take on this intense role – one for which they have little or no training or preparation. The nonstop demands leave little time for self-care and can lead to high rates of caregiver injury and illness.
Isolation often creeps in because it can be “hard to ask for help,” she said. About 30% of caregivers report having depression or anxiety, and 21% feel lonely.
“When he was very ill, I found it really difficult to connect with other people and my friends,” Dr. Washington recalled. “I didn’t feel like I could really adequately explain the kind of strain that I was under.”
Are patients fine?
Like caregivers, patients often say they are fine when they are not.
The toll cancer takes on patients is immense. Natacha Bolanos Fernandez, from the Lymphoma Coalition Europe, highlighted the physical, mental, and social strain that can affect patients with cancer.
The physical aspects can encompass a host of problems – fatigue, night sweats, weight loss, and the vomiting that accompanies many cancer treatments. Patients may face changes in their mobility and independence as well. The mental side of cancer can include anxiety, depression, and psychological distress, while the social aspects span changing, perhaps strained, relationships with family and friends.
Fatigue, in particular, is an underreported, underdiagnosed, and undertreated problem, Ms. Fernandez noted. According to recent survey data from the Lymphoma Coalition’s Global Patient Survey, 72% of patients reported fatigue. This problem worsened over time, with 59% reporting fatigue after their diagnosis and up to 82% among patients who experienced relapse two or more times.
Fatigue “may be getting worse rather than better over time,” Ms. Fernandez said, and many patients felt that their life had changed completely because of cancer-related fatigue.
To help patients manage, the Lymphoma Coalition has published a report on the impact of cancer-related fatigue and how to improve outcomes. Methods include greater awareness, regular screening, and interventions such as yoga or mindfulness-based cognitive therapy.
Are clinicians fine?
Nurses and physicians face challenges caring for patients with cancer.
Although “nurses love their jobs and are extremely committed,” the impact cancer has on a nursing career is often undervalued or “neglected,” said Lena Sharp, RN, PhD, of the Regional Cancer Centre, Stockholm-Gotland.
Burnout, in particular, remains a problem among oncologists and nurses, and it was made worse during the COVID-19 pandemic.
Fatima Cardoso, MD, explained that burnout has an impact on doctors as well as patients because it affects communication with patients and performance. Physicians can, for instance, appear detached, emotional, or tired.
Patients may then feel less inclined to tell their oncologist how they’re feeling, said Dr. Cardoso, director of the breast unit at Champalimaud Clinical Center, Lisbon.
It is important to remember to not just focus on the patient’s disease or treatment but to also ask how they are doing and what is going on in their lives.
Above all, “show that you care,” said Dr. Cardoso.
The Lymphoma Coalition Europe has relationships with Bristol-Myers Squibb, Establishment Labs, Kyowa Kirin, Novartis, Roche, Takeda. Dr. Cardoso has relationships with Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, and other companies. No other relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
PARIS – “I thought I was as exhausted, and isolated, and neglected as I could get, and then he came home.”
Those were the words of Kate Washington, PhD, from Sacramento as she gave a moving account of the immense burden she felt as caregiver to her husband with cancer.
She was taking part in the session, “I am FINE: Frustrated * Isolated * Neglected * Emotional,” at the annual meeting of the European Society for Medical Oncology. In that session,
Dr. Washington, author of “Already Toast: Caregiving and Burnout in America” (Boston: Beacon Press, 2021), explained that she cared for her husband and young family while he was “suffering through two different kinds of lymphoma and really devastating stem cell transplants.”
When her husband was first diagnosed with a rare form of lymphoma in 2015, he was placed on a watch-and-wait protocol. At that point, he seemed fine, Dr. Washington said.
A few months later, he started coughing up blood. After being rushed to the emergency department, doctors found that a slow-growing lung tumor had ruptured.
Three weeks later, he came out of the hospital with a collapsed lung – an effect of his chemotherapy, Dr. Washington said.
But that was hardly the last word. He soon experienced relapse with a “very aggressive” form of his disease, and in 2016, he underwent a stem cell transplant.
“He spent 1½ months in the hospital ... in isolation, not seeing our daughters,” Dr. Washington said. He lost his vision and developed grade 4 graft-versus-host disease, among other problems.
He was alive, just barely, Dr. Washington said.
“As you might imagine, I was pulled between the hospital and the home, taking care of our daughters, who were not seeing him during that time,” she recalled.
But every time someone asked her whether she was okay, she replied: “I am fine.”
“A total lie,” she admitted.
Dr. Washington felt frustrated, not only from the financial strain of out-of-pocket health care costs and lost earnings but also from fast evolving relationships and a feeling of being “unseen and underappreciated.”
Another jarring change: When her husband was discharged from the hospital, Dr. Washington was suddenly thrust into the role of full-time caretaker.
Her husband could not be left alone, his doctor had said. And with two young children, Dr. Washington did not know how she would manage.
The demands of being a full-time caregiver are intense. Caregivers, Dr. Washington explained, can spend 32 hours a week looking after a loved one with cancer.
Like Dr. Washington, most caregivers feel they have no choice but to take on this intense role – one for which they have little or no training or preparation. The nonstop demands leave little time for self-care and can lead to high rates of caregiver injury and illness.
Isolation often creeps in because it can be “hard to ask for help,” she said. About 30% of caregivers report having depression or anxiety, and 21% feel lonely.
“When he was very ill, I found it really difficult to connect with other people and my friends,” Dr. Washington recalled. “I didn’t feel like I could really adequately explain the kind of strain that I was under.”
Are patients fine?
Like caregivers, patients often say they are fine when they are not.
The toll cancer takes on patients is immense. Natacha Bolanos Fernandez, from the Lymphoma Coalition Europe, highlighted the physical, mental, and social strain that can affect patients with cancer.
The physical aspects can encompass a host of problems – fatigue, night sweats, weight loss, and the vomiting that accompanies many cancer treatments. Patients may face changes in their mobility and independence as well. The mental side of cancer can include anxiety, depression, and psychological distress, while the social aspects span changing, perhaps strained, relationships with family and friends.
Fatigue, in particular, is an underreported, underdiagnosed, and undertreated problem, Ms. Fernandez noted. According to recent survey data from the Lymphoma Coalition’s Global Patient Survey, 72% of patients reported fatigue. This problem worsened over time, with 59% reporting fatigue after their diagnosis and up to 82% among patients who experienced relapse two or more times.
Fatigue “may be getting worse rather than better over time,” Ms. Fernandez said, and many patients felt that their life had changed completely because of cancer-related fatigue.
To help patients manage, the Lymphoma Coalition has published a report on the impact of cancer-related fatigue and how to improve outcomes. Methods include greater awareness, regular screening, and interventions such as yoga or mindfulness-based cognitive therapy.
Are clinicians fine?
Nurses and physicians face challenges caring for patients with cancer.
Although “nurses love their jobs and are extremely committed,” the impact cancer has on a nursing career is often undervalued or “neglected,” said Lena Sharp, RN, PhD, of the Regional Cancer Centre, Stockholm-Gotland.
Burnout, in particular, remains a problem among oncologists and nurses, and it was made worse during the COVID-19 pandemic.
Fatima Cardoso, MD, explained that burnout has an impact on doctors as well as patients because it affects communication with patients and performance. Physicians can, for instance, appear detached, emotional, or tired.
Patients may then feel less inclined to tell their oncologist how they’re feeling, said Dr. Cardoso, director of the breast unit at Champalimaud Clinical Center, Lisbon.
It is important to remember to not just focus on the patient’s disease or treatment but to also ask how they are doing and what is going on in their lives.
Above all, “show that you care,” said Dr. Cardoso.
The Lymphoma Coalition Europe has relationships with Bristol-Myers Squibb, Establishment Labs, Kyowa Kirin, Novartis, Roche, Takeda. Dr. Cardoso has relationships with Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, and other companies. No other relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
PARIS – “I thought I was as exhausted, and isolated, and neglected as I could get, and then he came home.”
Those were the words of Kate Washington, PhD, from Sacramento as she gave a moving account of the immense burden she felt as caregiver to her husband with cancer.
She was taking part in the session, “I am FINE: Frustrated * Isolated * Neglected * Emotional,” at the annual meeting of the European Society for Medical Oncology. In that session,
Dr. Washington, author of “Already Toast: Caregiving and Burnout in America” (Boston: Beacon Press, 2021), explained that she cared for her husband and young family while he was “suffering through two different kinds of lymphoma and really devastating stem cell transplants.”
When her husband was first diagnosed with a rare form of lymphoma in 2015, he was placed on a watch-and-wait protocol. At that point, he seemed fine, Dr. Washington said.
A few months later, he started coughing up blood. After being rushed to the emergency department, doctors found that a slow-growing lung tumor had ruptured.
Three weeks later, he came out of the hospital with a collapsed lung – an effect of his chemotherapy, Dr. Washington said.
But that was hardly the last word. He soon experienced relapse with a “very aggressive” form of his disease, and in 2016, he underwent a stem cell transplant.
“He spent 1½ months in the hospital ... in isolation, not seeing our daughters,” Dr. Washington said. He lost his vision and developed grade 4 graft-versus-host disease, among other problems.
He was alive, just barely, Dr. Washington said.
“As you might imagine, I was pulled between the hospital and the home, taking care of our daughters, who were not seeing him during that time,” she recalled.
But every time someone asked her whether she was okay, she replied: “I am fine.”
“A total lie,” she admitted.
Dr. Washington felt frustrated, not only from the financial strain of out-of-pocket health care costs and lost earnings but also from fast evolving relationships and a feeling of being “unseen and underappreciated.”
Another jarring change: When her husband was discharged from the hospital, Dr. Washington was suddenly thrust into the role of full-time caretaker.
Her husband could not be left alone, his doctor had said. And with two young children, Dr. Washington did not know how she would manage.
The demands of being a full-time caregiver are intense. Caregivers, Dr. Washington explained, can spend 32 hours a week looking after a loved one with cancer.
Like Dr. Washington, most caregivers feel they have no choice but to take on this intense role – one for which they have little or no training or preparation. The nonstop demands leave little time for self-care and can lead to high rates of caregiver injury and illness.
Isolation often creeps in because it can be “hard to ask for help,” she said. About 30% of caregivers report having depression or anxiety, and 21% feel lonely.
“When he was very ill, I found it really difficult to connect with other people and my friends,” Dr. Washington recalled. “I didn’t feel like I could really adequately explain the kind of strain that I was under.”
Are patients fine?
Like caregivers, patients often say they are fine when they are not.
The toll cancer takes on patients is immense. Natacha Bolanos Fernandez, from the Lymphoma Coalition Europe, highlighted the physical, mental, and social strain that can affect patients with cancer.
The physical aspects can encompass a host of problems – fatigue, night sweats, weight loss, and the vomiting that accompanies many cancer treatments. Patients may face changes in their mobility and independence as well. The mental side of cancer can include anxiety, depression, and psychological distress, while the social aspects span changing, perhaps strained, relationships with family and friends.
Fatigue, in particular, is an underreported, underdiagnosed, and undertreated problem, Ms. Fernandez noted. According to recent survey data from the Lymphoma Coalition’s Global Patient Survey, 72% of patients reported fatigue. This problem worsened over time, with 59% reporting fatigue after their diagnosis and up to 82% among patients who experienced relapse two or more times.
Fatigue “may be getting worse rather than better over time,” Ms. Fernandez said, and many patients felt that their life had changed completely because of cancer-related fatigue.
To help patients manage, the Lymphoma Coalition has published a report on the impact of cancer-related fatigue and how to improve outcomes. Methods include greater awareness, regular screening, and interventions such as yoga or mindfulness-based cognitive therapy.
Are clinicians fine?
Nurses and physicians face challenges caring for patients with cancer.
Although “nurses love their jobs and are extremely committed,” the impact cancer has on a nursing career is often undervalued or “neglected,” said Lena Sharp, RN, PhD, of the Regional Cancer Centre, Stockholm-Gotland.
Burnout, in particular, remains a problem among oncologists and nurses, and it was made worse during the COVID-19 pandemic.
Fatima Cardoso, MD, explained that burnout has an impact on doctors as well as patients because it affects communication with patients and performance. Physicians can, for instance, appear detached, emotional, or tired.
Patients may then feel less inclined to tell their oncologist how they’re feeling, said Dr. Cardoso, director of the breast unit at Champalimaud Clinical Center, Lisbon.
It is important to remember to not just focus on the patient’s disease or treatment but to also ask how they are doing and what is going on in their lives.
Above all, “show that you care,” said Dr. Cardoso.
The Lymphoma Coalition Europe has relationships with Bristol-Myers Squibb, Establishment Labs, Kyowa Kirin, Novartis, Roche, Takeda. Dr. Cardoso has relationships with Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, and other companies. No other relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
AT ESMO CONGRESS 2022
Supporting career development for women in gastroenterology
When I was in fellowship in the late 1990s, it was rare to see women at many of the big gastroenterology conferences. And in terms of presentations, there was maybe one session led by or for women at lunchtime. These conferences were the only events I had ever been to where the line for the men’s room was longer than the line for the women’s room.
Over the years, the lines for the women’s room have gotten longer, and the sessions led by female gastroenterologists have grown exponentially. However, women are still underrepresented in our field. Two out of five GI fellows are women, but women constitute less than 18% of practicing gastroenterologists. And the number of women in leadership positions is even lower.
Women in medicine face many challenges
According to a report in JAMA Network Open, women have lower starting salaries more than 90% of the time, which can create income disparities in earning potential throughout our entire careers.
Other studies suggest that female physicians also spend more time with patients and answering messages from patients and colleagues as well. This extra time, although it is done in small increments, adds up quickly and could suggest the pay gap between women and men is wider than we think.
Of course, female physicians still spend more time parenting children and doing household labor. A study found that female physicians spent 8.5 hours more per week on activities that support the family and household.
We’ve been discussing equity for women in medicine, and in the workplace, for decades. But events over the past several years – such as the killing of George Floyd and the formation of the #MeToo movement in response to workplace sexual harassment – have accelerated a paradigm shift in how organizations are focusing on diversity, equity, and inclusion (DEI) and creating cultures that support leadership development for women.
The Gastro Health Women’s Network
In 2020, the leadership of Gastro Health reiterated its commitment to fight discrimination and support equity by sending out a company-wide correspondence that encouraged us to be good stewards within our communities during these turbulent times.
This led to the development of the Gastro Health DEI Council and the Gastro Health Women’s Network, led by Dr. Asma Khapra and based on the framework developed by Dr. Dawn Sears. The programs developed by Dr. Sears are focused on facilitating authentic and supportive relationships, and they helped us create a network for women focused on recruitment, mentorship and retention, networking and social events, and leadership development.
Our network started with a meet & greet, inviting all women in Gastro Health to join a virtual call and get to know each other in an informal setting. This was a great way to introduce people to each other in our natural elements. It was wonderful to see how people are when they are at home and not working.
Recruiting female gastroenterologists
Even though about half of gastroenterology fellows choose independent GI, most fellowship programs don’t educate students about private practice careers or promote that path. In addition, a lot of the national GI conferences are geared toward the academic experience.
It’s incumbent on those of us in private practice to educate students about the benefits and challenges we face as members of independent GI groups, and Gastro Health set out to hold networking and recruitment events at different national conferences with GI fellows and residents.
We’re also working to develop partnerships with fellowship programs. This past year, we’ve held several educational dinners for fellows and residents. Most recently, Dr. Khapra and others took a road trip to New York for dinners with fellows from Mount Sinai, Westchester Medical Center, and the Albert Einstein College of Medicine.
While it was beneficial for Gastro Health to provide information about life as private practice gastroenterologists, it was also helpful for us to hear how the GI leaders of tomorrow are navigating their career choices and what is impacting their decisions about the future.
Mentorship and retention are vital to practice sustainability
Once you’ve recruited physicians to join your practice, how do you ensure their success? Many practices are rightly concerned about their long-term sustainability and are exploring ways to help early-career physicians maintain the clinical skills they need to treat patients and learn the business skills they need to succeed in private practice.
Sometimes it’s as simple as reaching out to new associates on the first day to let them know you’re glad they’ve joined the practice and to let them know you’re available if they need anything. But there’s also growing recognition that implementing a formal mentorship program can help people feel included and supported.
The Women’s Network worked to pair its members with Gastro Health partners as mentors, and we’ve learned some things along the way. Initially, we tried to pair people with similar lifestyles and interests. What we found is that while this sometimes works, we may have overcomplicated the process. We learned that sometimes people would prefer mentors who have backgrounds that are different from their own. We were reminded that mentorship has many faces, and letting those relationships develop naturally can sometimes be more effective.
Networking and social events deter isolation and keep people engaged
Private practice can be different from working within a hospital because oftentimes your colleagues are working in different offices or facilities. In the case of our organization, those offices may be in different states hundreds of miles away. Within a hospital, there might be more potential to interact with your colleagues, whether in clinical conferences or through a chance encounter in the cafeteria.
In private practice, you may need to be more intentional about creating opportunities for people to network and get to know each other outside of work. This year, we developed an email and WhatsApp group so that women throughout the network can connect with each other. We have used it to disseminate information about upcoming events, fellowship opportunities with the national GI societies, interesting articles, and anything important that we think other women within Gastro Health would like to know.
In March, Gastro Health sponsored five women to attend the Scrubs & Heels Summit, which was developed by Dr. Anita Afzali and Dr. Aline Charabaty to create opportunities for women in GI at different stages of their GI careers and help them succeed and achieve their professional goals. There were 2 days of educational talks, but it also included plenty of events for our colleagues to get to know each other and network with other amazing female GI leaders from across the nation.
Where’s the boardroom?
A recent study found that the percentage of women on the boards of the 1,000 largest public companies in America is a little more than 28%, even though research shows that S&P 500 companies headquartered in California with 30% or more women on their boards had 29% higher revenue.
We’re working to develop opportunities for women to be in leadership positions, within our practices and on the national stage in terms of representation, within our national GI societies. It’s very exciting that we have women in leadership within AGA and ASGE, and that Dr. Latha Alaparthi has made increasing the focus on leadership and pipeline development one of her main priorities as the president and board chair of the Digestive Health Physicians Association (DHPA).
Another way private practices can support women who are leaders is by making recommendations for committees within our national societies and by recognizing that time spent developing presentations and speaking at national conferences is beneficial to the practice in terms of thought leadership, branding, and recruitment of the next generation of practice leaders.
While we have a long way to go, we’re also making strides in the board room at the practice level. I’m the first woman, and notably a woman of color, to join the Gastro Health board of directors under the guidance of support of CEO Joseph Garcia. Dr. Aja McCutchen, who serves as the chair of the DHPA Diversity, Equity, and Inclusion committee, is similarly the first woman and woman of color on the board of directors for United Digestive in Atlanta.
What to look for in joining a practice
When determining which practice you might join, ask how committed the leadership of the organization is to supporting career development for women. Does the practice have a network, a committee or other internal group that supports female physicians? What steps does the practice leadership take to support women who are interested in executive opportunities?
If the practice does have an internal organization, how does it measure progress? For example, we’ve implemented focus groups to measure what is working and where we face the most challenges. Gastro Health partnered with a consultant to hold three confidential sessions with 10 women at a time. This will allow for us to collect depersonalized data that can be compiled into a report for the Gastro Health Board and leadership.
If you’re a woman who is considering a career in independent GI, seek out women in private practice and ask about their experiences. Ask about their path and what opportunities they sought out when starting their careers. They may know of some great opportunities that are available to build your leadership skills.
By creating a network for women, Gastro Health is hoping to make it easier to develop relationships and create productive partnerships. We are certain that working to address the specific challenges that female physicians face in their careers will strengthen our group, and ultimately independent gastroenterology overall.
Dr. Adams is a practicing gastroenterologist and partner at Gastro Health Fairfax in Virginia and serves on the Digestive Health Physicians Association’s Diversity, Equity, and Inclusion Committee. Dr. Adams has no conflicts to declare.
When I was in fellowship in the late 1990s, it was rare to see women at many of the big gastroenterology conferences. And in terms of presentations, there was maybe one session led by or for women at lunchtime. These conferences were the only events I had ever been to where the line for the men’s room was longer than the line for the women’s room.
Over the years, the lines for the women’s room have gotten longer, and the sessions led by female gastroenterologists have grown exponentially. However, women are still underrepresented in our field. Two out of five GI fellows are women, but women constitute less than 18% of practicing gastroenterologists. And the number of women in leadership positions is even lower.
Women in medicine face many challenges
According to a report in JAMA Network Open, women have lower starting salaries more than 90% of the time, which can create income disparities in earning potential throughout our entire careers.
Other studies suggest that female physicians also spend more time with patients and answering messages from patients and colleagues as well. This extra time, although it is done in small increments, adds up quickly and could suggest the pay gap between women and men is wider than we think.
Of course, female physicians still spend more time parenting children and doing household labor. A study found that female physicians spent 8.5 hours more per week on activities that support the family and household.
We’ve been discussing equity for women in medicine, and in the workplace, for decades. But events over the past several years – such as the killing of George Floyd and the formation of the #MeToo movement in response to workplace sexual harassment – have accelerated a paradigm shift in how organizations are focusing on diversity, equity, and inclusion (DEI) and creating cultures that support leadership development for women.
The Gastro Health Women’s Network
In 2020, the leadership of Gastro Health reiterated its commitment to fight discrimination and support equity by sending out a company-wide correspondence that encouraged us to be good stewards within our communities during these turbulent times.
This led to the development of the Gastro Health DEI Council and the Gastro Health Women’s Network, led by Dr. Asma Khapra and based on the framework developed by Dr. Dawn Sears. The programs developed by Dr. Sears are focused on facilitating authentic and supportive relationships, and they helped us create a network for women focused on recruitment, mentorship and retention, networking and social events, and leadership development.
Our network started with a meet & greet, inviting all women in Gastro Health to join a virtual call and get to know each other in an informal setting. This was a great way to introduce people to each other in our natural elements. It was wonderful to see how people are when they are at home and not working.
Recruiting female gastroenterologists
Even though about half of gastroenterology fellows choose independent GI, most fellowship programs don’t educate students about private practice careers or promote that path. In addition, a lot of the national GI conferences are geared toward the academic experience.
It’s incumbent on those of us in private practice to educate students about the benefits and challenges we face as members of independent GI groups, and Gastro Health set out to hold networking and recruitment events at different national conferences with GI fellows and residents.
We’re also working to develop partnerships with fellowship programs. This past year, we’ve held several educational dinners for fellows and residents. Most recently, Dr. Khapra and others took a road trip to New York for dinners with fellows from Mount Sinai, Westchester Medical Center, and the Albert Einstein College of Medicine.
While it was beneficial for Gastro Health to provide information about life as private practice gastroenterologists, it was also helpful for us to hear how the GI leaders of tomorrow are navigating their career choices and what is impacting their decisions about the future.
Mentorship and retention are vital to practice sustainability
Once you’ve recruited physicians to join your practice, how do you ensure their success? Many practices are rightly concerned about their long-term sustainability and are exploring ways to help early-career physicians maintain the clinical skills they need to treat patients and learn the business skills they need to succeed in private practice.
Sometimes it’s as simple as reaching out to new associates on the first day to let them know you’re glad they’ve joined the practice and to let them know you’re available if they need anything. But there’s also growing recognition that implementing a formal mentorship program can help people feel included and supported.
The Women’s Network worked to pair its members with Gastro Health partners as mentors, and we’ve learned some things along the way. Initially, we tried to pair people with similar lifestyles and interests. What we found is that while this sometimes works, we may have overcomplicated the process. We learned that sometimes people would prefer mentors who have backgrounds that are different from their own. We were reminded that mentorship has many faces, and letting those relationships develop naturally can sometimes be more effective.
Networking and social events deter isolation and keep people engaged
Private practice can be different from working within a hospital because oftentimes your colleagues are working in different offices or facilities. In the case of our organization, those offices may be in different states hundreds of miles away. Within a hospital, there might be more potential to interact with your colleagues, whether in clinical conferences or through a chance encounter in the cafeteria.
In private practice, you may need to be more intentional about creating opportunities for people to network and get to know each other outside of work. This year, we developed an email and WhatsApp group so that women throughout the network can connect with each other. We have used it to disseminate information about upcoming events, fellowship opportunities with the national GI societies, interesting articles, and anything important that we think other women within Gastro Health would like to know.
In March, Gastro Health sponsored five women to attend the Scrubs & Heels Summit, which was developed by Dr. Anita Afzali and Dr. Aline Charabaty to create opportunities for women in GI at different stages of their GI careers and help them succeed and achieve their professional goals. There were 2 days of educational talks, but it also included plenty of events for our colleagues to get to know each other and network with other amazing female GI leaders from across the nation.
Where’s the boardroom?
A recent study found that the percentage of women on the boards of the 1,000 largest public companies in America is a little more than 28%, even though research shows that S&P 500 companies headquartered in California with 30% or more women on their boards had 29% higher revenue.
We’re working to develop opportunities for women to be in leadership positions, within our practices and on the national stage in terms of representation, within our national GI societies. It’s very exciting that we have women in leadership within AGA and ASGE, and that Dr. Latha Alaparthi has made increasing the focus on leadership and pipeline development one of her main priorities as the president and board chair of the Digestive Health Physicians Association (DHPA).
Another way private practices can support women who are leaders is by making recommendations for committees within our national societies and by recognizing that time spent developing presentations and speaking at national conferences is beneficial to the practice in terms of thought leadership, branding, and recruitment of the next generation of practice leaders.
While we have a long way to go, we’re also making strides in the board room at the practice level. I’m the first woman, and notably a woman of color, to join the Gastro Health board of directors under the guidance of support of CEO Joseph Garcia. Dr. Aja McCutchen, who serves as the chair of the DHPA Diversity, Equity, and Inclusion committee, is similarly the first woman and woman of color on the board of directors for United Digestive in Atlanta.
What to look for in joining a practice
When determining which practice you might join, ask how committed the leadership of the organization is to supporting career development for women. Does the practice have a network, a committee or other internal group that supports female physicians? What steps does the practice leadership take to support women who are interested in executive opportunities?
If the practice does have an internal organization, how does it measure progress? For example, we’ve implemented focus groups to measure what is working and where we face the most challenges. Gastro Health partnered with a consultant to hold three confidential sessions with 10 women at a time. This will allow for us to collect depersonalized data that can be compiled into a report for the Gastro Health Board and leadership.
If you’re a woman who is considering a career in independent GI, seek out women in private practice and ask about their experiences. Ask about their path and what opportunities they sought out when starting their careers. They may know of some great opportunities that are available to build your leadership skills.
By creating a network for women, Gastro Health is hoping to make it easier to develop relationships and create productive partnerships. We are certain that working to address the specific challenges that female physicians face in their careers will strengthen our group, and ultimately independent gastroenterology overall.
Dr. Adams is a practicing gastroenterologist and partner at Gastro Health Fairfax in Virginia and serves on the Digestive Health Physicians Association’s Diversity, Equity, and Inclusion Committee. Dr. Adams has no conflicts to declare.
When I was in fellowship in the late 1990s, it was rare to see women at many of the big gastroenterology conferences. And in terms of presentations, there was maybe one session led by or for women at lunchtime. These conferences were the only events I had ever been to where the line for the men’s room was longer than the line for the women’s room.
Over the years, the lines for the women’s room have gotten longer, and the sessions led by female gastroenterologists have grown exponentially. However, women are still underrepresented in our field. Two out of five GI fellows are women, but women constitute less than 18% of practicing gastroenterologists. And the number of women in leadership positions is even lower.
Women in medicine face many challenges
According to a report in JAMA Network Open, women have lower starting salaries more than 90% of the time, which can create income disparities in earning potential throughout our entire careers.
Other studies suggest that female physicians also spend more time with patients and answering messages from patients and colleagues as well. This extra time, although it is done in small increments, adds up quickly and could suggest the pay gap between women and men is wider than we think.
Of course, female physicians still spend more time parenting children and doing household labor. A study found that female physicians spent 8.5 hours more per week on activities that support the family and household.
We’ve been discussing equity for women in medicine, and in the workplace, for decades. But events over the past several years – such as the killing of George Floyd and the formation of the #MeToo movement in response to workplace sexual harassment – have accelerated a paradigm shift in how organizations are focusing on diversity, equity, and inclusion (DEI) and creating cultures that support leadership development for women.
The Gastro Health Women’s Network
In 2020, the leadership of Gastro Health reiterated its commitment to fight discrimination and support equity by sending out a company-wide correspondence that encouraged us to be good stewards within our communities during these turbulent times.
This led to the development of the Gastro Health DEI Council and the Gastro Health Women’s Network, led by Dr. Asma Khapra and based on the framework developed by Dr. Dawn Sears. The programs developed by Dr. Sears are focused on facilitating authentic and supportive relationships, and they helped us create a network for women focused on recruitment, mentorship and retention, networking and social events, and leadership development.
Our network started with a meet & greet, inviting all women in Gastro Health to join a virtual call and get to know each other in an informal setting. This was a great way to introduce people to each other in our natural elements. It was wonderful to see how people are when they are at home and not working.
Recruiting female gastroenterologists
Even though about half of gastroenterology fellows choose independent GI, most fellowship programs don’t educate students about private practice careers or promote that path. In addition, a lot of the national GI conferences are geared toward the academic experience.
It’s incumbent on those of us in private practice to educate students about the benefits and challenges we face as members of independent GI groups, and Gastro Health set out to hold networking and recruitment events at different national conferences with GI fellows and residents.
We’re also working to develop partnerships with fellowship programs. This past year, we’ve held several educational dinners for fellows and residents. Most recently, Dr. Khapra and others took a road trip to New York for dinners with fellows from Mount Sinai, Westchester Medical Center, and the Albert Einstein College of Medicine.
While it was beneficial for Gastro Health to provide information about life as private practice gastroenterologists, it was also helpful for us to hear how the GI leaders of tomorrow are navigating their career choices and what is impacting their decisions about the future.
Mentorship and retention are vital to practice sustainability
Once you’ve recruited physicians to join your practice, how do you ensure their success? Many practices are rightly concerned about their long-term sustainability and are exploring ways to help early-career physicians maintain the clinical skills they need to treat patients and learn the business skills they need to succeed in private practice.
Sometimes it’s as simple as reaching out to new associates on the first day to let them know you’re glad they’ve joined the practice and to let them know you’re available if they need anything. But there’s also growing recognition that implementing a formal mentorship program can help people feel included and supported.
The Women’s Network worked to pair its members with Gastro Health partners as mentors, and we’ve learned some things along the way. Initially, we tried to pair people with similar lifestyles and interests. What we found is that while this sometimes works, we may have overcomplicated the process. We learned that sometimes people would prefer mentors who have backgrounds that are different from their own. We were reminded that mentorship has many faces, and letting those relationships develop naturally can sometimes be more effective.
Networking and social events deter isolation and keep people engaged
Private practice can be different from working within a hospital because oftentimes your colleagues are working in different offices or facilities. In the case of our organization, those offices may be in different states hundreds of miles away. Within a hospital, there might be more potential to interact with your colleagues, whether in clinical conferences or through a chance encounter in the cafeteria.
In private practice, you may need to be more intentional about creating opportunities for people to network and get to know each other outside of work. This year, we developed an email and WhatsApp group so that women throughout the network can connect with each other. We have used it to disseminate information about upcoming events, fellowship opportunities with the national GI societies, interesting articles, and anything important that we think other women within Gastro Health would like to know.
In March, Gastro Health sponsored five women to attend the Scrubs & Heels Summit, which was developed by Dr. Anita Afzali and Dr. Aline Charabaty to create opportunities for women in GI at different stages of their GI careers and help them succeed and achieve their professional goals. There were 2 days of educational talks, but it also included plenty of events for our colleagues to get to know each other and network with other amazing female GI leaders from across the nation.
Where’s the boardroom?
A recent study found that the percentage of women on the boards of the 1,000 largest public companies in America is a little more than 28%, even though research shows that S&P 500 companies headquartered in California with 30% or more women on their boards had 29% higher revenue.
We’re working to develop opportunities for women to be in leadership positions, within our practices and on the national stage in terms of representation, within our national GI societies. It’s very exciting that we have women in leadership within AGA and ASGE, and that Dr. Latha Alaparthi has made increasing the focus on leadership and pipeline development one of her main priorities as the president and board chair of the Digestive Health Physicians Association (DHPA).
Another way private practices can support women who are leaders is by making recommendations for committees within our national societies and by recognizing that time spent developing presentations and speaking at national conferences is beneficial to the practice in terms of thought leadership, branding, and recruitment of the next generation of practice leaders.
While we have a long way to go, we’re also making strides in the board room at the practice level. I’m the first woman, and notably a woman of color, to join the Gastro Health board of directors under the guidance of support of CEO Joseph Garcia. Dr. Aja McCutchen, who serves as the chair of the DHPA Diversity, Equity, and Inclusion committee, is similarly the first woman and woman of color on the board of directors for United Digestive in Atlanta.
What to look for in joining a practice
When determining which practice you might join, ask how committed the leadership of the organization is to supporting career development for women. Does the practice have a network, a committee or other internal group that supports female physicians? What steps does the practice leadership take to support women who are interested in executive opportunities?
If the practice does have an internal organization, how does it measure progress? For example, we’ve implemented focus groups to measure what is working and where we face the most challenges. Gastro Health partnered with a consultant to hold three confidential sessions with 10 women at a time. This will allow for us to collect depersonalized data that can be compiled into a report for the Gastro Health Board and leadership.
If you’re a woman who is considering a career in independent GI, seek out women in private practice and ask about their experiences. Ask about their path and what opportunities they sought out when starting their careers. They may know of some great opportunities that are available to build your leadership skills.
By creating a network for women, Gastro Health is hoping to make it easier to develop relationships and create productive partnerships. We are certain that working to address the specific challenges that female physicians face in their careers will strengthen our group, and ultimately independent gastroenterology overall.
Dr. Adams is a practicing gastroenterologist and partner at Gastro Health Fairfax in Virginia and serves on the Digestive Health Physicians Association’s Diversity, Equity, and Inclusion Committee. Dr. Adams has no conflicts to declare.
52-week data show lebrikizumab atopic dermatitis effects maintained
from the phase 3 ADvocate1 and ADvocate2 trials.
“We’re focused on the responders,” said Andrew Blauvelt, MD, MBA, as he presented the positive findings at the annual congress of the European Academy of Dermatology and Venereology.
Responders were the 291 people whose atopic dermatitis greatly improved after an initial 16 weeks’ treatment with lebrikizumab in both trials and who were then randomly allocated to receive injections every 2 weeks (Q2W, n = 113) or every 4 weeks (Q4W, n = 118), or to receive placebo injections Q2W (n = 60).
“Very interestingly, for me, the Q4W maintenance dosing was just as good as the Q2W maintenance dosing,” said Dr. Blauvelt, president of Oregon Medical Research Center, Portland.
“Another highlight of these data is that the patients who went on to placebo, about 50% of the patients maintained good responses, despite no treatment from week 16 to week 52,” he added.
Most patients did not require topical steroids, and “there were no surprises here” in terms of the safety profile. Lebrikizumab, a monoclonal antibody, binds to soluble interleukin-13 and blocks IL-13 signaling.
“So, the study really shows that specific targeting of IL-13 with lebrikizumab, either Q2W or Q4W, has high maintenance of efficacy and is reasonably tolerated and safe in adolescents and adults with atopic dermatitis,” Dr. Blauvelt concluded.
“We know now that IL-13 is a critical cytokine in AD [atopic dermatitis] pathogenesis. The unique features of this drug I want to highlight is that it has high binding affinity for IL-13,” he said.
“It has a slow dissociation off rate, meaning it binds IL-13 tightly, very potently, and stays blocking and stays hold of IL-13 in a strong manner,” he added. The drug has a half-life of 25 days.
These features could be very important for long-term dosing of the drug, he argued.
Lebrikizumab phase 3 trials
ADvocate1 and ADvocate2 are two of several phase 3 trials evaluating the efficacy and safety of lebrikizumab for the treatment of atopic dermatitis.
These include the completed ADhere study, in which lebrikizumab was used in combination with topical steroids and showed positive results in skin improvement and relief of pruritus.
The ADore study, an open-label trial in adolescents, is yet to report. The ongoing ADjoin study, a long-term extension study, is actively recruiting.
ADvocate1 and ADvocate2 are two identically designed – multicenter, randomized, double-blind, placebo-controlled, parallel-group – monotherapy trials that initially pitched two dosing regimens of lebrikizumab (250 mg) against placebo with a double loading dose at baseline and week 2 and then one dose every 2 weeks. The pair of trials enrolled a total of 869 adolescents and adults.
After the 16-week induction period, all patients in the lebrikizumab arm who had responded to treatment were rerandomly assigned to receive lebrikizumab 250 mg Q2W or Q4W, or placebo Q2W during a 36-week long-term maintenance treatment period.
This brought the total treatment time to 52 weeks for those whose atopic dermatitis had initially responded to lebrikizumab, explained Blauvelt.
Responders were those who, at 16 weeks, had an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a 2-point improvement or who had a 75% improvement in the Eczema Area and Severity Index score (EASI 75) without the need for rescue medication, compared with baseline values.
Induction and maintenance phase results
At the end of the 16-week induction period, a greater proportion of patients who had been treated with lebrikizumab than placebo met a primary outcome of IGA 0/1 in each trial (43.1% vs. 12.7% in ADvocate1 and 33.2% vs. 10.8% in ADvocate2).
A similar result was seen for another primary outcome, EASI 75 (58.8% vs. 16.2% and 52.1% vs. 18.1%) and for a secondary outcome, improvement in pruritus using a numerical rating scale (45.9% vs. 13.0% and 39.8% vs. 11.5%).
In the maintenance phase, with respect to responders, Dr. Blauvelt reported “very similar results” between the QW2 and Q4W maintenance dosing, “and still a quite high response in [half] the patients who were randomized to placebo at week 16.”
In the ADvocate1 and ADvocate2 trials, respectively, an IGA 0/1 with at least a 2-point improvement was maintained at week 52 in 75.8% and 64.6% of patients treated with the Q2W lebrikizumab dose, 74.2% and 80.6% of those treated with the Q4W dose, and 46.5% and 49.8% of those given placebo.
EASI 75 was maintained at week 52 in a respective 79.2% and 77.4% of patients treated with the Q2W dose, 79.2% and 84.7% with the Q4W dose, and 61.3% and 72.0% with placebo.
As for maintenance of at least a 4-point improvement in pruritus score, results at 52 weeks were 81.2% and 90.3% for the 2-week dose, 80.4% and 88.1% for the 4-week dose, and 65.4% and 67.6% for placebo.
Although topical corticosteroid treatment was allowed during the maintenance phase, only about 15% of patients needed this, Dr. Blauvelt said.
Different dosing results questioned
During the discussion period, one delegate highlighted that the twice-weekly maintenance dosing schedule seemed to “do worse a little bit” than the 4-week dosing, with both “close to placebo,” although “the long-term effect is already very impressive.”
Dr. Blauvelt noted that a pooled analysis had been done and that “it’s very clear that being on lebrikizumab works better than not being on lebrikizumab.
“Now, Q2W versus Q4W. We believe that this may be due to the long half-life of the drug possibly. It could be due to the slow disassociation rate, it’s binding tightly,” he suggested.
“We also could talk about disease modification, right. So, it opens up the concept of hit hard, hit early for 16 weeks, and then maybe you can modify disease over time,” Dr. Blauvelt said.
He added: “That’s highly speculative, of course.”
Short-term safety data
The 52-week safety profile of lebrikizumab is consistent with previously published data at 16 weeks, Dr. Blauvelt said. The most common adverse events during the studies included atopic dermatitis, nasopharyngitis, conjunctivitis, conjunctivitis allergic, headache, and COVID-19.
“This drug has comparable efficacy with dupilumab and tralokinumab,” said Jashin J. Wu, MD, from the Dermatology Research and Education Foundation in Irvine, Calif., in an interview. He was not involved in the study.
“As it does not have any significant advantages with less long-term safety data, I do not see a place for it in my practice,” Dr. Wu said.
Dupilumab (Dupixent) and tralokinumab (Adbry) are monoclonal antibodies that also block IL-13. Both are already licensed for treating atopic dermatitis. Dupilumab was approved by the Food and Drug Administration in 2017, and tralokinumab was approved in 2021.
The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and all countries outside Europe; European rights belong to Almirall for all dermatology indications, including atopic dermatitis. Dr. Blauvelt acts as an investigator and adviser to these companies as well as many other pharmaceutical companies that are involved in developing new dermatologic treatments. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.
A version of this article first appeared on Medscape.com.
from the phase 3 ADvocate1 and ADvocate2 trials.
“We’re focused on the responders,” said Andrew Blauvelt, MD, MBA, as he presented the positive findings at the annual congress of the European Academy of Dermatology and Venereology.
Responders were the 291 people whose atopic dermatitis greatly improved after an initial 16 weeks’ treatment with lebrikizumab in both trials and who were then randomly allocated to receive injections every 2 weeks (Q2W, n = 113) or every 4 weeks (Q4W, n = 118), or to receive placebo injections Q2W (n = 60).
“Very interestingly, for me, the Q4W maintenance dosing was just as good as the Q2W maintenance dosing,” said Dr. Blauvelt, president of Oregon Medical Research Center, Portland.
“Another highlight of these data is that the patients who went on to placebo, about 50% of the patients maintained good responses, despite no treatment from week 16 to week 52,” he added.
Most patients did not require topical steroids, and “there were no surprises here” in terms of the safety profile. Lebrikizumab, a monoclonal antibody, binds to soluble interleukin-13 and blocks IL-13 signaling.
“So, the study really shows that specific targeting of IL-13 with lebrikizumab, either Q2W or Q4W, has high maintenance of efficacy and is reasonably tolerated and safe in adolescents and adults with atopic dermatitis,” Dr. Blauvelt concluded.
“We know now that IL-13 is a critical cytokine in AD [atopic dermatitis] pathogenesis. The unique features of this drug I want to highlight is that it has high binding affinity for IL-13,” he said.
“It has a slow dissociation off rate, meaning it binds IL-13 tightly, very potently, and stays blocking and stays hold of IL-13 in a strong manner,” he added. The drug has a half-life of 25 days.
These features could be very important for long-term dosing of the drug, he argued.
Lebrikizumab phase 3 trials
ADvocate1 and ADvocate2 are two of several phase 3 trials evaluating the efficacy and safety of lebrikizumab for the treatment of atopic dermatitis.
These include the completed ADhere study, in which lebrikizumab was used in combination with topical steroids and showed positive results in skin improvement and relief of pruritus.
The ADore study, an open-label trial in adolescents, is yet to report. The ongoing ADjoin study, a long-term extension study, is actively recruiting.
ADvocate1 and ADvocate2 are two identically designed – multicenter, randomized, double-blind, placebo-controlled, parallel-group – monotherapy trials that initially pitched two dosing regimens of lebrikizumab (250 mg) against placebo with a double loading dose at baseline and week 2 and then one dose every 2 weeks. The pair of trials enrolled a total of 869 adolescents and adults.
After the 16-week induction period, all patients in the lebrikizumab arm who had responded to treatment were rerandomly assigned to receive lebrikizumab 250 mg Q2W or Q4W, or placebo Q2W during a 36-week long-term maintenance treatment period.
This brought the total treatment time to 52 weeks for those whose atopic dermatitis had initially responded to lebrikizumab, explained Blauvelt.
Responders were those who, at 16 weeks, had an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a 2-point improvement or who had a 75% improvement in the Eczema Area and Severity Index score (EASI 75) without the need for rescue medication, compared with baseline values.
Induction and maintenance phase results
At the end of the 16-week induction period, a greater proportion of patients who had been treated with lebrikizumab than placebo met a primary outcome of IGA 0/1 in each trial (43.1% vs. 12.7% in ADvocate1 and 33.2% vs. 10.8% in ADvocate2).
A similar result was seen for another primary outcome, EASI 75 (58.8% vs. 16.2% and 52.1% vs. 18.1%) and for a secondary outcome, improvement in pruritus using a numerical rating scale (45.9% vs. 13.0% and 39.8% vs. 11.5%).
In the maintenance phase, with respect to responders, Dr. Blauvelt reported “very similar results” between the QW2 and Q4W maintenance dosing, “and still a quite high response in [half] the patients who were randomized to placebo at week 16.”
In the ADvocate1 and ADvocate2 trials, respectively, an IGA 0/1 with at least a 2-point improvement was maintained at week 52 in 75.8% and 64.6% of patients treated with the Q2W lebrikizumab dose, 74.2% and 80.6% of those treated with the Q4W dose, and 46.5% and 49.8% of those given placebo.
EASI 75 was maintained at week 52 in a respective 79.2% and 77.4% of patients treated with the Q2W dose, 79.2% and 84.7% with the Q4W dose, and 61.3% and 72.0% with placebo.
As for maintenance of at least a 4-point improvement in pruritus score, results at 52 weeks were 81.2% and 90.3% for the 2-week dose, 80.4% and 88.1% for the 4-week dose, and 65.4% and 67.6% for placebo.
Although topical corticosteroid treatment was allowed during the maintenance phase, only about 15% of patients needed this, Dr. Blauvelt said.
Different dosing results questioned
During the discussion period, one delegate highlighted that the twice-weekly maintenance dosing schedule seemed to “do worse a little bit” than the 4-week dosing, with both “close to placebo,” although “the long-term effect is already very impressive.”
Dr. Blauvelt noted that a pooled analysis had been done and that “it’s very clear that being on lebrikizumab works better than not being on lebrikizumab.
“Now, Q2W versus Q4W. We believe that this may be due to the long half-life of the drug possibly. It could be due to the slow disassociation rate, it’s binding tightly,” he suggested.
“We also could talk about disease modification, right. So, it opens up the concept of hit hard, hit early for 16 weeks, and then maybe you can modify disease over time,” Dr. Blauvelt said.
He added: “That’s highly speculative, of course.”
Short-term safety data
The 52-week safety profile of lebrikizumab is consistent with previously published data at 16 weeks, Dr. Blauvelt said. The most common adverse events during the studies included atopic dermatitis, nasopharyngitis, conjunctivitis, conjunctivitis allergic, headache, and COVID-19.
“This drug has comparable efficacy with dupilumab and tralokinumab,” said Jashin J. Wu, MD, from the Dermatology Research and Education Foundation in Irvine, Calif., in an interview. He was not involved in the study.
“As it does not have any significant advantages with less long-term safety data, I do not see a place for it in my practice,” Dr. Wu said.
Dupilumab (Dupixent) and tralokinumab (Adbry) are monoclonal antibodies that also block IL-13. Both are already licensed for treating atopic dermatitis. Dupilumab was approved by the Food and Drug Administration in 2017, and tralokinumab was approved in 2021.
The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and all countries outside Europe; European rights belong to Almirall for all dermatology indications, including atopic dermatitis. Dr. Blauvelt acts as an investigator and adviser to these companies as well as many other pharmaceutical companies that are involved in developing new dermatologic treatments. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.
A version of this article first appeared on Medscape.com.
from the phase 3 ADvocate1 and ADvocate2 trials.
“We’re focused on the responders,” said Andrew Blauvelt, MD, MBA, as he presented the positive findings at the annual congress of the European Academy of Dermatology and Venereology.
Responders were the 291 people whose atopic dermatitis greatly improved after an initial 16 weeks’ treatment with lebrikizumab in both trials and who were then randomly allocated to receive injections every 2 weeks (Q2W, n = 113) or every 4 weeks (Q4W, n = 118), or to receive placebo injections Q2W (n = 60).
“Very interestingly, for me, the Q4W maintenance dosing was just as good as the Q2W maintenance dosing,” said Dr. Blauvelt, president of Oregon Medical Research Center, Portland.
“Another highlight of these data is that the patients who went on to placebo, about 50% of the patients maintained good responses, despite no treatment from week 16 to week 52,” he added.
Most patients did not require topical steroids, and “there were no surprises here” in terms of the safety profile. Lebrikizumab, a monoclonal antibody, binds to soluble interleukin-13 and blocks IL-13 signaling.
“So, the study really shows that specific targeting of IL-13 with lebrikizumab, either Q2W or Q4W, has high maintenance of efficacy and is reasonably tolerated and safe in adolescents and adults with atopic dermatitis,” Dr. Blauvelt concluded.
“We know now that IL-13 is a critical cytokine in AD [atopic dermatitis] pathogenesis. The unique features of this drug I want to highlight is that it has high binding affinity for IL-13,” he said.
“It has a slow dissociation off rate, meaning it binds IL-13 tightly, very potently, and stays blocking and stays hold of IL-13 in a strong manner,” he added. The drug has a half-life of 25 days.
These features could be very important for long-term dosing of the drug, he argued.
Lebrikizumab phase 3 trials
ADvocate1 and ADvocate2 are two of several phase 3 trials evaluating the efficacy and safety of lebrikizumab for the treatment of atopic dermatitis.
These include the completed ADhere study, in which lebrikizumab was used in combination with topical steroids and showed positive results in skin improvement and relief of pruritus.
The ADore study, an open-label trial in adolescents, is yet to report. The ongoing ADjoin study, a long-term extension study, is actively recruiting.
ADvocate1 and ADvocate2 are two identically designed – multicenter, randomized, double-blind, placebo-controlled, parallel-group – monotherapy trials that initially pitched two dosing regimens of lebrikizumab (250 mg) against placebo with a double loading dose at baseline and week 2 and then one dose every 2 weeks. The pair of trials enrolled a total of 869 adolescents and adults.
After the 16-week induction period, all patients in the lebrikizumab arm who had responded to treatment were rerandomly assigned to receive lebrikizumab 250 mg Q2W or Q4W, or placebo Q2W during a 36-week long-term maintenance treatment period.
This brought the total treatment time to 52 weeks for those whose atopic dermatitis had initially responded to lebrikizumab, explained Blauvelt.
Responders were those who, at 16 weeks, had an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a 2-point improvement or who had a 75% improvement in the Eczema Area and Severity Index score (EASI 75) without the need for rescue medication, compared with baseline values.
Induction and maintenance phase results
At the end of the 16-week induction period, a greater proportion of patients who had been treated with lebrikizumab than placebo met a primary outcome of IGA 0/1 in each trial (43.1% vs. 12.7% in ADvocate1 and 33.2% vs. 10.8% in ADvocate2).
A similar result was seen for another primary outcome, EASI 75 (58.8% vs. 16.2% and 52.1% vs. 18.1%) and for a secondary outcome, improvement in pruritus using a numerical rating scale (45.9% vs. 13.0% and 39.8% vs. 11.5%).
In the maintenance phase, with respect to responders, Dr. Blauvelt reported “very similar results” between the QW2 and Q4W maintenance dosing, “and still a quite high response in [half] the patients who were randomized to placebo at week 16.”
In the ADvocate1 and ADvocate2 trials, respectively, an IGA 0/1 with at least a 2-point improvement was maintained at week 52 in 75.8% and 64.6% of patients treated with the Q2W lebrikizumab dose, 74.2% and 80.6% of those treated with the Q4W dose, and 46.5% and 49.8% of those given placebo.
EASI 75 was maintained at week 52 in a respective 79.2% and 77.4% of patients treated with the Q2W dose, 79.2% and 84.7% with the Q4W dose, and 61.3% and 72.0% with placebo.
As for maintenance of at least a 4-point improvement in pruritus score, results at 52 weeks were 81.2% and 90.3% for the 2-week dose, 80.4% and 88.1% for the 4-week dose, and 65.4% and 67.6% for placebo.
Although topical corticosteroid treatment was allowed during the maintenance phase, only about 15% of patients needed this, Dr. Blauvelt said.
Different dosing results questioned
During the discussion period, one delegate highlighted that the twice-weekly maintenance dosing schedule seemed to “do worse a little bit” than the 4-week dosing, with both “close to placebo,” although “the long-term effect is already very impressive.”
Dr. Blauvelt noted that a pooled analysis had been done and that “it’s very clear that being on lebrikizumab works better than not being on lebrikizumab.
“Now, Q2W versus Q4W. We believe that this may be due to the long half-life of the drug possibly. It could be due to the slow disassociation rate, it’s binding tightly,” he suggested.
“We also could talk about disease modification, right. So, it opens up the concept of hit hard, hit early for 16 weeks, and then maybe you can modify disease over time,” Dr. Blauvelt said.
He added: “That’s highly speculative, of course.”
Short-term safety data
The 52-week safety profile of lebrikizumab is consistent with previously published data at 16 weeks, Dr. Blauvelt said. The most common adverse events during the studies included atopic dermatitis, nasopharyngitis, conjunctivitis, conjunctivitis allergic, headache, and COVID-19.
“This drug has comparable efficacy with dupilumab and tralokinumab,” said Jashin J. Wu, MD, from the Dermatology Research and Education Foundation in Irvine, Calif., in an interview. He was not involved in the study.
“As it does not have any significant advantages with less long-term safety data, I do not see a place for it in my practice,” Dr. Wu said.
Dupilumab (Dupixent) and tralokinumab (Adbry) are monoclonal antibodies that also block IL-13. Both are already licensed for treating atopic dermatitis. Dupilumab was approved by the Food and Drug Administration in 2017, and tralokinumab was approved in 2021.
The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and all countries outside Europe; European rights belong to Almirall for all dermatology indications, including atopic dermatitis. Dr. Blauvelt acts as an investigator and adviser to these companies as well as many other pharmaceutical companies that are involved in developing new dermatologic treatments. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.
A version of this article first appeared on Medscape.com.
FROM THE EADV CONGRESS
Ruxolitinib repigments many vitiligo-affected body areas
.
Those difficult areas include the hands and feet, said Thierry Passeron, MD, PhD, of Université Côte d’Azur and Centre Hospitalier Universitaire de Nice (France).
Indeed, a 50% or greater improvement in the Vitiligo Area Scoring Index (VASI-50) of the hands and feet was achieved with ruxolitinib cream (Opzelura) in around one-third of patients after 52 weeks’ treatment, and more than half of patients showed improvement in the upper and lower extremities.
During one of the late-breaking news sessions, Dr. Passeron presented a pooled analysis of the Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1) and Study 2 (TruE-V2), which assessed VASI-50 data by body regions.
Similarly positive results were seen on the head and neck and the trunk, with VASI-50 being reached in a respective 68% and 48% of patients after a full year of treatment.
“VASI-50 response rates rose steadily through 52 weeks for both the head and trunk,” said Dr. Passeron. He noted that the trials were initially double-blinded for 24 weeks and that there was a further open-label extension phase through week 52.
In the latter phase, all patients were treated with ruxolitinib; those who originally received a vehicle agent as placebo crossed over to the active treatment.
First FDA-approved treatment for adults and adolescents with vitiligo
Ruxolitinib is a Janus kinase 1/2 inhibitor that has been available for the treatment for atopic dermatitis for more than a year. It was recently approved by the U.S. Food and Drug Administration for the treatment of vitiligo in adults and pediatric patients aged 12 years and older.
This approval was based on the positive findings of the TRuE-V1 and TRuE-V2 studies, which showed that after 24 weeks, 30% of patients treated with ruxolitinib had at least 75% improvement in the facial VASI, compared with 10% of placebo-treated patients.
“These studies demonstrated very nice results, especially on the face, which is the easiest part to repigment in vitiligo,” Dr. Passeron said.
“We know that the location is very important when it comes to repigmentation of vitiligo,” he added. He noted that other body areas, “the extremities, for example, are much more difficult.”
The analysis he presented specifically assessed the effect of ruxolitinib cream on repigmentation in other areas.
Pooled analysis performed
Data from the two TRuE-V trials were pooled. The new analysis included a total of 661 individuals; of those patients, 443 had been treated with topical ruxolitinib, and 218 had received a vehicle cream as a placebo.
For the first 24 weeks, patients received twice-daily 1.5% ruxolitinib cream or vehicle cream. This was followed by a 28-week extension phase in which everyone was treated with ruxolitinib cream, after which there was a 30-day final follow-up period.
Dr. Passeron reported data by body region for weeks 12, 24, and 52, which showed an increasing percentage of patients with VASI-50.
“We didn’t look at the face; that we know well, that is a very good result,” he said.
The best results were seen for the head and neck. VASI-50 was reached by 28.3%, 45.3%, and 68.1% of patients treated with ruxolitinib cream at weeks 12, 24, and 52, respectively. Corresponding rates for the placebo-crossover group were 19.8%, 23.8%, and 51%.
Repigmentation rates of the hand, upper extremities, trunk, lower extremities, and feet were about 9%-15% for both ruxolitinib and placebo at 12 weeks, but by 24 weeks, there was a clear increase in repigmentation rates in the ruxolitinib group for all body areas.
The 24-week VASI-50 rates for hand repigmentation were 24.9% for ruxolitinib cream and 14.4% for placebo. Corresponding rates for upper extremity repigmentation were 33.2% and 8.2%; for the trunk, 26.4% and 12.2%; for the lower extremities, 29.5% and 12.2%; and for the feet, 18.5% and 12.5%.
“The results are quite poor at 12 weeks,” Dr. Passeron said. “It’s very important to keep this in mind; it takes time to repigment vitiligo, it takes to 6-24 months. We have to explain to our patients that they will have to wait to see the results.”
Steady improvements, no new safety concerns
Regarding VASI-50 over time, there was a steady increase in total body scores; 47.7% of patients who received ruxolitinib and 23.3% of placebo-treated patients hit this target at 52 weeks.
“And what is also very important to see is that we didn’t reach the plateau,” Dr. Passeron reported.
Similar patterns were seen for all the other body areas. Again there was a suggestion that rates may continue to rise with continued long-term treatment.
“About one-third of the patients reached at least 50% repigmentation after 1 year of treatment in the hands and feet,” Dr. Passeron said. He noted that certain areas, such as the back of the hand or tips of the fingers, may be unresponsive.
“So, we have to also to warn the patient that probably on these areas we have to combine it with other treatment because it remains very, very difficult to treat.”
There were no new safety concerns regarding treatment-emergent adverse events, which were reported in 52% of patients who received ruxolitinib and in 36% of placebo-treated patients.
The most common adverse reactions included COVID-19 (6.1% vs. 3.1%), acne at the application site (5.3% vs. 1.3%), and pruritus at the application site (3.9% vs. 2.7%), although cases were “mild or moderate,” said Dr. Passeron.
An expert’s take-home
“The results of TRuE-V phase 3 studies are encouraging and exciting,” Viktoria Eleftheriadou, MD, MRCP(UK), SCE(Derm), PhD, said in providing an independent comment for this news organization.
“Although ruxolitinib cream is applied on the skin, this novel treatment for vitiligo is not without risks; therefore, careful monitoring of patients who are started on this topical treatment would be prudent,” said Dr. Eleftheriadou, who is a consultant dermatologist for Walsall Healthcare NHS Trust and the Royal Wolverhampton NHS Trust, Birmingham, United Kingdom.
“I would like to see how many patients achieved VASI-75 or VASI-80 score, which from patients’ perspectives is a more meaningful outcome, as well as how long these results will last for,” she added.
The study was funded by Incyte Corporation. Dr. Passeron has received grants, honoraria, or both from AbbVie, ACM Pharma, Almirall, Amgen, Astellas, Bristol-Myers Squibb, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte Corporation, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, Sun Pharmaceuticals, and UCB. Dr. Passeron is the cofounder of YUKIN Therapeutics and has patents on WNT agonists or GSK2b antagonist for repigmentation of vitiligo and on the use of CXCR3B blockers in vitiligo. Dr. Eleftheriadou is an investigator and trial development group member on the HI-Light Vitiligo Trial (specific), a lead investigator on the pilot HI-Light Vitiligo Trial, and a medical advisory panel member of the Vitiligo Society UK. Dr. Eleftheriadou also provides consultancy services to Incyte and Pfizer.
A version of this article first appeared on Medscape.com.
.
Those difficult areas include the hands and feet, said Thierry Passeron, MD, PhD, of Université Côte d’Azur and Centre Hospitalier Universitaire de Nice (France).
Indeed, a 50% or greater improvement in the Vitiligo Area Scoring Index (VASI-50) of the hands and feet was achieved with ruxolitinib cream (Opzelura) in around one-third of patients after 52 weeks’ treatment, and more than half of patients showed improvement in the upper and lower extremities.
During one of the late-breaking news sessions, Dr. Passeron presented a pooled analysis of the Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1) and Study 2 (TruE-V2), which assessed VASI-50 data by body regions.
Similarly positive results were seen on the head and neck and the trunk, with VASI-50 being reached in a respective 68% and 48% of patients after a full year of treatment.
“VASI-50 response rates rose steadily through 52 weeks for both the head and trunk,” said Dr. Passeron. He noted that the trials were initially double-blinded for 24 weeks and that there was a further open-label extension phase through week 52.
In the latter phase, all patients were treated with ruxolitinib; those who originally received a vehicle agent as placebo crossed over to the active treatment.
First FDA-approved treatment for adults and adolescents with vitiligo
Ruxolitinib is a Janus kinase 1/2 inhibitor that has been available for the treatment for atopic dermatitis for more than a year. It was recently approved by the U.S. Food and Drug Administration for the treatment of vitiligo in adults and pediatric patients aged 12 years and older.
This approval was based on the positive findings of the TRuE-V1 and TRuE-V2 studies, which showed that after 24 weeks, 30% of patients treated with ruxolitinib had at least 75% improvement in the facial VASI, compared with 10% of placebo-treated patients.
“These studies demonstrated very nice results, especially on the face, which is the easiest part to repigment in vitiligo,” Dr. Passeron said.
“We know that the location is very important when it comes to repigmentation of vitiligo,” he added. He noted that other body areas, “the extremities, for example, are much more difficult.”
The analysis he presented specifically assessed the effect of ruxolitinib cream on repigmentation in other areas.
Pooled analysis performed
Data from the two TRuE-V trials were pooled. The new analysis included a total of 661 individuals; of those patients, 443 had been treated with topical ruxolitinib, and 218 had received a vehicle cream as a placebo.
For the first 24 weeks, patients received twice-daily 1.5% ruxolitinib cream or vehicle cream. This was followed by a 28-week extension phase in which everyone was treated with ruxolitinib cream, after which there was a 30-day final follow-up period.
Dr. Passeron reported data by body region for weeks 12, 24, and 52, which showed an increasing percentage of patients with VASI-50.
“We didn’t look at the face; that we know well, that is a very good result,” he said.
The best results were seen for the head and neck. VASI-50 was reached by 28.3%, 45.3%, and 68.1% of patients treated with ruxolitinib cream at weeks 12, 24, and 52, respectively. Corresponding rates for the placebo-crossover group were 19.8%, 23.8%, and 51%.
Repigmentation rates of the hand, upper extremities, trunk, lower extremities, and feet were about 9%-15% for both ruxolitinib and placebo at 12 weeks, but by 24 weeks, there was a clear increase in repigmentation rates in the ruxolitinib group for all body areas.
The 24-week VASI-50 rates for hand repigmentation were 24.9% for ruxolitinib cream and 14.4% for placebo. Corresponding rates for upper extremity repigmentation were 33.2% and 8.2%; for the trunk, 26.4% and 12.2%; for the lower extremities, 29.5% and 12.2%; and for the feet, 18.5% and 12.5%.
“The results are quite poor at 12 weeks,” Dr. Passeron said. “It’s very important to keep this in mind; it takes time to repigment vitiligo, it takes to 6-24 months. We have to explain to our patients that they will have to wait to see the results.”
Steady improvements, no new safety concerns
Regarding VASI-50 over time, there was a steady increase in total body scores; 47.7% of patients who received ruxolitinib and 23.3% of placebo-treated patients hit this target at 52 weeks.
“And what is also very important to see is that we didn’t reach the plateau,” Dr. Passeron reported.
Similar patterns were seen for all the other body areas. Again there was a suggestion that rates may continue to rise with continued long-term treatment.
“About one-third of the patients reached at least 50% repigmentation after 1 year of treatment in the hands and feet,” Dr. Passeron said. He noted that certain areas, such as the back of the hand or tips of the fingers, may be unresponsive.
“So, we have to also to warn the patient that probably on these areas we have to combine it with other treatment because it remains very, very difficult to treat.”
There were no new safety concerns regarding treatment-emergent adverse events, which were reported in 52% of patients who received ruxolitinib and in 36% of placebo-treated patients.
The most common adverse reactions included COVID-19 (6.1% vs. 3.1%), acne at the application site (5.3% vs. 1.3%), and pruritus at the application site (3.9% vs. 2.7%), although cases were “mild or moderate,” said Dr. Passeron.
An expert’s take-home
“The results of TRuE-V phase 3 studies are encouraging and exciting,” Viktoria Eleftheriadou, MD, MRCP(UK), SCE(Derm), PhD, said in providing an independent comment for this news organization.
“Although ruxolitinib cream is applied on the skin, this novel treatment for vitiligo is not without risks; therefore, careful monitoring of patients who are started on this topical treatment would be prudent,” said Dr. Eleftheriadou, who is a consultant dermatologist for Walsall Healthcare NHS Trust and the Royal Wolverhampton NHS Trust, Birmingham, United Kingdom.
“I would like to see how many patients achieved VASI-75 or VASI-80 score, which from patients’ perspectives is a more meaningful outcome, as well as how long these results will last for,” she added.
The study was funded by Incyte Corporation. Dr. Passeron has received grants, honoraria, or both from AbbVie, ACM Pharma, Almirall, Amgen, Astellas, Bristol-Myers Squibb, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte Corporation, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, Sun Pharmaceuticals, and UCB. Dr. Passeron is the cofounder of YUKIN Therapeutics and has patents on WNT agonists or GSK2b antagonist for repigmentation of vitiligo and on the use of CXCR3B blockers in vitiligo. Dr. Eleftheriadou is an investigator and trial development group member on the HI-Light Vitiligo Trial (specific), a lead investigator on the pilot HI-Light Vitiligo Trial, and a medical advisory panel member of the Vitiligo Society UK. Dr. Eleftheriadou also provides consultancy services to Incyte and Pfizer.
A version of this article first appeared on Medscape.com.
.
Those difficult areas include the hands and feet, said Thierry Passeron, MD, PhD, of Université Côte d’Azur and Centre Hospitalier Universitaire de Nice (France).
Indeed, a 50% or greater improvement in the Vitiligo Area Scoring Index (VASI-50) of the hands and feet was achieved with ruxolitinib cream (Opzelura) in around one-third of patients after 52 weeks’ treatment, and more than half of patients showed improvement in the upper and lower extremities.
During one of the late-breaking news sessions, Dr. Passeron presented a pooled analysis of the Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1) and Study 2 (TruE-V2), which assessed VASI-50 data by body regions.
Similarly positive results were seen on the head and neck and the trunk, with VASI-50 being reached in a respective 68% and 48% of patients after a full year of treatment.
“VASI-50 response rates rose steadily through 52 weeks for both the head and trunk,” said Dr. Passeron. He noted that the trials were initially double-blinded for 24 weeks and that there was a further open-label extension phase through week 52.
In the latter phase, all patients were treated with ruxolitinib; those who originally received a vehicle agent as placebo crossed over to the active treatment.
First FDA-approved treatment for adults and adolescents with vitiligo
Ruxolitinib is a Janus kinase 1/2 inhibitor that has been available for the treatment for atopic dermatitis for more than a year. It was recently approved by the U.S. Food and Drug Administration for the treatment of vitiligo in adults and pediatric patients aged 12 years and older.
This approval was based on the positive findings of the TRuE-V1 and TRuE-V2 studies, which showed that after 24 weeks, 30% of patients treated with ruxolitinib had at least 75% improvement in the facial VASI, compared with 10% of placebo-treated patients.
“These studies demonstrated very nice results, especially on the face, which is the easiest part to repigment in vitiligo,” Dr. Passeron said.
“We know that the location is very important when it comes to repigmentation of vitiligo,” he added. He noted that other body areas, “the extremities, for example, are much more difficult.”
The analysis he presented specifically assessed the effect of ruxolitinib cream on repigmentation in other areas.
Pooled analysis performed
Data from the two TRuE-V trials were pooled. The new analysis included a total of 661 individuals; of those patients, 443 had been treated with topical ruxolitinib, and 218 had received a vehicle cream as a placebo.
For the first 24 weeks, patients received twice-daily 1.5% ruxolitinib cream or vehicle cream. This was followed by a 28-week extension phase in which everyone was treated with ruxolitinib cream, after which there was a 30-day final follow-up period.
Dr. Passeron reported data by body region for weeks 12, 24, and 52, which showed an increasing percentage of patients with VASI-50.
“We didn’t look at the face; that we know well, that is a very good result,” he said.
The best results were seen for the head and neck. VASI-50 was reached by 28.3%, 45.3%, and 68.1% of patients treated with ruxolitinib cream at weeks 12, 24, and 52, respectively. Corresponding rates for the placebo-crossover group were 19.8%, 23.8%, and 51%.
Repigmentation rates of the hand, upper extremities, trunk, lower extremities, and feet were about 9%-15% for both ruxolitinib and placebo at 12 weeks, but by 24 weeks, there was a clear increase in repigmentation rates in the ruxolitinib group for all body areas.
The 24-week VASI-50 rates for hand repigmentation were 24.9% for ruxolitinib cream and 14.4% for placebo. Corresponding rates for upper extremity repigmentation were 33.2% and 8.2%; for the trunk, 26.4% and 12.2%; for the lower extremities, 29.5% and 12.2%; and for the feet, 18.5% and 12.5%.
“The results are quite poor at 12 weeks,” Dr. Passeron said. “It’s very important to keep this in mind; it takes time to repigment vitiligo, it takes to 6-24 months. We have to explain to our patients that they will have to wait to see the results.”
Steady improvements, no new safety concerns
Regarding VASI-50 over time, there was a steady increase in total body scores; 47.7% of patients who received ruxolitinib and 23.3% of placebo-treated patients hit this target at 52 weeks.
“And what is also very important to see is that we didn’t reach the plateau,” Dr. Passeron reported.
Similar patterns were seen for all the other body areas. Again there was a suggestion that rates may continue to rise with continued long-term treatment.
“About one-third of the patients reached at least 50% repigmentation after 1 year of treatment in the hands and feet,” Dr. Passeron said. He noted that certain areas, such as the back of the hand or tips of the fingers, may be unresponsive.
“So, we have to also to warn the patient that probably on these areas we have to combine it with other treatment because it remains very, very difficult to treat.”
There were no new safety concerns regarding treatment-emergent adverse events, which were reported in 52% of patients who received ruxolitinib and in 36% of placebo-treated patients.
The most common adverse reactions included COVID-19 (6.1% vs. 3.1%), acne at the application site (5.3% vs. 1.3%), and pruritus at the application site (3.9% vs. 2.7%), although cases were “mild or moderate,” said Dr. Passeron.
An expert’s take-home
“The results of TRuE-V phase 3 studies are encouraging and exciting,” Viktoria Eleftheriadou, MD, MRCP(UK), SCE(Derm), PhD, said in providing an independent comment for this news organization.
“Although ruxolitinib cream is applied on the skin, this novel treatment for vitiligo is not without risks; therefore, careful monitoring of patients who are started on this topical treatment would be prudent,” said Dr. Eleftheriadou, who is a consultant dermatologist for Walsall Healthcare NHS Trust and the Royal Wolverhampton NHS Trust, Birmingham, United Kingdom.
“I would like to see how many patients achieved VASI-75 or VASI-80 score, which from patients’ perspectives is a more meaningful outcome, as well as how long these results will last for,” she added.
The study was funded by Incyte Corporation. Dr. Passeron has received grants, honoraria, or both from AbbVie, ACM Pharma, Almirall, Amgen, Astellas, Bristol-Myers Squibb, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte Corporation, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, Sun Pharmaceuticals, and UCB. Dr. Passeron is the cofounder of YUKIN Therapeutics and has patents on WNT agonists or GSK2b antagonist for repigmentation of vitiligo and on the use of CXCR3B blockers in vitiligo. Dr. Eleftheriadou is an investigator and trial development group member on the HI-Light Vitiligo Trial (specific), a lead investigator on the pilot HI-Light Vitiligo Trial, and a medical advisory panel member of the Vitiligo Society UK. Dr. Eleftheriadou also provides consultancy services to Incyte and Pfizer.
A version of this article first appeared on Medscape.com.
FROM THE EADV CONGRESS
Childhood peanut allergy linked with other legume allergies
French children with peanut allergy tend to have reactions to other legumes, including soy, lentil, pea, bean, lupin, and fenugreek, and those other allergies often lead to anaphylactic reactions, a retrospective study from France reports.
“Among children allergic to peanut, at least two-thirds were sensitized to one other legume, and legume allergy was diagnosed in one-quarter of the sensitized patients,” wrote senior study author Amandine Divaret-Chauveau, MD, of Centre Hospitalier Universitaire de Nancy, Vandoeuvre-les-Nancy, and colleagues. The report is in Pediatric Allergy and Immunology.
People worldwide are eating more legumes these days, the authors noted. High in protein, low in unsaturated fats, with low production costs, legumes are important components of increasingly vegetarian, healthy, sustainable diets.
Food allergens are the most common childhood triggers of allergic reactions. Among children in France, legumes cause 14.6% of food-related anaphylactic reactions, with peanut as the main allergen, they added.
Dr. Divaret-Chauveau and colleagues assessed the prevalence and relevance of sensitization to legumes among all children and adolescents aged 1-17 years who had peanut allergy and had been admitted to one academic pediatric allergy department over roughly 3 years, beginning in early 2017. For the 195 study participants, peanut allergy had been confirmed, and they had been documented to have consumed or to have sensitization to at least one non-peanut legume; 69.7% were boys.
The researchers analyzed data on consumption history, skin prick tests, specific immunoglobulin E status, prior allergic reactions, and oral food challenges for each legume. They found the following:
- Among the 195 children with peanut allergy, 98.4% had at least one other atopic disease.
- Of the 195 children with peanut allergy, 122 (63.9%) were sensitized to at least one other legume. Of these 122 children, 66.3% were sensitized to fenugreek, 42.2% to lentil, 39.9% to soy, and 34.2% to lupin.
- Allergy to one or more legumes was confirmed for 27.9% of the 122 sensitized children, including 4.9% who had multiple legume allergies. Lentil, lupin, and pea were the main allergens.
- Of the 118 children also having a non-legume food allergy, the main food allergens were egg (57.6%), cow’s milk (33.0%), cashew (39.0%), pistachio (23.7%), and hazelnut (30.5%).
- Fifty percent of allergic reactions to non-peanut legumes were severe, often showing as asthma. Atopic comorbidities, including asthma, in most participants may have contributed to the severity of allergic reactions, the authors noted.
Allergy awareness needs to grow with plant-based diets
“The high prevalence of legume sensitization reported in our study highlights the need to explore legume consumption in children with PA [peanut allergy], and the need to investigate sensitization in the absence of consumption,” they added.
Jodi A. Shroba, MSN, APRN, CPNP, coordinator for the Food Allergy Program at Children’s Mercy Kansas City, in Missouri, told this news organization that few data are available in the literature regarding allergies to legumes other than peanut.
“It was interesting that these authors found such a high legume sensitization in their peanut-allergic patients,” Ms. Shroba, who was not involved in the study, said by email. “As more people are starting to eat plant-based diets, it is important that we better understand their allergenicity and cross-reactivity so we can better help guide patient management and education.”
Deborah Albright, MD, assistant professor of pediatrics at the University of Pittsburgh, agreed.
“As plant-based protein consumption broadens worldwide, awareness of the potential for cross-reactivity and co-allergy amongst legumes will become increasingly important,” she said by email.
“However, positive allergy tests do not reliably correlate with true food allergy; therefore, the diagnosis of legume co-allergy should be confirmed by the individual patient’s history, a formal food challenge, or both,” advised Dr. Albright. She was not involved in the study.
“Cross-sensitization to other legumes in patients with a single legume allergy is common; however, true clinical reactivity is often not present,” she added. “Also, legume allergy test sensitization rates and objective reactivity on food challenge can vary by region, depending on diet and pollen aeroallergen exposure.
“Systematic exploration of tolerance versus co-allergy to other legumes should be considered in patients allergic to peanut or other legumes,” Dr. Albright said.
The authors recommend further research and registry data collection of legume anaphylaxis.
Details regarding funding for the study were not provided. The authors, Ms. Shroba, and Dr. Albright report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
French children with peanut allergy tend to have reactions to other legumes, including soy, lentil, pea, bean, lupin, and fenugreek, and those other allergies often lead to anaphylactic reactions, a retrospective study from France reports.
“Among children allergic to peanut, at least two-thirds were sensitized to one other legume, and legume allergy was diagnosed in one-quarter of the sensitized patients,” wrote senior study author Amandine Divaret-Chauveau, MD, of Centre Hospitalier Universitaire de Nancy, Vandoeuvre-les-Nancy, and colleagues. The report is in Pediatric Allergy and Immunology.
People worldwide are eating more legumes these days, the authors noted. High in protein, low in unsaturated fats, with low production costs, legumes are important components of increasingly vegetarian, healthy, sustainable diets.
Food allergens are the most common childhood triggers of allergic reactions. Among children in France, legumes cause 14.6% of food-related anaphylactic reactions, with peanut as the main allergen, they added.
Dr. Divaret-Chauveau and colleagues assessed the prevalence and relevance of sensitization to legumes among all children and adolescents aged 1-17 years who had peanut allergy and had been admitted to one academic pediatric allergy department over roughly 3 years, beginning in early 2017. For the 195 study participants, peanut allergy had been confirmed, and they had been documented to have consumed or to have sensitization to at least one non-peanut legume; 69.7% were boys.
The researchers analyzed data on consumption history, skin prick tests, specific immunoglobulin E status, prior allergic reactions, and oral food challenges for each legume. They found the following:
- Among the 195 children with peanut allergy, 98.4% had at least one other atopic disease.
- Of the 195 children with peanut allergy, 122 (63.9%) were sensitized to at least one other legume. Of these 122 children, 66.3% were sensitized to fenugreek, 42.2% to lentil, 39.9% to soy, and 34.2% to lupin.
- Allergy to one or more legumes was confirmed for 27.9% of the 122 sensitized children, including 4.9% who had multiple legume allergies. Lentil, lupin, and pea were the main allergens.
- Of the 118 children also having a non-legume food allergy, the main food allergens were egg (57.6%), cow’s milk (33.0%), cashew (39.0%), pistachio (23.7%), and hazelnut (30.5%).
- Fifty percent of allergic reactions to non-peanut legumes were severe, often showing as asthma. Atopic comorbidities, including asthma, in most participants may have contributed to the severity of allergic reactions, the authors noted.
Allergy awareness needs to grow with plant-based diets
“The high prevalence of legume sensitization reported in our study highlights the need to explore legume consumption in children with PA [peanut allergy], and the need to investigate sensitization in the absence of consumption,” they added.
Jodi A. Shroba, MSN, APRN, CPNP, coordinator for the Food Allergy Program at Children’s Mercy Kansas City, in Missouri, told this news organization that few data are available in the literature regarding allergies to legumes other than peanut.
“It was interesting that these authors found such a high legume sensitization in their peanut-allergic patients,” Ms. Shroba, who was not involved in the study, said by email. “As more people are starting to eat plant-based diets, it is important that we better understand their allergenicity and cross-reactivity so we can better help guide patient management and education.”
Deborah Albright, MD, assistant professor of pediatrics at the University of Pittsburgh, agreed.
“As plant-based protein consumption broadens worldwide, awareness of the potential for cross-reactivity and co-allergy amongst legumes will become increasingly important,” she said by email.
“However, positive allergy tests do not reliably correlate with true food allergy; therefore, the diagnosis of legume co-allergy should be confirmed by the individual patient’s history, a formal food challenge, or both,” advised Dr. Albright. She was not involved in the study.
“Cross-sensitization to other legumes in patients with a single legume allergy is common; however, true clinical reactivity is often not present,” she added. “Also, legume allergy test sensitization rates and objective reactivity on food challenge can vary by region, depending on diet and pollen aeroallergen exposure.
“Systematic exploration of tolerance versus co-allergy to other legumes should be considered in patients allergic to peanut or other legumes,” Dr. Albright said.
The authors recommend further research and registry data collection of legume anaphylaxis.
Details regarding funding for the study were not provided. The authors, Ms. Shroba, and Dr. Albright report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
French children with peanut allergy tend to have reactions to other legumes, including soy, lentil, pea, bean, lupin, and fenugreek, and those other allergies often lead to anaphylactic reactions, a retrospective study from France reports.
“Among children allergic to peanut, at least two-thirds were sensitized to one other legume, and legume allergy was diagnosed in one-quarter of the sensitized patients,” wrote senior study author Amandine Divaret-Chauveau, MD, of Centre Hospitalier Universitaire de Nancy, Vandoeuvre-les-Nancy, and colleagues. The report is in Pediatric Allergy and Immunology.
People worldwide are eating more legumes these days, the authors noted. High in protein, low in unsaturated fats, with low production costs, legumes are important components of increasingly vegetarian, healthy, sustainable diets.
Food allergens are the most common childhood triggers of allergic reactions. Among children in France, legumes cause 14.6% of food-related anaphylactic reactions, with peanut as the main allergen, they added.
Dr. Divaret-Chauveau and colleagues assessed the prevalence and relevance of sensitization to legumes among all children and adolescents aged 1-17 years who had peanut allergy and had been admitted to one academic pediatric allergy department over roughly 3 years, beginning in early 2017. For the 195 study participants, peanut allergy had been confirmed, and they had been documented to have consumed or to have sensitization to at least one non-peanut legume; 69.7% were boys.
The researchers analyzed data on consumption history, skin prick tests, specific immunoglobulin E status, prior allergic reactions, and oral food challenges for each legume. They found the following:
- Among the 195 children with peanut allergy, 98.4% had at least one other atopic disease.
- Of the 195 children with peanut allergy, 122 (63.9%) were sensitized to at least one other legume. Of these 122 children, 66.3% were sensitized to fenugreek, 42.2% to lentil, 39.9% to soy, and 34.2% to lupin.
- Allergy to one or more legumes was confirmed for 27.9% of the 122 sensitized children, including 4.9% who had multiple legume allergies. Lentil, lupin, and pea were the main allergens.
- Of the 118 children also having a non-legume food allergy, the main food allergens were egg (57.6%), cow’s milk (33.0%), cashew (39.0%), pistachio (23.7%), and hazelnut (30.5%).
- Fifty percent of allergic reactions to non-peanut legumes were severe, often showing as asthma. Atopic comorbidities, including asthma, in most participants may have contributed to the severity of allergic reactions, the authors noted.
Allergy awareness needs to grow with plant-based diets
“The high prevalence of legume sensitization reported in our study highlights the need to explore legume consumption in children with PA [peanut allergy], and the need to investigate sensitization in the absence of consumption,” they added.
Jodi A. Shroba, MSN, APRN, CPNP, coordinator for the Food Allergy Program at Children’s Mercy Kansas City, in Missouri, told this news organization that few data are available in the literature regarding allergies to legumes other than peanut.
“It was interesting that these authors found such a high legume sensitization in their peanut-allergic patients,” Ms. Shroba, who was not involved in the study, said by email. “As more people are starting to eat plant-based diets, it is important that we better understand their allergenicity and cross-reactivity so we can better help guide patient management and education.”
Deborah Albright, MD, assistant professor of pediatrics at the University of Pittsburgh, agreed.
“As plant-based protein consumption broadens worldwide, awareness of the potential for cross-reactivity and co-allergy amongst legumes will become increasingly important,” she said by email.
“However, positive allergy tests do not reliably correlate with true food allergy; therefore, the diagnosis of legume co-allergy should be confirmed by the individual patient’s history, a formal food challenge, or both,” advised Dr. Albright. She was not involved in the study.
“Cross-sensitization to other legumes in patients with a single legume allergy is common; however, true clinical reactivity is often not present,” she added. “Also, legume allergy test sensitization rates and objective reactivity on food challenge can vary by region, depending on diet and pollen aeroallergen exposure.
“Systematic exploration of tolerance versus co-allergy to other legumes should be considered in patients allergic to peanut or other legumes,” Dr. Albright said.
The authors recommend further research and registry data collection of legume anaphylaxis.
Details regarding funding for the study were not provided. The authors, Ms. Shroba, and Dr. Albright report no relevant financial relationships.
A version of this article first appeared on Medscape.com.