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Searching for the Optimal CRC Surveillance Test
About a third of the US population are eligible for colorectal cancer screening but aren’t up to date on screening.
Many patients are reluctant to test for colon cancer for a variety of reasons, said Jeffrey K. Lee, MD, MPH, a research scientist at the Kaiser Permanente Northern California Division of Research and an attending gastroenterologist at Kaiser Permanente San Francisco Medical Center.
“As a gastroenterologist, I strongly believe we should emphasize the importance of colorectal cancer screening. And there’s many tests available, not just a colonoscopy, to help reduce your chances of developing colorectal cancer and even dying from colorectal cancer,” said Dr. Lee.
Many patients prefer a test that’s more convenient, that doesn’t require them to take time out of their busy schedules. “We must educate our patients that there are some noninvasive screening options that are helpful, and to be able to share with them some of the benefits, but also some of the drawbacks compared to colonoscopy and allow them to have a choice,” he advised.
He is a recipient of the AGA Research Scholar Award, and has in turn supported other researchers by contributing to the AGA Research Foundation. In 2012, Dr. Lee received a grant from the Sylvia Allison Kaplan Clinical Research Fund to fund a study on long-term colorectal cancer risk in patients with normal colonoscopy results.
The findings, published in JAMA Internal Medicine, determined that 10 years after a negative colonoscopy, Kaiser Permanente members had a 46% lower risk of being diagnosed with CRC and were 88% less likely to die from disease compared with patients who didn’t undergo screening.
“Furthermore, the reduced risk of developing colorectal cancer, even dying from it, persisted for more than 12 years after the examination compared with an unscreened population,” said Dr. Lee. “I firmly believe our study really supports the ten-year screening interval after a normal colonoscopy, as currently recommended by our guidelines.”
In an interview, he discussed his research efforts to find the best detection regimens for CRC, and the mentors who guided his career path as a GI scientist.
Q: Why did you choose GI?
During medical school I was fortunate to work in the lab of Dr. John M. Carethers at UC San Diego. He introduced me to GI and inspired me to choose GI as a career. His mentorship was invaluable because he not only solidified my interest in GI, but also inspired me to become a physician scientist, focusing on colorectal cancer prevention and control. His amazing mentorship drew me to this field.
Q: One of your clinical focus areas is hereditary gastrointestinal cancer syndromes. How did you become interested in this area of GI medicine?
My interest in hereditary GI cancer syndromes stemmed from my work as a medical student in Dr. Carethers’ lab. One of my research projects was looking at certain gene mutations among patients with hereditary GI cancer syndromes, specifically, familial hamartomatous polyposis syndrome. It was through these research projects and seeing how these genetic mutations impacted their risk of developing colorectal cancer, inspired me to care for patients with hereditary GI cancer syndromes.
Q: Have you been doing any research on the reasons why more young people are getting colon cancer?
We recently published work looking at the potential factors that may be driving the rising rates of early onset colorectal cancer. One hypothesis that’s been floating around is antibiotic exposure in early adulthood or childhood because of its effect on the microbiome. Using our large database at Kaiser Permanente Northern California, we did not find an association between oral antibiotic use during early adulthood and the risk of early-onset colorectal cancer.
You have the usual suspects like obesity and diabetes, but it’s not explaining all that risk. While familial colorectal cancer syndromes contribute to a small proportion of early-onset colorectal, these syndromes are not increasing across generations. I really do feel it’s something in the diet or how foods are processed and environmental factors that’s driving some of the risk of early onset colorectal cancer and this should be explored further.
Q: In 2018, you issued a landmark study which found an association between a 10-year follow-up after negative colonoscopy and reduced risk of disease and mortality. Has there been any updates to these findings over the last 6 years?
We recently saw a study in JAMA Oncology of a Swedish cohort that showed a negative colonoscopy result was associated with a reduced risk of developing and even dying from colorectal cancer 15 years from that examination, compared to the general population of Sweden. I think there’s some things that we need to be cautious about regarding that study. We have to think about the comparison group that they used and the lack of information regarding the indication of the colonoscopy and the quality of the examination. So, it remains uncertain whether future guidelines are going to stretch out that 10-year interval to 15 years.
Q: What other CRC studies are you working on now?
We have several studies that we are working on right now. One is called the PREVENT CRC study, which is looking at whether a polygenic risk score can improve risk stratification following adenoma removal for colorectal cancer prevention and tailoring post-polypectomy surveillance. This is a large observational cohort study that we have teamed up with the Fred Hutchinson Cancer Center, Erasmus University, and Kaiser Permanente Northwest to answer this important question that may have implications for personalized medicine.
Then there’s the COOP study, funded by the Patient-Centered Outcomes Research Institute. This is looking at the best surveillance test to use among older adults 65 years and older with a history of polyps. The trial is randomizing them to either getting a colonoscopy for surveillance or annual fecal immunochemical test (FIT) for surveillance. This is to see which test is best for detecting colorectal cancer among older adults with a history of polyps.
Q: Do you think FIT tests could eventually replace colonoscopy, given that it’s less invasive?
Although FIT and other stool-based tests are less invasive and have been shown to have high accuracy for detecting colorectal cancer, I personally do not think they are going to replace colonoscopy as the most popular screening modality in the United States. Colonoscopy remains the gold standard for detecting and removing precancerous polyps and has the highest accuracy for detecting colorectal cancer.
Q: Besides Dr. Carethers, what teacher or mentor had the greatest impact on you?
Clinically it’s been Dr. Jonathan Terdiman from UCSF, who taught me everything I know about clinical GI, and the art of colonoscopy. In addition, Douglas A. Corley, MD, PhD, the Permanente Medical Group’s chief research officer, has made the greatest impact on my research career. He’s really taught me how to rigorously design a research study to answer important clinically relevant questions, and has given me the skill set to write NIH grants. I would not be here without these mentors who are truly giants in the field of GI.
Q: When you’re not being a GI, how do you spend your free weekend afternoons? Are you still a “Cal Bears” fan at your alma mater, UC Berkeley?
I spend a lot of time taking my kids to their activities on the weekends. I just took my son to a Cal Bears Game Day, which was hosted by ESPN at Berkeley.
It was an incredible experience hearing sports analyst Pat McAfee lead all the Cal chants, seeing Nick Saban from the University of Alabama take off his red tie and replace it with a Cal Bears tie, and watching a Cal student win a hundred thousand dollars by kicking a football through the goal posts wearing checkered vans.
Lightning Round
Texting or talking?
Text
Favorite breakfast?
Taiwanese breakfast
Place you most want to travel to?
Japan
Favorite junk food?
Trader Joe’s chili lime chips
Favorite season?
Springtime, baseball season
Favorite ice cream flavor?
Mint chocolate chip
How many cups of coffee do you drink per day?
2-3
Last movie you watched?
Oppenheimer
Best place you ever went on vacation?
Hawaii
If you weren’t a gastroenterologist, what would you be?
Barber
Best Halloween costume you ever wore?
SpongeBob SquarePants
Favorite sport?
Tennis
What song do you have to sing along with when you hear it?
Any classic 80s song
Introvert or extrovert?
Introvert
About a third of the US population are eligible for colorectal cancer screening but aren’t up to date on screening.
Many patients are reluctant to test for colon cancer for a variety of reasons, said Jeffrey K. Lee, MD, MPH, a research scientist at the Kaiser Permanente Northern California Division of Research and an attending gastroenterologist at Kaiser Permanente San Francisco Medical Center.
“As a gastroenterologist, I strongly believe we should emphasize the importance of colorectal cancer screening. And there’s many tests available, not just a colonoscopy, to help reduce your chances of developing colorectal cancer and even dying from colorectal cancer,” said Dr. Lee.
Many patients prefer a test that’s more convenient, that doesn’t require them to take time out of their busy schedules. “We must educate our patients that there are some noninvasive screening options that are helpful, and to be able to share with them some of the benefits, but also some of the drawbacks compared to colonoscopy and allow them to have a choice,” he advised.
He is a recipient of the AGA Research Scholar Award, and has in turn supported other researchers by contributing to the AGA Research Foundation. In 2012, Dr. Lee received a grant from the Sylvia Allison Kaplan Clinical Research Fund to fund a study on long-term colorectal cancer risk in patients with normal colonoscopy results.
The findings, published in JAMA Internal Medicine, determined that 10 years after a negative colonoscopy, Kaiser Permanente members had a 46% lower risk of being diagnosed with CRC and were 88% less likely to die from disease compared with patients who didn’t undergo screening.
“Furthermore, the reduced risk of developing colorectal cancer, even dying from it, persisted for more than 12 years after the examination compared with an unscreened population,” said Dr. Lee. “I firmly believe our study really supports the ten-year screening interval after a normal colonoscopy, as currently recommended by our guidelines.”
In an interview, he discussed his research efforts to find the best detection regimens for CRC, and the mentors who guided his career path as a GI scientist.
Q: Why did you choose GI?
During medical school I was fortunate to work in the lab of Dr. John M. Carethers at UC San Diego. He introduced me to GI and inspired me to choose GI as a career. His mentorship was invaluable because he not only solidified my interest in GI, but also inspired me to become a physician scientist, focusing on colorectal cancer prevention and control. His amazing mentorship drew me to this field.
Q: One of your clinical focus areas is hereditary gastrointestinal cancer syndromes. How did you become interested in this area of GI medicine?
My interest in hereditary GI cancer syndromes stemmed from my work as a medical student in Dr. Carethers’ lab. One of my research projects was looking at certain gene mutations among patients with hereditary GI cancer syndromes, specifically, familial hamartomatous polyposis syndrome. It was through these research projects and seeing how these genetic mutations impacted their risk of developing colorectal cancer, inspired me to care for patients with hereditary GI cancer syndromes.
Q: Have you been doing any research on the reasons why more young people are getting colon cancer?
We recently published work looking at the potential factors that may be driving the rising rates of early onset colorectal cancer. One hypothesis that’s been floating around is antibiotic exposure in early adulthood or childhood because of its effect on the microbiome. Using our large database at Kaiser Permanente Northern California, we did not find an association between oral antibiotic use during early adulthood and the risk of early-onset colorectal cancer.
You have the usual suspects like obesity and diabetes, but it’s not explaining all that risk. While familial colorectal cancer syndromes contribute to a small proportion of early-onset colorectal, these syndromes are not increasing across generations. I really do feel it’s something in the diet or how foods are processed and environmental factors that’s driving some of the risk of early onset colorectal cancer and this should be explored further.
Q: In 2018, you issued a landmark study which found an association between a 10-year follow-up after negative colonoscopy and reduced risk of disease and mortality. Has there been any updates to these findings over the last 6 years?
We recently saw a study in JAMA Oncology of a Swedish cohort that showed a negative colonoscopy result was associated with a reduced risk of developing and even dying from colorectal cancer 15 years from that examination, compared to the general population of Sweden. I think there’s some things that we need to be cautious about regarding that study. We have to think about the comparison group that they used and the lack of information regarding the indication of the colonoscopy and the quality of the examination. So, it remains uncertain whether future guidelines are going to stretch out that 10-year interval to 15 years.
Q: What other CRC studies are you working on now?
We have several studies that we are working on right now. One is called the PREVENT CRC study, which is looking at whether a polygenic risk score can improve risk stratification following adenoma removal for colorectal cancer prevention and tailoring post-polypectomy surveillance. This is a large observational cohort study that we have teamed up with the Fred Hutchinson Cancer Center, Erasmus University, and Kaiser Permanente Northwest to answer this important question that may have implications for personalized medicine.
Then there’s the COOP study, funded by the Patient-Centered Outcomes Research Institute. This is looking at the best surveillance test to use among older adults 65 years and older with a history of polyps. The trial is randomizing them to either getting a colonoscopy for surveillance or annual fecal immunochemical test (FIT) for surveillance. This is to see which test is best for detecting colorectal cancer among older adults with a history of polyps.
Q: Do you think FIT tests could eventually replace colonoscopy, given that it’s less invasive?
Although FIT and other stool-based tests are less invasive and have been shown to have high accuracy for detecting colorectal cancer, I personally do not think they are going to replace colonoscopy as the most popular screening modality in the United States. Colonoscopy remains the gold standard for detecting and removing precancerous polyps and has the highest accuracy for detecting colorectal cancer.
Q: Besides Dr. Carethers, what teacher or mentor had the greatest impact on you?
Clinically it’s been Dr. Jonathan Terdiman from UCSF, who taught me everything I know about clinical GI, and the art of colonoscopy. In addition, Douglas A. Corley, MD, PhD, the Permanente Medical Group’s chief research officer, has made the greatest impact on my research career. He’s really taught me how to rigorously design a research study to answer important clinically relevant questions, and has given me the skill set to write NIH grants. I would not be here without these mentors who are truly giants in the field of GI.
Q: When you’re not being a GI, how do you spend your free weekend afternoons? Are you still a “Cal Bears” fan at your alma mater, UC Berkeley?
I spend a lot of time taking my kids to their activities on the weekends. I just took my son to a Cal Bears Game Day, which was hosted by ESPN at Berkeley.
It was an incredible experience hearing sports analyst Pat McAfee lead all the Cal chants, seeing Nick Saban from the University of Alabama take off his red tie and replace it with a Cal Bears tie, and watching a Cal student win a hundred thousand dollars by kicking a football through the goal posts wearing checkered vans.
Lightning Round
Texting or talking?
Text
Favorite breakfast?
Taiwanese breakfast
Place you most want to travel to?
Japan
Favorite junk food?
Trader Joe’s chili lime chips
Favorite season?
Springtime, baseball season
Favorite ice cream flavor?
Mint chocolate chip
How many cups of coffee do you drink per day?
2-3
Last movie you watched?
Oppenheimer
Best place you ever went on vacation?
Hawaii
If you weren’t a gastroenterologist, what would you be?
Barber
Best Halloween costume you ever wore?
SpongeBob SquarePants
Favorite sport?
Tennis
What song do you have to sing along with when you hear it?
Any classic 80s song
Introvert or extrovert?
Introvert
About a third of the US population are eligible for colorectal cancer screening but aren’t up to date on screening.
Many patients are reluctant to test for colon cancer for a variety of reasons, said Jeffrey K. Lee, MD, MPH, a research scientist at the Kaiser Permanente Northern California Division of Research and an attending gastroenterologist at Kaiser Permanente San Francisco Medical Center.
“As a gastroenterologist, I strongly believe we should emphasize the importance of colorectal cancer screening. And there’s many tests available, not just a colonoscopy, to help reduce your chances of developing colorectal cancer and even dying from colorectal cancer,” said Dr. Lee.
Many patients prefer a test that’s more convenient, that doesn’t require them to take time out of their busy schedules. “We must educate our patients that there are some noninvasive screening options that are helpful, and to be able to share with them some of the benefits, but also some of the drawbacks compared to colonoscopy and allow them to have a choice,” he advised.
He is a recipient of the AGA Research Scholar Award, and has in turn supported other researchers by contributing to the AGA Research Foundation. In 2012, Dr. Lee received a grant from the Sylvia Allison Kaplan Clinical Research Fund to fund a study on long-term colorectal cancer risk in patients with normal colonoscopy results.
The findings, published in JAMA Internal Medicine, determined that 10 years after a negative colonoscopy, Kaiser Permanente members had a 46% lower risk of being diagnosed with CRC and were 88% less likely to die from disease compared with patients who didn’t undergo screening.
“Furthermore, the reduced risk of developing colorectal cancer, even dying from it, persisted for more than 12 years after the examination compared with an unscreened population,” said Dr. Lee. “I firmly believe our study really supports the ten-year screening interval after a normal colonoscopy, as currently recommended by our guidelines.”
In an interview, he discussed his research efforts to find the best detection regimens for CRC, and the mentors who guided his career path as a GI scientist.
Q: Why did you choose GI?
During medical school I was fortunate to work in the lab of Dr. John M. Carethers at UC San Diego. He introduced me to GI and inspired me to choose GI as a career. His mentorship was invaluable because he not only solidified my interest in GI, but also inspired me to become a physician scientist, focusing on colorectal cancer prevention and control. His amazing mentorship drew me to this field.
Q: One of your clinical focus areas is hereditary gastrointestinal cancer syndromes. How did you become interested in this area of GI medicine?
My interest in hereditary GI cancer syndromes stemmed from my work as a medical student in Dr. Carethers’ lab. One of my research projects was looking at certain gene mutations among patients with hereditary GI cancer syndromes, specifically, familial hamartomatous polyposis syndrome. It was through these research projects and seeing how these genetic mutations impacted their risk of developing colorectal cancer, inspired me to care for patients with hereditary GI cancer syndromes.
Q: Have you been doing any research on the reasons why more young people are getting colon cancer?
We recently published work looking at the potential factors that may be driving the rising rates of early onset colorectal cancer. One hypothesis that’s been floating around is antibiotic exposure in early adulthood or childhood because of its effect on the microbiome. Using our large database at Kaiser Permanente Northern California, we did not find an association between oral antibiotic use during early adulthood and the risk of early-onset colorectal cancer.
You have the usual suspects like obesity and diabetes, but it’s not explaining all that risk. While familial colorectal cancer syndromes contribute to a small proportion of early-onset colorectal, these syndromes are not increasing across generations. I really do feel it’s something in the diet or how foods are processed and environmental factors that’s driving some of the risk of early onset colorectal cancer and this should be explored further.
Q: In 2018, you issued a landmark study which found an association between a 10-year follow-up after negative colonoscopy and reduced risk of disease and mortality. Has there been any updates to these findings over the last 6 years?
We recently saw a study in JAMA Oncology of a Swedish cohort that showed a negative colonoscopy result was associated with a reduced risk of developing and even dying from colorectal cancer 15 years from that examination, compared to the general population of Sweden. I think there’s some things that we need to be cautious about regarding that study. We have to think about the comparison group that they used and the lack of information regarding the indication of the colonoscopy and the quality of the examination. So, it remains uncertain whether future guidelines are going to stretch out that 10-year interval to 15 years.
Q: What other CRC studies are you working on now?
We have several studies that we are working on right now. One is called the PREVENT CRC study, which is looking at whether a polygenic risk score can improve risk stratification following adenoma removal for colorectal cancer prevention and tailoring post-polypectomy surveillance. This is a large observational cohort study that we have teamed up with the Fred Hutchinson Cancer Center, Erasmus University, and Kaiser Permanente Northwest to answer this important question that may have implications for personalized medicine.
Then there’s the COOP study, funded by the Patient-Centered Outcomes Research Institute. This is looking at the best surveillance test to use among older adults 65 years and older with a history of polyps. The trial is randomizing them to either getting a colonoscopy for surveillance or annual fecal immunochemical test (FIT) for surveillance. This is to see which test is best for detecting colorectal cancer among older adults with a history of polyps.
Q: Do you think FIT tests could eventually replace colonoscopy, given that it’s less invasive?
Although FIT and other stool-based tests are less invasive and have been shown to have high accuracy for detecting colorectal cancer, I personally do not think they are going to replace colonoscopy as the most popular screening modality in the United States. Colonoscopy remains the gold standard for detecting and removing precancerous polyps and has the highest accuracy for detecting colorectal cancer.
Q: Besides Dr. Carethers, what teacher or mentor had the greatest impact on you?
Clinically it’s been Dr. Jonathan Terdiman from UCSF, who taught me everything I know about clinical GI, and the art of colonoscopy. In addition, Douglas A. Corley, MD, PhD, the Permanente Medical Group’s chief research officer, has made the greatest impact on my research career. He’s really taught me how to rigorously design a research study to answer important clinically relevant questions, and has given me the skill set to write NIH grants. I would not be here without these mentors who are truly giants in the field of GI.
Q: When you’re not being a GI, how do you spend your free weekend afternoons? Are you still a “Cal Bears” fan at your alma mater, UC Berkeley?
I spend a lot of time taking my kids to their activities on the weekends. I just took my son to a Cal Bears Game Day, which was hosted by ESPN at Berkeley.
It was an incredible experience hearing sports analyst Pat McAfee lead all the Cal chants, seeing Nick Saban from the University of Alabama take off his red tie and replace it with a Cal Bears tie, and watching a Cal student win a hundred thousand dollars by kicking a football through the goal posts wearing checkered vans.
Lightning Round
Texting or talking?
Text
Favorite breakfast?
Taiwanese breakfast
Place you most want to travel to?
Japan
Favorite junk food?
Trader Joe’s chili lime chips
Favorite season?
Springtime, baseball season
Favorite ice cream flavor?
Mint chocolate chip
How many cups of coffee do you drink per day?
2-3
Last movie you watched?
Oppenheimer
Best place you ever went on vacation?
Hawaii
If you weren’t a gastroenterologist, what would you be?
Barber
Best Halloween costume you ever wore?
SpongeBob SquarePants
Favorite sport?
Tennis
What song do you have to sing along with when you hear it?
Any classic 80s song
Introvert or extrovert?
Introvert
Giving the Smallest GI Transplant Patients a New Lease On Life
The best part about working with kids is that “I get to laugh every day,” said Ke-You (Yoyo) Zhang, MD, clinical assistant professor for pediatrics–gastroenterology and hepatology at Stanford Medicine in California.
Everyday life for them is a challenge.
Dealing with sick children is difficult. “But I think the difference between pediatrics and adults is despite how hard things get, children are the single most resilient people you’re ever going to meet,” she said.
Kids don’t always know they’re sick and they don’t act sick, even when they are. “Every day, I literally get on the floor, I get to play, I get to run around. And truly, I have fun every single day. I get excited to go to work. And I think that’s what makes work not feel like work,” said Dr. Zhang.
In an interview, she discussed the satisfaction of following patients throughout their care continuum and her research to reduce the likelihood of transplant rejection.
She also shared an inspirational story of one young patient who spent his life tied to an IV, and how a transplant exposed him to the normal joys of life, like swimming, going to camp and getting on a plane for the first time.
Q: Why did you choose this subspecialty of pediatric GI?
I think it’s the best subspecialty because I think it combines a lot of the things that I enjoy, which is long-term continuity of care. It’s about growing up with your patients and seeing them through all the various stages of their life, often meeting patients when they’re babies. I get pictures of high school graduations and life milestones and even see some of my patients have families of their own. Becoming a part of their family is very meaningful to me. I also like complexity and acuity, and gastroenterology and hepatology provide those things.
And then lastly, it’s great to be able to exercise procedural skills and constantly learn new procedural skills.
Q: How did you become interested in the field of pediatric intestinal and liver transplantation?
I did all my training here at Stanford. We have one of the largest pediatric transplant centers and we also have a very large intestinal rehabilitation population.
Coming through residency and fellowship, I had a lot of exposure to transplant and intestinal failure, intestinal rehabilitation. I really liked the longitudinal relationship I got to form with my patients. Sometimes they’re in the neonatal ICU, where you’re meeting them in their very first days of life. You follow them through their chronic illness, through transplant and after transplant for many years. You become not just their GI, but the center of their care.
Q: What challenges are unique to this type of transplant work?
Pediatric intestinal failure and intestinal transplant represents an incredibly small subset of children. Oftentimes, they do not get the resources and recognition on a national policy level or even at the hospital level that other gastrointestinal diseases receive. What’s difficult is they are such a small subset but their complexity and their needs are probably in the highest percentile. So that’s a really challenging combination to start with. And there’s only a few centers that specialize in doing intestinal rehabilitation and intestinal transplantation for children in the country.
Developing expertise has been slow. But I think in the last decade or so, our understanding and success with intestinal rehabilitation and intestinal transplantation has really improved, especially at large centers like Stanford. We’ve had a lot of success stories and have not had any graft loss since 2014.
Q: Are these transplants hard to acquire?
Yes, especially when you’re transplanting not just the intestines but the liver as well. You’re waiting for two organs, not just one organ. And on top of that, you’re waiting for an appropriately sized donor; usually a child who’s around the same size or same age who’s passed away. Those organs would have to be a good match. Children can wait multiple years for a transplant.
Q: Is there a success story you’d like to share?
One patient I met in the neonatal ICU had congenital short bowel syndrome. He was born with hardly any intestines. He developed complications of being on long-term intravenous nutrition, which included recurrent central line infections and liver disease. He was never able to eat because he really didn’t have a digestive system that could adequately absorb anything. He had a central line in one of his large veins, so he couldn’t go swimming.
He had to have special adaptive wear to even shower or bathe and couldn’t travel. It’s these types of patients that benefit so much from transplant. Putting any kid through transplant is a massive undertaking and it certainly has risks. But he underwent a successful transplant at the age of 8—not just an intestinal transplant, but a multi-visceral transplant of the liver, intestine, and pancreas. He’s 9 years old now, and no longer needs intravenous nutrition. He ate by mouth for the very first time after transplant. He’s trying all sorts of new foods and he was able to go to a special transplant camp for children. Getting on a plane to Los Angeles, which is where our transplant camp is, was a huge deal.
He was able to swim in the lake. He’s never been able to do that. And he wants to start doing sports this fall. This was really a life-changing story for him.
Q: What advancements lie ahead for this field of work? Have you work on any notable research?
I think our understanding of transplant immunology has really progressed, especially recently. That’s what part of my research is about—using novel therapies to modulate the immune system of pediatric transplant recipients. The No. 1 complication that occurs after intestinal transplant is rejection because obviously you’re implanting somebody else’s organs into a patient.
I am involved in a clinical trial that’s looking at the use of extracellular vesicles that are isolated from hematopoietic stem cells. These vesicles contain various growth factors, anti-inflammatory proteins and tissue repair factors that we are infusing into intestinal transplant patients with the aim to repair the intestinal tissue patients are rejecting.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
My husband and I have an almost 2-year-old little girl. She keeps us busy and I spend my afternoons chasing after a crazy toddler.
Lightning Round
Texting or talking?
Huge texter
Favorite junk food?
French fries
Cat or dog person?
Dog
Favorite ice cream?
Strawberry
If you weren’t a gastroenterologist, what would you be?Florist
Best place you’ve traveled to?
Thailand
Number of cups of coffee you drink per day?
Too many
Favorite city in the US besides the one you live in?
New York City
Favorite sport?
Tennis
Optimist or pessimist?
Optimist
The best part about working with kids is that “I get to laugh every day,” said Ke-You (Yoyo) Zhang, MD, clinical assistant professor for pediatrics–gastroenterology and hepatology at Stanford Medicine in California.
Everyday life for them is a challenge.
Dealing with sick children is difficult. “But I think the difference between pediatrics and adults is despite how hard things get, children are the single most resilient people you’re ever going to meet,” she said.
Kids don’t always know they’re sick and they don’t act sick, even when they are. “Every day, I literally get on the floor, I get to play, I get to run around. And truly, I have fun every single day. I get excited to go to work. And I think that’s what makes work not feel like work,” said Dr. Zhang.
In an interview, she discussed the satisfaction of following patients throughout their care continuum and her research to reduce the likelihood of transplant rejection.
She also shared an inspirational story of one young patient who spent his life tied to an IV, and how a transplant exposed him to the normal joys of life, like swimming, going to camp and getting on a plane for the first time.
Q: Why did you choose this subspecialty of pediatric GI?
I think it’s the best subspecialty because I think it combines a lot of the things that I enjoy, which is long-term continuity of care. It’s about growing up with your patients and seeing them through all the various stages of their life, often meeting patients when they’re babies. I get pictures of high school graduations and life milestones and even see some of my patients have families of their own. Becoming a part of their family is very meaningful to me. I also like complexity and acuity, and gastroenterology and hepatology provide those things.
And then lastly, it’s great to be able to exercise procedural skills and constantly learn new procedural skills.
Q: How did you become interested in the field of pediatric intestinal and liver transplantation?
I did all my training here at Stanford. We have one of the largest pediatric transplant centers and we also have a very large intestinal rehabilitation population.
Coming through residency and fellowship, I had a lot of exposure to transplant and intestinal failure, intestinal rehabilitation. I really liked the longitudinal relationship I got to form with my patients. Sometimes they’re in the neonatal ICU, where you’re meeting them in their very first days of life. You follow them through their chronic illness, through transplant and after transplant for many years. You become not just their GI, but the center of their care.
Q: What challenges are unique to this type of transplant work?
Pediatric intestinal failure and intestinal transplant represents an incredibly small subset of children. Oftentimes, they do not get the resources and recognition on a national policy level or even at the hospital level that other gastrointestinal diseases receive. What’s difficult is they are such a small subset but their complexity and their needs are probably in the highest percentile. So that’s a really challenging combination to start with. And there’s only a few centers that specialize in doing intestinal rehabilitation and intestinal transplantation for children in the country.
Developing expertise has been slow. But I think in the last decade or so, our understanding and success with intestinal rehabilitation and intestinal transplantation has really improved, especially at large centers like Stanford. We’ve had a lot of success stories and have not had any graft loss since 2014.
Q: Are these transplants hard to acquire?
Yes, especially when you’re transplanting not just the intestines but the liver as well. You’re waiting for two organs, not just one organ. And on top of that, you’re waiting for an appropriately sized donor; usually a child who’s around the same size or same age who’s passed away. Those organs would have to be a good match. Children can wait multiple years for a transplant.
Q: Is there a success story you’d like to share?
One patient I met in the neonatal ICU had congenital short bowel syndrome. He was born with hardly any intestines. He developed complications of being on long-term intravenous nutrition, which included recurrent central line infections and liver disease. He was never able to eat because he really didn’t have a digestive system that could adequately absorb anything. He had a central line in one of his large veins, so he couldn’t go swimming.
He had to have special adaptive wear to even shower or bathe and couldn’t travel. It’s these types of patients that benefit so much from transplant. Putting any kid through transplant is a massive undertaking and it certainly has risks. But he underwent a successful transplant at the age of 8—not just an intestinal transplant, but a multi-visceral transplant of the liver, intestine, and pancreas. He’s 9 years old now, and no longer needs intravenous nutrition. He ate by mouth for the very first time after transplant. He’s trying all sorts of new foods and he was able to go to a special transplant camp for children. Getting on a plane to Los Angeles, which is where our transplant camp is, was a huge deal.
He was able to swim in the lake. He’s never been able to do that. And he wants to start doing sports this fall. This was really a life-changing story for him.
Q: What advancements lie ahead for this field of work? Have you work on any notable research?
I think our understanding of transplant immunology has really progressed, especially recently. That’s what part of my research is about—using novel therapies to modulate the immune system of pediatric transplant recipients. The No. 1 complication that occurs after intestinal transplant is rejection because obviously you’re implanting somebody else’s organs into a patient.
I am involved in a clinical trial that’s looking at the use of extracellular vesicles that are isolated from hematopoietic stem cells. These vesicles contain various growth factors, anti-inflammatory proteins and tissue repair factors that we are infusing into intestinal transplant patients with the aim to repair the intestinal tissue patients are rejecting.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
My husband and I have an almost 2-year-old little girl. She keeps us busy and I spend my afternoons chasing after a crazy toddler.
Lightning Round
Texting or talking?
Huge texter
Favorite junk food?
French fries
Cat or dog person?
Dog
Favorite ice cream?
Strawberry
If you weren’t a gastroenterologist, what would you be?Florist
Best place you’ve traveled to?
Thailand
Number of cups of coffee you drink per day?
Too many
Favorite city in the US besides the one you live in?
New York City
Favorite sport?
Tennis
Optimist or pessimist?
Optimist
The best part about working with kids is that “I get to laugh every day,” said Ke-You (Yoyo) Zhang, MD, clinical assistant professor for pediatrics–gastroenterology and hepatology at Stanford Medicine in California.
Everyday life for them is a challenge.
Dealing with sick children is difficult. “But I think the difference between pediatrics and adults is despite how hard things get, children are the single most resilient people you’re ever going to meet,” she said.
Kids don’t always know they’re sick and they don’t act sick, even when they are. “Every day, I literally get on the floor, I get to play, I get to run around. And truly, I have fun every single day. I get excited to go to work. And I think that’s what makes work not feel like work,” said Dr. Zhang.
In an interview, she discussed the satisfaction of following patients throughout their care continuum and her research to reduce the likelihood of transplant rejection.
She also shared an inspirational story of one young patient who spent his life tied to an IV, and how a transplant exposed him to the normal joys of life, like swimming, going to camp and getting on a plane for the first time.
Q: Why did you choose this subspecialty of pediatric GI?
I think it’s the best subspecialty because I think it combines a lot of the things that I enjoy, which is long-term continuity of care. It’s about growing up with your patients and seeing them through all the various stages of their life, often meeting patients when they’re babies. I get pictures of high school graduations and life milestones and even see some of my patients have families of their own. Becoming a part of their family is very meaningful to me. I also like complexity and acuity, and gastroenterology and hepatology provide those things.
And then lastly, it’s great to be able to exercise procedural skills and constantly learn new procedural skills.
Q: How did you become interested in the field of pediatric intestinal and liver transplantation?
I did all my training here at Stanford. We have one of the largest pediatric transplant centers and we also have a very large intestinal rehabilitation population.
Coming through residency and fellowship, I had a lot of exposure to transplant and intestinal failure, intestinal rehabilitation. I really liked the longitudinal relationship I got to form with my patients. Sometimes they’re in the neonatal ICU, where you’re meeting them in their very first days of life. You follow them through their chronic illness, through transplant and after transplant for many years. You become not just their GI, but the center of their care.
Q: What challenges are unique to this type of transplant work?
Pediatric intestinal failure and intestinal transplant represents an incredibly small subset of children. Oftentimes, they do not get the resources and recognition on a national policy level or even at the hospital level that other gastrointestinal diseases receive. What’s difficult is they are such a small subset but their complexity and their needs are probably in the highest percentile. So that’s a really challenging combination to start with. And there’s only a few centers that specialize in doing intestinal rehabilitation and intestinal transplantation for children in the country.
Developing expertise has been slow. But I think in the last decade or so, our understanding and success with intestinal rehabilitation and intestinal transplantation has really improved, especially at large centers like Stanford. We’ve had a lot of success stories and have not had any graft loss since 2014.
Q: Are these transplants hard to acquire?
Yes, especially when you’re transplanting not just the intestines but the liver as well. You’re waiting for two organs, not just one organ. And on top of that, you’re waiting for an appropriately sized donor; usually a child who’s around the same size or same age who’s passed away. Those organs would have to be a good match. Children can wait multiple years for a transplant.
Q: Is there a success story you’d like to share?
One patient I met in the neonatal ICU had congenital short bowel syndrome. He was born with hardly any intestines. He developed complications of being on long-term intravenous nutrition, which included recurrent central line infections and liver disease. He was never able to eat because he really didn’t have a digestive system that could adequately absorb anything. He had a central line in one of his large veins, so he couldn’t go swimming.
He had to have special adaptive wear to even shower or bathe and couldn’t travel. It’s these types of patients that benefit so much from transplant. Putting any kid through transplant is a massive undertaking and it certainly has risks. But he underwent a successful transplant at the age of 8—not just an intestinal transplant, but a multi-visceral transplant of the liver, intestine, and pancreas. He’s 9 years old now, and no longer needs intravenous nutrition. He ate by mouth for the very first time after transplant. He’s trying all sorts of new foods and he was able to go to a special transplant camp for children. Getting on a plane to Los Angeles, which is where our transplant camp is, was a huge deal.
He was able to swim in the lake. He’s never been able to do that. And he wants to start doing sports this fall. This was really a life-changing story for him.
Q: What advancements lie ahead for this field of work? Have you work on any notable research?
I think our understanding of transplant immunology has really progressed, especially recently. That’s what part of my research is about—using novel therapies to modulate the immune system of pediatric transplant recipients. The No. 1 complication that occurs after intestinal transplant is rejection because obviously you’re implanting somebody else’s organs into a patient.
I am involved in a clinical trial that’s looking at the use of extracellular vesicles that are isolated from hematopoietic stem cells. These vesicles contain various growth factors, anti-inflammatory proteins and tissue repair factors that we are infusing into intestinal transplant patients with the aim to repair the intestinal tissue patients are rejecting.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
My husband and I have an almost 2-year-old little girl. She keeps us busy and I spend my afternoons chasing after a crazy toddler.
Lightning Round
Texting or talking?
Huge texter
Favorite junk food?
French fries
Cat or dog person?
Dog
Favorite ice cream?
Strawberry
If you weren’t a gastroenterologist, what would you be?Florist
Best place you’ve traveled to?
Thailand
Number of cups of coffee you drink per day?
Too many
Favorite city in the US besides the one you live in?
New York City
Favorite sport?
Tennis
Optimist or pessimist?
Optimist
In a Parallel Universe, “I’d Be a Concert Pianist” Says Tennessee GI
She also relishes opportunities to think, to analyze, and solve problems for her patients.
One of her chief interests is inflammatory bowel disease (IBD). It’s reassuring to focus on a field of work “where I know exactly what’s causing the issue, and I can select a therapeutic approach (medication and lifestyle changes) that help a patient achieve remission,” said Dr. Pointer, co-owner and managing partner of Digestive and Liver Health Specialists in Hendersonville, Tenn. She’s also the medical director and a principal investigator of Quality Medical Research in Nashville, and currently serves as chair of the AGA Trainee and Early Career Committee.
Starting her own practice has been just as challenging and rewarding as going through medical school. Medical training does not prepare you for starting your own practice, Dr. Pointer said, so she and her business partner have had to learn as they go. “But I think we’ve done very well. We’ve taken the ups and downs in stride.”
In an interview, Dr. Pointer spoke more about her work in IBD and the ways in which she’s given back to the community through music and mentoring.
Q: Why did you choose GI?
I knew from a very young age that I was going to be a physician. I had always been interested in science. When I got into medical school and became exposed to the different areas, I really liked the cognitive skills where you had to think through a problem or an issue. But I also liked the procedural things as well.
During my internal medicine residency training, I felt that I had a knack for it. As I was looking at different options, I decided on gastroenterology because it combined both cognitive thinking through issues, but also taking it to the next step and intervening through procedures.
Q: During fellowship, your focus was inflammatory bowel disease. What drew your interest to this condition?
There are a lot of different areas within gastroenterology that one can subspecialize in, as we see the full gamut of gastrointestinal and hepatic disorders. But treating some conditions, like functional disorders, means taking more of a ‘trial and error’ approach, and you may not always get the patient a hundred percent better. That’s not to say that we can’t improve a patient’s quality of life, but it’s not always a guarantee.
But inflammatory bowel disease is a little bit different. Because I can point to an exact spot in the intestines that’s causing the problem, it’s very fulfilling for me as a physician to take a patient who is having 10-12 bloody bowel movements a day, to normal form stools and no abdominal pain. They’re able to gain weight and go on about their lives and about their day. So that was why I picked inflammatory bowel disease as my subspecialty.
Q: Tell me about the gastroenterology elective you developed for family medicine residents and undergraduate students. What’s the status of the program now?
I’ve always been interested in teaching and giving back to the next generations. I feel like I had great mentor opportunities and people who helped me along the way. In my previous hospital position, I was able to work with the family medicine department and create an elective through which residents and even undergraduate students could come and shadow and work with me in the clinic and see me performing procedures.
That elective ended once I left that position, at least as far as I’m aware. But in the private practice that I co-own now, we have numerous shadowing opportunities. I was able to give a lecture at Middle Tennessee State University for some students. And through that lecture, many students have reached out to me to shadow. I have allowed them to come shadow and do clinic work as a medical assistant and watch me perform procedures. I have multiple students working with me weekly.
Q: Years ago, you founded the non-profit Enchanted Fingers Piano Lessons, which gave free piano lessons to underserved youth. What was that experience like?
Piano was one of my first loves. In some parallel universe, there’s a Dr. Pointer who is a classical, concert pianist. I started taking piano lessons when I was in early middle school, and I took to it very quickly. I was able to excel. I just loved it. I enjoyed practicing and I still play.
The impetus for starting Enchanted Fingers Piano lessons was because I wanted to give back again to the community. I came from an underserved community. Oftentimes children and young adults in those communities don’t get exposed to extracurricular activities and they don’t even know what they could potentially have a passion for. And I definitely had a passion for piano. I partnered with a church organization and they allowed me to use their church to host these piano lessons, and it was a phenomenal and rewarding experience. I would definitely like to start it up again one day in the future. It was an amazing experience.
It’s actually how I met my husband. He was one of the young adult students who signed up to take lessons. We both still enjoy playing the piano together.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
I’m a creative at heart. I really enjoy sewing and I’m working on a few sewing projects. I just got a serger. It is a machine that helps you finish a seam. It can also be used to sew entire garments. That has been fun, learning how to thread that machine. When I’m not doing that or just relaxing with my family, I do enjoy curling up with a good book. Stephen King is one of my favorite authors.
Lightning Round
Texting or talking?
Talking
Favorite junk food?
Chocolate chip cookies
Cat or dog person?
Cat
Favorite vacation?
Hawaii
How many cups of coffee do you drink per day?
I don’t drink coffee
Favorite ice cream?
Butter pecan
Favorite sport?
I don’t watch sports
Optimist or pessimist?
Optimist
She also relishes opportunities to think, to analyze, and solve problems for her patients.
One of her chief interests is inflammatory bowel disease (IBD). It’s reassuring to focus on a field of work “where I know exactly what’s causing the issue, and I can select a therapeutic approach (medication and lifestyle changes) that help a patient achieve remission,” said Dr. Pointer, co-owner and managing partner of Digestive and Liver Health Specialists in Hendersonville, Tenn. She’s also the medical director and a principal investigator of Quality Medical Research in Nashville, and currently serves as chair of the AGA Trainee and Early Career Committee.
Starting her own practice has been just as challenging and rewarding as going through medical school. Medical training does not prepare you for starting your own practice, Dr. Pointer said, so she and her business partner have had to learn as they go. “But I think we’ve done very well. We’ve taken the ups and downs in stride.”
In an interview, Dr. Pointer spoke more about her work in IBD and the ways in which she’s given back to the community through music and mentoring.
Q: Why did you choose GI?
I knew from a very young age that I was going to be a physician. I had always been interested in science. When I got into medical school and became exposed to the different areas, I really liked the cognitive skills where you had to think through a problem or an issue. But I also liked the procedural things as well.
During my internal medicine residency training, I felt that I had a knack for it. As I was looking at different options, I decided on gastroenterology because it combined both cognitive thinking through issues, but also taking it to the next step and intervening through procedures.
Q: During fellowship, your focus was inflammatory bowel disease. What drew your interest to this condition?
There are a lot of different areas within gastroenterology that one can subspecialize in, as we see the full gamut of gastrointestinal and hepatic disorders. But treating some conditions, like functional disorders, means taking more of a ‘trial and error’ approach, and you may not always get the patient a hundred percent better. That’s not to say that we can’t improve a patient’s quality of life, but it’s not always a guarantee.
But inflammatory bowel disease is a little bit different. Because I can point to an exact spot in the intestines that’s causing the problem, it’s very fulfilling for me as a physician to take a patient who is having 10-12 bloody bowel movements a day, to normal form stools and no abdominal pain. They’re able to gain weight and go on about their lives and about their day. So that was why I picked inflammatory bowel disease as my subspecialty.
Q: Tell me about the gastroenterology elective you developed for family medicine residents and undergraduate students. What’s the status of the program now?
I’ve always been interested in teaching and giving back to the next generations. I feel like I had great mentor opportunities and people who helped me along the way. In my previous hospital position, I was able to work with the family medicine department and create an elective through which residents and even undergraduate students could come and shadow and work with me in the clinic and see me performing procedures.
That elective ended once I left that position, at least as far as I’m aware. But in the private practice that I co-own now, we have numerous shadowing opportunities. I was able to give a lecture at Middle Tennessee State University for some students. And through that lecture, many students have reached out to me to shadow. I have allowed them to come shadow and do clinic work as a medical assistant and watch me perform procedures. I have multiple students working with me weekly.
Q: Years ago, you founded the non-profit Enchanted Fingers Piano Lessons, which gave free piano lessons to underserved youth. What was that experience like?
Piano was one of my first loves. In some parallel universe, there’s a Dr. Pointer who is a classical, concert pianist. I started taking piano lessons when I was in early middle school, and I took to it very quickly. I was able to excel. I just loved it. I enjoyed practicing and I still play.
The impetus for starting Enchanted Fingers Piano lessons was because I wanted to give back again to the community. I came from an underserved community. Oftentimes children and young adults in those communities don’t get exposed to extracurricular activities and they don’t even know what they could potentially have a passion for. And I definitely had a passion for piano. I partnered with a church organization and they allowed me to use their church to host these piano lessons, and it was a phenomenal and rewarding experience. I would definitely like to start it up again one day in the future. It was an amazing experience.
It’s actually how I met my husband. He was one of the young adult students who signed up to take lessons. We both still enjoy playing the piano together.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
I’m a creative at heart. I really enjoy sewing and I’m working on a few sewing projects. I just got a serger. It is a machine that helps you finish a seam. It can also be used to sew entire garments. That has been fun, learning how to thread that machine. When I’m not doing that or just relaxing with my family, I do enjoy curling up with a good book. Stephen King is one of my favorite authors.
Lightning Round
Texting or talking?
Talking
Favorite junk food?
Chocolate chip cookies
Cat or dog person?
Cat
Favorite vacation?
Hawaii
How many cups of coffee do you drink per day?
I don’t drink coffee
Favorite ice cream?
Butter pecan
Favorite sport?
I don’t watch sports
Optimist or pessimist?
Optimist
She also relishes opportunities to think, to analyze, and solve problems for her patients.
One of her chief interests is inflammatory bowel disease (IBD). It’s reassuring to focus on a field of work “where I know exactly what’s causing the issue, and I can select a therapeutic approach (medication and lifestyle changes) that help a patient achieve remission,” said Dr. Pointer, co-owner and managing partner of Digestive and Liver Health Specialists in Hendersonville, Tenn. She’s also the medical director and a principal investigator of Quality Medical Research in Nashville, and currently serves as chair of the AGA Trainee and Early Career Committee.
Starting her own practice has been just as challenging and rewarding as going through medical school. Medical training does not prepare you for starting your own practice, Dr. Pointer said, so she and her business partner have had to learn as they go. “But I think we’ve done very well. We’ve taken the ups and downs in stride.”
In an interview, Dr. Pointer spoke more about her work in IBD and the ways in which she’s given back to the community through music and mentoring.
Q: Why did you choose GI?
I knew from a very young age that I was going to be a physician. I had always been interested in science. When I got into medical school and became exposed to the different areas, I really liked the cognitive skills where you had to think through a problem or an issue. But I also liked the procedural things as well.
During my internal medicine residency training, I felt that I had a knack for it. As I was looking at different options, I decided on gastroenterology because it combined both cognitive thinking through issues, but also taking it to the next step and intervening through procedures.
Q: During fellowship, your focus was inflammatory bowel disease. What drew your interest to this condition?
There are a lot of different areas within gastroenterology that one can subspecialize in, as we see the full gamut of gastrointestinal and hepatic disorders. But treating some conditions, like functional disorders, means taking more of a ‘trial and error’ approach, and you may not always get the patient a hundred percent better. That’s not to say that we can’t improve a patient’s quality of life, but it’s not always a guarantee.
But inflammatory bowel disease is a little bit different. Because I can point to an exact spot in the intestines that’s causing the problem, it’s very fulfilling for me as a physician to take a patient who is having 10-12 bloody bowel movements a day, to normal form stools and no abdominal pain. They’re able to gain weight and go on about their lives and about their day. So that was why I picked inflammatory bowel disease as my subspecialty.
Q: Tell me about the gastroenterology elective you developed for family medicine residents and undergraduate students. What’s the status of the program now?
I’ve always been interested in teaching and giving back to the next generations. I feel like I had great mentor opportunities and people who helped me along the way. In my previous hospital position, I was able to work with the family medicine department and create an elective through which residents and even undergraduate students could come and shadow and work with me in the clinic and see me performing procedures.
That elective ended once I left that position, at least as far as I’m aware. But in the private practice that I co-own now, we have numerous shadowing opportunities. I was able to give a lecture at Middle Tennessee State University for some students. And through that lecture, many students have reached out to me to shadow. I have allowed them to come shadow and do clinic work as a medical assistant and watch me perform procedures. I have multiple students working with me weekly.
Q: Years ago, you founded the non-profit Enchanted Fingers Piano Lessons, which gave free piano lessons to underserved youth. What was that experience like?
Piano was one of my first loves. In some parallel universe, there’s a Dr. Pointer who is a classical, concert pianist. I started taking piano lessons when I was in early middle school, and I took to it very quickly. I was able to excel. I just loved it. I enjoyed practicing and I still play.
The impetus for starting Enchanted Fingers Piano lessons was because I wanted to give back again to the community. I came from an underserved community. Oftentimes children and young adults in those communities don’t get exposed to extracurricular activities and they don’t even know what they could potentially have a passion for. And I definitely had a passion for piano. I partnered with a church organization and they allowed me to use their church to host these piano lessons, and it was a phenomenal and rewarding experience. I would definitely like to start it up again one day in the future. It was an amazing experience.
It’s actually how I met my husband. He was one of the young adult students who signed up to take lessons. We both still enjoy playing the piano together.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
I’m a creative at heart. I really enjoy sewing and I’m working on a few sewing projects. I just got a serger. It is a machine that helps you finish a seam. It can also be used to sew entire garments. That has been fun, learning how to thread that machine. When I’m not doing that or just relaxing with my family, I do enjoy curling up with a good book. Stephen King is one of my favorite authors.
Lightning Round
Texting or talking?
Talking
Favorite junk food?
Chocolate chip cookies
Cat or dog person?
Cat
Favorite vacation?
Hawaii
How many cups of coffee do you drink per day?
I don’t drink coffee
Favorite ice cream?
Butter pecan
Favorite sport?
I don’t watch sports
Optimist or pessimist?
Optimist
Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
The 12 Dangers of Christmas
The 12 Dangers of Christmas
The carol promises partridges and pears. The reality, every December, is a predictable spike in injuries, illness, and emergency care.
Framed around the familiar “12 Days of Christmas,” this seasonal guide sets out the most common festive hazards — many of them preventable — and the practical advice clinicians can share to help patients enjoy a safer holiday.
1. Fire
Candles, open fires, and busy kitchens make December the most dangerous month for house fires. Home fires rise 10% in December and peak on Christmas Day at 53% above average, according to the National Fire Chiefs Council.
Alcohol, distraction, and festive cooking all add to the risk.
- Check for fire hazards before Christmas.
- Never leave cookers or candle unattended.
- Check Christmas lights and avoid overloading sockets.
- Ensure a working smoke alarm on each floor and keep escape routes clear.
- Remember that emollient residues on fabrics are highly flammable.
2. Christmas Trees and Decorations
Trees and trimmings bring their own risk. Christmas trees injure about 1000 people each year, according to the Royal Society for the Prevention of Accidents (RoSPA).
A National Accident Helpline (NAH) survey found that 2.7% of respondents had experienced electric shock from faulty lights. Artificial trees, chosen by 76% of households, carry a sixfold higher injury risk. Real trees dry out and become highly flammable — “a giant bundle of kindling covered in electrical wires,” warned safety analysts TapRooT.
- Water live trees regularly — unplug lights first.
- Keep trees stable and at least 3 feet from heat sources.
- Switch off lights before bed or leaving the house.
- Do not hang stockings near open flames.
- Hang fragile decorations high up.
- Supervise children and pets.
3. Slips, Trips, and Falls
The third danger is underfoot. Falls, burns, and cuts send around 80,000 people to A&E each Christmas, according to RoSPA.
One in 50 people fall from their loft while retrieving decorations, the NAH warned.
- Use sturdy ladders and wear footwear with good grip.
- Keep floors clear of presents, wrapping, cables, and spills.
- Never melt ice with boiling water; refreezing can make surfaces more treacherous.
4. Food and Drug Interactions
Festive eating can interfere with medicines. The Medicines and Healthcare products Regulatory Agency (MHRA) warned that drug-food interactions are not always listed on packaging.
- Grapefruit interacts with multiple drugs.
- Cranberries can enhance warfarin's anticoagulant effect, while vitamin K-rich foods, including sprouts, may reduce it.
- Rich desserts can destabilize blood glucose.
- Tyramine-rich foods, including cheeses and dark chocolate, may trigger migraines or hypertensive crises with monoamine oxidase inhibitors.
5. Alcohol
Up to 70% of weekend A&E attendances are alcohol-related, with numbers rising over Christmas. The MHRA warned that mixing alcohol with medicines can cause drowsiness, impaired coordination, and accidents.
- Avoid drinking on an empty stomach.
- Be cautious of unfamiliar drinks.
- Alternate alcoholic and soft drinks.
- Avoid potentially aggressive intoxicated people.
6. Kitchen Calamities
The festive kitchen is a frequent source of injury. NAH data showed that 49% of people reported accidents while preparing Christmas food. Cuts accounted for 18%, and burns from hot fat 11%. In addition, the Food Standards Agency said that 46% of Christmas cooks do not check use-by dates.
- Keep children and trip hazards out of the kitchen.
- Use back hobs and turn saucepan handles inward.
- Never leave ovens or pans unattended.
- Discard out-of-date food.
- Refrigerate leftovers within 2 hours.
7. Children's Vulnerabilities
Christmas presents bring hidden dangers for children. Button batteries and magnets can inflict serious gastrointestinal damage if swallowed.
- Choose age-appropriate, well-made toys.
- Store batteries, magnets, medicines, and chemicals out of reach.
- Avoid sharp or breakable decorations.
- Place holly, mistletoe, and poinsettias well out of reach.
8. Eye Injuries
Eye injuries surge over Christmas. Champagne corks can travel at nearly 50 mph, risking globe rupture or retinal detachment.
Conifer needles, glitter, and artificial snow can all cause corneal injury.
- Point champagne bottles and party poppers away from people's faces.
- Take care when handling Christmas trees.
- Avoid hanging ornaments at children's eye level.
- Rinse glitter-contaminated eyes with sterile saline.
9. Existing Ailments
By the ninth day, routine has often collapsed. Festive excess, stress and disrupted schedules can destabilize chronic disease.
- Ensure adequate medicines and testing supplies.
- Let hosts know dietary needs in advance.
- Avoid excess salt and alcohol in cardiovascular disease, and excess potassium in kidney disease.
- Increase blood glucose monitoring in diabetes.
10. Presents
Not all gifts are benign. The Child Accident Prevention Trust warned that cheap or counterfeit products may bypass safety standards.
UK safety authorities report that counterfeit Labubu dolls have made up a large share of the roughly 259,000 counterfeit toys seized at UK borders this year, and many have failed safety tests.
- Be cautious when buying for toddlers.
- Look for recognized safety markings.
- Avoid toys with strong magnets or button batteries.
- Laser pointers can cause permanent damage to vision.
11. Stress
As Christmas approaches, pressure mounts. In an NAH survey, 12% of men and 20% of women said they felt rushed, 32% of women were stressed, and 18% overwhelmed.
- Prioritize sleep.
- Get outdoors for early morning light.
- Ask for help and delegate chores.
12. Other People
The final hazard is often the most familiar: Family tension is almost traditional. In one survey, 37% of people said Christmas "wouldn't be the same" without arguments, and 54% admitted enjoying them.
- Set boundaries and agree expectations early.
- Stick to a budget.
- Avoid known flashpoint topics, such as politics.
- Create a quiet space for time out.
- One in 9 people spend Christmas alone. Plan ahead to make it a special day.
The hazards may feel seasonal, but the outcomes are not. For clinicians, the 12 risks offer a reminder that small interventions before Christmas can prevent significant harm after it.
Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.
A version of this article first appeared on Medscape.com.
The carol promises partridges and pears. The reality, every December, is a predictable spike in injuries, illness, and emergency care.
Framed around the familiar “12 Days of Christmas,” this seasonal guide sets out the most common festive hazards — many of them preventable — and the practical advice clinicians can share to help patients enjoy a safer holiday.
1. Fire
Candles, open fires, and busy kitchens make December the most dangerous month for house fires. Home fires rise 10% in December and peak on Christmas Day at 53% above average, according to the National Fire Chiefs Council.
Alcohol, distraction, and festive cooking all add to the risk.
- Check for fire hazards before Christmas.
- Never leave cookers or candle unattended.
- Check Christmas lights and avoid overloading sockets.
- Ensure a working smoke alarm on each floor and keep escape routes clear.
- Remember that emollient residues on fabrics are highly flammable.
2. Christmas Trees and Decorations
Trees and trimmings bring their own risk. Christmas trees injure about 1000 people each year, according to the Royal Society for the Prevention of Accidents (RoSPA).
A National Accident Helpline (NAH) survey found that 2.7% of respondents had experienced electric shock from faulty lights. Artificial trees, chosen by 76% of households, carry a sixfold higher injury risk. Real trees dry out and become highly flammable — “a giant bundle of kindling covered in electrical wires,” warned safety analysts TapRooT.
- Water live trees regularly — unplug lights first.
- Keep trees stable and at least 3 feet from heat sources.
- Switch off lights before bed or leaving the house.
- Do not hang stockings near open flames.
- Hang fragile decorations high up.
- Supervise children and pets.
3. Slips, Trips, and Falls
The third danger is underfoot. Falls, burns, and cuts send around 80,000 people to A&E each Christmas, according to RoSPA.
One in 50 people fall from their loft while retrieving decorations, the NAH warned.
- Use sturdy ladders and wear footwear with good grip.
- Keep floors clear of presents, wrapping, cables, and spills.
- Never melt ice with boiling water; refreezing can make surfaces more treacherous.
4. Food and Drug Interactions
Festive eating can interfere with medicines. The Medicines and Healthcare products Regulatory Agency (MHRA) warned that drug-food interactions are not always listed on packaging.
- Grapefruit interacts with multiple drugs.
- Cranberries can enhance warfarin's anticoagulant effect, while vitamin K-rich foods, including sprouts, may reduce it.
- Rich desserts can destabilize blood glucose.
- Tyramine-rich foods, including cheeses and dark chocolate, may trigger migraines or hypertensive crises with monoamine oxidase inhibitors.
5. Alcohol
Up to 70% of weekend A&E attendances are alcohol-related, with numbers rising over Christmas. The MHRA warned that mixing alcohol with medicines can cause drowsiness, impaired coordination, and accidents.
- Avoid drinking on an empty stomach.
- Be cautious of unfamiliar drinks.
- Alternate alcoholic and soft drinks.
- Avoid potentially aggressive intoxicated people.
6. Kitchen Calamities
The festive kitchen is a frequent source of injury. NAH data showed that 49% of people reported accidents while preparing Christmas food. Cuts accounted for 18%, and burns from hot fat 11%. In addition, the Food Standards Agency said that 46% of Christmas cooks do not check use-by dates.
- Keep children and trip hazards out of the kitchen.
- Use back hobs and turn saucepan handles inward.
- Never leave ovens or pans unattended.
- Discard out-of-date food.
- Refrigerate leftovers within 2 hours.
7. Children's Vulnerabilities
Christmas presents bring hidden dangers for children. Button batteries and magnets can inflict serious gastrointestinal damage if swallowed.
- Choose age-appropriate, well-made toys.
- Store batteries, magnets, medicines, and chemicals out of reach.
- Avoid sharp or breakable decorations.
- Place holly, mistletoe, and poinsettias well out of reach.
8. Eye Injuries
Eye injuries surge over Christmas. Champagne corks can travel at nearly 50 mph, risking globe rupture or retinal detachment.
Conifer needles, glitter, and artificial snow can all cause corneal injury.
- Point champagne bottles and party poppers away from people's faces.
- Take care when handling Christmas trees.
- Avoid hanging ornaments at children's eye level.
- Rinse glitter-contaminated eyes with sterile saline.
9. Existing Ailments
By the ninth day, routine has often collapsed. Festive excess, stress and disrupted schedules can destabilize chronic disease.
- Ensure adequate medicines and testing supplies.
- Let hosts know dietary needs in advance.
- Avoid excess salt and alcohol in cardiovascular disease, and excess potassium in kidney disease.
- Increase blood glucose monitoring in diabetes.
10. Presents
Not all gifts are benign. The Child Accident Prevention Trust warned that cheap or counterfeit products may bypass safety standards.
UK safety authorities report that counterfeit Labubu dolls have made up a large share of the roughly 259,000 counterfeit toys seized at UK borders this year, and many have failed safety tests.
- Be cautious when buying for toddlers.
- Look for recognized safety markings.
- Avoid toys with strong magnets or button batteries.
- Laser pointers can cause permanent damage to vision.
11. Stress
As Christmas approaches, pressure mounts. In an NAH survey, 12% of men and 20% of women said they felt rushed, 32% of women were stressed, and 18% overwhelmed.
- Prioritize sleep.
- Get outdoors for early morning light.
- Ask for help and delegate chores.
12. Other People
The final hazard is often the most familiar: Family tension is almost traditional. In one survey, 37% of people said Christmas "wouldn't be the same" without arguments, and 54% admitted enjoying them.
- Set boundaries and agree expectations early.
- Stick to a budget.
- Avoid known flashpoint topics, such as politics.
- Create a quiet space for time out.
- One in 9 people spend Christmas alone. Plan ahead to make it a special day.
The hazards may feel seasonal, but the outcomes are not. For clinicians, the 12 risks offer a reminder that small interventions before Christmas can prevent significant harm after it.
Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.
A version of this article first appeared on Medscape.com.
The carol promises partridges and pears. The reality, every December, is a predictable spike in injuries, illness, and emergency care.
Framed around the familiar “12 Days of Christmas,” this seasonal guide sets out the most common festive hazards — many of them preventable — and the practical advice clinicians can share to help patients enjoy a safer holiday.
1. Fire
Candles, open fires, and busy kitchens make December the most dangerous month for house fires. Home fires rise 10% in December and peak on Christmas Day at 53% above average, according to the National Fire Chiefs Council.
Alcohol, distraction, and festive cooking all add to the risk.
- Check for fire hazards before Christmas.
- Never leave cookers or candle unattended.
- Check Christmas lights and avoid overloading sockets.
- Ensure a working smoke alarm on each floor and keep escape routes clear.
- Remember that emollient residues on fabrics are highly flammable.
2. Christmas Trees and Decorations
Trees and trimmings bring their own risk. Christmas trees injure about 1000 people each year, according to the Royal Society for the Prevention of Accidents (RoSPA).
A National Accident Helpline (NAH) survey found that 2.7% of respondents had experienced electric shock from faulty lights. Artificial trees, chosen by 76% of households, carry a sixfold higher injury risk. Real trees dry out and become highly flammable — “a giant bundle of kindling covered in electrical wires,” warned safety analysts TapRooT.
- Water live trees regularly — unplug lights first.
- Keep trees stable and at least 3 feet from heat sources.
- Switch off lights before bed or leaving the house.
- Do not hang stockings near open flames.
- Hang fragile decorations high up.
- Supervise children and pets.
3. Slips, Trips, and Falls
The third danger is underfoot. Falls, burns, and cuts send around 80,000 people to A&E each Christmas, according to RoSPA.
One in 50 people fall from their loft while retrieving decorations, the NAH warned.
- Use sturdy ladders and wear footwear with good grip.
- Keep floors clear of presents, wrapping, cables, and spills.
- Never melt ice with boiling water; refreezing can make surfaces more treacherous.
4. Food and Drug Interactions
Festive eating can interfere with medicines. The Medicines and Healthcare products Regulatory Agency (MHRA) warned that drug-food interactions are not always listed on packaging.
- Grapefruit interacts with multiple drugs.
- Cranberries can enhance warfarin's anticoagulant effect, while vitamin K-rich foods, including sprouts, may reduce it.
- Rich desserts can destabilize blood glucose.
- Tyramine-rich foods, including cheeses and dark chocolate, may trigger migraines or hypertensive crises with monoamine oxidase inhibitors.
5. Alcohol
Up to 70% of weekend A&E attendances are alcohol-related, with numbers rising over Christmas. The MHRA warned that mixing alcohol with medicines can cause drowsiness, impaired coordination, and accidents.
- Avoid drinking on an empty stomach.
- Be cautious of unfamiliar drinks.
- Alternate alcoholic and soft drinks.
- Avoid potentially aggressive intoxicated people.
6. Kitchen Calamities
The festive kitchen is a frequent source of injury. NAH data showed that 49% of people reported accidents while preparing Christmas food. Cuts accounted for 18%, and burns from hot fat 11%. In addition, the Food Standards Agency said that 46% of Christmas cooks do not check use-by dates.
- Keep children and trip hazards out of the kitchen.
- Use back hobs and turn saucepan handles inward.
- Never leave ovens or pans unattended.
- Discard out-of-date food.
- Refrigerate leftovers within 2 hours.
7. Children's Vulnerabilities
Christmas presents bring hidden dangers for children. Button batteries and magnets can inflict serious gastrointestinal damage if swallowed.
- Choose age-appropriate, well-made toys.
- Store batteries, magnets, medicines, and chemicals out of reach.
- Avoid sharp or breakable decorations.
- Place holly, mistletoe, and poinsettias well out of reach.
8. Eye Injuries
Eye injuries surge over Christmas. Champagne corks can travel at nearly 50 mph, risking globe rupture or retinal detachment.
Conifer needles, glitter, and artificial snow can all cause corneal injury.
- Point champagne bottles and party poppers away from people's faces.
- Take care when handling Christmas trees.
- Avoid hanging ornaments at children's eye level.
- Rinse glitter-contaminated eyes with sterile saline.
9. Existing Ailments
By the ninth day, routine has often collapsed. Festive excess, stress and disrupted schedules can destabilize chronic disease.
- Ensure adequate medicines and testing supplies.
- Let hosts know dietary needs in advance.
- Avoid excess salt and alcohol in cardiovascular disease, and excess potassium in kidney disease.
- Increase blood glucose monitoring in diabetes.
10. Presents
Not all gifts are benign. The Child Accident Prevention Trust warned that cheap or counterfeit products may bypass safety standards.
UK safety authorities report that counterfeit Labubu dolls have made up a large share of the roughly 259,000 counterfeit toys seized at UK borders this year, and many have failed safety tests.
- Be cautious when buying for toddlers.
- Look for recognized safety markings.
- Avoid toys with strong magnets or button batteries.
- Laser pointers can cause permanent damage to vision.
11. Stress
As Christmas approaches, pressure mounts. In an NAH survey, 12% of men and 20% of women said they felt rushed, 32% of women were stressed, and 18% overwhelmed.
- Prioritize sleep.
- Get outdoors for early morning light.
- Ask for help and delegate chores.
12. Other People
The final hazard is often the most familiar: Family tension is almost traditional. In one survey, 37% of people said Christmas "wouldn't be the same" without arguments, and 54% admitted enjoying them.
- Set boundaries and agree expectations early.
- Stick to a budget.
- Avoid known flashpoint topics, such as politics.
- Create a quiet space for time out.
- One in 9 people spend Christmas alone. Plan ahead to make it a special day.
The hazards may feel seasonal, but the outcomes are not. For clinicians, the 12 risks offer a reminder that small interventions before Christmas can prevent significant harm after it.
Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.
A version of this article first appeared on Medscape.com.
The 12 Dangers of Christmas
The 12 Dangers of Christmas
Female Veterans' Telemental Health Use: Rural-Urban Shift
Female Veterans' Telemental Health Use: Rural-Urban Shift
TOPLINE:
The use of services for mental health involving video chats with medical professionals increased in female veterans from 2019 to 2022, with women living in urban areas more likely to use the services than their rural counterparts. Black and Hispanic women showed the largest increases.
METHODOLOGY:
- Researchers analyzed trends in video telemental health utilization among female veterans within an observational cohort of Veterans Health Administration (VHA) mental health outpatient visits, by rurality and race, from 2019 to 2022.
- The study included 470,863 female veterans (mean age, 43 years; 51% White individuals) who had ≥ 1 outpatient mental health visit; a subsample of 141,349 veterans with mental health visits in both 2019 and 2022 was analyzed for changes in telemental health use.
- Video telemental health encounters were identified using specific codes for synchronous, video-based mental health care and included both visits at clinics and those at home through the VA Video Connect system.
- The researchers categorized race into 5 groups and classified veterans’ residences as rural and urban using commuting area codes.
TAKEAWAY:
- The use of synchronous video telemental health services among female veterans increased from < 7% to 32% from 2019 to 2022, with stable in-person care rates.
- In 2019, female veterans living in rural areas had an increased likelihood of using video telemental health. However, by 2022, this difference decreased, and female veterans living in urban areas showed equivalent or higher usage. Female veterans living in urban areas had a greater increase in the number of visits in 2022 than their peers living in rural areas.
- Black and Hispanic female veterans showed greater increases in video tele-mental health usage in both urban and rural areas. No significant change in telemental health visits was noted for American Indian and Alaska Native female veterans between 2019 and 2022.
- In the analysis of the subsample, female veterans living in urban areas were 21-35 times more likely to use video telemental health in 2022 vs 2019, whereas female veterans living in rural areas were 7-11 times more likely.
IN PRACTICE:
“The rapid changes observed in SVT-MH [synchronous video telehealth for mental health] use over a relatively short time period underscore the potential for achieving equity through intentional system-level efforts. However, our findings also highlight the risk of overgeneralizing telehealth utilization patterns,” the authors wrote. “Our findings underscore the need for targeted digital care strategies — especially for rural and AIAN [American Indian and Alaska Native] women veterans — to ensure that all veterans benefit equally from virtual care options,” they added.
SOURCE:
This study was led by Michelle A. Mengeling, PhD, MS, of the VHA Office of Rural Health at the Veterans Rural Health Resource Center in Iowa City, Iowa. It was published online on December 10, 2025, in The Journal of Rural Health.
LIMITATIONS:
Female veterans older than 60 years were excluded to avoid confounding with Medicare service usage. Rurality was classified as urban or rural, which may overlook variations in highly rural or isolated areas. The focus on VHA-delivered mental health care might not fully capture the use of video-based telemental health services.
DISCLOSURES:
This study was supported by grants from the US Department of Veterans Affairs, VHA, Office of Rural Health, Veterans Rural Health Resource Center - Iowa City. The authors declared having no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this story first appeared on Medscape.com.
TOPLINE:
The use of services for mental health involving video chats with medical professionals increased in female veterans from 2019 to 2022, with women living in urban areas more likely to use the services than their rural counterparts. Black and Hispanic women showed the largest increases.
METHODOLOGY:
- Researchers analyzed trends in video telemental health utilization among female veterans within an observational cohort of Veterans Health Administration (VHA) mental health outpatient visits, by rurality and race, from 2019 to 2022.
- The study included 470,863 female veterans (mean age, 43 years; 51% White individuals) who had ≥ 1 outpatient mental health visit; a subsample of 141,349 veterans with mental health visits in both 2019 and 2022 was analyzed for changes in telemental health use.
- Video telemental health encounters were identified using specific codes for synchronous, video-based mental health care and included both visits at clinics and those at home through the VA Video Connect system.
- The researchers categorized race into 5 groups and classified veterans’ residences as rural and urban using commuting area codes.
TAKEAWAY:
- The use of synchronous video telemental health services among female veterans increased from < 7% to 32% from 2019 to 2022, with stable in-person care rates.
- In 2019, female veterans living in rural areas had an increased likelihood of using video telemental health. However, by 2022, this difference decreased, and female veterans living in urban areas showed equivalent or higher usage. Female veterans living in urban areas had a greater increase in the number of visits in 2022 than their peers living in rural areas.
- Black and Hispanic female veterans showed greater increases in video tele-mental health usage in both urban and rural areas. No significant change in telemental health visits was noted for American Indian and Alaska Native female veterans between 2019 and 2022.
- In the analysis of the subsample, female veterans living in urban areas were 21-35 times more likely to use video telemental health in 2022 vs 2019, whereas female veterans living in rural areas were 7-11 times more likely.
IN PRACTICE:
“The rapid changes observed in SVT-MH [synchronous video telehealth for mental health] use over a relatively short time period underscore the potential for achieving equity through intentional system-level efforts. However, our findings also highlight the risk of overgeneralizing telehealth utilization patterns,” the authors wrote. “Our findings underscore the need for targeted digital care strategies — especially for rural and AIAN [American Indian and Alaska Native] women veterans — to ensure that all veterans benefit equally from virtual care options,” they added.
SOURCE:
This study was led by Michelle A. Mengeling, PhD, MS, of the VHA Office of Rural Health at the Veterans Rural Health Resource Center in Iowa City, Iowa. It was published online on December 10, 2025, in The Journal of Rural Health.
LIMITATIONS:
Female veterans older than 60 years were excluded to avoid confounding with Medicare service usage. Rurality was classified as urban or rural, which may overlook variations in highly rural or isolated areas. The focus on VHA-delivered mental health care might not fully capture the use of video-based telemental health services.
DISCLOSURES:
This study was supported by grants from the US Department of Veterans Affairs, VHA, Office of Rural Health, Veterans Rural Health Resource Center - Iowa City. The authors declared having no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this story first appeared on Medscape.com.
TOPLINE:
The use of services for mental health involving video chats with medical professionals increased in female veterans from 2019 to 2022, with women living in urban areas more likely to use the services than their rural counterparts. Black and Hispanic women showed the largest increases.
METHODOLOGY:
- Researchers analyzed trends in video telemental health utilization among female veterans within an observational cohort of Veterans Health Administration (VHA) mental health outpatient visits, by rurality and race, from 2019 to 2022.
- The study included 470,863 female veterans (mean age, 43 years; 51% White individuals) who had ≥ 1 outpatient mental health visit; a subsample of 141,349 veterans with mental health visits in both 2019 and 2022 was analyzed for changes in telemental health use.
- Video telemental health encounters were identified using specific codes for synchronous, video-based mental health care and included both visits at clinics and those at home through the VA Video Connect system.
- The researchers categorized race into 5 groups and classified veterans’ residences as rural and urban using commuting area codes.
TAKEAWAY:
- The use of synchronous video telemental health services among female veterans increased from < 7% to 32% from 2019 to 2022, with stable in-person care rates.
- In 2019, female veterans living in rural areas had an increased likelihood of using video telemental health. However, by 2022, this difference decreased, and female veterans living in urban areas showed equivalent or higher usage. Female veterans living in urban areas had a greater increase in the number of visits in 2022 than their peers living in rural areas.
- Black and Hispanic female veterans showed greater increases in video tele-mental health usage in both urban and rural areas. No significant change in telemental health visits was noted for American Indian and Alaska Native female veterans between 2019 and 2022.
- In the analysis of the subsample, female veterans living in urban areas were 21-35 times more likely to use video telemental health in 2022 vs 2019, whereas female veterans living in rural areas were 7-11 times more likely.
IN PRACTICE:
“The rapid changes observed in SVT-MH [synchronous video telehealth for mental health] use over a relatively short time period underscore the potential for achieving equity through intentional system-level efforts. However, our findings also highlight the risk of overgeneralizing telehealth utilization patterns,” the authors wrote. “Our findings underscore the need for targeted digital care strategies — especially for rural and AIAN [American Indian and Alaska Native] women veterans — to ensure that all veterans benefit equally from virtual care options,” they added.
SOURCE:
This study was led by Michelle A. Mengeling, PhD, MS, of the VHA Office of Rural Health at the Veterans Rural Health Resource Center in Iowa City, Iowa. It was published online on December 10, 2025, in The Journal of Rural Health.
LIMITATIONS:
Female veterans older than 60 years were excluded to avoid confounding with Medicare service usage. Rurality was classified as urban or rural, which may overlook variations in highly rural or isolated areas. The focus on VHA-delivered mental health care might not fully capture the use of video-based telemental health services.
DISCLOSURES:
This study was supported by grants from the US Department of Veterans Affairs, VHA, Office of Rural Health, Veterans Rural Health Resource Center - Iowa City. The authors declared having no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this story first appeared on Medscape.com.
Female Veterans' Telemental Health Use: Rural-Urban Shift
Female Veterans' Telemental Health Use: Rural-Urban Shift
Novel Treatment Combo Ups Survival in Multiple Myeloma
Novel Treatment Combo Ups Survival in Multiple Myeloma
Adding teclistamab to daratumumab dramatically improved progression-free survival and overall survival vs standard-of-care (SOC) therapy in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 MajesTEC-3 trial.
At median follow-up of 34.5 months, progression-free survival was not reached in study participants randomized to receive teclistamab plus daratumumab (Tec-Dara). Starkly contrasting that was the 18.1 months progression-free survival among those randomized to a control group who received the standard of care: investigator’s choice of daratumumab and dexamethasone plus either pomalidomide or bortezomib (DPd/DVd (hazard ratio [HR], 0.17). Overall survival also significantly favored Tec-Dara (HR, 0.46).
Lead investigator María-Victoria Mateos, MD, PhD, reported the findings in a late-breaking abstract session at American Society of Hematology (ASH) 2025 Annual Meeting. They were published simultaneously in The New England Journal of Medicine.
“[Tec-Dara in this setting] generated the greatest progression-free survival treatment effect to date [in RRMR] with a plateau phase after 6 months of therapy, suggesting potential for functional cure,” said Mateos, a consultant physician and associate professor at the University of Salamanca, Salamanca, Spain.
“We consider that this synergistic immunotherapy combination…is a new potential standard of care for relapsed or refractory multiple myeloma after at least on prior line of therapy, with broad potential across academic and community settings,” added Mateos, who also directs the Multiple Myeloma Program at the University.
Based on the MajesTEC-3 findings, the FDA proactively awarded a national priority voucher to Tec-Dara under the Commissioner’s National Priority Voucher pilot program designed to accelerate the review of certain promising products.
About Tec-Dara
Teclistamab (Tecvayli) is an off-the-shelf first-in-class bispecific monoclonal antibody shown in the MajesTEC-1 trial to provide deep, durable responses in RRMM, with improved efficacy and safety with earlier lines of therapy. The FDA approved the agent for use in 4th or greater lines of therapy in 2022 based on those findings.
Daratumumab (Darzalex) is a widely used anti-CD38 monoclonal antibody currently considered the SOC therapy for RRMM. Both agents are products of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Although front-line therapy for multiple myeloma has dramatically improved, there is a need for new, more effective treatment strategies in patients with disease progression, Mateos noted.
Therefore, she and her colleagues conducted MajesTEC-3, a randomized trial exploring the fully immunotherapy-based regimen of Tec-Dara vs daratumumab-based SOC in patients who had received one to three prior lines of therapy, including a proteasome inhibitor and lenalidomide (Len).
The study was the first to test a bispecific monoclonal antibody as early as the first relapse after initial treatment, she noted.
About MajesTEC-3
Study participants were 587 adults aged 25-88 years. Those with one prior line of therapy were required to be Len-refractory with progressive disease on or after the last therapy. Prior anti-CD-38 Patients with prior B-cell maturation antigen-directed therapy or who were refractory to anti-CD38 treatment were excluded.
The 291 patients randomized to the Tec-Dara treatment group and 296 randomized to the control group were treated in 28-day cycles according to the standard daratumumab schedule: weekly treatment during cycles 1 and 2, biweekly treatment during cycles 3-6, and monthly treatments beginning with cycle 7.
Teclistamab was initiated with an approved step-up dose school followed by 1.5 mg/kg weekly in cycles 1 and 2, 3 mg/kg biweekly in cycles 3-6, and 3 mg/kg monthly beginning with cycle 7.
The 36-month progression-free survival rates with Tec-Dara vs DPd/DVd were 83.4% and 29.7%, with the 36-month overall survival rates having been 83.3% and 65.0%. More than 90% of patients in the Tec-Dara group who were alive at 6 months were also alive at 30 months, Mateos noted.
For both progression-free survival and overall survival, the “clinically remarkable and statistically significant” differences were apparent across all prespecified and clinically relevant subgroups, she added. These included patients who were 75 years or older, Len-refractory patients, and those with high-risk cytogenetics, ≥ 60% bone marrow plasma cells, soft-tissue plasmacytomas, and anti-CD38 exposure.
Patients receiving Tec-Dara also had significantly higher rates of complete or better responses (81.8% vs 32.1%; odds ratio [OR], 9.56), overall response (89.0% vs 75.3%; OR, 2.65), and minimal residual disease-negativity (58.4% vs 17.1%; OR, 6.78).
The median time to first response and first complete or better response was similar in the two groups, but 36-month duration of response was 88.5 vs 36.4 months. At data cutoff, 49.4% of patients remained on study treatment — 71.0% in the Tec-Dara group and 28.3% in the DPd/DVd group, and median treatment duration was twice as long with Tec-Dara (32.4 vs 16.1 months), she said.
Serious adverse events occurred at similar rates in the treatment and control groups (70.7% and 62.4%) and most (44.2%) were grade 1 cytokine release syndrome (CRS). No grade 3 CRS occurred, and all CRS cases resolved.
Immune effector-cell-associated neurotoxicity occurred in 1.1% of patients, and all cases resolved.
Treatment-related adverse events leading to discontinuation occurred in 4.6% and 5.5% of patients in the Tec-Dara and DPd/DVd groups. The rates of deaths due to treatment-emergent adverse events were also similar in the groups (7.1% vs 5.9%).
Infections of any grade occurred in 96.5% and 84.1% of Tec-Dara and DPd/DVd patients, and grade 3/4 infections occurred in 54.1% and 43.4%. New-onset grade 3 or greater infections decreased over time.
“It’s important to acknowledge that patients with infections needed to be supported with adequate prophylaxis and immunoglobulins,” Mateo stressed.
Implications for Patients With RRMM
Teclistamab is currently only approved after three prior lines of therapy, but under the FDA Commissioner’s National Priority Voucher program, the agency will aim to complete its review of Tec-Dara for earlier treatment within 1-2 months following submission of an application for approval by Johnson & Johnson.
If an approval for that indication were to occur, it would be transformative for patients with RRMM, said Michael Rosenzweig, MD, of City of Hope, Duarte, California, in an interview with Medscape Medical News.
The [MajesTEC-3] findings suggest that Tec-Dar “really gives patients a chance at long-term disease control,” added Rosenzweig, chief of the Division of Multiple Myeloma, and an associate professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope.
MajesTEC-3 was funded by Johnson & Johnson. Mateos disclosed relationships with numerous pharmaceutical companies, including Johnson & Johnson. Rosenzweig reported consulting for Johnson & Johnson and was previously on the company’s speakers bureau.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and health care topics. She can be reached at [email protected] or on X: @SW_MedReporter.
Adding teclistamab to daratumumab dramatically improved progression-free survival and overall survival vs standard-of-care (SOC) therapy in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 MajesTEC-3 trial.
At median follow-up of 34.5 months, progression-free survival was not reached in study participants randomized to receive teclistamab plus daratumumab (Tec-Dara). Starkly contrasting that was the 18.1 months progression-free survival among those randomized to a control group who received the standard of care: investigator’s choice of daratumumab and dexamethasone plus either pomalidomide or bortezomib (DPd/DVd (hazard ratio [HR], 0.17). Overall survival also significantly favored Tec-Dara (HR, 0.46).
Lead investigator María-Victoria Mateos, MD, PhD, reported the findings in a late-breaking abstract session at American Society of Hematology (ASH) 2025 Annual Meeting. They were published simultaneously in The New England Journal of Medicine.
“[Tec-Dara in this setting] generated the greatest progression-free survival treatment effect to date [in RRMR] with a plateau phase after 6 months of therapy, suggesting potential for functional cure,” said Mateos, a consultant physician and associate professor at the University of Salamanca, Salamanca, Spain.
“We consider that this synergistic immunotherapy combination…is a new potential standard of care for relapsed or refractory multiple myeloma after at least on prior line of therapy, with broad potential across academic and community settings,” added Mateos, who also directs the Multiple Myeloma Program at the University.
Based on the MajesTEC-3 findings, the FDA proactively awarded a national priority voucher to Tec-Dara under the Commissioner’s National Priority Voucher pilot program designed to accelerate the review of certain promising products.
About Tec-Dara
Teclistamab (Tecvayli) is an off-the-shelf first-in-class bispecific monoclonal antibody shown in the MajesTEC-1 trial to provide deep, durable responses in RRMM, with improved efficacy and safety with earlier lines of therapy. The FDA approved the agent for use in 4th or greater lines of therapy in 2022 based on those findings.
Daratumumab (Darzalex) is a widely used anti-CD38 monoclonal antibody currently considered the SOC therapy for RRMM. Both agents are products of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Although front-line therapy for multiple myeloma has dramatically improved, there is a need for new, more effective treatment strategies in patients with disease progression, Mateos noted.
Therefore, she and her colleagues conducted MajesTEC-3, a randomized trial exploring the fully immunotherapy-based regimen of Tec-Dara vs daratumumab-based SOC in patients who had received one to three prior lines of therapy, including a proteasome inhibitor and lenalidomide (Len).
The study was the first to test a bispecific monoclonal antibody as early as the first relapse after initial treatment, she noted.
About MajesTEC-3
Study participants were 587 adults aged 25-88 years. Those with one prior line of therapy were required to be Len-refractory with progressive disease on or after the last therapy. Prior anti-CD-38 Patients with prior B-cell maturation antigen-directed therapy or who were refractory to anti-CD38 treatment were excluded.
The 291 patients randomized to the Tec-Dara treatment group and 296 randomized to the control group were treated in 28-day cycles according to the standard daratumumab schedule: weekly treatment during cycles 1 and 2, biweekly treatment during cycles 3-6, and monthly treatments beginning with cycle 7.
Teclistamab was initiated with an approved step-up dose school followed by 1.5 mg/kg weekly in cycles 1 and 2, 3 mg/kg biweekly in cycles 3-6, and 3 mg/kg monthly beginning with cycle 7.
The 36-month progression-free survival rates with Tec-Dara vs DPd/DVd were 83.4% and 29.7%, with the 36-month overall survival rates having been 83.3% and 65.0%. More than 90% of patients in the Tec-Dara group who were alive at 6 months were also alive at 30 months, Mateos noted.
For both progression-free survival and overall survival, the “clinically remarkable and statistically significant” differences were apparent across all prespecified and clinically relevant subgroups, she added. These included patients who were 75 years or older, Len-refractory patients, and those with high-risk cytogenetics, ≥ 60% bone marrow plasma cells, soft-tissue plasmacytomas, and anti-CD38 exposure.
Patients receiving Tec-Dara also had significantly higher rates of complete or better responses (81.8% vs 32.1%; odds ratio [OR], 9.56), overall response (89.0% vs 75.3%; OR, 2.65), and minimal residual disease-negativity (58.4% vs 17.1%; OR, 6.78).
The median time to first response and first complete or better response was similar in the two groups, but 36-month duration of response was 88.5 vs 36.4 months. At data cutoff, 49.4% of patients remained on study treatment — 71.0% in the Tec-Dara group and 28.3% in the DPd/DVd group, and median treatment duration was twice as long with Tec-Dara (32.4 vs 16.1 months), she said.
Serious adverse events occurred at similar rates in the treatment and control groups (70.7% and 62.4%) and most (44.2%) were grade 1 cytokine release syndrome (CRS). No grade 3 CRS occurred, and all CRS cases resolved.
Immune effector-cell-associated neurotoxicity occurred in 1.1% of patients, and all cases resolved.
Treatment-related adverse events leading to discontinuation occurred in 4.6% and 5.5% of patients in the Tec-Dara and DPd/DVd groups. The rates of deaths due to treatment-emergent adverse events were also similar in the groups (7.1% vs 5.9%).
Infections of any grade occurred in 96.5% and 84.1% of Tec-Dara and DPd/DVd patients, and grade 3/4 infections occurred in 54.1% and 43.4%. New-onset grade 3 or greater infections decreased over time.
“It’s important to acknowledge that patients with infections needed to be supported with adequate prophylaxis and immunoglobulins,” Mateo stressed.
Implications for Patients With RRMM
Teclistamab is currently only approved after three prior lines of therapy, but under the FDA Commissioner’s National Priority Voucher program, the agency will aim to complete its review of Tec-Dara for earlier treatment within 1-2 months following submission of an application for approval by Johnson & Johnson.
If an approval for that indication were to occur, it would be transformative for patients with RRMM, said Michael Rosenzweig, MD, of City of Hope, Duarte, California, in an interview with Medscape Medical News.
The [MajesTEC-3] findings suggest that Tec-Dar “really gives patients a chance at long-term disease control,” added Rosenzweig, chief of the Division of Multiple Myeloma, and an associate professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope.
MajesTEC-3 was funded by Johnson & Johnson. Mateos disclosed relationships with numerous pharmaceutical companies, including Johnson & Johnson. Rosenzweig reported consulting for Johnson & Johnson and was previously on the company’s speakers bureau.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and health care topics. She can be reached at [email protected] or on X: @SW_MedReporter.
Adding teclistamab to daratumumab dramatically improved progression-free survival and overall survival vs standard-of-care (SOC) therapy in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 MajesTEC-3 trial.
At median follow-up of 34.5 months, progression-free survival was not reached in study participants randomized to receive teclistamab plus daratumumab (Tec-Dara). Starkly contrasting that was the 18.1 months progression-free survival among those randomized to a control group who received the standard of care: investigator’s choice of daratumumab and dexamethasone plus either pomalidomide or bortezomib (DPd/DVd (hazard ratio [HR], 0.17). Overall survival also significantly favored Tec-Dara (HR, 0.46).
Lead investigator María-Victoria Mateos, MD, PhD, reported the findings in a late-breaking abstract session at American Society of Hematology (ASH) 2025 Annual Meeting. They were published simultaneously in The New England Journal of Medicine.
“[Tec-Dara in this setting] generated the greatest progression-free survival treatment effect to date [in RRMR] with a plateau phase after 6 months of therapy, suggesting potential for functional cure,” said Mateos, a consultant physician and associate professor at the University of Salamanca, Salamanca, Spain.
“We consider that this synergistic immunotherapy combination…is a new potential standard of care for relapsed or refractory multiple myeloma after at least on prior line of therapy, with broad potential across academic and community settings,” added Mateos, who also directs the Multiple Myeloma Program at the University.
Based on the MajesTEC-3 findings, the FDA proactively awarded a national priority voucher to Tec-Dara under the Commissioner’s National Priority Voucher pilot program designed to accelerate the review of certain promising products.
About Tec-Dara
Teclistamab (Tecvayli) is an off-the-shelf first-in-class bispecific monoclonal antibody shown in the MajesTEC-1 trial to provide deep, durable responses in RRMM, with improved efficacy and safety with earlier lines of therapy. The FDA approved the agent for use in 4th or greater lines of therapy in 2022 based on those findings.
Daratumumab (Darzalex) is a widely used anti-CD38 monoclonal antibody currently considered the SOC therapy for RRMM. Both agents are products of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Although front-line therapy for multiple myeloma has dramatically improved, there is a need for new, more effective treatment strategies in patients with disease progression, Mateos noted.
Therefore, she and her colleagues conducted MajesTEC-3, a randomized trial exploring the fully immunotherapy-based regimen of Tec-Dara vs daratumumab-based SOC in patients who had received one to three prior lines of therapy, including a proteasome inhibitor and lenalidomide (Len).
The study was the first to test a bispecific monoclonal antibody as early as the first relapse after initial treatment, she noted.
About MajesTEC-3
Study participants were 587 adults aged 25-88 years. Those with one prior line of therapy were required to be Len-refractory with progressive disease on or after the last therapy. Prior anti-CD-38 Patients with prior B-cell maturation antigen-directed therapy or who were refractory to anti-CD38 treatment were excluded.
The 291 patients randomized to the Tec-Dara treatment group and 296 randomized to the control group were treated in 28-day cycles according to the standard daratumumab schedule: weekly treatment during cycles 1 and 2, biweekly treatment during cycles 3-6, and monthly treatments beginning with cycle 7.
Teclistamab was initiated with an approved step-up dose school followed by 1.5 mg/kg weekly in cycles 1 and 2, 3 mg/kg biweekly in cycles 3-6, and 3 mg/kg monthly beginning with cycle 7.
The 36-month progression-free survival rates with Tec-Dara vs DPd/DVd were 83.4% and 29.7%, with the 36-month overall survival rates having been 83.3% and 65.0%. More than 90% of patients in the Tec-Dara group who were alive at 6 months were also alive at 30 months, Mateos noted.
For both progression-free survival and overall survival, the “clinically remarkable and statistically significant” differences were apparent across all prespecified and clinically relevant subgroups, she added. These included patients who were 75 years or older, Len-refractory patients, and those with high-risk cytogenetics, ≥ 60% bone marrow plasma cells, soft-tissue plasmacytomas, and anti-CD38 exposure.
Patients receiving Tec-Dara also had significantly higher rates of complete or better responses (81.8% vs 32.1%; odds ratio [OR], 9.56), overall response (89.0% vs 75.3%; OR, 2.65), and minimal residual disease-negativity (58.4% vs 17.1%; OR, 6.78).
The median time to first response and first complete or better response was similar in the two groups, but 36-month duration of response was 88.5 vs 36.4 months. At data cutoff, 49.4% of patients remained on study treatment — 71.0% in the Tec-Dara group and 28.3% in the DPd/DVd group, and median treatment duration was twice as long with Tec-Dara (32.4 vs 16.1 months), she said.
Serious adverse events occurred at similar rates in the treatment and control groups (70.7% and 62.4%) and most (44.2%) were grade 1 cytokine release syndrome (CRS). No grade 3 CRS occurred, and all CRS cases resolved.
Immune effector-cell-associated neurotoxicity occurred in 1.1% of patients, and all cases resolved.
Treatment-related adverse events leading to discontinuation occurred in 4.6% and 5.5% of patients in the Tec-Dara and DPd/DVd groups. The rates of deaths due to treatment-emergent adverse events were also similar in the groups (7.1% vs 5.9%).
Infections of any grade occurred in 96.5% and 84.1% of Tec-Dara and DPd/DVd patients, and grade 3/4 infections occurred in 54.1% and 43.4%. New-onset grade 3 or greater infections decreased over time.
“It’s important to acknowledge that patients with infections needed to be supported with adequate prophylaxis and immunoglobulins,” Mateo stressed.
Implications for Patients With RRMM
Teclistamab is currently only approved after three prior lines of therapy, but under the FDA Commissioner’s National Priority Voucher program, the agency will aim to complete its review of Tec-Dara for earlier treatment within 1-2 months following submission of an application for approval by Johnson & Johnson.
If an approval for that indication were to occur, it would be transformative for patients with RRMM, said Michael Rosenzweig, MD, of City of Hope, Duarte, California, in an interview with Medscape Medical News.
The [MajesTEC-3] findings suggest that Tec-Dar “really gives patients a chance at long-term disease control,” added Rosenzweig, chief of the Division of Multiple Myeloma, and an associate professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope.
MajesTEC-3 was funded by Johnson & Johnson. Mateos disclosed relationships with numerous pharmaceutical companies, including Johnson & Johnson. Rosenzweig reported consulting for Johnson & Johnson and was previously on the company’s speakers bureau.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and health care topics. She can be reached at [email protected] or on X: @SW_MedReporter.
Novel Treatment Combo Ups Survival in Multiple Myeloma
Novel Treatment Combo Ups Survival in Multiple Myeloma
NICE Endorses Chemo-Free First-Line Options for EGFR NSCLC
NICE Endorses Chemo-Free First-Line Options for EGFR NSCLC
The National Institute for Health and Care Excellence (NICE) has recommended amivantamab (Rybrevant) plus lazertinib (Lazcluze) as a first-line option for adults with previously untreated advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
In final draft guidance, NICE said the combination therapy should be funded by the NHS in England for eligible patients when it is the most appropriate option. Around 1115 people are expected to benefit.
Lung cancer is the third most common cancer and the leading cause of cancer mortality in the UK. It accounted for 10% of all new cancer diagnoses and 20% of cancer deaths in 2020. Approximately 31,000 people received NSCLC diagnoses in England in 2021, comprising 91% of all lung cancer cases. EGFR mutation-positive NSCLC is more common in women, non-smokers, and individuals from Asian ethnic backgrounds.
Welcoming the decision, Virginia Harrison, research trustee, EGFR+ UK, said, “This is a meaningful advance for patients and their families facing this diagnosis. [It] provides something the EGFR community urgently needs: more choice in first-line treatment.”
How Practice May Shift
The recommendation adds an alternative to existing standards, including osimertinib monotherapy or osimertinib plus pemetrexed/platinum-based chemotherapy. Clinical specialists noted that no single standard care exists for this patient group.
Younger patients and those willing to accept greater side effects may choose between amivantamab plus lazertinib or osimertinib plus chemotherapy. Patients older than 80 years might prefer osimertinib monotherapy due to adverse event considerations.
Mechanism of Action and Clinical Evidence
Amivantamab is a bispecific antibody that simultaneously binds EGFR and mesenchymal-epithelial transition receptors, blocking downstream signaling pathways that drive tumor growth and promoting immune-mediated cancer cell killing. Lazertinib is an oral third-generation EGFR TKI that selectively inhibits mutant EGFR signaling. Together, the agents provides complementary suppression of EGFR-driven tumour growth and resistance mechanisms.
The NICE recommendation is supported by results from the phase 3 MARIPOSA trial, which met its primary endpoint of progression-free survival (PFS). Treatment with amivantamab plus lazertinib significantly prolonged median PFS to 23.7 months compared with 16.6 months with osimertinib. The combination also demonstrated a significant improvement in overall survival, reducing the risk for death by 25% vs osimertinib. Median OS was not reached in the combination arm and was 36.7 months with osimertinib.
The most common adverse reactions with the combination included rash, nail toxicity, hypoalbuminaemia, hepatotoxicity, and stomatitis.
A Medicines and Healthcare products Regulatory Agency-approved subcutaneous formulation of amivantamab, authorized after the committee’s initial meeting, may further improve tolerability and convenience. Administration-related reactions occurred in 63% of patients with the intravenous formulation vs 14% with the subcutaneous formulation. Clinicians expect subcutaneous dosing to replace intravenous use in practice.
Dosing, Access, and Implementation
Amivantamab is administered every 2 weeks, either intravenously or subcutaneously. Lazertinib is taken as a daily oral tablet.
Rybrevant costs £1079 for a 350-mg per 7-mL vial. Lazcluze is priced at £4128.50 for 56 x 80-mg tablets and £6192.75 for 28 x 240-mg tablets. Confidential NHS discounts are available through simple patient access schemes.
Integrated care boards, NHS England, and local authorities must implement the guidance within 90 days of publication. For drugs receiving positive draft recommendations for routine commissioning, interim funding becomes accessible from the Cancer Drugs Fund budget starting from the point of marketing authorisation or publication of draft guidance.
The National Institute for Health and Care Excellence (NICE) has recommended amivantamab (Rybrevant) plus lazertinib (Lazcluze) as a first-line option for adults with previously untreated advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
In final draft guidance, NICE said the combination therapy should be funded by the NHS in England for eligible patients when it is the most appropriate option. Around 1115 people are expected to benefit.
Lung cancer is the third most common cancer and the leading cause of cancer mortality in the UK. It accounted for 10% of all new cancer diagnoses and 20% of cancer deaths in 2020. Approximately 31,000 people received NSCLC diagnoses in England in 2021, comprising 91% of all lung cancer cases. EGFR mutation-positive NSCLC is more common in women, non-smokers, and individuals from Asian ethnic backgrounds.
Welcoming the decision, Virginia Harrison, research trustee, EGFR+ UK, said, “This is a meaningful advance for patients and their families facing this diagnosis. [It] provides something the EGFR community urgently needs: more choice in first-line treatment.”
How Practice May Shift
The recommendation adds an alternative to existing standards, including osimertinib monotherapy or osimertinib plus pemetrexed/platinum-based chemotherapy. Clinical specialists noted that no single standard care exists for this patient group.
Younger patients and those willing to accept greater side effects may choose between amivantamab plus lazertinib or osimertinib plus chemotherapy. Patients older than 80 years might prefer osimertinib monotherapy due to adverse event considerations.
Mechanism of Action and Clinical Evidence
Amivantamab is a bispecific antibody that simultaneously binds EGFR and mesenchymal-epithelial transition receptors, blocking downstream signaling pathways that drive tumor growth and promoting immune-mediated cancer cell killing. Lazertinib is an oral third-generation EGFR TKI that selectively inhibits mutant EGFR signaling. Together, the agents provides complementary suppression of EGFR-driven tumour growth and resistance mechanisms.
The NICE recommendation is supported by results from the phase 3 MARIPOSA trial, which met its primary endpoint of progression-free survival (PFS). Treatment with amivantamab plus lazertinib significantly prolonged median PFS to 23.7 months compared with 16.6 months with osimertinib. The combination also demonstrated a significant improvement in overall survival, reducing the risk for death by 25% vs osimertinib. Median OS was not reached in the combination arm and was 36.7 months with osimertinib.
The most common adverse reactions with the combination included rash, nail toxicity, hypoalbuminaemia, hepatotoxicity, and stomatitis.
A Medicines and Healthcare products Regulatory Agency-approved subcutaneous formulation of amivantamab, authorized after the committee’s initial meeting, may further improve tolerability and convenience. Administration-related reactions occurred in 63% of patients with the intravenous formulation vs 14% with the subcutaneous formulation. Clinicians expect subcutaneous dosing to replace intravenous use in practice.
Dosing, Access, and Implementation
Amivantamab is administered every 2 weeks, either intravenously or subcutaneously. Lazertinib is taken as a daily oral tablet.
Rybrevant costs £1079 for a 350-mg per 7-mL vial. Lazcluze is priced at £4128.50 for 56 x 80-mg tablets and £6192.75 for 28 x 240-mg tablets. Confidential NHS discounts are available through simple patient access schemes.
Integrated care boards, NHS England, and local authorities must implement the guidance within 90 days of publication. For drugs receiving positive draft recommendations for routine commissioning, interim funding becomes accessible from the Cancer Drugs Fund budget starting from the point of marketing authorisation or publication of draft guidance.
The National Institute for Health and Care Excellence (NICE) has recommended amivantamab (Rybrevant) plus lazertinib (Lazcluze) as a first-line option for adults with previously untreated advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
In final draft guidance, NICE said the combination therapy should be funded by the NHS in England for eligible patients when it is the most appropriate option. Around 1115 people are expected to benefit.
Lung cancer is the third most common cancer and the leading cause of cancer mortality in the UK. It accounted for 10% of all new cancer diagnoses and 20% of cancer deaths in 2020. Approximately 31,000 people received NSCLC diagnoses in England in 2021, comprising 91% of all lung cancer cases. EGFR mutation-positive NSCLC is more common in women, non-smokers, and individuals from Asian ethnic backgrounds.
Welcoming the decision, Virginia Harrison, research trustee, EGFR+ UK, said, “This is a meaningful advance for patients and their families facing this diagnosis. [It] provides something the EGFR community urgently needs: more choice in first-line treatment.”
How Practice May Shift
The recommendation adds an alternative to existing standards, including osimertinib monotherapy or osimertinib plus pemetrexed/platinum-based chemotherapy. Clinical specialists noted that no single standard care exists for this patient group.
Younger patients and those willing to accept greater side effects may choose between amivantamab plus lazertinib or osimertinib plus chemotherapy. Patients older than 80 years might prefer osimertinib monotherapy due to adverse event considerations.
Mechanism of Action and Clinical Evidence
Amivantamab is a bispecific antibody that simultaneously binds EGFR and mesenchymal-epithelial transition receptors, blocking downstream signaling pathways that drive tumor growth and promoting immune-mediated cancer cell killing. Lazertinib is an oral third-generation EGFR TKI that selectively inhibits mutant EGFR signaling. Together, the agents provides complementary suppression of EGFR-driven tumour growth and resistance mechanisms.
The NICE recommendation is supported by results from the phase 3 MARIPOSA trial, which met its primary endpoint of progression-free survival (PFS). Treatment with amivantamab plus lazertinib significantly prolonged median PFS to 23.7 months compared with 16.6 months with osimertinib. The combination also demonstrated a significant improvement in overall survival, reducing the risk for death by 25% vs osimertinib. Median OS was not reached in the combination arm and was 36.7 months with osimertinib.
The most common adverse reactions with the combination included rash, nail toxicity, hypoalbuminaemia, hepatotoxicity, and stomatitis.
A Medicines and Healthcare products Regulatory Agency-approved subcutaneous formulation of amivantamab, authorized after the committee’s initial meeting, may further improve tolerability and convenience. Administration-related reactions occurred in 63% of patients with the intravenous formulation vs 14% with the subcutaneous formulation. Clinicians expect subcutaneous dosing to replace intravenous use in practice.
Dosing, Access, and Implementation
Amivantamab is administered every 2 weeks, either intravenously or subcutaneously. Lazertinib is taken as a daily oral tablet.
Rybrevant costs £1079 for a 350-mg per 7-mL vial. Lazcluze is priced at £4128.50 for 56 x 80-mg tablets and £6192.75 for 28 x 240-mg tablets. Confidential NHS discounts are available through simple patient access schemes.
Integrated care boards, NHS England, and local authorities must implement the guidance within 90 days of publication. For drugs receiving positive draft recommendations for routine commissioning, interim funding becomes accessible from the Cancer Drugs Fund budget starting from the point of marketing authorisation or publication of draft guidance.
NICE Endorses Chemo-Free First-Line Options for EGFR NSCLC
NICE Endorses Chemo-Free First-Line Options for EGFR NSCLC
Marathon Runners May Have Higher Colon Cancer Risk
Marathon Runners May Have Higher Colon Cancer Risk
Intensive long-distance running could be a risk for advanced adenomas (AAs) for the colon, a small prospective study reported this summer at the American Society of Clinical Oncology (ASCO) 2025.
Refined screening strategies for this running population are therefore warranted, and pathologic and epidemiologic evaluations should explore causation and ancillary risk factors in this unique population, according to Timothy L. Cannon, MD, oncologist at Inova Schar Cancer Institute in Fairfax, Virginia, and colleagues.
The full study (NCT 05419531), which is currently being reviewed for publication, looked at colonoscopy results from 100 marathon and ultramarathon runners and found that almost half had polyps, and 15% (95% CI, 7.9-22.4) had confirmed AAs).
The AA rate was higher than the 4.5% to 6% seen in adults in their late 40s in the general population and was higher even than the 12% found in Alaska Natives, who are at heightened risk for colon cancer.
"After meeting 3 extreme endurance athletes — 2 who ran 100-mile ultramarathons and 1 lady who ran dozens of triathlons — with stage IV colon cancer before age 40, I began to be suspicious of a link," Cannon told Medscape Medical News. At least 2 of them said they were told that bleeding after long runs was common, which they took to mean as normal. "I could imagine multiple reasons that endurance runners would be predisposed to cancer, with my initial focus on the inflammation and cell turnover incited by the well-described ischemia and runner's colitis."
Study Details
From October 2022 to December 2024, 100 eligible participants aged 35 to 50 years had colonoscopies. The median age was 42.5 years; 55 participants were female and 45 were male. In terms of endurance eligibility, all had completed at ≥ 2 registered ultramarathons (50 km or longer) or 5 registered marathons (26.2 miles). Patients were excluded if they were known or suspected to have inflammatory bowel disease, familial adenomatous polyposis, or Lynch syndrome (hereditary nonpolyposis colorectal cancer).
The historical 1.2% in average-risk individuals aged 40-49 years was used for the expected rate of AAs, defined as lesions > 10 mm, lesions with 25% tubulovillous features, or high-grade dysplasia.
In other findings, 39 had ≥ 1 adenoma and had ≥ 3 adenomas but did not meet AA criteria and were not included in the 15% with AA.
While no colon cancer was detected in the cohort, Cannon said 30% experienced rectal bleeding after exercise, especially those with AAs compared with those without: 53% vs 22%. "While rectal bleeding had a significant association with finding advanced adenomas on the colonoscopy, there were still many with advanced adenomas who reported no bleeding," he said.
Runner's colitis, or trots, is a common condition thought to be related to ischemia, mechanical stress, or adverse impact on the gut microbiome. "Mechanism is the huge question that I certainly can't answer at this point," Cannon said. "At some distance, blood flow gets diverted from the splanchnic circulation to the legs, and gut ischemia seems to ensue. I envision high rates of disorderly cell turnover and more opportunities for mutagenesis. This needs to be studied, and what I am describing is certainly either an oversimplification or simply not related at all."
The authors noted that exercise-induced gastrointestinal injury is likely associated with reduced blood flow to the intestines during long-distance running, but not evidence has linked this bowel ischemia to carcinogenesis.
Diet could be another factor. "I am fascinated with runners' diets. They seem to consume, on average, a huge amount of ultraprocessed bars and goos. They also may drink from plastic bottles far more than the average person. These are just 2 of many possibilities," Cannon said. "Nearly a third of our participants were vegan or vegetarian. We are planning a second, more detailed, survey or our participants. We will really dig down on these questions as well as specifics regarding their training regimens."
Commenting on the study but not involved in it, Thomas F. Imperiale, MD, professor of gastroenterology and hepatology at Indiana University Indianapolis, said that while the findings are provocative, several methodological issues require consideration in subsequent research.
"First, the comparative benchmark of advanced adenoma prevalence of 1.2% is based on screening colonoscopy data from 25 years ago. At the very least, a concurrent benchmark should be used," he told Medscape Medical News. The second issue is the absence of a control group of persons who may exercise but who do not run marathons. "This addition would strengthen study validity more than using a concurrent comparison."
The case group of long-distance runners and a control group of nonmarathon runners could be compared for prevalence of AAs with adjustment for age, sex, race or ethnicity, family history of colorectal cancer, diet, other physical activity, tobacco use history, BMI or waist circumference, ethanol use, and perhaps other early-life exposures and indication for colonoscopy. "Last, it would be interesting to know whether and how often the 100 participants developed symptoms possibly consistent with colonic ischemia either during or after long-distance runs, which might provide indirect support for the presumptive mechanism of action."
In other comments, Hamed Khalili, MD, MPH, gastroenterologist at Massachusetts General Hospital and associate professor at Harvard Medical School, both in Boston, called the results very preliminary. "The sample size is small, and the comparator group is a historical control, so it's unclear whether the observed differences are just a sampling issue," he said.
Cannon has this advice for physicians: "Please don't dismiss symptoms of runner's colitis as benign. This condition requires investigation," he said. While he hasn't seen any expert recommendation to treat postrunning bleeding any differently from other causes of melena or hematochezia, both of which would normally merit a colonoscopy, in practice many gastroenterologists dismiss this type of bleeding as benign. "If larger studies confirm our findings, I don't think it's out of the question that marathoners will have unique screening recommendations. But this study is not robust enough, of course, to merit such a recommendation."
His group is planning a study on the runner's microbiome and on the proteome of the colonic tissue in this group.
Cannon reported having no relevant conflicts of interest to disclose. Imperiale and Khalili reported having no conflicts of interest relevant to their comments on the study.
A version of this article first appeared on Medscape.com.
Intensive long-distance running could be a risk for advanced adenomas (AAs) for the colon, a small prospective study reported this summer at the American Society of Clinical Oncology (ASCO) 2025.
Refined screening strategies for this running population are therefore warranted, and pathologic and epidemiologic evaluations should explore causation and ancillary risk factors in this unique population, according to Timothy L. Cannon, MD, oncologist at Inova Schar Cancer Institute in Fairfax, Virginia, and colleagues.
The full study (NCT 05419531), which is currently being reviewed for publication, looked at colonoscopy results from 100 marathon and ultramarathon runners and found that almost half had polyps, and 15% (95% CI, 7.9-22.4) had confirmed AAs).
The AA rate was higher than the 4.5% to 6% seen in adults in their late 40s in the general population and was higher even than the 12% found in Alaska Natives, who are at heightened risk for colon cancer.
"After meeting 3 extreme endurance athletes — 2 who ran 100-mile ultramarathons and 1 lady who ran dozens of triathlons — with stage IV colon cancer before age 40, I began to be suspicious of a link," Cannon told Medscape Medical News. At least 2 of them said they were told that bleeding after long runs was common, which they took to mean as normal. "I could imagine multiple reasons that endurance runners would be predisposed to cancer, with my initial focus on the inflammation and cell turnover incited by the well-described ischemia and runner's colitis."
Study Details
From October 2022 to December 2024, 100 eligible participants aged 35 to 50 years had colonoscopies. The median age was 42.5 years; 55 participants were female and 45 were male. In terms of endurance eligibility, all had completed at ≥ 2 registered ultramarathons (50 km or longer) or 5 registered marathons (26.2 miles). Patients were excluded if they were known or suspected to have inflammatory bowel disease, familial adenomatous polyposis, or Lynch syndrome (hereditary nonpolyposis colorectal cancer).
The historical 1.2% in average-risk individuals aged 40-49 years was used for the expected rate of AAs, defined as lesions > 10 mm, lesions with 25% tubulovillous features, or high-grade dysplasia.
In other findings, 39 had ≥ 1 adenoma and had ≥ 3 adenomas but did not meet AA criteria and were not included in the 15% with AA.
While no colon cancer was detected in the cohort, Cannon said 30% experienced rectal bleeding after exercise, especially those with AAs compared with those without: 53% vs 22%. "While rectal bleeding had a significant association with finding advanced adenomas on the colonoscopy, there were still many with advanced adenomas who reported no bleeding," he said.
Runner's colitis, or trots, is a common condition thought to be related to ischemia, mechanical stress, or adverse impact on the gut microbiome. "Mechanism is the huge question that I certainly can't answer at this point," Cannon said. "At some distance, blood flow gets diverted from the splanchnic circulation to the legs, and gut ischemia seems to ensue. I envision high rates of disorderly cell turnover and more opportunities for mutagenesis. This needs to be studied, and what I am describing is certainly either an oversimplification or simply not related at all."
The authors noted that exercise-induced gastrointestinal injury is likely associated with reduced blood flow to the intestines during long-distance running, but not evidence has linked this bowel ischemia to carcinogenesis.
Diet could be another factor. "I am fascinated with runners' diets. They seem to consume, on average, a huge amount of ultraprocessed bars and goos. They also may drink from plastic bottles far more than the average person. These are just 2 of many possibilities," Cannon said. "Nearly a third of our participants were vegan or vegetarian. We are planning a second, more detailed, survey or our participants. We will really dig down on these questions as well as specifics regarding their training regimens."
Commenting on the study but not involved in it, Thomas F. Imperiale, MD, professor of gastroenterology and hepatology at Indiana University Indianapolis, said that while the findings are provocative, several methodological issues require consideration in subsequent research.
"First, the comparative benchmark of advanced adenoma prevalence of 1.2% is based on screening colonoscopy data from 25 years ago. At the very least, a concurrent benchmark should be used," he told Medscape Medical News. The second issue is the absence of a control group of persons who may exercise but who do not run marathons. "This addition would strengthen study validity more than using a concurrent comparison."
The case group of long-distance runners and a control group of nonmarathon runners could be compared for prevalence of AAs with adjustment for age, sex, race or ethnicity, family history of colorectal cancer, diet, other physical activity, tobacco use history, BMI or waist circumference, ethanol use, and perhaps other early-life exposures and indication for colonoscopy. "Last, it would be interesting to know whether and how often the 100 participants developed symptoms possibly consistent with colonic ischemia either during or after long-distance runs, which might provide indirect support for the presumptive mechanism of action."
In other comments, Hamed Khalili, MD, MPH, gastroenterologist at Massachusetts General Hospital and associate professor at Harvard Medical School, both in Boston, called the results very preliminary. "The sample size is small, and the comparator group is a historical control, so it's unclear whether the observed differences are just a sampling issue," he said.
Cannon has this advice for physicians: "Please don't dismiss symptoms of runner's colitis as benign. This condition requires investigation," he said. While he hasn't seen any expert recommendation to treat postrunning bleeding any differently from other causes of melena or hematochezia, both of which would normally merit a colonoscopy, in practice many gastroenterologists dismiss this type of bleeding as benign. "If larger studies confirm our findings, I don't think it's out of the question that marathoners will have unique screening recommendations. But this study is not robust enough, of course, to merit such a recommendation."
His group is planning a study on the runner's microbiome and on the proteome of the colonic tissue in this group.
Cannon reported having no relevant conflicts of interest to disclose. Imperiale and Khalili reported having no conflicts of interest relevant to their comments on the study.
A version of this article first appeared on Medscape.com.
Intensive long-distance running could be a risk for advanced adenomas (AAs) for the colon, a small prospective study reported this summer at the American Society of Clinical Oncology (ASCO) 2025.
Refined screening strategies for this running population are therefore warranted, and pathologic and epidemiologic evaluations should explore causation and ancillary risk factors in this unique population, according to Timothy L. Cannon, MD, oncologist at Inova Schar Cancer Institute in Fairfax, Virginia, and colleagues.
The full study (NCT 05419531), which is currently being reviewed for publication, looked at colonoscopy results from 100 marathon and ultramarathon runners and found that almost half had polyps, and 15% (95% CI, 7.9-22.4) had confirmed AAs).
The AA rate was higher than the 4.5% to 6% seen in adults in their late 40s in the general population and was higher even than the 12% found in Alaska Natives, who are at heightened risk for colon cancer.
"After meeting 3 extreme endurance athletes — 2 who ran 100-mile ultramarathons and 1 lady who ran dozens of triathlons — with stage IV colon cancer before age 40, I began to be suspicious of a link," Cannon told Medscape Medical News. At least 2 of them said they were told that bleeding after long runs was common, which they took to mean as normal. "I could imagine multiple reasons that endurance runners would be predisposed to cancer, with my initial focus on the inflammation and cell turnover incited by the well-described ischemia and runner's colitis."
Study Details
From October 2022 to December 2024, 100 eligible participants aged 35 to 50 years had colonoscopies. The median age was 42.5 years; 55 participants were female and 45 were male. In terms of endurance eligibility, all had completed at ≥ 2 registered ultramarathons (50 km or longer) or 5 registered marathons (26.2 miles). Patients were excluded if they were known or suspected to have inflammatory bowel disease, familial adenomatous polyposis, or Lynch syndrome (hereditary nonpolyposis colorectal cancer).
The historical 1.2% in average-risk individuals aged 40-49 years was used for the expected rate of AAs, defined as lesions > 10 mm, lesions with 25% tubulovillous features, or high-grade dysplasia.
In other findings, 39 had ≥ 1 adenoma and had ≥ 3 adenomas but did not meet AA criteria and were not included in the 15% with AA.
While no colon cancer was detected in the cohort, Cannon said 30% experienced rectal bleeding after exercise, especially those with AAs compared with those without: 53% vs 22%. "While rectal bleeding had a significant association with finding advanced adenomas on the colonoscopy, there were still many with advanced adenomas who reported no bleeding," he said.
Runner's colitis, or trots, is a common condition thought to be related to ischemia, mechanical stress, or adverse impact on the gut microbiome. "Mechanism is the huge question that I certainly can't answer at this point," Cannon said. "At some distance, blood flow gets diverted from the splanchnic circulation to the legs, and gut ischemia seems to ensue. I envision high rates of disorderly cell turnover and more opportunities for mutagenesis. This needs to be studied, and what I am describing is certainly either an oversimplification or simply not related at all."
The authors noted that exercise-induced gastrointestinal injury is likely associated with reduced blood flow to the intestines during long-distance running, but not evidence has linked this bowel ischemia to carcinogenesis.
Diet could be another factor. "I am fascinated with runners' diets. They seem to consume, on average, a huge amount of ultraprocessed bars and goos. They also may drink from plastic bottles far more than the average person. These are just 2 of many possibilities," Cannon said. "Nearly a third of our participants were vegan or vegetarian. We are planning a second, more detailed, survey or our participants. We will really dig down on these questions as well as specifics regarding their training regimens."
Commenting on the study but not involved in it, Thomas F. Imperiale, MD, professor of gastroenterology and hepatology at Indiana University Indianapolis, said that while the findings are provocative, several methodological issues require consideration in subsequent research.
"First, the comparative benchmark of advanced adenoma prevalence of 1.2% is based on screening colonoscopy data from 25 years ago. At the very least, a concurrent benchmark should be used," he told Medscape Medical News. The second issue is the absence of a control group of persons who may exercise but who do not run marathons. "This addition would strengthen study validity more than using a concurrent comparison."
The case group of long-distance runners and a control group of nonmarathon runners could be compared for prevalence of AAs with adjustment for age, sex, race or ethnicity, family history of colorectal cancer, diet, other physical activity, tobacco use history, BMI or waist circumference, ethanol use, and perhaps other early-life exposures and indication for colonoscopy. "Last, it would be interesting to know whether and how often the 100 participants developed symptoms possibly consistent with colonic ischemia either during or after long-distance runs, which might provide indirect support for the presumptive mechanism of action."
In other comments, Hamed Khalili, MD, MPH, gastroenterologist at Massachusetts General Hospital and associate professor at Harvard Medical School, both in Boston, called the results very preliminary. "The sample size is small, and the comparator group is a historical control, so it's unclear whether the observed differences are just a sampling issue," he said.
Cannon has this advice for physicians: "Please don't dismiss symptoms of runner's colitis as benign. This condition requires investigation," he said. While he hasn't seen any expert recommendation to treat postrunning bleeding any differently from other causes of melena or hematochezia, both of which would normally merit a colonoscopy, in practice many gastroenterologists dismiss this type of bleeding as benign. "If larger studies confirm our findings, I don't think it's out of the question that marathoners will have unique screening recommendations. But this study is not robust enough, of course, to merit such a recommendation."
His group is planning a study on the runner's microbiome and on the proteome of the colonic tissue in this group.
Cannon reported having no relevant conflicts of interest to disclose. Imperiale and Khalili reported having no conflicts of interest relevant to their comments on the study.
A version of this article first appeared on Medscape.com.
Marathon Runners May Have Higher Colon Cancer Risk
Marathon Runners May Have Higher Colon Cancer Risk
Updated Crohn’s Disease Guideline Stresses Early Use of Advanced Drugs
As the science of Crohn’s disease (CD) rapidly evolves,
The guideline was published in Gastroenterology by an expert panel chaired by Frank I. Scott, MD, MSCE, a gastroenterologist at the Crohn’s and Colitis Center in the Division of Gastroenterology and Hepatology at the University of Colorado Anschutz School of Medicine in Aurora, Colorado.
It makes 16 main recommendations in a comprehensive, patient-centered, evidence-based approach to utilizing an array of medical options endorsing early use of advanced therapies such as biologics. Of these, one is a strong recommendation, nine are conditional recommendations, and six are identified as knowledge gaps.
“There’s been a significant increase in the number of therapies available for clinicians and patients when considering treatment options for moderate-to-severe [CD] since the prior guidelines in 2021,” Scott told GI & Hepatology News. “We hope these guidelines will help clinicians determine how to maximize the potential benefit of the full armamentarium of therapies available to treat this disease.”
Guideline co-author Siddharth Singh, MD, MS, of the Division of Gastroenterology and Hepatology at the Mayo Clinic Arizona in Scottsdale, Arizona, said the goal of the guideline is to translate evidence into clear, meaningful recommendations for frontline clinicians. “It’s patient centered but also provider centric. We want to help physicians and advanced practice providers make timely, actionable decisions for their patients.”
Among the recommendations:
- Early initiation of high-efficacy advanced therapy to prevent progression is recommended over insurance-driven step therapy.
- For adult patients naive to advanced therapies, the AGA recommends infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, or upadacitinib over no treatment and suggests the use of certolizumab pegol or vedolizumab over no treatment.
- For adults naive to advanced therapies, the AGA suggests using a higher-efficacy medication (infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab, mirikizumab, or guselkumab) rather than a lower-efficacy option (certolizumab pegol or upadacitinib).
- For those previously exposed to one or more advanced therapies, the AGA suggests a higher-efficacy medication (adalimumab, risankizumab, guselkumab, or upadacitinib) or an intermediate-efficacy medication (ustekinumab or mirikizumab) rather than a lower-efficacy medication (vedolizumab or certolizumab pegol).
- For adult outpatients, the AGA suggests against thiopurine monotherapy for induction of remission but suggests thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission.
- The guideline favors subcutaneous methotrexate for induction and maintenance of remission but suggests against oral methotrexate.
- Combination therapy with infliximab and thiopurines is suggested over infliximab monotherapy, particularly in those naive to thiopurines.
“We identified several critical knowledge gaps, including the role of combination therapy for non-[TNF] biologics, as well as whether targeting endoscopic remission as opposed to clinical remission yields additional benefit,” Scott said.
Most of the panel’s time was spent considering evidence and recommendations in relation to how therapies should be positioned among each other in light of patients’ treatment history. “For those who were advanced therapy-naive, we used two groups, or ‘buckets’: higher and lower efficacy,” Scott said. “For advanced therapy-exposed individuals, we used higher, intermediate, and lower buckets, recommending the use of higher- or intermediate-efficacy medications.” Network meta-analyses were done to determine which therapies belong in which categories.
Perhaps the most unexpected outcome from the panel’s review was the inability to make a recommendation on treating to a target of mucosal healing. “This target conceptually makes sense, but prospective clinical trial data supporting this approach over targeting clinical remission unfortunately are currently limited,” Scott said. Several ongoing clinical trials are assessing this endpoint. “We hope future versions of these guidelines can make a formal recommendation regarding targeting mucosal healing. The benefit of our living guideline approach is that as these data become available, we will be able incorporate them more rapidly.”
Offering a nonparticipant’s perspective on the living, updatable guideline, Ahmed Hassan Gemei, MD, a gastroenterologist at Northwell North Shore University Hospital in Manhasset, New York, said the update was needed because of the shifting therapeutic landscape.
“As great as that is for patient care, it can be daunting for gastroenterologists to keep up with the onslaught of evidence and growing repertoire of advanced therapies,” he told GI & Hepatology News. “For a rapidly evolving field like inflammatory bowel disease, having a guideline come out once every 3-5 years can lag behind the evidence significantly. There is something special and much needed about a living guideline that gets regularly updated as newer data come out, which we have come to appreciate with the AGA living guidelines for ulcerative colitis.”
As to facilitating clinical decision-making, Gemei added, “It does a great job at summarizing the available evidence, making life easier for gastroenterologists who are trying to make evidence-based decisions for their patients. But having a straightforward algorithmic approach to the management of [CD] is ultimately limited by patient-specific differences and patient and payor preferences, as well as gaps in the data such as comparative effectiveness, sequencing of therapy, and advanced dual therapies.”
When it comes to choosing a drug, for example, gastroenterologists are given a general overview of which ones have higher or lower efficacy, but the choice depends on multiple factors, including CD phenotype, previous medications, and patient preference with regard to relative safety, as well as payor preference (although clinicians often try to influence this).
The guidelines align broadly but with some differences with other societal guidelines in the US and Europe. But, said Gemei, the absence of a recommendation for or against treating to a target of endoscopic healing was surprising. “This has been standard practice in recent years based on the updated STRIDE [Selecting Therapeutic Targets in Inflammatory Bowel Disease] consensus statements, as well as recent American College of Gastroenterology guidelines. Though I understand the reason behind this decision, which was simply lack of strong data, it’s still a departure from other society recommendations and current practice. I doubt this will change how we manage our patient, though, and luckily, this is a living guideline, so as more data come out, we should see an update in this area.”
He noted that despite this and other guidelines recommending against the use of 5-aminosalicylic acids in CD, “we still see many of our colleagues using it for their [CD] patients. Hopefully, this guideline can be a helpful resource for everyone trying to update their practice.”
Gemei agreed with the authors that there are persistent knowledge gaps, including insufficient data from head-to-head effectiveness studies, optimal biologic sequencing after failure, advanced combination therapy (such as JAK inhibitors plus anti-interleukin-23), radiologic and endoscopic disease monitoring intervals, and therapy withdrawal strategies after long-term remission. “So there’s a lot we still need to understand better,” he said. “Until we have more data and guidance, we are still practicing all these things based on the available evidence as well as local practice patterns.”
Overall, said Scott, the guidance highlights the options with the best supporting evidence while incorporating the patient’s prior treatment journey. “It’s also important to emphasize that treatment decisions should be individualized and should involve shared decision-making among providers and their patients,” he added. “Patient preferences, age, active comorbidities, and pregnancy should always be considered when selecting the appropriate treatment plan.”
All funding for this guidance was supplied by AGA. The guideline chairs had no conflicts of interest, and fewer than 50% of guideline panel members had conflicts of interest. Gemei had no conflicts of interest.
A version of this article appeared on Medscape.com.
As the science of Crohn’s disease (CD) rapidly evolves,
The guideline was published in Gastroenterology by an expert panel chaired by Frank I. Scott, MD, MSCE, a gastroenterologist at the Crohn’s and Colitis Center in the Division of Gastroenterology and Hepatology at the University of Colorado Anschutz School of Medicine in Aurora, Colorado.
It makes 16 main recommendations in a comprehensive, patient-centered, evidence-based approach to utilizing an array of medical options endorsing early use of advanced therapies such as biologics. Of these, one is a strong recommendation, nine are conditional recommendations, and six are identified as knowledge gaps.
“There’s been a significant increase in the number of therapies available for clinicians and patients when considering treatment options for moderate-to-severe [CD] since the prior guidelines in 2021,” Scott told GI & Hepatology News. “We hope these guidelines will help clinicians determine how to maximize the potential benefit of the full armamentarium of therapies available to treat this disease.”
Guideline co-author Siddharth Singh, MD, MS, of the Division of Gastroenterology and Hepatology at the Mayo Clinic Arizona in Scottsdale, Arizona, said the goal of the guideline is to translate evidence into clear, meaningful recommendations for frontline clinicians. “It’s patient centered but also provider centric. We want to help physicians and advanced practice providers make timely, actionable decisions for their patients.”
Among the recommendations:
- Early initiation of high-efficacy advanced therapy to prevent progression is recommended over insurance-driven step therapy.
- For adult patients naive to advanced therapies, the AGA recommends infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, or upadacitinib over no treatment and suggests the use of certolizumab pegol or vedolizumab over no treatment.
- For adults naive to advanced therapies, the AGA suggests using a higher-efficacy medication (infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab, mirikizumab, or guselkumab) rather than a lower-efficacy option (certolizumab pegol or upadacitinib).
- For those previously exposed to one or more advanced therapies, the AGA suggests a higher-efficacy medication (adalimumab, risankizumab, guselkumab, or upadacitinib) or an intermediate-efficacy medication (ustekinumab or mirikizumab) rather than a lower-efficacy medication (vedolizumab or certolizumab pegol).
- For adult outpatients, the AGA suggests against thiopurine monotherapy for induction of remission but suggests thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission.
- The guideline favors subcutaneous methotrexate for induction and maintenance of remission but suggests against oral methotrexate.
- Combination therapy with infliximab and thiopurines is suggested over infliximab monotherapy, particularly in those naive to thiopurines.
“We identified several critical knowledge gaps, including the role of combination therapy for non-[TNF] biologics, as well as whether targeting endoscopic remission as opposed to clinical remission yields additional benefit,” Scott said.
Most of the panel’s time was spent considering evidence and recommendations in relation to how therapies should be positioned among each other in light of patients’ treatment history. “For those who were advanced therapy-naive, we used two groups, or ‘buckets’: higher and lower efficacy,” Scott said. “For advanced therapy-exposed individuals, we used higher, intermediate, and lower buckets, recommending the use of higher- or intermediate-efficacy medications.” Network meta-analyses were done to determine which therapies belong in which categories.
Perhaps the most unexpected outcome from the panel’s review was the inability to make a recommendation on treating to a target of mucosal healing. “This target conceptually makes sense, but prospective clinical trial data supporting this approach over targeting clinical remission unfortunately are currently limited,” Scott said. Several ongoing clinical trials are assessing this endpoint. “We hope future versions of these guidelines can make a formal recommendation regarding targeting mucosal healing. The benefit of our living guideline approach is that as these data become available, we will be able incorporate them more rapidly.”
Offering a nonparticipant’s perspective on the living, updatable guideline, Ahmed Hassan Gemei, MD, a gastroenterologist at Northwell North Shore University Hospital in Manhasset, New York, said the update was needed because of the shifting therapeutic landscape.
“As great as that is for patient care, it can be daunting for gastroenterologists to keep up with the onslaught of evidence and growing repertoire of advanced therapies,” he told GI & Hepatology News. “For a rapidly evolving field like inflammatory bowel disease, having a guideline come out once every 3-5 years can lag behind the evidence significantly. There is something special and much needed about a living guideline that gets regularly updated as newer data come out, which we have come to appreciate with the AGA living guidelines for ulcerative colitis.”
As to facilitating clinical decision-making, Gemei added, “It does a great job at summarizing the available evidence, making life easier for gastroenterologists who are trying to make evidence-based decisions for their patients. But having a straightforward algorithmic approach to the management of [CD] is ultimately limited by patient-specific differences and patient and payor preferences, as well as gaps in the data such as comparative effectiveness, sequencing of therapy, and advanced dual therapies.”
When it comes to choosing a drug, for example, gastroenterologists are given a general overview of which ones have higher or lower efficacy, but the choice depends on multiple factors, including CD phenotype, previous medications, and patient preference with regard to relative safety, as well as payor preference (although clinicians often try to influence this).
The guidelines align broadly but with some differences with other societal guidelines in the US and Europe. But, said Gemei, the absence of a recommendation for or against treating to a target of endoscopic healing was surprising. “This has been standard practice in recent years based on the updated STRIDE [Selecting Therapeutic Targets in Inflammatory Bowel Disease] consensus statements, as well as recent American College of Gastroenterology guidelines. Though I understand the reason behind this decision, which was simply lack of strong data, it’s still a departure from other society recommendations and current practice. I doubt this will change how we manage our patient, though, and luckily, this is a living guideline, so as more data come out, we should see an update in this area.”
He noted that despite this and other guidelines recommending against the use of 5-aminosalicylic acids in CD, “we still see many of our colleagues using it for their [CD] patients. Hopefully, this guideline can be a helpful resource for everyone trying to update their practice.”
Gemei agreed with the authors that there are persistent knowledge gaps, including insufficient data from head-to-head effectiveness studies, optimal biologic sequencing after failure, advanced combination therapy (such as JAK inhibitors plus anti-interleukin-23), radiologic and endoscopic disease monitoring intervals, and therapy withdrawal strategies after long-term remission. “So there’s a lot we still need to understand better,” he said. “Until we have more data and guidance, we are still practicing all these things based on the available evidence as well as local practice patterns.”
Overall, said Scott, the guidance highlights the options with the best supporting evidence while incorporating the patient’s prior treatment journey. “It’s also important to emphasize that treatment decisions should be individualized and should involve shared decision-making among providers and their patients,” he added. “Patient preferences, age, active comorbidities, and pregnancy should always be considered when selecting the appropriate treatment plan.”
All funding for this guidance was supplied by AGA. The guideline chairs had no conflicts of interest, and fewer than 50% of guideline panel members had conflicts of interest. Gemei had no conflicts of interest.
A version of this article appeared on Medscape.com.
As the science of Crohn’s disease (CD) rapidly evolves,
The guideline was published in Gastroenterology by an expert panel chaired by Frank I. Scott, MD, MSCE, a gastroenterologist at the Crohn’s and Colitis Center in the Division of Gastroenterology and Hepatology at the University of Colorado Anschutz School of Medicine in Aurora, Colorado.
It makes 16 main recommendations in a comprehensive, patient-centered, evidence-based approach to utilizing an array of medical options endorsing early use of advanced therapies such as biologics. Of these, one is a strong recommendation, nine are conditional recommendations, and six are identified as knowledge gaps.
“There’s been a significant increase in the number of therapies available for clinicians and patients when considering treatment options for moderate-to-severe [CD] since the prior guidelines in 2021,” Scott told GI & Hepatology News. “We hope these guidelines will help clinicians determine how to maximize the potential benefit of the full armamentarium of therapies available to treat this disease.”
Guideline co-author Siddharth Singh, MD, MS, of the Division of Gastroenterology and Hepatology at the Mayo Clinic Arizona in Scottsdale, Arizona, said the goal of the guideline is to translate evidence into clear, meaningful recommendations for frontline clinicians. “It’s patient centered but also provider centric. We want to help physicians and advanced practice providers make timely, actionable decisions for their patients.”
Among the recommendations:
- Early initiation of high-efficacy advanced therapy to prevent progression is recommended over insurance-driven step therapy.
- For adult patients naive to advanced therapies, the AGA recommends infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, or upadacitinib over no treatment and suggests the use of certolizumab pegol or vedolizumab over no treatment.
- For adults naive to advanced therapies, the AGA suggests using a higher-efficacy medication (infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab, mirikizumab, or guselkumab) rather than a lower-efficacy option (certolizumab pegol or upadacitinib).
- For those previously exposed to one or more advanced therapies, the AGA suggests a higher-efficacy medication (adalimumab, risankizumab, guselkumab, or upadacitinib) or an intermediate-efficacy medication (ustekinumab or mirikizumab) rather than a lower-efficacy medication (vedolizumab or certolizumab pegol).
- For adult outpatients, the AGA suggests against thiopurine monotherapy for induction of remission but suggests thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission.
- The guideline favors subcutaneous methotrexate for induction and maintenance of remission but suggests against oral methotrexate.
- Combination therapy with infliximab and thiopurines is suggested over infliximab monotherapy, particularly in those naive to thiopurines.
“We identified several critical knowledge gaps, including the role of combination therapy for non-[TNF] biologics, as well as whether targeting endoscopic remission as opposed to clinical remission yields additional benefit,” Scott said.
Most of the panel’s time was spent considering evidence and recommendations in relation to how therapies should be positioned among each other in light of patients’ treatment history. “For those who were advanced therapy-naive, we used two groups, or ‘buckets’: higher and lower efficacy,” Scott said. “For advanced therapy-exposed individuals, we used higher, intermediate, and lower buckets, recommending the use of higher- or intermediate-efficacy medications.” Network meta-analyses were done to determine which therapies belong in which categories.
Perhaps the most unexpected outcome from the panel’s review was the inability to make a recommendation on treating to a target of mucosal healing. “This target conceptually makes sense, but prospective clinical trial data supporting this approach over targeting clinical remission unfortunately are currently limited,” Scott said. Several ongoing clinical trials are assessing this endpoint. “We hope future versions of these guidelines can make a formal recommendation regarding targeting mucosal healing. The benefit of our living guideline approach is that as these data become available, we will be able incorporate them more rapidly.”
Offering a nonparticipant’s perspective on the living, updatable guideline, Ahmed Hassan Gemei, MD, a gastroenterologist at Northwell North Shore University Hospital in Manhasset, New York, said the update was needed because of the shifting therapeutic landscape.
“As great as that is for patient care, it can be daunting for gastroenterologists to keep up with the onslaught of evidence and growing repertoire of advanced therapies,” he told GI & Hepatology News. “For a rapidly evolving field like inflammatory bowel disease, having a guideline come out once every 3-5 years can lag behind the evidence significantly. There is something special and much needed about a living guideline that gets regularly updated as newer data come out, which we have come to appreciate with the AGA living guidelines for ulcerative colitis.”
As to facilitating clinical decision-making, Gemei added, “It does a great job at summarizing the available evidence, making life easier for gastroenterologists who are trying to make evidence-based decisions for their patients. But having a straightforward algorithmic approach to the management of [CD] is ultimately limited by patient-specific differences and patient and payor preferences, as well as gaps in the data such as comparative effectiveness, sequencing of therapy, and advanced dual therapies.”
When it comes to choosing a drug, for example, gastroenterologists are given a general overview of which ones have higher or lower efficacy, but the choice depends on multiple factors, including CD phenotype, previous medications, and patient preference with regard to relative safety, as well as payor preference (although clinicians often try to influence this).
The guidelines align broadly but with some differences with other societal guidelines in the US and Europe. But, said Gemei, the absence of a recommendation for or against treating to a target of endoscopic healing was surprising. “This has been standard practice in recent years based on the updated STRIDE [Selecting Therapeutic Targets in Inflammatory Bowel Disease] consensus statements, as well as recent American College of Gastroenterology guidelines. Though I understand the reason behind this decision, which was simply lack of strong data, it’s still a departure from other society recommendations and current practice. I doubt this will change how we manage our patient, though, and luckily, this is a living guideline, so as more data come out, we should see an update in this area.”
He noted that despite this and other guidelines recommending against the use of 5-aminosalicylic acids in CD, “we still see many of our colleagues using it for their [CD] patients. Hopefully, this guideline can be a helpful resource for everyone trying to update their practice.”
Gemei agreed with the authors that there are persistent knowledge gaps, including insufficient data from head-to-head effectiveness studies, optimal biologic sequencing after failure, advanced combination therapy (such as JAK inhibitors plus anti-interleukin-23), radiologic and endoscopic disease monitoring intervals, and therapy withdrawal strategies after long-term remission. “So there’s a lot we still need to understand better,” he said. “Until we have more data and guidance, we are still practicing all these things based on the available evidence as well as local practice patterns.”
Overall, said Scott, the guidance highlights the options with the best supporting evidence while incorporating the patient’s prior treatment journey. “It’s also important to emphasize that treatment decisions should be individualized and should involve shared decision-making among providers and their patients,” he added. “Patient preferences, age, active comorbidities, and pregnancy should always be considered when selecting the appropriate treatment plan.”
All funding for this guidance was supplied by AGA. The guideline chairs had no conflicts of interest, and fewer than 50% of guideline panel members had conflicts of interest. Gemei had no conflicts of interest.
A version of this article appeared on Medscape.com.
FROM GASTROENTEROLOGY