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Where Are All the Nurses? Data Show That Some States Have a Far Higher Number of Nurses Per Capita Than Others
During their 12-hour shifts, registered nurses (RNs) in Arizona and Arkansas perform many of the same tasks as RNs in Wisconsin and Wyoming: Assessing patients, monitoring vital signs, administering medications, and charting records to provide the best patient care. The work might be similar, but there are vast differences in the number of RNs in each state.
In states like Idaho, Utah, and Nevada, which have the lowest number of nurses per capita, there are as few as 7 nurses per 1000 residents, compared with South Dakota and the District of Columbia, which have double the number of nurses than underserved states — giving them the highest number of nurses per capita.
Even states with the largest number of nurses per capita are not immune to the nursing shortage. The National Bureau of Labor Statistics estimates that there will be 195,400 job openings for RNs from 2021 to 2031.
So, what makes it easier for some states to recruit and retain RNs than others?
States With the Highest Number of Nurses Per Capita
South Dakota
RNs per 1000 residents: 15.79
Average wage: $67,030 or $32.23 per hour
Average rent in Sioux Falls: $1192 per month
The Midwestern state has more miles of shoreline than Florida, herds of wild buffalo, the highest summit east of the Rockies, and more nurses per capita than all other states . Healthcare is one of the major industries in the Mount Rushmore State.
Haifa Abou Samra, dean and professor at the University of South Dakota School of Health Sciences, Vermillion, isn’t surprised that RNs want to call the state home.
“South Dakota is a nice place to live,” Samra said. “[The] schools are wonderful. If people are growing families, there is support; neighbors support their neighbors, and it’s a relatively safe community.”
South Dakota has 19 approved nursing education programs that graduated 878 RNs in 2022. Scholarships and student loan forgiveness programs have helped attract qualified RNs, and collaborations between education and industry have been instrumental in addressing the nursing shortage, Samra told this news organization.
Even though RNs earn less than the median wage ($87,070 per year/41.38 per hour), South Dakota has a low cost of living and no individual income tax, which helps stretch those earnings.
District of Columbia
RNs per 1000 residents: 15.39
Average wage: $105,220 or $50.59 per hour
Average rent in Washington, DC: $2485 per month
After a shift at some of the top-ranking hospitals in the nation, RNs working in the compact capital region can explore museums, monuments, and cultural sites; walk along the banks of the Potomac River; or grab a bite at award-winning restaurants.
Washington, a top-ranking metro area because of its growth, high wages, and access to economic opportunities, is also home to several top-tier hospitals and some of the best healthcare in the nation, and RNs who want to pursue continuing education have access to top-tier universities.
Nurses in Washington, DC, might make some of the highest wages in the nation, but the region also has the second-highest cost of living in the United States, with average rents topping $2400 per month and an average home price of $594,337.
North Dakota
RNs per 1000 residents: 12.99
Average wage: $74,930 or $36.03 per hour
Average rent in Fargo: $1051 per month
North Dakota projects a 10.4% increase in employment for RNs, which is higher than the national average, and the state has implemented several strategies to address chronic nursing shortages. The Nurse Staffing Clearinghouse connects nursing school graduates with local employers and created a statewide nursing staffing pool for in-state recruitment of travel nurses.
But it’s not just plentiful job opportunities and a low cost of living that attract nurses to the Peace Garden State. The state and its largest cities, Bismarck and Fargo, hold several “best of” accolades, including nods for the safest places to live and among the Best Places to Raise a Family, giving it high marks for quality of life.
Sure, the winters are cold, but the outdoor recreation can’t be beaten. RNs can bundle up and see the bighorn sheep in the Badlands at Theodore Roosevelt National Park or explore expansive terrain for skiing, snowboarding, and snowmobile trails.
States With the Lowest Number of Nurses Per Capita
Nevada
RNs per 1000 residents: 7.92
Average wage: $96,201 or $46.25 per hour
Average rent in Las Vegas: $1478 per month
Despite a projected 23% job growth for RNs between 2020 and 2030, the state has struggled to fill open positions. It might be the higher-than-average cost of living (9.7% higher than the US average) or higher-than-average crime rates that make RNs reluctant to gamble on a job in the Silver State. But there are some big wins for nurses in the state.
Salaries are higher than the national average, there is no state income tax, and some of the lowest property taxes in the nation. Thanks to new legislation, RNs with student loan debt won’t have to bet on black at the casino to make their payments. The Health Equity and Loan Assistance Program is a new initiative that offers up to $120,000 in loan repayment assistance to providers, including RNs, who commit to working in underserved and rural areas across the state for 5 years.
The state also has incredible attractions, from the neon lights and over-the-top architecture in Las Vegas to iconic red rock canyons, stunning state parks, and landmarks like Hoover Dam and Lake Tahoe.
Utah
RNs per 1000 residents: 7.05
Average wage: $79,790 or $38.36 per hour
Average rent in Salt Lake City: $1611 per month
Healthcare is one of the biggest employers in Utah, and nurses are the most in-demand healthcare workers in the state. But below-average wages and a cost of living that is a whopping 28% higher than the national average could be some reasons that the Beehive State is struggling to attract nurses.
A high number of job vacancies mean higher patient-to-nurse ratios, creating additional stress for a workforce prone to burnout. Much of the state is rural, public transportation is inadequate, and poor air quality causes frequent haze and smog.
The challenges are offset by some big benefits: Utah has been ranked as the “best state” thanks to the strong economy, infrastructure, and quality education — and it doesn’t hurt that Utah is home to myriad outdoor recreation opportunities and the stunning scenery at landmarks like Bryce Canyon and Arches National Park.
Moreover, Utah is hustling to boost its RN workforce. The University of Utah, Salt Lake City, has increased enrollment by 25% and hired additional faculty to help boost the nursing workforce — and those who work in hospitals and health clinics across the state benefit from a flat 4.55% individual income tax rate.
Idaho
RNs per 1000 residents: 7.02
Average wage: $80,130 or $38.53 per hour
Average rent in Boise: $1646 per month
Although the nursing workforce in Idaho has increased, it still ranks as the lowest in the nation. Teresa Stanfill, DNP, RN, executive director for the Idaho Center for Nursing, said that the number of new nurses is too low to replace the number of retiring nurses.
The state introduced loan repayment programs that award up to $25,000 to cover student loan debt, and hospitals and health systems often offer sign-on bonuses and relocation packages to attract RNs. But long winters, an isolated location, and limited cultural options can make it harder to attract nurses to the state.
It’s easier to recruit RNs to suburban areas like Boise, Meridian, and Nampa, but rural parts of the state struggle, Stanfill added. The nursing shortage is among the reasons that 11 hospitals and emergency departments closed in 2024, and healthcare organizations slashed services across the state.
Idaho has a lot to offer RNs, from small-town charm, reasonable cost of living, and gorgeous landscapes that make it one of the top 10 fastest-growing states in the nation. Collaboration between industry leaders and nursing programs is focused on finding creative solutions to boost the nursing workforce in Idaho.
A version of this article first appeared on Medscape.com.
During their 12-hour shifts, registered nurses (RNs) in Arizona and Arkansas perform many of the same tasks as RNs in Wisconsin and Wyoming: Assessing patients, monitoring vital signs, administering medications, and charting records to provide the best patient care. The work might be similar, but there are vast differences in the number of RNs in each state.
In states like Idaho, Utah, and Nevada, which have the lowest number of nurses per capita, there are as few as 7 nurses per 1000 residents, compared with South Dakota and the District of Columbia, which have double the number of nurses than underserved states — giving them the highest number of nurses per capita.
Even states with the largest number of nurses per capita are not immune to the nursing shortage. The National Bureau of Labor Statistics estimates that there will be 195,400 job openings for RNs from 2021 to 2031.
So, what makes it easier for some states to recruit and retain RNs than others?
States With the Highest Number of Nurses Per Capita
South Dakota
RNs per 1000 residents: 15.79
Average wage: $67,030 or $32.23 per hour
Average rent in Sioux Falls: $1192 per month
The Midwestern state has more miles of shoreline than Florida, herds of wild buffalo, the highest summit east of the Rockies, and more nurses per capita than all other states . Healthcare is one of the major industries in the Mount Rushmore State.
Haifa Abou Samra, dean and professor at the University of South Dakota School of Health Sciences, Vermillion, isn’t surprised that RNs want to call the state home.
“South Dakota is a nice place to live,” Samra said. “[The] schools are wonderful. If people are growing families, there is support; neighbors support their neighbors, and it’s a relatively safe community.”
South Dakota has 19 approved nursing education programs that graduated 878 RNs in 2022. Scholarships and student loan forgiveness programs have helped attract qualified RNs, and collaborations between education and industry have been instrumental in addressing the nursing shortage, Samra told this news organization.
Even though RNs earn less than the median wage ($87,070 per year/41.38 per hour), South Dakota has a low cost of living and no individual income tax, which helps stretch those earnings.
District of Columbia
RNs per 1000 residents: 15.39
Average wage: $105,220 or $50.59 per hour
Average rent in Washington, DC: $2485 per month
After a shift at some of the top-ranking hospitals in the nation, RNs working in the compact capital region can explore museums, monuments, and cultural sites; walk along the banks of the Potomac River; or grab a bite at award-winning restaurants.
Washington, a top-ranking metro area because of its growth, high wages, and access to economic opportunities, is also home to several top-tier hospitals and some of the best healthcare in the nation, and RNs who want to pursue continuing education have access to top-tier universities.
Nurses in Washington, DC, might make some of the highest wages in the nation, but the region also has the second-highest cost of living in the United States, with average rents topping $2400 per month and an average home price of $594,337.
North Dakota
RNs per 1000 residents: 12.99
Average wage: $74,930 or $36.03 per hour
Average rent in Fargo: $1051 per month
North Dakota projects a 10.4% increase in employment for RNs, which is higher than the national average, and the state has implemented several strategies to address chronic nursing shortages. The Nurse Staffing Clearinghouse connects nursing school graduates with local employers and created a statewide nursing staffing pool for in-state recruitment of travel nurses.
But it’s not just plentiful job opportunities and a low cost of living that attract nurses to the Peace Garden State. The state and its largest cities, Bismarck and Fargo, hold several “best of” accolades, including nods for the safest places to live and among the Best Places to Raise a Family, giving it high marks for quality of life.
Sure, the winters are cold, but the outdoor recreation can’t be beaten. RNs can bundle up and see the bighorn sheep in the Badlands at Theodore Roosevelt National Park or explore expansive terrain for skiing, snowboarding, and snowmobile trails.
States With the Lowest Number of Nurses Per Capita
Nevada
RNs per 1000 residents: 7.92
Average wage: $96,201 or $46.25 per hour
Average rent in Las Vegas: $1478 per month
Despite a projected 23% job growth for RNs between 2020 and 2030, the state has struggled to fill open positions. It might be the higher-than-average cost of living (9.7% higher than the US average) or higher-than-average crime rates that make RNs reluctant to gamble on a job in the Silver State. But there are some big wins for nurses in the state.
Salaries are higher than the national average, there is no state income tax, and some of the lowest property taxes in the nation. Thanks to new legislation, RNs with student loan debt won’t have to bet on black at the casino to make their payments. The Health Equity and Loan Assistance Program is a new initiative that offers up to $120,000 in loan repayment assistance to providers, including RNs, who commit to working in underserved and rural areas across the state for 5 years.
The state also has incredible attractions, from the neon lights and over-the-top architecture in Las Vegas to iconic red rock canyons, stunning state parks, and landmarks like Hoover Dam and Lake Tahoe.
Utah
RNs per 1000 residents: 7.05
Average wage: $79,790 or $38.36 per hour
Average rent in Salt Lake City: $1611 per month
Healthcare is one of the biggest employers in Utah, and nurses are the most in-demand healthcare workers in the state. But below-average wages and a cost of living that is a whopping 28% higher than the national average could be some reasons that the Beehive State is struggling to attract nurses.
A high number of job vacancies mean higher patient-to-nurse ratios, creating additional stress for a workforce prone to burnout. Much of the state is rural, public transportation is inadequate, and poor air quality causes frequent haze and smog.
The challenges are offset by some big benefits: Utah has been ranked as the “best state” thanks to the strong economy, infrastructure, and quality education — and it doesn’t hurt that Utah is home to myriad outdoor recreation opportunities and the stunning scenery at landmarks like Bryce Canyon and Arches National Park.
Moreover, Utah is hustling to boost its RN workforce. The University of Utah, Salt Lake City, has increased enrollment by 25% and hired additional faculty to help boost the nursing workforce — and those who work in hospitals and health clinics across the state benefit from a flat 4.55% individual income tax rate.
Idaho
RNs per 1000 residents: 7.02
Average wage: $80,130 or $38.53 per hour
Average rent in Boise: $1646 per month
Although the nursing workforce in Idaho has increased, it still ranks as the lowest in the nation. Teresa Stanfill, DNP, RN, executive director for the Idaho Center for Nursing, said that the number of new nurses is too low to replace the number of retiring nurses.
The state introduced loan repayment programs that award up to $25,000 to cover student loan debt, and hospitals and health systems often offer sign-on bonuses and relocation packages to attract RNs. But long winters, an isolated location, and limited cultural options can make it harder to attract nurses to the state.
It’s easier to recruit RNs to suburban areas like Boise, Meridian, and Nampa, but rural parts of the state struggle, Stanfill added. The nursing shortage is among the reasons that 11 hospitals and emergency departments closed in 2024, and healthcare organizations slashed services across the state.
Idaho has a lot to offer RNs, from small-town charm, reasonable cost of living, and gorgeous landscapes that make it one of the top 10 fastest-growing states in the nation. Collaboration between industry leaders and nursing programs is focused on finding creative solutions to boost the nursing workforce in Idaho.
A version of this article first appeared on Medscape.com.
During their 12-hour shifts, registered nurses (RNs) in Arizona and Arkansas perform many of the same tasks as RNs in Wisconsin and Wyoming: Assessing patients, monitoring vital signs, administering medications, and charting records to provide the best patient care. The work might be similar, but there are vast differences in the number of RNs in each state.
In states like Idaho, Utah, and Nevada, which have the lowest number of nurses per capita, there are as few as 7 nurses per 1000 residents, compared with South Dakota and the District of Columbia, which have double the number of nurses than underserved states — giving them the highest number of nurses per capita.
Even states with the largest number of nurses per capita are not immune to the nursing shortage. The National Bureau of Labor Statistics estimates that there will be 195,400 job openings for RNs from 2021 to 2031.
So, what makes it easier for some states to recruit and retain RNs than others?
States With the Highest Number of Nurses Per Capita
South Dakota
RNs per 1000 residents: 15.79
Average wage: $67,030 or $32.23 per hour
Average rent in Sioux Falls: $1192 per month
The Midwestern state has more miles of shoreline than Florida, herds of wild buffalo, the highest summit east of the Rockies, and more nurses per capita than all other states . Healthcare is one of the major industries in the Mount Rushmore State.
Haifa Abou Samra, dean and professor at the University of South Dakota School of Health Sciences, Vermillion, isn’t surprised that RNs want to call the state home.
“South Dakota is a nice place to live,” Samra said. “[The] schools are wonderful. If people are growing families, there is support; neighbors support their neighbors, and it’s a relatively safe community.”
South Dakota has 19 approved nursing education programs that graduated 878 RNs in 2022. Scholarships and student loan forgiveness programs have helped attract qualified RNs, and collaborations between education and industry have been instrumental in addressing the nursing shortage, Samra told this news organization.
Even though RNs earn less than the median wage ($87,070 per year/41.38 per hour), South Dakota has a low cost of living and no individual income tax, which helps stretch those earnings.
District of Columbia
RNs per 1000 residents: 15.39
Average wage: $105,220 or $50.59 per hour
Average rent in Washington, DC: $2485 per month
After a shift at some of the top-ranking hospitals in the nation, RNs working in the compact capital region can explore museums, monuments, and cultural sites; walk along the banks of the Potomac River; or grab a bite at award-winning restaurants.
Washington, a top-ranking metro area because of its growth, high wages, and access to economic opportunities, is also home to several top-tier hospitals and some of the best healthcare in the nation, and RNs who want to pursue continuing education have access to top-tier universities.
Nurses in Washington, DC, might make some of the highest wages in the nation, but the region also has the second-highest cost of living in the United States, with average rents topping $2400 per month and an average home price of $594,337.
North Dakota
RNs per 1000 residents: 12.99
Average wage: $74,930 or $36.03 per hour
Average rent in Fargo: $1051 per month
North Dakota projects a 10.4% increase in employment for RNs, which is higher than the national average, and the state has implemented several strategies to address chronic nursing shortages. The Nurse Staffing Clearinghouse connects nursing school graduates with local employers and created a statewide nursing staffing pool for in-state recruitment of travel nurses.
But it’s not just plentiful job opportunities and a low cost of living that attract nurses to the Peace Garden State. The state and its largest cities, Bismarck and Fargo, hold several “best of” accolades, including nods for the safest places to live and among the Best Places to Raise a Family, giving it high marks for quality of life.
Sure, the winters are cold, but the outdoor recreation can’t be beaten. RNs can bundle up and see the bighorn sheep in the Badlands at Theodore Roosevelt National Park or explore expansive terrain for skiing, snowboarding, and snowmobile trails.
States With the Lowest Number of Nurses Per Capita
Nevada
RNs per 1000 residents: 7.92
Average wage: $96,201 or $46.25 per hour
Average rent in Las Vegas: $1478 per month
Despite a projected 23% job growth for RNs between 2020 and 2030, the state has struggled to fill open positions. It might be the higher-than-average cost of living (9.7% higher than the US average) or higher-than-average crime rates that make RNs reluctant to gamble on a job in the Silver State. But there are some big wins for nurses in the state.
Salaries are higher than the national average, there is no state income tax, and some of the lowest property taxes in the nation. Thanks to new legislation, RNs with student loan debt won’t have to bet on black at the casino to make their payments. The Health Equity and Loan Assistance Program is a new initiative that offers up to $120,000 in loan repayment assistance to providers, including RNs, who commit to working in underserved and rural areas across the state for 5 years.
The state also has incredible attractions, from the neon lights and over-the-top architecture in Las Vegas to iconic red rock canyons, stunning state parks, and landmarks like Hoover Dam and Lake Tahoe.
Utah
RNs per 1000 residents: 7.05
Average wage: $79,790 or $38.36 per hour
Average rent in Salt Lake City: $1611 per month
Healthcare is one of the biggest employers in Utah, and nurses are the most in-demand healthcare workers in the state. But below-average wages and a cost of living that is a whopping 28% higher than the national average could be some reasons that the Beehive State is struggling to attract nurses.
A high number of job vacancies mean higher patient-to-nurse ratios, creating additional stress for a workforce prone to burnout. Much of the state is rural, public transportation is inadequate, and poor air quality causes frequent haze and smog.
The challenges are offset by some big benefits: Utah has been ranked as the “best state” thanks to the strong economy, infrastructure, and quality education — and it doesn’t hurt that Utah is home to myriad outdoor recreation opportunities and the stunning scenery at landmarks like Bryce Canyon and Arches National Park.
Moreover, Utah is hustling to boost its RN workforce. The University of Utah, Salt Lake City, has increased enrollment by 25% and hired additional faculty to help boost the nursing workforce — and those who work in hospitals and health clinics across the state benefit from a flat 4.55% individual income tax rate.
Idaho
RNs per 1000 residents: 7.02
Average wage: $80,130 or $38.53 per hour
Average rent in Boise: $1646 per month
Although the nursing workforce in Idaho has increased, it still ranks as the lowest in the nation. Teresa Stanfill, DNP, RN, executive director for the Idaho Center for Nursing, said that the number of new nurses is too low to replace the number of retiring nurses.
The state introduced loan repayment programs that award up to $25,000 to cover student loan debt, and hospitals and health systems often offer sign-on bonuses and relocation packages to attract RNs. But long winters, an isolated location, and limited cultural options can make it harder to attract nurses to the state.
It’s easier to recruit RNs to suburban areas like Boise, Meridian, and Nampa, but rural parts of the state struggle, Stanfill added. The nursing shortage is among the reasons that 11 hospitals and emergency departments closed in 2024, and healthcare organizations slashed services across the state.
Idaho has a lot to offer RNs, from small-town charm, reasonable cost of living, and gorgeous landscapes that make it one of the top 10 fastest-growing states in the nation. Collaboration between industry leaders and nursing programs is focused on finding creative solutions to boost the nursing workforce in Idaho.
A version of this article first appeared on Medscape.com.
Bariatric Surgery: Nutrition’s Role in Patient Outcomes
, according to an updated clinical practice statement from the Obesity Medicine Association (OMA).
The update offers guidance on how to manage metabolic and bariatric surgery patients’ nutrition, from preoperative nutritional assessments through identification and treatment of the most common nutritional problems associated with bariatric procedures.
“The main takeaway really is that obesity is a complex and chronic disease. It requires the same model of care as diabetes or other chronic conditions,” said Rutuja Patel, DO, senior author and an obesity medicine specialist at Northwestern Medicine Regional Medical Group in Winfield, Illinois.
The development of an interdisciplinary team of medical providers with evidence-based nutrition knowledge and consistent information improves the quality of nutrition care provided to bariatric surgery patients, the authors wrote.
“Collaborative multidisciplinary care that takes into consideration the whole patient in a biopsychosocial way and uses multiple modalities — including medical, behavioral, nutritional, and others — leads to the best outcomes in these complex patients,” Patel said.
The updated statement, published online in Obesity Pillars, offers a variety of tools and checklists to aid clinicians, especially those who may not have access to a multidisciplinary team or dietitian knowledgeable about bariatric nutrition.
It is a follow-up to the OMA’s 2022 clinical practice statement, which provided an overview of bariatric surgery, gastrointestinal hormones, and the microbiome in patients with obesity.
Presurgical Guidance
The new guidance lays out the various components of preoperative nutrition screenings, among which is a medication review to determine if the patient is taking drugs that may affect weight and calorie intake. These include antihypertensives, diabetes agents, hormonal contraceptives, antidepressants, migraine medications, and antipsychotics.
In taking a patient’s history, clinicians should ask about major events associated with weight changes, such as medication changes, illness, pregnancy, divorce, stressful employment, food insecurity, and periods of disordered eating.
The fundamental approach to conducting a nutrition assessment is an understanding of the role that various sections of the gastrointestinal tract play in micronutrient absorption, the authors wrote. As an educational tool, the update includes a diagram that indicates the areas of the stomach, duodenum, jejunum, and ileum that may be altered by bariatric surgery and how they factor into micronutrient absorption.
“It makes it easier to see why certain surgical procedures are more likely to cause certain deficiencies,” Patel said.
Postsurgery Patient Management
Post surgery, clinicians should monitor patients for other problems that could affect nutrient absorption, including food intolerances, drug-nutrient interactions, and increased gastrointestinal transit time.
Patel and coauthors discussed the pros and cons of multivitamin mineral supplement formulations as well as specific vitamin and mineral recommendations for patients undergoing certain metabolic or bariatric surgery procedures. They included three supplemental cases in the appendix to illustrate supplementation recommendations and long-term maintenance suggestions.
“It’s important to remember that most of these deficiencies present without many clinical symptoms, so it becomes essential to screen for them and repeat as needed,” Patel said.
The update also tackles postoperative nutritional assessments and diet progression. No evidence supports following one postsurgical diet progression protocol over another, but they generally proceed from a clear liquid diet to foods with normal textures, the authors noted. Clinicians should adapt them according to the procedure type, they added.
In addition, clinicians must troubleshoot any nutrition-related concerns, including constipation, dehydration, nausea, heartburn, and fatigue, for up to a year after surgery, they wrote.
Metabolic and bariatric surgery patients should be evaluated annually at a minimum, if not more frequently, to gauge nutritional health, the authors wrote. Treating obesity as a disease involves more than weight loss — instead, it’s about improving the quality of life of patients through procedures, medications, and lifestyle modifications, they added.
Track New Developments
With ongoing changes in the field of metabolic and bariatric surgery, it’s helpful for clinicians to remain updated about new approaches across various disciplines linked to obesity management and treatment, said Christina Poa-Li, MD, a surgeon at Huntington Health Medical Center, affiliated with Cedars-Sinai Health System, in Pasadena, California, who was not involved in developing the updated practice statement.
“For example, the rapidly growing prescription of anti-obesity medications and their use in both preoperative and postoperative surgical patients drastically affect their nutrition,” she said. “Providers of various backgrounds and specialties will benefit from the most updated guidance on evaluating patient nutrition.”
Clinicians should consider expanding their patient population to include those with metabolic dysfunction–associated steatohepatitis or metabolic dysfunction–associated steatotic liver disease, Poa-Li said.
“These patient subpopulations may not have been considered for bariatric surgery or even referral to a bariatric surgeon for consultation previously,” she said. “It is important to increase awareness among clinicians of the potential benefits for metabolic and bariatric surgery for these patients.”
The report didn’t receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Patel and Poa-Li reported no relevant disclosures.
A version of this article appeared on Medscape.com.
, according to an updated clinical practice statement from the Obesity Medicine Association (OMA).
The update offers guidance on how to manage metabolic and bariatric surgery patients’ nutrition, from preoperative nutritional assessments through identification and treatment of the most common nutritional problems associated with bariatric procedures.
“The main takeaway really is that obesity is a complex and chronic disease. It requires the same model of care as diabetes or other chronic conditions,” said Rutuja Patel, DO, senior author and an obesity medicine specialist at Northwestern Medicine Regional Medical Group in Winfield, Illinois.
The development of an interdisciplinary team of medical providers with evidence-based nutrition knowledge and consistent information improves the quality of nutrition care provided to bariatric surgery patients, the authors wrote.
“Collaborative multidisciplinary care that takes into consideration the whole patient in a biopsychosocial way and uses multiple modalities — including medical, behavioral, nutritional, and others — leads to the best outcomes in these complex patients,” Patel said.
The updated statement, published online in Obesity Pillars, offers a variety of tools and checklists to aid clinicians, especially those who may not have access to a multidisciplinary team or dietitian knowledgeable about bariatric nutrition.
It is a follow-up to the OMA’s 2022 clinical practice statement, which provided an overview of bariatric surgery, gastrointestinal hormones, and the microbiome in patients with obesity.
Presurgical Guidance
The new guidance lays out the various components of preoperative nutrition screenings, among which is a medication review to determine if the patient is taking drugs that may affect weight and calorie intake. These include antihypertensives, diabetes agents, hormonal contraceptives, antidepressants, migraine medications, and antipsychotics.
In taking a patient’s history, clinicians should ask about major events associated with weight changes, such as medication changes, illness, pregnancy, divorce, stressful employment, food insecurity, and periods of disordered eating.
The fundamental approach to conducting a nutrition assessment is an understanding of the role that various sections of the gastrointestinal tract play in micronutrient absorption, the authors wrote. As an educational tool, the update includes a diagram that indicates the areas of the stomach, duodenum, jejunum, and ileum that may be altered by bariatric surgery and how they factor into micronutrient absorption.
“It makes it easier to see why certain surgical procedures are more likely to cause certain deficiencies,” Patel said.
Postsurgery Patient Management
Post surgery, clinicians should monitor patients for other problems that could affect nutrient absorption, including food intolerances, drug-nutrient interactions, and increased gastrointestinal transit time.
Patel and coauthors discussed the pros and cons of multivitamin mineral supplement formulations as well as specific vitamin and mineral recommendations for patients undergoing certain metabolic or bariatric surgery procedures. They included three supplemental cases in the appendix to illustrate supplementation recommendations and long-term maintenance suggestions.
“It’s important to remember that most of these deficiencies present without many clinical symptoms, so it becomes essential to screen for them and repeat as needed,” Patel said.
The update also tackles postoperative nutritional assessments and diet progression. No evidence supports following one postsurgical diet progression protocol over another, but they generally proceed from a clear liquid diet to foods with normal textures, the authors noted. Clinicians should adapt them according to the procedure type, they added.
In addition, clinicians must troubleshoot any nutrition-related concerns, including constipation, dehydration, nausea, heartburn, and fatigue, for up to a year after surgery, they wrote.
Metabolic and bariatric surgery patients should be evaluated annually at a minimum, if not more frequently, to gauge nutritional health, the authors wrote. Treating obesity as a disease involves more than weight loss — instead, it’s about improving the quality of life of patients through procedures, medications, and lifestyle modifications, they added.
Track New Developments
With ongoing changes in the field of metabolic and bariatric surgery, it’s helpful for clinicians to remain updated about new approaches across various disciplines linked to obesity management and treatment, said Christina Poa-Li, MD, a surgeon at Huntington Health Medical Center, affiliated with Cedars-Sinai Health System, in Pasadena, California, who was not involved in developing the updated practice statement.
“For example, the rapidly growing prescription of anti-obesity medications and their use in both preoperative and postoperative surgical patients drastically affect their nutrition,” she said. “Providers of various backgrounds and specialties will benefit from the most updated guidance on evaluating patient nutrition.”
Clinicians should consider expanding their patient population to include those with metabolic dysfunction–associated steatohepatitis or metabolic dysfunction–associated steatotic liver disease, Poa-Li said.
“These patient subpopulations may not have been considered for bariatric surgery or even referral to a bariatric surgeon for consultation previously,” she said. “It is important to increase awareness among clinicians of the potential benefits for metabolic and bariatric surgery for these patients.”
The report didn’t receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Patel and Poa-Li reported no relevant disclosures.
A version of this article appeared on Medscape.com.
, according to an updated clinical practice statement from the Obesity Medicine Association (OMA).
The update offers guidance on how to manage metabolic and bariatric surgery patients’ nutrition, from preoperative nutritional assessments through identification and treatment of the most common nutritional problems associated with bariatric procedures.
“The main takeaway really is that obesity is a complex and chronic disease. It requires the same model of care as diabetes or other chronic conditions,” said Rutuja Patel, DO, senior author and an obesity medicine specialist at Northwestern Medicine Regional Medical Group in Winfield, Illinois.
The development of an interdisciplinary team of medical providers with evidence-based nutrition knowledge and consistent information improves the quality of nutrition care provided to bariatric surgery patients, the authors wrote.
“Collaborative multidisciplinary care that takes into consideration the whole patient in a biopsychosocial way and uses multiple modalities — including medical, behavioral, nutritional, and others — leads to the best outcomes in these complex patients,” Patel said.
The updated statement, published online in Obesity Pillars, offers a variety of tools and checklists to aid clinicians, especially those who may not have access to a multidisciplinary team or dietitian knowledgeable about bariatric nutrition.
It is a follow-up to the OMA’s 2022 clinical practice statement, which provided an overview of bariatric surgery, gastrointestinal hormones, and the microbiome in patients with obesity.
Presurgical Guidance
The new guidance lays out the various components of preoperative nutrition screenings, among which is a medication review to determine if the patient is taking drugs that may affect weight and calorie intake. These include antihypertensives, diabetes agents, hormonal contraceptives, antidepressants, migraine medications, and antipsychotics.
In taking a patient’s history, clinicians should ask about major events associated with weight changes, such as medication changes, illness, pregnancy, divorce, stressful employment, food insecurity, and periods of disordered eating.
The fundamental approach to conducting a nutrition assessment is an understanding of the role that various sections of the gastrointestinal tract play in micronutrient absorption, the authors wrote. As an educational tool, the update includes a diagram that indicates the areas of the stomach, duodenum, jejunum, and ileum that may be altered by bariatric surgery and how they factor into micronutrient absorption.
“It makes it easier to see why certain surgical procedures are more likely to cause certain deficiencies,” Patel said.
Postsurgery Patient Management
Post surgery, clinicians should monitor patients for other problems that could affect nutrient absorption, including food intolerances, drug-nutrient interactions, and increased gastrointestinal transit time.
Patel and coauthors discussed the pros and cons of multivitamin mineral supplement formulations as well as specific vitamin and mineral recommendations for patients undergoing certain metabolic or bariatric surgery procedures. They included three supplemental cases in the appendix to illustrate supplementation recommendations and long-term maintenance suggestions.
“It’s important to remember that most of these deficiencies present without many clinical symptoms, so it becomes essential to screen for them and repeat as needed,” Patel said.
The update also tackles postoperative nutritional assessments and diet progression. No evidence supports following one postsurgical diet progression protocol over another, but they generally proceed from a clear liquid diet to foods with normal textures, the authors noted. Clinicians should adapt them according to the procedure type, they added.
In addition, clinicians must troubleshoot any nutrition-related concerns, including constipation, dehydration, nausea, heartburn, and fatigue, for up to a year after surgery, they wrote.
Metabolic and bariatric surgery patients should be evaluated annually at a minimum, if not more frequently, to gauge nutritional health, the authors wrote. Treating obesity as a disease involves more than weight loss — instead, it’s about improving the quality of life of patients through procedures, medications, and lifestyle modifications, they added.
Track New Developments
With ongoing changes in the field of metabolic and bariatric surgery, it’s helpful for clinicians to remain updated about new approaches across various disciplines linked to obesity management and treatment, said Christina Poa-Li, MD, a surgeon at Huntington Health Medical Center, affiliated with Cedars-Sinai Health System, in Pasadena, California, who was not involved in developing the updated practice statement.
“For example, the rapidly growing prescription of anti-obesity medications and their use in both preoperative and postoperative surgical patients drastically affect their nutrition,” she said. “Providers of various backgrounds and specialties will benefit from the most updated guidance on evaluating patient nutrition.”
Clinicians should consider expanding their patient population to include those with metabolic dysfunction–associated steatohepatitis or metabolic dysfunction–associated steatotic liver disease, Poa-Li said.
“These patient subpopulations may not have been considered for bariatric surgery or even referral to a bariatric surgeon for consultation previously,” she said. “It is important to increase awareness among clinicians of the potential benefits for metabolic and bariatric surgery for these patients.”
The report didn’t receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Patel and Poa-Li reported no relevant disclosures.
A version of this article appeared on Medscape.com.
How Many Patients in Early Cancer Trials Get Drugs Ultimately Approved by FDA?
TOPLINE:
One in six patients in phase 2 cancer trials received treatments that were eventually approved by the Food and Drug Administration (FDA), a new analysis found. This proportion increased to 1 in 5 when considering National Comprehensive Cancer Network (NCCN) off-label recommendations and decreased to about 1 in 11 for approved regimens considered to have a substantial clinical benefit.
METHODOLOGY:
- Patients enroll in phase 2 oncology trials seeking access to promising new treatments, but the risk-benefit assessments and the likelihood of receiving a therapy that ultimately gains FDA approval remain unclear. Previous research suggests that the odds are 1 in 83 patients for those enrolled in a phase 1 cancer trial.
- Researchers randomly selected 400 phase 2 cancer trials initiated between November 2012 and November 2015 (to give enough time for an approval to occur); these trials included more than 25,000 patients across 608 specific treatment cohorts testing 332 drugs.
- The primary endpoint was the proportion of patients enrolled in phase 2 trials who received a treatment regimen that later attained FDA approval — defined as the “therapeutic proportion.”
- A secondary endpoint was determining the therapeutic proportion based on the therapeutic value of drugs. The three benchmarks were FDA approval alone, FDA approval plus NCCN off-label recommendations, and FDA approval for drugs considered to have a substantial clinical benefit, based on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS).
TAKEAWAY:
- A total of 4045 patients received a treatment regimen that advanced to FDA approval, corresponding to a therapeutic proportion of 16.2%.
- The therapeutic proportion increased to 19.4% when considering NCCN off-label recommendations and decreased to 9.3% for FDA-approved regimens considered to have a substantial clinical benefit, based on the ESMO-MCBS.
- The proportion of patients who participated in a trial in which the drug-indication pairing went on to phase 3 testing was 32.5%.
- Enrollment in a trial featuring biomarker enrichment, an immunotherapy drug, a large phase 2 cohort, and a nonrandomized, industry-sponsored trial all showed a trend toward a higher therapeutic proportion.
IN PRACTICE:
“By entering a phase 2 trial, a patient has a one in six chance of receiving a treatment that will later be approved for their condition,” the authors wrote. “The proportions described here, when juxtaposed with those estimated previously for phase 1 trials, suggest a striking improvement for a patient’s therapeutic prospects. This suggests that phase 1 trials do a good job at protecting patients downstream from unsafe and ineffective cancer treatments.”
In an editorial accompanying the study, Howard S. Hochster, MD, of the Rutgers Cancer Institute in New Brunswick, New Jersey, suggested that the 16.2% therapeutic proportion reported may be understated. For instance, “if using the criterion of drugs that were FDA approved in any indication and dose, the proportion of patient benefit in these trials rises to 38%, with a 51% benefit rate considering inclusion in NCCN guidelines,” he wrote.
SOURCE:
This study, led by Charlotte Ouimet, MSc, Department of Equity, Ethics and Policy, McGill University School of Population and Global Health, Montréal, Québec, Canada, was published online in Journal of the National Cancer Institute.
LIMITATIONS:
The longitudinal design of this study required using a historical cohort of phase 2 clinical trials, which may not reflect current drug development patterns. This study was underpowered to determine trial characteristics that predicted higher therapeutic proportions. Furthermore, the exclusion of cytotoxic drugs from the analysis resulted in a somewhat restricted view of overall drug development.
DISCLOSURES:
This study was supported by the Canadian Institutes of Health Research. The authors reported having no relevant 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 article first appeared on Medscape.com.
TOPLINE:
One in six patients in phase 2 cancer trials received treatments that were eventually approved by the Food and Drug Administration (FDA), a new analysis found. This proportion increased to 1 in 5 when considering National Comprehensive Cancer Network (NCCN) off-label recommendations and decreased to about 1 in 11 for approved regimens considered to have a substantial clinical benefit.
METHODOLOGY:
- Patients enroll in phase 2 oncology trials seeking access to promising new treatments, but the risk-benefit assessments and the likelihood of receiving a therapy that ultimately gains FDA approval remain unclear. Previous research suggests that the odds are 1 in 83 patients for those enrolled in a phase 1 cancer trial.
- Researchers randomly selected 400 phase 2 cancer trials initiated between November 2012 and November 2015 (to give enough time for an approval to occur); these trials included more than 25,000 patients across 608 specific treatment cohorts testing 332 drugs.
- The primary endpoint was the proportion of patients enrolled in phase 2 trials who received a treatment regimen that later attained FDA approval — defined as the “therapeutic proportion.”
- A secondary endpoint was determining the therapeutic proportion based on the therapeutic value of drugs. The three benchmarks were FDA approval alone, FDA approval plus NCCN off-label recommendations, and FDA approval for drugs considered to have a substantial clinical benefit, based on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS).
TAKEAWAY:
- A total of 4045 patients received a treatment regimen that advanced to FDA approval, corresponding to a therapeutic proportion of 16.2%.
- The therapeutic proportion increased to 19.4% when considering NCCN off-label recommendations and decreased to 9.3% for FDA-approved regimens considered to have a substantial clinical benefit, based on the ESMO-MCBS.
- The proportion of patients who participated in a trial in which the drug-indication pairing went on to phase 3 testing was 32.5%.
- Enrollment in a trial featuring biomarker enrichment, an immunotherapy drug, a large phase 2 cohort, and a nonrandomized, industry-sponsored trial all showed a trend toward a higher therapeutic proportion.
IN PRACTICE:
“By entering a phase 2 trial, a patient has a one in six chance of receiving a treatment that will later be approved for their condition,” the authors wrote. “The proportions described here, when juxtaposed with those estimated previously for phase 1 trials, suggest a striking improvement for a patient’s therapeutic prospects. This suggests that phase 1 trials do a good job at protecting patients downstream from unsafe and ineffective cancer treatments.”
In an editorial accompanying the study, Howard S. Hochster, MD, of the Rutgers Cancer Institute in New Brunswick, New Jersey, suggested that the 16.2% therapeutic proportion reported may be understated. For instance, “if using the criterion of drugs that were FDA approved in any indication and dose, the proportion of patient benefit in these trials rises to 38%, with a 51% benefit rate considering inclusion in NCCN guidelines,” he wrote.
SOURCE:
This study, led by Charlotte Ouimet, MSc, Department of Equity, Ethics and Policy, McGill University School of Population and Global Health, Montréal, Québec, Canada, was published online in Journal of the National Cancer Institute.
LIMITATIONS:
The longitudinal design of this study required using a historical cohort of phase 2 clinical trials, which may not reflect current drug development patterns. This study was underpowered to determine trial characteristics that predicted higher therapeutic proportions. Furthermore, the exclusion of cytotoxic drugs from the analysis resulted in a somewhat restricted view of overall drug development.
DISCLOSURES:
This study was supported by the Canadian Institutes of Health Research. The authors reported having no relevant 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 article first appeared on Medscape.com.
TOPLINE:
One in six patients in phase 2 cancer trials received treatments that were eventually approved by the Food and Drug Administration (FDA), a new analysis found. This proportion increased to 1 in 5 when considering National Comprehensive Cancer Network (NCCN) off-label recommendations and decreased to about 1 in 11 for approved regimens considered to have a substantial clinical benefit.
METHODOLOGY:
- Patients enroll in phase 2 oncology trials seeking access to promising new treatments, but the risk-benefit assessments and the likelihood of receiving a therapy that ultimately gains FDA approval remain unclear. Previous research suggests that the odds are 1 in 83 patients for those enrolled in a phase 1 cancer trial.
- Researchers randomly selected 400 phase 2 cancer trials initiated between November 2012 and November 2015 (to give enough time for an approval to occur); these trials included more than 25,000 patients across 608 specific treatment cohorts testing 332 drugs.
- The primary endpoint was the proportion of patients enrolled in phase 2 trials who received a treatment regimen that later attained FDA approval — defined as the “therapeutic proportion.”
- A secondary endpoint was determining the therapeutic proportion based on the therapeutic value of drugs. The three benchmarks were FDA approval alone, FDA approval plus NCCN off-label recommendations, and FDA approval for drugs considered to have a substantial clinical benefit, based on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS).
TAKEAWAY:
- A total of 4045 patients received a treatment regimen that advanced to FDA approval, corresponding to a therapeutic proportion of 16.2%.
- The therapeutic proportion increased to 19.4% when considering NCCN off-label recommendations and decreased to 9.3% for FDA-approved regimens considered to have a substantial clinical benefit, based on the ESMO-MCBS.
- The proportion of patients who participated in a trial in which the drug-indication pairing went on to phase 3 testing was 32.5%.
- Enrollment in a trial featuring biomarker enrichment, an immunotherapy drug, a large phase 2 cohort, and a nonrandomized, industry-sponsored trial all showed a trend toward a higher therapeutic proportion.
IN PRACTICE:
“By entering a phase 2 trial, a patient has a one in six chance of receiving a treatment that will later be approved for their condition,” the authors wrote. “The proportions described here, when juxtaposed with those estimated previously for phase 1 trials, suggest a striking improvement for a patient’s therapeutic prospects. This suggests that phase 1 trials do a good job at protecting patients downstream from unsafe and ineffective cancer treatments.”
In an editorial accompanying the study, Howard S. Hochster, MD, of the Rutgers Cancer Institute in New Brunswick, New Jersey, suggested that the 16.2% therapeutic proportion reported may be understated. For instance, “if using the criterion of drugs that were FDA approved in any indication and dose, the proportion of patient benefit in these trials rises to 38%, with a 51% benefit rate considering inclusion in NCCN guidelines,” he wrote.
SOURCE:
This study, led by Charlotte Ouimet, MSc, Department of Equity, Ethics and Policy, McGill University School of Population and Global Health, Montréal, Québec, Canada, was published online in Journal of the National Cancer Institute.
LIMITATIONS:
The longitudinal design of this study required using a historical cohort of phase 2 clinical trials, which may not reflect current drug development patterns. This study was underpowered to determine trial characteristics that predicted higher therapeutic proportions. Furthermore, the exclusion of cytotoxic drugs from the analysis resulted in a somewhat restricted view of overall drug development.
DISCLOSURES:
This study was supported by the Canadian Institutes of Health Research. The authors reported having no relevant 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 article first appeared on Medscape.com.
Bariatric Surgery Lowers Risk for Long-Term Liver Complications in MASH-Related Cirrhosis
according to a recent study by Cleveland Clinic researchers.
Compared with patients who received medical therapy alone, those who underwent bariatric surgery had a 72% lower risk of developing serious complications of liver disease and an 80% lower risk for progression to decompensated cirrhosis.
The results could have major implications for patients with metabolic dysfunction–associated steatohepatitis (MASH), particularly given that about 20% of patients with MASH progress to cirrhosis, the researchers said.
“Currently, lifestyle intervention is the only therapeutic recommendation for compensated MASH-related cirrhosis,” said Steven Nissen, MD, the senior author and chief academic officer of the Miller Family Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Ohio.
“However, lifestyle changes alone rarely provide the weight loss and metabolic changes needed to reduce the risk of liver complications in this patient population,” he said. “This study shows that bariatric surgery is an effective treatment that can influence the trajectory of cirrhosis progression in select patients.”
The study was published online in Nature Medicine.
Significantly Reduced Risks
As part of the Surgical Procedures Eliminate Compensated Cirrhosis in Advancing Long-Term (SPECCIAL) observational study, Nissen and colleagues compared the long-term effects of metabolic surgery and medical treatment in patients with obesity and compensated, biopsy-proven MASH-related cirrhosis. They looked for six major adverse liver outcomes (MALO): ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, liver transplantation, and all-cause mortality.
Among nearly 37,000 patients who underwent liver biopsy at the Cleveland Clinic Health System between 1995 and 2020, the research team identified 168 patients (69.6% women) with MASH-related cirrhosis, Child-Pugh class A, and model for end-stage liver disease scores ≤ 10. Among those, 62 underwent metabolic surgery (37 Roux-en-Y gastric bypass and 25 sleeve gastrectomy) and 106 had nonsurgical treatment.
After overlap weighting, the groups had balanced baseline characteristics, including mean body mass index of 42.7, Fibrosis-4 score of 2.1, albumin of 4.1 g/dL, bilirubin of 0.6 mg/dL, and Elixhauser comorbidity index of 9. In each group, 84.5% had type 2 diabetes and 79.1% had Ishak fibrosis stage 6.
Overall, the 15-year cumulative incidence of MALO was 20.9% in the surgical group and 46.4% in the nonsurgical group (adjusted hazard ratio [aHR], 0.28; P = .003), with MALO occurring in 10 surgical patients and 42 nonsurgical patients.
Assuming a causal effect, the number needed to treat with metabolic surgery to avoid one incidence of MALO over a 15-year timespan was 4.5.
The 15-year incidence of MALO was similar between surgical methods, with 20.1% for Roux-en-Y gastric bypass and 19.9% for sleeve gastrectomy.
In addition, the 15-year cumulative incidence of progression to decompensated cirrhosis was 15.6% in the surgical group and 30.7% in the nonsurgical group (aHR, 0.2; P = .01), with decompensation occurring in four surgical patients and 33 nonsurgical patients.
At 15 years, patients in the surgical group lost 31.6 kg or about 26.6% of their weight, and those in the nonsurgical group lost 10.7 kg or 9.8%.
Among patients with type 2 diabetes at baseline, metabolic surgery was associated with a reduction in hemoglobin A1c levels, as well as diabetes remission for some patients.
Potential to Fill an Unmet Need
Previous studies have indicated that bariatric surgery can effectively treat noncirrhotic MASH and lead to histologic resolution of MASH. In a 2021 study, Nissen and colleagues found bariatric surgery was associated with a lower risk for MALO and major adverse cardiovascular events in patients with biopsy-proven MASH without cirrhosis. Now, Nissen said, the SPECCIAL study indicates surgery may be a good option for MASH-related cirrhosis as well.
The study authors also noted that similar findings are theoretically possible from medical therapies, given the emergence of a new generation of anti-obesity medications. In this study, 16.8% of the surgical group and 14.3% of the nonsurgical group took semaglutide or tirzepatide at some point during the follow-up period.
“Patients with MASH-related cirrhosis have extremely limited treatment options,” said Sobia Laique, MD, study coauthor and a transplant hepatologist at the Cleveland Clinic who specializes in MASH-related cirrhosis. She cofounded the Cleveland Clinic’s task force on metabolic dysfunction–associated steatotic liver disease (MASLD) to improve screening, management, and patient outcomes for MASLD and related comorbidities.
“No therapeutic interventions have demonstrated efficacy in mitigating the risk of severe liver complications for these patients,” she said. “This underscores a critical unmet need for the development of effective therapies specifically targeting patients with compensated MASH-related cirrhosis.”
No funding was reported for this study. Several authors reported receiving grant funding, consultant fees, and advisory roles for various pharmaceutical companies.
A version of this article appeared on Medscape.com.
according to a recent study by Cleveland Clinic researchers.
Compared with patients who received medical therapy alone, those who underwent bariatric surgery had a 72% lower risk of developing serious complications of liver disease and an 80% lower risk for progression to decompensated cirrhosis.
The results could have major implications for patients with metabolic dysfunction–associated steatohepatitis (MASH), particularly given that about 20% of patients with MASH progress to cirrhosis, the researchers said.
“Currently, lifestyle intervention is the only therapeutic recommendation for compensated MASH-related cirrhosis,” said Steven Nissen, MD, the senior author and chief academic officer of the Miller Family Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Ohio.
“However, lifestyle changes alone rarely provide the weight loss and metabolic changes needed to reduce the risk of liver complications in this patient population,” he said. “This study shows that bariatric surgery is an effective treatment that can influence the trajectory of cirrhosis progression in select patients.”
The study was published online in Nature Medicine.
Significantly Reduced Risks
As part of the Surgical Procedures Eliminate Compensated Cirrhosis in Advancing Long-Term (SPECCIAL) observational study, Nissen and colleagues compared the long-term effects of metabolic surgery and medical treatment in patients with obesity and compensated, biopsy-proven MASH-related cirrhosis. They looked for six major adverse liver outcomes (MALO): ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, liver transplantation, and all-cause mortality.
Among nearly 37,000 patients who underwent liver biopsy at the Cleveland Clinic Health System between 1995 and 2020, the research team identified 168 patients (69.6% women) with MASH-related cirrhosis, Child-Pugh class A, and model for end-stage liver disease scores ≤ 10. Among those, 62 underwent metabolic surgery (37 Roux-en-Y gastric bypass and 25 sleeve gastrectomy) and 106 had nonsurgical treatment.
After overlap weighting, the groups had balanced baseline characteristics, including mean body mass index of 42.7, Fibrosis-4 score of 2.1, albumin of 4.1 g/dL, bilirubin of 0.6 mg/dL, and Elixhauser comorbidity index of 9. In each group, 84.5% had type 2 diabetes and 79.1% had Ishak fibrosis stage 6.
Overall, the 15-year cumulative incidence of MALO was 20.9% in the surgical group and 46.4% in the nonsurgical group (adjusted hazard ratio [aHR], 0.28; P = .003), with MALO occurring in 10 surgical patients and 42 nonsurgical patients.
Assuming a causal effect, the number needed to treat with metabolic surgery to avoid one incidence of MALO over a 15-year timespan was 4.5.
The 15-year incidence of MALO was similar between surgical methods, with 20.1% for Roux-en-Y gastric bypass and 19.9% for sleeve gastrectomy.
In addition, the 15-year cumulative incidence of progression to decompensated cirrhosis was 15.6% in the surgical group and 30.7% in the nonsurgical group (aHR, 0.2; P = .01), with decompensation occurring in four surgical patients and 33 nonsurgical patients.
At 15 years, patients in the surgical group lost 31.6 kg or about 26.6% of their weight, and those in the nonsurgical group lost 10.7 kg or 9.8%.
Among patients with type 2 diabetes at baseline, metabolic surgery was associated with a reduction in hemoglobin A1c levels, as well as diabetes remission for some patients.
Potential to Fill an Unmet Need
Previous studies have indicated that bariatric surgery can effectively treat noncirrhotic MASH and lead to histologic resolution of MASH. In a 2021 study, Nissen and colleagues found bariatric surgery was associated with a lower risk for MALO and major adverse cardiovascular events in patients with biopsy-proven MASH without cirrhosis. Now, Nissen said, the SPECCIAL study indicates surgery may be a good option for MASH-related cirrhosis as well.
The study authors also noted that similar findings are theoretically possible from medical therapies, given the emergence of a new generation of anti-obesity medications. In this study, 16.8% of the surgical group and 14.3% of the nonsurgical group took semaglutide or tirzepatide at some point during the follow-up period.
“Patients with MASH-related cirrhosis have extremely limited treatment options,” said Sobia Laique, MD, study coauthor and a transplant hepatologist at the Cleveland Clinic who specializes in MASH-related cirrhosis. She cofounded the Cleveland Clinic’s task force on metabolic dysfunction–associated steatotic liver disease (MASLD) to improve screening, management, and patient outcomes for MASLD and related comorbidities.
“No therapeutic interventions have demonstrated efficacy in mitigating the risk of severe liver complications for these patients,” she said. “This underscores a critical unmet need for the development of effective therapies specifically targeting patients with compensated MASH-related cirrhosis.”
No funding was reported for this study. Several authors reported receiving grant funding, consultant fees, and advisory roles for various pharmaceutical companies.
A version of this article appeared on Medscape.com.
according to a recent study by Cleveland Clinic researchers.
Compared with patients who received medical therapy alone, those who underwent bariatric surgery had a 72% lower risk of developing serious complications of liver disease and an 80% lower risk for progression to decompensated cirrhosis.
The results could have major implications for patients with metabolic dysfunction–associated steatohepatitis (MASH), particularly given that about 20% of patients with MASH progress to cirrhosis, the researchers said.
“Currently, lifestyle intervention is the only therapeutic recommendation for compensated MASH-related cirrhosis,” said Steven Nissen, MD, the senior author and chief academic officer of the Miller Family Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Ohio.
“However, lifestyle changes alone rarely provide the weight loss and metabolic changes needed to reduce the risk of liver complications in this patient population,” he said. “This study shows that bariatric surgery is an effective treatment that can influence the trajectory of cirrhosis progression in select patients.”
The study was published online in Nature Medicine.
Significantly Reduced Risks
As part of the Surgical Procedures Eliminate Compensated Cirrhosis in Advancing Long-Term (SPECCIAL) observational study, Nissen and colleagues compared the long-term effects of metabolic surgery and medical treatment in patients with obesity and compensated, biopsy-proven MASH-related cirrhosis. They looked for six major adverse liver outcomes (MALO): ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, liver transplantation, and all-cause mortality.
Among nearly 37,000 patients who underwent liver biopsy at the Cleveland Clinic Health System between 1995 and 2020, the research team identified 168 patients (69.6% women) with MASH-related cirrhosis, Child-Pugh class A, and model for end-stage liver disease scores ≤ 10. Among those, 62 underwent metabolic surgery (37 Roux-en-Y gastric bypass and 25 sleeve gastrectomy) and 106 had nonsurgical treatment.
After overlap weighting, the groups had balanced baseline characteristics, including mean body mass index of 42.7, Fibrosis-4 score of 2.1, albumin of 4.1 g/dL, bilirubin of 0.6 mg/dL, and Elixhauser comorbidity index of 9. In each group, 84.5% had type 2 diabetes and 79.1% had Ishak fibrosis stage 6.
Overall, the 15-year cumulative incidence of MALO was 20.9% in the surgical group and 46.4% in the nonsurgical group (adjusted hazard ratio [aHR], 0.28; P = .003), with MALO occurring in 10 surgical patients and 42 nonsurgical patients.
Assuming a causal effect, the number needed to treat with metabolic surgery to avoid one incidence of MALO over a 15-year timespan was 4.5.
The 15-year incidence of MALO was similar between surgical methods, with 20.1% for Roux-en-Y gastric bypass and 19.9% for sleeve gastrectomy.
In addition, the 15-year cumulative incidence of progression to decompensated cirrhosis was 15.6% in the surgical group and 30.7% in the nonsurgical group (aHR, 0.2; P = .01), with decompensation occurring in four surgical patients and 33 nonsurgical patients.
At 15 years, patients in the surgical group lost 31.6 kg or about 26.6% of their weight, and those in the nonsurgical group lost 10.7 kg or 9.8%.
Among patients with type 2 diabetes at baseline, metabolic surgery was associated with a reduction in hemoglobin A1c levels, as well as diabetes remission for some patients.
Potential to Fill an Unmet Need
Previous studies have indicated that bariatric surgery can effectively treat noncirrhotic MASH and lead to histologic resolution of MASH. In a 2021 study, Nissen and colleagues found bariatric surgery was associated with a lower risk for MALO and major adverse cardiovascular events in patients with biopsy-proven MASH without cirrhosis. Now, Nissen said, the SPECCIAL study indicates surgery may be a good option for MASH-related cirrhosis as well.
The study authors also noted that similar findings are theoretically possible from medical therapies, given the emergence of a new generation of anti-obesity medications. In this study, 16.8% of the surgical group and 14.3% of the nonsurgical group took semaglutide or tirzepatide at some point during the follow-up period.
“Patients with MASH-related cirrhosis have extremely limited treatment options,” said Sobia Laique, MD, study coauthor and a transplant hepatologist at the Cleveland Clinic who specializes in MASH-related cirrhosis. She cofounded the Cleveland Clinic’s task force on metabolic dysfunction–associated steatotic liver disease (MASLD) to improve screening, management, and patient outcomes for MASLD and related comorbidities.
“No therapeutic interventions have demonstrated efficacy in mitigating the risk of severe liver complications for these patients,” she said. “This underscores a critical unmet need for the development of effective therapies specifically targeting patients with compensated MASH-related cirrhosis.”
No funding was reported for this study. Several authors reported receiving grant funding, consultant fees, and advisory roles for various pharmaceutical companies.
A version of this article appeared on Medscape.com.
FROM NATURE MEDICINE
Preventing Hepatitis B Reactivation: Updated Clinical Guidance From AGA
The document was published in Gastroenterology and replaces a previous guideline on prophylaxis for immunosuppressed patients issued in 2014.
Since then, many novel classes of immunosuppressives have been approved for various conditions, and potentially immunosuppressive therapies such as transcatheter arterial chemoembolization have been recognized as relevant to potential HBVr.
With reactivation a risk after immune-modulating exposures, such as to multiple drug classes and disease states, the update provides frontline clinicians with evidence-based advice for the management of HBVr in vulnerable individuals. And while antiviral prophylaxis is recommended for many, in select cases careful clinical monitoring may suffice for risk management.
“The risk of HBV reactivation depends on patient-, drug-, and disease-specific factors — and so it can range from very rare to more frequent,” said guideline coauthor Tracey G. Simon, MD, MPH, a hepatologist in the division of gastroenterology at Massachusetts General Hospital and an instructor at Harvard Medical School, both in Boston. “Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors.”
Simon stressed the importance of creating this guideline to include many new therapies that carry varying degrees of reactivation risk. As to the strength of the evidence, she added, “for some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.”
Main Recommendations
AGA based its clinical recommendations on balancing desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. It also provided a clinical decision support tool for making pharmacologic management decisions.
The panelists reviewed data on multiple immunosuppressive therapies from older agents such as anthracycline derivatives, corticosteroids, and anti–tumor necrosis factor (anti-TNF) drugs to chimeric antigen receptor T cells and recent biologics and inhibitors.
1. For individuals at high risk for HBVr, AGA recommended antiviral prophylaxis over monitoring alone. Strong recommendation, moderate-certainty evidence.
Implementation considerations: Use antivirals with a high barrier to resistance. Prophylaxis should be started before initiating medications that carry a risk for HBVr and should be continued for at least 6 months after discontinuation of risk-imposing therapy (at least 12 months for B cell–depleting agents).
2. For individuals at moderate risk for HBVr, antiviral prophylaxis was recommended over monitoring alone. Conditional recommendation, moderate-certainty evidence.
Implementation considerations: Use antivirals with a high barrier to resistance. Patients who place a higher value on avoiding long-term antiviral therapy and its associated cost and place a lower value on avoiding the small risk of reactivation (particularly those who are hepatitis B surface antigen [HBsAg]–negative) may reasonably select active monitoring over antiviral prophylaxis.
Careful consideration should be given to the feasibility and likelihood of adherence to long-term monitoring performed at 1- to 3-month intervals and including assessment of hepatitis B viral load and alanine aminotransferase.
3. For low-risk individuals, the AGA said monitoring alone may be used. Conditional recommendation, moderate-certainty evidence.
Implementation considerations: This recommendation assumes regular and sufficient follow-up with continued monitoring. Patients who place a higher value on avoiding the small risk of reactivation (particularly those on more than one low-risk immunosuppressive) and a lower value on the burden and cost of antiviral therapy may reasonably select antiviral therapy.
4. For individuals at risk for HBVr, the guideline recommended testing for hepatitis B. Strong recommendation, moderate-certainty evidence.
Implementation considerations: Given the Centers for Disease Control and Prevention’s universal screening guidance on hepatitis B for everyone aged 18 years or older by testing for HBsAg, anti-HBs, and total anti-hepatitis B core (HBc), the guideline said that stratifying screening practices by magnitude of HBVr risk is no longer needed.
It is reasonable to test initially for serologic markers alone (at minimum for HBsAg or anti-HBc) followed by viral load testing (HBV-DNA) if HBsAg and/or anti-HBc is positive.
Hepatitis C Virus (HCV) Coinfection With Direct-Acting Antiviral (DAA) Treatment
The panel identified 11 studies that provided data for the computation of baseline risk for HBVr in the HCV coinfection cohort undergoing DAA therapy.
In patients who were HBsAg-positive, the pooled baseline risk for HBVr was 240 per 1000, categorizing them to be at high risk for HBVr. The panel stated it is therefore reasonable to extend antiviral prophylaxis beyond the 12-24 weeks of DAA therapy to 6-12 months after cessation of DAA therapy, tailored by clinician judgment and patient preference.
A ‘Useful Clinical Tool’
Commenting on the guideline but not involved in it, Saikiran Kilaru, MD, a hepatologist at NYU Langone Health in New York City, said the update is “absolutely a useful clinical tool. Since the prior guidance was published, there has been a deluge of new medications and medication classes. Prior to the guidance, I was making recommendations based on the limited data available for hepatitis B reactivation risk for these new medications, using the 1%-10% moderate-risk category as guidance.”
In addition, Kilaru said, this guidance is driven by a higher level of evidence certainty than the mostly retrospective evidence that was previously available.
She cautioned that few downgraded risk categories are likely to cause consternation among physicians who have been operating without the benefit of larger meta-analyses of HBVr in new medication categories. “For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk.” And other medications such as immune checkpoint inhibitors, which seemed to pose at least moderate risk based on smaller, retrospective studies are now considered to be in the low-risk category.
“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years,” Kilaru said.
Kilaru pointed out that the guidance update does not clearly cover some standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens, such as mycophenolate, tacrolimus, and cyclosporine. Nor does it address HBVr risk in some liver cancer treatments such as yttrium-90, which have been associated with reports of HBV reactivation.
The Future
According to Simon, more data are needed to better estimate HBVr risk in several important settings, including treatment with the most recently approved immunosuppressive drugs for which data are still limited, as well as combination treatments.
Kilaru noted that guideline updates such as this become increasingly relevant as cancer diagnoses rise and hepatitis B exposure and detection increase as well.
The AGA panel acknowledged that uncertainty remains in some patient risk categorizations. “As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr,” the panelists wrote.
AGA provided all financial support for the development of this guideline. No funding from industry was offered or accepted to support the writing effort.
The authors reported no relevant competing interests, but one coauthor is an adviser for Gilead Sciences, and other authors disclosed various relationships with multiple private sector companies. Kilaru had no competing interests to disclose.
A version of this article appeared on Medscape.com.
The document was published in Gastroenterology and replaces a previous guideline on prophylaxis for immunosuppressed patients issued in 2014.
Since then, many novel classes of immunosuppressives have been approved for various conditions, and potentially immunosuppressive therapies such as transcatheter arterial chemoembolization have been recognized as relevant to potential HBVr.
With reactivation a risk after immune-modulating exposures, such as to multiple drug classes and disease states, the update provides frontline clinicians with evidence-based advice for the management of HBVr in vulnerable individuals. And while antiviral prophylaxis is recommended for many, in select cases careful clinical monitoring may suffice for risk management.
“The risk of HBV reactivation depends on patient-, drug-, and disease-specific factors — and so it can range from very rare to more frequent,” said guideline coauthor Tracey G. Simon, MD, MPH, a hepatologist in the division of gastroenterology at Massachusetts General Hospital and an instructor at Harvard Medical School, both in Boston. “Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors.”
Simon stressed the importance of creating this guideline to include many new therapies that carry varying degrees of reactivation risk. As to the strength of the evidence, she added, “for some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.”
Main Recommendations
AGA based its clinical recommendations on balancing desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. It also provided a clinical decision support tool for making pharmacologic management decisions.
The panelists reviewed data on multiple immunosuppressive therapies from older agents such as anthracycline derivatives, corticosteroids, and anti–tumor necrosis factor (anti-TNF) drugs to chimeric antigen receptor T cells and recent biologics and inhibitors.
1. For individuals at high risk for HBVr, AGA recommended antiviral prophylaxis over monitoring alone. Strong recommendation, moderate-certainty evidence.
Implementation considerations: Use antivirals with a high barrier to resistance. Prophylaxis should be started before initiating medications that carry a risk for HBVr and should be continued for at least 6 months after discontinuation of risk-imposing therapy (at least 12 months for B cell–depleting agents).
2. For individuals at moderate risk for HBVr, antiviral prophylaxis was recommended over monitoring alone. Conditional recommendation, moderate-certainty evidence.
Implementation considerations: Use antivirals with a high barrier to resistance. Patients who place a higher value on avoiding long-term antiviral therapy and its associated cost and place a lower value on avoiding the small risk of reactivation (particularly those who are hepatitis B surface antigen [HBsAg]–negative) may reasonably select active monitoring over antiviral prophylaxis.
Careful consideration should be given to the feasibility and likelihood of adherence to long-term monitoring performed at 1- to 3-month intervals and including assessment of hepatitis B viral load and alanine aminotransferase.
3. For low-risk individuals, the AGA said monitoring alone may be used. Conditional recommendation, moderate-certainty evidence.
Implementation considerations: This recommendation assumes regular and sufficient follow-up with continued monitoring. Patients who place a higher value on avoiding the small risk of reactivation (particularly those on more than one low-risk immunosuppressive) and a lower value on the burden and cost of antiviral therapy may reasonably select antiviral therapy.
4. For individuals at risk for HBVr, the guideline recommended testing for hepatitis B. Strong recommendation, moderate-certainty evidence.
Implementation considerations: Given the Centers for Disease Control and Prevention’s universal screening guidance on hepatitis B for everyone aged 18 years or older by testing for HBsAg, anti-HBs, and total anti-hepatitis B core (HBc), the guideline said that stratifying screening practices by magnitude of HBVr risk is no longer needed.
It is reasonable to test initially for serologic markers alone (at minimum for HBsAg or anti-HBc) followed by viral load testing (HBV-DNA) if HBsAg and/or anti-HBc is positive.
Hepatitis C Virus (HCV) Coinfection With Direct-Acting Antiviral (DAA) Treatment
The panel identified 11 studies that provided data for the computation of baseline risk for HBVr in the HCV coinfection cohort undergoing DAA therapy.
In patients who were HBsAg-positive, the pooled baseline risk for HBVr was 240 per 1000, categorizing them to be at high risk for HBVr. The panel stated it is therefore reasonable to extend antiviral prophylaxis beyond the 12-24 weeks of DAA therapy to 6-12 months after cessation of DAA therapy, tailored by clinician judgment and patient preference.
A ‘Useful Clinical Tool’
Commenting on the guideline but not involved in it, Saikiran Kilaru, MD, a hepatologist at NYU Langone Health in New York City, said the update is “absolutely a useful clinical tool. Since the prior guidance was published, there has been a deluge of new medications and medication classes. Prior to the guidance, I was making recommendations based on the limited data available for hepatitis B reactivation risk for these new medications, using the 1%-10% moderate-risk category as guidance.”
In addition, Kilaru said, this guidance is driven by a higher level of evidence certainty than the mostly retrospective evidence that was previously available.
She cautioned that few downgraded risk categories are likely to cause consternation among physicians who have been operating without the benefit of larger meta-analyses of HBVr in new medication categories. “For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk.” And other medications such as immune checkpoint inhibitors, which seemed to pose at least moderate risk based on smaller, retrospective studies are now considered to be in the low-risk category.
“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years,” Kilaru said.
Kilaru pointed out that the guidance update does not clearly cover some standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens, such as mycophenolate, tacrolimus, and cyclosporine. Nor does it address HBVr risk in some liver cancer treatments such as yttrium-90, which have been associated with reports of HBV reactivation.
The Future
According to Simon, more data are needed to better estimate HBVr risk in several important settings, including treatment with the most recently approved immunosuppressive drugs for which data are still limited, as well as combination treatments.
Kilaru noted that guideline updates such as this become increasingly relevant as cancer diagnoses rise and hepatitis B exposure and detection increase as well.
The AGA panel acknowledged that uncertainty remains in some patient risk categorizations. “As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr,” the panelists wrote.
AGA provided all financial support for the development of this guideline. No funding from industry was offered or accepted to support the writing effort.
The authors reported no relevant competing interests, but one coauthor is an adviser for Gilead Sciences, and other authors disclosed various relationships with multiple private sector companies. Kilaru had no competing interests to disclose.
A version of this article appeared on Medscape.com.
The document was published in Gastroenterology and replaces a previous guideline on prophylaxis for immunosuppressed patients issued in 2014.
Since then, many novel classes of immunosuppressives have been approved for various conditions, and potentially immunosuppressive therapies such as transcatheter arterial chemoembolization have been recognized as relevant to potential HBVr.
With reactivation a risk after immune-modulating exposures, such as to multiple drug classes and disease states, the update provides frontline clinicians with evidence-based advice for the management of HBVr in vulnerable individuals. And while antiviral prophylaxis is recommended for many, in select cases careful clinical monitoring may suffice for risk management.
“The risk of HBV reactivation depends on patient-, drug-, and disease-specific factors — and so it can range from very rare to more frequent,” said guideline coauthor Tracey G. Simon, MD, MPH, a hepatologist in the division of gastroenterology at Massachusetts General Hospital and an instructor at Harvard Medical School, both in Boston. “Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors.”
Simon stressed the importance of creating this guideline to include many new therapies that carry varying degrees of reactivation risk. As to the strength of the evidence, she added, “for some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.”
Main Recommendations
AGA based its clinical recommendations on balancing desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. It also provided a clinical decision support tool for making pharmacologic management decisions.
The panelists reviewed data on multiple immunosuppressive therapies from older agents such as anthracycline derivatives, corticosteroids, and anti–tumor necrosis factor (anti-TNF) drugs to chimeric antigen receptor T cells and recent biologics and inhibitors.
1. For individuals at high risk for HBVr, AGA recommended antiviral prophylaxis over monitoring alone. Strong recommendation, moderate-certainty evidence.
Implementation considerations: Use antivirals with a high barrier to resistance. Prophylaxis should be started before initiating medications that carry a risk for HBVr and should be continued for at least 6 months after discontinuation of risk-imposing therapy (at least 12 months for B cell–depleting agents).
2. For individuals at moderate risk for HBVr, antiviral prophylaxis was recommended over monitoring alone. Conditional recommendation, moderate-certainty evidence.
Implementation considerations: Use antivirals with a high barrier to resistance. Patients who place a higher value on avoiding long-term antiviral therapy and its associated cost and place a lower value on avoiding the small risk of reactivation (particularly those who are hepatitis B surface antigen [HBsAg]–negative) may reasonably select active monitoring over antiviral prophylaxis.
Careful consideration should be given to the feasibility and likelihood of adherence to long-term monitoring performed at 1- to 3-month intervals and including assessment of hepatitis B viral load and alanine aminotransferase.
3. For low-risk individuals, the AGA said monitoring alone may be used. Conditional recommendation, moderate-certainty evidence.
Implementation considerations: This recommendation assumes regular and sufficient follow-up with continued monitoring. Patients who place a higher value on avoiding the small risk of reactivation (particularly those on more than one low-risk immunosuppressive) and a lower value on the burden and cost of antiviral therapy may reasonably select antiviral therapy.
4. For individuals at risk for HBVr, the guideline recommended testing for hepatitis B. Strong recommendation, moderate-certainty evidence.
Implementation considerations: Given the Centers for Disease Control and Prevention’s universal screening guidance on hepatitis B for everyone aged 18 years or older by testing for HBsAg, anti-HBs, and total anti-hepatitis B core (HBc), the guideline said that stratifying screening practices by magnitude of HBVr risk is no longer needed.
It is reasonable to test initially for serologic markers alone (at minimum for HBsAg or anti-HBc) followed by viral load testing (HBV-DNA) if HBsAg and/or anti-HBc is positive.
Hepatitis C Virus (HCV) Coinfection With Direct-Acting Antiviral (DAA) Treatment
The panel identified 11 studies that provided data for the computation of baseline risk for HBVr in the HCV coinfection cohort undergoing DAA therapy.
In patients who were HBsAg-positive, the pooled baseline risk for HBVr was 240 per 1000, categorizing them to be at high risk for HBVr. The panel stated it is therefore reasonable to extend antiviral prophylaxis beyond the 12-24 weeks of DAA therapy to 6-12 months after cessation of DAA therapy, tailored by clinician judgment and patient preference.
A ‘Useful Clinical Tool’
Commenting on the guideline but not involved in it, Saikiran Kilaru, MD, a hepatologist at NYU Langone Health in New York City, said the update is “absolutely a useful clinical tool. Since the prior guidance was published, there has been a deluge of new medications and medication classes. Prior to the guidance, I was making recommendations based on the limited data available for hepatitis B reactivation risk for these new medications, using the 1%-10% moderate-risk category as guidance.”
In addition, Kilaru said, this guidance is driven by a higher level of evidence certainty than the mostly retrospective evidence that was previously available.
She cautioned that few downgraded risk categories are likely to cause consternation among physicians who have been operating without the benefit of larger meta-analyses of HBVr in new medication categories. “For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk.” And other medications such as immune checkpoint inhibitors, which seemed to pose at least moderate risk based on smaller, retrospective studies are now considered to be in the low-risk category.
“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years,” Kilaru said.
Kilaru pointed out that the guidance update does not clearly cover some standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens, such as mycophenolate, tacrolimus, and cyclosporine. Nor does it address HBVr risk in some liver cancer treatments such as yttrium-90, which have been associated with reports of HBV reactivation.
The Future
According to Simon, more data are needed to better estimate HBVr risk in several important settings, including treatment with the most recently approved immunosuppressive drugs for which data are still limited, as well as combination treatments.
Kilaru noted that guideline updates such as this become increasingly relevant as cancer diagnoses rise and hepatitis B exposure and detection increase as well.
The AGA panel acknowledged that uncertainty remains in some patient risk categorizations. “As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr,” the panelists wrote.
AGA provided all financial support for the development of this guideline. No funding from industry was offered or accepted to support the writing effort.
The authors reported no relevant competing interests, but one coauthor is an adviser for Gilead Sciences, and other authors disclosed various relationships with multiple private sector companies. Kilaru had no competing interests to disclose.
A version of this article appeared on Medscape.com.
FROM GASTROENTEROLOGY
Vedolizumab Beats Infliximab as Second-Line Therapy for Ulcerative Colitis
BERLIN — suggests EFFICACI, the first trial directly comparing second-line advanced therapies in patients with the disease.
Vedolizumab was superior to infliximab to achieving steroid-free clinical remission at week 14 in patients who had failed on a first-line subcutaneous anti–tumor necrosis factor (anti-TNF) therapy, said study presenter Guillaume Bouguen, MD, PhD, of the gastroenterology gepartment, CHU Rennes – Pontchaillou Hospital, France.
The drug also outperformed infliximab in the induction of endoscopic improvement, and its safety outcomes were “consistent with the known profile of both drugs in previous trials,” Bouguen said.
The research was presented at the European Crohn’s and Colitis Organisation 2025 Congress.
The study reports only short-term outcomes, so it “remains unclear whether vedolizumab’s advantage is sustained over time or whether infliximab may catch up in effectiveness,” Tauseef Ali, MD, AGAF, executive medical director, SSM Health St. Anthony Digestive Care, Crohn’s and Colitis Center, Oklahoma City, said in an interview.
Bouguen noted that the trial was unblinded at week 14 and that patients were followed up to week 54, data for which will be presented in the near future.
Head-to-Head Trial
Treating ulcerative colitis beyond the first line of therapy is “becoming challenging” because there are several therapeutic classes and drugs to choose from but no strong evidence to support physician decision-making, Bouguen said.
No head-to-head trials for second-line advanced therapies for UC had been performed, he said. So Bouguen and colleagues conducted a randomized, double-blind trial to determine whether vedolizumab, an integrin receptor agonist, is superior to infliximab, a TNF antagonist, in ulcerative colitis patients who had failed a first-line subcutaneous TNF antagonist.
They enrolled patients with moderate to severe disease, defined by a total Mayo score ≥ 6, despite at least 12 weeks of treatment with the TNF antagonists golimumab (Simponi) or adalimumab (Humira and others), from 24 centers across France.
Participants were randomly assigned to intravenous 300 mg vedolizumab or 5 mg/kg infliximab. Clinical biological assessments performed at baseline and at weeks 2 and 6. The primary endpoint was steroid-free clinical remission (Mayo score ≤ 2) at week 14.
Of 165 patients assessed for eligibility, 78 were randomly assigned to vedolizumab and 73 to infliximab, of whom 77 and 70 and patients, respectively, were available for assessment at week 14. Approximately 40% of the participants were women, and the average age was almost 40 years.
The mean total Mayo score at baseline was comparable between the two groups (9.0 vedolizumab; 8.7 infliximab). The majority in both groups had previously been treated with adalimumab, and almost 60% had experienced a loss of response to therapy.
Steroid-free clinical remission at week 14 was achieved by 34.6% of patients treated with vedolizumab vs 19.2% of those given infliximab (P = .033).
Endoscopic remission at week 14 was achieved by 19.5% of patients in the vedolizumab group vs 8.3% of those treated with infliximab (P = .0507), while endoscopic improvement was seen in 46.8% and 29.2% of patients, respectively (P = .0273).
There were no statistically significant differences between the two treatment groups in rates of clinical response or mean C-reactive protein (CRP) levels between baseline and week 14, and there was no significant difference in fecal calprotectin levels at week 14.
Interestingly, Bouguen said that, from parameters such as age, sex, Mayo score, CRP levels, and concomitant immunosuppressant use, there were no significant predictors of clinical remission.
The overall incidence of adverse events, including respiratory tract and Clostridioides difficile infections, was comparable between the vedolizumab and infliximab groups, although patients receiving infliximab had higher rates of disease worsening and infusion reactions.
Questions Remain
Study coinvestigator Matthieu Allez, MD, PhD, head of the gastroenterology department, Hôpital Saint-Louis, Assistance Publique Hopitaux de Paris, said in an interview that he was surprised by the findings.
“I think infliximab is a much better drug than vedolizumab,” considering the rate of immunosuppressant combination therapy that is administered in ulcerative colitis, said Allez, who was the session’s co-chair.
This is a “key aspect” as “you can give more” of such therapy to patients receiving infliximab, “but, in fact, it seems like they do better” with vedolizumab, Allez said.
Ali said that the trial “addresses a critical gap in the treatment of ulcerative colitis: Whether switching within the anti-TNF class or swapping to vedolizumab is more effective after failure of a first subcutaneous anti-TNF.”
“This question has real-world clinical relevance, as gastroenterologists often face this decision,” he added.
Ali, who was not involved in the study, said that even though the results “suggest that vedolizumab may be a more effective option than infliximab in this patient population” and there were no major safety concerns with either drug, “one must exercise caution in interpreting and applying the results to clinical practice.”
Moreover, the lack of statistically significant clinical response rates between the drugs “raises questions about whether the primary endpoint difference is clinically meaningful over the long term,” he said.
The study was conducted in only one country, thus potentially limiting its generalizability, Ali noted, and it included only patients who had failed on subcutaneous, not intravenous, anti-TNF therapy. There was also a lack of biomarker stratification, “making it unclear which patients would benefit most from switching vs swapping strategies,” he added.
“While vedolizumab may be preferable, many other factors,” such as drug serum levels, immunogenicity, urgency of response, access, and cost, “should guide decision-making,” Ali said.
The study was funded by the French national research program, with additional funding from Takeda. Bouguen declared relationships with Abbvie, Janssen, Lilly, Takeda, Celltrion, Sandoz, Galapagos, Tillotts, and Amgen. No other disclosures were reported.
A version of this article appeared on Medscape.com.
BERLIN — suggests EFFICACI, the first trial directly comparing second-line advanced therapies in patients with the disease.
Vedolizumab was superior to infliximab to achieving steroid-free clinical remission at week 14 in patients who had failed on a first-line subcutaneous anti–tumor necrosis factor (anti-TNF) therapy, said study presenter Guillaume Bouguen, MD, PhD, of the gastroenterology gepartment, CHU Rennes – Pontchaillou Hospital, France.
The drug also outperformed infliximab in the induction of endoscopic improvement, and its safety outcomes were “consistent with the known profile of both drugs in previous trials,” Bouguen said.
The research was presented at the European Crohn’s and Colitis Organisation 2025 Congress.
The study reports only short-term outcomes, so it “remains unclear whether vedolizumab’s advantage is sustained over time or whether infliximab may catch up in effectiveness,” Tauseef Ali, MD, AGAF, executive medical director, SSM Health St. Anthony Digestive Care, Crohn’s and Colitis Center, Oklahoma City, said in an interview.
Bouguen noted that the trial was unblinded at week 14 and that patients were followed up to week 54, data for which will be presented in the near future.
Head-to-Head Trial
Treating ulcerative colitis beyond the first line of therapy is “becoming challenging” because there are several therapeutic classes and drugs to choose from but no strong evidence to support physician decision-making, Bouguen said.
No head-to-head trials for second-line advanced therapies for UC had been performed, he said. So Bouguen and colleagues conducted a randomized, double-blind trial to determine whether vedolizumab, an integrin receptor agonist, is superior to infliximab, a TNF antagonist, in ulcerative colitis patients who had failed a first-line subcutaneous TNF antagonist.
They enrolled patients with moderate to severe disease, defined by a total Mayo score ≥ 6, despite at least 12 weeks of treatment with the TNF antagonists golimumab (Simponi) or adalimumab (Humira and others), from 24 centers across France.
Participants were randomly assigned to intravenous 300 mg vedolizumab or 5 mg/kg infliximab. Clinical biological assessments performed at baseline and at weeks 2 and 6. The primary endpoint was steroid-free clinical remission (Mayo score ≤ 2) at week 14.
Of 165 patients assessed for eligibility, 78 were randomly assigned to vedolizumab and 73 to infliximab, of whom 77 and 70 and patients, respectively, were available for assessment at week 14. Approximately 40% of the participants were women, and the average age was almost 40 years.
The mean total Mayo score at baseline was comparable between the two groups (9.0 vedolizumab; 8.7 infliximab). The majority in both groups had previously been treated with adalimumab, and almost 60% had experienced a loss of response to therapy.
Steroid-free clinical remission at week 14 was achieved by 34.6% of patients treated with vedolizumab vs 19.2% of those given infliximab (P = .033).
Endoscopic remission at week 14 was achieved by 19.5% of patients in the vedolizumab group vs 8.3% of those treated with infliximab (P = .0507), while endoscopic improvement was seen in 46.8% and 29.2% of patients, respectively (P = .0273).
There were no statistically significant differences between the two treatment groups in rates of clinical response or mean C-reactive protein (CRP) levels between baseline and week 14, and there was no significant difference in fecal calprotectin levels at week 14.
Interestingly, Bouguen said that, from parameters such as age, sex, Mayo score, CRP levels, and concomitant immunosuppressant use, there were no significant predictors of clinical remission.
The overall incidence of adverse events, including respiratory tract and Clostridioides difficile infections, was comparable between the vedolizumab and infliximab groups, although patients receiving infliximab had higher rates of disease worsening and infusion reactions.
Questions Remain
Study coinvestigator Matthieu Allez, MD, PhD, head of the gastroenterology department, Hôpital Saint-Louis, Assistance Publique Hopitaux de Paris, said in an interview that he was surprised by the findings.
“I think infliximab is a much better drug than vedolizumab,” considering the rate of immunosuppressant combination therapy that is administered in ulcerative colitis, said Allez, who was the session’s co-chair.
This is a “key aspect” as “you can give more” of such therapy to patients receiving infliximab, “but, in fact, it seems like they do better” with vedolizumab, Allez said.
Ali said that the trial “addresses a critical gap in the treatment of ulcerative colitis: Whether switching within the anti-TNF class or swapping to vedolizumab is more effective after failure of a first subcutaneous anti-TNF.”
“This question has real-world clinical relevance, as gastroenterologists often face this decision,” he added.
Ali, who was not involved in the study, said that even though the results “suggest that vedolizumab may be a more effective option than infliximab in this patient population” and there were no major safety concerns with either drug, “one must exercise caution in interpreting and applying the results to clinical practice.”
Moreover, the lack of statistically significant clinical response rates between the drugs “raises questions about whether the primary endpoint difference is clinically meaningful over the long term,” he said.
The study was conducted in only one country, thus potentially limiting its generalizability, Ali noted, and it included only patients who had failed on subcutaneous, not intravenous, anti-TNF therapy. There was also a lack of biomarker stratification, “making it unclear which patients would benefit most from switching vs swapping strategies,” he added.
“While vedolizumab may be preferable, many other factors,” such as drug serum levels, immunogenicity, urgency of response, access, and cost, “should guide decision-making,” Ali said.
The study was funded by the French national research program, with additional funding from Takeda. Bouguen declared relationships with Abbvie, Janssen, Lilly, Takeda, Celltrion, Sandoz, Galapagos, Tillotts, and Amgen. No other disclosures were reported.
A version of this article appeared on Medscape.com.
BERLIN — suggests EFFICACI, the first trial directly comparing second-line advanced therapies in patients with the disease.
Vedolizumab was superior to infliximab to achieving steroid-free clinical remission at week 14 in patients who had failed on a first-line subcutaneous anti–tumor necrosis factor (anti-TNF) therapy, said study presenter Guillaume Bouguen, MD, PhD, of the gastroenterology gepartment, CHU Rennes – Pontchaillou Hospital, France.
The drug also outperformed infliximab in the induction of endoscopic improvement, and its safety outcomes were “consistent with the known profile of both drugs in previous trials,” Bouguen said.
The research was presented at the European Crohn’s and Colitis Organisation 2025 Congress.
The study reports only short-term outcomes, so it “remains unclear whether vedolizumab’s advantage is sustained over time or whether infliximab may catch up in effectiveness,” Tauseef Ali, MD, AGAF, executive medical director, SSM Health St. Anthony Digestive Care, Crohn’s and Colitis Center, Oklahoma City, said in an interview.
Bouguen noted that the trial was unblinded at week 14 and that patients were followed up to week 54, data for which will be presented in the near future.
Head-to-Head Trial
Treating ulcerative colitis beyond the first line of therapy is “becoming challenging” because there are several therapeutic classes and drugs to choose from but no strong evidence to support physician decision-making, Bouguen said.
No head-to-head trials for second-line advanced therapies for UC had been performed, he said. So Bouguen and colleagues conducted a randomized, double-blind trial to determine whether vedolizumab, an integrin receptor agonist, is superior to infliximab, a TNF antagonist, in ulcerative colitis patients who had failed a first-line subcutaneous TNF antagonist.
They enrolled patients with moderate to severe disease, defined by a total Mayo score ≥ 6, despite at least 12 weeks of treatment with the TNF antagonists golimumab (Simponi) or adalimumab (Humira and others), from 24 centers across France.
Participants were randomly assigned to intravenous 300 mg vedolizumab or 5 mg/kg infliximab. Clinical biological assessments performed at baseline and at weeks 2 and 6. The primary endpoint was steroid-free clinical remission (Mayo score ≤ 2) at week 14.
Of 165 patients assessed for eligibility, 78 were randomly assigned to vedolizumab and 73 to infliximab, of whom 77 and 70 and patients, respectively, were available for assessment at week 14. Approximately 40% of the participants were women, and the average age was almost 40 years.
The mean total Mayo score at baseline was comparable between the two groups (9.0 vedolizumab; 8.7 infliximab). The majority in both groups had previously been treated with adalimumab, and almost 60% had experienced a loss of response to therapy.
Steroid-free clinical remission at week 14 was achieved by 34.6% of patients treated with vedolizumab vs 19.2% of those given infliximab (P = .033).
Endoscopic remission at week 14 was achieved by 19.5% of patients in the vedolizumab group vs 8.3% of those treated with infliximab (P = .0507), while endoscopic improvement was seen in 46.8% and 29.2% of patients, respectively (P = .0273).
There were no statistically significant differences between the two treatment groups in rates of clinical response or mean C-reactive protein (CRP) levels between baseline and week 14, and there was no significant difference in fecal calprotectin levels at week 14.
Interestingly, Bouguen said that, from parameters such as age, sex, Mayo score, CRP levels, and concomitant immunosuppressant use, there were no significant predictors of clinical remission.
The overall incidence of adverse events, including respiratory tract and Clostridioides difficile infections, was comparable between the vedolizumab and infliximab groups, although patients receiving infliximab had higher rates of disease worsening and infusion reactions.
Questions Remain
Study coinvestigator Matthieu Allez, MD, PhD, head of the gastroenterology department, Hôpital Saint-Louis, Assistance Publique Hopitaux de Paris, said in an interview that he was surprised by the findings.
“I think infliximab is a much better drug than vedolizumab,” considering the rate of immunosuppressant combination therapy that is administered in ulcerative colitis, said Allez, who was the session’s co-chair.
This is a “key aspect” as “you can give more” of such therapy to patients receiving infliximab, “but, in fact, it seems like they do better” with vedolizumab, Allez said.
Ali said that the trial “addresses a critical gap in the treatment of ulcerative colitis: Whether switching within the anti-TNF class or swapping to vedolizumab is more effective after failure of a first subcutaneous anti-TNF.”
“This question has real-world clinical relevance, as gastroenterologists often face this decision,” he added.
Ali, who was not involved in the study, said that even though the results “suggest that vedolizumab may be a more effective option than infliximab in this patient population” and there were no major safety concerns with either drug, “one must exercise caution in interpreting and applying the results to clinical practice.”
Moreover, the lack of statistically significant clinical response rates between the drugs “raises questions about whether the primary endpoint difference is clinically meaningful over the long term,” he said.
The study was conducted in only one country, thus potentially limiting its generalizability, Ali noted, and it included only patients who had failed on subcutaneous, not intravenous, anti-TNF therapy. There was also a lack of biomarker stratification, “making it unclear which patients would benefit most from switching vs swapping strategies,” he added.
“While vedolizumab may be preferable, many other factors,” such as drug serum levels, immunogenicity, urgency of response, access, and cost, “should guide decision-making,” Ali said.
The study was funded by the French national research program, with additional funding from Takeda. Bouguen declared relationships with Abbvie, Janssen, Lilly, Takeda, Celltrion, Sandoz, Galapagos, Tillotts, and Amgen. No other disclosures were reported.
A version of this article appeared on Medscape.com.
FROM ECCO 2025
Subcutaneous Guselkumab Proves Efficacious for IBD in Two Studies: ASTRO and GRAVITI
BERLIN — according to results from the phase 3, randomized, double-blind, placebo-controlled ASTRO study.
Importantly, the study also showed that subcutaneous induction is consistent with intravenous (IV) induction of guselkumab in UC.
“The flexibility of a fully subcutaneous treatment regimen would be a welcome option for many patients, especially those with busy and active lifestyles,” said study lead Laurent Peyrin-Biroulet, MD, head of the inflammatory bowel disease (IBD) unit at University Hospital of Nancy, France.
Peyrin-Biroulet presented the results at European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
“I think it’s an evolution and improvement in terms of IBD management,” he said. “We are happy that our patients will have the choice.”
Guselkumab is a selective dual-acting interleukin (IL)–23p19 subunit inhibitor that potently blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23, and is the only full subcutaneous IL-23 available. The drug is approved in some countries, including the United States, for UC.
The ASTRO Study
Building on data from the QUASAR studies, which showed the efficacy of induction of IV guselkumab and subcutaneous maintenance in patients with UC, the ASTRO study randomly assigned 418 patients with moderately to severely active UC to receive either induction with 400 mg subcutaneous guselkumab at weeks 0, 4, and 8 or placebo.
After induction, the treatment group either received a maintenance dose of 200 mg subcutaneous guselkumab at week 12 and then every 4 weeks or 100 mg every 8 weeks (starting week 16).
All patients had an inadequate response or intolerance to conventional therapy. Around 60% were naive to biologics, Janus kinase (JAK) inhibitors, or sphingosine-1-phosphate receptor modulators (S1Ps).
Clinical remission at week 12 — the primary endpoint — was achieved by 27.6% of all patients treated with guselkumab compared with 6.5% of patients on placebo (P < .001).
“These results are in line with the QUASAR data,” in which clinical remission was 22.6% with IV guselkumab at 12 weeks, noted Peyrin-Biroulet.
The researchers also divided the results by prespecified subgroups based on previous treatments.
Clinical remission was achieved at week 12 by 36% of patients naive to biologics, JAK inhibitors, or S1Ps in the guselkumab group and by 8.9% of these patients in the placebo group (P < .001). Among patients who had previously received biologics, JAK inhibitors, or S1Ps, 16.1% of those in the guselkumab group achieved clinical remission compared with 3.6% of those in the placebo group (P = .005).
“In terms of symptomatic remission at week 12, the difference between the overall guselkumab result and placebo was 30%,” reported Peyrin-Biroulet.
Clinical response — defined as a decrease in the modified Mayo score by ≥ 30% and ≥ 2 points, with either a ≥ 1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1 — was 65.6% in the guselkumab group compared with 34.5% in the placebo group (P < .001).
Among patients naive to biologics, JAK inhibitors, or S1Ps, clinical response was 71.3% in the guselkumab group, compared with 41.8% in the placebo group (P < .001). Among those who had previously received biologics, JAK inhibitors, or S1Ps, it was 57.1% in the guselkumab group, compared with 25.0% in the placebo group (P < .001).
Turning to endoscopic improvement (ie, an endoscopic subscore of 0 or 1 with no friability), 37.3% of those in the guselkumab group overall, compared with 12.9% of those in the placebo group who achieved this endpoint (P < .001).
“This is a treatment effect of over 20%,” said Peyrin-Biroulet. “We know that when it is over 20%, it is considered game changer.”
In patients naive to biologics, JAK inhibitors, or S1Ps, endoscopic improvement was 45.7% with guselkumab vs 17.7% with placebo. In those who had previously received biologics, JAK inhibitors, or S1Ps, endoscopic improvement was 24.1% with guselkumab vs 7.1% with placebo. Both were statistically significant.
The safety of subcutaneous induction therapy was consistent with the well-characterized and favorable safety profile of guselkumab in approved indications.
The GRAVITI Study
In the phase 3, randomized, double-blind, placebo-controlled GRAVITI study, also presented at ECCO 2025 Congress, researchers evaluated the efficacy and safety of induction with subcutaneous guselkumab followed by subcutaneous maintenance compared with placebo in patients with moderately to severely active Crohn’s disease.
The GRAVITI study followed the same induction and maintenance dosage and treatment intervals as the ASTRO study.
In addition, the patients randomly assigned to placebo were able to receive subcutaneous guselkumab (400 mg every 4 weeks followed by 100 mg every 8 weeks) if rescue criteria were met at week 16.
The co-primary endpoints were clinical remission and endoscopic response at week 12.
Ailsa Hart, MD, director, IBD Research, and consultant gastroenterologist, St. Mark’s Hospital and Imperial College, both in London, reported the 12-week and 48-week results, which were initially presented at the American College of Gastroenterology (ACG) meeting in October 2024.
At week 12, 56.1% of patients who received guselkumab achieved clinical remission, compared with 21.4% of patients who received placebo. Endoscopic response was achieved in 41.3% of patients treated with guselkumab compared with 21.4% in the placebo group.
Regarding the 48-week results, Hart noted that the rate of clinical remission was more than three times higher with both maintenance doses of guselkumab at 66.1% (200 mg) and 60.0% (100 mg) vs 17.1% with placebo.
Endoscopic response at 48 weeks was achieved in 51.3% of patients on the 200-mg maintenance dose and in 44.3% on the 100-mg maintenance dose, compared with 6.8% of patients on placebo.
In addition, endoscopic remission was achieved in 38.3% of patients in the 200-mg guselkumab group and in 30.4% in the 100-mg guselkumab group, compared with 6.0% in the placebo group.
Safety findings were consistent with the known safety profile of guselkumab in approved indications and other studies in IBD.
“These results complement the GALAXI data and demonstrate that both IV and subcutaneous guselkumab induction are efficacious and therapeutic in Crohn’s disease,” Hart said. Furthermore, data from the ASTRO study demonstrated similar data in the UC population.
As clinicians, this gives us flexibility in how we treat our patients; although, the rationale for choosing subcutaneous or IV is likely to be pragmatic, Hart said.
Additionally, the flexibility of the maintenance therapy, that is, 200 mg subcutaneous guselkumab every 4 weeks or 100 mg every 8 weeks, “is expected to positively affect several parameters of therapy, including increased compliance, hospital avoidance, and better safety profiling,” comoderator Giorgos Bamias, MD, professor of gastroenterology at the School of Medicine, National and Kapodistrian University of Athens, said in an interview.
It appears that multiple options will be offered to patients regarding treatment with guselkumab for patients with Crohn’s disease, Bamias said. “Interestingly, a similar multiplicity of options has also been shown for ulcerative colitis, through the QUASAR and ASTRO studies.”
Peyrin-Biroulet declared receiving grants and other/support travel from multiple companies. Hart declared receiving grants and personal fees from multiple companies. Bamias declared receiving grants and personal fees/honoraria as an advisor/lecturer from multiple companies.
A version of this article appeared on Medscape.com.
BERLIN — according to results from the phase 3, randomized, double-blind, placebo-controlled ASTRO study.
Importantly, the study also showed that subcutaneous induction is consistent with intravenous (IV) induction of guselkumab in UC.
“The flexibility of a fully subcutaneous treatment regimen would be a welcome option for many patients, especially those with busy and active lifestyles,” said study lead Laurent Peyrin-Biroulet, MD, head of the inflammatory bowel disease (IBD) unit at University Hospital of Nancy, France.
Peyrin-Biroulet presented the results at European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
“I think it’s an evolution and improvement in terms of IBD management,” he said. “We are happy that our patients will have the choice.”
Guselkumab is a selective dual-acting interleukin (IL)–23p19 subunit inhibitor that potently blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23, and is the only full subcutaneous IL-23 available. The drug is approved in some countries, including the United States, for UC.
The ASTRO Study
Building on data from the QUASAR studies, which showed the efficacy of induction of IV guselkumab and subcutaneous maintenance in patients with UC, the ASTRO study randomly assigned 418 patients with moderately to severely active UC to receive either induction with 400 mg subcutaneous guselkumab at weeks 0, 4, and 8 or placebo.
After induction, the treatment group either received a maintenance dose of 200 mg subcutaneous guselkumab at week 12 and then every 4 weeks or 100 mg every 8 weeks (starting week 16).
All patients had an inadequate response or intolerance to conventional therapy. Around 60% were naive to biologics, Janus kinase (JAK) inhibitors, or sphingosine-1-phosphate receptor modulators (S1Ps).
Clinical remission at week 12 — the primary endpoint — was achieved by 27.6% of all patients treated with guselkumab compared with 6.5% of patients on placebo (P < .001).
“These results are in line with the QUASAR data,” in which clinical remission was 22.6% with IV guselkumab at 12 weeks, noted Peyrin-Biroulet.
The researchers also divided the results by prespecified subgroups based on previous treatments.
Clinical remission was achieved at week 12 by 36% of patients naive to biologics, JAK inhibitors, or S1Ps in the guselkumab group and by 8.9% of these patients in the placebo group (P < .001). Among patients who had previously received biologics, JAK inhibitors, or S1Ps, 16.1% of those in the guselkumab group achieved clinical remission compared with 3.6% of those in the placebo group (P = .005).
“In terms of symptomatic remission at week 12, the difference between the overall guselkumab result and placebo was 30%,” reported Peyrin-Biroulet.
Clinical response — defined as a decrease in the modified Mayo score by ≥ 30% and ≥ 2 points, with either a ≥ 1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1 — was 65.6% in the guselkumab group compared with 34.5% in the placebo group (P < .001).
Among patients naive to biologics, JAK inhibitors, or S1Ps, clinical response was 71.3% in the guselkumab group, compared with 41.8% in the placebo group (P < .001). Among those who had previously received biologics, JAK inhibitors, or S1Ps, it was 57.1% in the guselkumab group, compared with 25.0% in the placebo group (P < .001).
Turning to endoscopic improvement (ie, an endoscopic subscore of 0 or 1 with no friability), 37.3% of those in the guselkumab group overall, compared with 12.9% of those in the placebo group who achieved this endpoint (P < .001).
“This is a treatment effect of over 20%,” said Peyrin-Biroulet. “We know that when it is over 20%, it is considered game changer.”
In patients naive to biologics, JAK inhibitors, or S1Ps, endoscopic improvement was 45.7% with guselkumab vs 17.7% with placebo. In those who had previously received biologics, JAK inhibitors, or S1Ps, endoscopic improvement was 24.1% with guselkumab vs 7.1% with placebo. Both were statistically significant.
The safety of subcutaneous induction therapy was consistent with the well-characterized and favorable safety profile of guselkumab in approved indications.
The GRAVITI Study
In the phase 3, randomized, double-blind, placebo-controlled GRAVITI study, also presented at ECCO 2025 Congress, researchers evaluated the efficacy and safety of induction with subcutaneous guselkumab followed by subcutaneous maintenance compared with placebo in patients with moderately to severely active Crohn’s disease.
The GRAVITI study followed the same induction and maintenance dosage and treatment intervals as the ASTRO study.
In addition, the patients randomly assigned to placebo were able to receive subcutaneous guselkumab (400 mg every 4 weeks followed by 100 mg every 8 weeks) if rescue criteria were met at week 16.
The co-primary endpoints were clinical remission and endoscopic response at week 12.
Ailsa Hart, MD, director, IBD Research, and consultant gastroenterologist, St. Mark’s Hospital and Imperial College, both in London, reported the 12-week and 48-week results, which were initially presented at the American College of Gastroenterology (ACG) meeting in October 2024.
At week 12, 56.1% of patients who received guselkumab achieved clinical remission, compared with 21.4% of patients who received placebo. Endoscopic response was achieved in 41.3% of patients treated with guselkumab compared with 21.4% in the placebo group.
Regarding the 48-week results, Hart noted that the rate of clinical remission was more than three times higher with both maintenance doses of guselkumab at 66.1% (200 mg) and 60.0% (100 mg) vs 17.1% with placebo.
Endoscopic response at 48 weeks was achieved in 51.3% of patients on the 200-mg maintenance dose and in 44.3% on the 100-mg maintenance dose, compared with 6.8% of patients on placebo.
In addition, endoscopic remission was achieved in 38.3% of patients in the 200-mg guselkumab group and in 30.4% in the 100-mg guselkumab group, compared with 6.0% in the placebo group.
Safety findings were consistent with the known safety profile of guselkumab in approved indications and other studies in IBD.
“These results complement the GALAXI data and demonstrate that both IV and subcutaneous guselkumab induction are efficacious and therapeutic in Crohn’s disease,” Hart said. Furthermore, data from the ASTRO study demonstrated similar data in the UC population.
As clinicians, this gives us flexibility in how we treat our patients; although, the rationale for choosing subcutaneous or IV is likely to be pragmatic, Hart said.
Additionally, the flexibility of the maintenance therapy, that is, 200 mg subcutaneous guselkumab every 4 weeks or 100 mg every 8 weeks, “is expected to positively affect several parameters of therapy, including increased compliance, hospital avoidance, and better safety profiling,” comoderator Giorgos Bamias, MD, professor of gastroenterology at the School of Medicine, National and Kapodistrian University of Athens, said in an interview.
It appears that multiple options will be offered to patients regarding treatment with guselkumab for patients with Crohn’s disease, Bamias said. “Interestingly, a similar multiplicity of options has also been shown for ulcerative colitis, through the QUASAR and ASTRO studies.”
Peyrin-Biroulet declared receiving grants and other/support travel from multiple companies. Hart declared receiving grants and personal fees from multiple companies. Bamias declared receiving grants and personal fees/honoraria as an advisor/lecturer from multiple companies.
A version of this article appeared on Medscape.com.
BERLIN — according to results from the phase 3, randomized, double-blind, placebo-controlled ASTRO study.
Importantly, the study also showed that subcutaneous induction is consistent with intravenous (IV) induction of guselkumab in UC.
“The flexibility of a fully subcutaneous treatment regimen would be a welcome option for many patients, especially those with busy and active lifestyles,” said study lead Laurent Peyrin-Biroulet, MD, head of the inflammatory bowel disease (IBD) unit at University Hospital of Nancy, France.
Peyrin-Biroulet presented the results at European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
“I think it’s an evolution and improvement in terms of IBD management,” he said. “We are happy that our patients will have the choice.”
Guselkumab is a selective dual-acting interleukin (IL)–23p19 subunit inhibitor that potently blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23, and is the only full subcutaneous IL-23 available. The drug is approved in some countries, including the United States, for UC.
The ASTRO Study
Building on data from the QUASAR studies, which showed the efficacy of induction of IV guselkumab and subcutaneous maintenance in patients with UC, the ASTRO study randomly assigned 418 patients with moderately to severely active UC to receive either induction with 400 mg subcutaneous guselkumab at weeks 0, 4, and 8 or placebo.
After induction, the treatment group either received a maintenance dose of 200 mg subcutaneous guselkumab at week 12 and then every 4 weeks or 100 mg every 8 weeks (starting week 16).
All patients had an inadequate response or intolerance to conventional therapy. Around 60% were naive to biologics, Janus kinase (JAK) inhibitors, or sphingosine-1-phosphate receptor modulators (S1Ps).
Clinical remission at week 12 — the primary endpoint — was achieved by 27.6% of all patients treated with guselkumab compared with 6.5% of patients on placebo (P < .001).
“These results are in line with the QUASAR data,” in which clinical remission was 22.6% with IV guselkumab at 12 weeks, noted Peyrin-Biroulet.
The researchers also divided the results by prespecified subgroups based on previous treatments.
Clinical remission was achieved at week 12 by 36% of patients naive to biologics, JAK inhibitors, or S1Ps in the guselkumab group and by 8.9% of these patients in the placebo group (P < .001). Among patients who had previously received biologics, JAK inhibitors, or S1Ps, 16.1% of those in the guselkumab group achieved clinical remission compared with 3.6% of those in the placebo group (P = .005).
“In terms of symptomatic remission at week 12, the difference between the overall guselkumab result and placebo was 30%,” reported Peyrin-Biroulet.
Clinical response — defined as a decrease in the modified Mayo score by ≥ 30% and ≥ 2 points, with either a ≥ 1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1 — was 65.6% in the guselkumab group compared with 34.5% in the placebo group (P < .001).
Among patients naive to biologics, JAK inhibitors, or S1Ps, clinical response was 71.3% in the guselkumab group, compared with 41.8% in the placebo group (P < .001). Among those who had previously received biologics, JAK inhibitors, or S1Ps, it was 57.1% in the guselkumab group, compared with 25.0% in the placebo group (P < .001).
Turning to endoscopic improvement (ie, an endoscopic subscore of 0 or 1 with no friability), 37.3% of those in the guselkumab group overall, compared with 12.9% of those in the placebo group who achieved this endpoint (P < .001).
“This is a treatment effect of over 20%,” said Peyrin-Biroulet. “We know that when it is over 20%, it is considered game changer.”
In patients naive to biologics, JAK inhibitors, or S1Ps, endoscopic improvement was 45.7% with guselkumab vs 17.7% with placebo. In those who had previously received biologics, JAK inhibitors, or S1Ps, endoscopic improvement was 24.1% with guselkumab vs 7.1% with placebo. Both were statistically significant.
The safety of subcutaneous induction therapy was consistent with the well-characterized and favorable safety profile of guselkumab in approved indications.
The GRAVITI Study
In the phase 3, randomized, double-blind, placebo-controlled GRAVITI study, also presented at ECCO 2025 Congress, researchers evaluated the efficacy and safety of induction with subcutaneous guselkumab followed by subcutaneous maintenance compared with placebo in patients with moderately to severely active Crohn’s disease.
The GRAVITI study followed the same induction and maintenance dosage and treatment intervals as the ASTRO study.
In addition, the patients randomly assigned to placebo were able to receive subcutaneous guselkumab (400 mg every 4 weeks followed by 100 mg every 8 weeks) if rescue criteria were met at week 16.
The co-primary endpoints were clinical remission and endoscopic response at week 12.
Ailsa Hart, MD, director, IBD Research, and consultant gastroenterologist, St. Mark’s Hospital and Imperial College, both in London, reported the 12-week and 48-week results, which were initially presented at the American College of Gastroenterology (ACG) meeting in October 2024.
At week 12, 56.1% of patients who received guselkumab achieved clinical remission, compared with 21.4% of patients who received placebo. Endoscopic response was achieved in 41.3% of patients treated with guselkumab compared with 21.4% in the placebo group.
Regarding the 48-week results, Hart noted that the rate of clinical remission was more than three times higher with both maintenance doses of guselkumab at 66.1% (200 mg) and 60.0% (100 mg) vs 17.1% with placebo.
Endoscopic response at 48 weeks was achieved in 51.3% of patients on the 200-mg maintenance dose and in 44.3% on the 100-mg maintenance dose, compared with 6.8% of patients on placebo.
In addition, endoscopic remission was achieved in 38.3% of patients in the 200-mg guselkumab group and in 30.4% in the 100-mg guselkumab group, compared with 6.0% in the placebo group.
Safety findings were consistent with the known safety profile of guselkumab in approved indications and other studies in IBD.
“These results complement the GALAXI data and demonstrate that both IV and subcutaneous guselkumab induction are efficacious and therapeutic in Crohn’s disease,” Hart said. Furthermore, data from the ASTRO study demonstrated similar data in the UC population.
As clinicians, this gives us flexibility in how we treat our patients; although, the rationale for choosing subcutaneous or IV is likely to be pragmatic, Hart said.
Additionally, the flexibility of the maintenance therapy, that is, 200 mg subcutaneous guselkumab every 4 weeks or 100 mg every 8 weeks, “is expected to positively affect several parameters of therapy, including increased compliance, hospital avoidance, and better safety profiling,” comoderator Giorgos Bamias, MD, professor of gastroenterology at the School of Medicine, National and Kapodistrian University of Athens, said in an interview.
It appears that multiple options will be offered to patients regarding treatment with guselkumab for patients with Crohn’s disease, Bamias said. “Interestingly, a similar multiplicity of options has also been shown for ulcerative colitis, through the QUASAR and ASTRO studies.”
Peyrin-Biroulet declared receiving grants and other/support travel from multiple companies. Hart declared receiving grants and personal fees from multiple companies. Bamias declared receiving grants and personal fees/honoraria as an advisor/lecturer from multiple companies.
A version of this article appeared on Medscape.com.
FROM ECCO 2025
Anxiety, Depression, and Insufficient Exercise Linked to IBD Flare
BERLIN — suggested a study of UK patients.
The research was presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
“Despite clinical remission, there is a significant burden of psychosocial comorbidity in IBD patients,” said study presenter Lauranne A.A.P. Derikx, PhD, a gastroenterology researcher at Erasmus University MC, Rotterdam, the Netherlands.
“Anxiety, sleep, and somatization were associated with an increased risk of clinical flare, and depression and lack of exercise were associated with an increased risk of hard flare,” she said. “Altogether, this supports a holistic approach in IBD patients.”
Stephen E. Lupe, PsyD, director of behavioral medicine for the department of gastroenterology, hepatology and nutrition at the Cleveland Clinic, Ohio, who was not involved in the study, agreed.
“Whole-person care is so important” in IBD, and this study is part of a growing literature making the connection between symptom flare and factors such as anxiety, depression, stress, and even trauma, he said in an interview.
Searching for Predictive Links
The relapsing and remitting disease course in IBD is dynamic and hard to predict, Derikx said. Unfortunately, clinicians don’t know which patients with IBD will develop a flare or when it will occur.
There’s a high prevalence of psychosocial comorbidity among patients with IBD and a “bidirectional relationship between psychosocial vulnerabilities” and the disease course via the gut-brain axis, Derikx noted.
To determine which psychosocial factors may be associated with and predictive of IBD flare, researchers analyzed data from the PREdiCCt study, a large prospective study of patients with IBD from 47 centers across the United Kingdom that aims to determine the factors associated with developing a flare.
The median age of PREdiCCT study participants was 44 years, median duration of IBD was 10 years, and 35% were receiving advanced IBD therapy. The median fecal calprotectin level was 49 mcg/g, although 18% of patients had a level > 250 mcg/g, Derikx noted.
To be included in PREdiCCT, patients must have received the diagnosis of IBD more than 6 months previously, had not change their medication for more than 2 months, and answered “yes” to the question: Do you think your disease has been well controlled in the past 1 month? The question was chosen as a measure of clinical remission.
The team collected stool samples and gathered information via questionnaires about lifestyle, diet, and other factors.
Depression and Anxiety Increase Risk
Researchers included 1641 patients — 830 with Crohn’s and 811 with ulcerative colitis or IBD unclassified (IBDU) — with complete datasets in their analysis of associations between psychosocial factors and IBD flare.
Baseline questionnaires identified moderate anxiety in 18.8% of participants, severe anxiety in 16.1%, moderate depression in 9.8%, severe depression in 5.7%, sleep disturbances in 46.4%, moderate somatization in 22.8%, severe somatization in 7.9%, insufficient exercise in 22.2%, and consumption of more than 14 units of alcohol in 24%.
After 24 months of follow-up, 36% of patients had experienced a clinical flare, defined as answering “no” to the question: Do you think your disease has been well controlled in the past 1 month/since you last logged in to the [study] portal?
In addition, 13% of patients experienced a hard flare, defined as a clinical flare plus C-reactive protein levels > 5 mg/L and/or a calprotectin level > 250 mcg/g and a change in IBD therapy.
Survival analyses with Cox frailty models adjusted for baseline fecal calprotectin, sex, index of multiple deprivation, hospital site, and patient age revealed statistically significant associations between several psychosocial factors and increased risk for flare.
Moderate anxiety in Crohn’s disease increased clinical flare risk (adjusted hazard ratio [aHR], 1.64), as did severe anxiety in both Crohn’s disease (aHR, 1.86) and ulcerative colitis/IBDU (aHR, 1.46). Moderate depression and severe depression increased the flare risk in ulcerative colitis/IBDU (aHR, 1.72 and 1.67, respectively). Also increasing clinical flare risk was poor sleep quality in Crohn’s disease (aHR, 1.58), and severe somatization in Crohn’s disease (aHR, 3.86) and ulcerative colitis/IBDU (aHR, 1.96).
Fewer psychosocial factors were associated with increased risk for hard flare: moderate depression in ulcerative colitis/IBDU (aHR, 2.5), severe somatization in Crohn’s disease (aHR, 2.34), and lack of exercise in ulcerative colitis/IBDU (aHR, 1.55).
Physician-Patient Disconnect
There is “very little correlation” between self-reported and symptomatic flare in IBD, Lupe said. “This happens all the time, where the gastroenterologist will come out of the endoscopy suite and go: ‘You’re in remission.’ And the patient goes: ‘What are you talking about? I’m still going to the bathroom 20 times a day.’ ”
Now there are data showing that, if the care team undertakes behavioral work with patients who have IBD, “the medications work more effectively,” Lupe said.
“I think medicine is in a point of transition right now,” he added. “We’re (moving from) looking at people as disease states and ‘how do I treat the disease’ to ‘how do I take care of this human being,’ knowing that everything this human being does, including everything we put in our mouth, everything we experience, changes what happens inside our body, and it’s measurable.”
The PREdiCCt study is sponsored by the University of Edinburgh, Scotland. Derikx declared relationships with AbbVie, Janssen Pharmaceuticals, Sandoz, Galapagos, and Pfizer. Other authors also declared relationships with pharmaceutical companies.
A version of this article appeared on Medscape.com.
BERLIN — suggested a study of UK patients.
The research was presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
“Despite clinical remission, there is a significant burden of psychosocial comorbidity in IBD patients,” said study presenter Lauranne A.A.P. Derikx, PhD, a gastroenterology researcher at Erasmus University MC, Rotterdam, the Netherlands.
“Anxiety, sleep, and somatization were associated with an increased risk of clinical flare, and depression and lack of exercise were associated with an increased risk of hard flare,” she said. “Altogether, this supports a holistic approach in IBD patients.”
Stephen E. Lupe, PsyD, director of behavioral medicine for the department of gastroenterology, hepatology and nutrition at the Cleveland Clinic, Ohio, who was not involved in the study, agreed.
“Whole-person care is so important” in IBD, and this study is part of a growing literature making the connection between symptom flare and factors such as anxiety, depression, stress, and even trauma, he said in an interview.
Searching for Predictive Links
The relapsing and remitting disease course in IBD is dynamic and hard to predict, Derikx said. Unfortunately, clinicians don’t know which patients with IBD will develop a flare or when it will occur.
There’s a high prevalence of psychosocial comorbidity among patients with IBD and a “bidirectional relationship between psychosocial vulnerabilities” and the disease course via the gut-brain axis, Derikx noted.
To determine which psychosocial factors may be associated with and predictive of IBD flare, researchers analyzed data from the PREdiCCt study, a large prospective study of patients with IBD from 47 centers across the United Kingdom that aims to determine the factors associated with developing a flare.
The median age of PREdiCCT study participants was 44 years, median duration of IBD was 10 years, and 35% were receiving advanced IBD therapy. The median fecal calprotectin level was 49 mcg/g, although 18% of patients had a level > 250 mcg/g, Derikx noted.
To be included in PREdiCCT, patients must have received the diagnosis of IBD more than 6 months previously, had not change their medication for more than 2 months, and answered “yes” to the question: Do you think your disease has been well controlled in the past 1 month? The question was chosen as a measure of clinical remission.
The team collected stool samples and gathered information via questionnaires about lifestyle, diet, and other factors.
Depression and Anxiety Increase Risk
Researchers included 1641 patients — 830 with Crohn’s and 811 with ulcerative colitis or IBD unclassified (IBDU) — with complete datasets in their analysis of associations between psychosocial factors and IBD flare.
Baseline questionnaires identified moderate anxiety in 18.8% of participants, severe anxiety in 16.1%, moderate depression in 9.8%, severe depression in 5.7%, sleep disturbances in 46.4%, moderate somatization in 22.8%, severe somatization in 7.9%, insufficient exercise in 22.2%, and consumption of more than 14 units of alcohol in 24%.
After 24 months of follow-up, 36% of patients had experienced a clinical flare, defined as answering “no” to the question: Do you think your disease has been well controlled in the past 1 month/since you last logged in to the [study] portal?
In addition, 13% of patients experienced a hard flare, defined as a clinical flare plus C-reactive protein levels > 5 mg/L and/or a calprotectin level > 250 mcg/g and a change in IBD therapy.
Survival analyses with Cox frailty models adjusted for baseline fecal calprotectin, sex, index of multiple deprivation, hospital site, and patient age revealed statistically significant associations between several psychosocial factors and increased risk for flare.
Moderate anxiety in Crohn’s disease increased clinical flare risk (adjusted hazard ratio [aHR], 1.64), as did severe anxiety in both Crohn’s disease (aHR, 1.86) and ulcerative colitis/IBDU (aHR, 1.46). Moderate depression and severe depression increased the flare risk in ulcerative colitis/IBDU (aHR, 1.72 and 1.67, respectively). Also increasing clinical flare risk was poor sleep quality in Crohn’s disease (aHR, 1.58), and severe somatization in Crohn’s disease (aHR, 3.86) and ulcerative colitis/IBDU (aHR, 1.96).
Fewer psychosocial factors were associated with increased risk for hard flare: moderate depression in ulcerative colitis/IBDU (aHR, 2.5), severe somatization in Crohn’s disease (aHR, 2.34), and lack of exercise in ulcerative colitis/IBDU (aHR, 1.55).
Physician-Patient Disconnect
There is “very little correlation” between self-reported and symptomatic flare in IBD, Lupe said. “This happens all the time, where the gastroenterologist will come out of the endoscopy suite and go: ‘You’re in remission.’ And the patient goes: ‘What are you talking about? I’m still going to the bathroom 20 times a day.’ ”
Now there are data showing that, if the care team undertakes behavioral work with patients who have IBD, “the medications work more effectively,” Lupe said.
“I think medicine is in a point of transition right now,” he added. “We’re (moving from) looking at people as disease states and ‘how do I treat the disease’ to ‘how do I take care of this human being,’ knowing that everything this human being does, including everything we put in our mouth, everything we experience, changes what happens inside our body, and it’s measurable.”
The PREdiCCt study is sponsored by the University of Edinburgh, Scotland. Derikx declared relationships with AbbVie, Janssen Pharmaceuticals, Sandoz, Galapagos, and Pfizer. Other authors also declared relationships with pharmaceutical companies.
A version of this article appeared on Medscape.com.
BERLIN — suggested a study of UK patients.
The research was presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
“Despite clinical remission, there is a significant burden of psychosocial comorbidity in IBD patients,” said study presenter Lauranne A.A.P. Derikx, PhD, a gastroenterology researcher at Erasmus University MC, Rotterdam, the Netherlands.
“Anxiety, sleep, and somatization were associated with an increased risk of clinical flare, and depression and lack of exercise were associated with an increased risk of hard flare,” she said. “Altogether, this supports a holistic approach in IBD patients.”
Stephen E. Lupe, PsyD, director of behavioral medicine for the department of gastroenterology, hepatology and nutrition at the Cleveland Clinic, Ohio, who was not involved in the study, agreed.
“Whole-person care is so important” in IBD, and this study is part of a growing literature making the connection between symptom flare and factors such as anxiety, depression, stress, and even trauma, he said in an interview.
Searching for Predictive Links
The relapsing and remitting disease course in IBD is dynamic and hard to predict, Derikx said. Unfortunately, clinicians don’t know which patients with IBD will develop a flare or when it will occur.
There’s a high prevalence of psychosocial comorbidity among patients with IBD and a “bidirectional relationship between psychosocial vulnerabilities” and the disease course via the gut-brain axis, Derikx noted.
To determine which psychosocial factors may be associated with and predictive of IBD flare, researchers analyzed data from the PREdiCCt study, a large prospective study of patients with IBD from 47 centers across the United Kingdom that aims to determine the factors associated with developing a flare.
The median age of PREdiCCT study participants was 44 years, median duration of IBD was 10 years, and 35% were receiving advanced IBD therapy. The median fecal calprotectin level was 49 mcg/g, although 18% of patients had a level > 250 mcg/g, Derikx noted.
To be included in PREdiCCT, patients must have received the diagnosis of IBD more than 6 months previously, had not change their medication for more than 2 months, and answered “yes” to the question: Do you think your disease has been well controlled in the past 1 month? The question was chosen as a measure of clinical remission.
The team collected stool samples and gathered information via questionnaires about lifestyle, diet, and other factors.
Depression and Anxiety Increase Risk
Researchers included 1641 patients — 830 with Crohn’s and 811 with ulcerative colitis or IBD unclassified (IBDU) — with complete datasets in their analysis of associations between psychosocial factors and IBD flare.
Baseline questionnaires identified moderate anxiety in 18.8% of participants, severe anxiety in 16.1%, moderate depression in 9.8%, severe depression in 5.7%, sleep disturbances in 46.4%, moderate somatization in 22.8%, severe somatization in 7.9%, insufficient exercise in 22.2%, and consumption of more than 14 units of alcohol in 24%.
After 24 months of follow-up, 36% of patients had experienced a clinical flare, defined as answering “no” to the question: Do you think your disease has been well controlled in the past 1 month/since you last logged in to the [study] portal?
In addition, 13% of patients experienced a hard flare, defined as a clinical flare plus C-reactive protein levels > 5 mg/L and/or a calprotectin level > 250 mcg/g and a change in IBD therapy.
Survival analyses with Cox frailty models adjusted for baseline fecal calprotectin, sex, index of multiple deprivation, hospital site, and patient age revealed statistically significant associations between several psychosocial factors and increased risk for flare.
Moderate anxiety in Crohn’s disease increased clinical flare risk (adjusted hazard ratio [aHR], 1.64), as did severe anxiety in both Crohn’s disease (aHR, 1.86) and ulcerative colitis/IBDU (aHR, 1.46). Moderate depression and severe depression increased the flare risk in ulcerative colitis/IBDU (aHR, 1.72 and 1.67, respectively). Also increasing clinical flare risk was poor sleep quality in Crohn’s disease (aHR, 1.58), and severe somatization in Crohn’s disease (aHR, 3.86) and ulcerative colitis/IBDU (aHR, 1.96).
Fewer psychosocial factors were associated with increased risk for hard flare: moderate depression in ulcerative colitis/IBDU (aHR, 2.5), severe somatization in Crohn’s disease (aHR, 2.34), and lack of exercise in ulcerative colitis/IBDU (aHR, 1.55).
Physician-Patient Disconnect
There is “very little correlation” between self-reported and symptomatic flare in IBD, Lupe said. “This happens all the time, where the gastroenterologist will come out of the endoscopy suite and go: ‘You’re in remission.’ And the patient goes: ‘What are you talking about? I’m still going to the bathroom 20 times a day.’ ”
Now there are data showing that, if the care team undertakes behavioral work with patients who have IBD, “the medications work more effectively,” Lupe said.
“I think medicine is in a point of transition right now,” he added. “We’re (moving from) looking at people as disease states and ‘how do I treat the disease’ to ‘how do I take care of this human being,’ knowing that everything this human being does, including everything we put in our mouth, everything we experience, changes what happens inside our body, and it’s measurable.”
The PREdiCCt study is sponsored by the University of Edinburgh, Scotland. Derikx declared relationships with AbbVie, Janssen Pharmaceuticals, Sandoz, Galapagos, and Pfizer. Other authors also declared relationships with pharmaceutical companies.
A version of this article appeared on Medscape.com.
FROM ECCO 2025
Machine-Learning Model Identifies Gut Biomarkers That May Help Diagnose IBD Patients
BERLIN — according to a study presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
Of the four techniques the researchers tested, a “machine-learning approach achieves the highest diagnostic accuracy, effectively distinguishing IBD and particularly differentiating Crohn’s disease from healthy controls in independent cohorts,” said study presenter Jee-Won Choi, department of biology, Kyung Hee University, Seoul, Republic of Korea.
“Integrating microbial markers with conventional diagnostics could enhance [their] clinical utility,” Choi said. However, further research is needed to determine the long-term validity of the biomarkers.
Some experts questioned the reliability of the markers for IBD diagnosis because of the makeup of study populations, which included patients with known IBD who likely have undergone treatment that may have altered their gut microbiomes.
Biomarkers Found and Tested
The gut microbiota exists in two states: Eubiosis, which supports health, and inflammatory dysbiosis, an imbalanced state associated with disease, most notably IBD, Choi noted.
Although many studies have explored the differences between these two states, there have been three major challenges in identifying IBD biomarkers: The studies have had small sample sizes, they’ve concentrated on a single analytical approach, and they’ve had low reproducibility.
To overcome those challenges, researchers used a large-scale dataset and used multiple methods to determine which analytical approach yielded the most reliable results, Choi said. They validated their results in three independent cohorts with diverse populations.
The study included 414 patients with Crohn’s disease, 880 with ulcerative colitis, and 2467 healthy control individuals from 21 centers in the Republic of Korea. Their gut microbiota profiles were analyzed from stool samples using 16S ribosomal RNA gene sequencing.
Researchers used four techniques to identify potential IBD biomarkers in the samples: differential abundance analysis, supervised random forest machine learning, unsupervised network analysis, and literature-based curation.
Biomarker candidates generated by these methods were then compared for their diagnostic ability using a machine learning model. The findings were tested in three independent cohorts — one domestic and one international population, both of which included patients with IBD and healthy control individuals, and one dataset of patients without IBD.
The results showed that there were distinct differences in the microbial composition between healthy control individuals and patients with Crohn’s disease and with ulcerative colitis. Patients with IBD, particularly those with Crohn’s disease, consistently had a significantly higher prevalence of dysbiosis, Choi said.
Each of the four analytical techniques revealed distinct microbial biomarkers associated with IBD in general, as well as with Crohn’s disease and ulcerative colitis individually.
When comparing IBD patients overall with healthy control individuals, supervised machine learning resulted in the most effective biomarker sets for distinguishing between groups, with the area under the receiver operating characteristics curve (AUC) reaching 0.971. By comparison, the AUC results were 0.94 for literature-based curation, 0.924 for differential abundance analyses, and 0.914 for unsupervised network analysis.
Supervised machine learning also outperformed the other techniques when distinguishing between healthy control individuals and patients with ulcerative colitis (AUC, 0.958), and between patients with ulcerative colitis and those with Crohn’s disease (AUC, 0.902).
All the techniques performed strongly when distinguishing between healthy control individuals and patients with Crohn’s disease, with AUCs ranging from 0.911 to 0.95.
When the researchers turned to the independent datasets, they found that the biomarkers were able to distinguish between healthy control individuals and patients with IBD in general and particularly between healthy control individuals and those with Crohn’s disease, with AUCs of 0.969 in the domestic cohort and 0.848 in the international cohort.
The non-IBD cohort also demonstrated that the biomarkers were able to differentiate patients with metabolic dysfunction–associated steatotic liver disease, colorectal cancer, rheumatoid arthritis, and irritable bowel syndrome from those with ulcerative colitis and Crohn’s disease with a high degree of accuracy (AUCs ranging from 0.97 to 0.999).
Diagnostic Utility Questioned
Speaking from the audience, James Lindsay, PhD, professor of inflammatory bowel disease, Barts and The London School of Medicine and Dentistry, England, questioned the utility of the findings.
“Obviously, all these patients had IBD, and so they will have had treatment with antibiotics, etc,” he said. “Surely the right validation cohort would be a group of people who have not yet been diagnosed with IBD to see whether your biomarker is able to separate those because the reason that people with IBD will have a difference is all the reasons that you have explained, ie, these patients were on treatment at the time that you took the samples.”
As a result, the biomarker panel isn’t for diagnosis but to confirm known disease, he added.
It’s important to look for microbiome signals of IBD, session co-chair, Lissy de Ridder, MD, PhD, associate professor of pediatric gastroenterology, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands, said in an interview.
De Ridder agreed that the biomarkers need to be validated in patients who aren’t on treatments that could affect their gut microbiomes. Not only do medications for IBD make a big difference but also do other drugs such as proton-pump inhibitors and antibiotics, as well as dietary interventions.
“Having said that, because it’s a large population, that’s always a good start to take lessons from and then go more into the details” in further analyses, de Ridder added.
This research was funded by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute, funded by the Ministry of Health & Welfare, Republic of Korea. No relevant financial relationships were declared.
A version of this article appeared on Medscape.com.
BERLIN — according to a study presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
Of the four techniques the researchers tested, a “machine-learning approach achieves the highest diagnostic accuracy, effectively distinguishing IBD and particularly differentiating Crohn’s disease from healthy controls in independent cohorts,” said study presenter Jee-Won Choi, department of biology, Kyung Hee University, Seoul, Republic of Korea.
“Integrating microbial markers with conventional diagnostics could enhance [their] clinical utility,” Choi said. However, further research is needed to determine the long-term validity of the biomarkers.
Some experts questioned the reliability of the markers for IBD diagnosis because of the makeup of study populations, which included patients with known IBD who likely have undergone treatment that may have altered their gut microbiomes.
Biomarkers Found and Tested
The gut microbiota exists in two states: Eubiosis, which supports health, and inflammatory dysbiosis, an imbalanced state associated with disease, most notably IBD, Choi noted.
Although many studies have explored the differences between these two states, there have been three major challenges in identifying IBD biomarkers: The studies have had small sample sizes, they’ve concentrated on a single analytical approach, and they’ve had low reproducibility.
To overcome those challenges, researchers used a large-scale dataset and used multiple methods to determine which analytical approach yielded the most reliable results, Choi said. They validated their results in three independent cohorts with diverse populations.
The study included 414 patients with Crohn’s disease, 880 with ulcerative colitis, and 2467 healthy control individuals from 21 centers in the Republic of Korea. Their gut microbiota profiles were analyzed from stool samples using 16S ribosomal RNA gene sequencing.
Researchers used four techniques to identify potential IBD biomarkers in the samples: differential abundance analysis, supervised random forest machine learning, unsupervised network analysis, and literature-based curation.
Biomarker candidates generated by these methods were then compared for their diagnostic ability using a machine learning model. The findings were tested in three independent cohorts — one domestic and one international population, both of which included patients with IBD and healthy control individuals, and one dataset of patients without IBD.
The results showed that there were distinct differences in the microbial composition between healthy control individuals and patients with Crohn’s disease and with ulcerative colitis. Patients with IBD, particularly those with Crohn’s disease, consistently had a significantly higher prevalence of dysbiosis, Choi said.
Each of the four analytical techniques revealed distinct microbial biomarkers associated with IBD in general, as well as with Crohn’s disease and ulcerative colitis individually.
When comparing IBD patients overall with healthy control individuals, supervised machine learning resulted in the most effective biomarker sets for distinguishing between groups, with the area under the receiver operating characteristics curve (AUC) reaching 0.971. By comparison, the AUC results were 0.94 for literature-based curation, 0.924 for differential abundance analyses, and 0.914 for unsupervised network analysis.
Supervised machine learning also outperformed the other techniques when distinguishing between healthy control individuals and patients with ulcerative colitis (AUC, 0.958), and between patients with ulcerative colitis and those with Crohn’s disease (AUC, 0.902).
All the techniques performed strongly when distinguishing between healthy control individuals and patients with Crohn’s disease, with AUCs ranging from 0.911 to 0.95.
When the researchers turned to the independent datasets, they found that the biomarkers were able to distinguish between healthy control individuals and patients with IBD in general and particularly between healthy control individuals and those with Crohn’s disease, with AUCs of 0.969 in the domestic cohort and 0.848 in the international cohort.
The non-IBD cohort also demonstrated that the biomarkers were able to differentiate patients with metabolic dysfunction–associated steatotic liver disease, colorectal cancer, rheumatoid arthritis, and irritable bowel syndrome from those with ulcerative colitis and Crohn’s disease with a high degree of accuracy (AUCs ranging from 0.97 to 0.999).
Diagnostic Utility Questioned
Speaking from the audience, James Lindsay, PhD, professor of inflammatory bowel disease, Barts and The London School of Medicine and Dentistry, England, questioned the utility of the findings.
“Obviously, all these patients had IBD, and so they will have had treatment with antibiotics, etc,” he said. “Surely the right validation cohort would be a group of people who have not yet been diagnosed with IBD to see whether your biomarker is able to separate those because the reason that people with IBD will have a difference is all the reasons that you have explained, ie, these patients were on treatment at the time that you took the samples.”
As a result, the biomarker panel isn’t for diagnosis but to confirm known disease, he added.
It’s important to look for microbiome signals of IBD, session co-chair, Lissy de Ridder, MD, PhD, associate professor of pediatric gastroenterology, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands, said in an interview.
De Ridder agreed that the biomarkers need to be validated in patients who aren’t on treatments that could affect their gut microbiomes. Not only do medications for IBD make a big difference but also do other drugs such as proton-pump inhibitors and antibiotics, as well as dietary interventions.
“Having said that, because it’s a large population, that’s always a good start to take lessons from and then go more into the details” in further analyses, de Ridder added.
This research was funded by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute, funded by the Ministry of Health & Welfare, Republic of Korea. No relevant financial relationships were declared.
A version of this article appeared on Medscape.com.
BERLIN — according to a study presented at the European Crohn’s and Colitis Organisation (ECCO) 2025 Congress.
Of the four techniques the researchers tested, a “machine-learning approach achieves the highest diagnostic accuracy, effectively distinguishing IBD and particularly differentiating Crohn’s disease from healthy controls in independent cohorts,” said study presenter Jee-Won Choi, department of biology, Kyung Hee University, Seoul, Republic of Korea.
“Integrating microbial markers with conventional diagnostics could enhance [their] clinical utility,” Choi said. However, further research is needed to determine the long-term validity of the biomarkers.
Some experts questioned the reliability of the markers for IBD diagnosis because of the makeup of study populations, which included patients with known IBD who likely have undergone treatment that may have altered their gut microbiomes.
Biomarkers Found and Tested
The gut microbiota exists in two states: Eubiosis, which supports health, and inflammatory dysbiosis, an imbalanced state associated with disease, most notably IBD, Choi noted.
Although many studies have explored the differences between these two states, there have been three major challenges in identifying IBD biomarkers: The studies have had small sample sizes, they’ve concentrated on a single analytical approach, and they’ve had low reproducibility.
To overcome those challenges, researchers used a large-scale dataset and used multiple methods to determine which analytical approach yielded the most reliable results, Choi said. They validated their results in three independent cohorts with diverse populations.
The study included 414 patients with Crohn’s disease, 880 with ulcerative colitis, and 2467 healthy control individuals from 21 centers in the Republic of Korea. Their gut microbiota profiles were analyzed from stool samples using 16S ribosomal RNA gene sequencing.
Researchers used four techniques to identify potential IBD biomarkers in the samples: differential abundance analysis, supervised random forest machine learning, unsupervised network analysis, and literature-based curation.
Biomarker candidates generated by these methods were then compared for their diagnostic ability using a machine learning model. The findings were tested in three independent cohorts — one domestic and one international population, both of which included patients with IBD and healthy control individuals, and one dataset of patients without IBD.
The results showed that there were distinct differences in the microbial composition between healthy control individuals and patients with Crohn’s disease and with ulcerative colitis. Patients with IBD, particularly those with Crohn’s disease, consistently had a significantly higher prevalence of dysbiosis, Choi said.
Each of the four analytical techniques revealed distinct microbial biomarkers associated with IBD in general, as well as with Crohn’s disease and ulcerative colitis individually.
When comparing IBD patients overall with healthy control individuals, supervised machine learning resulted in the most effective biomarker sets for distinguishing between groups, with the area under the receiver operating characteristics curve (AUC) reaching 0.971. By comparison, the AUC results were 0.94 for literature-based curation, 0.924 for differential abundance analyses, and 0.914 for unsupervised network analysis.
Supervised machine learning also outperformed the other techniques when distinguishing between healthy control individuals and patients with ulcerative colitis (AUC, 0.958), and between patients with ulcerative colitis and those with Crohn’s disease (AUC, 0.902).
All the techniques performed strongly when distinguishing between healthy control individuals and patients with Crohn’s disease, with AUCs ranging from 0.911 to 0.95.
When the researchers turned to the independent datasets, they found that the biomarkers were able to distinguish between healthy control individuals and patients with IBD in general and particularly between healthy control individuals and those with Crohn’s disease, with AUCs of 0.969 in the domestic cohort and 0.848 in the international cohort.
The non-IBD cohort also demonstrated that the biomarkers were able to differentiate patients with metabolic dysfunction–associated steatotic liver disease, colorectal cancer, rheumatoid arthritis, and irritable bowel syndrome from those with ulcerative colitis and Crohn’s disease with a high degree of accuracy (AUCs ranging from 0.97 to 0.999).
Diagnostic Utility Questioned
Speaking from the audience, James Lindsay, PhD, professor of inflammatory bowel disease, Barts and The London School of Medicine and Dentistry, England, questioned the utility of the findings.
“Obviously, all these patients had IBD, and so they will have had treatment with antibiotics, etc,” he said. “Surely the right validation cohort would be a group of people who have not yet been diagnosed with IBD to see whether your biomarker is able to separate those because the reason that people with IBD will have a difference is all the reasons that you have explained, ie, these patients were on treatment at the time that you took the samples.”
As a result, the biomarker panel isn’t for diagnosis but to confirm known disease, he added.
It’s important to look for microbiome signals of IBD, session co-chair, Lissy de Ridder, MD, PhD, associate professor of pediatric gastroenterology, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands, said in an interview.
De Ridder agreed that the biomarkers need to be validated in patients who aren’t on treatments that could affect their gut microbiomes. Not only do medications for IBD make a big difference but also do other drugs such as proton-pump inhibitors and antibiotics, as well as dietary interventions.
“Having said that, because it’s a large population, that’s always a good start to take lessons from and then go more into the details” in further analyses, de Ridder added.
This research was funded by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute, funded by the Ministry of Health & Welfare, Republic of Korea. No relevant financial relationships were declared.
A version of this article appeared on Medscape.com.
FROM ECCO 2025