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Weight Loss Treatments Beyond the Reach of Many in Need
SAN ANTONIO — Weight loss treatments aren’t reaching many of the people who need them most because of coverage barriers, new data suggested.
Findings from three studies presented at The Obesity Society’s Obesity Week 2024 meeting illustrate different aspects of the problem.
One, presented by Alissa S. Chen, MD, MPH, a postdoctoral fellow at Yale University, New Haven, Connecticut, found that people with obesity, particularly those with cardiovascular disease (CVD) and those who are Black and Hispanic, have high rates of cost-related prescription drug rationing. Those findings were simultaneously published as a research letter in JAMA Network Open.
“The implications are that structural barriers impede access to medications for Black and Hispanic adults with obesity, which might worsen if there’s not expanding coverage for GLP-1 RAs [glucagon-like peptide 1 receptor agonists], and it’s possible that broader insurance coverage could ameliorate some of these issues,” Chen said.
She noted that patients don’t always volunteer that information. “In my clinical practice, I always start by saying something like, ‘I have a lot of patients who can’t afford their medications. In the last week, was there a time [you didn’t take your medications due to cost]?’ ”
State Medicaid programs vary widely in the degree to which they cover weight loss treatments. But not a single one covers all modalities — nutrition counseling (NC), intensive behavioral therapy (IBT), obesity medications (OMs), and metabolic and bariatric surgery (MBS) — without restrictions or limitations, and only seven states cover them all with restrictions, according to a dual presentation by Christine Gallagher, MPAff, associate director for research and policy with the STOP Obesity Alliance at George Washington University, Washington, DC, and Tracy Zvenyach, PhD, MS, RN, director of policy strategy and alliances at the Obesity Action Coalition, also in Washington, DC.
Detailed Medicaid coverage data for each state are posted on the STOP Obesity Alliance website. (As of now, Medicare doesn’t cover medications specifically for obesity at all.)
A third presentation, by Treah Haggerty, MD, of the Department of Family Medicine and director of the Pediatric Medical Weight Management program at West Virginia University, Morgantown, was of a qualitative descriptive study exploring the impact on 22 individuals enrolled in a medical weight loss management program whose state employee insurance carrier made a policy decision to stop covering all anti-OMs in March 2024. All had been prescribed GLP-1 agonists for weight loss, and the decision forced most to stop using them.
Those findings were published in the September 2024 issue of Obesity Pillars.
“Patients perceive the discontinuation of anti-obesity medication coverage as stigmatizing and unjust, leading to feelings of hopelessness and fear. With more insurance companies denying coverage for these costly medications, more information is needed to identify best ways to address the loss of coverage with patients. Clinical management of these patients should incorporate evidence-based obesity treatments while navigating insurance constraints,” Haggerty said.
Create a Safe Space to Discuss the Barriers
Asked to comment, Session Moderator John D. Clark, MD, PhD, chief population health officer at Sharp Rees-Stealy Medical Group, San Diego, California, told Medscape Medical News, “Health systems and payers are determining what can and can’t be covered, and at the end of the day, it frequently comes down to finances…I think the big challenge is really identifying patients who may have the greatest need. ... If we have limited resources, how and where should we be directing those resources? I would say the current system hasn’t really answered that question or identified patients for whom we would say that the cost truly is less than either the financial or long-term health benefits.”
But Clark said, “When some of these newer anti-obesity medications are able to go generic and be less expensive, which will happen eventually, I think things will change ... and in the future, there will be more options on the market as well.”
In the meantime, he advised that clinicians “try to have conversations with patients about these barriers, acknowledge that these barriers exist, and create a safe space to discuss those barriers. ... Let’s see where we are right now, and let’s come up with a plan.”
People With Obesity More Susceptible to Drug Rationing
Chen reported on a sample of 51,720 adults who participated in the 2020-2022 National Health Interview Survey who did not have diabetes and who used at least one prescription medication of any type. Of those, 80% were White, 9.7% were Hispanic, and 9.7% were Black, and 33.9% overall had obesity.
Cost-related prescription rationing, defined as any self-reported skipping, taking less, or delaying filling a prescription to save money, was reported by 8.3% of those with obesity vs 5.9% without. After adjustment, rationing among those with obesity was significantly associated with younger age (aged 18-44 years), female sex, lower incomes, lack of health insurance coverage, and CVD.
The adjusted estimated probability of cost-related prescription drug rationing was 7.4% for those with CVD vs 4.4% for those without. By race/ethnicity, the proportions reporting rationing were 7.7%, 9.8%, and 10.7% for White, Black, and Hispanics, respectively.
“Given that few insurance providers cover GLP-1 RAs for obesity, cost-related prescription drug rationing could be exacerbated if patients were prescribed GLP-1 RAs at their current price of more than $1000 a month,” Chen noted, adding that the high prices could worsen health disparities among Black and Hispanic individuals with obesity.
Medicaid Coverage Lacking for All Obesity Treatments
For their project, Gallagher and Zvenyach delved into a database that aggregates Medicaid manuals, fee schedules, statutes, regulations, and preferred drug lists for each US state, both for Medicaid fee for service and top Medicaid managed care plans, in order to determine 2024 levels of coverage for NC, IBT, OMs, and MBS for adults with obesity.
No state provides coverage for all those treatments without either limitations — such as body mass index (BMI) cutoffs, age, or “comorbidity regardless of body mass index (BMI)” for OM and MBS — or outright restrictions, such as “proof of failed attempts.” And only seven states provide coverage for the four modalities “with limitations”: California, Arizona, New Mexico, South Carolina, Delaware, Rhode Island, and Massachusetts.
Twenty-two states don’t cover NC, although just one state doesn’t cover IBT. Overall, 37 states don’t cover OMs, and other states ranged considerably in various restrictions and limitations for OMs and MBS. Only four states fully covered the surgery without limitations or restrictions.
“The vast majority of states have significant barriers and conditions of coverage for obesity care,” Gallagher said.
Zvenyach added, “Most of the applied exclusions, limitations, or restrictions do not align with evidence-based practice standards or guidelines.”
When Coverage Stops, Hopelessness and Anger Emerge
Haggerty and colleagues’ research involved semi-structured interviews of the 22 participants — all of them women — who had lost their obesity medication coverage due to their insurers’ decision. Four themes emerged:
- 1. Feelings of hope replaced by hopelessness upon loss of medication coverage: One person said, “I’m afraid for my mental health. It’s tough to be in a situation where you’re never right. And it doesn’t matter what you do; it’s not going to work, and then to have just a glimmer of hope, a little spark of hey, look, this might help. And for someone else to take that away from you for no reason. I don’t know what am I supposed to do.”
- 2. Anger regarding the perceived injustice of anti-obesity medication coverage termination: For example, “They can pay for heart attacks, they could pay for me to have a stroke, they could pay for me to have diabetes, but they won’t let me have this one medicine that could take all of that away. Makes no sense.”
- 3. Perceptions of past and present stigma within the healthcare system and insurance company: “I’m not trying for vanity. I’m way too old to be a Victoria’s Secret model. I’m not trying to do it to be cute and skinny and hot. I just want to make it through a day of work and not be exhausted.”
- 4. Generational influences on obesity treatment: “I’m married, and my husband, since I’ve started this medicine, he’s been eating better. He’s been eating what I eat, and he’s been losing weight as well.”
- Some participants said they planned to cope in different ways, including trying to obtain compounded versions of the drugs from “spas” or online pharmacies, as well as skipping doses, reducing doses, or sharing medications — in other words, rationing.
Asked by this news organization what clinicians should keep in mind, Haggerty said, “that there are big barriers and that we need to take care of the patients within this system that has their arm tied behind their back.
Chen was funded by a grant from the National Institute on Aging outside the submitted work, and she was funded as a Yale National Clinician Scholar. A coauthor received grants from the Food and Drug Administration, Johnson & Johnson, the National Institutes of Health, the Agency for Healthcare Research and Quality, and Arnold Ventures. Another coauthor reported receiving personal fees from UpToDate and the Centers for Medicare & Medicaid Services. Gallagher has received research funding from Altimmune, Amgen, Boehringer Ingelheim, Currax, Eli Lilly and Company, Found, Novo Nordisk, Pfizer, Structure Therapeutics, and WeightWatchers. Haggerty reported article publishing charge was provided by West Virginia Alliance for Creative Health Solutions. Zvenyach and Clark had no disclosures.
A version of this article first appeared on Medscape.com.
SAN ANTONIO — Weight loss treatments aren’t reaching many of the people who need them most because of coverage barriers, new data suggested.
Findings from three studies presented at The Obesity Society’s Obesity Week 2024 meeting illustrate different aspects of the problem.
One, presented by Alissa S. Chen, MD, MPH, a postdoctoral fellow at Yale University, New Haven, Connecticut, found that people with obesity, particularly those with cardiovascular disease (CVD) and those who are Black and Hispanic, have high rates of cost-related prescription drug rationing. Those findings were simultaneously published as a research letter in JAMA Network Open.
“The implications are that structural barriers impede access to medications for Black and Hispanic adults with obesity, which might worsen if there’s not expanding coverage for GLP-1 RAs [glucagon-like peptide 1 receptor agonists], and it’s possible that broader insurance coverage could ameliorate some of these issues,” Chen said.
She noted that patients don’t always volunteer that information. “In my clinical practice, I always start by saying something like, ‘I have a lot of patients who can’t afford their medications. In the last week, was there a time [you didn’t take your medications due to cost]?’ ”
State Medicaid programs vary widely in the degree to which they cover weight loss treatments. But not a single one covers all modalities — nutrition counseling (NC), intensive behavioral therapy (IBT), obesity medications (OMs), and metabolic and bariatric surgery (MBS) — without restrictions or limitations, and only seven states cover them all with restrictions, according to a dual presentation by Christine Gallagher, MPAff, associate director for research and policy with the STOP Obesity Alliance at George Washington University, Washington, DC, and Tracy Zvenyach, PhD, MS, RN, director of policy strategy and alliances at the Obesity Action Coalition, also in Washington, DC.
Detailed Medicaid coverage data for each state are posted on the STOP Obesity Alliance website. (As of now, Medicare doesn’t cover medications specifically for obesity at all.)
A third presentation, by Treah Haggerty, MD, of the Department of Family Medicine and director of the Pediatric Medical Weight Management program at West Virginia University, Morgantown, was of a qualitative descriptive study exploring the impact on 22 individuals enrolled in a medical weight loss management program whose state employee insurance carrier made a policy decision to stop covering all anti-OMs in March 2024. All had been prescribed GLP-1 agonists for weight loss, and the decision forced most to stop using them.
Those findings were published in the September 2024 issue of Obesity Pillars.
“Patients perceive the discontinuation of anti-obesity medication coverage as stigmatizing and unjust, leading to feelings of hopelessness and fear. With more insurance companies denying coverage for these costly medications, more information is needed to identify best ways to address the loss of coverage with patients. Clinical management of these patients should incorporate evidence-based obesity treatments while navigating insurance constraints,” Haggerty said.
Create a Safe Space to Discuss the Barriers
Asked to comment, Session Moderator John D. Clark, MD, PhD, chief population health officer at Sharp Rees-Stealy Medical Group, San Diego, California, told Medscape Medical News, “Health systems and payers are determining what can and can’t be covered, and at the end of the day, it frequently comes down to finances…I think the big challenge is really identifying patients who may have the greatest need. ... If we have limited resources, how and where should we be directing those resources? I would say the current system hasn’t really answered that question or identified patients for whom we would say that the cost truly is less than either the financial or long-term health benefits.”
But Clark said, “When some of these newer anti-obesity medications are able to go generic and be less expensive, which will happen eventually, I think things will change ... and in the future, there will be more options on the market as well.”
In the meantime, he advised that clinicians “try to have conversations with patients about these barriers, acknowledge that these barriers exist, and create a safe space to discuss those barriers. ... Let’s see where we are right now, and let’s come up with a plan.”
People With Obesity More Susceptible to Drug Rationing
Chen reported on a sample of 51,720 adults who participated in the 2020-2022 National Health Interview Survey who did not have diabetes and who used at least one prescription medication of any type. Of those, 80% were White, 9.7% were Hispanic, and 9.7% were Black, and 33.9% overall had obesity.
Cost-related prescription rationing, defined as any self-reported skipping, taking less, or delaying filling a prescription to save money, was reported by 8.3% of those with obesity vs 5.9% without. After adjustment, rationing among those with obesity was significantly associated with younger age (aged 18-44 years), female sex, lower incomes, lack of health insurance coverage, and CVD.
The adjusted estimated probability of cost-related prescription drug rationing was 7.4% for those with CVD vs 4.4% for those without. By race/ethnicity, the proportions reporting rationing were 7.7%, 9.8%, and 10.7% for White, Black, and Hispanics, respectively.
“Given that few insurance providers cover GLP-1 RAs for obesity, cost-related prescription drug rationing could be exacerbated if patients were prescribed GLP-1 RAs at their current price of more than $1000 a month,” Chen noted, adding that the high prices could worsen health disparities among Black and Hispanic individuals with obesity.
Medicaid Coverage Lacking for All Obesity Treatments
For their project, Gallagher and Zvenyach delved into a database that aggregates Medicaid manuals, fee schedules, statutes, regulations, and preferred drug lists for each US state, both for Medicaid fee for service and top Medicaid managed care plans, in order to determine 2024 levels of coverage for NC, IBT, OMs, and MBS for adults with obesity.
No state provides coverage for all those treatments without either limitations — such as body mass index (BMI) cutoffs, age, or “comorbidity regardless of body mass index (BMI)” for OM and MBS — or outright restrictions, such as “proof of failed attempts.” And only seven states provide coverage for the four modalities “with limitations”: California, Arizona, New Mexico, South Carolina, Delaware, Rhode Island, and Massachusetts.
Twenty-two states don’t cover NC, although just one state doesn’t cover IBT. Overall, 37 states don’t cover OMs, and other states ranged considerably in various restrictions and limitations for OMs and MBS. Only four states fully covered the surgery without limitations or restrictions.
“The vast majority of states have significant barriers and conditions of coverage for obesity care,” Gallagher said.
Zvenyach added, “Most of the applied exclusions, limitations, or restrictions do not align with evidence-based practice standards or guidelines.”
When Coverage Stops, Hopelessness and Anger Emerge
Haggerty and colleagues’ research involved semi-structured interviews of the 22 participants — all of them women — who had lost their obesity medication coverage due to their insurers’ decision. Four themes emerged:
- 1. Feelings of hope replaced by hopelessness upon loss of medication coverage: One person said, “I’m afraid for my mental health. It’s tough to be in a situation where you’re never right. And it doesn’t matter what you do; it’s not going to work, and then to have just a glimmer of hope, a little spark of hey, look, this might help. And for someone else to take that away from you for no reason. I don’t know what am I supposed to do.”
- 2. Anger regarding the perceived injustice of anti-obesity medication coverage termination: For example, “They can pay for heart attacks, they could pay for me to have a stroke, they could pay for me to have diabetes, but they won’t let me have this one medicine that could take all of that away. Makes no sense.”
- 3. Perceptions of past and present stigma within the healthcare system and insurance company: “I’m not trying for vanity. I’m way too old to be a Victoria’s Secret model. I’m not trying to do it to be cute and skinny and hot. I just want to make it through a day of work and not be exhausted.”
- 4. Generational influences on obesity treatment: “I’m married, and my husband, since I’ve started this medicine, he’s been eating better. He’s been eating what I eat, and he’s been losing weight as well.”
- Some participants said they planned to cope in different ways, including trying to obtain compounded versions of the drugs from “spas” or online pharmacies, as well as skipping doses, reducing doses, or sharing medications — in other words, rationing.
Asked by this news organization what clinicians should keep in mind, Haggerty said, “that there are big barriers and that we need to take care of the patients within this system that has their arm tied behind their back.
Chen was funded by a grant from the National Institute on Aging outside the submitted work, and she was funded as a Yale National Clinician Scholar. A coauthor received grants from the Food and Drug Administration, Johnson & Johnson, the National Institutes of Health, the Agency for Healthcare Research and Quality, and Arnold Ventures. Another coauthor reported receiving personal fees from UpToDate and the Centers for Medicare & Medicaid Services. Gallagher has received research funding from Altimmune, Amgen, Boehringer Ingelheim, Currax, Eli Lilly and Company, Found, Novo Nordisk, Pfizer, Structure Therapeutics, and WeightWatchers. Haggerty reported article publishing charge was provided by West Virginia Alliance for Creative Health Solutions. Zvenyach and Clark had no disclosures.
A version of this article first appeared on Medscape.com.
SAN ANTONIO — Weight loss treatments aren’t reaching many of the people who need them most because of coverage barriers, new data suggested.
Findings from three studies presented at The Obesity Society’s Obesity Week 2024 meeting illustrate different aspects of the problem.
One, presented by Alissa S. Chen, MD, MPH, a postdoctoral fellow at Yale University, New Haven, Connecticut, found that people with obesity, particularly those with cardiovascular disease (CVD) and those who are Black and Hispanic, have high rates of cost-related prescription drug rationing. Those findings were simultaneously published as a research letter in JAMA Network Open.
“The implications are that structural barriers impede access to medications for Black and Hispanic adults with obesity, which might worsen if there’s not expanding coverage for GLP-1 RAs [glucagon-like peptide 1 receptor agonists], and it’s possible that broader insurance coverage could ameliorate some of these issues,” Chen said.
She noted that patients don’t always volunteer that information. “In my clinical practice, I always start by saying something like, ‘I have a lot of patients who can’t afford their medications. In the last week, was there a time [you didn’t take your medications due to cost]?’ ”
State Medicaid programs vary widely in the degree to which they cover weight loss treatments. But not a single one covers all modalities — nutrition counseling (NC), intensive behavioral therapy (IBT), obesity medications (OMs), and metabolic and bariatric surgery (MBS) — without restrictions or limitations, and only seven states cover them all with restrictions, according to a dual presentation by Christine Gallagher, MPAff, associate director for research and policy with the STOP Obesity Alliance at George Washington University, Washington, DC, and Tracy Zvenyach, PhD, MS, RN, director of policy strategy and alliances at the Obesity Action Coalition, also in Washington, DC.
Detailed Medicaid coverage data for each state are posted on the STOP Obesity Alliance website. (As of now, Medicare doesn’t cover medications specifically for obesity at all.)
A third presentation, by Treah Haggerty, MD, of the Department of Family Medicine and director of the Pediatric Medical Weight Management program at West Virginia University, Morgantown, was of a qualitative descriptive study exploring the impact on 22 individuals enrolled in a medical weight loss management program whose state employee insurance carrier made a policy decision to stop covering all anti-OMs in March 2024. All had been prescribed GLP-1 agonists for weight loss, and the decision forced most to stop using them.
Those findings were published in the September 2024 issue of Obesity Pillars.
“Patients perceive the discontinuation of anti-obesity medication coverage as stigmatizing and unjust, leading to feelings of hopelessness and fear. With more insurance companies denying coverage for these costly medications, more information is needed to identify best ways to address the loss of coverage with patients. Clinical management of these patients should incorporate evidence-based obesity treatments while navigating insurance constraints,” Haggerty said.
Create a Safe Space to Discuss the Barriers
Asked to comment, Session Moderator John D. Clark, MD, PhD, chief population health officer at Sharp Rees-Stealy Medical Group, San Diego, California, told Medscape Medical News, “Health systems and payers are determining what can and can’t be covered, and at the end of the day, it frequently comes down to finances…I think the big challenge is really identifying patients who may have the greatest need. ... If we have limited resources, how and where should we be directing those resources? I would say the current system hasn’t really answered that question or identified patients for whom we would say that the cost truly is less than either the financial or long-term health benefits.”
But Clark said, “When some of these newer anti-obesity medications are able to go generic and be less expensive, which will happen eventually, I think things will change ... and in the future, there will be more options on the market as well.”
In the meantime, he advised that clinicians “try to have conversations with patients about these barriers, acknowledge that these barriers exist, and create a safe space to discuss those barriers. ... Let’s see where we are right now, and let’s come up with a plan.”
People With Obesity More Susceptible to Drug Rationing
Chen reported on a sample of 51,720 adults who participated in the 2020-2022 National Health Interview Survey who did not have diabetes and who used at least one prescription medication of any type. Of those, 80% were White, 9.7% were Hispanic, and 9.7% were Black, and 33.9% overall had obesity.
Cost-related prescription rationing, defined as any self-reported skipping, taking less, or delaying filling a prescription to save money, was reported by 8.3% of those with obesity vs 5.9% without. After adjustment, rationing among those with obesity was significantly associated with younger age (aged 18-44 years), female sex, lower incomes, lack of health insurance coverage, and CVD.
The adjusted estimated probability of cost-related prescription drug rationing was 7.4% for those with CVD vs 4.4% for those without. By race/ethnicity, the proportions reporting rationing were 7.7%, 9.8%, and 10.7% for White, Black, and Hispanics, respectively.
“Given that few insurance providers cover GLP-1 RAs for obesity, cost-related prescription drug rationing could be exacerbated if patients were prescribed GLP-1 RAs at their current price of more than $1000 a month,” Chen noted, adding that the high prices could worsen health disparities among Black and Hispanic individuals with obesity.
Medicaid Coverage Lacking for All Obesity Treatments
For their project, Gallagher and Zvenyach delved into a database that aggregates Medicaid manuals, fee schedules, statutes, regulations, and preferred drug lists for each US state, both for Medicaid fee for service and top Medicaid managed care plans, in order to determine 2024 levels of coverage for NC, IBT, OMs, and MBS for adults with obesity.
No state provides coverage for all those treatments without either limitations — such as body mass index (BMI) cutoffs, age, or “comorbidity regardless of body mass index (BMI)” for OM and MBS — or outright restrictions, such as “proof of failed attempts.” And only seven states provide coverage for the four modalities “with limitations”: California, Arizona, New Mexico, South Carolina, Delaware, Rhode Island, and Massachusetts.
Twenty-two states don’t cover NC, although just one state doesn’t cover IBT. Overall, 37 states don’t cover OMs, and other states ranged considerably in various restrictions and limitations for OMs and MBS. Only four states fully covered the surgery without limitations or restrictions.
“The vast majority of states have significant barriers and conditions of coverage for obesity care,” Gallagher said.
Zvenyach added, “Most of the applied exclusions, limitations, or restrictions do not align with evidence-based practice standards or guidelines.”
When Coverage Stops, Hopelessness and Anger Emerge
Haggerty and colleagues’ research involved semi-structured interviews of the 22 participants — all of them women — who had lost their obesity medication coverage due to their insurers’ decision. Four themes emerged:
- 1. Feelings of hope replaced by hopelessness upon loss of medication coverage: One person said, “I’m afraid for my mental health. It’s tough to be in a situation where you’re never right. And it doesn’t matter what you do; it’s not going to work, and then to have just a glimmer of hope, a little spark of hey, look, this might help. And for someone else to take that away from you for no reason. I don’t know what am I supposed to do.”
- 2. Anger regarding the perceived injustice of anti-obesity medication coverage termination: For example, “They can pay for heart attacks, they could pay for me to have a stroke, they could pay for me to have diabetes, but they won’t let me have this one medicine that could take all of that away. Makes no sense.”
- 3. Perceptions of past and present stigma within the healthcare system and insurance company: “I’m not trying for vanity. I’m way too old to be a Victoria’s Secret model. I’m not trying to do it to be cute and skinny and hot. I just want to make it through a day of work and not be exhausted.”
- 4. Generational influences on obesity treatment: “I’m married, and my husband, since I’ve started this medicine, he’s been eating better. He’s been eating what I eat, and he’s been losing weight as well.”
- Some participants said they planned to cope in different ways, including trying to obtain compounded versions of the drugs from “spas” or online pharmacies, as well as skipping doses, reducing doses, or sharing medications — in other words, rationing.
Asked by this news organization what clinicians should keep in mind, Haggerty said, “that there are big barriers and that we need to take care of the patients within this system that has their arm tied behind their back.
Chen was funded by a grant from the National Institute on Aging outside the submitted work, and she was funded as a Yale National Clinician Scholar. A coauthor received grants from the Food and Drug Administration, Johnson & Johnson, the National Institutes of Health, the Agency for Healthcare Research and Quality, and Arnold Ventures. Another coauthor reported receiving personal fees from UpToDate and the Centers for Medicare & Medicaid Services. Gallagher has received research funding from Altimmune, Amgen, Boehringer Ingelheim, Currax, Eli Lilly and Company, Found, Novo Nordisk, Pfizer, Structure Therapeutics, and WeightWatchers. Haggerty reported article publishing charge was provided by West Virginia Alliance for Creative Health Solutions. Zvenyach and Clark had no disclosures.
A version of this article first appeared on Medscape.com.
FROM OBESITY WEEK 2024
Alcohol Use Disorder Therapy Remains Underutilized in Alcohol-Associated Liver Disease
PHILADELPHIA — according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In an analysis of commercially insured Americans, AUD medications were prescribed to only 1 in 50 patients with ALD and about 1 in 10 patients with acute alcohol-associated hepatitis (AAH).
“Providers caring for these patients should consider early initiation of this therapy in select cases,” said lead author Alex R. Jones, MD, chief resident of internal medicine at the University of Texas Southwestern Medical Center in Dallas.
“Based on additional analyses looking at the prescriber subspecialty, we didn’t identify any gastroenterologists or hepatologists who prescribed pharmacotherapy,” he said. “This could be a great opportunity for hepatologists to engage in the pharmacologic treatment of AUD.”
Jones and colleagues analyzed 2006-2021 data from IQVIA PharMetrics Plus for Academics, a nationally representative database of commercially insured patients in the United States. They looked for AUD pharmacologic treatment at any time after AUD diagnosis, including prescriptions for gabapentin, naltrexone, topiramate, acamprosate, baclofen, and disulfiram.
Among 28,625 patients with AUD (defined as at least two outpatient codes or at least one inpatient code), 1201 had ALD with cirrhosis and 439 had AAH.
Pharmacologic therapy was prescribed in 3924 (14.5%) patients without ALD, 28 (2.3%) with ALD, and 42 (9.8%) with AAH.
In addition, one-time prescriptions were observed in 1113 (28.4%) patients without ALD, three patients (10.7%) with ALD, and eight patients (18.6%) with AAH.
Overall, 64.5% of the general population consisted of men. About 46% had a psychiatric diagnosis other than substance use disorder (SUD), and 35.7% had a non-AUD SUD.
Patients who received AUD pharmacotherapy tended to be older, at a median age of 45 years, than those aged 42 years without a prescription.
The median time to prescription was 302 days, with no significant differences based on the presence of liver disease.
By medication, gabapentin was prescribed most often (9.4%), followed by oral naltrexone (2.6%) and topiramate (2%). Oral naltrexone was prescribed at a lower rate in patients with ALD and at a higher rate in patients with AAH than in patients without ALD. Baclofen was also prescribed at lower rates in patients with ALD and AAH.
In a multivariable logistic regression analysis, several characteristics were more significantly associated with pharmacologic therapy, such as age ≥ 50 years (adjusted odds ratio [aOR], 1.33), female sex (aOR, 1.31), a non-liver Charlson Comorbidity Index ≥ 3 (aOR, 2.21), and psychiatric comorbidities (aOR, 2.76).
On the other hand, the presence of hepatic decompensation — defined as ascites, hepatic encephalopathy, or bleeding varices — was associated with lower odds of receiving pharmacotherapy (aOR, 0.08). ALD cirrhosis (non-AAH) also had lower odds (aOR, 0.24).
The study was limited by only incorporating patients with commercial insurance, lacking demographic details related to race or ethnicity, and potentially misclassifying patients despite validated definitions of ALD and AUD, Jones said.
As the study couldn’t determine the indications for prescriptions, such as gabapentin use for migraines or diabetes-associated neuropathy, for instance, future studies could look at these precise details, he added.
“It’s important to know we’re underutilizing therapies that we have a lot of information about, such as gabapentin, which is an old medication that we should feel fairly comfortable using,” said Patricia Jones, MD, a hepatologist and associate professor of clinical medicine at the University of Miami Miller School of Medicine, in Florida. Patricia Jones comoderated the plenary session on small intestine, functional, and liver research.
“I also expect that, if a future study reviewed this data and excluded people with valid indications, such as migraines or diabetic neuropathy, we’d see even lower rates of prescription,” she said.
From a clinical perspective, patient communication and clinical decision-making are key, Patricia Jones added, particularly when clinical gastroenterologists and hepatologists may not offer this type of therapy or patients refuse this type of therapy.
“We need to think about our practice patterns and how we can offer therapy,” she said. “In general, we know these medications are very safe. Even though they’re not widely used in people with cirrhosis, there’s not enough evidence to suggest we shouldn’t use them.”
Alex Jones and Patricia Jones reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA — according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In an analysis of commercially insured Americans, AUD medications were prescribed to only 1 in 50 patients with ALD and about 1 in 10 patients with acute alcohol-associated hepatitis (AAH).
“Providers caring for these patients should consider early initiation of this therapy in select cases,” said lead author Alex R. Jones, MD, chief resident of internal medicine at the University of Texas Southwestern Medical Center in Dallas.
“Based on additional analyses looking at the prescriber subspecialty, we didn’t identify any gastroenterologists or hepatologists who prescribed pharmacotherapy,” he said. “This could be a great opportunity for hepatologists to engage in the pharmacologic treatment of AUD.”
Jones and colleagues analyzed 2006-2021 data from IQVIA PharMetrics Plus for Academics, a nationally representative database of commercially insured patients in the United States. They looked for AUD pharmacologic treatment at any time after AUD diagnosis, including prescriptions for gabapentin, naltrexone, topiramate, acamprosate, baclofen, and disulfiram.
Among 28,625 patients with AUD (defined as at least two outpatient codes or at least one inpatient code), 1201 had ALD with cirrhosis and 439 had AAH.
Pharmacologic therapy was prescribed in 3924 (14.5%) patients without ALD, 28 (2.3%) with ALD, and 42 (9.8%) with AAH.
In addition, one-time prescriptions were observed in 1113 (28.4%) patients without ALD, three patients (10.7%) with ALD, and eight patients (18.6%) with AAH.
Overall, 64.5% of the general population consisted of men. About 46% had a psychiatric diagnosis other than substance use disorder (SUD), and 35.7% had a non-AUD SUD.
Patients who received AUD pharmacotherapy tended to be older, at a median age of 45 years, than those aged 42 years without a prescription.
The median time to prescription was 302 days, with no significant differences based on the presence of liver disease.
By medication, gabapentin was prescribed most often (9.4%), followed by oral naltrexone (2.6%) and topiramate (2%). Oral naltrexone was prescribed at a lower rate in patients with ALD and at a higher rate in patients with AAH than in patients without ALD. Baclofen was also prescribed at lower rates in patients with ALD and AAH.
In a multivariable logistic regression analysis, several characteristics were more significantly associated with pharmacologic therapy, such as age ≥ 50 years (adjusted odds ratio [aOR], 1.33), female sex (aOR, 1.31), a non-liver Charlson Comorbidity Index ≥ 3 (aOR, 2.21), and psychiatric comorbidities (aOR, 2.76).
On the other hand, the presence of hepatic decompensation — defined as ascites, hepatic encephalopathy, or bleeding varices — was associated with lower odds of receiving pharmacotherapy (aOR, 0.08). ALD cirrhosis (non-AAH) also had lower odds (aOR, 0.24).
The study was limited by only incorporating patients with commercial insurance, lacking demographic details related to race or ethnicity, and potentially misclassifying patients despite validated definitions of ALD and AUD, Jones said.
As the study couldn’t determine the indications for prescriptions, such as gabapentin use for migraines or diabetes-associated neuropathy, for instance, future studies could look at these precise details, he added.
“It’s important to know we’re underutilizing therapies that we have a lot of information about, such as gabapentin, which is an old medication that we should feel fairly comfortable using,” said Patricia Jones, MD, a hepatologist and associate professor of clinical medicine at the University of Miami Miller School of Medicine, in Florida. Patricia Jones comoderated the plenary session on small intestine, functional, and liver research.
“I also expect that, if a future study reviewed this data and excluded people with valid indications, such as migraines or diabetic neuropathy, we’d see even lower rates of prescription,” she said.
From a clinical perspective, patient communication and clinical decision-making are key, Patricia Jones added, particularly when clinical gastroenterologists and hepatologists may not offer this type of therapy or patients refuse this type of therapy.
“We need to think about our practice patterns and how we can offer therapy,” she said. “In general, we know these medications are very safe. Even though they’re not widely used in people with cirrhosis, there’s not enough evidence to suggest we shouldn’t use them.”
Alex Jones and Patricia Jones reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA — according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In an analysis of commercially insured Americans, AUD medications were prescribed to only 1 in 50 patients with ALD and about 1 in 10 patients with acute alcohol-associated hepatitis (AAH).
“Providers caring for these patients should consider early initiation of this therapy in select cases,” said lead author Alex R. Jones, MD, chief resident of internal medicine at the University of Texas Southwestern Medical Center in Dallas.
“Based on additional analyses looking at the prescriber subspecialty, we didn’t identify any gastroenterologists or hepatologists who prescribed pharmacotherapy,” he said. “This could be a great opportunity for hepatologists to engage in the pharmacologic treatment of AUD.”
Jones and colleagues analyzed 2006-2021 data from IQVIA PharMetrics Plus for Academics, a nationally representative database of commercially insured patients in the United States. They looked for AUD pharmacologic treatment at any time after AUD diagnosis, including prescriptions for gabapentin, naltrexone, topiramate, acamprosate, baclofen, and disulfiram.
Among 28,625 patients with AUD (defined as at least two outpatient codes or at least one inpatient code), 1201 had ALD with cirrhosis and 439 had AAH.
Pharmacologic therapy was prescribed in 3924 (14.5%) patients without ALD, 28 (2.3%) with ALD, and 42 (9.8%) with AAH.
In addition, one-time prescriptions were observed in 1113 (28.4%) patients without ALD, three patients (10.7%) with ALD, and eight patients (18.6%) with AAH.
Overall, 64.5% of the general population consisted of men. About 46% had a psychiatric diagnosis other than substance use disorder (SUD), and 35.7% had a non-AUD SUD.
Patients who received AUD pharmacotherapy tended to be older, at a median age of 45 years, than those aged 42 years without a prescription.
The median time to prescription was 302 days, with no significant differences based on the presence of liver disease.
By medication, gabapentin was prescribed most often (9.4%), followed by oral naltrexone (2.6%) and topiramate (2%). Oral naltrexone was prescribed at a lower rate in patients with ALD and at a higher rate in patients with AAH than in patients without ALD. Baclofen was also prescribed at lower rates in patients with ALD and AAH.
In a multivariable logistic regression analysis, several characteristics were more significantly associated with pharmacologic therapy, such as age ≥ 50 years (adjusted odds ratio [aOR], 1.33), female sex (aOR, 1.31), a non-liver Charlson Comorbidity Index ≥ 3 (aOR, 2.21), and psychiatric comorbidities (aOR, 2.76).
On the other hand, the presence of hepatic decompensation — defined as ascites, hepatic encephalopathy, or bleeding varices — was associated with lower odds of receiving pharmacotherapy (aOR, 0.08). ALD cirrhosis (non-AAH) also had lower odds (aOR, 0.24).
The study was limited by only incorporating patients with commercial insurance, lacking demographic details related to race or ethnicity, and potentially misclassifying patients despite validated definitions of ALD and AUD, Jones said.
As the study couldn’t determine the indications for prescriptions, such as gabapentin use for migraines or diabetes-associated neuropathy, for instance, future studies could look at these precise details, he added.
“It’s important to know we’re underutilizing therapies that we have a lot of information about, such as gabapentin, which is an old medication that we should feel fairly comfortable using,” said Patricia Jones, MD, a hepatologist and associate professor of clinical medicine at the University of Miami Miller School of Medicine, in Florida. Patricia Jones comoderated the plenary session on small intestine, functional, and liver research.
“I also expect that, if a future study reviewed this data and excluded people with valid indications, such as migraines or diabetic neuropathy, we’d see even lower rates of prescription,” she said.
From a clinical perspective, patient communication and clinical decision-making are key, Patricia Jones added, particularly when clinical gastroenterologists and hepatologists may not offer this type of therapy or patients refuse this type of therapy.
“We need to think about our practice patterns and how we can offer therapy,” she said. “In general, we know these medications are very safe. Even though they’re not widely used in people with cirrhosis, there’s not enough evidence to suggest we shouldn’t use them.”
Alex Jones and Patricia Jones reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM ACG 2024
Endoscopic Sleeve Gastroplasty Yields Durable Weight Loss at 10 Years
PHILADELPHIA —
“The procedure is dependable and safe and should be considered among individuals who have not attained their desired results through lifestyle medications and those who are not eligible for or choose not to undergo bariatric procedures,” said Ali Lahooti, with the Department of Gastroenterology and Hepatology, Weill Cornell Medical College, New York City. He presented his research at the annual meeting of the American College of Gastroenterology (ACG).
Obesity is a growing global health challenge. Lifestyle modification as a standalone therapy has limited effectiveness achieving weight loss. Pharmacotherapies are more efficacious, but they’re also associated with higher costs of and risk for side effects, leading to lower rates of compliance, Lahooti explained.
Bariatric surgery remains the most effective therapy for management of obesity and improvement of comorbid conditions, yet < 1% of candidates undergo a surgical intervention either because of access, cost, or fear of the procedure.
“Endoscopic treatments for obesity, such as ESG, can potentially fill this gap by combining durable weight loss with lower risk and costs,” Lahooti said.
He and his colleagues assessed outcomes out to 10 years in 404 patients (mean age, 45 years; 76% women; mean body mass index, 37.3) who underwent ESG between 2013 and 2024 at a single large tertiary hospital.
Out of the 404 patients, 397, 335, 249, and 110 patients were eligible for 1-, 3-, 5-, and 10-year follow-up, with complete follow-up rates of 85%, 66%, 79%, and 62%, respectively.
The primary outcome was weight loss at 10 years after ESG reported at percent total body weight loss (%TBWL).
At 10 years, mean %TBWL (the primary outcome) was 10.5% — with 53% of patients maintaining at least 5% TBWL and 42% maintaining at least 10% weight loss, Lahooti reported.
ESG had a favorable safety profile; 20% of patients experienced mild abdominal pain, constipation, heartburn, and nausea after the procedure that typically resolved within 2 weeks of the procedure.
“There were a total of three moderate adverse events — two perigastric leaks, one repaired endoscopically, and another that only required antibiotics,” Lahooti reported. There were no severe or fatal adverse events.
About 11% of patients had endoscopic revision via retightening or resuturing at 10 years, the study team noted in their conference abstract.
Bariatric Surgery Remains Gold Standard
Lahooti shared that in his experience, some patients will need a revision at “about 40 months,” but at the same time, he’s seen some patients at 10 years “and their sutures are still in place.”
Session comoderator Shivangi Kothari, MD, with the Center for Advanced Therapeutic Endoscopy, University of Rochester Medical Center in New York, congratulated Lahooti for providing “robust” long-term data on ESG and said, “there is a need for more studies like this.”
In an interview, Ann M. Rogers, MD, president of the American Society for Metabolic and Bariatric Surgery, noted that bariatric surgery remains the “gold standard for weight loss and metabolic improvements,” with studies showing “around 30%” TWBL at 10 years, compared with about 10% at 10 years in this study.
Another key caveat, said Rogers, is that there are practical barriers to ESG; insurance typically does not cover the procedure because they view it as “cosmetic.”
The study had no commercial funding. Lahooti and Rogers had no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA —
“The procedure is dependable and safe and should be considered among individuals who have not attained their desired results through lifestyle medications and those who are not eligible for or choose not to undergo bariatric procedures,” said Ali Lahooti, with the Department of Gastroenterology and Hepatology, Weill Cornell Medical College, New York City. He presented his research at the annual meeting of the American College of Gastroenterology (ACG).
Obesity is a growing global health challenge. Lifestyle modification as a standalone therapy has limited effectiveness achieving weight loss. Pharmacotherapies are more efficacious, but they’re also associated with higher costs of and risk for side effects, leading to lower rates of compliance, Lahooti explained.
Bariatric surgery remains the most effective therapy for management of obesity and improvement of comorbid conditions, yet < 1% of candidates undergo a surgical intervention either because of access, cost, or fear of the procedure.
“Endoscopic treatments for obesity, such as ESG, can potentially fill this gap by combining durable weight loss with lower risk and costs,” Lahooti said.
He and his colleagues assessed outcomes out to 10 years in 404 patients (mean age, 45 years; 76% women; mean body mass index, 37.3) who underwent ESG between 2013 and 2024 at a single large tertiary hospital.
Out of the 404 patients, 397, 335, 249, and 110 patients were eligible for 1-, 3-, 5-, and 10-year follow-up, with complete follow-up rates of 85%, 66%, 79%, and 62%, respectively.
The primary outcome was weight loss at 10 years after ESG reported at percent total body weight loss (%TBWL).
At 10 years, mean %TBWL (the primary outcome) was 10.5% — with 53% of patients maintaining at least 5% TBWL and 42% maintaining at least 10% weight loss, Lahooti reported.
ESG had a favorable safety profile; 20% of patients experienced mild abdominal pain, constipation, heartburn, and nausea after the procedure that typically resolved within 2 weeks of the procedure.
“There were a total of three moderate adverse events — two perigastric leaks, one repaired endoscopically, and another that only required antibiotics,” Lahooti reported. There were no severe or fatal adverse events.
About 11% of patients had endoscopic revision via retightening or resuturing at 10 years, the study team noted in their conference abstract.
Bariatric Surgery Remains Gold Standard
Lahooti shared that in his experience, some patients will need a revision at “about 40 months,” but at the same time, he’s seen some patients at 10 years “and their sutures are still in place.”
Session comoderator Shivangi Kothari, MD, with the Center for Advanced Therapeutic Endoscopy, University of Rochester Medical Center in New York, congratulated Lahooti for providing “robust” long-term data on ESG and said, “there is a need for more studies like this.”
In an interview, Ann M. Rogers, MD, president of the American Society for Metabolic and Bariatric Surgery, noted that bariatric surgery remains the “gold standard for weight loss and metabolic improvements,” with studies showing “around 30%” TWBL at 10 years, compared with about 10% at 10 years in this study.
Another key caveat, said Rogers, is that there are practical barriers to ESG; insurance typically does not cover the procedure because they view it as “cosmetic.”
The study had no commercial funding. Lahooti and Rogers had no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA —
“The procedure is dependable and safe and should be considered among individuals who have not attained their desired results through lifestyle medications and those who are not eligible for or choose not to undergo bariatric procedures,” said Ali Lahooti, with the Department of Gastroenterology and Hepatology, Weill Cornell Medical College, New York City. He presented his research at the annual meeting of the American College of Gastroenterology (ACG).
Obesity is a growing global health challenge. Lifestyle modification as a standalone therapy has limited effectiveness achieving weight loss. Pharmacotherapies are more efficacious, but they’re also associated with higher costs of and risk for side effects, leading to lower rates of compliance, Lahooti explained.
Bariatric surgery remains the most effective therapy for management of obesity and improvement of comorbid conditions, yet < 1% of candidates undergo a surgical intervention either because of access, cost, or fear of the procedure.
“Endoscopic treatments for obesity, such as ESG, can potentially fill this gap by combining durable weight loss with lower risk and costs,” Lahooti said.
He and his colleagues assessed outcomes out to 10 years in 404 patients (mean age, 45 years; 76% women; mean body mass index, 37.3) who underwent ESG between 2013 and 2024 at a single large tertiary hospital.
Out of the 404 patients, 397, 335, 249, and 110 patients were eligible for 1-, 3-, 5-, and 10-year follow-up, with complete follow-up rates of 85%, 66%, 79%, and 62%, respectively.
The primary outcome was weight loss at 10 years after ESG reported at percent total body weight loss (%TBWL).
At 10 years, mean %TBWL (the primary outcome) was 10.5% — with 53% of patients maintaining at least 5% TBWL and 42% maintaining at least 10% weight loss, Lahooti reported.
ESG had a favorable safety profile; 20% of patients experienced mild abdominal pain, constipation, heartburn, and nausea after the procedure that typically resolved within 2 weeks of the procedure.
“There were a total of three moderate adverse events — two perigastric leaks, one repaired endoscopically, and another that only required antibiotics,” Lahooti reported. There were no severe or fatal adverse events.
About 11% of patients had endoscopic revision via retightening or resuturing at 10 years, the study team noted in their conference abstract.
Bariatric Surgery Remains Gold Standard
Lahooti shared that in his experience, some patients will need a revision at “about 40 months,” but at the same time, he’s seen some patients at 10 years “and their sutures are still in place.”
Session comoderator Shivangi Kothari, MD, with the Center for Advanced Therapeutic Endoscopy, University of Rochester Medical Center in New York, congratulated Lahooti for providing “robust” long-term data on ESG and said, “there is a need for more studies like this.”
In an interview, Ann M. Rogers, MD, president of the American Society for Metabolic and Bariatric Surgery, noted that bariatric surgery remains the “gold standard for weight loss and metabolic improvements,” with studies showing “around 30%” TWBL at 10 years, compared with about 10% at 10 years in this study.
Another key caveat, said Rogers, is that there are practical barriers to ESG; insurance typically does not cover the procedure because they view it as “cosmetic.”
The study had no commercial funding. Lahooti and Rogers had no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM ACG 2024
PRECISE-DAPT Score Predicts GI Bleeding Risk Among Post-PCI Patients
PHILADELPHIA — Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year.
“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.
Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.
“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”
Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.
In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.
Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.
The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.
Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.
In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).
However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.
“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.
“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”
Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.
“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”
The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA — Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year.
“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.
Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.
“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”
Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.
In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.
Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.
The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.
Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.
In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).
However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.
“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.
“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”
Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.
“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”
The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA — Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year.
“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.
Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.
“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”
Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.
In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.
Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.
The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.
Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.
In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).
However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.
“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.
“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”
Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.
“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”
The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM ACG 2024
Reassuring Data on GLP-1 RAs and Pancreatic Cancer Risk
PHILADELPHIA —
Instead, the large electronic health record (EHR) analysis of patients with type 2 diabetes (T2D) found those taking GLP-1 RAs had a significantly lower risk for pancreatic cancer than peers on other antidiabetic medications.
“Although there were previous reports suggesting possible association between pancreatic cancer and GLP-1 receptor agonist medications, this study provides reassurance that there is no observed increased incidence of pancreatic cancer in patients prescribed these medications,” said Khaled Alsabbagh Alchirazi, MD, a gastroenterology fellow with Aurora Healthcare in Brookfield, Wisconsin.
He presented the study findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
Important Topic
Patients with T2D are at increased risk for several malignancies, including pancreatic cancer. Given the unique mechanism of action of GLP-1 RAs in the pancreas, it was important to investigate the relationship between use of these drugs and incidence of pancreatic cancer, he explained.
Using the TriNetX database, the study team identified 4.95 million antidiabetic drug naive T2D patients who were prescribed antidiabetic medications for the first time between 2005 and 2020. None had a history of pancreatic cancer.
A total of 245,532 were prescribed a GLP-1 RA. The researchers compared GLP-1 RAs users to users of other antidiabetic medications — namely, insulin, metformin, alpha-glucosidase inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), sulfonylureas, and thiazolidinediones.
Patients were propensity score-matched based on demographics, health determinants, lifestyle factors, medical history, family history of cancers, and acute/chronic pancreatitis.
The risk for pancreatic cancer was significantly lower among patients on GLP-1 RAs vs insulin (hazard ratio [HR], 0.47; 95% CI, 0.40-0.55), DPP-4i (HR, 0.80; 95% CI, 0.73-0.89), SGLT2i (HR, 0.78; 95% CI, 0.69-0.89), and sulfonylureas (HR, 0.84; 95% CI, 0.74-0.95), Alchirazi reported.
The results were consistent across different groups, including patients with obesity/ overweight on GLP-1 RAs vs insulin (HR, 0.53; 95% CI, 0.43-0.65) and SGLT2i (HR, 0.81; 95% CI, 0.69-0.96).
Strengths of the analysis included the large and diverse cohort of propensity score-matched patients. Limitations included the retrospective design and use of claims data that did not provide granular data on pathology reports.
The study by Alchirazi and colleagues aligns with a large population-based cohort study from Israel that found no evidence that GLP-1 RAs increase risk for pancreatic cancer over 7 years following initiation.
Separately, a study of more than 1.6 million patients with T2D found that treatment with a GLP-1 RA (vs insulin or metformin) was associated with lower risks for specific types of obesity-related cancers, including pancreatic cancer.
The study had no specific funding. Alchirazi had no relevant disclosures.
A version of this article appeared on Medscape.com.
PHILADELPHIA —
Instead, the large electronic health record (EHR) analysis of patients with type 2 diabetes (T2D) found those taking GLP-1 RAs had a significantly lower risk for pancreatic cancer than peers on other antidiabetic medications.
“Although there were previous reports suggesting possible association between pancreatic cancer and GLP-1 receptor agonist medications, this study provides reassurance that there is no observed increased incidence of pancreatic cancer in patients prescribed these medications,” said Khaled Alsabbagh Alchirazi, MD, a gastroenterology fellow with Aurora Healthcare in Brookfield, Wisconsin.
He presented the study findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
Important Topic
Patients with T2D are at increased risk for several malignancies, including pancreatic cancer. Given the unique mechanism of action of GLP-1 RAs in the pancreas, it was important to investigate the relationship between use of these drugs and incidence of pancreatic cancer, he explained.
Using the TriNetX database, the study team identified 4.95 million antidiabetic drug naive T2D patients who were prescribed antidiabetic medications for the first time between 2005 and 2020. None had a history of pancreatic cancer.
A total of 245,532 were prescribed a GLP-1 RA. The researchers compared GLP-1 RAs users to users of other antidiabetic medications — namely, insulin, metformin, alpha-glucosidase inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), sulfonylureas, and thiazolidinediones.
Patients were propensity score-matched based on demographics, health determinants, lifestyle factors, medical history, family history of cancers, and acute/chronic pancreatitis.
The risk for pancreatic cancer was significantly lower among patients on GLP-1 RAs vs insulin (hazard ratio [HR], 0.47; 95% CI, 0.40-0.55), DPP-4i (HR, 0.80; 95% CI, 0.73-0.89), SGLT2i (HR, 0.78; 95% CI, 0.69-0.89), and sulfonylureas (HR, 0.84; 95% CI, 0.74-0.95), Alchirazi reported.
The results were consistent across different groups, including patients with obesity/ overweight on GLP-1 RAs vs insulin (HR, 0.53; 95% CI, 0.43-0.65) and SGLT2i (HR, 0.81; 95% CI, 0.69-0.96).
Strengths of the analysis included the large and diverse cohort of propensity score-matched patients. Limitations included the retrospective design and use of claims data that did not provide granular data on pathology reports.
The study by Alchirazi and colleagues aligns with a large population-based cohort study from Israel that found no evidence that GLP-1 RAs increase risk for pancreatic cancer over 7 years following initiation.
Separately, a study of more than 1.6 million patients with T2D found that treatment with a GLP-1 RA (vs insulin or metformin) was associated with lower risks for specific types of obesity-related cancers, including pancreatic cancer.
The study had no specific funding. Alchirazi had no relevant disclosures.
A version of this article appeared on Medscape.com.
PHILADELPHIA —
Instead, the large electronic health record (EHR) analysis of patients with type 2 diabetes (T2D) found those taking GLP-1 RAs had a significantly lower risk for pancreatic cancer than peers on other antidiabetic medications.
“Although there were previous reports suggesting possible association between pancreatic cancer and GLP-1 receptor agonist medications, this study provides reassurance that there is no observed increased incidence of pancreatic cancer in patients prescribed these medications,” said Khaled Alsabbagh Alchirazi, MD, a gastroenterology fellow with Aurora Healthcare in Brookfield, Wisconsin.
He presented the study findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
Important Topic
Patients with T2D are at increased risk for several malignancies, including pancreatic cancer. Given the unique mechanism of action of GLP-1 RAs in the pancreas, it was important to investigate the relationship between use of these drugs and incidence of pancreatic cancer, he explained.
Using the TriNetX database, the study team identified 4.95 million antidiabetic drug naive T2D patients who were prescribed antidiabetic medications for the first time between 2005 and 2020. None had a history of pancreatic cancer.
A total of 245,532 were prescribed a GLP-1 RA. The researchers compared GLP-1 RAs users to users of other antidiabetic medications — namely, insulin, metformin, alpha-glucosidase inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), sulfonylureas, and thiazolidinediones.
Patients were propensity score-matched based on demographics, health determinants, lifestyle factors, medical history, family history of cancers, and acute/chronic pancreatitis.
The risk for pancreatic cancer was significantly lower among patients on GLP-1 RAs vs insulin (hazard ratio [HR], 0.47; 95% CI, 0.40-0.55), DPP-4i (HR, 0.80; 95% CI, 0.73-0.89), SGLT2i (HR, 0.78; 95% CI, 0.69-0.89), and sulfonylureas (HR, 0.84; 95% CI, 0.74-0.95), Alchirazi reported.
The results were consistent across different groups, including patients with obesity/ overweight on GLP-1 RAs vs insulin (HR, 0.53; 95% CI, 0.43-0.65) and SGLT2i (HR, 0.81; 95% CI, 0.69-0.96).
Strengths of the analysis included the large and diverse cohort of propensity score-matched patients. Limitations included the retrospective design and use of claims data that did not provide granular data on pathology reports.
The study by Alchirazi and colleagues aligns with a large population-based cohort study from Israel that found no evidence that GLP-1 RAs increase risk for pancreatic cancer over 7 years following initiation.
Separately, a study of more than 1.6 million patients with T2D found that treatment with a GLP-1 RA (vs insulin or metformin) was associated with lower risks for specific types of obesity-related cancers, including pancreatic cancer.
The study had no specific funding. Alchirazi had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM ACG 2024
Topical Retinoids a Key Component of Acne Treatment Regimens
LAS VEGAS —
Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.
“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”
No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.
More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.
Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.
Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”
To improve retinoid tolerability, Baldwin offered the following tips:
- Use a pea-sized amount for the entire affected area and avoid spot treatments.
- Start with every other day application.
- Moisturize regularly, possibly applying moisturizer before the retinoid.
- Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
- Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”
Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).
Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.
A version of this article appeared on Medscape.com.
LAS VEGAS —
Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.
“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”
No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.
More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.
Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.
Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”
To improve retinoid tolerability, Baldwin offered the following tips:
- Use a pea-sized amount for the entire affected area and avoid spot treatments.
- Start with every other day application.
- Moisturize regularly, possibly applying moisturizer before the retinoid.
- Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
- Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”
Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).
Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.
A version of this article appeared on Medscape.com.
LAS VEGAS —
Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.
“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”
No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.
More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.
Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.
Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”
To improve retinoid tolerability, Baldwin offered the following tips:
- Use a pea-sized amount for the entire affected area and avoid spot treatments.
- Start with every other day application.
- Moisturize regularly, possibly applying moisturizer before the retinoid.
- Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
- Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”
Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).
Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.
A version of this article appeared on Medscape.com.
FROM SDPA 2024
A Child’s Picky Eating: Normal Phase or Health Concern?
PARIS — “My child is a poor eater” is a complaint frequently heard during medical consultations. Such concerns are often unjustified but a source of much parental frustration.
Marc Bellaïche, MD, a pediatrician at Robert-Debré Hospital in Paris, addressed this issue at France’s annual general medicine conference (JNMG 2024). His presentation focused on distinguishing between parental perception, typical childhood behaviors, and feeding issues that require intervention.
In assessing parental worries, tools such as The Montreal Children’s Hospital Feeding Scale for children aged 6 months to 6 years and the Baby Eating Behavior Questionnaire for those under 6 months can help identify and monitor feeding issues. Observing the child eat, when possible, is also valuable.
Key Phases and Development
Bellaïche focused on children under 6 years, as they frequently experience feeding challenges during critical development phases, such as weaning or when the child is able to sit up.
A phase of neophilia (interest in new foods) typically occurs before 12 months, followed by a phase of neophobia (fear of new foods) between ages 1 and 3 years. This neophobia is a normal part of neuropsychological, sensory, and taste development and can persist if a key developmental moment is marked by a choking incident, mealtime stress, or forced feeding. “Challenges differ between a difficult 3-year-old and a 6- or 7-year-old who still refuses new foods,” he explained.
Parental Pressure and Nutritional Balance
Nutritional balance is essential, but “parental pressure is often too high.” Parents worry because they see food as a “nutraceutical.” Bellaïche recommended defusing anxiety by keeping mealtimes calm, allowing the child to eat at their pace, avoiding force-feeding, keeping meals brief, and avoiding snacks. While “it’s important to stay vigilant — as it’s incorrect to assume a child won’t let themselves starve — most cases can be managed in general practice through parental guidance, empathy, and a positive approach.”
Monitoring growth and weight curves is crucial, with the Kanawati index (ratio of arm circumference to head circumference) being a reliable indicator for specialist referral if < 0.31. A varied diet is important for nutritional balance; when this isn’t achieved, continued consumption of toddler formula after age 3 can prevent iron and calcium deficiencies.
When eating difficulties are documented, healthcare providers should investigate for underlying organic, digestive, or extra-digestive diseases (neurologic, cardiac, renal, etc.). “It’s best not to hastily diagnose cow’s milk protein allergy,” Bellaïche advised, as cases are relatively rare and unnecessarily eliminating milk can complicate a child’s relationship with food. Similarly, gastroesophageal reflux disease should be objectively diagnosed to avoid unnecessary proton pump inhibitor treatment and associated side effects.
For children with low birth weight, mild congenital heart disease, or suggestive dysmorphology, consider evaluating for a genetic syndrome.
Avoidant/Restrictive Food Intake Disorder (ARFID)
ARFID is marked by a lack of interest in food and avoidance due to sensory characteristics. Often observed in anxious children, ARFID is diagnosed in approximately 20% of children with autism spectrum disorder, where food selectivity is prevalent. This condition can hinder a child’s development and may necessitate nutritional supplementation.
Case Profiles in Eating Issues
Bellaïche outlined three typical cases among children considered “picky eaters”:
- The small eater: Often near the lower growth curve limits, this child “grazes and doesn’t sit still.” These children are usually active and have a family history of similar eating habits. Parents should encourage psychomotor activities, discourage snacks outside of mealtimes, and consider fun family picnics on the floor, offering a mezze-style variety of foods.
- The child with a history of trauma: Children with trauma (from intubation, nasogastric tubes, severe vomiting, forced feeding, or choking) may develop aversions requiring behavioral intervention.
- The child with high sensory sensitivity: This child dislikes getting the hands dirty, avoids mouthing objects, or resists certain textures, such as grass and sand. Gradual behavioral approaches with sensory play and visually appealing new foods can be beneficial. Guided self-led food exploration (baby-led weaning) may also help, though dairy intake is often needed to prevent deficiencies during this stage.
Finally, gastroesophageal reflux disease or constipation can contribute to appetite loss. Studies have shown that treating these issues can improve appetite in small eaters.
This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
PARIS — “My child is a poor eater” is a complaint frequently heard during medical consultations. Such concerns are often unjustified but a source of much parental frustration.
Marc Bellaïche, MD, a pediatrician at Robert-Debré Hospital in Paris, addressed this issue at France’s annual general medicine conference (JNMG 2024). His presentation focused on distinguishing between parental perception, typical childhood behaviors, and feeding issues that require intervention.
In assessing parental worries, tools such as The Montreal Children’s Hospital Feeding Scale for children aged 6 months to 6 years and the Baby Eating Behavior Questionnaire for those under 6 months can help identify and monitor feeding issues. Observing the child eat, when possible, is also valuable.
Key Phases and Development
Bellaïche focused on children under 6 years, as they frequently experience feeding challenges during critical development phases, such as weaning or when the child is able to sit up.
A phase of neophilia (interest in new foods) typically occurs before 12 months, followed by a phase of neophobia (fear of new foods) between ages 1 and 3 years. This neophobia is a normal part of neuropsychological, sensory, and taste development and can persist if a key developmental moment is marked by a choking incident, mealtime stress, or forced feeding. “Challenges differ between a difficult 3-year-old and a 6- or 7-year-old who still refuses new foods,” he explained.
Parental Pressure and Nutritional Balance
Nutritional balance is essential, but “parental pressure is often too high.” Parents worry because they see food as a “nutraceutical.” Bellaïche recommended defusing anxiety by keeping mealtimes calm, allowing the child to eat at their pace, avoiding force-feeding, keeping meals brief, and avoiding snacks. While “it’s important to stay vigilant — as it’s incorrect to assume a child won’t let themselves starve — most cases can be managed in general practice through parental guidance, empathy, and a positive approach.”
Monitoring growth and weight curves is crucial, with the Kanawati index (ratio of arm circumference to head circumference) being a reliable indicator for specialist referral if < 0.31. A varied diet is important for nutritional balance; when this isn’t achieved, continued consumption of toddler formula after age 3 can prevent iron and calcium deficiencies.
When eating difficulties are documented, healthcare providers should investigate for underlying organic, digestive, or extra-digestive diseases (neurologic, cardiac, renal, etc.). “It’s best not to hastily diagnose cow’s milk protein allergy,” Bellaïche advised, as cases are relatively rare and unnecessarily eliminating milk can complicate a child’s relationship with food. Similarly, gastroesophageal reflux disease should be objectively diagnosed to avoid unnecessary proton pump inhibitor treatment and associated side effects.
For children with low birth weight, mild congenital heart disease, or suggestive dysmorphology, consider evaluating for a genetic syndrome.
Avoidant/Restrictive Food Intake Disorder (ARFID)
ARFID is marked by a lack of interest in food and avoidance due to sensory characteristics. Often observed in anxious children, ARFID is diagnosed in approximately 20% of children with autism spectrum disorder, where food selectivity is prevalent. This condition can hinder a child’s development and may necessitate nutritional supplementation.
Case Profiles in Eating Issues
Bellaïche outlined three typical cases among children considered “picky eaters”:
- The small eater: Often near the lower growth curve limits, this child “grazes and doesn’t sit still.” These children are usually active and have a family history of similar eating habits. Parents should encourage psychomotor activities, discourage snacks outside of mealtimes, and consider fun family picnics on the floor, offering a mezze-style variety of foods.
- The child with a history of trauma: Children with trauma (from intubation, nasogastric tubes, severe vomiting, forced feeding, or choking) may develop aversions requiring behavioral intervention.
- The child with high sensory sensitivity: This child dislikes getting the hands dirty, avoids mouthing objects, or resists certain textures, such as grass and sand. Gradual behavioral approaches with sensory play and visually appealing new foods can be beneficial. Guided self-led food exploration (baby-led weaning) may also help, though dairy intake is often needed to prevent deficiencies during this stage.
Finally, gastroesophageal reflux disease or constipation can contribute to appetite loss. Studies have shown that treating these issues can improve appetite in small eaters.
This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
PARIS — “My child is a poor eater” is a complaint frequently heard during medical consultations. Such concerns are often unjustified but a source of much parental frustration.
Marc Bellaïche, MD, a pediatrician at Robert-Debré Hospital in Paris, addressed this issue at France’s annual general medicine conference (JNMG 2024). His presentation focused on distinguishing between parental perception, typical childhood behaviors, and feeding issues that require intervention.
In assessing parental worries, tools such as The Montreal Children’s Hospital Feeding Scale for children aged 6 months to 6 years and the Baby Eating Behavior Questionnaire for those under 6 months can help identify and monitor feeding issues. Observing the child eat, when possible, is also valuable.
Key Phases and Development
Bellaïche focused on children under 6 years, as they frequently experience feeding challenges during critical development phases, such as weaning or when the child is able to sit up.
A phase of neophilia (interest in new foods) typically occurs before 12 months, followed by a phase of neophobia (fear of new foods) between ages 1 and 3 years. This neophobia is a normal part of neuropsychological, sensory, and taste development and can persist if a key developmental moment is marked by a choking incident, mealtime stress, or forced feeding. “Challenges differ between a difficult 3-year-old and a 6- or 7-year-old who still refuses new foods,” he explained.
Parental Pressure and Nutritional Balance
Nutritional balance is essential, but “parental pressure is often too high.” Parents worry because they see food as a “nutraceutical.” Bellaïche recommended defusing anxiety by keeping mealtimes calm, allowing the child to eat at their pace, avoiding force-feeding, keeping meals brief, and avoiding snacks. While “it’s important to stay vigilant — as it’s incorrect to assume a child won’t let themselves starve — most cases can be managed in general practice through parental guidance, empathy, and a positive approach.”
Monitoring growth and weight curves is crucial, with the Kanawati index (ratio of arm circumference to head circumference) being a reliable indicator for specialist referral if < 0.31. A varied diet is important for nutritional balance; when this isn’t achieved, continued consumption of toddler formula after age 3 can prevent iron and calcium deficiencies.
When eating difficulties are documented, healthcare providers should investigate for underlying organic, digestive, or extra-digestive diseases (neurologic, cardiac, renal, etc.). “It’s best not to hastily diagnose cow’s milk protein allergy,” Bellaïche advised, as cases are relatively rare and unnecessarily eliminating milk can complicate a child’s relationship with food. Similarly, gastroesophageal reflux disease should be objectively diagnosed to avoid unnecessary proton pump inhibitor treatment and associated side effects.
For children with low birth weight, mild congenital heart disease, or suggestive dysmorphology, consider evaluating for a genetic syndrome.
Avoidant/Restrictive Food Intake Disorder (ARFID)
ARFID is marked by a lack of interest in food and avoidance due to sensory characteristics. Often observed in anxious children, ARFID is diagnosed in approximately 20% of children with autism spectrum disorder, where food selectivity is prevalent. This condition can hinder a child’s development and may necessitate nutritional supplementation.
Case Profiles in Eating Issues
Bellaïche outlined three typical cases among children considered “picky eaters”:
- The small eater: Often near the lower growth curve limits, this child “grazes and doesn’t sit still.” These children are usually active and have a family history of similar eating habits. Parents should encourage psychomotor activities, discourage snacks outside of mealtimes, and consider fun family picnics on the floor, offering a mezze-style variety of foods.
- The child with a history of trauma: Children with trauma (from intubation, nasogastric tubes, severe vomiting, forced feeding, or choking) may develop aversions requiring behavioral intervention.
- The child with high sensory sensitivity: This child dislikes getting the hands dirty, avoids mouthing objects, or resists certain textures, such as grass and sand. Gradual behavioral approaches with sensory play and visually appealing new foods can be beneficial. Guided self-led food exploration (baby-led weaning) may also help, though dairy intake is often needed to prevent deficiencies during this stage.
Finally, gastroesophageal reflux disease or constipation can contribute to appetite loss. Studies have shown that treating these issues can improve appetite in small eaters.
This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
FROM JNMG 2024
Hemorrhoidal Disease Management: When and How to Intervene
France’s annual general medicine conference (JNMG 2024) on the management of hemorrhoidal disease, he noted, “this [NSAID and analgesic] treatment is highly effective, initially relieving pain and reducing edema, though the clot takes longer to resolve.” In cases where residual skin tags (marisques) remain after an episode, resection may be considered if they cause discomfort.
according to Vincent de Parades, MD, PhD, of Hôpital Paris Saint-Joseph in France. In his presentation atWhile patients often turn to over-the-counter topical treatments during flare-ups, de Parades noted that these have not been proven effective for hemorrhoidal disease. For hemorrhoidal thrombosis, however, a topical treatment with a corticosteroid and anesthetic may be prescribed.
No NSAIDs for Abscesses
In addition to NSAIDs, a local treatment may provide soothing benefits, especially when combined with topical application, as highlighted by Nadia Fathallah, MD, of Hôpital Paris Saint-Joseph, who joined de Parades in the presentation. “I recommend massaging the ointment to help dissolve the thrombus,” she added. However, “NSAIDs should not be prescribed in the case of an abscess,” cautioned de Parades, emphasizing that “any patient with a painful anal swelling needs an examination.” When in doubt, administer an analgesic and reexamine the patient 1-2 days later. If an abscess is present, it will not resolve on its own, and pain will persist.
The two proctologists reviewed various interventions for managing hemorrhoidal conditions, underscoring the benefits of minimally invasive surgery as an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.
Hemorrhoidal disease involves abnormal dilation of the vascular system in the anus and rectum. External hemorrhoids affect the external vascular plexus, while internal hemorrhoids occur in the upper part of the anal canal at the internal plexus.
Hygiene and Dietary Guidelines
Common symptoms include light to heavy bleeding during bowel movements and the sensation of a lump inside the anus. In some cases, this is accompanied by throbbing pain, which suggests hemorrhoidal thrombosis, a condition often associated with a painful external swelling. Hemorrhoidal prolapse, meanwhile, is characterized by the protrusion of internal hemorrhoids and is classified into four grades:
- Grade 1: Hemorrhoids emerge during straining but do not protrude externally.
- Grade 2: Hemorrhoids protrude but spontaneously retract after straining.
- Grade 3: Hemorrhoids protrude with straining and require manual reinsertion.
- Grade 4: Prolapse is permanent.
In all cases, medical treatment is recommended as the initial approach. European guidelines recommend to first implement lifestyle and dietary measures, encouraging regular physical activity and adequate water and fiber intake to promote intestinal transit. Laxatives may also be recommended.
Elastic Band Ligation
For hemorrhoidal thrombosis, NSAIDs and nonopioid analgesics are recommended as first-line treatments. For patients with contraindications to NSAIDs, such as pregnant women, corticosteroid treatment may be administered, although it is less effective. Routine incision is no longer recommended, according to de Parades.
For prolapsed internal hemorrhoids, instrumental treatment is recommended as a second-line option if medical management fails for grades 1 and 2, or for isolated grade 3 hemorrhoids. With sclerotherapy injections largely phased out, two options remain: Infrared photocoagulation and elastic band ligation.
The objective of instrumental treatment is to create a scar at the top of the hemorrhoidal plexus to reduce vascularization and secure the hemorrhoid to the rectal wall. When correctly performed above the insensitive mucosal area in the anal canal, the procedure is painless.
Ligation involves placing an elastic band at the base of the hemorrhoid, with the intervention taking only a few minutes. “Within 4 weeks, the hemorrhoid disappears,” explained de Parades. Photocoagulation is a more superficial treatment requiring several spaced sessions, mainly to address bleeding.
Advances in Minimally Invasive Surgery
Surgery is recommended if instrumental treatment fails and as a first-line option for circular grade 3 hemorrhoids (multiple hemorrhoidal masses) and grade 4 cases.
Milligan-Morgan hemorrhoidectomy is considered the “gold standard” surgical technique and is used primarily for grades 2, 3, and 4 cases. This technique involves resecting the three main hemorrhoidal bundles while preserving surrounding tissue, providing a “radical and definitive” treatment.
While effective in the long term, hemorrhoid bundle resection requires a lengthy healing process and typically requires the patient to take 15-20 days off work. It is also not recommended for people who engage in anal intercourse, as “removing hemorrhoidal tissue can reduce flexibility and sensation in the anal canal,” Fathallah noted.
Another widely used technique in France is Doppler-guided hemorrhoidal artery ligation, which selectively reduces blood flow to the hemorrhoidal plexus. It is often combined with a mucopexy to secure the prolapse above the anal canal and restore normal anatomy.
Minimally invasive surgery is today increasingly considered an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.
Laser and radiofrequency techniques induce submucosal coagulation, reducing arterial flow and creating fibrous tissue to retract the hemorrhoidal bundle. Because the procedure is applied above the anal canal, “it is associated with little or no pain.”
Hemorrhoidal Embolization
Recent studies have validated the benefits of minimally invasive surgery for this condition. In a French multicenter study, radiofrequency treatment significantly improved quality of life 3 months post operation, requiring only 4 days off work. The vast majority of patients said they were satisfied with the results.
The procedure is less uncomfortable than hemorrhoidectomy and allows for quicker recovery, but it carries a risk for recurrence. In the French study, nearly 8% of patients required reoperation within a year, mostly by hemorrhoidectomy. “The estimated recurrence rate is 20%-30% over 10 years,” said de Parades.
Overall, the specialist emphasized the value of surgery, including hemorrhoidectomy, in treating hemorrhoidal prolapse. With substantial benefits from minimally invasive options, “patients should be referred early” to prevent prolapse progression “that might leave no choice but hemorrhoidectomy.”
Finally, another technique is available for bleeding without prolapse: Hemorrhoidal embolization. Practiced for about a decade, the procedure involves blocking blood flow to the hemorrhoids by inserting tiny metal coils through a catheter, which is inserted via a transcutaneous route through an artery in the arm.
This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version appeared on Medscape.com.
France’s annual general medicine conference (JNMG 2024) on the management of hemorrhoidal disease, he noted, “this [NSAID and analgesic] treatment is highly effective, initially relieving pain and reducing edema, though the clot takes longer to resolve.” In cases where residual skin tags (marisques) remain after an episode, resection may be considered if they cause discomfort.
according to Vincent de Parades, MD, PhD, of Hôpital Paris Saint-Joseph in France. In his presentation atWhile patients often turn to over-the-counter topical treatments during flare-ups, de Parades noted that these have not been proven effective for hemorrhoidal disease. For hemorrhoidal thrombosis, however, a topical treatment with a corticosteroid and anesthetic may be prescribed.
No NSAIDs for Abscesses
In addition to NSAIDs, a local treatment may provide soothing benefits, especially when combined with topical application, as highlighted by Nadia Fathallah, MD, of Hôpital Paris Saint-Joseph, who joined de Parades in the presentation. “I recommend massaging the ointment to help dissolve the thrombus,” she added. However, “NSAIDs should not be prescribed in the case of an abscess,” cautioned de Parades, emphasizing that “any patient with a painful anal swelling needs an examination.” When in doubt, administer an analgesic and reexamine the patient 1-2 days later. If an abscess is present, it will not resolve on its own, and pain will persist.
The two proctologists reviewed various interventions for managing hemorrhoidal conditions, underscoring the benefits of minimally invasive surgery as an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.
Hemorrhoidal disease involves abnormal dilation of the vascular system in the anus and rectum. External hemorrhoids affect the external vascular plexus, while internal hemorrhoids occur in the upper part of the anal canal at the internal plexus.
Hygiene and Dietary Guidelines
Common symptoms include light to heavy bleeding during bowel movements and the sensation of a lump inside the anus. In some cases, this is accompanied by throbbing pain, which suggests hemorrhoidal thrombosis, a condition often associated with a painful external swelling. Hemorrhoidal prolapse, meanwhile, is characterized by the protrusion of internal hemorrhoids and is classified into four grades:
- Grade 1: Hemorrhoids emerge during straining but do not protrude externally.
- Grade 2: Hemorrhoids protrude but spontaneously retract after straining.
- Grade 3: Hemorrhoids protrude with straining and require manual reinsertion.
- Grade 4: Prolapse is permanent.
In all cases, medical treatment is recommended as the initial approach. European guidelines recommend to first implement lifestyle and dietary measures, encouraging regular physical activity and adequate water and fiber intake to promote intestinal transit. Laxatives may also be recommended.
Elastic Band Ligation
For hemorrhoidal thrombosis, NSAIDs and nonopioid analgesics are recommended as first-line treatments. For patients with contraindications to NSAIDs, such as pregnant women, corticosteroid treatment may be administered, although it is less effective. Routine incision is no longer recommended, according to de Parades.
For prolapsed internal hemorrhoids, instrumental treatment is recommended as a second-line option if medical management fails for grades 1 and 2, or for isolated grade 3 hemorrhoids. With sclerotherapy injections largely phased out, two options remain: Infrared photocoagulation and elastic band ligation.
The objective of instrumental treatment is to create a scar at the top of the hemorrhoidal plexus to reduce vascularization and secure the hemorrhoid to the rectal wall. When correctly performed above the insensitive mucosal area in the anal canal, the procedure is painless.
Ligation involves placing an elastic band at the base of the hemorrhoid, with the intervention taking only a few minutes. “Within 4 weeks, the hemorrhoid disappears,” explained de Parades. Photocoagulation is a more superficial treatment requiring several spaced sessions, mainly to address bleeding.
Advances in Minimally Invasive Surgery
Surgery is recommended if instrumental treatment fails and as a first-line option for circular grade 3 hemorrhoids (multiple hemorrhoidal masses) and grade 4 cases.
Milligan-Morgan hemorrhoidectomy is considered the “gold standard” surgical technique and is used primarily for grades 2, 3, and 4 cases. This technique involves resecting the three main hemorrhoidal bundles while preserving surrounding tissue, providing a “radical and definitive” treatment.
While effective in the long term, hemorrhoid bundle resection requires a lengthy healing process and typically requires the patient to take 15-20 days off work. It is also not recommended for people who engage in anal intercourse, as “removing hemorrhoidal tissue can reduce flexibility and sensation in the anal canal,” Fathallah noted.
Another widely used technique in France is Doppler-guided hemorrhoidal artery ligation, which selectively reduces blood flow to the hemorrhoidal plexus. It is often combined with a mucopexy to secure the prolapse above the anal canal and restore normal anatomy.
Minimally invasive surgery is today increasingly considered an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.
Laser and radiofrequency techniques induce submucosal coagulation, reducing arterial flow and creating fibrous tissue to retract the hemorrhoidal bundle. Because the procedure is applied above the anal canal, “it is associated with little or no pain.”
Hemorrhoidal Embolization
Recent studies have validated the benefits of minimally invasive surgery for this condition. In a French multicenter study, radiofrequency treatment significantly improved quality of life 3 months post operation, requiring only 4 days off work. The vast majority of patients said they were satisfied with the results.
The procedure is less uncomfortable than hemorrhoidectomy and allows for quicker recovery, but it carries a risk for recurrence. In the French study, nearly 8% of patients required reoperation within a year, mostly by hemorrhoidectomy. “The estimated recurrence rate is 20%-30% over 10 years,” said de Parades.
Overall, the specialist emphasized the value of surgery, including hemorrhoidectomy, in treating hemorrhoidal prolapse. With substantial benefits from minimally invasive options, “patients should be referred early” to prevent prolapse progression “that might leave no choice but hemorrhoidectomy.”
Finally, another technique is available for bleeding without prolapse: Hemorrhoidal embolization. Practiced for about a decade, the procedure involves blocking blood flow to the hemorrhoids by inserting tiny metal coils through a catheter, which is inserted via a transcutaneous route through an artery in the arm.
This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version appeared on Medscape.com.
France’s annual general medicine conference (JNMG 2024) on the management of hemorrhoidal disease, he noted, “this [NSAID and analgesic] treatment is highly effective, initially relieving pain and reducing edema, though the clot takes longer to resolve.” In cases where residual skin tags (marisques) remain after an episode, resection may be considered if they cause discomfort.
according to Vincent de Parades, MD, PhD, of Hôpital Paris Saint-Joseph in France. In his presentation atWhile patients often turn to over-the-counter topical treatments during flare-ups, de Parades noted that these have not been proven effective for hemorrhoidal disease. For hemorrhoidal thrombosis, however, a topical treatment with a corticosteroid and anesthetic may be prescribed.
No NSAIDs for Abscesses
In addition to NSAIDs, a local treatment may provide soothing benefits, especially when combined with topical application, as highlighted by Nadia Fathallah, MD, of Hôpital Paris Saint-Joseph, who joined de Parades in the presentation. “I recommend massaging the ointment to help dissolve the thrombus,” she added. However, “NSAIDs should not be prescribed in the case of an abscess,” cautioned de Parades, emphasizing that “any patient with a painful anal swelling needs an examination.” When in doubt, administer an analgesic and reexamine the patient 1-2 days later. If an abscess is present, it will not resolve on its own, and pain will persist.
The two proctologists reviewed various interventions for managing hemorrhoidal conditions, underscoring the benefits of minimally invasive surgery as an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.
Hemorrhoidal disease involves abnormal dilation of the vascular system in the anus and rectum. External hemorrhoids affect the external vascular plexus, while internal hemorrhoids occur in the upper part of the anal canal at the internal plexus.
Hygiene and Dietary Guidelines
Common symptoms include light to heavy bleeding during bowel movements and the sensation of a lump inside the anus. In some cases, this is accompanied by throbbing pain, which suggests hemorrhoidal thrombosis, a condition often associated with a painful external swelling. Hemorrhoidal prolapse, meanwhile, is characterized by the protrusion of internal hemorrhoids and is classified into four grades:
- Grade 1: Hemorrhoids emerge during straining but do not protrude externally.
- Grade 2: Hemorrhoids protrude but spontaneously retract after straining.
- Grade 3: Hemorrhoids protrude with straining and require manual reinsertion.
- Grade 4: Prolapse is permanent.
In all cases, medical treatment is recommended as the initial approach. European guidelines recommend to first implement lifestyle and dietary measures, encouraging regular physical activity and adequate water and fiber intake to promote intestinal transit. Laxatives may also be recommended.
Elastic Band Ligation
For hemorrhoidal thrombosis, NSAIDs and nonopioid analgesics are recommended as first-line treatments. For patients with contraindications to NSAIDs, such as pregnant women, corticosteroid treatment may be administered, although it is less effective. Routine incision is no longer recommended, according to de Parades.
For prolapsed internal hemorrhoids, instrumental treatment is recommended as a second-line option if medical management fails for grades 1 and 2, or for isolated grade 3 hemorrhoids. With sclerotherapy injections largely phased out, two options remain: Infrared photocoagulation and elastic band ligation.
The objective of instrumental treatment is to create a scar at the top of the hemorrhoidal plexus to reduce vascularization and secure the hemorrhoid to the rectal wall. When correctly performed above the insensitive mucosal area in the anal canal, the procedure is painless.
Ligation involves placing an elastic band at the base of the hemorrhoid, with the intervention taking only a few minutes. “Within 4 weeks, the hemorrhoid disappears,” explained de Parades. Photocoagulation is a more superficial treatment requiring several spaced sessions, mainly to address bleeding.
Advances in Minimally Invasive Surgery
Surgery is recommended if instrumental treatment fails and as a first-line option for circular grade 3 hemorrhoids (multiple hemorrhoidal masses) and grade 4 cases.
Milligan-Morgan hemorrhoidectomy is considered the “gold standard” surgical technique and is used primarily for grades 2, 3, and 4 cases. This technique involves resecting the three main hemorrhoidal bundles while preserving surrounding tissue, providing a “radical and definitive” treatment.
While effective in the long term, hemorrhoid bundle resection requires a lengthy healing process and typically requires the patient to take 15-20 days off work. It is also not recommended for people who engage in anal intercourse, as “removing hemorrhoidal tissue can reduce flexibility and sensation in the anal canal,” Fathallah noted.
Another widely used technique in France is Doppler-guided hemorrhoidal artery ligation, which selectively reduces blood flow to the hemorrhoidal plexus. It is often combined with a mucopexy to secure the prolapse above the anal canal and restore normal anatomy.
Minimally invasive surgery is today increasingly considered an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.
Laser and radiofrequency techniques induce submucosal coagulation, reducing arterial flow and creating fibrous tissue to retract the hemorrhoidal bundle. Because the procedure is applied above the anal canal, “it is associated with little or no pain.”
Hemorrhoidal Embolization
Recent studies have validated the benefits of minimally invasive surgery for this condition. In a French multicenter study, radiofrequency treatment significantly improved quality of life 3 months post operation, requiring only 4 days off work. The vast majority of patients said they were satisfied with the results.
The procedure is less uncomfortable than hemorrhoidectomy and allows for quicker recovery, but it carries a risk for recurrence. In the French study, nearly 8% of patients required reoperation within a year, mostly by hemorrhoidectomy. “The estimated recurrence rate is 20%-30% over 10 years,” said de Parades.
Overall, the specialist emphasized the value of surgery, including hemorrhoidectomy, in treating hemorrhoidal prolapse. With substantial benefits from minimally invasive options, “patients should be referred early” to prevent prolapse progression “that might leave no choice but hemorrhoidectomy.”
Finally, another technique is available for bleeding without prolapse: Hemorrhoidal embolization. Practiced for about a decade, the procedure involves blocking blood flow to the hemorrhoids by inserting tiny metal coils through a catheter, which is inserted via a transcutaneous route through an artery in the arm.
This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version appeared on Medscape.com.
Endometriosis Raises Rates of Postpartum Depression, Other Disorders
Women with endometriosis have a much higher risk of being diagnosed with several psychiatric disorders during the postpartum period according to an oral abstract presented at the American Society for Reproductive Medicine’s 2024 Scientific Congress and Expo in Denver, Colorado.
Researchers compared rates of postpartum depression, anxiety, mood disturbance (temporary low or anxious mood requiring no treatment), and obsessive-compulsive disorder (OCD) diagnoses among over 200 million adult women from 67 healthcare organizations who had a child between 2005 and 2023.
Within a year after giving birth, women with prepregnancy endometriosis were 25% more likely to be diagnosed with postpartum depression, 85% more likely to be diagnosed with postpartum mood disturbance, 44% more likely to be diagnosed with anxiety, and 1.26 times more likely to be diagnosed with OCD.
About 75% of women studied had no preexisting depression. This population had a 17% higher risk of receiving a postpartum depression diagnosis, a 95% higher risk of receiving an OCD diagnosis, a 72% higher risk of receiving a postpartum mood disturbance diagnosis, and a 38% risk of receiving an anxiety diagnosis.
Among women without preexisting depression, the risk increased by 64% for OCD, 42% for postpartum mood disturbance, and 25% for anxiety, while the risk for postpartum depression was negligible, indicating that women already experiencing depression likely have a higher baseline risk for worsening symptoms postpartum, said the study’s lead author Tina Yi-Jin Hsieh, MD, MPH, biomedical researcher at Harvard Medical School in Boston, Massachusetts.
“We think that because preexisting depression is the more dominant risk factor, it doesn’t really matter if you have another additional risk factor like endometriosis to really change the risk of postpartum depression,” said Hsieh.
Endometriosis is a debilitating condition in which tissue similar to uterine lining grows on the outside of the uterus, causing chronic pain and infertility. It affects between 6% and 10% of women worldwide and takes an average of between 4 and 11 years to be diagnosed. It has been linked to depression and anxiety disorders, yet the study authors say there’s little research examining its impact on women in the year after giving birth.
“Endometriosis is a complex condition that can affect both physical and mental health over much of a person’s life,” said Anna Modest, PhD, assistant professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School and a study author. “Perinatal and maternal mental health can have a huge impact on children and their family — we need to better understand who is at risk for challenges in the postpartum period.”
“Most chronic medical illnesses, particularly those causing pain, have been shown to increase the risk of mood disorders,” said Ripal Shah, MD, MPH, clinical associate professor of Psychiatry and Behavioral Sciences at Stanford Medicine in California. Shah specializes in reproductive psychiatry and was not associated with the study.
“What’s interesting about endometriosis though is that genome-wide association studies have shown that there may be a genetic predisposition for some women to develop both endometriosis and a mood disorder,” said Shah.
A 2023 study suggested that endometriosis, anxiety, and depression may be connected through a shared genetic basis.
But the experience patients with endometriosis go through also lends itself to the development of mood disorders, said Daniel Ginn, DO, assistant clinical professor of Obstetrics and Gynecology at the David Geffen School of Medicine at the University of California, Los Angeles. Ginn specializes in the treatment of endometriosis and was not a part of the study.
Beyond postpartum depression, Ginn wasn’t surprised by the association of endometriosis with anxiety or OCD because what he hears from patients “on a daily basis is the telling of a history that has been hallmarked by not being listened to, not being believed, and not having symptoms managed well.”
As a result, he said many patients focus heavily on learning about their condition, coming into office visits with binders full of test results and information in an effort to understand and manage it themselves. This “does lead to a certain sense of a need to grasp for control because no one else is helping them [treat their condition effectively].”
He added: “I find it hard to believe that anxiety and OCD were preexisting of the conditions rather than the consequence of a long-term suboptimally managed disease.”
The authors reported no disclosures or sources of funding.
A version of this article first appeared on Medscape.com.
Women with endometriosis have a much higher risk of being diagnosed with several psychiatric disorders during the postpartum period according to an oral abstract presented at the American Society for Reproductive Medicine’s 2024 Scientific Congress and Expo in Denver, Colorado.
Researchers compared rates of postpartum depression, anxiety, mood disturbance (temporary low or anxious mood requiring no treatment), and obsessive-compulsive disorder (OCD) diagnoses among over 200 million adult women from 67 healthcare organizations who had a child between 2005 and 2023.
Within a year after giving birth, women with prepregnancy endometriosis were 25% more likely to be diagnosed with postpartum depression, 85% more likely to be diagnosed with postpartum mood disturbance, 44% more likely to be diagnosed with anxiety, and 1.26 times more likely to be diagnosed with OCD.
About 75% of women studied had no preexisting depression. This population had a 17% higher risk of receiving a postpartum depression diagnosis, a 95% higher risk of receiving an OCD diagnosis, a 72% higher risk of receiving a postpartum mood disturbance diagnosis, and a 38% risk of receiving an anxiety diagnosis.
Among women without preexisting depression, the risk increased by 64% for OCD, 42% for postpartum mood disturbance, and 25% for anxiety, while the risk for postpartum depression was negligible, indicating that women already experiencing depression likely have a higher baseline risk for worsening symptoms postpartum, said the study’s lead author Tina Yi-Jin Hsieh, MD, MPH, biomedical researcher at Harvard Medical School in Boston, Massachusetts.
“We think that because preexisting depression is the more dominant risk factor, it doesn’t really matter if you have another additional risk factor like endometriosis to really change the risk of postpartum depression,” said Hsieh.
Endometriosis is a debilitating condition in which tissue similar to uterine lining grows on the outside of the uterus, causing chronic pain and infertility. It affects between 6% and 10% of women worldwide and takes an average of between 4 and 11 years to be diagnosed. It has been linked to depression and anxiety disorders, yet the study authors say there’s little research examining its impact on women in the year after giving birth.
“Endometriosis is a complex condition that can affect both physical and mental health over much of a person’s life,” said Anna Modest, PhD, assistant professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School and a study author. “Perinatal and maternal mental health can have a huge impact on children and their family — we need to better understand who is at risk for challenges in the postpartum period.”
“Most chronic medical illnesses, particularly those causing pain, have been shown to increase the risk of mood disorders,” said Ripal Shah, MD, MPH, clinical associate professor of Psychiatry and Behavioral Sciences at Stanford Medicine in California. Shah specializes in reproductive psychiatry and was not associated with the study.
“What’s interesting about endometriosis though is that genome-wide association studies have shown that there may be a genetic predisposition for some women to develop both endometriosis and a mood disorder,” said Shah.
A 2023 study suggested that endometriosis, anxiety, and depression may be connected through a shared genetic basis.
But the experience patients with endometriosis go through also lends itself to the development of mood disorders, said Daniel Ginn, DO, assistant clinical professor of Obstetrics and Gynecology at the David Geffen School of Medicine at the University of California, Los Angeles. Ginn specializes in the treatment of endometriosis and was not a part of the study.
Beyond postpartum depression, Ginn wasn’t surprised by the association of endometriosis with anxiety or OCD because what he hears from patients “on a daily basis is the telling of a history that has been hallmarked by not being listened to, not being believed, and not having symptoms managed well.”
As a result, he said many patients focus heavily on learning about their condition, coming into office visits with binders full of test results and information in an effort to understand and manage it themselves. This “does lead to a certain sense of a need to grasp for control because no one else is helping them [treat their condition effectively].”
He added: “I find it hard to believe that anxiety and OCD were preexisting of the conditions rather than the consequence of a long-term suboptimally managed disease.”
The authors reported no disclosures or sources of funding.
A version of this article first appeared on Medscape.com.
Women with endometriosis have a much higher risk of being diagnosed with several psychiatric disorders during the postpartum period according to an oral abstract presented at the American Society for Reproductive Medicine’s 2024 Scientific Congress and Expo in Denver, Colorado.
Researchers compared rates of postpartum depression, anxiety, mood disturbance (temporary low or anxious mood requiring no treatment), and obsessive-compulsive disorder (OCD) diagnoses among over 200 million adult women from 67 healthcare organizations who had a child between 2005 and 2023.
Within a year after giving birth, women with prepregnancy endometriosis were 25% more likely to be diagnosed with postpartum depression, 85% more likely to be diagnosed with postpartum mood disturbance, 44% more likely to be diagnosed with anxiety, and 1.26 times more likely to be diagnosed with OCD.
About 75% of women studied had no preexisting depression. This population had a 17% higher risk of receiving a postpartum depression diagnosis, a 95% higher risk of receiving an OCD diagnosis, a 72% higher risk of receiving a postpartum mood disturbance diagnosis, and a 38% risk of receiving an anxiety diagnosis.
Among women without preexisting depression, the risk increased by 64% for OCD, 42% for postpartum mood disturbance, and 25% for anxiety, while the risk for postpartum depression was negligible, indicating that women already experiencing depression likely have a higher baseline risk for worsening symptoms postpartum, said the study’s lead author Tina Yi-Jin Hsieh, MD, MPH, biomedical researcher at Harvard Medical School in Boston, Massachusetts.
“We think that because preexisting depression is the more dominant risk factor, it doesn’t really matter if you have another additional risk factor like endometriosis to really change the risk of postpartum depression,” said Hsieh.
Endometriosis is a debilitating condition in which tissue similar to uterine lining grows on the outside of the uterus, causing chronic pain and infertility. It affects between 6% and 10% of women worldwide and takes an average of between 4 and 11 years to be diagnosed. It has been linked to depression and anxiety disorders, yet the study authors say there’s little research examining its impact on women in the year after giving birth.
“Endometriosis is a complex condition that can affect both physical and mental health over much of a person’s life,” said Anna Modest, PhD, assistant professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School and a study author. “Perinatal and maternal mental health can have a huge impact on children and their family — we need to better understand who is at risk for challenges in the postpartum period.”
“Most chronic medical illnesses, particularly those causing pain, have been shown to increase the risk of mood disorders,” said Ripal Shah, MD, MPH, clinical associate professor of Psychiatry and Behavioral Sciences at Stanford Medicine in California. Shah specializes in reproductive psychiatry and was not associated with the study.
“What’s interesting about endometriosis though is that genome-wide association studies have shown that there may be a genetic predisposition for some women to develop both endometriosis and a mood disorder,” said Shah.
A 2023 study suggested that endometriosis, anxiety, and depression may be connected through a shared genetic basis.
But the experience patients with endometriosis go through also lends itself to the development of mood disorders, said Daniel Ginn, DO, assistant clinical professor of Obstetrics and Gynecology at the David Geffen School of Medicine at the University of California, Los Angeles. Ginn specializes in the treatment of endometriosis and was not a part of the study.
Beyond postpartum depression, Ginn wasn’t surprised by the association of endometriosis with anxiety or OCD because what he hears from patients “on a daily basis is the telling of a history that has been hallmarked by not being listened to, not being believed, and not having symptoms managed well.”
As a result, he said many patients focus heavily on learning about their condition, coming into office visits with binders full of test results and information in an effort to understand and manage it themselves. This “does lead to a certain sense of a need to grasp for control because no one else is helping them [treat their condition effectively].”
He added: “I find it hard to believe that anxiety and OCD were preexisting of the conditions rather than the consequence of a long-term suboptimally managed disease.”
The authors reported no disclosures or sources of funding.
A version of this article first appeared on Medscape.com.
FROM ASRM 2024
Barzolvolimab Effective for CSU in Phase 2 Study
Moreover, in the study, barzolvolimab, an anti-KIT monoclonal antibody that inhibits the activation of and depletes mast cells, induced comparable responses in a subset of patients who had taken omalizumab, an anti–immunoglobulin E monoclonal antibody approved by the Food and Drug Administration for treating CSU.
The findings were presented at the annual European Academy of Dermatology and Venereology (EADV) 2024 Congress. Barzolvolimab is being developed by Celldex Therapeutics.
“Barzolvolimab treatment resulted in rapid, profound, and durable improvement in UAS7 [weekly Urticaria Activity Score 7],” said presenter Martin Metz, MD, professor of dermatology, Institute of Allergology, Charité – Universitätsmedizin Berlin in Germany, “with a deepening of response over 52 weeks in patients with antihistamine-refractory CSU.”
“Similar robust improvement was seen in patients previously treated with omalizumab, including refractory patients,” he added.
Because barzolvolimab was well tolerated over the course of the follow-up period, Metz said, it “has the potential to be an important new treatment option,” noting that patients are now being enrolled in global phase 3 studies of barzolvolimab.
Sustained Symptom Relief
Ana M. Giménez-Arnau, MD, PhD, associate professor of dermatology, Autonomous University and Pompeu Fabra University, Barcelona, Spain, told Medscape Medical News that the results are important, as they showed people who switched from placebo to the active drug also saw a long-term benefit.
What is “remarkable” about barzolvolimab, continued Giménez-Arnau, who was not involved in the study, is that it is the first drug to target the KIT receptor on mast cells and interfere with stimulating growth factors, thus making the cells that drive the development of CSU “disappear.”
The study included three different barzolvolimab regimens, with the 150-mg dose every 4 weeks and the 300-mg dose every 8 weeks achieving similar results, noted Giménez-Arnau.
For her, there are important questions to answer around the pharmacokinetic and pharmacodynamic profiles of the two regimens that remain, but she underlined that for the patient, the choice of regimen could have an impact on their quality of life.
“If we give 300 mg every 8 weeks,” she said, it appears “you can achieve disease control” while halving the frequency of subcutaneous injections.
She said that it would be “interesting to know” if 300 mg every 8 weeks is given as two 150-mg injections every 2 months or one 300-mg injection. If it is the former, Giménez Arnau said, “This is potentially an important benefit for the patient.”
Sustained Benefits at 1 Year
The study enrolled 208 patients with antihistamine-refractory CSU at sites in 10 countries, randomizing them to one of four arms: Subcutaneous injections of barzolvolimab 75 mg or 150 mg every 4 weeks, 300 mg every 8 weeks, or placebo every 4 weeks.
The mean age in each arm was between 42 and 47 years, and around 75% were women. Across the arms, 64%-76% had severe disease, as measured on the UAS7, at a mean score of 30.0-31.3. Around 20% had previously been treated with omalizumab.
Patients were treated for 16 weeks, during which time they completed daily and weekly diaries and attended six clinic visits at weeks 0, 2, 4, 8, 12, and 16. Results from the trial published earlier this year demonstrated that both the regimens (150 mg every 4 weeks and 300 mg every 8 weeks) achieved clinically meaningful and statistically significant improvement in UAS7, the primary endpoint, vs placebo at 12 weeks.
Participants in the barzolvolimab 75 mg and placebo arms were then randomized to receive barzolvolimab 150 mg every 4 weeks or 300 mg every 8 weeks, and those who had been in the 150-mg and 300-mg treatment arms continued with that treatment for a further 36 weeks. (The remaining patients have been continued on a further 24-week follow-up, but the data are not yet available.)
By the 52-week follow-up, 25% of patients who started in each of the barzolvolimab arms had discontinued treatment, as well as 16% first randomized to the placebo arm.
Metz reported that the improvements in UAS7 scores, observed as early as week 1, were sustained through week 52 in patients in both the ongoing 150-mg and 300-mg arms. Patients who initially started in the placebo and the barzolvolimab 75-mg groups caught up with those who had started on the higher doses, so that by week 52, there were no significant differences in urticaria activity, hives, or itch scores between the arms.
By week 52, the proportion of patients achieving well-controlled disease, defined as a UAS7 score ≤ 6, was 73.7% in the barzolvolimab 150 mg every 4-week arm and 68.2% in the 300 mg barzolvolimab every 8-week arm.
Notably, just 12.8% of patients in the placebo arm had achieved well-controlled CSU by week 16, but after switching to barzolvolimab 150 mg every 4 weeks or 300 mg every 8 weeks, 63% reached that target at week 52.
“Maybe even more striking and very interesting to look at,” said Metz, was the complete control of symptoms, meaning “not one single wheal and no itch.” By week 52, 52% of those on 300 mg every 8 weeks and 71.1% of those on 150 mg every 4 weeks had a complete response, with no itch/hives (UAS7 of 0).
Importantly, complete responses with barzolvolimab were observed early and were sustained or improved to week 52, Metz said, with, again, placebo and former barzolvolimab 75 mg patients catching up with those who started on 150 mg every 4 weeks and 300 mg every 8 weeks once they switched at week 16.
“This is the best data for chronic spontaneous urticaria that we have so far seen,” he said, adding that the responses were seen regardless of prior experience with omalizumab.
Changes in Hair Color, Skin Pigmentation
As for safety, during the first 16 weeks, 66% of those on active treatment and 39% on placebo experienced at least one adverse event. There were no treatment-related serious adverse events, compared with two among those who received treatment for the full 52 weeks.
The most common adverse events with active treatment were hair color changes (14% in the first 16 weeks and 26% among those treated for the full 52 weeks), neutropenia/reduced neutrophil count (9% in the first 16 weeks and 17% among those treated for the full 52 weeks), and skin hypopigmentation (1% in the first 16 weeks, 13% among those treated for the full 52 weeks, and 19% among those who switched from placebo to active treatment at 36 weeks). Urticaria was reported by 10% among patients on active treatment and 10% among those on placebo in the first 16 weeks, and by 15% of those treated for the full 52 weeks.
In the post-presentation discussion, Metz explained that the hypopigmentation appears to start around the hair follicle and is diffuse, so tends to look like vitiligo.
He suggested that the melanocytes around the hair follicle “seem to be the ones that are more stressed, maybe because of the hair follicle cycling,” adding that the effect is reversible and does not appear to be dose dependent.
The study was funded by Celldex Therapeutics. Metz declared relationships with AbbVie, ALK-Abelló, Almirall, Amgen, argenx, AstraZeneca, Astria, Attovia Therapeutics, Celldex, Celltrion, Escient Pharmaceuticals, Galen, Galderma, GSK, Incyte, Jasper, Lilly, Novartis, Pfizer, Pharvaris, Regeneron, Sanofi, Teva, Third Harmonic Bio, and Vifor.
A version of this article first appeared on Medscape.com.
Moreover, in the study, barzolvolimab, an anti-KIT monoclonal antibody that inhibits the activation of and depletes mast cells, induced comparable responses in a subset of patients who had taken omalizumab, an anti–immunoglobulin E monoclonal antibody approved by the Food and Drug Administration for treating CSU.
The findings were presented at the annual European Academy of Dermatology and Venereology (EADV) 2024 Congress. Barzolvolimab is being developed by Celldex Therapeutics.
“Barzolvolimab treatment resulted in rapid, profound, and durable improvement in UAS7 [weekly Urticaria Activity Score 7],” said presenter Martin Metz, MD, professor of dermatology, Institute of Allergology, Charité – Universitätsmedizin Berlin in Germany, “with a deepening of response over 52 weeks in patients with antihistamine-refractory CSU.”
“Similar robust improvement was seen in patients previously treated with omalizumab, including refractory patients,” he added.
Because barzolvolimab was well tolerated over the course of the follow-up period, Metz said, it “has the potential to be an important new treatment option,” noting that patients are now being enrolled in global phase 3 studies of barzolvolimab.
Sustained Symptom Relief
Ana M. Giménez-Arnau, MD, PhD, associate professor of dermatology, Autonomous University and Pompeu Fabra University, Barcelona, Spain, told Medscape Medical News that the results are important, as they showed people who switched from placebo to the active drug also saw a long-term benefit.
What is “remarkable” about barzolvolimab, continued Giménez-Arnau, who was not involved in the study, is that it is the first drug to target the KIT receptor on mast cells and interfere with stimulating growth factors, thus making the cells that drive the development of CSU “disappear.”
The study included three different barzolvolimab regimens, with the 150-mg dose every 4 weeks and the 300-mg dose every 8 weeks achieving similar results, noted Giménez-Arnau.
For her, there are important questions to answer around the pharmacokinetic and pharmacodynamic profiles of the two regimens that remain, but she underlined that for the patient, the choice of regimen could have an impact on their quality of life.
“If we give 300 mg every 8 weeks,” she said, it appears “you can achieve disease control” while halving the frequency of subcutaneous injections.
She said that it would be “interesting to know” if 300 mg every 8 weeks is given as two 150-mg injections every 2 months or one 300-mg injection. If it is the former, Giménez Arnau said, “This is potentially an important benefit for the patient.”
Sustained Benefits at 1 Year
The study enrolled 208 patients with antihistamine-refractory CSU at sites in 10 countries, randomizing them to one of four arms: Subcutaneous injections of barzolvolimab 75 mg or 150 mg every 4 weeks, 300 mg every 8 weeks, or placebo every 4 weeks.
The mean age in each arm was between 42 and 47 years, and around 75% were women. Across the arms, 64%-76% had severe disease, as measured on the UAS7, at a mean score of 30.0-31.3. Around 20% had previously been treated with omalizumab.
Patients were treated for 16 weeks, during which time they completed daily and weekly diaries and attended six clinic visits at weeks 0, 2, 4, 8, 12, and 16. Results from the trial published earlier this year demonstrated that both the regimens (150 mg every 4 weeks and 300 mg every 8 weeks) achieved clinically meaningful and statistically significant improvement in UAS7, the primary endpoint, vs placebo at 12 weeks.
Participants in the barzolvolimab 75 mg and placebo arms were then randomized to receive barzolvolimab 150 mg every 4 weeks or 300 mg every 8 weeks, and those who had been in the 150-mg and 300-mg treatment arms continued with that treatment for a further 36 weeks. (The remaining patients have been continued on a further 24-week follow-up, but the data are not yet available.)
By the 52-week follow-up, 25% of patients who started in each of the barzolvolimab arms had discontinued treatment, as well as 16% first randomized to the placebo arm.
Metz reported that the improvements in UAS7 scores, observed as early as week 1, were sustained through week 52 in patients in both the ongoing 150-mg and 300-mg arms. Patients who initially started in the placebo and the barzolvolimab 75-mg groups caught up with those who had started on the higher doses, so that by week 52, there were no significant differences in urticaria activity, hives, or itch scores between the arms.
By week 52, the proportion of patients achieving well-controlled disease, defined as a UAS7 score ≤ 6, was 73.7% in the barzolvolimab 150 mg every 4-week arm and 68.2% in the 300 mg barzolvolimab every 8-week arm.
Notably, just 12.8% of patients in the placebo arm had achieved well-controlled CSU by week 16, but after switching to barzolvolimab 150 mg every 4 weeks or 300 mg every 8 weeks, 63% reached that target at week 52.
“Maybe even more striking and very interesting to look at,” said Metz, was the complete control of symptoms, meaning “not one single wheal and no itch.” By week 52, 52% of those on 300 mg every 8 weeks and 71.1% of those on 150 mg every 4 weeks had a complete response, with no itch/hives (UAS7 of 0).
Importantly, complete responses with barzolvolimab were observed early and were sustained or improved to week 52, Metz said, with, again, placebo and former barzolvolimab 75 mg patients catching up with those who started on 150 mg every 4 weeks and 300 mg every 8 weeks once they switched at week 16.
“This is the best data for chronic spontaneous urticaria that we have so far seen,” he said, adding that the responses were seen regardless of prior experience with omalizumab.
Changes in Hair Color, Skin Pigmentation
As for safety, during the first 16 weeks, 66% of those on active treatment and 39% on placebo experienced at least one adverse event. There were no treatment-related serious adverse events, compared with two among those who received treatment for the full 52 weeks.
The most common adverse events with active treatment were hair color changes (14% in the first 16 weeks and 26% among those treated for the full 52 weeks), neutropenia/reduced neutrophil count (9% in the first 16 weeks and 17% among those treated for the full 52 weeks), and skin hypopigmentation (1% in the first 16 weeks, 13% among those treated for the full 52 weeks, and 19% among those who switched from placebo to active treatment at 36 weeks). Urticaria was reported by 10% among patients on active treatment and 10% among those on placebo in the first 16 weeks, and by 15% of those treated for the full 52 weeks.
In the post-presentation discussion, Metz explained that the hypopigmentation appears to start around the hair follicle and is diffuse, so tends to look like vitiligo.
He suggested that the melanocytes around the hair follicle “seem to be the ones that are more stressed, maybe because of the hair follicle cycling,” adding that the effect is reversible and does not appear to be dose dependent.
The study was funded by Celldex Therapeutics. Metz declared relationships with AbbVie, ALK-Abelló, Almirall, Amgen, argenx, AstraZeneca, Astria, Attovia Therapeutics, Celldex, Celltrion, Escient Pharmaceuticals, Galen, Galderma, GSK, Incyte, Jasper, Lilly, Novartis, Pfizer, Pharvaris, Regeneron, Sanofi, Teva, Third Harmonic Bio, and Vifor.
A version of this article first appeared on Medscape.com.
Moreover, in the study, barzolvolimab, an anti-KIT monoclonal antibody that inhibits the activation of and depletes mast cells, induced comparable responses in a subset of patients who had taken omalizumab, an anti–immunoglobulin E monoclonal antibody approved by the Food and Drug Administration for treating CSU.
The findings were presented at the annual European Academy of Dermatology and Venereology (EADV) 2024 Congress. Barzolvolimab is being developed by Celldex Therapeutics.
“Barzolvolimab treatment resulted in rapid, profound, and durable improvement in UAS7 [weekly Urticaria Activity Score 7],” said presenter Martin Metz, MD, professor of dermatology, Institute of Allergology, Charité – Universitätsmedizin Berlin in Germany, “with a deepening of response over 52 weeks in patients with antihistamine-refractory CSU.”
“Similar robust improvement was seen in patients previously treated with omalizumab, including refractory patients,” he added.
Because barzolvolimab was well tolerated over the course of the follow-up period, Metz said, it “has the potential to be an important new treatment option,” noting that patients are now being enrolled in global phase 3 studies of barzolvolimab.
Sustained Symptom Relief
Ana M. Giménez-Arnau, MD, PhD, associate professor of dermatology, Autonomous University and Pompeu Fabra University, Barcelona, Spain, told Medscape Medical News that the results are important, as they showed people who switched from placebo to the active drug also saw a long-term benefit.
What is “remarkable” about barzolvolimab, continued Giménez-Arnau, who was not involved in the study, is that it is the first drug to target the KIT receptor on mast cells and interfere with stimulating growth factors, thus making the cells that drive the development of CSU “disappear.”
The study included three different barzolvolimab regimens, with the 150-mg dose every 4 weeks and the 300-mg dose every 8 weeks achieving similar results, noted Giménez-Arnau.
For her, there are important questions to answer around the pharmacokinetic and pharmacodynamic profiles of the two regimens that remain, but she underlined that for the patient, the choice of regimen could have an impact on their quality of life.
“If we give 300 mg every 8 weeks,” she said, it appears “you can achieve disease control” while halving the frequency of subcutaneous injections.
She said that it would be “interesting to know” if 300 mg every 8 weeks is given as two 150-mg injections every 2 months or one 300-mg injection. If it is the former, Giménez Arnau said, “This is potentially an important benefit for the patient.”
Sustained Benefits at 1 Year
The study enrolled 208 patients with antihistamine-refractory CSU at sites in 10 countries, randomizing them to one of four arms: Subcutaneous injections of barzolvolimab 75 mg or 150 mg every 4 weeks, 300 mg every 8 weeks, or placebo every 4 weeks.
The mean age in each arm was between 42 and 47 years, and around 75% were women. Across the arms, 64%-76% had severe disease, as measured on the UAS7, at a mean score of 30.0-31.3. Around 20% had previously been treated with omalizumab.
Patients were treated for 16 weeks, during which time they completed daily and weekly diaries and attended six clinic visits at weeks 0, 2, 4, 8, 12, and 16. Results from the trial published earlier this year demonstrated that both the regimens (150 mg every 4 weeks and 300 mg every 8 weeks) achieved clinically meaningful and statistically significant improvement in UAS7, the primary endpoint, vs placebo at 12 weeks.
Participants in the barzolvolimab 75 mg and placebo arms were then randomized to receive barzolvolimab 150 mg every 4 weeks or 300 mg every 8 weeks, and those who had been in the 150-mg and 300-mg treatment arms continued with that treatment for a further 36 weeks. (The remaining patients have been continued on a further 24-week follow-up, but the data are not yet available.)
By the 52-week follow-up, 25% of patients who started in each of the barzolvolimab arms had discontinued treatment, as well as 16% first randomized to the placebo arm.
Metz reported that the improvements in UAS7 scores, observed as early as week 1, were sustained through week 52 in patients in both the ongoing 150-mg and 300-mg arms. Patients who initially started in the placebo and the barzolvolimab 75-mg groups caught up with those who had started on the higher doses, so that by week 52, there were no significant differences in urticaria activity, hives, or itch scores between the arms.
By week 52, the proportion of patients achieving well-controlled disease, defined as a UAS7 score ≤ 6, was 73.7% in the barzolvolimab 150 mg every 4-week arm and 68.2% in the 300 mg barzolvolimab every 8-week arm.
Notably, just 12.8% of patients in the placebo arm had achieved well-controlled CSU by week 16, but after switching to barzolvolimab 150 mg every 4 weeks or 300 mg every 8 weeks, 63% reached that target at week 52.
“Maybe even more striking and very interesting to look at,” said Metz, was the complete control of symptoms, meaning “not one single wheal and no itch.” By week 52, 52% of those on 300 mg every 8 weeks and 71.1% of those on 150 mg every 4 weeks had a complete response, with no itch/hives (UAS7 of 0).
Importantly, complete responses with barzolvolimab were observed early and were sustained or improved to week 52, Metz said, with, again, placebo and former barzolvolimab 75 mg patients catching up with those who started on 150 mg every 4 weeks and 300 mg every 8 weeks once they switched at week 16.
“This is the best data for chronic spontaneous urticaria that we have so far seen,” he said, adding that the responses were seen regardless of prior experience with omalizumab.
Changes in Hair Color, Skin Pigmentation
As for safety, during the first 16 weeks, 66% of those on active treatment and 39% on placebo experienced at least one adverse event. There were no treatment-related serious adverse events, compared with two among those who received treatment for the full 52 weeks.
The most common adverse events with active treatment were hair color changes (14% in the first 16 weeks and 26% among those treated for the full 52 weeks), neutropenia/reduced neutrophil count (9% in the first 16 weeks and 17% among those treated for the full 52 weeks), and skin hypopigmentation (1% in the first 16 weeks, 13% among those treated for the full 52 weeks, and 19% among those who switched from placebo to active treatment at 36 weeks). Urticaria was reported by 10% among patients on active treatment and 10% among those on placebo in the first 16 weeks, and by 15% of those treated for the full 52 weeks.
In the post-presentation discussion, Metz explained that the hypopigmentation appears to start around the hair follicle and is diffuse, so tends to look like vitiligo.
He suggested that the melanocytes around the hair follicle “seem to be the ones that are more stressed, maybe because of the hair follicle cycling,” adding that the effect is reversible and does not appear to be dose dependent.
The study was funded by Celldex Therapeutics. Metz declared relationships with AbbVie, ALK-Abelló, Almirall, Amgen, argenx, AstraZeneca, Astria, Attovia Therapeutics, Celldex, Celltrion, Escient Pharmaceuticals, Galen, Galderma, GSK, Incyte, Jasper, Lilly, Novartis, Pfizer, Pharvaris, Regeneron, Sanofi, Teva, Third Harmonic Bio, and Vifor.
A version of this article first appeared on Medscape.com.
FROM EADV 2024