News

Whether you’re gearing up for an ABIM exam or quarterly check-in test, or just updating your knowledge to provide exceptional care, DDSEP Plus is here to support your educational needs.

Challenge yourself with these practice questions! This is just a sample of the nearly 900 questions available with an annual DDSEP Plus subscription. AGA member trainees receive a discounted subscription.

Purchase a subscription to continue learning.

 

Practice Question #1

A 45-year-old woman diagnosed with irritable bowel syndrome with diarrhea presents to your clinic. Her diarrhea is well controlled with loperamide, but her abdominal pain persists.

Her primary care provider previously prescribed dicyclomine, but this did not improve her abdominal pain symptoms.

What is the next best medication to treat her abdominal pain?

A. Amitriptyline

B. Codeine/acetaminophen

C. Hydrocodone

D. Meloxicam

Correct answer:

A. Amitriptyline

Commentary:

Amitriptyline is a tricyclic antidepressant medication that functions as a central neuromodulator. A systematic review of randomized controlled trials of 6-12 weeks’ duration showed a modest improvement in global symptom relief and abdominal pain in patients with IBS treated with tricyclic anti-depressants. Opioid medications and nonsteroidal anti-inflammatory medications are not recommended to treat abdominal pain in patients with IBS.

Practice Question #2

A 52-year-old man with hypertension and diabetes mellitus type 2 is referred to you for 8 months of troublesome regurgitation and heartburn. He has a body mass index of 29 kg/m².

He had minimal relief with single-dose proton pump inhibitor (PPI) therapy before breakfast and partial response with double-dose PPI therapy taken before breakfast and before dinner. Regurgitation after dinner and at bedtime is his most troublesome symptom.

What is the next best step in management?

A. Counsel on weight management

B. Increase PPI to quadruple dose

C. Perform gastric emptying study

D. Refer for bariatric surgery evaluation

E. Switch PPI to before bedtime

Correct answer:

A. Counsel on weight management

Commentary:

This presentation represents typical symptoms of gastroesophageal reflux disease that are not responsive to an optimized regimen of PPI therapy.

Management of refractory gastroesophageal reflux disease symptoms begins with optimizing lifestyle and weight loss. 

Quadruple-dose PPI therapy has no established role. A gastric emptying study would be recommended if gastroparesis was suspected. 

This patient does not meet criteria for bariatric surgery as his body mass index is less than 30 kg/m². 

PPI therapy optimization with before-meal dosing (30-60 min before breakfast for single-dose therapy and before breakfast and dinner for double-dose therapy) would be the next step after weight management.







 

Whether you’re gearing up for an ABIM exam or quarterly check-in test, or just updating your knowledge to provide exceptional care, DDSEP Plus is here to support your educational needs.

Challenge yourself with these practice questions! This is just a sample of the nearly 900 questions available with an annual DDSEP Plus subscription. AGA member trainees receive a discounted subscription.

Purchase a subscription to continue learning.

 

Practice Question #1

A 45-year-old woman diagnosed with irritable bowel syndrome with diarrhea presents to your clinic. Her diarrhea is well controlled with loperamide, but her abdominal pain persists.

Her primary care provider previously prescribed dicyclomine, but this did not improve her abdominal pain symptoms.

What is the next best medication to treat her abdominal pain?

A. Amitriptyline

B. Codeine/acetaminophen

C. Hydrocodone

D. Meloxicam

Correct answer:

A. Amitriptyline

Commentary:

Amitriptyline is a tricyclic antidepressant medication that functions as a central neuromodulator. A systematic review of randomized controlled trials of 6-12 weeks’ duration showed a modest improvement in global symptom relief and abdominal pain in patients with IBS treated with tricyclic anti-depressants. Opioid medications and nonsteroidal anti-inflammatory medications are not recommended to treat abdominal pain in patients with IBS.

Practice Question #2

A 52-year-old man with hypertension and diabetes mellitus type 2 is referred to you for 8 months of troublesome regurgitation and heartburn. He has a body mass index of 29 kg/m².

He had minimal relief with single-dose proton pump inhibitor (PPI) therapy before breakfast and partial response with double-dose PPI therapy taken before breakfast and before dinner. Regurgitation after dinner and at bedtime is his most troublesome symptom.

What is the next best step in management?

A. Counsel on weight management

B. Increase PPI to quadruple dose

C. Perform gastric emptying study

D. Refer for bariatric surgery evaluation

E. Switch PPI to before bedtime

Correct answer:

A. Counsel on weight management

Commentary:

This presentation represents typical symptoms of gastroesophageal reflux disease that are not responsive to an optimized regimen of PPI therapy.

Management of refractory gastroesophageal reflux disease symptoms begins with optimizing lifestyle and weight loss. 

Quadruple-dose PPI therapy has no established role. A gastric emptying study would be recommended if gastroparesis was suspected. 

This patient does not meet criteria for bariatric surgery as his body mass index is less than 30 kg/m². 

PPI therapy optimization with before-meal dosing (30-60 min before breakfast for single-dose therapy and before breakfast and dinner for double-dose therapy) would be the next step after weight management.







 

Whether you’re gearing up for an ABIM exam or quarterly check-in test, or just updating your knowledge to provide exceptional care, DDSEP Plus is here to support your educational needs.

Challenge yourself with these practice questions! This is just a sample of the nearly 900 questions available with an annual DDSEP Plus subscription. AGA member trainees receive a discounted subscription.

Purchase a subscription to continue learning.

 

Practice Question #1

A 45-year-old woman diagnosed with irritable bowel syndrome with diarrhea presents to your clinic. Her diarrhea is well controlled with loperamide, but her abdominal pain persists.

Her primary care provider previously prescribed dicyclomine, but this did not improve her abdominal pain symptoms.

What is the next best medication to treat her abdominal pain?

A. Amitriptyline

B. Codeine/acetaminophen

C. Hydrocodone

D. Meloxicam

Correct answer:

A. Amitriptyline

Commentary:

Amitriptyline is a tricyclic antidepressant medication that functions as a central neuromodulator. A systematic review of randomized controlled trials of 6-12 weeks’ duration showed a modest improvement in global symptom relief and abdominal pain in patients with IBS treated with tricyclic anti-depressants. Opioid medications and nonsteroidal anti-inflammatory medications are not recommended to treat abdominal pain in patients with IBS.

Practice Question #2

A 52-year-old man with hypertension and diabetes mellitus type 2 is referred to you for 8 months of troublesome regurgitation and heartburn. He has a body mass index of 29 kg/m².

He had minimal relief with single-dose proton pump inhibitor (PPI) therapy before breakfast and partial response with double-dose PPI therapy taken before breakfast and before dinner. Regurgitation after dinner and at bedtime is his most troublesome symptom.

What is the next best step in management?

A. Counsel on weight management

B. Increase PPI to quadruple dose

C. Perform gastric emptying study

D. Refer for bariatric surgery evaluation

E. Switch PPI to before bedtime

Correct answer:

A. Counsel on weight management

Commentary:

This presentation represents typical symptoms of gastroesophageal reflux disease that are not responsive to an optimized regimen of PPI therapy.

Management of refractory gastroesophageal reflux disease symptoms begins with optimizing lifestyle and weight loss. 

Quadruple-dose PPI therapy has no established role. A gastric emptying study would be recommended if gastroparesis was suspected. 

This patient does not meet criteria for bariatric surgery as his body mass index is less than 30 kg/m². 

PPI therapy optimization with before-meal dosing (30-60 min before breakfast for single-dose therapy and before breakfast and dinner for double-dose therapy) would be the next step after weight management.







 

SAN DIEGO — The prevalence of and number of deaths from alcohol-associated liver disease (ALD) and alcohol use disorder (AUD) are growing among people age 70 and older in the United States, according to the results of a new study.

Even as mortality rates decline globally, AUD deaths rose in the United States, increasing 1.63% per year between 2010 and 2019. Deaths from cirrhosis increased by 0.56% each year, and deaths from primary liver cancer associated with alcohol increased by 3.09% per year.

Several factors, such as an aging US population and increasing alcohol consumption, play a major role in the uptick in mortality, said lead author Pojsakorn Danpanichkul, MD, an internal medicine resident at Texas Tech University Health Sciences Center, Lubbock, who presented the findings at The Liver Meeting 2024: American Association for the Study of Liver Diseases (AASLD).

“Healthcare providers should increase screening for alcohol use among older adults and consider the added risks of alcohol consumption. Public health strategies should target alcohol prevention and treatment programs tailored to older adults,” he said.

“Older adults are more vulnerable to the harmful effects of alcohol due to natural declines in liver function and metabolism, leading to a higher risk of liver disease and complications,” he explained. However, “little research has focused on this issue.”

 

Trends in US Not Seen Globally

Danpanichkul and colleagues analyzed data from the Global Burden of Disease Study for 2010-2019, calculating the annual percent change for the burden of AUD, ALD, and liver cancer from alcohol in patients age 70 and older. The research team then compared data in the United States to global estimates for these same diseases.

In 2019, there were 556,340 cases of AUD, 112,560 cases of ALD, and 3720 cases of liver cancer from alcohol in older adults in the United States. In addition, there were 1750 deaths attributed to AUD, 4860 deaths from ALD, and 3010 deaths caused by primary liver cancer from alcohol.

The age-standardized prevalence rates (ASPRs) per 100,000 people were 1547 cases of AUD, 313 cases of ALD, and 10 cases of primary liver cancer caused by alcohol.

The age-standardized death rates (ASDRs) per 100,000 people were 4.88 for AUD, 13.52 for ALD, and 8.38 for primary liver cancer.

During the time period studied, upward trends occurred in the United States, with annual ASPRs increasing by 2.52% for AUD, 1.78% for ALD, and 3.31% for primary liver cancer due to alcohol. Globally, the trends were lower, with annual increases of 0.2% for AUD, 0.38% for ALD, and 0.67% for primary liver cancer from alcohol.

During the same time, ASDRs also increased in all three categories in the United States, while global trends showed a 0.91% decline in AUD deaths and 0.6% decline in ALD deaths. Liver cancer deaths, however, increased by 0.3% worldwide.

Targeted strategies are essential to reduce this growing health burden, especially in an aging population, Danpanichkul said. “These interventions should focus on early detection, intervention, and management for individuals at risk or already affected by ALD and AUD.”

Future studies should investigate alcohol consumption and mortality trends in other age groups, including by sex, location (such as state or territory), and race and ethnicity, he said. Data for more recent years would be compelling as well.

 

Increased Alcohol Use During and After Pandemic

Numerous studies have indicated that alcohol use increased in 2020 during the COVID-19 pandemic and has remained elevated since then. 

In a study published in the Annals of Internal Medicine, for instance, alcohol use per 100 people increased 2.69% in 2020 and 2.96% in 2022, as compared with 2018. Increases occurred across all subgroups, including age, sex, race, ethnicity, and US region.

“During the COVID-19 pandemic, many people stayed at home, watched the television, and increased their alcohol intake” — in the United States and also in Japan — said Hisanori Muto, MD, senior assistant professor of gastroenterology at Fujita Health University in Nagoya, Japan, who wasn’t involved with this study.

“Although the global numbers may appear lower, we’re also seeing an increase in AUD and ALD in Japan, similar to the United States,” he said. “It’s very important to watch these trends and address these diseases.”

Danpanichkul and Muto reported no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — The prevalence of and number of deaths from alcohol-associated liver disease (ALD) and alcohol use disorder (AUD) are growing among people age 70 and older in the United States, according to the results of a new study.

Even as mortality rates decline globally, AUD deaths rose in the United States, increasing 1.63% per year between 2010 and 2019. Deaths from cirrhosis increased by 0.56% each year, and deaths from primary liver cancer associated with alcohol increased by 3.09% per year.

Several factors, such as an aging US population and increasing alcohol consumption, play a major role in the uptick in mortality, said lead author Pojsakorn Danpanichkul, MD, an internal medicine resident at Texas Tech University Health Sciences Center, Lubbock, who presented the findings at The Liver Meeting 2024: American Association for the Study of Liver Diseases (AASLD).

“Healthcare providers should increase screening for alcohol use among older adults and consider the added risks of alcohol consumption. Public health strategies should target alcohol prevention and treatment programs tailored to older adults,” he said.

“Older adults are more vulnerable to the harmful effects of alcohol due to natural declines in liver function and metabolism, leading to a higher risk of liver disease and complications,” he explained. However, “little research has focused on this issue.”

 

Trends in US Not Seen Globally

Danpanichkul and colleagues analyzed data from the Global Burden of Disease Study for 2010-2019, calculating the annual percent change for the burden of AUD, ALD, and liver cancer from alcohol in patients age 70 and older. The research team then compared data in the United States to global estimates for these same diseases.

In 2019, there were 556,340 cases of AUD, 112,560 cases of ALD, and 3720 cases of liver cancer from alcohol in older adults in the United States. In addition, there were 1750 deaths attributed to AUD, 4860 deaths from ALD, and 3010 deaths caused by primary liver cancer from alcohol.

The age-standardized prevalence rates (ASPRs) per 100,000 people were 1547 cases of AUD, 313 cases of ALD, and 10 cases of primary liver cancer caused by alcohol.

The age-standardized death rates (ASDRs) per 100,000 people were 4.88 for AUD, 13.52 for ALD, and 8.38 for primary liver cancer.

During the time period studied, upward trends occurred in the United States, with annual ASPRs increasing by 2.52% for AUD, 1.78% for ALD, and 3.31% for primary liver cancer due to alcohol. Globally, the trends were lower, with annual increases of 0.2% for AUD, 0.38% for ALD, and 0.67% for primary liver cancer from alcohol.

During the same time, ASDRs also increased in all three categories in the United States, while global trends showed a 0.91% decline in AUD deaths and 0.6% decline in ALD deaths. Liver cancer deaths, however, increased by 0.3% worldwide.

Targeted strategies are essential to reduce this growing health burden, especially in an aging population, Danpanichkul said. “These interventions should focus on early detection, intervention, and management for individuals at risk or already affected by ALD and AUD.”

Future studies should investigate alcohol consumption and mortality trends in other age groups, including by sex, location (such as state or territory), and race and ethnicity, he said. Data for more recent years would be compelling as well.

 

Increased Alcohol Use During and After Pandemic

Numerous studies have indicated that alcohol use increased in 2020 during the COVID-19 pandemic and has remained elevated since then. 

In a study published in the Annals of Internal Medicine, for instance, alcohol use per 100 people increased 2.69% in 2020 and 2.96% in 2022, as compared with 2018. Increases occurred across all subgroups, including age, sex, race, ethnicity, and US region.

“During the COVID-19 pandemic, many people stayed at home, watched the television, and increased their alcohol intake” — in the United States and also in Japan — said Hisanori Muto, MD, senior assistant professor of gastroenterology at Fujita Health University in Nagoya, Japan, who wasn’t involved with this study.

“Although the global numbers may appear lower, we’re also seeing an increase in AUD and ALD in Japan, similar to the United States,” he said. “It’s very important to watch these trends and address these diseases.”

Danpanichkul and Muto reported no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — The prevalence of and number of deaths from alcohol-associated liver disease (ALD) and alcohol use disorder (AUD) are growing among people age 70 and older in the United States, according to the results of a new study.

Even as mortality rates decline globally, AUD deaths rose in the United States, increasing 1.63% per year between 2010 and 2019. Deaths from cirrhosis increased by 0.56% each year, and deaths from primary liver cancer associated with alcohol increased by 3.09% per year.

Several factors, such as an aging US population and increasing alcohol consumption, play a major role in the uptick in mortality, said lead author Pojsakorn Danpanichkul, MD, an internal medicine resident at Texas Tech University Health Sciences Center, Lubbock, who presented the findings at The Liver Meeting 2024: American Association for the Study of Liver Diseases (AASLD).

“Healthcare providers should increase screening for alcohol use among older adults and consider the added risks of alcohol consumption. Public health strategies should target alcohol prevention and treatment programs tailored to older adults,” he said.

“Older adults are more vulnerable to the harmful effects of alcohol due to natural declines in liver function and metabolism, leading to a higher risk of liver disease and complications,” he explained. However, “little research has focused on this issue.”

 

Trends in US Not Seen Globally

Danpanichkul and colleagues analyzed data from the Global Burden of Disease Study for 2010-2019, calculating the annual percent change for the burden of AUD, ALD, and liver cancer from alcohol in patients age 70 and older. The research team then compared data in the United States to global estimates for these same diseases.

In 2019, there were 556,340 cases of AUD, 112,560 cases of ALD, and 3720 cases of liver cancer from alcohol in older adults in the United States. In addition, there were 1750 deaths attributed to AUD, 4860 deaths from ALD, and 3010 deaths caused by primary liver cancer from alcohol.

The age-standardized prevalence rates (ASPRs) per 100,000 people were 1547 cases of AUD, 313 cases of ALD, and 10 cases of primary liver cancer caused by alcohol.

The age-standardized death rates (ASDRs) per 100,000 people were 4.88 for AUD, 13.52 for ALD, and 8.38 for primary liver cancer.

During the time period studied, upward trends occurred in the United States, with annual ASPRs increasing by 2.52% for AUD, 1.78% for ALD, and 3.31% for primary liver cancer due to alcohol. Globally, the trends were lower, with annual increases of 0.2% for AUD, 0.38% for ALD, and 0.67% for primary liver cancer from alcohol.

During the same time, ASDRs also increased in all three categories in the United States, while global trends showed a 0.91% decline in AUD deaths and 0.6% decline in ALD deaths. Liver cancer deaths, however, increased by 0.3% worldwide.

Targeted strategies are essential to reduce this growing health burden, especially in an aging population, Danpanichkul said. “These interventions should focus on early detection, intervention, and management for individuals at risk or already affected by ALD and AUD.”

Future studies should investigate alcohol consumption and mortality trends in other age groups, including by sex, location (such as state or territory), and race and ethnicity, he said. Data for more recent years would be compelling as well.

 

Increased Alcohol Use During and After Pandemic

Numerous studies have indicated that alcohol use increased in 2020 during the COVID-19 pandemic and has remained elevated since then. 

In a study published in the Annals of Internal Medicine, for instance, alcohol use per 100 people increased 2.69% in 2020 and 2.96% in 2022, as compared with 2018. Increases occurred across all subgroups, including age, sex, race, ethnicity, and US region.

“During the COVID-19 pandemic, many people stayed at home, watched the television, and increased their alcohol intake” — in the United States and also in Japan — said Hisanori Muto, MD, senior assistant professor of gastroenterology at Fujita Health University in Nagoya, Japan, who wasn’t involved with this study.

“Although the global numbers may appear lower, we’re also seeing an increase in AUD and ALD in Japan, similar to the United States,” he said. “It’s very important to watch these trends and address these diseases.”

Danpanichkul and Muto reported no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Patients with inflammatory bowel disease (IBD) don’t appear to face an increased risk of major adverse cardiovascular events (MACE) or venous thromboembolism (VTE) when taking Janus kinase inhibitors (JAKi), compared with anti–tumor necrosis factor (TNF) agents, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

In particular, 1.76% of patients taking JAKi and 1.94% of patients taking anti-TNF developed MACE. There also weren’t significant differences when comparing ulcerative colitis with Crohn’s disease, upadacitinib with tofacitinib, or JAKi with infliximab.

“IBD is associated with an increased risk of cardiovascular diseases, and with the emergence of JAK inhibitors and anti-TNF therapies, there is a concern about the increased risk of MACE,” said lead author Saqr Alsakarneh, MD, an internal medicine resident at the University of Missouri–Kansas City School of Medicine.

Previous randomized controlled trials have indicated increased risks of MACE with JAKi and anti-TNF agents, compared with placebo, but researchers haven’t conducted a head-to-head comparison, he said.

“A potential explanation for previous associations could be linked to immune modulation and inflammation that can increase coagulation risk, as well as fluctuation in disease severity while patients are on the medications, which can impact cardiovascular risk factors,” he added.

Alsakarneh and colleagues conducted a retrospective cohort study using the TriNetX database to identify adult patients with IBD who were treated with JAKi or anti-TNF therapy after diagnosis. After matching patients in the JAKi cohort with patients in the anti-TNF cohort, the research team looked for MACE and VTE within a year of medication initiation, as well as associations by age, sex, and IBD type.

Overall, 3740 patients in the JAKi cohort had a mean age of 43.1 and were 48.9% women and 75.3% White individuals, while 3,740 patients in the anti-TNF cohort had a mean age of 43 and were 48.9% women and 75.3% White individuals.

After excluding those with a history of a prior cardiovascular event, 57 patients (1.76%) in the JAKi cohort developed MACE, compared with 63 patients (1.94%) in the anti-TNF cohort. There weren’t significant differences between the groups in MACE (adjusted hazard ratio [aHR], 0.99) or VTE (aHR, 0.9).

Among patients aged ≥ 65, 25 patients (5.3%) in the JAKi cohort developed MACE, as compared with 30 patients (6.4%) in the anti-TNF cohort. There weren’t significant differences between the groups in MACE (aHR, 0.83) or VTE (aHR, 0.77).

In addition, there were no differences when comparing Crohn’s disease with ulcerative colitis for MACE (aHR, 1.69) or VTE (aHR, 0.85); upadacitinib with tofacitinib for MACE (aHR, 1.1) or VTE (aHR, 1.13); or JAKi medications with infliximab for MACE (aHR, 0.85) or VTE (aHR, 0.8).

Patients in the JAKi group were more likely to undergo intestinal resection surgery (aHR, 1.32), but there wasn’t a statistically significant difference in systematic corticosteroid use (aHR, 0.99).

The study limitations included the inability to assess for disease severity, dose-dependent risk for MACE or VTE, or long-term outcomes among the two cohorts, Alsakarneh said. Prospective controlled trials are needed to confirm findings.

 

“This is a wonderful study and nice to see. We presented the same thing at Digestive Disease Week that’s being confirmed in this data,” said Miguel Regueiro, MD, AGAF, chief of Cleveland Clinic’s Digestive Disease Institute in Ohio. Regueiro, who wasn’t involved with the study, attended the conference session.

“Looking ahead, all of us are wondering if the regulatory guidance by the FDA [Food and Drug Administration] is going to change the label so we don’t need to step through a TNF,” he said. “I think we’re seeing study after study showing safety or at least not an increased risk with JAK.”

The study was awarded an ACG Noteworthy Abstract. Alsakarneh and Regueiro reported no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Patients with inflammatory bowel disease (IBD) don’t appear to face an increased risk of major adverse cardiovascular events (MACE) or venous thromboembolism (VTE) when taking Janus kinase inhibitors (JAKi), compared with anti–tumor necrosis factor (TNF) agents, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

In particular, 1.76% of patients taking JAKi and 1.94% of patients taking anti-TNF developed MACE. There also weren’t significant differences when comparing ulcerative colitis with Crohn’s disease, upadacitinib with tofacitinib, or JAKi with infliximab.

“IBD is associated with an increased risk of cardiovascular diseases, and with the emergence of JAK inhibitors and anti-TNF therapies, there is a concern about the increased risk of MACE,” said lead author Saqr Alsakarneh, MD, an internal medicine resident at the University of Missouri–Kansas City School of Medicine.

Previous randomized controlled trials have indicated increased risks of MACE with JAKi and anti-TNF agents, compared with placebo, but researchers haven’t conducted a head-to-head comparison, he said.

“A potential explanation for previous associations could be linked to immune modulation and inflammation that can increase coagulation risk, as well as fluctuation in disease severity while patients are on the medications, which can impact cardiovascular risk factors,” he added.

Alsakarneh and colleagues conducted a retrospective cohort study using the TriNetX database to identify adult patients with IBD who were treated with JAKi or anti-TNF therapy after diagnosis. After matching patients in the JAKi cohort with patients in the anti-TNF cohort, the research team looked for MACE and VTE within a year of medication initiation, as well as associations by age, sex, and IBD type.

Overall, 3740 patients in the JAKi cohort had a mean age of 43.1 and were 48.9% women and 75.3% White individuals, while 3,740 patients in the anti-TNF cohort had a mean age of 43 and were 48.9% women and 75.3% White individuals.

After excluding those with a history of a prior cardiovascular event, 57 patients (1.76%) in the JAKi cohort developed MACE, compared with 63 patients (1.94%) in the anti-TNF cohort. There weren’t significant differences between the groups in MACE (adjusted hazard ratio [aHR], 0.99) or VTE (aHR, 0.9).

Among patients aged ≥ 65, 25 patients (5.3%) in the JAKi cohort developed MACE, as compared with 30 patients (6.4%) in the anti-TNF cohort. There weren’t significant differences between the groups in MACE (aHR, 0.83) or VTE (aHR, 0.77).

In addition, there were no differences when comparing Crohn’s disease with ulcerative colitis for MACE (aHR, 1.69) or VTE (aHR, 0.85); upadacitinib with tofacitinib for MACE (aHR, 1.1) or VTE (aHR, 1.13); or JAKi medications with infliximab for MACE (aHR, 0.85) or VTE (aHR, 0.8).

Patients in the JAKi group were more likely to undergo intestinal resection surgery (aHR, 1.32), but there wasn’t a statistically significant difference in systematic corticosteroid use (aHR, 0.99).

The study limitations included the inability to assess for disease severity, dose-dependent risk for MACE or VTE, or long-term outcomes among the two cohorts, Alsakarneh said. Prospective controlled trials are needed to confirm findings.

 

“This is a wonderful study and nice to see. We presented the same thing at Digestive Disease Week that’s being confirmed in this data,” said Miguel Regueiro, MD, AGAF, chief of Cleveland Clinic’s Digestive Disease Institute in Ohio. Regueiro, who wasn’t involved with the study, attended the conference session.

“Looking ahead, all of us are wondering if the regulatory guidance by the FDA [Food and Drug Administration] is going to change the label so we don’t need to step through a TNF,” he said. “I think we’re seeing study after study showing safety or at least not an increased risk with JAK.”

The study was awarded an ACG Noteworthy Abstract. Alsakarneh and Regueiro reported no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Patients with inflammatory bowel disease (IBD) don’t appear to face an increased risk of major adverse cardiovascular events (MACE) or venous thromboembolism (VTE) when taking Janus kinase inhibitors (JAKi), compared with anti–tumor necrosis factor (TNF) agents, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

In particular, 1.76% of patients taking JAKi and 1.94% of patients taking anti-TNF developed MACE. There also weren’t significant differences when comparing ulcerative colitis with Crohn’s disease, upadacitinib with tofacitinib, or JAKi with infliximab.

“IBD is associated with an increased risk of cardiovascular diseases, and with the emergence of JAK inhibitors and anti-TNF therapies, there is a concern about the increased risk of MACE,” said lead author Saqr Alsakarneh, MD, an internal medicine resident at the University of Missouri–Kansas City School of Medicine.

Previous randomized controlled trials have indicated increased risks of MACE with JAKi and anti-TNF agents, compared with placebo, but researchers haven’t conducted a head-to-head comparison, he said.

“A potential explanation for previous associations could be linked to immune modulation and inflammation that can increase coagulation risk, as well as fluctuation in disease severity while patients are on the medications, which can impact cardiovascular risk factors,” he added.

Alsakarneh and colleagues conducted a retrospective cohort study using the TriNetX database to identify adult patients with IBD who were treated with JAKi or anti-TNF therapy after diagnosis. After matching patients in the JAKi cohort with patients in the anti-TNF cohort, the research team looked for MACE and VTE within a year of medication initiation, as well as associations by age, sex, and IBD type.

Overall, 3740 patients in the JAKi cohort had a mean age of 43.1 and were 48.9% women and 75.3% White individuals, while 3,740 patients in the anti-TNF cohort had a mean age of 43 and were 48.9% women and 75.3% White individuals.

After excluding those with a history of a prior cardiovascular event, 57 patients (1.76%) in the JAKi cohort developed MACE, compared with 63 patients (1.94%) in the anti-TNF cohort. There weren’t significant differences between the groups in MACE (adjusted hazard ratio [aHR], 0.99) or VTE (aHR, 0.9).

Among patients aged ≥ 65, 25 patients (5.3%) in the JAKi cohort developed MACE, as compared with 30 patients (6.4%) in the anti-TNF cohort. There weren’t significant differences between the groups in MACE (aHR, 0.83) or VTE (aHR, 0.77).

In addition, there were no differences when comparing Crohn’s disease with ulcerative colitis for MACE (aHR, 1.69) or VTE (aHR, 0.85); upadacitinib with tofacitinib for MACE (aHR, 1.1) or VTE (aHR, 1.13); or JAKi medications with infliximab for MACE (aHR, 0.85) or VTE (aHR, 0.8).

Patients in the JAKi group were more likely to undergo intestinal resection surgery (aHR, 1.32), but there wasn’t a statistically significant difference in systematic corticosteroid use (aHR, 0.99).

The study limitations included the inability to assess for disease severity, dose-dependent risk for MACE or VTE, or long-term outcomes among the two cohorts, Alsakarneh said. Prospective controlled trials are needed to confirm findings.

 

“This is a wonderful study and nice to see. We presented the same thing at Digestive Disease Week that’s being confirmed in this data,” said Miguel Regueiro, MD, AGAF, chief of Cleveland Clinic’s Digestive Disease Institute in Ohio. Regueiro, who wasn’t involved with the study, attended the conference session.

“Looking ahead, all of us are wondering if the regulatory guidance by the FDA [Food and Drug Administration] is going to change the label so we don’t need to step through a TNF,” he said. “I think we’re seeing study after study showing safety or at least not an increased risk with JAK.”

The study was awarded an ACG Noteworthy Abstract. Alsakarneh and Regueiro reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Muvalaplin, a novel oral medication, safely and effectively lowers high levels of lipoprotein(a), or Lp(a), results from the phase 2 KRAKEN trial show.

Concentrations of Lp(a) cholesterol are genetically determined and remain steady throughout life. Levels of 125 nmol/L or higher promote clotting and inflammation, significantly increasing the risk for heart attack, stroke, aortic stenosis, and peripheral artery disease. This affects about 20% of the population, particularly people of Black African and South Asian descent.

There are currently no approved therapies that lower Lp(a), said study author Stephen Nicholls, MBBS, PhD, director of the Victorian Heart Institute at Monash University in Melbourne, Australia. Several injectable therapies are currently in clinical trials, but muvalaplin is the only oral option. The new drug lowers Lp(a) levels by disrupting the bond between the two parts of the Lp(a) particle.

 

The KRAKEN Trial

In the KRAKEN trial, 233 adults from around the world with very high Lp(a) levels (> 175 nmol/L) were randomized either to one of three daily doses of muvalaplin — 10, 60, or 240 mg — or to placebo for 12 weeks.

The researchers measured Lp(a) levels with a standard blood test and with a novel test designed to specifically measure levels of intact Lp(a) particles in the blood. In addition to Lp(a), the standard test detects one of its components, apolipoprotein A particles, that are bound to the drug, which can lead to an underestimation of Lp(a) reductions.

Lp(a) levels were up to 70.0% lower in the muvalaplin group than in the placebo group when measured with the traditional blood test and by up to 85.5% lower when measured with the new test. Approximately 82% of participants achieved an Lp(a) level lower than 125 nmol/L when measured with the traditional blood test, and 97% achieved that level when the new test was used. Patients who received either 60 or 240 mg of muvalaplin had similar reductions in Lp(a) levels, which were greater than the reductions seen in the 10 mg group. The drug was safe and generally well tolerated.

“This is a very reassuring phase 2 result,” Nicholls said when he presented the KRAKEN findings at the American Heart Association (AHA) Scientific Sessions 2024 in Chicago, which were simultaneously published online in JAMA. “It encourages the ongoing development of this agent.”

Lp(a) levels are not affected by changes in lifestyle or diet or by traditional lipid-lowering treatments like statins, said Erin Michos, MD, a cardiologist at the Johns Hopkins University School of Medicine in Baltimore, Maryland, who was not involved in the study.

And high Lp(a) levels confer significant cardiovascular risk even when other risks are reduced. So muvalaplin is “a highly promising approach to treat a previously untreatable disorder,” she explained.

Larger and longer studies, with more diverse patient populations, are needed to confirm the results and to determine whether reducing Lp(a) also improves cardiovascular outcomes, Michos pointed out.

“While muvalaplin appears to be an effective approach to lowering Lp(a) levels, we still need to study whether Lp(a) lowering will result in fewer heart attacks and strokes,” Nicholls added.

A version of this article appeared on Medscape.com.

Muvalaplin, a novel oral medication, safely and effectively lowers high levels of lipoprotein(a), or Lp(a), results from the phase 2 KRAKEN trial show.

Concentrations of Lp(a) cholesterol are genetically determined and remain steady throughout life. Levels of 125 nmol/L or higher promote clotting and inflammation, significantly increasing the risk for heart attack, stroke, aortic stenosis, and peripheral artery disease. This affects about 20% of the population, particularly people of Black African and South Asian descent.

There are currently no approved therapies that lower Lp(a), said study author Stephen Nicholls, MBBS, PhD, director of the Victorian Heart Institute at Monash University in Melbourne, Australia. Several injectable therapies are currently in clinical trials, but muvalaplin is the only oral option. The new drug lowers Lp(a) levels by disrupting the bond between the two parts of the Lp(a) particle.

 

The KRAKEN Trial

In the KRAKEN trial, 233 adults from around the world with very high Lp(a) levels (> 175 nmol/L) were randomized either to one of three daily doses of muvalaplin — 10, 60, or 240 mg — or to placebo for 12 weeks.

The researchers measured Lp(a) levels with a standard blood test and with a novel test designed to specifically measure levels of intact Lp(a) particles in the blood. In addition to Lp(a), the standard test detects one of its components, apolipoprotein A particles, that are bound to the drug, which can lead to an underestimation of Lp(a) reductions.

Lp(a) levels were up to 70.0% lower in the muvalaplin group than in the placebo group when measured with the traditional blood test and by up to 85.5% lower when measured with the new test. Approximately 82% of participants achieved an Lp(a) level lower than 125 nmol/L when measured with the traditional blood test, and 97% achieved that level when the new test was used. Patients who received either 60 or 240 mg of muvalaplin had similar reductions in Lp(a) levels, which were greater than the reductions seen in the 10 mg group. The drug was safe and generally well tolerated.

“This is a very reassuring phase 2 result,” Nicholls said when he presented the KRAKEN findings at the American Heart Association (AHA) Scientific Sessions 2024 in Chicago, which were simultaneously published online in JAMA. “It encourages the ongoing development of this agent.”

Lp(a) levels are not affected by changes in lifestyle or diet or by traditional lipid-lowering treatments like statins, said Erin Michos, MD, a cardiologist at the Johns Hopkins University School of Medicine in Baltimore, Maryland, who was not involved in the study.

And high Lp(a) levels confer significant cardiovascular risk even when other risks are reduced. So muvalaplin is “a highly promising approach to treat a previously untreatable disorder,” she explained.

Larger and longer studies, with more diverse patient populations, are needed to confirm the results and to determine whether reducing Lp(a) also improves cardiovascular outcomes, Michos pointed out.

“While muvalaplin appears to be an effective approach to lowering Lp(a) levels, we still need to study whether Lp(a) lowering will result in fewer heart attacks and strokes,” Nicholls added.

A version of this article appeared on Medscape.com.

Muvalaplin, a novel oral medication, safely and effectively lowers high levels of lipoprotein(a), or Lp(a), results from the phase 2 KRAKEN trial show.

Concentrations of Lp(a) cholesterol are genetically determined and remain steady throughout life. Levels of 125 nmol/L or higher promote clotting and inflammation, significantly increasing the risk for heart attack, stroke, aortic stenosis, and peripheral artery disease. This affects about 20% of the population, particularly people of Black African and South Asian descent.

There are currently no approved therapies that lower Lp(a), said study author Stephen Nicholls, MBBS, PhD, director of the Victorian Heart Institute at Monash University in Melbourne, Australia. Several injectable therapies are currently in clinical trials, but muvalaplin is the only oral option. The new drug lowers Lp(a) levels by disrupting the bond between the two parts of the Lp(a) particle.

 

The KRAKEN Trial

In the KRAKEN trial, 233 adults from around the world with very high Lp(a) levels (> 175 nmol/L) were randomized either to one of three daily doses of muvalaplin — 10, 60, or 240 mg — or to placebo for 12 weeks.

The researchers measured Lp(a) levels with a standard blood test and with a novel test designed to specifically measure levels of intact Lp(a) particles in the blood. In addition to Lp(a), the standard test detects one of its components, apolipoprotein A particles, that are bound to the drug, which can lead to an underestimation of Lp(a) reductions.

Lp(a) levels were up to 70.0% lower in the muvalaplin group than in the placebo group when measured with the traditional blood test and by up to 85.5% lower when measured with the new test. Approximately 82% of participants achieved an Lp(a) level lower than 125 nmol/L when measured with the traditional blood test, and 97% achieved that level when the new test was used. Patients who received either 60 or 240 mg of muvalaplin had similar reductions in Lp(a) levels, which were greater than the reductions seen in the 10 mg group. The drug was safe and generally well tolerated.

“This is a very reassuring phase 2 result,” Nicholls said when he presented the KRAKEN findings at the American Heart Association (AHA) Scientific Sessions 2024 in Chicago, which were simultaneously published online in JAMA. “It encourages the ongoing development of this agent.”

Lp(a) levels are not affected by changes in lifestyle or diet or by traditional lipid-lowering treatments like statins, said Erin Michos, MD, a cardiologist at the Johns Hopkins University School of Medicine in Baltimore, Maryland, who was not involved in the study.

And high Lp(a) levels confer significant cardiovascular risk even when other risks are reduced. So muvalaplin is “a highly promising approach to treat a previously untreatable disorder,” she explained.

Larger and longer studies, with more diverse patient populations, are needed to confirm the results and to determine whether reducing Lp(a) also improves cardiovascular outcomes, Michos pointed out.

“While muvalaplin appears to be an effective approach to lowering Lp(a) levels, we still need to study whether Lp(a) lowering will result in fewer heart attacks and strokes,” Nicholls added.

A version of this article appeared on Medscape.com.

TOPLINE:

Light-intensity walking reduces postprandial glucose and diastolic blood pressure in young adults with obesity and can improve insulin levels, depending on the walking pattern.

METHODOLOGY:

• Researchers conducted a randomized crossover trial with 16 young adults aged 18-34 years with body mass index (BMI) ≥ 25 in Bangkok, Thailand, to examine the effects of different light-intensity walking patterns on postprandial cardiometabolic responses.
• Participants (mean age, 25; mean BMI, 29.8) engaged in four 7-hour experimental conditions, each involving a different activity: Uninterrupted sitting, 30-minutes of light-intensity walking, 3-minute light-intensity walking every 30 minutes, or a combination of both walking regimens. There was a 7- to 20-day washout period between each experiment period.
• Baseline and 6-hour postprandial concentrations of glucose, insulin, triglycerides, and blood pressure were measured.
• Incremental areas under the curve (iAUC) for each outcome and average blood pressure were compared between sitting and walking conditions.

TAKEAWAY:

• All the walking interventions reduced postprandial glucose concentrations and diastolic blood pressure compared with uninterrupted sitting.
• Continuous 30-minute light-intensity walking alone or combined with brief 3-minute bouts also attenuated postprandial insulin concentrations.
• No significant differences were found for triglycerides iAUC and systolic blood pressure between the four experiment conditions.

IN PRACTICE:

“These findings support the notion that engaging in light-intensity walking, regardless of the pattern, provides benefits to glycemic control. Moreover, the timing and patterns of light-intensity physical activity may be an important factor in reducing postprandial insulin concentrations,” the authors wrote.

SOURCE:

The study, led by Waris Wongpipit, PhD, Division of Health and Physical Education, Chulalongkorn University in Bangkok, Thailand, was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study’s small sample size of 16 participants may limit the generalizability of the findings. The short duration of the study (7-hour experimental conditions) may not reflect long-term effects. The prescribed activities and dietary profiles, along with the controlled laboratory setting, may not accurately represent real-world conditions. The lack of objective physical activity/sedentary behavior measurement to confirm compliance between conditions is a limitation.

DISCLOSURES:

This study was supported by grants from the Office of the Permanent Secretary, Ministry of Higher Education, Science, Research and Innovation, Thailand Science Research and Innovation, and Chulalongkorn University. Wongpipit received grant support from these organizations. Paddy C. Dempsey is supported by a National Health and Medical Research Council of Australia research fellowship. The other authors had no disclosures.

 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Light-intensity walking reduces postprandial glucose and diastolic blood pressure in young adults with obesity and can improve insulin levels, depending on the walking pattern.

METHODOLOGY:

• Researchers conducted a randomized crossover trial with 16 young adults aged 18-34 years with body mass index (BMI) ≥ 25 in Bangkok, Thailand, to examine the effects of different light-intensity walking patterns on postprandial cardiometabolic responses.
• Participants (mean age, 25; mean BMI, 29.8) engaged in four 7-hour experimental conditions, each involving a different activity: Uninterrupted sitting, 30-minutes of light-intensity walking, 3-minute light-intensity walking every 30 minutes, or a combination of both walking regimens. There was a 7- to 20-day washout period between each experiment period.
• Baseline and 6-hour postprandial concentrations of glucose, insulin, triglycerides, and blood pressure were measured.
• Incremental areas under the curve (iAUC) for each outcome and average blood pressure were compared between sitting and walking conditions.

TAKEAWAY:

• All the walking interventions reduced postprandial glucose concentrations and diastolic blood pressure compared with uninterrupted sitting.
• Continuous 30-minute light-intensity walking alone or combined with brief 3-minute bouts also attenuated postprandial insulin concentrations.
• No significant differences were found for triglycerides iAUC and systolic blood pressure between the four experiment conditions.

IN PRACTICE:

“These findings support the notion that engaging in light-intensity walking, regardless of the pattern, provides benefits to glycemic control. Moreover, the timing and patterns of light-intensity physical activity may be an important factor in reducing postprandial insulin concentrations,” the authors wrote.

SOURCE:

The study, led by Waris Wongpipit, PhD, Division of Health and Physical Education, Chulalongkorn University in Bangkok, Thailand, was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study’s small sample size of 16 participants may limit the generalizability of the findings. The short duration of the study (7-hour experimental conditions) may not reflect long-term effects. The prescribed activities and dietary profiles, along with the controlled laboratory setting, may not accurately represent real-world conditions. The lack of objective physical activity/sedentary behavior measurement to confirm compliance between conditions is a limitation.

DISCLOSURES:

This study was supported by grants from the Office of the Permanent Secretary, Ministry of Higher Education, Science, Research and Innovation, Thailand Science Research and Innovation, and Chulalongkorn University. Wongpipit received grant support from these organizations. Paddy C. Dempsey is supported by a National Health and Medical Research Council of Australia research fellowship. The other authors had no disclosures.

 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Light-intensity walking reduces postprandial glucose and diastolic blood pressure in young adults with obesity and can improve insulin levels, depending on the walking pattern.

METHODOLOGY:

• Researchers conducted a randomized crossover trial with 16 young adults aged 18-34 years with body mass index (BMI) ≥ 25 in Bangkok, Thailand, to examine the effects of different light-intensity walking patterns on postprandial cardiometabolic responses.
• Participants (mean age, 25; mean BMI, 29.8) engaged in four 7-hour experimental conditions, each involving a different activity: Uninterrupted sitting, 30-minutes of light-intensity walking, 3-minute light-intensity walking every 30 minutes, or a combination of both walking regimens. There was a 7- to 20-day washout period between each experiment period.
• Baseline and 6-hour postprandial concentrations of glucose, insulin, triglycerides, and blood pressure were measured.
• Incremental areas under the curve (iAUC) for each outcome and average blood pressure were compared between sitting and walking conditions.

TAKEAWAY:

• All the walking interventions reduced postprandial glucose concentrations and diastolic blood pressure compared with uninterrupted sitting.
• Continuous 30-minute light-intensity walking alone or combined with brief 3-minute bouts also attenuated postprandial insulin concentrations.
• No significant differences were found for triglycerides iAUC and systolic blood pressure between the four experiment conditions.

IN PRACTICE:

“These findings support the notion that engaging in light-intensity walking, regardless of the pattern, provides benefits to glycemic control. Moreover, the timing and patterns of light-intensity physical activity may be an important factor in reducing postprandial insulin concentrations,” the authors wrote.

SOURCE:

The study, led by Waris Wongpipit, PhD, Division of Health and Physical Education, Chulalongkorn University in Bangkok, Thailand, was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study’s small sample size of 16 participants may limit the generalizability of the findings. The short duration of the study (7-hour experimental conditions) may not reflect long-term effects. The prescribed activities and dietary profiles, along with the controlled laboratory setting, may not accurately represent real-world conditions. The lack of objective physical activity/sedentary behavior measurement to confirm compliance between conditions is a limitation.

DISCLOSURES:

This study was supported by grants from the Office of the Permanent Secretary, Ministry of Higher Education, Science, Research and Innovation, Thailand Science Research and Innovation, and Chulalongkorn University. Wongpipit received grant support from these organizations. Paddy C. Dempsey is supported by a National Health and Medical Research Council of Australia research fellowship. The other authors had no disclosures.

 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Replacing animal-based protein sources with plant-based alternatives in older adults reduced both the quality and quantity of protein intake only when all animal-based foods were eliminated for a vegan scenario, finds a simulation study that suggests a switch to 60% plant-based protein seems to be safe.

METHODOLOGY:

• For environmental and health reasons, the Dutch Health Council advises a switch to an animal-based to plant-based protein ratio of 40:60, but older adults also need adequate protein intake to prevent muscle loss and maintain health, and it’s uncertain if they can meet their protein requirements through a more sustainable diet.
• This simulation study evaluated the impact of more sustainable eating patterns on protein quantity and quality by using data of 607 community-dwelling older adults aged 65-79 years from the Dutch National Food Consumption Survey 2019-2021.
• Data on food consumption were collected via two 24-hour dietary recalls per participant on nonconsecutive days and calculated as three main meals and four in-between moments each day.
• In the simulation, certain food products in the original diet were replaced from a list of similar plant-based alternatives, using a random number generator, to create scenarios for two flexitarian diets (40% and 80% meat and fish were replaced), one pescetarian diet (meat was replaced, but not fish and other animal-based products), one vegetarian diet (meat and fish were replaced, but not other animal-based products), and one vegan diet (fish, meat, and animal-based products were replaced).
• Protein intake was calculated in three ways for each meal moment, including by total protein intake (quantity) and by the proportion of indispensable amino acids that must be eaten together within a limited timeframe (quality).

TAKEAWAY:

• In the reference diet, the total daily plant-based protein intake was 39.0% in men and 37.7% in women, while in the vegetarian scenario, it was 59.1% in men and 54.2% in women.
• In the flexitarian, pescetarian, and vegetarian scenarios, the usable protein intake was comparable; in the vegan scenario, both total protein intake and usable protein intake were lower, leading to nearly 50% less usable protein than in the original diet.
• In the original diet, 7.5% of men and 11.1% of women did not meet the estimated average requirements (EARs) for utilizable protein; in the vegan scenario, 83.3% of both sexes had a protein intake below the EAR.
• The loss in protein intake (quantity) in all scenarios was mainly observed at dinner; the loss in protein quality was greatest at breakfast and lunch, especially in lysine (found in beans or soy milk).

IN PRACTICE:

“Changing protein intake to 60% plant-based protein seems to be safe for older adults in terms of protein intake. In contrast, a vegan pattern was associated with a substantial decline in protein availability, leading to a majority of older adults not reaching the recommended protein levels,” the authors wrote.

SOURCE:

The study was led by Jos W. Borkent, HAN University of Applied Sciences, Nijmegen, the Netherlands. It was published online in The Journal of Nutrition, Health and Aging.

LIMITATIONS:

Study limitations included the use of a simulation model, which may not fully reflect real-life dietary practices. The strict timeframe for assessing protein quality (optimal combinations of indispensible amino acids) within one meal moment may have led to an underestimation of protein availability, especially in the vegan scenario. Additionally, the choice of processed meat replacements in the vegan scenario may not have represented protein sources of the highest quality available. Higher protein quality per meal in the vegan scenario is possible when smart combinations are made in multiple meal components.

DISCLOSURES:

The study was partly funded by a grant from the Taskforce for Applied Research SIA, which is part of the Netherlands Organisation for Scientific Research and financed by the Dutch Ministry of Education, Culture and Science and by a fund of the Dutch Dairy Association. The authors declared that they had no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Replacing animal-based protein sources with plant-based alternatives in older adults reduced both the quality and quantity of protein intake only when all animal-based foods were eliminated for a vegan scenario, finds a simulation study that suggests a switch to 60% plant-based protein seems to be safe.

METHODOLOGY:

• For environmental and health reasons, the Dutch Health Council advises a switch to an animal-based to plant-based protein ratio of 40:60, but older adults also need adequate protein intake to prevent muscle loss and maintain health, and it’s uncertain if they can meet their protein requirements through a more sustainable diet.
• This simulation study evaluated the impact of more sustainable eating patterns on protein quantity and quality by using data of 607 community-dwelling older adults aged 65-79 years from the Dutch National Food Consumption Survey 2019-2021.
• Data on food consumption were collected via two 24-hour dietary recalls per participant on nonconsecutive days and calculated as three main meals and four in-between moments each day.
• In the simulation, certain food products in the original diet were replaced from a list of similar plant-based alternatives, using a random number generator, to create scenarios for two flexitarian diets (40% and 80% meat and fish were replaced), one pescetarian diet (meat was replaced, but not fish and other animal-based products), one vegetarian diet (meat and fish were replaced, but not other animal-based products), and one vegan diet (fish, meat, and animal-based products were replaced).
• Protein intake was calculated in three ways for each meal moment, including by total protein intake (quantity) and by the proportion of indispensable amino acids that must be eaten together within a limited timeframe (quality).

TAKEAWAY:

• In the reference diet, the total daily plant-based protein intake was 39.0% in men and 37.7% in women, while in the vegetarian scenario, it was 59.1% in men and 54.2% in women.
• In the flexitarian, pescetarian, and vegetarian scenarios, the usable protein intake was comparable; in the vegan scenario, both total protein intake and usable protein intake were lower, leading to nearly 50% less usable protein than in the original diet.
• In the original diet, 7.5% of men and 11.1% of women did not meet the estimated average requirements (EARs) for utilizable protein; in the vegan scenario, 83.3% of both sexes had a protein intake below the EAR.
• The loss in protein intake (quantity) in all scenarios was mainly observed at dinner; the loss in protein quality was greatest at breakfast and lunch, especially in lysine (found in beans or soy milk).

IN PRACTICE:

“Changing protein intake to 60% plant-based protein seems to be safe for older adults in terms of protein intake. In contrast, a vegan pattern was associated with a substantial decline in protein availability, leading to a majority of older adults not reaching the recommended protein levels,” the authors wrote.

SOURCE:

The study was led by Jos W. Borkent, HAN University of Applied Sciences, Nijmegen, the Netherlands. It was published online in The Journal of Nutrition, Health and Aging.

LIMITATIONS:

Study limitations included the use of a simulation model, which may not fully reflect real-life dietary practices. The strict timeframe for assessing protein quality (optimal combinations of indispensible amino acids) within one meal moment may have led to an underestimation of protein availability, especially in the vegan scenario. Additionally, the choice of processed meat replacements in the vegan scenario may not have represented protein sources of the highest quality available. Higher protein quality per meal in the vegan scenario is possible when smart combinations are made in multiple meal components.

DISCLOSURES:

The study was partly funded by a grant from the Taskforce for Applied Research SIA, which is part of the Netherlands Organisation for Scientific Research and financed by the Dutch Ministry of Education, Culture and Science and by a fund of the Dutch Dairy Association. The authors declared that they had no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Replacing animal-based protein sources with plant-based alternatives in older adults reduced both the quality and quantity of protein intake only when all animal-based foods were eliminated for a vegan scenario, finds a simulation study that suggests a switch to 60% plant-based protein seems to be safe.

METHODOLOGY:

• For environmental and health reasons, the Dutch Health Council advises a switch to an animal-based to plant-based protein ratio of 40:60, but older adults also need adequate protein intake to prevent muscle loss and maintain health, and it’s uncertain if they can meet their protein requirements through a more sustainable diet.
• This simulation study evaluated the impact of more sustainable eating patterns on protein quantity and quality by using data of 607 community-dwelling older adults aged 65-79 years from the Dutch National Food Consumption Survey 2019-2021.
• Data on food consumption were collected via two 24-hour dietary recalls per participant on nonconsecutive days and calculated as three main meals and four in-between moments each day.
• In the simulation, certain food products in the original diet were replaced from a list of similar plant-based alternatives, using a random number generator, to create scenarios for two flexitarian diets (40% and 80% meat and fish were replaced), one pescetarian diet (meat was replaced, but not fish and other animal-based products), one vegetarian diet (meat and fish were replaced, but not other animal-based products), and one vegan diet (fish, meat, and animal-based products were replaced).
• Protein intake was calculated in three ways for each meal moment, including by total protein intake (quantity) and by the proportion of indispensable amino acids that must be eaten together within a limited timeframe (quality).

TAKEAWAY:

• In the reference diet, the total daily plant-based protein intake was 39.0% in men and 37.7% in women, while in the vegetarian scenario, it was 59.1% in men and 54.2% in women.
• In the flexitarian, pescetarian, and vegetarian scenarios, the usable protein intake was comparable; in the vegan scenario, both total protein intake and usable protein intake were lower, leading to nearly 50% less usable protein than in the original diet.
• In the original diet, 7.5% of men and 11.1% of women did not meet the estimated average requirements (EARs) for utilizable protein; in the vegan scenario, 83.3% of both sexes had a protein intake below the EAR.
• The loss in protein intake (quantity) in all scenarios was mainly observed at dinner; the loss in protein quality was greatest at breakfast and lunch, especially in lysine (found in beans or soy milk).

IN PRACTICE:

“Changing protein intake to 60% plant-based protein seems to be safe for older adults in terms of protein intake. In contrast, a vegan pattern was associated with a substantial decline in protein availability, leading to a majority of older adults not reaching the recommended protein levels,” the authors wrote.

SOURCE:

The study was led by Jos W. Borkent, HAN University of Applied Sciences, Nijmegen, the Netherlands. It was published online in The Journal of Nutrition, Health and Aging.

LIMITATIONS:

Study limitations included the use of a simulation model, which may not fully reflect real-life dietary practices. The strict timeframe for assessing protein quality (optimal combinations of indispensible amino acids) within one meal moment may have led to an underestimation of protein availability, especially in the vegan scenario. Additionally, the choice of processed meat replacements in the vegan scenario may not have represented protein sources of the highest quality available. Higher protein quality per meal in the vegan scenario is possible when smart combinations are made in multiple meal components.

DISCLOSURES:

The study was partly funded by a grant from the Taskforce for Applied Research SIA, which is part of the Netherlands Organisation for Scientific Research and financed by the Dutch Ministry of Education, Culture and Science and by a fund of the Dutch Dairy Association. The authors declared that they had no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

WASHINGTON — A diagnostic test to predict preeclampsia does not effectively rule in or out this pregnancy complication in women with systemic lupus erythematosus (SLE) and proteinuria, according to new research presented at the annual meeting of the American College of Rheumatology (ACR).

“If you have a patient who has proteinuria during pregnancy, I’m not sure we know what to do with this test,” said Megan Clowse, MD, MPH, associate professor of medicine and chief of the Division of Rheumatology and Immunology at Duke University School of Medicine in Durham, North Carolina. She led the research and presented the work.

The results “are probably a step in the right direction to understanding that we need more biochemical markers for differentiating preeclampsia [in this patient population],” Leanna Wise, MD, of the Keck School of Medicine at the University of Southern California, Los Angeles, said in an interview. She comoderated the session where the research was presented. “It exposed that we have a lot of gray areas in which we need to do more research.”

The test is a ratio of two biomarkers that measure spiral artery and placental health: Soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF). In the general population, a sFlt-1/PlGF ratio ≤ 38 effectively rules out the short-term risk for preeclampsia, whereas a ratio ≥ 85 is moderately predictive of preeclampsia. However, it was not known how this test would fare in pregnant women with SLE who are already at a higher risk for the complication.

To answer this question, Clowse and colleagues pulled patient data from an ongoing prospective registry of lupus pregnancies. The analysis included patients with a confirmed SLE diagnosis who had enrolled in the registry prior to 30 weeks’ gestation. All participants had provided a serum sample prior to 16 weeks’ gestation and had singleton pregnancies.

In an extensive chart review, preeclampsia was determined by a roundtable of six experts: Two rheumatologists, two maternal-fetal medicine doctors, and two nephrologists.

The analysis included 79 pregnancies, of which 30% developed preeclampsia. Nearly half (47%) of the participants identified as Black or African American. About 30% had a history of lupus nephritis, and half of these patients had active disease during their pregnancy. About half of the women reported that this was their first pregnancy, and an additional 17% of women reported a prior episode of preeclampsia. Most patients were on aspirin (92%) and hydroxychloroquine (87%), and another 43% were prescribed prednisone and 37% were taking azathioprine.

Researchers assessed whether a low sFlt-1/PlGF ratio (≤ 38) was associated with the absence of preeclampsia at 4- and 8-weeks post–blood draw, as well as during the entire pregnancy. They also tested if a high ratio (≥ 85) was associated with the development of preeclampsia within 4- and 8-weeks post–blood draw and through the entire pregnancy.

Across all pregnancies in the cohort, those with sFlt-1/PlGF ≤ 38 were unlikely to develop preeclampsia at 4 weeks post draw (negative predictive value [NPV], 98%) and 8 weeks post draw (NPV, 96%). Still, 20% of patients with this low ratio went on to develop preeclampsia at some point during their pregnancy.

Similar to the general population, sFlt-1/PlGF ≥ 85 was only moderately predictive of preeclampsia. Over half of all patients with this high ratio developed preeclampsia, but more than 40% did not.

Researchers also stratified patients by urine protein:creatinine ratio (UPCR) at the time of their rheumatology visit, defining proteinuria as a UPCR ≥ 300 mg/g.

In patients without proteinuria (n = 63), a low sFlt-1/PlGF ratio ruled out preeclampsia over the next 8 weeks, but a high sFlt-1/PlGF ratio was not usefully predictive of preeclampsia.

 

Low Ratio to Rule Out Preeclampsia ‘Reassuring’

The high reliability in ruling out preeclampsia in this subset of patients with a low sFlt-1/PlGF ratio is “reassuring,” Wise said, and suggests that these patients are “relatively safe moving forward,” given regular follow-up.

In the small group of patients with proteinuria (n = 16), 44% ultimately developed preeclampsia. One third of patients with sFlt-1/PlGF ≤ 38 developed preeclampsia in 8 weeks, and half experienced preeclampsia at some point during their pregnancy. Among the patients with sFlt-1:PlGF ≥ 85, 56% developed preeclampsia during their pregnancy.

“The negative predictive values are not really great, and the positive predictive values are not really very useful,” Clowse said. For a pregnant patient with proteinuria, “I don’t think that a high [ratio] is going to tell us that she definitely has preeclampsia today or tomorrow. I also am not convinced yet that a low [ratio] tells us that she’s out of the woods. So, I think we definitely need more research on what to do with this test in patients with proteinuria.”

Clowse is a consultant and has received research support/grants from GSK and UCB. She also reported consulting for AstraZeneca. Wise is a consultant for Aurinia Pharmaceuticals and has received honoraria from AstraZeneca, Aurinia Pharmaceuticals, and GSK.

A version of this article first appeared on Medscape.com.

WASHINGTON — A diagnostic test to predict preeclampsia does not effectively rule in or out this pregnancy complication in women with systemic lupus erythematosus (SLE) and proteinuria, according to new research presented at the annual meeting of the American College of Rheumatology (ACR).

“If you have a patient who has proteinuria during pregnancy, I’m not sure we know what to do with this test,” said Megan Clowse, MD, MPH, associate professor of medicine and chief of the Division of Rheumatology and Immunology at Duke University School of Medicine in Durham, North Carolina. She led the research and presented the work.

The results “are probably a step in the right direction to understanding that we need more biochemical markers for differentiating preeclampsia [in this patient population],” Leanna Wise, MD, of the Keck School of Medicine at the University of Southern California, Los Angeles, said in an interview. She comoderated the session where the research was presented. “It exposed that we have a lot of gray areas in which we need to do more research.”

The test is a ratio of two biomarkers that measure spiral artery and placental health: Soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF). In the general population, a sFlt-1/PlGF ratio ≤ 38 effectively rules out the short-term risk for preeclampsia, whereas a ratio ≥ 85 is moderately predictive of preeclampsia. However, it was not known how this test would fare in pregnant women with SLE who are already at a higher risk for the complication.

To answer this question, Clowse and colleagues pulled patient data from an ongoing prospective registry of lupus pregnancies. The analysis included patients with a confirmed SLE diagnosis who had enrolled in the registry prior to 30 weeks’ gestation. All participants had provided a serum sample prior to 16 weeks’ gestation and had singleton pregnancies.

In an extensive chart review, preeclampsia was determined by a roundtable of six experts: Two rheumatologists, two maternal-fetal medicine doctors, and two nephrologists.

The analysis included 79 pregnancies, of which 30% developed preeclampsia. Nearly half (47%) of the participants identified as Black or African American. About 30% had a history of lupus nephritis, and half of these patients had active disease during their pregnancy. About half of the women reported that this was their first pregnancy, and an additional 17% of women reported a prior episode of preeclampsia. Most patients were on aspirin (92%) and hydroxychloroquine (87%), and another 43% were prescribed prednisone and 37% were taking azathioprine.

Researchers assessed whether a low sFlt-1/PlGF ratio (≤ 38) was associated with the absence of preeclampsia at 4- and 8-weeks post–blood draw, as well as during the entire pregnancy. They also tested if a high ratio (≥ 85) was associated with the development of preeclampsia within 4- and 8-weeks post–blood draw and through the entire pregnancy.

Across all pregnancies in the cohort, those with sFlt-1/PlGF ≤ 38 were unlikely to develop preeclampsia at 4 weeks post draw (negative predictive value [NPV], 98%) and 8 weeks post draw (NPV, 96%). Still, 20% of patients with this low ratio went on to develop preeclampsia at some point during their pregnancy.

Similar to the general population, sFlt-1/PlGF ≥ 85 was only moderately predictive of preeclampsia. Over half of all patients with this high ratio developed preeclampsia, but more than 40% did not.

Researchers also stratified patients by urine protein:creatinine ratio (UPCR) at the time of their rheumatology visit, defining proteinuria as a UPCR ≥ 300 mg/g.

In patients without proteinuria (n = 63), a low sFlt-1/PlGF ratio ruled out preeclampsia over the next 8 weeks, but a high sFlt-1/PlGF ratio was not usefully predictive of preeclampsia.

 

Low Ratio to Rule Out Preeclampsia ‘Reassuring’

The high reliability in ruling out preeclampsia in this subset of patients with a low sFlt-1/PlGF ratio is “reassuring,” Wise said, and suggests that these patients are “relatively safe moving forward,” given regular follow-up.

In the small group of patients with proteinuria (n = 16), 44% ultimately developed preeclampsia. One third of patients with sFlt-1/PlGF ≤ 38 developed preeclampsia in 8 weeks, and half experienced preeclampsia at some point during their pregnancy. Among the patients with sFlt-1:PlGF ≥ 85, 56% developed preeclampsia during their pregnancy.

“The negative predictive values are not really great, and the positive predictive values are not really very useful,” Clowse said. For a pregnant patient with proteinuria, “I don’t think that a high [ratio] is going to tell us that she definitely has preeclampsia today or tomorrow. I also am not convinced yet that a low [ratio] tells us that she’s out of the woods. So, I think we definitely need more research on what to do with this test in patients with proteinuria.”

Clowse is a consultant and has received research support/grants from GSK and UCB. She also reported consulting for AstraZeneca. Wise is a consultant for Aurinia Pharmaceuticals and has received honoraria from AstraZeneca, Aurinia Pharmaceuticals, and GSK.

A version of this article first appeared on Medscape.com.

WASHINGTON — A diagnostic test to predict preeclampsia does not effectively rule in or out this pregnancy complication in women with systemic lupus erythematosus (SLE) and proteinuria, according to new research presented at the annual meeting of the American College of Rheumatology (ACR).

“If you have a patient who has proteinuria during pregnancy, I’m not sure we know what to do with this test,” said Megan Clowse, MD, MPH, associate professor of medicine and chief of the Division of Rheumatology and Immunology at Duke University School of Medicine in Durham, North Carolina. She led the research and presented the work.

The results “are probably a step in the right direction to understanding that we need more biochemical markers for differentiating preeclampsia [in this patient population],” Leanna Wise, MD, of the Keck School of Medicine at the University of Southern California, Los Angeles, said in an interview. She comoderated the session where the research was presented. “It exposed that we have a lot of gray areas in which we need to do more research.”

The test is a ratio of two biomarkers that measure spiral artery and placental health: Soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF). In the general population, a sFlt-1/PlGF ratio ≤ 38 effectively rules out the short-term risk for preeclampsia, whereas a ratio ≥ 85 is moderately predictive of preeclampsia. However, it was not known how this test would fare in pregnant women with SLE who are already at a higher risk for the complication.

To answer this question, Clowse and colleagues pulled patient data from an ongoing prospective registry of lupus pregnancies. The analysis included patients with a confirmed SLE diagnosis who had enrolled in the registry prior to 30 weeks’ gestation. All participants had provided a serum sample prior to 16 weeks’ gestation and had singleton pregnancies.

In an extensive chart review, preeclampsia was determined by a roundtable of six experts: Two rheumatologists, two maternal-fetal medicine doctors, and two nephrologists.

The analysis included 79 pregnancies, of which 30% developed preeclampsia. Nearly half (47%) of the participants identified as Black or African American. About 30% had a history of lupus nephritis, and half of these patients had active disease during their pregnancy. About half of the women reported that this was their first pregnancy, and an additional 17% of women reported a prior episode of preeclampsia. Most patients were on aspirin (92%) and hydroxychloroquine (87%), and another 43% were prescribed prednisone and 37% were taking azathioprine.

Researchers assessed whether a low sFlt-1/PlGF ratio (≤ 38) was associated with the absence of preeclampsia at 4- and 8-weeks post–blood draw, as well as during the entire pregnancy. They also tested if a high ratio (≥ 85) was associated with the development of preeclampsia within 4- and 8-weeks post–blood draw and through the entire pregnancy.

Across all pregnancies in the cohort, those with sFlt-1/PlGF ≤ 38 were unlikely to develop preeclampsia at 4 weeks post draw (negative predictive value [NPV], 98%) and 8 weeks post draw (NPV, 96%). Still, 20% of patients with this low ratio went on to develop preeclampsia at some point during their pregnancy.

Similar to the general population, sFlt-1/PlGF ≥ 85 was only moderately predictive of preeclampsia. Over half of all patients with this high ratio developed preeclampsia, but more than 40% did not.

Researchers also stratified patients by urine protein:creatinine ratio (UPCR) at the time of their rheumatology visit, defining proteinuria as a UPCR ≥ 300 mg/g.

In patients without proteinuria (n = 63), a low sFlt-1/PlGF ratio ruled out preeclampsia over the next 8 weeks, but a high sFlt-1/PlGF ratio was not usefully predictive of preeclampsia.

 

Low Ratio to Rule Out Preeclampsia ‘Reassuring’

The high reliability in ruling out preeclampsia in this subset of patients with a low sFlt-1/PlGF ratio is “reassuring,” Wise said, and suggests that these patients are “relatively safe moving forward,” given regular follow-up.

In the small group of patients with proteinuria (n = 16), 44% ultimately developed preeclampsia. One third of patients with sFlt-1/PlGF ≤ 38 developed preeclampsia in 8 weeks, and half experienced preeclampsia at some point during their pregnancy. Among the patients with sFlt-1:PlGF ≥ 85, 56% developed preeclampsia during their pregnancy.

“The negative predictive values are not really great, and the positive predictive values are not really very useful,” Clowse said. For a pregnant patient with proteinuria, “I don’t think that a high [ratio] is going to tell us that she definitely has preeclampsia today or tomorrow. I also am not convinced yet that a low [ratio] tells us that she’s out of the woods. So, I think we definitely need more research on what to do with this test in patients with proteinuria.”

Clowse is a consultant and has received research support/grants from GSK and UCB. She also reported consulting for AstraZeneca. Wise is a consultant for Aurinia Pharmaceuticals and has received honoraria from AstraZeneca, Aurinia Pharmaceuticals, and GSK.

A version of this article first appeared on Medscape.com.

SEATTLE — A novel, quick, and low-cost dementia screening test could significantly improve early detection of Alzheimer’s disease in primary care settings, according to research presented at the Gerontological Society of America (GSA) 2024 Annual Scientific Meeting.

The test, called qBEANS — short for Quick Behavioral Exam to Advance Neuropsychological Screening — involves patients spooning raw kidney beans into small plastic cups in a specific sequence to assess motor learning, visuospatial memory, and executive function. It requires no technology or wearable sensors, making it accessible and easy to implement.

Previous research has shown qBEANS to be sensitive and specific to Alzheimer’s disease pathology, as well as predictive of cognitive and functional decline, the researchers said.

However, the current version of the test takes around 7 minutes to administer, which is too long for use in primary care, according to study author Sydney Schaefer, PhD, associate professor in the School of Biological and Health Systems Engineering at Arizona State University, Tempe, Arizona.

“The purpose of this study was to identify the minimum number of trials needed for reliability relative to the original longer version,” said Schaefer.

The study involved 48 participants without dementia, 77% of whom were women, and an average age of 75.4 years.

The researchers found that the shortened version of the qBEANS test takes only about 3.85 minutes on average — nearly 48% faster than the original version — while still maintaining high reliability (intraclass correlation of 0.85).

With its brevity and simplicity, the test could be easily administered by medical assistants during patient check-in, potentially increasing early dementia detection rates in primary care, said Schaefer.

While the shortened qBEANS test shows promise, further research is needed to assess its acceptability in primary care settings.

“The findings also warrant further development of the BEAN as a direct-to-consumer product, given its low cost and ease of administration,” said Schaefer.

However, Carla Perissinotto, MD, MHS, professor in the Division of Geriatrics at the University of California, San Francisco, cautioned that direct-to-consumer plans “could lead to participants not knowing what to do with the results out of context and without clinical input.”

“I’m not sure that we need to have a new evaluation tool, but instead, greater adoption of known and existing tools,” said Perissinotto, who was not involved in the study.

According to Perissinotto, existing cognitive screening tools Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) are more commonly used to evaluate cognition and are also relatively quick to administer.

“If [qBEANS] is not benchmarked to other standard tools like the MMSE or MoCA, clinicians may have trouble interpreting results,” said Perissinotto.

Study co-authors Schaefer and Jill Love are co-founders and managing members of Neurosessments LLC, which developed the qBEANS test.

 

A version of this article appeared on Medscape.com.

SEATTLE — A novel, quick, and low-cost dementia screening test could significantly improve early detection of Alzheimer’s disease in primary care settings, according to research presented at the Gerontological Society of America (GSA) 2024 Annual Scientific Meeting.

The test, called qBEANS — short for Quick Behavioral Exam to Advance Neuropsychological Screening — involves patients spooning raw kidney beans into small plastic cups in a specific sequence to assess motor learning, visuospatial memory, and executive function. It requires no technology or wearable sensors, making it accessible and easy to implement.

Previous research has shown qBEANS to be sensitive and specific to Alzheimer’s disease pathology, as well as predictive of cognitive and functional decline, the researchers said.

However, the current version of the test takes around 7 minutes to administer, which is too long for use in primary care, according to study author Sydney Schaefer, PhD, associate professor in the School of Biological and Health Systems Engineering at Arizona State University, Tempe, Arizona.

“The purpose of this study was to identify the minimum number of trials needed for reliability relative to the original longer version,” said Schaefer.

The study involved 48 participants without dementia, 77% of whom were women, and an average age of 75.4 years.

The researchers found that the shortened version of the qBEANS test takes only about 3.85 minutes on average — nearly 48% faster than the original version — while still maintaining high reliability (intraclass correlation of 0.85).

With its brevity and simplicity, the test could be easily administered by medical assistants during patient check-in, potentially increasing early dementia detection rates in primary care, said Schaefer.

While the shortened qBEANS test shows promise, further research is needed to assess its acceptability in primary care settings.

“The findings also warrant further development of the BEAN as a direct-to-consumer product, given its low cost and ease of administration,” said Schaefer.

However, Carla Perissinotto, MD, MHS, professor in the Division of Geriatrics at the University of California, San Francisco, cautioned that direct-to-consumer plans “could lead to participants not knowing what to do with the results out of context and without clinical input.”

“I’m not sure that we need to have a new evaluation tool, but instead, greater adoption of known and existing tools,” said Perissinotto, who was not involved in the study.

According to Perissinotto, existing cognitive screening tools Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) are more commonly used to evaluate cognition and are also relatively quick to administer.

“If [qBEANS] is not benchmarked to other standard tools like the MMSE or MoCA, clinicians may have trouble interpreting results,” said Perissinotto.

Study co-authors Schaefer and Jill Love are co-founders and managing members of Neurosessments LLC, which developed the qBEANS test.

 

A version of this article appeared on Medscape.com.

SEATTLE — A novel, quick, and low-cost dementia screening test could significantly improve early detection of Alzheimer’s disease in primary care settings, according to research presented at the Gerontological Society of America (GSA) 2024 Annual Scientific Meeting.

The test, called qBEANS — short for Quick Behavioral Exam to Advance Neuropsychological Screening — involves patients spooning raw kidney beans into small plastic cups in a specific sequence to assess motor learning, visuospatial memory, and executive function. It requires no technology or wearable sensors, making it accessible and easy to implement.

Previous research has shown qBEANS to be sensitive and specific to Alzheimer’s disease pathology, as well as predictive of cognitive and functional decline, the researchers said.

However, the current version of the test takes around 7 minutes to administer, which is too long for use in primary care, according to study author Sydney Schaefer, PhD, associate professor in the School of Biological and Health Systems Engineering at Arizona State University, Tempe, Arizona.

“The purpose of this study was to identify the minimum number of trials needed for reliability relative to the original longer version,” said Schaefer.

The study involved 48 participants without dementia, 77% of whom were women, and an average age of 75.4 years.

The researchers found that the shortened version of the qBEANS test takes only about 3.85 minutes on average — nearly 48% faster than the original version — while still maintaining high reliability (intraclass correlation of 0.85).

With its brevity and simplicity, the test could be easily administered by medical assistants during patient check-in, potentially increasing early dementia detection rates in primary care, said Schaefer.

While the shortened qBEANS test shows promise, further research is needed to assess its acceptability in primary care settings.

“The findings also warrant further development of the BEAN as a direct-to-consumer product, given its low cost and ease of administration,” said Schaefer.

However, Carla Perissinotto, MD, MHS, professor in the Division of Geriatrics at the University of California, San Francisco, cautioned that direct-to-consumer plans “could lead to participants not knowing what to do with the results out of context and without clinical input.”

“I’m not sure that we need to have a new evaluation tool, but instead, greater adoption of known and existing tools,” said Perissinotto, who was not involved in the study.

According to Perissinotto, existing cognitive screening tools Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) are more commonly used to evaluate cognition and are also relatively quick to administer.

“If [qBEANS] is not benchmarked to other standard tools like the MMSE or MoCA, clinicians may have trouble interpreting results,” said Perissinotto.

Study co-authors Schaefer and Jill Love are co-founders and managing members of Neurosessments LLC, which developed the qBEANS test.

 

A version of this article appeared on Medscape.com.

Despite 4 years of med school and 3-7 years in residency, when you enter the workforce as a doctor, you still have much to learn. There is only so much your professors and attending physicians can pack in. Going forward, you’ll continue to learn on the job and via continuing education.

Some of that lifelong learning will involve soft skills — how to compassionately work with your patients and their families, for instance. Other lessons will get down to the business of medicine — the paperwork, the work/life balance, and the moral dilemmas you never saw coming. And still others will involve learning how to take care of yourself in the middle of seemingly endless hours on the job.

“We all have things we wish we had known upon starting our careers,” said Daniel Opris, MD, a primary care physician at Ohio-based Executive Medical Centers.

We tapped several veteran physicians and an educator to learn what they wish med students knew as they enter the workforce. We’ve compiled them here to give you a head start on the lessons ahead. 

 

You Won’t Know Everything, and That’s Okay

When you go through your medical training, it can feel overwhelming to absorb all the knowledge your professors and attendings impart. The bottom line, said Shoshana Ungerleider, MD, an internal medicine specialist, is that you shouldn’t worry about it.

“No one expects you to know it all,” she explained. “What’s important is to cultivate curiosity and a willingness to ask for help when needed.” 

David Lenihan, PhD, CEO at Ponce Health Sciences University, agrees. “What we’ve lost in recent years, is the ability to apply your skill set and say, ‘let me take a day and get back to you,’” he said. “Doctors love it when you do that because it shows you can pitch in and work as part of a team.”

Medicine is a collaborative field, said Ungerleider, and learning from others, whether peers, nurses, or specialists, is “not a weakness.” She recommends embracing uncertainty and getting comfortable with the unknown.

 

You’ll Take Your Work Home With You

Doctors enter the field because they care about their patients and want to help. Successful outcomes are never guaranteed, however, no matter how much you try. The result? Some days you’ll bring home those upsetting and haunting cases, said Lenihan. 

“We often believe that we should leave our work at the office, but sometimes you need to bring it home and think it through,” he said. “It can’t overwhelm you, but you should digest what happened.”

When you do, said Lenihan, you’ll come out the other end more empathetic and that helps the healthcare system in the long run. “The more you reflect on your day, the better you’ll get at reading the room and treating your patients.”

Drew Remignanti, MD, a retired emergency medicine physician from New Hampshire, agrees, but puts a different spin on bringing work home. 

“We revisit the patient care decisions we made, second-guess ourselves, and worry about our patients’ welfare and outcomes,” he said. “I think it can only lead to better outcomes down the road, however, if you learn from that bad decision, preventing you from committing a similar mistake.”

 

Burnout Is Real — Make Self-Care a Priority 

As a retired physician who spent 40 years practicing medicine, Remignanti experienced the evolution of healthcare as it has become what he calls a “consumer-provider” model. “Productivity didn’t use to be part of the equation, but now it’s the focus,” he said. 

The result is burnout, a very real threat to incoming physicians. Remignanti holds that if you are aware of the risk, you can resist it. Part of avoiding burnout is self-care, according to Ungerleider. “The sooner you prioritize your mental, emotional, and physical well-being, the better,” she said. “Balancing work and life may feel impossible at times but taking care of yourself is essential to being a better physician in the long run.”

That means carving out time for exercise, hobbies, and connections outside of the medical field. It also means making sleep and nutrition a priority, even when that feels hard to accomplish. “If you don’t take care of yourself, you can’t take care of others,” added Opris. “It’s so common to lose yourself in your career, but you need to hold onto your physical, emotional, and spiritual self.”

 

Avoid Relying Too Heavily on Tech

Technology is invading every aspect of our lives — often for the greater good — but in medicine, it’s important to always return to your core knowledge above all else. Case in point, said Opris, the UpToDate app. While it can be a useful tool, it’s important not to become too reliant on it. “UpToDate is expert opinion-based guidance, and it’s a fantastic resource,” he said. “But you need to use your references and knowledge in every case.”

It’s key to remember that every patient is different, and their case may not line up perfectly with the guidance presented in UpToDate or other technology source. Piggybacking on that, Ungerleider added that it’s important to remember medicine is about people, not just conditions.

“It’s easy to focus on mastering the science, but the real art of medicine comes from seeing the whole person in front of you,” she said. “Your patients are more than their diagnoses — they come with complex emotions, life stories, and needs.” Being compassionate, listening carefully, and building trust should match up to your clinical skills.

 

Partner With Your Patients, Even When It’s Difficult

Perhaps the most difficult lesson of all is remembering that your patients may not always agree with your recommendations and choose to ignore them. After all your years spent learning, there may be times when it feels your education is going to waste.

“Remember that the landscape today is so varied, and that bleeds into medicine,” said Opris. “We go into cases with our own biases, and it’s important to take a step back to reset, every time.”

Opris reminds himself of Sir William Osler’s famous essay, “Aequanimitas,” in which he tells graduating medical students to practice with “coolness and presence of mind under all circumstances.”

Remignanti offers this advice: “Physicians need to be able to partner with their patients and jointly decide which courses of action are most effective,” he said. “Cling to the idea that you are forming a partnership with your patients — what can we together determine is the best course?”

At the same time, the path the patient chooses may not be what’s best for them — potentially even leading to a poor outcome.

“You may not always understand their choices,” said Opris. “But they do have a choice. Think of yourself almost like a consultant.”

 

A version of this article first appeared on Medscape.com.

Despite 4 years of med school and 3-7 years in residency, when you enter the workforce as a doctor, you still have much to learn. There is only so much your professors and attending physicians can pack in. Going forward, you’ll continue to learn on the job and via continuing education.

Some of that lifelong learning will involve soft skills — how to compassionately work with your patients and their families, for instance. Other lessons will get down to the business of medicine — the paperwork, the work/life balance, and the moral dilemmas you never saw coming. And still others will involve learning how to take care of yourself in the middle of seemingly endless hours on the job.

“We all have things we wish we had known upon starting our careers,” said Daniel Opris, MD, a primary care physician at Ohio-based Executive Medical Centers.

We tapped several veteran physicians and an educator to learn what they wish med students knew as they enter the workforce. We’ve compiled them here to give you a head start on the lessons ahead. 

 

You Won’t Know Everything, and That’s Okay

When you go through your medical training, it can feel overwhelming to absorb all the knowledge your professors and attendings impart. The bottom line, said Shoshana Ungerleider, MD, an internal medicine specialist, is that you shouldn’t worry about it.

“No one expects you to know it all,” she explained. “What’s important is to cultivate curiosity and a willingness to ask for help when needed.” 

David Lenihan, PhD, CEO at Ponce Health Sciences University, agrees. “What we’ve lost in recent years, is the ability to apply your skill set and say, ‘let me take a day and get back to you,’” he said. “Doctors love it when you do that because it shows you can pitch in and work as part of a team.”

Medicine is a collaborative field, said Ungerleider, and learning from others, whether peers, nurses, or specialists, is “not a weakness.” She recommends embracing uncertainty and getting comfortable with the unknown.

 

You’ll Take Your Work Home With You

Doctors enter the field because they care about their patients and want to help. Successful outcomes are never guaranteed, however, no matter how much you try. The result? Some days you’ll bring home those upsetting and haunting cases, said Lenihan. 

“We often believe that we should leave our work at the office, but sometimes you need to bring it home and think it through,” he said. “It can’t overwhelm you, but you should digest what happened.”

When you do, said Lenihan, you’ll come out the other end more empathetic and that helps the healthcare system in the long run. “The more you reflect on your day, the better you’ll get at reading the room and treating your patients.”

Drew Remignanti, MD, a retired emergency medicine physician from New Hampshire, agrees, but puts a different spin on bringing work home. 

“We revisit the patient care decisions we made, second-guess ourselves, and worry about our patients’ welfare and outcomes,” he said. “I think it can only lead to better outcomes down the road, however, if you learn from that bad decision, preventing you from committing a similar mistake.”

 

Burnout Is Real — Make Self-Care a Priority 

As a retired physician who spent 40 years practicing medicine, Remignanti experienced the evolution of healthcare as it has become what he calls a “consumer-provider” model. “Productivity didn’t use to be part of the equation, but now it’s the focus,” he said. 

The result is burnout, a very real threat to incoming physicians. Remignanti holds that if you are aware of the risk, you can resist it. Part of avoiding burnout is self-care, according to Ungerleider. “The sooner you prioritize your mental, emotional, and physical well-being, the better,” she said. “Balancing work and life may feel impossible at times but taking care of yourself is essential to being a better physician in the long run.”

That means carving out time for exercise, hobbies, and connections outside of the medical field. It also means making sleep and nutrition a priority, even when that feels hard to accomplish. “If you don’t take care of yourself, you can’t take care of others,” added Opris. “It’s so common to lose yourself in your career, but you need to hold onto your physical, emotional, and spiritual self.”

 

Avoid Relying Too Heavily on Tech

Technology is invading every aspect of our lives — often for the greater good — but in medicine, it’s important to always return to your core knowledge above all else. Case in point, said Opris, the UpToDate app. While it can be a useful tool, it’s important not to become too reliant on it. “UpToDate is expert opinion-based guidance, and it’s a fantastic resource,” he said. “But you need to use your references and knowledge in every case.”

It’s key to remember that every patient is different, and their case may not line up perfectly with the guidance presented in UpToDate or other technology source. Piggybacking on that, Ungerleider added that it’s important to remember medicine is about people, not just conditions.

“It’s easy to focus on mastering the science, but the real art of medicine comes from seeing the whole person in front of you,” she said. “Your patients are more than their diagnoses — they come with complex emotions, life stories, and needs.” Being compassionate, listening carefully, and building trust should match up to your clinical skills.

 

Partner With Your Patients, Even When It’s Difficult

Perhaps the most difficult lesson of all is remembering that your patients may not always agree with your recommendations and choose to ignore them. After all your years spent learning, there may be times when it feels your education is going to waste.

“Remember that the landscape today is so varied, and that bleeds into medicine,” said Opris. “We go into cases with our own biases, and it’s important to take a step back to reset, every time.”

Opris reminds himself of Sir William Osler’s famous essay, “Aequanimitas,” in which he tells graduating medical students to practice with “coolness and presence of mind under all circumstances.”

Remignanti offers this advice: “Physicians need to be able to partner with their patients and jointly decide which courses of action are most effective,” he said. “Cling to the idea that you are forming a partnership with your patients — what can we together determine is the best course?”

At the same time, the path the patient chooses may not be what’s best for them — potentially even leading to a poor outcome.

“You may not always understand their choices,” said Opris. “But they do have a choice. Think of yourself almost like a consultant.”

 

A version of this article first appeared on Medscape.com.

Despite 4 years of med school and 3-7 years in residency, when you enter the workforce as a doctor, you still have much to learn. There is only so much your professors and attending physicians can pack in. Going forward, you’ll continue to learn on the job and via continuing education.

Some of that lifelong learning will involve soft skills — how to compassionately work with your patients and their families, for instance. Other lessons will get down to the business of medicine — the paperwork, the work/life balance, and the moral dilemmas you never saw coming. And still others will involve learning how to take care of yourself in the middle of seemingly endless hours on the job.

“We all have things we wish we had known upon starting our careers,” said Daniel Opris, MD, a primary care physician at Ohio-based Executive Medical Centers.

We tapped several veteran physicians and an educator to learn what they wish med students knew as they enter the workforce. We’ve compiled them here to give you a head start on the lessons ahead. 

 

You Won’t Know Everything, and That’s Okay

When you go through your medical training, it can feel overwhelming to absorb all the knowledge your professors and attendings impart. The bottom line, said Shoshana Ungerleider, MD, an internal medicine specialist, is that you shouldn’t worry about it.

“No one expects you to know it all,” she explained. “What’s important is to cultivate curiosity and a willingness to ask for help when needed.” 

David Lenihan, PhD, CEO at Ponce Health Sciences University, agrees. “What we’ve lost in recent years, is the ability to apply your skill set and say, ‘let me take a day and get back to you,’” he said. “Doctors love it when you do that because it shows you can pitch in and work as part of a team.”

Medicine is a collaborative field, said Ungerleider, and learning from others, whether peers, nurses, or specialists, is “not a weakness.” She recommends embracing uncertainty and getting comfortable with the unknown.

 

You’ll Take Your Work Home With You

Doctors enter the field because they care about their patients and want to help. Successful outcomes are never guaranteed, however, no matter how much you try. The result? Some days you’ll bring home those upsetting and haunting cases, said Lenihan. 

“We often believe that we should leave our work at the office, but sometimes you need to bring it home and think it through,” he said. “It can’t overwhelm you, but you should digest what happened.”

When you do, said Lenihan, you’ll come out the other end more empathetic and that helps the healthcare system in the long run. “The more you reflect on your day, the better you’ll get at reading the room and treating your patients.”

Drew Remignanti, MD, a retired emergency medicine physician from New Hampshire, agrees, but puts a different spin on bringing work home. 

“We revisit the patient care decisions we made, second-guess ourselves, and worry about our patients’ welfare and outcomes,” he said. “I think it can only lead to better outcomes down the road, however, if you learn from that bad decision, preventing you from committing a similar mistake.”

 

Burnout Is Real — Make Self-Care a Priority 

As a retired physician who spent 40 years practicing medicine, Remignanti experienced the evolution of healthcare as it has become what he calls a “consumer-provider” model. “Productivity didn’t use to be part of the equation, but now it’s the focus,” he said. 

The result is burnout, a very real threat to incoming physicians. Remignanti holds that if you are aware of the risk, you can resist it. Part of avoiding burnout is self-care, according to Ungerleider. “The sooner you prioritize your mental, emotional, and physical well-being, the better,” she said. “Balancing work and life may feel impossible at times but taking care of yourself is essential to being a better physician in the long run.”

That means carving out time for exercise, hobbies, and connections outside of the medical field. It also means making sleep and nutrition a priority, even when that feels hard to accomplish. “If you don’t take care of yourself, you can’t take care of others,” added Opris. “It’s so common to lose yourself in your career, but you need to hold onto your physical, emotional, and spiritual self.”

 

Avoid Relying Too Heavily on Tech

Technology is invading every aspect of our lives — often for the greater good — but in medicine, it’s important to always return to your core knowledge above all else. Case in point, said Opris, the UpToDate app. While it can be a useful tool, it’s important not to become too reliant on it. “UpToDate is expert opinion-based guidance, and it’s a fantastic resource,” he said. “But you need to use your references and knowledge in every case.”

It’s key to remember that every patient is different, and their case may not line up perfectly with the guidance presented in UpToDate or other technology source. Piggybacking on that, Ungerleider added that it’s important to remember medicine is about people, not just conditions.

“It’s easy to focus on mastering the science, but the real art of medicine comes from seeing the whole person in front of you,” she said. “Your patients are more than their diagnoses — they come with complex emotions, life stories, and needs.” Being compassionate, listening carefully, and building trust should match up to your clinical skills.

 

Partner With Your Patients, Even When It’s Difficult

Perhaps the most difficult lesson of all is remembering that your patients may not always agree with your recommendations and choose to ignore them. After all your years spent learning, there may be times when it feels your education is going to waste.

“Remember that the landscape today is so varied, and that bleeds into medicine,” said Opris. “We go into cases with our own biases, and it’s important to take a step back to reset, every time.”

Opris reminds himself of Sir William Osler’s famous essay, “Aequanimitas,” in which he tells graduating medical students to practice with “coolness and presence of mind under all circumstances.”

Remignanti offers this advice: “Physicians need to be able to partner with their patients and jointly decide which courses of action are most effective,” he said. “Cling to the idea that you are forming a partnership with your patients — what can we together determine is the best course?”

At the same time, the path the patient chooses may not be what’s best for them — potentially even leading to a poor outcome.

“You may not always understand their choices,” said Opris. “But they do have a choice. Think of yourself almost like a consultant.”

 

A version of this article first appeared on Medscape.com.

WASHINGTON — There is no benefit to interrupting treatment with many of the available targeted synthetic or biologic disease-modifying antirheumatic drugs for rheumatoid arthritis (RA) or spondyloarthritis (SpA) at the time of a repeat COVID-19 vaccine dose, new research found.

In the multicenter, randomized controlled COVID Vaccine Response (COVER) trial of 577 patients with RA or SpA taking either abatacept, Janus kinase (JAK) inhibitors, interleukin (IL)–17 inhibitors, or tumor necrosis factor (TNF) inhibitors, holding those drugs for 2 weeks at the time of COVID-19 vaccination supplemental doses didn’t improve antibody response to the vaccine but did lead to disease flares. Most participants had significant antibody responses to the vaccine, regardless of whether their medication had been held or continued, Jeffrey R. Curtis, MD, the Harbert-Ball Professor of Medicine, Epidemiology, and Computer Science at the University of Alabama at Birmingham, reported at the annual meeting of the American College of Rheumatology (ACR).

Guidelines issued by ACR in 2023 recommended holding abatacept for the COVID vaccine but said that “the task force failed to reach consensus” on whether or not to temporarily interrupt the other medications following primary vaccination or supplemental/booster dosing.

Curtis, who was an author on those guidelines, said in an interview, “to date, we haven’t known whether it might be a good idea to hold certain drugs at the time patients receive their next dose of the COVID vaccine. ... That’s because without direct evidence, you have people trading opinions based on extrapolated data.” 

The inability to measure cell-mediated immunity and only humoral (ie, antibody-based) immunity is a limitation in COVER. “Nevertheless, based on what we know now, it isn’t advisable to hold any of the four drug classes that we studied at the time patients receive their next COVID vaccine dose. This finding is in contrast to data from a different trial showing that holding methotrexate for 2 weeks does appear to help in response to COVID-19 vaccination, as well as influenza vaccine,” Curtis said.

Asked to comment, session moderator Elena Myasoedova, MD, PhD, consultant rheumatologist and director of the Inflammatory Arthritis Clinic at the Mayo Clinic, Rochester, Minnesota, said in an interview: “This has been an area of clinical uncertainty. It raises a lot of questions from patients and from physicians alike as to whether or not to hold the medication because the implications are flares, and that’s impactful for patients. Patients care about their RA status and how it is controlled, and if there is no difference, then there is no reason to change the medication regimen.”

 

To Hold or Not to Hold: COVER Shows It Makes Little Difference to Vaccine Response

In COVER, 128 patients were taking abatacept, 96 IL-17 inhibitors, 237 JAK inhibitors, and 116 TNF inhibitors. The study was conducted within 30 sites of the Excellence Network in Rheumatology, a rheumatology practice–based research network launched in 2021. Participants were identified and enrolled at clinic visits immediately prior to receiving their COVID-19 boosters (in routine settings).

All had previously received two or more doses of the mRNA vaccines made by Pfizer or Moderna. Blood was drawn, and they were randomized 1:1 to either continue or hold their disease medication for 2 weeks following the booster. Blood was collected again at 6 weeks post vaccine.

Anti–receptor-binding domain (RBD) IgG antibody titers increased significantly in all drug categories across both study arms, with no differences between the hold vs continue medication groups, even after adjustments for age, sex, body mass index, methotrexate use, steroid use, and time from booster to measurement. All groups also showed increases in geometric mean fold rise of more than 3%.

Subgroup analyses showed no major differences between antibody responses in the hold vs continue groups. The anti-RBD IgG response was lower for abatacept and JAK inhibitors than for the other two drugs, but there was still no significant benefit to holding them for 2 weeks post vaccination.

 

Holding Drugs Leads to Disease Flares

On the flip side, there were significant differences between the two groups in their responses to the question: “Did you experience any flare or worsening of your autoimmune disease following your recent COVID-19 booster dose?” Overall, 27% of the hold group responded that they had, compared with just 13% of the continue group (P < .05). This difference was greatest in the JAK inhibitor group (33% vs 9%; P < .05).

Among those reporting flares or worsening disease, both the severity and the duration of the flares were about the same. “Interestingly, the duration is beyond a week for the majority of patients. The reason that’s important is, any symptoms that are so-called flare might simply be reactogenicity symptoms, and that might be confused for flare or disease worsening, but you see that a majority of patients actually have those symptoms extending beyond the week. Most of them are worsening in arthritis, as you might expect,” Curtis said in his presentation.

Asked what they did about the flare, only a minority of patients reported contacting a healthcare provider. In all, 68% of the hold group and 78% of the continue group took no action. That’s good in the sense that most of the flares weren’t severe, but it has implications for research, Curtis pointed out.

“A lot of times in the vaccine literature, people do retrospective chart review by looking to see what the doctor said as to whether the patient had a flare. And what this would tell you is patients may be reporting a lot of flares that their doctor doesn’t know anything about. So if you really want to know whether people are having a flare, even a mild flare, you really have to collect prospective data.”

 

COVID is Not the Last Pandemic

“These results are reassuring, although I think we need a bit more data on abatacept,” Myasoedova said, adding, “I was also interested in the outcomes, such as severe infections, that actually happened to these patients. What we see in the labs in their immune response is one thing, but then also important is what actually evolves in terms of the outcomes, especially with abatacept.”

Overall, she said, “I think it’s reassuring and definitely informs clinical practice going forward. But then probably we’ll learn more. What we’re hearing is COVID is not the last pandemic.”

The COVER trial receives support from AbbVie, BMS, Eli Lilly, Novartis, and Pfizer. Curtis has received research grants and consulting fees from AbbVie, Amgen, BMS, GSK, Eli Lilly, Novartis, Pfizer, Sanofi, and UCB. Myasoedova has no disclosures.

A version of this article first appeared on Medscape.com.

WASHINGTON — There is no benefit to interrupting treatment with many of the available targeted synthetic or biologic disease-modifying antirheumatic drugs for rheumatoid arthritis (RA) or spondyloarthritis (SpA) at the time of a repeat COVID-19 vaccine dose, new research found.

In the multicenter, randomized controlled COVID Vaccine Response (COVER) trial of 577 patients with RA or SpA taking either abatacept, Janus kinase (JAK) inhibitors, interleukin (IL)–17 inhibitors, or tumor necrosis factor (TNF) inhibitors, holding those drugs for 2 weeks at the time of COVID-19 vaccination supplemental doses didn’t improve antibody response to the vaccine but did lead to disease flares. Most participants had significant antibody responses to the vaccine, regardless of whether their medication had been held or continued, Jeffrey R. Curtis, MD, the Harbert-Ball Professor of Medicine, Epidemiology, and Computer Science at the University of Alabama at Birmingham, reported at the annual meeting of the American College of Rheumatology (ACR).

Guidelines issued by ACR in 2023 recommended holding abatacept for the COVID vaccine but said that “the task force failed to reach consensus” on whether or not to temporarily interrupt the other medications following primary vaccination or supplemental/booster dosing.

Curtis, who was an author on those guidelines, said in an interview, “to date, we haven’t known whether it might be a good idea to hold certain drugs at the time patients receive their next dose of the COVID vaccine. ... That’s because without direct evidence, you have people trading opinions based on extrapolated data.” 

The inability to measure cell-mediated immunity and only humoral (ie, antibody-based) immunity is a limitation in COVER. “Nevertheless, based on what we know now, it isn’t advisable to hold any of the four drug classes that we studied at the time patients receive their next COVID vaccine dose. This finding is in contrast to data from a different trial showing that holding methotrexate for 2 weeks does appear to help in response to COVID-19 vaccination, as well as influenza vaccine,” Curtis said.

Asked to comment, session moderator Elena Myasoedova, MD, PhD, consultant rheumatologist and director of the Inflammatory Arthritis Clinic at the Mayo Clinic, Rochester, Minnesota, said in an interview: “This has been an area of clinical uncertainty. It raises a lot of questions from patients and from physicians alike as to whether or not to hold the medication because the implications are flares, and that’s impactful for patients. Patients care about their RA status and how it is controlled, and if there is no difference, then there is no reason to change the medication regimen.”

 

To Hold or Not to Hold: COVER Shows It Makes Little Difference to Vaccine Response

In COVER, 128 patients were taking abatacept, 96 IL-17 inhibitors, 237 JAK inhibitors, and 116 TNF inhibitors. The study was conducted within 30 sites of the Excellence Network in Rheumatology, a rheumatology practice–based research network launched in 2021. Participants were identified and enrolled at clinic visits immediately prior to receiving their COVID-19 boosters (in routine settings).

All had previously received two or more doses of the mRNA vaccines made by Pfizer or Moderna. Blood was drawn, and they were randomized 1:1 to either continue or hold their disease medication for 2 weeks following the booster. Blood was collected again at 6 weeks post vaccine.

Anti–receptor-binding domain (RBD) IgG antibody titers increased significantly in all drug categories across both study arms, with no differences between the hold vs continue medication groups, even after adjustments for age, sex, body mass index, methotrexate use, steroid use, and time from booster to measurement. All groups also showed increases in geometric mean fold rise of more than 3%.

Subgroup analyses showed no major differences between antibody responses in the hold vs continue groups. The anti-RBD IgG response was lower for abatacept and JAK inhibitors than for the other two drugs, but there was still no significant benefit to holding them for 2 weeks post vaccination.

 

Holding Drugs Leads to Disease Flares

On the flip side, there were significant differences between the two groups in their responses to the question: “Did you experience any flare or worsening of your autoimmune disease following your recent COVID-19 booster dose?” Overall, 27% of the hold group responded that they had, compared with just 13% of the continue group (P < .05). This difference was greatest in the JAK inhibitor group (33% vs 9%; P < .05).

Among those reporting flares or worsening disease, both the severity and the duration of the flares were about the same. “Interestingly, the duration is beyond a week for the majority of patients. The reason that’s important is, any symptoms that are so-called flare might simply be reactogenicity symptoms, and that might be confused for flare or disease worsening, but you see that a majority of patients actually have those symptoms extending beyond the week. Most of them are worsening in arthritis, as you might expect,” Curtis said in his presentation.

Asked what they did about the flare, only a minority of patients reported contacting a healthcare provider. In all, 68% of the hold group and 78% of the continue group took no action. That’s good in the sense that most of the flares weren’t severe, but it has implications for research, Curtis pointed out.

“A lot of times in the vaccine literature, people do retrospective chart review by looking to see what the doctor said as to whether the patient had a flare. And what this would tell you is patients may be reporting a lot of flares that their doctor doesn’t know anything about. So if you really want to know whether people are having a flare, even a mild flare, you really have to collect prospective data.”

 

COVID is Not the Last Pandemic

“These results are reassuring, although I think we need a bit more data on abatacept,” Myasoedova said, adding, “I was also interested in the outcomes, such as severe infections, that actually happened to these patients. What we see in the labs in their immune response is one thing, but then also important is what actually evolves in terms of the outcomes, especially with abatacept.”

Overall, she said, “I think it’s reassuring and definitely informs clinical practice going forward. But then probably we’ll learn more. What we’re hearing is COVID is not the last pandemic.”

The COVER trial receives support from AbbVie, BMS, Eli Lilly, Novartis, and Pfizer. Curtis has received research grants and consulting fees from AbbVie, Amgen, BMS, GSK, Eli Lilly, Novartis, Pfizer, Sanofi, and UCB. Myasoedova has no disclosures.

A version of this article first appeared on Medscape.com.

WASHINGTON — There is no benefit to interrupting treatment with many of the available targeted synthetic or biologic disease-modifying antirheumatic drugs for rheumatoid arthritis (RA) or spondyloarthritis (SpA) at the time of a repeat COVID-19 vaccine dose, new research found.

In the multicenter, randomized controlled COVID Vaccine Response (COVER) trial of 577 patients with RA or SpA taking either abatacept, Janus kinase (JAK) inhibitors, interleukin (IL)–17 inhibitors, or tumor necrosis factor (TNF) inhibitors, holding those drugs for 2 weeks at the time of COVID-19 vaccination supplemental doses didn’t improve antibody response to the vaccine but did lead to disease flares. Most participants had significant antibody responses to the vaccine, regardless of whether their medication had been held or continued, Jeffrey R. Curtis, MD, the Harbert-Ball Professor of Medicine, Epidemiology, and Computer Science at the University of Alabama at Birmingham, reported at the annual meeting of the American College of Rheumatology (ACR).

Guidelines issued by ACR in 2023 recommended holding abatacept for the COVID vaccine but said that “the task force failed to reach consensus” on whether or not to temporarily interrupt the other medications following primary vaccination or supplemental/booster dosing.

Curtis, who was an author on those guidelines, said in an interview, “to date, we haven’t known whether it might be a good idea to hold certain drugs at the time patients receive their next dose of the COVID vaccine. ... That’s because without direct evidence, you have people trading opinions based on extrapolated data.” 

The inability to measure cell-mediated immunity and only humoral (ie, antibody-based) immunity is a limitation in COVER. “Nevertheless, based on what we know now, it isn’t advisable to hold any of the four drug classes that we studied at the time patients receive their next COVID vaccine dose. This finding is in contrast to data from a different trial showing that holding methotrexate for 2 weeks does appear to help in response to COVID-19 vaccination, as well as influenza vaccine,” Curtis said.

Asked to comment, session moderator Elena Myasoedova, MD, PhD, consultant rheumatologist and director of the Inflammatory Arthritis Clinic at the Mayo Clinic, Rochester, Minnesota, said in an interview: “This has been an area of clinical uncertainty. It raises a lot of questions from patients and from physicians alike as to whether or not to hold the medication because the implications are flares, and that’s impactful for patients. Patients care about their RA status and how it is controlled, and if there is no difference, then there is no reason to change the medication regimen.”

 

To Hold or Not to Hold: COVER Shows It Makes Little Difference to Vaccine Response

In COVER, 128 patients were taking abatacept, 96 IL-17 inhibitors, 237 JAK inhibitors, and 116 TNF inhibitors. The study was conducted within 30 sites of the Excellence Network in Rheumatology, a rheumatology practice–based research network launched in 2021. Participants were identified and enrolled at clinic visits immediately prior to receiving their COVID-19 boosters (in routine settings).

All had previously received two or more doses of the mRNA vaccines made by Pfizer or Moderna. Blood was drawn, and they were randomized 1:1 to either continue or hold their disease medication for 2 weeks following the booster. Blood was collected again at 6 weeks post vaccine.

Anti–receptor-binding domain (RBD) IgG antibody titers increased significantly in all drug categories across both study arms, with no differences between the hold vs continue medication groups, even after adjustments for age, sex, body mass index, methotrexate use, steroid use, and time from booster to measurement. All groups also showed increases in geometric mean fold rise of more than 3%.

Subgroup analyses showed no major differences between antibody responses in the hold vs continue groups. The anti-RBD IgG response was lower for abatacept and JAK inhibitors than for the other two drugs, but there was still no significant benefit to holding them for 2 weeks post vaccination.

 

Holding Drugs Leads to Disease Flares

On the flip side, there were significant differences between the two groups in their responses to the question: “Did you experience any flare or worsening of your autoimmune disease following your recent COVID-19 booster dose?” Overall, 27% of the hold group responded that they had, compared with just 13% of the continue group (P < .05). This difference was greatest in the JAK inhibitor group (33% vs 9%; P < .05).

Among those reporting flares or worsening disease, both the severity and the duration of the flares were about the same. “Interestingly, the duration is beyond a week for the majority of patients. The reason that’s important is, any symptoms that are so-called flare might simply be reactogenicity symptoms, and that might be confused for flare or disease worsening, but you see that a majority of patients actually have those symptoms extending beyond the week. Most of them are worsening in arthritis, as you might expect,” Curtis said in his presentation.

Asked what they did about the flare, only a minority of patients reported contacting a healthcare provider. In all, 68% of the hold group and 78% of the continue group took no action. That’s good in the sense that most of the flares weren’t severe, but it has implications for research, Curtis pointed out.

“A lot of times in the vaccine literature, people do retrospective chart review by looking to see what the doctor said as to whether the patient had a flare. And what this would tell you is patients may be reporting a lot of flares that their doctor doesn’t know anything about. So if you really want to know whether people are having a flare, even a mild flare, you really have to collect prospective data.”

 

COVID is Not the Last Pandemic

“These results are reassuring, although I think we need a bit more data on abatacept,” Myasoedova said, adding, “I was also interested in the outcomes, such as severe infections, that actually happened to these patients. What we see in the labs in their immune response is one thing, but then also important is what actually evolves in terms of the outcomes, especially with abatacept.”

Overall, she said, “I think it’s reassuring and definitely informs clinical practice going forward. But then probably we’ll learn more. What we’re hearing is COVID is not the last pandemic.”

The COVER trial receives support from AbbVie, BMS, Eli Lilly, Novartis, and Pfizer. Curtis has received research grants and consulting fees from AbbVie, Amgen, BMS, GSK, Eli Lilly, Novartis, Pfizer, Sanofi, and UCB. Myasoedova has no disclosures.

A version of this article first appeared on Medscape.com.