A diet in which the primary source of fat is plant sources is associated with decreased mortality. Animal fat, on the other hand, is associated with an increased risk for death. These are the results of a study published in JAMA Internal Medicine that followed more than 600,000 participants over 2 decades.

Bin Zhao, PhD, of the National Clinical Research Center for Metabolic Diseases at the Key Laboratory of Diabetes Immunology in Changsha, China, and colleagues concluded from these data that consuming plant-based fats instead of animal fats could be beneficial for health and improve survival.

It may not be so simple, however. “We are one step ahead of the publication: We no longer just distinguish between animal and plant fats but mainly consider the composition,” said Stefan Lorkowski, PhD, chair of biochemistry and physiology of nutrition at the Institute of Nutritional Sciences at the University of Jena in Germany, in response to inquiries from this news organization.
 

What’s in a Fat?

Although Dr. Zhao and colleagues studied the effect of different plant and animal fat sources (eg, grains, nuts, legumes, plant oils, red and white meat, dairy, eggs, and fish), they did not consider the composition of the fatty acids that they contained. “It matters which dairy products, which plant oils, and which fish are consumed,” said Dr. Lorkowski.

The data analyzed in the Chinese study come from a prospective cohort study (NIH-AARP Diet and Health Study) conducted in the United States from 1995 to 2019. At the beginning, the 407,531 study participants (average age, 61 years) filled out dietary questionnaires once. They were then followed for up to 24 years for total and cardiovascular mortality.

During this period, 185,111 study participants died, including 58,526 from cardiovascular diseases. Participants who consumed the most plant-based fats, according to the dietary questionnaires filled out in 1995, had a lower risk for death than those who consumed the least plant-based fats. Their overall mortality risk was 9% lower, and their cardiovascular mortality risk was 14% lower. This finding was especially noticeable when it came to plant fats from grains or plant oils.
 

Animal Fat and Mortality

In contrast, a higher intake of animal fat was associated with both a higher overall mortality risk (16%) and a higher cardiovascular mortality risk (14%). This was especially true for fat from dairy products and eggs.

A trend towards a reduced overall and cardiovascular mortality risk was observed for fat from fish. “The fact that only a trend towards fish consumption was observed may be due to the study having many more meat eaters than fish eaters,” said Dr. Lorkowski.

Another imbalance limits the significance of the study, he added. The two groups, those who primarily consumed plant fats and those who primarily consumed animal fats, were already distinct at the beginning of the study. Those who consumed more plant fats were more likely to have diabetes, a higher body mass index (BMI), higher energy intake, and higher alcohol consumption but consumed more fiber, fruits, and vegetables and were more physically active. “They may have been trying to live healthier because they were sicker,” said Dr. Lorkowski.
 

Potential Confounding

Dr. Zhao and his team adjusted the results for various potential confounding factors, including age, gender, BMI, ethnicity, smoking, physical activity, education, marital status, diabetes, health status, vitamin intake, protein, carbohydrates, fiber, trans fats, cholesterol intake, and alcohol consumption. However, according to Dr. Lorkowski, “statistical adjustment is always incomplete, and confounding cannot be completely ruled out.”

Nevertheless, these results provide relevant insights for dietary recommendations that could help improve health and related outcomes, according to the authors. “Replacement of 5% energy from animal fat with 5% energy from plant fat, particularly fat from grains or vegetable oils, was associated with a lower risk for mortality: 4%-24% reduction in overall mortality and 5%-30% reduction in cardiovascular disease mortality.”
 

Fat Composition Matters

Animal fat, however, should not simply be replaced with plant fat, said Dr. Lorkowski. “Cold-water fish, which provides important long-chain omega-3 fatty acids, is also considered animal fat. And palm and coconut fat, while plant-based, contain unhealthy long-chain saturated fats. And the type of plant oils also makes a difference, whether one uses corn germ or sunflower oil rich in omega-6 fatty acids or flaxseed or rapeseed oil rich in omega-3 fatty acids.

“A diet rich in unsaturated fats, with sufficient and balanced intake of omega-3 and omega-6 fatty acids, that is also abundant in fiber-rich carbohydrate sources and plant-based protein, is always better than too much fat from animal sources.”

This story was translated from the Medscape German edition 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.

A diet in which the primary source of fat is plant sources is associated with decreased mortality. Animal fat, on the other hand, is associated with an increased risk for death. These are the results of a study published in JAMA Internal Medicine that followed more than 600,000 participants over 2 decades.

Bin Zhao, PhD, of the National Clinical Research Center for Metabolic Diseases at the Key Laboratory of Diabetes Immunology in Changsha, China, and colleagues concluded from these data that consuming plant-based fats instead of animal fats could be beneficial for health and improve survival.

It may not be so simple, however. “We are one step ahead of the publication: We no longer just distinguish between animal and plant fats but mainly consider the composition,” said Stefan Lorkowski, PhD, chair of biochemistry and physiology of nutrition at the Institute of Nutritional Sciences at the University of Jena in Germany, in response to inquiries from this news organization.
 

What’s in a Fat?

Although Dr. Zhao and colleagues studied the effect of different plant and animal fat sources (eg, grains, nuts, legumes, plant oils, red and white meat, dairy, eggs, and fish), they did not consider the composition of the fatty acids that they contained. “It matters which dairy products, which plant oils, and which fish are consumed,” said Dr. Lorkowski.

The data analyzed in the Chinese study come from a prospective cohort study (NIH-AARP Diet and Health Study) conducted in the United States from 1995 to 2019. At the beginning, the 407,531 study participants (average age, 61 years) filled out dietary questionnaires once. They were then followed for up to 24 years for total and cardiovascular mortality.

During this period, 185,111 study participants died, including 58,526 from cardiovascular diseases. Participants who consumed the most plant-based fats, according to the dietary questionnaires filled out in 1995, had a lower risk for death than those who consumed the least plant-based fats. Their overall mortality risk was 9% lower, and their cardiovascular mortality risk was 14% lower. This finding was especially noticeable when it came to plant fats from grains or plant oils.
 

Animal Fat and Mortality

In contrast, a higher intake of animal fat was associated with both a higher overall mortality risk (16%) and a higher cardiovascular mortality risk (14%). This was especially true for fat from dairy products and eggs.

A trend towards a reduced overall and cardiovascular mortality risk was observed for fat from fish. “The fact that only a trend towards fish consumption was observed may be due to the study having many more meat eaters than fish eaters,” said Dr. Lorkowski.

Another imbalance limits the significance of the study, he added. The two groups, those who primarily consumed plant fats and those who primarily consumed animal fats, were already distinct at the beginning of the study. Those who consumed more plant fats were more likely to have diabetes, a higher body mass index (BMI), higher energy intake, and higher alcohol consumption but consumed more fiber, fruits, and vegetables and were more physically active. “They may have been trying to live healthier because they were sicker,” said Dr. Lorkowski.
 

Potential Confounding

Dr. Zhao and his team adjusted the results for various potential confounding factors, including age, gender, BMI, ethnicity, smoking, physical activity, education, marital status, diabetes, health status, vitamin intake, protein, carbohydrates, fiber, trans fats, cholesterol intake, and alcohol consumption. However, according to Dr. Lorkowski, “statistical adjustment is always incomplete, and confounding cannot be completely ruled out.”

Nevertheless, these results provide relevant insights for dietary recommendations that could help improve health and related outcomes, according to the authors. “Replacement of 5% energy from animal fat with 5% energy from plant fat, particularly fat from grains or vegetable oils, was associated with a lower risk for mortality: 4%-24% reduction in overall mortality and 5%-30% reduction in cardiovascular disease mortality.”
 

Fat Composition Matters

Animal fat, however, should not simply be replaced with plant fat, said Dr. Lorkowski. “Cold-water fish, which provides important long-chain omega-3 fatty acids, is also considered animal fat. And palm and coconut fat, while plant-based, contain unhealthy long-chain saturated fats. And the type of plant oils also makes a difference, whether one uses corn germ or sunflower oil rich in omega-6 fatty acids or flaxseed or rapeseed oil rich in omega-3 fatty acids.

“A diet rich in unsaturated fats, with sufficient and balanced intake of omega-3 and omega-6 fatty acids, that is also abundant in fiber-rich carbohydrate sources and plant-based protein, is always better than too much fat from animal sources.”

This story was translated from the Medscape German edition 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.

A diet in which the primary source of fat is plant sources is associated with decreased mortality. Animal fat, on the other hand, is associated with an increased risk for death. These are the results of a study published in JAMA Internal Medicine that followed more than 600,000 participants over 2 decades.

Bin Zhao, PhD, of the National Clinical Research Center for Metabolic Diseases at the Key Laboratory of Diabetes Immunology in Changsha, China, and colleagues concluded from these data that consuming plant-based fats instead of animal fats could be beneficial for health and improve survival.

It may not be so simple, however. “We are one step ahead of the publication: We no longer just distinguish between animal and plant fats but mainly consider the composition,” said Stefan Lorkowski, PhD, chair of biochemistry and physiology of nutrition at the Institute of Nutritional Sciences at the University of Jena in Germany, in response to inquiries from this news organization.
 

What’s in a Fat?

Although Dr. Zhao and colleagues studied the effect of different plant and animal fat sources (eg, grains, nuts, legumes, plant oils, red and white meat, dairy, eggs, and fish), they did not consider the composition of the fatty acids that they contained. “It matters which dairy products, which plant oils, and which fish are consumed,” said Dr. Lorkowski.

The data analyzed in the Chinese study come from a prospective cohort study (NIH-AARP Diet and Health Study) conducted in the United States from 1995 to 2019. At the beginning, the 407,531 study participants (average age, 61 years) filled out dietary questionnaires once. They were then followed for up to 24 years for total and cardiovascular mortality.

During this period, 185,111 study participants died, including 58,526 from cardiovascular diseases. Participants who consumed the most plant-based fats, according to the dietary questionnaires filled out in 1995, had a lower risk for death than those who consumed the least plant-based fats. Their overall mortality risk was 9% lower, and their cardiovascular mortality risk was 14% lower. This finding was especially noticeable when it came to plant fats from grains or plant oils.
 

Animal Fat and Mortality

In contrast, a higher intake of animal fat was associated with both a higher overall mortality risk (16%) and a higher cardiovascular mortality risk (14%). This was especially true for fat from dairy products and eggs.

A trend towards a reduced overall and cardiovascular mortality risk was observed for fat from fish. “The fact that only a trend towards fish consumption was observed may be due to the study having many more meat eaters than fish eaters,” said Dr. Lorkowski.

Another imbalance limits the significance of the study, he added. The two groups, those who primarily consumed plant fats and those who primarily consumed animal fats, were already distinct at the beginning of the study. Those who consumed more plant fats were more likely to have diabetes, a higher body mass index (BMI), higher energy intake, and higher alcohol consumption but consumed more fiber, fruits, and vegetables and were more physically active. “They may have been trying to live healthier because they were sicker,” said Dr. Lorkowski.
 

Potential Confounding

Dr. Zhao and his team adjusted the results for various potential confounding factors, including age, gender, BMI, ethnicity, smoking, physical activity, education, marital status, diabetes, health status, vitamin intake, protein, carbohydrates, fiber, trans fats, cholesterol intake, and alcohol consumption. However, according to Dr. Lorkowski, “statistical adjustment is always incomplete, and confounding cannot be completely ruled out.”

Nevertheless, these results provide relevant insights for dietary recommendations that could help improve health and related outcomes, according to the authors. “Replacement of 5% energy from animal fat with 5% energy from plant fat, particularly fat from grains or vegetable oils, was associated with a lower risk for mortality: 4%-24% reduction in overall mortality and 5%-30% reduction in cardiovascular disease mortality.”
 

Fat Composition Matters

Animal fat, however, should not simply be replaced with plant fat, said Dr. Lorkowski. “Cold-water fish, which provides important long-chain omega-3 fatty acids, is also considered animal fat. And palm and coconut fat, while plant-based, contain unhealthy long-chain saturated fats. And the type of plant oils also makes a difference, whether one uses corn germ or sunflower oil rich in omega-6 fatty acids or flaxseed or rapeseed oil rich in omega-3 fatty acids.

“A diet rich in unsaturated fats, with sufficient and balanced intake of omega-3 and omega-6 fatty acids, that is also abundant in fiber-rich carbohydrate sources and plant-based protein, is always better than too much fat from animal sources.”

This story was translated from the Medscape German edition 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:

MADRID — Elevated interleukin (IL) 6 levels are associated with an increased risk for obesity-related cancers in patients newly diagnosed with type 2 diabetes (T2D), potentially enabling the identification of higher-risk individuals through a simple blood test.

METHODOLOGY:

• T2D is associated with an increased risk for obesity-related cancers, including breast, renal, uterine, thyroid, ovarian, and gastrointestinal cancers, as well as multiple myeloma, possibly because of chronic low-grade inflammation.
• Researchers explored whether the markers of inflammation IL-6, tumor necrosis factor alpha (TNF-alpha), and high-sensitivity C-reactive protein (hsCRP) can serve as predictive biomarkers for obesity-related cancers in patients recently diagnosed with T2D.
• They identified patients with recent-onset T2D and no prior history of cancer participating in the ongoing Danish Centre for Strategic Research in Type 2 Diabetes cohort study.
• At study initiation, plasma levels of IL-6 and TNF-alpha were measured using Meso Scale Discovery assays, and serum levels of hsCRP were measured using immunofluorometric assays.

TAKEAWAY:

• Among 6,466 eligible patients (40.5% women; median age, 60.9 years), 327 developed obesity-related cancers over a median follow-up of 8.8 years.
• Each SD increase in log-transformed IL-6 levels increased the risk for obesity-related cancers by 19%.
• The researchers did not find a strong association between TNF-alpha or hsCRP and obesity-related cancers.
• The addition of baseline IL-6 levels to other well-known risk factors for obesity-related cancers improved the performance of a cancer prediction model from 0.685 to 0.693, translating to a small but important increase in the ability to predict whether an individual would develop one of these cancers.

IN PRACTICE:

“In future, a simple blood test could identify those at higher risk of the cancers,” said the study’s lead author in an accompanying press release.

SOURCE:

The study was led by Mathilde D. Bennetsen, Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark, and published online on August 27 as an early release from the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

LIMITATIONS:

No limitations were discussed in this abstract. However, the reliance on registry data may have introduced potential biases related to data accuracy and completeness.

DISCLOSURES:

The Danish Centre for Strategic Research in Type 2 Diabetes was supported by grants from the Danish Agency for Science and the Novo Nordisk Foundation. The authors declared 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 first appeared on Medscape.com.

TOPLINE:

MADRID — Elevated interleukin (IL) 6 levels are associated with an increased risk for obesity-related cancers in patients newly diagnosed with type 2 diabetes (T2D), potentially enabling the identification of higher-risk individuals through a simple blood test.

METHODOLOGY:

• T2D is associated with an increased risk for obesity-related cancers, including breast, renal, uterine, thyroid, ovarian, and gastrointestinal cancers, as well as multiple myeloma, possibly because of chronic low-grade inflammation.
• Researchers explored whether the markers of inflammation IL-6, tumor necrosis factor alpha (TNF-alpha), and high-sensitivity C-reactive protein (hsCRP) can serve as predictive biomarkers for obesity-related cancers in patients recently diagnosed with T2D.
• They identified patients with recent-onset T2D and no prior history of cancer participating in the ongoing Danish Centre for Strategic Research in Type 2 Diabetes cohort study.
• At study initiation, plasma levels of IL-6 and TNF-alpha were measured using Meso Scale Discovery assays, and serum levels of hsCRP were measured using immunofluorometric assays.

TAKEAWAY:

• Among 6,466 eligible patients (40.5% women; median age, 60.9 years), 327 developed obesity-related cancers over a median follow-up of 8.8 years.
• Each SD increase in log-transformed IL-6 levels increased the risk for obesity-related cancers by 19%.
• The researchers did not find a strong association between TNF-alpha or hsCRP and obesity-related cancers.
• The addition of baseline IL-6 levels to other well-known risk factors for obesity-related cancers improved the performance of a cancer prediction model from 0.685 to 0.693, translating to a small but important increase in the ability to predict whether an individual would develop one of these cancers.

IN PRACTICE:

“In future, a simple blood test could identify those at higher risk of the cancers,” said the study’s lead author in an accompanying press release.

SOURCE:

The study was led by Mathilde D. Bennetsen, Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark, and published online on August 27 as an early release from the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

LIMITATIONS:

No limitations were discussed in this abstract. However, the reliance on registry data may have introduced potential biases related to data accuracy and completeness.

DISCLOSURES:

The Danish Centre for Strategic Research in Type 2 Diabetes was supported by grants from the Danish Agency for Science and the Novo Nordisk Foundation. The authors declared 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 first appeared on Medscape.com.

TOPLINE:

MADRID — Elevated interleukin (IL) 6 levels are associated with an increased risk for obesity-related cancers in patients newly diagnosed with type 2 diabetes (T2D), potentially enabling the identification of higher-risk individuals through a simple blood test.

METHODOLOGY:

• T2D is associated with an increased risk for obesity-related cancers, including breast, renal, uterine, thyroid, ovarian, and gastrointestinal cancers, as well as multiple myeloma, possibly because of chronic low-grade inflammation.
• Researchers explored whether the markers of inflammation IL-6, tumor necrosis factor alpha (TNF-alpha), and high-sensitivity C-reactive protein (hsCRP) can serve as predictive biomarkers for obesity-related cancers in patients recently diagnosed with T2D.
• They identified patients with recent-onset T2D and no prior history of cancer participating in the ongoing Danish Centre for Strategic Research in Type 2 Diabetes cohort study.
• At study initiation, plasma levels of IL-6 and TNF-alpha were measured using Meso Scale Discovery assays, and serum levels of hsCRP were measured using immunofluorometric assays.

TAKEAWAY:

• Among 6,466 eligible patients (40.5% women; median age, 60.9 years), 327 developed obesity-related cancers over a median follow-up of 8.8 years.
• Each SD increase in log-transformed IL-6 levels increased the risk for obesity-related cancers by 19%.
• The researchers did not find a strong association between TNF-alpha or hsCRP and obesity-related cancers.
• The addition of baseline IL-6 levels to other well-known risk factors for obesity-related cancers improved the performance of a cancer prediction model from 0.685 to 0.693, translating to a small but important increase in the ability to predict whether an individual would develop one of these cancers.

IN PRACTICE:

“In future, a simple blood test could identify those at higher risk of the cancers,” said the study’s lead author in an accompanying press release.

SOURCE:

The study was led by Mathilde D. Bennetsen, Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark, and published online on August 27 as an early release from the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

LIMITATIONS:

No limitations were discussed in this abstract. However, the reliance on registry data may have introduced potential biases related to data accuracy and completeness.

DISCLOSURES:

The Danish Centre for Strategic Research in Type 2 Diabetes was supported by grants from the Danish Agency for Science and the Novo Nordisk Foundation. The authors declared 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 first appeared on Medscape.com.

Subcutaneous (SC) infliximab is safe and effective, compared with placebo, for maintenance therapy in patients with inflammatory bowel disease (IBD), based on results of the phase 3 LIBERTY trials.

These two randomized trials should increase confidence in SC infliximab as a convenient alternative to intravenous delivery, reported co–lead authors Stephen B. Hanauer, MD, AGAF, of Northwestern Feinberg School of Medicine, Chicago, Illinois, and Bruce E. Sands, MD, AGAF, of Icahn School of Medicine at Mount Sinai, New York City, and colleagues.

Northwestern University

Specifically, the trials evaluated CT-P13, an infliximab biosimilar, which was Food and Drug Administration approved for intravenous (IV) use in 2016. The SC formulation was approved in the United States in 2023 as a new drug, requiring phase 3 efficacy confirmatory trials.

“Physicians and patients may prefer SC to IV treatment for IBD, owing to the convenience and flexibility of at-home self-administration, a different exposure profile with high steady-state levels, reduced exposure to nosocomial infection, and health care system resource benefits,” the investigators wrote in Gastroenterology.

One trial included patients with Crohn’s disease (CD), while the other enrolled patients with ulcerative colitis (UC). Eligibility depended upon inadequate responses or intolerance to corticosteroids and immunomodulators.

Courtesy Icahn School of Medicine at Mount Sinai

All participants began by receiving open-label IV CT-P13, at a dosage of 5 mg/kg, at weeks 0, 2, and 6. At week 10, those who responded to the IV induction therapy were randomized in a 2:1 ratio to continue with either the SC formulation of CT-P13 (120 mg) or switch to placebo, administered every 2 weeks until week 54.

The CD study randomized 343 patients, while the UC study had a larger cohort, with 438 randomized. Median age of participants was in the mid-30s to late 30s, with a majority being White and male. Baseline disease severity, assessed by the Crohn’s Disease Activity Index (CDAI) for CD and the modified Mayo score for UC, was similar across treatment groups.

The primary efficacy endpoint was clinical remission at week 54, defined as a CDAI score of less than 150 for CD and a modified Mayo score of 0-1 for UC.

In the CD study, 62.3% of patients receiving CT-P13 SC achieved clinical remission, compared with 32.1% in the placebo group, with a treatment difference of 32.1% (95% CI, 20.9-42.1; P < .0001). In addition, 51.1% of CT-P13 SC-treated patients achieved endoscopic response, compared with 17.9% in the placebo group, yielding a treatment difference of 34.6% (95% CI, 24.1-43.5; P < .0001).

In the UC study, 43.2% of patients on CT-P13 SC achieved clinical remission at week 54, compared with 20.8% of those on placebo, with a treatment difference of 21.1% (95% CI, 11.8-29.3; P < .0001). Key secondary endpoints, including endoscopic-histologic mucosal improvement, also favored CT-P13 SC over placebo with statistically significant differences.

The safety profile of CT-P13 SC was comparable with that of IV infliximab, with no new safety concerns emerging during the trials.

“Our results demonstrate the superior efficacy of CT-P13 SC over placebo for maintenance therapy in patients with moderately to severely active CD or UC after induction with CT-P13 IV,” the investigators wrote. “Importantly, the findings confirm that CT-P13 SC is well tolerated in this population, with no clinically meaningful differences in safety profile, compared with placebo. Overall, the results support CT-P13 SC as a treatment option for maintenance therapy in patients with IBD.”

The LIBERTY studies were funded by Celltrion. The investigators disclosed relationships with Pfizer, Gilead, Takeda, and others.

Subcutaneous (SC) infliximab is safe and effective, compared with placebo, for maintenance therapy in patients with inflammatory bowel disease (IBD), based on results of the phase 3 LIBERTY trials.

These two randomized trials should increase confidence in SC infliximab as a convenient alternative to intravenous delivery, reported co–lead authors Stephen B. Hanauer, MD, AGAF, of Northwestern Feinberg School of Medicine, Chicago, Illinois, and Bruce E. Sands, MD, AGAF, of Icahn School of Medicine at Mount Sinai, New York City, and colleagues.

Northwestern University

Specifically, the trials evaluated CT-P13, an infliximab biosimilar, which was Food and Drug Administration approved for intravenous (IV) use in 2016. The SC formulation was approved in the United States in 2023 as a new drug, requiring phase 3 efficacy confirmatory trials.

“Physicians and patients may prefer SC to IV treatment for IBD, owing to the convenience and flexibility of at-home self-administration, a different exposure profile with high steady-state levels, reduced exposure to nosocomial infection, and health care system resource benefits,” the investigators wrote in Gastroenterology.

One trial included patients with Crohn’s disease (CD), while the other enrolled patients with ulcerative colitis (UC). Eligibility depended upon inadequate responses or intolerance to corticosteroids and immunomodulators.

Courtesy Icahn School of Medicine at Mount Sinai

All participants began by receiving open-label IV CT-P13, at a dosage of 5 mg/kg, at weeks 0, 2, and 6. At week 10, those who responded to the IV induction therapy were randomized in a 2:1 ratio to continue with either the SC formulation of CT-P13 (120 mg) or switch to placebo, administered every 2 weeks until week 54.

The CD study randomized 343 patients, while the UC study had a larger cohort, with 438 randomized. Median age of participants was in the mid-30s to late 30s, with a majority being White and male. Baseline disease severity, assessed by the Crohn’s Disease Activity Index (CDAI) for CD and the modified Mayo score for UC, was similar across treatment groups.

The primary efficacy endpoint was clinical remission at week 54, defined as a CDAI score of less than 150 for CD and a modified Mayo score of 0-1 for UC.

In the CD study, 62.3% of patients receiving CT-P13 SC achieved clinical remission, compared with 32.1% in the placebo group, with a treatment difference of 32.1% (95% CI, 20.9-42.1; P < .0001). In addition, 51.1% of CT-P13 SC-treated patients achieved endoscopic response, compared with 17.9% in the placebo group, yielding a treatment difference of 34.6% (95% CI, 24.1-43.5; P < .0001).

In the UC study, 43.2% of patients on CT-P13 SC achieved clinical remission at week 54, compared with 20.8% of those on placebo, with a treatment difference of 21.1% (95% CI, 11.8-29.3; P < .0001). Key secondary endpoints, including endoscopic-histologic mucosal improvement, also favored CT-P13 SC over placebo with statistically significant differences.

The safety profile of CT-P13 SC was comparable with that of IV infliximab, with no new safety concerns emerging during the trials.

“Our results demonstrate the superior efficacy of CT-P13 SC over placebo for maintenance therapy in patients with moderately to severely active CD or UC after induction with CT-P13 IV,” the investigators wrote. “Importantly, the findings confirm that CT-P13 SC is well tolerated in this population, with no clinically meaningful differences in safety profile, compared with placebo. Overall, the results support CT-P13 SC as a treatment option for maintenance therapy in patients with IBD.”

The LIBERTY studies were funded by Celltrion. The investigators disclosed relationships with Pfizer, Gilead, Takeda, and others.

Subcutaneous (SC) infliximab is safe and effective, compared with placebo, for maintenance therapy in patients with inflammatory bowel disease (IBD), based on results of the phase 3 LIBERTY trials.

These two randomized trials should increase confidence in SC infliximab as a convenient alternative to intravenous delivery, reported co–lead authors Stephen B. Hanauer, MD, AGAF, of Northwestern Feinberg School of Medicine, Chicago, Illinois, and Bruce E. Sands, MD, AGAF, of Icahn School of Medicine at Mount Sinai, New York City, and colleagues.

Northwestern University

Specifically, the trials evaluated CT-P13, an infliximab biosimilar, which was Food and Drug Administration approved for intravenous (IV) use in 2016. The SC formulation was approved in the United States in 2023 as a new drug, requiring phase 3 efficacy confirmatory trials.

“Physicians and patients may prefer SC to IV treatment for IBD, owing to the convenience and flexibility of at-home self-administration, a different exposure profile with high steady-state levels, reduced exposure to nosocomial infection, and health care system resource benefits,” the investigators wrote in Gastroenterology.

One trial included patients with Crohn’s disease (CD), while the other enrolled patients with ulcerative colitis (UC). Eligibility depended upon inadequate responses or intolerance to corticosteroids and immunomodulators.

Courtesy Icahn School of Medicine at Mount Sinai

All participants began by receiving open-label IV CT-P13, at a dosage of 5 mg/kg, at weeks 0, 2, and 6. At week 10, those who responded to the IV induction therapy were randomized in a 2:1 ratio to continue with either the SC formulation of CT-P13 (120 mg) or switch to placebo, administered every 2 weeks until week 54.

The CD study randomized 343 patients, while the UC study had a larger cohort, with 438 randomized. Median age of participants was in the mid-30s to late 30s, with a majority being White and male. Baseline disease severity, assessed by the Crohn’s Disease Activity Index (CDAI) for CD and the modified Mayo score for UC, was similar across treatment groups.

The primary efficacy endpoint was clinical remission at week 54, defined as a CDAI score of less than 150 for CD and a modified Mayo score of 0-1 for UC.

In the CD study, 62.3% of patients receiving CT-P13 SC achieved clinical remission, compared with 32.1% in the placebo group, with a treatment difference of 32.1% (95% CI, 20.9-42.1; P < .0001). In addition, 51.1% of CT-P13 SC-treated patients achieved endoscopic response, compared with 17.9% in the placebo group, yielding a treatment difference of 34.6% (95% CI, 24.1-43.5; P < .0001).

In the UC study, 43.2% of patients on CT-P13 SC achieved clinical remission at week 54, compared with 20.8% of those on placebo, with a treatment difference of 21.1% (95% CI, 11.8-29.3; P < .0001). Key secondary endpoints, including endoscopic-histologic mucosal improvement, also favored CT-P13 SC over placebo with statistically significant differences.

The safety profile of CT-P13 SC was comparable with that of IV infliximab, with no new safety concerns emerging during the trials.

“Our results demonstrate the superior efficacy of CT-P13 SC over placebo for maintenance therapy in patients with moderately to severely active CD or UC after induction with CT-P13 IV,” the investigators wrote. “Importantly, the findings confirm that CT-P13 SC is well tolerated in this population, with no clinically meaningful differences in safety profile, compared with placebo. Overall, the results support CT-P13 SC as a treatment option for maintenance therapy in patients with IBD.”

The LIBERTY studies were funded by Celltrion. The investigators disclosed relationships with Pfizer, Gilead, Takeda, and others.

A more definitive picture of how some hormones and moisturizers can offer relief to women experiencing vaginal dryness or painful intercourse during menopause was published in a recent systematic review in Annals of Internal Medicine. However, researchers noted scant long-term data on the safety of these products.

Vaginal dryness and challenges with intercourse and urination are among the symptoms of genitourinary syndrome of menopause (GSM). Hormones such as vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), or oral ospemifene are common treatments, along with moisturizers.

“The main finding is that commonly used therapies are likely to be effective for the common symptoms people have for GSM,” particularly vaginal dryness and painful intercourse, said Elisheva Danan, MD, MPH, a primary care physician and health services researcher at the Minneapolis VA Health Care System and assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, who was the lead study author.

Many women might recognize hot flashes as connected to menopause, Dr. Danan said, as these tend to occur with the cessation of the menstrual cycle. However, genitourinary effects may not manifest until a few years later and worsen over time, when the connection to menopause is less clear.

“Women might not bring it up or think there’s a treatment that can work,” Dr. Danan said.

The systematic review may provide clinicians with more evidence of specific treatments to recommend. However, most of the trials included in the analysis studied treatment periods of 12 weeks or less, so the safety of long-term use is unclear.

“One question that hasn’t been answered yet in clinical trials is whether there could be a risk of uterine cancer with extended use of any of these treatments,” Dr. Danan said, because vaginal estrogen or ospemifene could stimulate growth of the uterine lining.

The studies Dr. Danan and colleagues found showed no increased risk for uterine cancer, but Dr, Danan noted that the maximum follow-up was 1 year, and study participants had a low risk for cancer to begin with. She advised that clinicians closely monitor women with risk factors if they use hormones to treat GSM indefinitely.
 

Forty-Six Randomized Controlled Trials, Many Open Questions

Dr. Danan and her colleagues conducted a systematic review of 46 randomized controlled trials, meant to inform an upcoming clinical practice guideline from the American Urological Association on treatment of GSM. Dr. Danan’s work was funded by the Patient-Centered Outcomes Research Institute.

Studies evaluated vaginal estrogen (22), other hormones such as vaginal oxytocin or vaginal testosterone (16), vaginal moisturizers (4), and multiple interventions (4).

Included trials lasted at least 8 weeks and included at least 20 postmenopausal women; most treatments lasted 12 weeks or less. Studies used varying definitions of GSM, and no head-to-head trials of different treatments were found.

Researchers used the Core Outcomes in Menopause (COMMA) framework, developed in 2021 to standardize outcomes research in menopause care and to understand treatment effectiveness. They applied this framework retroactively, as almost all the studies in the review were written before the COMMA framework existed.

Hormonal treatments were associated with reduced pain during intercourse and decreased vaginal dryness; moisturizers were linked to reduced dryness.

Vaginal estrogen did not reduce pain during intercourse as consistently as DHEA or oral ospemifene, per the review. Dr. Danan and her coauthors said this could be because the DHEA and ospemifene trials were larger and more uniformly conducted than those for vaginal estrogen. Even so, vaginal estrogen outperformed placebo at reducing painful intercourse.

But given the short timeframe of most studies and the differing definitions of GSM symptoms, Dr. Danan cautioned that all their conclusions have low certainty.

Few studies examined whether these treatments reduced vaginal itchiness or difficulties with urination. And the authors found no evidence for the benefit of oral DHEA, raloxifene, bazedoxifene, vaginal oxytocin, or vaginal testosterone for GSM treatment.

In an accompanying report, the researchers found no evidence for the benefits of treatments such as vaginal testosterone or vaginal laser therapy.

Stephanie Faubion, MD, MBA, medical director for the North American Menopause Society and director of the Mayo Clinic Center for Women’s Health, Rochester, Minnesota, wrote an accompanying editorial noting that the patients represented in the GSM treatment clinical trials were not diverse and that the exclusion criteria generally meant that women with cardiovascular challenges or cancer were not included.

“That’s one of the biggest questions — what is the safety in women with cardiovascular risk factors or history of a blood clot or history of a cancer? The data is just completely absent there,” Dr. Faubion said.
 

The Connection Between GSM and Urinary Tract Infections (UTIs)

“Genitourinary syndrome of menopause is not just a little bit of vaginal dryness that can be cured with moisturizers and lubricants, but the syndrome can lead to recurrent urinary tract infections, which are extremely harmful and dangerous to our patients and cost the healthcare system a lot of money,” said Rachel Rubin, MD, a urologist and sexual medicine specialist in Bethesda, Maryland.

Lubricants and moisturizers can all help with the symptoms of GSM, at least in the short term, Dr. Rubin noted. But only hormones can get to the root of the problem and reduce the risk for a recurrent UTI (rUTI), Dr. Rubin added, noting that the American Urological Association recommends the use of vaginal estrogen to reduce the risk for rUTIs and is developing the clinical practice guidelines for GSM.

Dr. Danan’s review did not address the association between UTIs and GSM, but Dr. Rubin said she sees the link in clinical practice.

“Recurrent urinary tract infections occur because of GSM, because of the lack of hormones to the tissue,” sometimes when a woman is in her 60s or 70s and thinks menopause is long over, Dr. Rubin said.

The reality is that women may need to take hormones for decades to reduce the risk for UTIs, another reason longer-term safety data are needed, Dr. Rubin said.

Dr. Danan, Dr. Faubion, and Dr. Rubin reported no relevant financial relationships.

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

A more definitive picture of how some hormones and moisturizers can offer relief to women experiencing vaginal dryness or painful intercourse during menopause was published in a recent systematic review in Annals of Internal Medicine. However, researchers noted scant long-term data on the safety of these products.

Vaginal dryness and challenges with intercourse and urination are among the symptoms of genitourinary syndrome of menopause (GSM). Hormones such as vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), or oral ospemifene are common treatments, along with moisturizers.

“The main finding is that commonly used therapies are likely to be effective for the common symptoms people have for GSM,” particularly vaginal dryness and painful intercourse, said Elisheva Danan, MD, MPH, a primary care physician and health services researcher at the Minneapolis VA Health Care System and assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, who was the lead study author.

Many women might recognize hot flashes as connected to menopause, Dr. Danan said, as these tend to occur with the cessation of the menstrual cycle. However, genitourinary effects may not manifest until a few years later and worsen over time, when the connection to menopause is less clear.

“Women might not bring it up or think there’s a treatment that can work,” Dr. Danan said.

The systematic review may provide clinicians with more evidence of specific treatments to recommend. However, most of the trials included in the analysis studied treatment periods of 12 weeks or less, so the safety of long-term use is unclear.

“One question that hasn’t been answered yet in clinical trials is whether there could be a risk of uterine cancer with extended use of any of these treatments,” Dr. Danan said, because vaginal estrogen or ospemifene could stimulate growth of the uterine lining.

The studies Dr. Danan and colleagues found showed no increased risk for uterine cancer, but Dr, Danan noted that the maximum follow-up was 1 year, and study participants had a low risk for cancer to begin with. She advised that clinicians closely monitor women with risk factors if they use hormones to treat GSM indefinitely.
 

Forty-Six Randomized Controlled Trials, Many Open Questions

Dr. Danan and her colleagues conducted a systematic review of 46 randomized controlled trials, meant to inform an upcoming clinical practice guideline from the American Urological Association on treatment of GSM. Dr. Danan’s work was funded by the Patient-Centered Outcomes Research Institute.

Studies evaluated vaginal estrogen (22), other hormones such as vaginal oxytocin or vaginal testosterone (16), vaginal moisturizers (4), and multiple interventions (4).

Included trials lasted at least 8 weeks and included at least 20 postmenopausal women; most treatments lasted 12 weeks or less. Studies used varying definitions of GSM, and no head-to-head trials of different treatments were found.

Researchers used the Core Outcomes in Menopause (COMMA) framework, developed in 2021 to standardize outcomes research in menopause care and to understand treatment effectiveness. They applied this framework retroactively, as almost all the studies in the review were written before the COMMA framework existed.

Hormonal treatments were associated with reduced pain during intercourse and decreased vaginal dryness; moisturizers were linked to reduced dryness.

Vaginal estrogen did not reduce pain during intercourse as consistently as DHEA or oral ospemifene, per the review. Dr. Danan and her coauthors said this could be because the DHEA and ospemifene trials were larger and more uniformly conducted than those for vaginal estrogen. Even so, vaginal estrogen outperformed placebo at reducing painful intercourse.

But given the short timeframe of most studies and the differing definitions of GSM symptoms, Dr. Danan cautioned that all their conclusions have low certainty.

Few studies examined whether these treatments reduced vaginal itchiness or difficulties with urination. And the authors found no evidence for the benefit of oral DHEA, raloxifene, bazedoxifene, vaginal oxytocin, or vaginal testosterone for GSM treatment.

In an accompanying report, the researchers found no evidence for the benefits of treatments such as vaginal testosterone or vaginal laser therapy.

Stephanie Faubion, MD, MBA, medical director for the North American Menopause Society and director of the Mayo Clinic Center for Women’s Health, Rochester, Minnesota, wrote an accompanying editorial noting that the patients represented in the GSM treatment clinical trials were not diverse and that the exclusion criteria generally meant that women with cardiovascular challenges or cancer were not included.

“That’s one of the biggest questions — what is the safety in women with cardiovascular risk factors or history of a blood clot or history of a cancer? The data is just completely absent there,” Dr. Faubion said.
 

The Connection Between GSM and Urinary Tract Infections (UTIs)

“Genitourinary syndrome of menopause is not just a little bit of vaginal dryness that can be cured with moisturizers and lubricants, but the syndrome can lead to recurrent urinary tract infections, which are extremely harmful and dangerous to our patients and cost the healthcare system a lot of money,” said Rachel Rubin, MD, a urologist and sexual medicine specialist in Bethesda, Maryland.

Lubricants and moisturizers can all help with the symptoms of GSM, at least in the short term, Dr. Rubin noted. But only hormones can get to the root of the problem and reduce the risk for a recurrent UTI (rUTI), Dr. Rubin added, noting that the American Urological Association recommends the use of vaginal estrogen to reduce the risk for rUTIs and is developing the clinical practice guidelines for GSM.

Dr. Danan’s review did not address the association between UTIs and GSM, but Dr. Rubin said she sees the link in clinical practice.

“Recurrent urinary tract infections occur because of GSM, because of the lack of hormones to the tissue,” sometimes when a woman is in her 60s or 70s and thinks menopause is long over, Dr. Rubin said.

The reality is that women may need to take hormones for decades to reduce the risk for UTIs, another reason longer-term safety data are needed, Dr. Rubin said.

Dr. Danan, Dr. Faubion, and Dr. Rubin reported no relevant financial relationships.

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

A more definitive picture of how some hormones and moisturizers can offer relief to women experiencing vaginal dryness or painful intercourse during menopause was published in a recent systematic review in Annals of Internal Medicine. However, researchers noted scant long-term data on the safety of these products.

Vaginal dryness and challenges with intercourse and urination are among the symptoms of genitourinary syndrome of menopause (GSM). Hormones such as vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), or oral ospemifene are common treatments, along with moisturizers.

“The main finding is that commonly used therapies are likely to be effective for the common symptoms people have for GSM,” particularly vaginal dryness and painful intercourse, said Elisheva Danan, MD, MPH, a primary care physician and health services researcher at the Minneapolis VA Health Care System and assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, who was the lead study author.

Many women might recognize hot flashes as connected to menopause, Dr. Danan said, as these tend to occur with the cessation of the menstrual cycle. However, genitourinary effects may not manifest until a few years later and worsen over time, when the connection to menopause is less clear.

“Women might not bring it up or think there’s a treatment that can work,” Dr. Danan said.

The systematic review may provide clinicians with more evidence of specific treatments to recommend. However, most of the trials included in the analysis studied treatment periods of 12 weeks or less, so the safety of long-term use is unclear.

“One question that hasn’t been answered yet in clinical trials is whether there could be a risk of uterine cancer with extended use of any of these treatments,” Dr. Danan said, because vaginal estrogen or ospemifene could stimulate growth of the uterine lining.

The studies Dr. Danan and colleagues found showed no increased risk for uterine cancer, but Dr, Danan noted that the maximum follow-up was 1 year, and study participants had a low risk for cancer to begin with. She advised that clinicians closely monitor women with risk factors if they use hormones to treat GSM indefinitely.
 

Forty-Six Randomized Controlled Trials, Many Open Questions

Dr. Danan and her colleagues conducted a systematic review of 46 randomized controlled trials, meant to inform an upcoming clinical practice guideline from the American Urological Association on treatment of GSM. Dr. Danan’s work was funded by the Patient-Centered Outcomes Research Institute.

Studies evaluated vaginal estrogen (22), other hormones such as vaginal oxytocin or vaginal testosterone (16), vaginal moisturizers (4), and multiple interventions (4).

Included trials lasted at least 8 weeks and included at least 20 postmenopausal women; most treatments lasted 12 weeks or less. Studies used varying definitions of GSM, and no head-to-head trials of different treatments were found.

Researchers used the Core Outcomes in Menopause (COMMA) framework, developed in 2021 to standardize outcomes research in menopause care and to understand treatment effectiveness. They applied this framework retroactively, as almost all the studies in the review were written before the COMMA framework existed.

Hormonal treatments were associated with reduced pain during intercourse and decreased vaginal dryness; moisturizers were linked to reduced dryness.

Vaginal estrogen did not reduce pain during intercourse as consistently as DHEA or oral ospemifene, per the review. Dr. Danan and her coauthors said this could be because the DHEA and ospemifene trials were larger and more uniformly conducted than those for vaginal estrogen. Even so, vaginal estrogen outperformed placebo at reducing painful intercourse.

But given the short timeframe of most studies and the differing definitions of GSM symptoms, Dr. Danan cautioned that all their conclusions have low certainty.

Few studies examined whether these treatments reduced vaginal itchiness or difficulties with urination. And the authors found no evidence for the benefit of oral DHEA, raloxifene, bazedoxifene, vaginal oxytocin, or vaginal testosterone for GSM treatment.

In an accompanying report, the researchers found no evidence for the benefits of treatments such as vaginal testosterone or vaginal laser therapy.

Stephanie Faubion, MD, MBA, medical director for the North American Menopause Society and director of the Mayo Clinic Center for Women’s Health, Rochester, Minnesota, wrote an accompanying editorial noting that the patients represented in the GSM treatment clinical trials were not diverse and that the exclusion criteria generally meant that women with cardiovascular challenges or cancer were not included.

“That’s one of the biggest questions — what is the safety in women with cardiovascular risk factors or history of a blood clot or history of a cancer? The data is just completely absent there,” Dr. Faubion said.
 

The Connection Between GSM and Urinary Tract Infections (UTIs)

“Genitourinary syndrome of menopause is not just a little bit of vaginal dryness that can be cured with moisturizers and lubricants, but the syndrome can lead to recurrent urinary tract infections, which are extremely harmful and dangerous to our patients and cost the healthcare system a lot of money,” said Rachel Rubin, MD, a urologist and sexual medicine specialist in Bethesda, Maryland.

Lubricants and moisturizers can all help with the symptoms of GSM, at least in the short term, Dr. Rubin noted. But only hormones can get to the root of the problem and reduce the risk for a recurrent UTI (rUTI), Dr. Rubin added, noting that the American Urological Association recommends the use of vaginal estrogen to reduce the risk for rUTIs and is developing the clinical practice guidelines for GSM.

Dr. Danan’s review did not address the association between UTIs and GSM, but Dr. Rubin said she sees the link in clinical practice.

“Recurrent urinary tract infections occur because of GSM, because of the lack of hormones to the tissue,” sometimes when a woman is in her 60s or 70s and thinks menopause is long over, Dr. Rubin said.

The reality is that women may need to take hormones for decades to reduce the risk for UTIs, another reason longer-term safety data are needed, Dr. Rubin said.

Dr. Danan, Dr. Faubion, and Dr. Rubin reported no relevant financial relationships.

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

Vitiligo, the most common skin pigmentation disorder, has affected patients for thousands of years.¹ The psychological and social impacts on patients include sleep and sexual disorders, low self-esteem, low quality of life, anxiety, and depression when compared to those without vitiligo.^2,3 There have been substantial therapeutic advancements in the treatment of vitiligo, with the recent approval of ruxolitinib cream 1.5% by the US Food and Drug Administration (FDA) in 2022 and by the European Medicines Agency in 2023.⁴ Ruxolitinib is the first topical Janus kinase (JAK) inhibitor approved by the FDA for the treatment of nonsegmental vitiligo in patients 12 years and older, ushering in the era of JAK inhibitors for patients affected by vitiligo. The efficacy and safety of ruxolitinib was supported by 2 randomized clinical trials.⁴ It also is FDA approved for the intermittent and short-term treatment of mild to moderate atopic dermatitis in nonimmunocompromised patients 12 years and older whose disease is not adequately controlled with other topical medications.⁵

Vitiligo is characterized by an important inflammatory component, with the JAK/STAT (signal transducer and activator of transcription) pathway playing a crucial role in transmitting signals of inflammatory cytokines. In particular, IFN-γ and chemokines CXCL9 and CXCL10 are major contributors to the development of vitiligo, acting through the JAK/STAT pathway in local keratinocytes. Inhibiting JAK activity helps mitigate the effects of IFN-γ and downstream chemokines.⁶

Currently, baricitinib is not FDA approved for the treatment of vitiligo; it is FDA approved for moderate to severe active rheumatoid arthritis, severe alopecia areata, and in specific cases for COVID-19.⁷ Mumford et al⁸ first reported the use of oral baricitinib for the treatment of nonsegmental vitiligo. This patient experienced poor improvement using the oral JAK inhibitor tofacitinib for 5 months but achieved near-complete repigmentation after switching to baricitinib for 8 months (4 mg daily).⁸ Furthermore, a recent study found that in vitro baricitinib could increase tyrosinase activity and melanin content as well as stimulate the expression of genes related to tyrosinase in damaged melanocytes.⁹

A recent study by Li et al¹⁰ has shown satisfactory repigmentation and good tolerance in 2 cases of vitiligo treated with oral baricitinib in combination with narrowband UVB (NB-UVB) phototherapy. These findings are supported by a prior study of oral tofacitinib and NB-UVB phototherapy in 10 cases; the JAK inhibitor treatment demonstrated enhanced effectiveness when combined with light exposure.¹¹

Large-scale randomized clinical trials are needed to evaluate the efficacy and safety of oral baricitinib for vitiligo treatment. Currently, a clinical trial is underway (recruiting phase) to compare the efficacy and safety of combining baricitinib and excimer lamp phototherapy vs phototherapy alone.¹² The results of this trial can provide valuable information about whether baricitinib is promising as part of the therapeutic arsenal for vitiligo treatment in the future. A recently completed multicenter, randomized, double-blind clinical trial assessed the efficacy and tolerability of oral baricitinib in combination with NB-UVB phototherapy for the treatment of vitiligo. The trial included 49 patients and may provide valuable insights for the potential future application of baricitinib in the treatment of vitiligo.¹³ If the results of these clinical trials are favorable, approval of the first orally administered JAK inhibitor for repigmentation treatment in patients with vitiligo could follow, which would be a major breakthrough.

The off-label use of baricitinib—alone or in combination with phototherapy—appears to be promising in studies with a small sample size (an important limitation). The results of clinical trials will help us elucidate the efficacy and safety of baricitinib for vitiligo treatment, which could be a subject of debate. Recently, the FDA issued a warning due to findings showing that the use of tofacitinib has been associated with an increased risk of serious heart-related events, such heart attack, stroke, cancer, blood clots, and death.¹⁴ In response, the FDA issued warnings for 2 other JAK inhibitors—baricitinib and upadacitinib. Unlike tofacitinib, baricitinib and upadacitinib have not been studied in large safety clinical trials, and as a result, their risks have not been adequately evaluated. However, due to the shared mechanisms of action of these drugs, the FDA believes that these medications may pose similar risks as those observed in the tofacitinib safety trial.¹⁴

Disadvantages of JAK inhibitors include the high cost, immune-related side effects, potential cardiovascular adverse effects, and limited availability worldwide. If current and future clinical trials obtain objective evidence with a large sample size that yields positive outcomes with tolerable or acceptable side effects, and if the drug is affordable for hospitals and patients, the use of oral or topical baricitinib will be embraced and may be approved for vitiligo.

Vitiligo, the most common skin pigmentation disorder, has affected patients for thousands of years.¹ The psychological and social impacts on patients include sleep and sexual disorders, low self-esteem, low quality of life, anxiety, and depression when compared to those without vitiligo.^2,3 There have been substantial therapeutic advancements in the treatment of vitiligo, with the recent approval of ruxolitinib cream 1.5% by the US Food and Drug Administration (FDA) in 2022 and by the European Medicines Agency in 2023.⁴ Ruxolitinib is the first topical Janus kinase (JAK) inhibitor approved by the FDA for the treatment of nonsegmental vitiligo in patients 12 years and older, ushering in the era of JAK inhibitors for patients affected by vitiligo. The efficacy and safety of ruxolitinib was supported by 2 randomized clinical trials.⁴ It also is FDA approved for the intermittent and short-term treatment of mild to moderate atopic dermatitis in nonimmunocompromised patients 12 years and older whose disease is not adequately controlled with other topical medications.⁵

Vitiligo is characterized by an important inflammatory component, with the JAK/STAT (signal transducer and activator of transcription) pathway playing a crucial role in transmitting signals of inflammatory cytokines. In particular, IFN-γ and chemokines CXCL9 and CXCL10 are major contributors to the development of vitiligo, acting through the JAK/STAT pathway in local keratinocytes. Inhibiting JAK activity helps mitigate the effects of IFN-γ and downstream chemokines.⁶

Currently, baricitinib is not FDA approved for the treatment of vitiligo; it is FDA approved for moderate to severe active rheumatoid arthritis, severe alopecia areata, and in specific cases for COVID-19.⁷ Mumford et al⁸ first reported the use of oral baricitinib for the treatment of nonsegmental vitiligo. This patient experienced poor improvement using the oral JAK inhibitor tofacitinib for 5 months but achieved near-complete repigmentation after switching to baricitinib for 8 months (4 mg daily).⁸ Furthermore, a recent study found that in vitro baricitinib could increase tyrosinase activity and melanin content as well as stimulate the expression of genes related to tyrosinase in damaged melanocytes.⁹

A recent study by Li et al¹⁰ has shown satisfactory repigmentation and good tolerance in 2 cases of vitiligo treated with oral baricitinib in combination with narrowband UVB (NB-UVB) phototherapy. These findings are supported by a prior study of oral tofacitinib and NB-UVB phototherapy in 10 cases; the JAK inhibitor treatment demonstrated enhanced effectiveness when combined with light exposure.¹¹

Large-scale randomized clinical trials are needed to evaluate the efficacy and safety of oral baricitinib for vitiligo treatment. Currently, a clinical trial is underway (recruiting phase) to compare the efficacy and safety of combining baricitinib and excimer lamp phototherapy vs phototherapy alone.¹² The results of this trial can provide valuable information about whether baricitinib is promising as part of the therapeutic arsenal for vitiligo treatment in the future. A recently completed multicenter, randomized, double-blind clinical trial assessed the efficacy and tolerability of oral baricitinib in combination with NB-UVB phototherapy for the treatment of vitiligo. The trial included 49 patients and may provide valuable insights for the potential future application of baricitinib in the treatment of vitiligo.¹³ If the results of these clinical trials are favorable, approval of the first orally administered JAK inhibitor for repigmentation treatment in patients with vitiligo could follow, which would be a major breakthrough.

The off-label use of baricitinib—alone or in combination with phototherapy—appears to be promising in studies with a small sample size (an important limitation). The results of clinical trials will help us elucidate the efficacy and safety of baricitinib for vitiligo treatment, which could be a subject of debate. Recently, the FDA issued a warning due to findings showing that the use of tofacitinib has been associated with an increased risk of serious heart-related events, such heart attack, stroke, cancer, blood clots, and death.¹⁴ In response, the FDA issued warnings for 2 other JAK inhibitors—baricitinib and upadacitinib. Unlike tofacitinib, baricitinib and upadacitinib have not been studied in large safety clinical trials, and as a result, their risks have not been adequately evaluated. However, due to the shared mechanisms of action of these drugs, the FDA believes that these medications may pose similar risks as those observed in the tofacitinib safety trial.¹⁴

Disadvantages of JAK inhibitors include the high cost, immune-related side effects, potential cardiovascular adverse effects, and limited availability worldwide. If current and future clinical trials obtain objective evidence with a large sample size that yields positive outcomes with tolerable or acceptable side effects, and if the drug is affordable for hospitals and patients, the use of oral or topical baricitinib will be embraced and may be approved for vitiligo.

Vitiligo, the most common skin pigmentation disorder, has affected patients for thousands of years.¹ The psychological and social impacts on patients include sleep and sexual disorders, low self-esteem, low quality of life, anxiety, and depression when compared to those without vitiligo.^2,3 There have been substantial therapeutic advancements in the treatment of vitiligo, with the recent approval of ruxolitinib cream 1.5% by the US Food and Drug Administration (FDA) in 2022 and by the European Medicines Agency in 2023.⁴ Ruxolitinib is the first topical Janus kinase (JAK) inhibitor approved by the FDA for the treatment of nonsegmental vitiligo in patients 12 years and older, ushering in the era of JAK inhibitors for patients affected by vitiligo. The efficacy and safety of ruxolitinib was supported by 2 randomized clinical trials.⁴ It also is FDA approved for the intermittent and short-term treatment of mild to moderate atopic dermatitis in nonimmunocompromised patients 12 years and older whose disease is not adequately controlled with other topical medications.⁵

Vitiligo is characterized by an important inflammatory component, with the JAK/STAT (signal transducer and activator of transcription) pathway playing a crucial role in transmitting signals of inflammatory cytokines. In particular, IFN-γ and chemokines CXCL9 and CXCL10 are major contributors to the development of vitiligo, acting through the JAK/STAT pathway in local keratinocytes. Inhibiting JAK activity helps mitigate the effects of IFN-γ and downstream chemokines.⁶

Currently, baricitinib is not FDA approved for the treatment of vitiligo; it is FDA approved for moderate to severe active rheumatoid arthritis, severe alopecia areata, and in specific cases for COVID-19.⁷ Mumford et al⁸ first reported the use of oral baricitinib for the treatment of nonsegmental vitiligo. This patient experienced poor improvement using the oral JAK inhibitor tofacitinib for 5 months but achieved near-complete repigmentation after switching to baricitinib for 8 months (4 mg daily).⁸ Furthermore, a recent study found that in vitro baricitinib could increase tyrosinase activity and melanin content as well as stimulate the expression of genes related to tyrosinase in damaged melanocytes.⁹

A recent study by Li et al¹⁰ has shown satisfactory repigmentation and good tolerance in 2 cases of vitiligo treated with oral baricitinib in combination with narrowband UVB (NB-UVB) phototherapy. These findings are supported by a prior study of oral tofacitinib and NB-UVB phototherapy in 10 cases; the JAK inhibitor treatment demonstrated enhanced effectiveness when combined with light exposure.¹¹

Large-scale randomized clinical trials are needed to evaluate the efficacy and safety of oral baricitinib for vitiligo treatment. Currently, a clinical trial is underway (recruiting phase) to compare the efficacy and safety of combining baricitinib and excimer lamp phototherapy vs phototherapy alone.¹² The results of this trial can provide valuable information about whether baricitinib is promising as part of the therapeutic arsenal for vitiligo treatment in the future. A recently completed multicenter, randomized, double-blind clinical trial assessed the efficacy and tolerability of oral baricitinib in combination with NB-UVB phototherapy for the treatment of vitiligo. The trial included 49 patients and may provide valuable insights for the potential future application of baricitinib in the treatment of vitiligo.¹³ If the results of these clinical trials are favorable, approval of the first orally administered JAK inhibitor for repigmentation treatment in patients with vitiligo could follow, which would be a major breakthrough.

The off-label use of baricitinib—alone or in combination with phototherapy—appears to be promising in studies with a small sample size (an important limitation). The results of clinical trials will help us elucidate the efficacy and safety of baricitinib for vitiligo treatment, which could be a subject of debate. Recently, the FDA issued a warning due to findings showing that the use of tofacitinib has been associated with an increased risk of serious heart-related events, such heart attack, stroke, cancer, blood clots, and death.¹⁴ In response, the FDA issued warnings for 2 other JAK inhibitors—baricitinib and upadacitinib. Unlike tofacitinib, baricitinib and upadacitinib have not been studied in large safety clinical trials, and as a result, their risks have not been adequately evaluated. However, due to the shared mechanisms of action of these drugs, the FDA believes that these medications may pose similar risks as those observed in the tofacitinib safety trial.¹⁴

Disadvantages of JAK inhibitors include the high cost, immune-related side effects, potential cardiovascular adverse effects, and limited availability worldwide. If current and future clinical trials obtain objective evidence with a large sample size that yields positive outcomes with tolerable or acceptable side effects, and if the drug is affordable for hospitals and patients, the use of oral or topical baricitinib will be embraced and may be approved for vitiligo.

TOPLINE:

MRI-derived abdominal adipose tissue is linked to chronic musculoskeletal pain in multiple sites. The association is stronger in women, suggesting sex differences in fat distribution and hormones.

METHODOLOGY:

• Researchers used data from the UK Biobank, a large population-based cohort study, to investigate the associations between MRI-measured abdominal adipose tissue and chronic musculoskeletal pain.
• A total of 32,409 participants (50.8% women; mean age, 55.0 ± 7.4 years) were included in the analysis, with abdominal MRI scans performed at two imaging visits.
• Pain in the neck/shoulder, back, hip, knee, or “all over the body” was assessed, and participants were categorized based on the number of chronic pain sites.
• Mixed-effects ordinal, multinomial, and logistic regression models were used to analyze the associations between visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and their ratio with chronic pain.

TAKEAWAY:

• According to the authors, there was a dose-response association between VAT, SAT, and their ratio with the number of chronic pain sites in both women and men.
• Higher levels of abdominal adipose tissue were associated with greater odds of reporting chronic pain in both sexes, with effect estimates being relatively larger in women.
• The researchers found that the VAT/SAT ratio was associated with the number of chronic pain sites and chronic pain in both sexes, reflecting differences in fat distribution and hormones.
• The study suggested that excessive abdominal adipose tissue may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain.

IN PRACTICE:

“Abdominal adipose tissue was associated with chronic musculoskeletal pain, suggesting that excessive and ectopic fat depositions may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain,” wrote the authors of the study.

SOURCE:

This study was led by Zemene Demelash Kifle, University of Tasmania Menzies Institute for Medical Research in Hobart, Australia. It was published online in Regional Anesthesia & Pain Medicine.

LIMITATIONS: 

The study’s limitations included the use of a pain questionnaire that did not assess pain severity, which limited the ability to examine the relationship between fat measures and pain severity. Additionally, MRI was conducted on only two occasions, which may have not captured patterns and fluctuations in chronic pain sites. The relatively small size of the imaging sample, compared with the original baseline sample limited the generalizability of the findings. The predominant White ethnicity of participants also limited the generalizability to diverse populations.

DISCLOSURES:

The study was supported by grants from the Australian National Health and Medical Research Council (NHMRC). Mr. Kifle disclosed receiving grants from the Australian NHMRC. Additional disclosures are noted in the original article.

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

TOPLINE:

MRI-derived abdominal adipose tissue is linked to chronic musculoskeletal pain in multiple sites. The association is stronger in women, suggesting sex differences in fat distribution and hormones.

METHODOLOGY:

• Researchers used data from the UK Biobank, a large population-based cohort study, to investigate the associations between MRI-measured abdominal adipose tissue and chronic musculoskeletal pain.
• A total of 32,409 participants (50.8% women; mean age, 55.0 ± 7.4 years) were included in the analysis, with abdominal MRI scans performed at two imaging visits.
• Pain in the neck/shoulder, back, hip, knee, or “all over the body” was assessed, and participants were categorized based on the number of chronic pain sites.
• Mixed-effects ordinal, multinomial, and logistic regression models were used to analyze the associations between visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and their ratio with chronic pain.

TAKEAWAY:

• According to the authors, there was a dose-response association between VAT, SAT, and their ratio with the number of chronic pain sites in both women and men.
• Higher levels of abdominal adipose tissue were associated with greater odds of reporting chronic pain in both sexes, with effect estimates being relatively larger in women.
• The researchers found that the VAT/SAT ratio was associated with the number of chronic pain sites and chronic pain in both sexes, reflecting differences in fat distribution and hormones.
• The study suggested that excessive abdominal adipose tissue may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain.

IN PRACTICE:

“Abdominal adipose tissue was associated with chronic musculoskeletal pain, suggesting that excessive and ectopic fat depositions may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain,” wrote the authors of the study.

SOURCE:

This study was led by Zemene Demelash Kifle, University of Tasmania Menzies Institute for Medical Research in Hobart, Australia. It was published online in Regional Anesthesia & Pain Medicine.

LIMITATIONS: 

The study’s limitations included the use of a pain questionnaire that did not assess pain severity, which limited the ability to examine the relationship between fat measures and pain severity. Additionally, MRI was conducted on only two occasions, which may have not captured patterns and fluctuations in chronic pain sites. The relatively small size of the imaging sample, compared with the original baseline sample limited the generalizability of the findings. The predominant White ethnicity of participants also limited the generalizability to diverse populations.

DISCLOSURES:

The study was supported by grants from the Australian National Health and Medical Research Council (NHMRC). Mr. Kifle disclosed receiving grants from the Australian NHMRC. Additional disclosures are noted in the original article.

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

TOPLINE:

MRI-derived abdominal adipose tissue is linked to chronic musculoskeletal pain in multiple sites. The association is stronger in women, suggesting sex differences in fat distribution and hormones.

METHODOLOGY:

• Researchers used data from the UK Biobank, a large population-based cohort study, to investigate the associations between MRI-measured abdominal adipose tissue and chronic musculoskeletal pain.
• A total of 32,409 participants (50.8% women; mean age, 55.0 ± 7.4 years) were included in the analysis, with abdominal MRI scans performed at two imaging visits.
• Pain in the neck/shoulder, back, hip, knee, or “all over the body” was assessed, and participants were categorized based on the number of chronic pain sites.
• Mixed-effects ordinal, multinomial, and logistic regression models were used to analyze the associations between visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and their ratio with chronic pain.

TAKEAWAY:

• According to the authors, there was a dose-response association between VAT, SAT, and their ratio with the number of chronic pain sites in both women and men.
• Higher levels of abdominal adipose tissue were associated with greater odds of reporting chronic pain in both sexes, with effect estimates being relatively larger in women.
• The researchers found that the VAT/SAT ratio was associated with the number of chronic pain sites and chronic pain in both sexes, reflecting differences in fat distribution and hormones.
• The study suggested that excessive abdominal adipose tissue may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain.

IN PRACTICE:

“Abdominal adipose tissue was associated with chronic musculoskeletal pain, suggesting that excessive and ectopic fat depositions may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain,” wrote the authors of the study.

SOURCE:

This study was led by Zemene Demelash Kifle, University of Tasmania Menzies Institute for Medical Research in Hobart, Australia. It was published online in Regional Anesthesia & Pain Medicine.

LIMITATIONS: 

The study’s limitations included the use of a pain questionnaire that did not assess pain severity, which limited the ability to examine the relationship between fat measures and pain severity. Additionally, MRI was conducted on only two occasions, which may have not captured patterns and fluctuations in chronic pain sites. The relatively small size of the imaging sample, compared with the original baseline sample limited the generalizability of the findings. The predominant White ethnicity of participants also limited the generalizability to diverse populations.

DISCLOSURES:

The study was supported by grants from the Australian National Health and Medical Research Council (NHMRC). Mr. Kifle disclosed receiving grants from the Australian NHMRC. Additional disclosures are noted in the original article.

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

TOPLINE:

The likelihood of receiving a dementia diagnosis in older adults varies significantly by region across the United States, a new study suggests. Rates ranged from 1.7% to 5.4%, with variations more pronounced in those aged 66-74 years and Black or Hispanic individuals.

METHODOLOGY:

• Researchers analyzed newly diagnosed cases of Alzheimer’s disease and related dementias (ADRD) using the 2018-2019 Medicare claims data for 4.8 million older adults across 306 hospital referral regions (HRRs).
• Participants were categorized by age and race or ethnicity to examine variations in diagnosis rates.
• Regional characteristics such as education level and prevalence of obesity, smoking, and diabetes were included to adjust for population risk factors.
• ADRD-specific diagnostic intensity was calculated as the ratio of the observed-to-expected new cases of ADRD in each HRR.

TAKEAWAY:

• Unadjusted analysis for that overall, 3% of older adults received a new ADRD diagnosis in 2019, with rates ranging from 1.7 to 5.4 per 100 individuals across HRRs and varied by age category.
• Regions in the South had the highest unadjusted ADRD case concentration, and the areas in the West/Northwest had the lowest.
• The ADRD-specific diagnosis intensity was 0.69-1.47 and varied the most in Black and Hispanic individuals and those aged 66-74 years.
• Regional differences in ADRD diagnosis rates are not fully explained by population risk factors, indicating potential health system-level differences.

IN PRACTICE:

“From place to place, the likelihood of getting your dementia diagnosed varies, and that may happen because of everything from practice norms for healthcare providers to individual patients’ knowledge and care-seeking behavior. These findings go beyond demographic and population-level differences in risk and indicate that there are health system-level differences that could be targeted and remediated,” lead author Julie P.W. Bynum, MD, MPH, said in a press release.

SOURCE:

The study was led by Dr. Bynum, professor of internal medicine, University of Michigan Medical School, Ann Arbor, Michigan, and published online in Alzheimer’s & Dementia.

LIMITATIONS:

The results may not be generalizable to other groups. The observational design of the study cannot completely negate residual confounding. The measures of population risks are coarser than those used in well-characterized epidemiologic studies, leading to potential imprecision. Finally, the study was not designed to determine whether regional differences in the likelihood of ADRD diagnosis resulted in differences in the population health outcomes.

DISCLOSURES:

The study was supported by a grant from the National Institute on Aging. The authors reported 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 first appeared on Medscape.com.

TOPLINE:

The likelihood of receiving a dementia diagnosis in older adults varies significantly by region across the United States, a new study suggests. Rates ranged from 1.7% to 5.4%, with variations more pronounced in those aged 66-74 years and Black or Hispanic individuals.

METHODOLOGY:

• Researchers analyzed newly diagnosed cases of Alzheimer’s disease and related dementias (ADRD) using the 2018-2019 Medicare claims data for 4.8 million older adults across 306 hospital referral regions (HRRs).
• Participants were categorized by age and race or ethnicity to examine variations in diagnosis rates.
• Regional characteristics such as education level and prevalence of obesity, smoking, and diabetes were included to adjust for population risk factors.
• ADRD-specific diagnostic intensity was calculated as the ratio of the observed-to-expected new cases of ADRD in each HRR.

TAKEAWAY:

• Unadjusted analysis for that overall, 3% of older adults received a new ADRD diagnosis in 2019, with rates ranging from 1.7 to 5.4 per 100 individuals across HRRs and varied by age category.
• Regions in the South had the highest unadjusted ADRD case concentration, and the areas in the West/Northwest had the lowest.
• The ADRD-specific diagnosis intensity was 0.69-1.47 and varied the most in Black and Hispanic individuals and those aged 66-74 years.
• Regional differences in ADRD diagnosis rates are not fully explained by population risk factors, indicating potential health system-level differences.

IN PRACTICE:

“From place to place, the likelihood of getting your dementia diagnosed varies, and that may happen because of everything from practice norms for healthcare providers to individual patients’ knowledge and care-seeking behavior. These findings go beyond demographic and population-level differences in risk and indicate that there are health system-level differences that could be targeted and remediated,” lead author Julie P.W. Bynum, MD, MPH, said in a press release.

SOURCE:

The study was led by Dr. Bynum, professor of internal medicine, University of Michigan Medical School, Ann Arbor, Michigan, and published online in Alzheimer’s & Dementia.

LIMITATIONS:

The results may not be generalizable to other groups. The observational design of the study cannot completely negate residual confounding. The measures of population risks are coarser than those used in well-characterized epidemiologic studies, leading to potential imprecision. Finally, the study was not designed to determine whether regional differences in the likelihood of ADRD diagnosis resulted in differences in the population health outcomes.

DISCLOSURES:

The study was supported by a grant from the National Institute on Aging. The authors reported 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 first appeared on Medscape.com.

TOPLINE:

The likelihood of receiving a dementia diagnosis in older adults varies significantly by region across the United States, a new study suggests. Rates ranged from 1.7% to 5.4%, with variations more pronounced in those aged 66-74 years and Black or Hispanic individuals.

METHODOLOGY:

• Researchers analyzed newly diagnosed cases of Alzheimer’s disease and related dementias (ADRD) using the 2018-2019 Medicare claims data for 4.8 million older adults across 306 hospital referral regions (HRRs).
• Participants were categorized by age and race or ethnicity to examine variations in diagnosis rates.
• Regional characteristics such as education level and prevalence of obesity, smoking, and diabetes were included to adjust for population risk factors.
• ADRD-specific diagnostic intensity was calculated as the ratio of the observed-to-expected new cases of ADRD in each HRR.

TAKEAWAY:

• Unadjusted analysis for that overall, 3% of older adults received a new ADRD diagnosis in 2019, with rates ranging from 1.7 to 5.4 per 100 individuals across HRRs and varied by age category.
• Regions in the South had the highest unadjusted ADRD case concentration, and the areas in the West/Northwest had the lowest.
• The ADRD-specific diagnosis intensity was 0.69-1.47 and varied the most in Black and Hispanic individuals and those aged 66-74 years.
• Regional differences in ADRD diagnosis rates are not fully explained by population risk factors, indicating potential health system-level differences.

IN PRACTICE:

“From place to place, the likelihood of getting your dementia diagnosed varies, and that may happen because of everything from practice norms for healthcare providers to individual patients’ knowledge and care-seeking behavior. These findings go beyond demographic and population-level differences in risk and indicate that there are health system-level differences that could be targeted and remediated,” lead author Julie P.W. Bynum, MD, MPH, said in a press release.

SOURCE:

The study was led by Dr. Bynum, professor of internal medicine, University of Michigan Medical School, Ann Arbor, Michigan, and published online in Alzheimer’s & Dementia.

LIMITATIONS:

The results may not be generalizable to other groups. The observational design of the study cannot completely negate residual confounding. The measures of population risks are coarser than those used in well-characterized epidemiologic studies, leading to potential imprecision. Finally, the study was not designed to determine whether regional differences in the likelihood of ADRD diagnosis resulted in differences in the population health outcomes.

DISCLOSURES:

The study was supported by a grant from the National Institute on Aging. The authors reported 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 first appeared on Medscape.com.

TOPLINE:

A history of migraine is not associated with an elevated risk for Parkinson’s disease (PD) in women, regardless of headache frequency or migraine subtype, a new study suggests.

METHODOLOGY:

• Researchers analyzed data on 39,312 women health professionals aged ≥ 45 years and having no history of PD who enrolled in the Women’s Health Study between 1992 and 1995 and were followed until 2021.
• At baseline, 7321 women (18.6%) had migraine.
• The mean follow-up duration was 22 years.
• The primary outcome was a self-reported, physician-confirmed diagnosis of PD.

TAKEAWAY:

• During the study period, 685 women self-reported a diagnosis of PD.
• Of these, 18.7% of reported cases were in women with any migraine and 81.3% in women without migraine.
• No significant association was found between PD risk and a history of migraine, migraine subtypes (with or without aura), or migraine frequency.
• Migraine was not associated with a higher risk for PD than that of nonmigraine headaches.

IN PRACTICE:

“These results are reassuring for women who have migraine, which itself causes many burdens, that they don’t have to worry about an increased risk of Parkinson’s disease in the future,” study author Tobias Kurth, Charité - Universitätsmedizin Berlin, Germany, said in a press release.

SOURCE:

The study was led by Ricarda S. Schulz, MSc, Charité - Universitätsmedizin Berlin. It was published online in Neurology.

LIMITATIONS:

The study’s findings may not be generalizable to other populations, such as men and non-White individuals. The self-reported data on migraine and PD may be subject to inaccuracies. PD is often not diagnosed until symptoms have reached an advanced stage, potentially leading to cases being underreported. Changes in the status and frequency of migraine over the study period were not accounted for, which may have affected the results.

DISCLOSURES:

The authors did not disclose any specific funding for this work. The Women’s Health Study was supported by the National Cancer Institute and National Heart, Lung, and Blood Institute. Two authors reported having financial ties outside this work. Full disclosures are available in the original article.

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

TOPLINE:

A history of migraine is not associated with an elevated risk for Parkinson’s disease (PD) in women, regardless of headache frequency or migraine subtype, a new study suggests.

METHODOLOGY:

• Researchers analyzed data on 39,312 women health professionals aged ≥ 45 years and having no history of PD who enrolled in the Women’s Health Study between 1992 and 1995 and were followed until 2021.
• At baseline, 7321 women (18.6%) had migraine.
• The mean follow-up duration was 22 years.
• The primary outcome was a self-reported, physician-confirmed diagnosis of PD.

TAKEAWAY:

• During the study period, 685 women self-reported a diagnosis of PD.
• Of these, 18.7% of reported cases were in women with any migraine and 81.3% in women without migraine.
• No significant association was found between PD risk and a history of migraine, migraine subtypes (with or without aura), or migraine frequency.
• Migraine was not associated with a higher risk for PD than that of nonmigraine headaches.

IN PRACTICE:

“These results are reassuring for women who have migraine, which itself causes many burdens, that they don’t have to worry about an increased risk of Parkinson’s disease in the future,” study author Tobias Kurth, Charité - Universitätsmedizin Berlin, Germany, said in a press release.

SOURCE:

The study was led by Ricarda S. Schulz, MSc, Charité - Universitätsmedizin Berlin. It was published online in Neurology.

LIMITATIONS:

The study’s findings may not be generalizable to other populations, such as men and non-White individuals. The self-reported data on migraine and PD may be subject to inaccuracies. PD is often not diagnosed until symptoms have reached an advanced stage, potentially leading to cases being underreported. Changes in the status and frequency of migraine over the study period were not accounted for, which may have affected the results.

DISCLOSURES:

The authors did not disclose any specific funding for this work. The Women’s Health Study was supported by the National Cancer Institute and National Heart, Lung, and Blood Institute. Two authors reported having financial ties outside this work. Full disclosures are available in the original article.

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

TOPLINE:

A history of migraine is not associated with an elevated risk for Parkinson’s disease (PD) in women, regardless of headache frequency or migraine subtype, a new study suggests.

METHODOLOGY:

• Researchers analyzed data on 39,312 women health professionals aged ≥ 45 years and having no history of PD who enrolled in the Women’s Health Study between 1992 and 1995 and were followed until 2021.
• At baseline, 7321 women (18.6%) had migraine.
• The mean follow-up duration was 22 years.
• The primary outcome was a self-reported, physician-confirmed diagnosis of PD.

TAKEAWAY:

• During the study period, 685 women self-reported a diagnosis of PD.
• Of these, 18.7% of reported cases were in women with any migraine and 81.3% in women without migraine.
• No significant association was found between PD risk and a history of migraine, migraine subtypes (with or without aura), or migraine frequency.
• Migraine was not associated with a higher risk for PD than that of nonmigraine headaches.

IN PRACTICE:

“These results are reassuring for women who have migraine, which itself causes many burdens, that they don’t have to worry about an increased risk of Parkinson’s disease in the future,” study author Tobias Kurth, Charité - Universitätsmedizin Berlin, Germany, said in a press release.

SOURCE:

The study was led by Ricarda S. Schulz, MSc, Charité - Universitätsmedizin Berlin. It was published online in Neurology.

LIMITATIONS:

The study’s findings may not be generalizable to other populations, such as men and non-White individuals. The self-reported data on migraine and PD may be subject to inaccuracies. PD is often not diagnosed until symptoms have reached an advanced stage, potentially leading to cases being underreported. Changes in the status and frequency of migraine over the study period were not accounted for, which may have affected the results.

DISCLOSURES:

The authors did not disclose any specific funding for this work. The Women’s Health Study was supported by the National Cancer Institute and National Heart, Lung, and Blood Institute. Two authors reported having financial ties outside this work. Full disclosures are available in the original article.

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

I first heard the term “baby-led weaning” about 20 years ago, which turns out was just a few years after the concept was introduced to the public by a public health/midwife in Britain. Starting infants on solid foods when they could feed themselves didn’t sound as off-the-wall to me as it did to most other folks, but I chose not to include it in my list of standard recommendations at the 4- and 6-month well child visits. If any parent had asked me my opinion I would have told them to give it a try with a few specific cautions about what and how. But, I don’t recall any parents asking me. The ones who knew me well or had read, or at least heard about, my book on picky eating must have already figured out what my answer would be. The parents who didn’t know me may have been afraid I would tell them it was a crazy idea.

Twelve years ago I retired from office practice and hadn’t heard a peep about baby-led weaning until last week when I encountered a story in The New York Times. It appears that while I have been reveling in my post-practice existence, baby-led weaning has become a “thing.” As the author of the article observed: “The concept seems to appeal to millennials who favor parenting philosophies that prioritize child autonomy.”

Baby-led weaning’s traction has been so robust that the largest manufacturer of baby food in this country has been labeling some of its products “baby-led friendly since 2021.” There are several online businesses that have tapped into the growing market. One offers a very detailed free directory that lists almost any edible you can imagine with recommendations of when and how they can be presented in a safe and appealing matter to little hand feeders. Of course the company has also figured out a way to monetize the product.

Not surprisingly the American Academy of Pediatrics (AAP) has remained silent on baby-led weaning. However, in The New York Times article, Dr. Mark R. Corkins, chair of the AAP nutrition committee, is quoted as describing baby-led weaning is “a social media–driven invention.”

While I was interested to learn about the concept’s growth and commercialization, I was troubled to find that like co-sleeping, sleep training, and exclusive breastfeeding, baby-led weaning has become one of those angst-producing topics that is torturing new parents who live every day in fear that they “aren’t doing it right.” We pediatricians might deserve a small dose of blame for not vigorously emphasizing that there are numerous ways to skin that cat known as parenting. However, social media websites and Mom chat rooms are probably more responsible for creating an atmosphere in which parents are afraid of being ostracized for the decisions they have made in good faith whether it is about weaning or when to start toilet training.

In isolated cultures, weaning a baby to solids was probably never a topic for discussion or debate. New parents did what their parents did, or more likely a child’s grandmother advised or took over the process herself. The child was fed what the rest of the family ate. If it was something the infant could handle himself you gave it to him. If not you mashed it up or maybe you chewed it for him into a consistency he could manage.

However, most new parents have become so distanced from their own parents’ childrearing practices geographically, temporally, and philosophically, that they must rely on folks like us and others whom they believe are, or at least claim to be, experts. Young adults are no longer hesitant to cross ethnic thresholds when they decide to be co-parents, meaning that any remnant of family tradition is either diluted or lost outright. In the void created by this abandonment of tradition, corporations were happy to step in with easy-to-prepare baby food that lacks in nutritional and dietary variety. Baby-led weaning is just one more logical step in the metamorphosis of our society’s infant feeding patterns.

I still have no problem with baby-led weaning as an option for parents, particularly if with just a click of a mouse they can access safe and healthy advice to make up for generations of grandmotherly experience acquired over hundreds of years. However, I am deeply concerned when baby-led weaning is confused with the all-too-common disaster of child-led family meals.

It is one thing when parents hoping to encourage the process of self-feeding offer their infants an edible that may not be in the family’s usual diet. However, it is a totally different matter when a family allows itself to become dietary contortionists to a accommodate a 4-year-old whose diet consists of a monotonous rotation of three pasta shapes topped with grated Parmesan cheese, and on a good day a raw carrot slice or two. Parents living in this nutritional wasteland may have given up on managing their children’s pickiness, and may find it is less stressful to join the child and eat a few forkfuls of pasta to preserve some semblance of a family dinner. Then after the child has been put to bed they have their own balanced meal.

Almost by definition family meals are a compromise. Even adults without children negotiate often unspoken menu patterns with their partners. “This evening we’ll have your favorite, I may have my favorite next week.”

Most parents of young children understand that their diet may be a bit heavier on pasta than they might prefer and a little less varied when it comes to vegetables. It is just part of the deal. However, when mealtimes become totally dictated by the pickiness of a child there is a problem. While a poorly structured child-led family diet may be nutritionally deficient, the bigger problem is that it is expensive in time and labor, two resources usually in short supply in young families.

Theoretically, infants who have led their own weaning are more likely to have been introduced to a broad variety of flavors and textures and this may carry them into childhood as more adventuresome eaters. Picky eating can be managed successfully and result in a family that can enjoy the psychological and emotional benefits of nutritionally balanced family meals, but it requires a combination of parental courage and patience.

It is unclear exactly how we got into a situation in which a generation of parents makes things more difficult for themselves by favoring practices that overemphasize child autonomy. It may be that the parents had suffered under autocratic parents themselves, or more likely they have read too many novels or watched too many movies and TV shows in which the parents were portrayed as overbearing or controlling. Or, it may simply be that they haven’t had enough exposure to young children to realize that they all benefit from clear limits to a varying degree.

In the process of watching tens of thousands of parents, it has become clear to me that those who are the most successful are leaders and that they lead primarily by example. They have learned to be masters in the art of deception by creating a safe environment with sensible limits while at the same time fostering an atmosphere in which the child sees himself as participating in the process.

The biblical prophet Isaiah (11:6-9) in his description of how things will be different after the Lord acts to help his people predicts: “and a little child shall lead them.” This prediction fits nicely as the last in a string of crazy situations that includes a wolf living with a lamb and a leopard lying down with a calf.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I first heard the term “baby-led weaning” about 20 years ago, which turns out was just a few years after the concept was introduced to the public by a public health/midwife in Britain. Starting infants on solid foods when they could feed themselves didn’t sound as off-the-wall to me as it did to most other folks, but I chose not to include it in my list of standard recommendations at the 4- and 6-month well child visits. If any parent had asked me my opinion I would have told them to give it a try with a few specific cautions about what and how. But, I don’t recall any parents asking me. The ones who knew me well or had read, or at least heard about, my book on picky eating must have already figured out what my answer would be. The parents who didn’t know me may have been afraid I would tell them it was a crazy idea.

Twelve years ago I retired from office practice and hadn’t heard a peep about baby-led weaning until last week when I encountered a story in The New York Times. It appears that while I have been reveling in my post-practice existence, baby-led weaning has become a “thing.” As the author of the article observed: “The concept seems to appeal to millennials who favor parenting philosophies that prioritize child autonomy.”

Baby-led weaning’s traction has been so robust that the largest manufacturer of baby food in this country has been labeling some of its products “baby-led friendly since 2021.” There are several online businesses that have tapped into the growing market. One offers a very detailed free directory that lists almost any edible you can imagine with recommendations of when and how they can be presented in a safe and appealing matter to little hand feeders. Of course the company has also figured out a way to monetize the product.

Not surprisingly the American Academy of Pediatrics (AAP) has remained silent on baby-led weaning. However, in The New York Times article, Dr. Mark R. Corkins, chair of the AAP nutrition committee, is quoted as describing baby-led weaning is “a social media–driven invention.”

While I was interested to learn about the concept’s growth and commercialization, I was troubled to find that like co-sleeping, sleep training, and exclusive breastfeeding, baby-led weaning has become one of those angst-producing topics that is torturing new parents who live every day in fear that they “aren’t doing it right.” We pediatricians might deserve a small dose of blame for not vigorously emphasizing that there are numerous ways to skin that cat known as parenting. However, social media websites and Mom chat rooms are probably more responsible for creating an atmosphere in which parents are afraid of being ostracized for the decisions they have made in good faith whether it is about weaning or when to start toilet training.

In isolated cultures, weaning a baby to solids was probably never a topic for discussion or debate. New parents did what their parents did, or more likely a child’s grandmother advised or took over the process herself. The child was fed what the rest of the family ate. If it was something the infant could handle himself you gave it to him. If not you mashed it up or maybe you chewed it for him into a consistency he could manage.

However, most new parents have become so distanced from their own parents’ childrearing practices geographically, temporally, and philosophically, that they must rely on folks like us and others whom they believe are, or at least claim to be, experts. Young adults are no longer hesitant to cross ethnic thresholds when they decide to be co-parents, meaning that any remnant of family tradition is either diluted or lost outright. In the void created by this abandonment of tradition, corporations were happy to step in with easy-to-prepare baby food that lacks in nutritional and dietary variety. Baby-led weaning is just one more logical step in the metamorphosis of our society’s infant feeding patterns.

I still have no problem with baby-led weaning as an option for parents, particularly if with just a click of a mouse they can access safe and healthy advice to make up for generations of grandmotherly experience acquired over hundreds of years. However, I am deeply concerned when baby-led weaning is confused with the all-too-common disaster of child-led family meals.

It is one thing when parents hoping to encourage the process of self-feeding offer their infants an edible that may not be in the family’s usual diet. However, it is a totally different matter when a family allows itself to become dietary contortionists to a accommodate a 4-year-old whose diet consists of a monotonous rotation of three pasta shapes topped with grated Parmesan cheese, and on a good day a raw carrot slice or two. Parents living in this nutritional wasteland may have given up on managing their children’s pickiness, and may find it is less stressful to join the child and eat a few forkfuls of pasta to preserve some semblance of a family dinner. Then after the child has been put to bed they have their own balanced meal.

Almost by definition family meals are a compromise. Even adults without children negotiate often unspoken menu patterns with their partners. “This evening we’ll have your favorite, I may have my favorite next week.”

Most parents of young children understand that their diet may be a bit heavier on pasta than they might prefer and a little less varied when it comes to vegetables. It is just part of the deal. However, when mealtimes become totally dictated by the pickiness of a child there is a problem. While a poorly structured child-led family diet may be nutritionally deficient, the bigger problem is that it is expensive in time and labor, two resources usually in short supply in young families.

Theoretically, infants who have led their own weaning are more likely to have been introduced to a broad variety of flavors and textures and this may carry them into childhood as more adventuresome eaters. Picky eating can be managed successfully and result in a family that can enjoy the psychological and emotional benefits of nutritionally balanced family meals, but it requires a combination of parental courage and patience.

It is unclear exactly how we got into a situation in which a generation of parents makes things more difficult for themselves by favoring practices that overemphasize child autonomy. It may be that the parents had suffered under autocratic parents themselves, or more likely they have read too many novels or watched too many movies and TV shows in which the parents were portrayed as overbearing or controlling. Or, it may simply be that they haven’t had enough exposure to young children to realize that they all benefit from clear limits to a varying degree.

In the process of watching tens of thousands of parents, it has become clear to me that those who are the most successful are leaders and that they lead primarily by example. They have learned to be masters in the art of deception by creating a safe environment with sensible limits while at the same time fostering an atmosphere in which the child sees himself as participating in the process.

The biblical prophet Isaiah (11:6-9) in his description of how things will be different after the Lord acts to help his people predicts: “and a little child shall lead them.” This prediction fits nicely as the last in a string of crazy situations that includes a wolf living with a lamb and a leopard lying down with a calf.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I first heard the term “baby-led weaning” about 20 years ago, which turns out was just a few years after the concept was introduced to the public by a public health/midwife in Britain. Starting infants on solid foods when they could feed themselves didn’t sound as off-the-wall to me as it did to most other folks, but I chose not to include it in my list of standard recommendations at the 4- and 6-month well child visits. If any parent had asked me my opinion I would have told them to give it a try with a few specific cautions about what and how. But, I don’t recall any parents asking me. The ones who knew me well or had read, or at least heard about, my book on picky eating must have already figured out what my answer would be. The parents who didn’t know me may have been afraid I would tell them it was a crazy idea.

Twelve years ago I retired from office practice and hadn’t heard a peep about baby-led weaning until last week when I encountered a story in The New York Times. It appears that while I have been reveling in my post-practice existence, baby-led weaning has become a “thing.” As the author of the article observed: “The concept seems to appeal to millennials who favor parenting philosophies that prioritize child autonomy.”

Baby-led weaning’s traction has been so robust that the largest manufacturer of baby food in this country has been labeling some of its products “baby-led friendly since 2021.” There are several online businesses that have tapped into the growing market. One offers a very detailed free directory that lists almost any edible you can imagine with recommendations of when and how they can be presented in a safe and appealing matter to little hand feeders. Of course the company has also figured out a way to monetize the product.

Not surprisingly the American Academy of Pediatrics (AAP) has remained silent on baby-led weaning. However, in The New York Times article, Dr. Mark R. Corkins, chair of the AAP nutrition committee, is quoted as describing baby-led weaning is “a social media–driven invention.”

While I was interested to learn about the concept’s growth and commercialization, I was troubled to find that like co-sleeping, sleep training, and exclusive breastfeeding, baby-led weaning has become one of those angst-producing topics that is torturing new parents who live every day in fear that they “aren’t doing it right.” We pediatricians might deserve a small dose of blame for not vigorously emphasizing that there are numerous ways to skin that cat known as parenting. However, social media websites and Mom chat rooms are probably more responsible for creating an atmosphere in which parents are afraid of being ostracized for the decisions they have made in good faith whether it is about weaning or when to start toilet training.

In isolated cultures, weaning a baby to solids was probably never a topic for discussion or debate. New parents did what their parents did, or more likely a child’s grandmother advised or took over the process herself. The child was fed what the rest of the family ate. If it was something the infant could handle himself you gave it to him. If not you mashed it up or maybe you chewed it for him into a consistency he could manage.

However, most new parents have become so distanced from their own parents’ childrearing practices geographically, temporally, and philosophically, that they must rely on folks like us and others whom they believe are, or at least claim to be, experts. Young adults are no longer hesitant to cross ethnic thresholds when they decide to be co-parents, meaning that any remnant of family tradition is either diluted or lost outright. In the void created by this abandonment of tradition, corporations were happy to step in with easy-to-prepare baby food that lacks in nutritional and dietary variety. Baby-led weaning is just one more logical step in the metamorphosis of our society’s infant feeding patterns.

I still have no problem with baby-led weaning as an option for parents, particularly if with just a click of a mouse they can access safe and healthy advice to make up for generations of grandmotherly experience acquired over hundreds of years. However, I am deeply concerned when baby-led weaning is confused with the all-too-common disaster of child-led family meals.

It is one thing when parents hoping to encourage the process of self-feeding offer their infants an edible that may not be in the family’s usual diet. However, it is a totally different matter when a family allows itself to become dietary contortionists to a accommodate a 4-year-old whose diet consists of a monotonous rotation of three pasta shapes topped with grated Parmesan cheese, and on a good day a raw carrot slice or two. Parents living in this nutritional wasteland may have given up on managing their children’s pickiness, and may find it is less stressful to join the child and eat a few forkfuls of pasta to preserve some semblance of a family dinner. Then after the child has been put to bed they have their own balanced meal.

Almost by definition family meals are a compromise. Even adults without children negotiate often unspoken menu patterns with their partners. “This evening we’ll have your favorite, I may have my favorite next week.”

Most parents of young children understand that their diet may be a bit heavier on pasta than they might prefer and a little less varied when it comes to vegetables. It is just part of the deal. However, when mealtimes become totally dictated by the pickiness of a child there is a problem. While a poorly structured child-led family diet may be nutritionally deficient, the bigger problem is that it is expensive in time and labor, two resources usually in short supply in young families.

Theoretically, infants who have led their own weaning are more likely to have been introduced to a broad variety of flavors and textures and this may carry them into childhood as more adventuresome eaters. Picky eating can be managed successfully and result in a family that can enjoy the psychological and emotional benefits of nutritionally balanced family meals, but it requires a combination of parental courage and patience.

It is unclear exactly how we got into a situation in which a generation of parents makes things more difficult for themselves by favoring practices that overemphasize child autonomy. It may be that the parents had suffered under autocratic parents themselves, or more likely they have read too many novels or watched too many movies and TV shows in which the parents were portrayed as overbearing or controlling. Or, it may simply be that they haven’t had enough exposure to young children to realize that they all benefit from clear limits to a varying degree.

In the process of watching tens of thousands of parents, it has become clear to me that those who are the most successful are leaders and that they lead primarily by example. They have learned to be masters in the art of deception by creating a safe environment with sensible limits while at the same time fostering an atmosphere in which the child sees himself as participating in the process.

The biblical prophet Isaiah (11:6-9) in his description of how things will be different after the Lord acts to help his people predicts: “and a little child shall lead them.” This prediction fits nicely as the last in a string of crazy situations that includes a wolf living with a lamb and a leopard lying down with a calf.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A joint American College of Gastroenterology (ACG) and American Society for Gastrointestinal Endoscopy (ASGE) task force has updated quality indicators considered “fundamental” to all gastrointestinal (GI) endoscopic procedures — most of which have a performance target > 98%, implying they should be achieved in nearly every case. 

The task force’s work was published online in The American Journal of Gastroenterology.

“The purpose of this paper is to delineate all of the steps that the endoscopist should be thinking about before they perform any endoscopy,” task force member Nicholas Shaheen, MD, MPH, Division of Gastroenterology and Hepatology, the University of North Carolina at Chapel Hill, said in an interview. 

“Some of these are straightforward — for instance, did we get informed consent? Others are more nuanced — did we appropriately plan for sedation for the procedure, or did we give the right antibiotics before the procedure to prevent an infectious complication after?

“While the vast majority of endoscopists do these measures with every procedure, especially in unusual circumstances or when the procedure is an emergency, they can be overlooked. Having these quality indicators listed in one place should minimize these omissions,” Dr. Shaheen said.
 

Four Priority Indicators

The update represents the third iteration of the ACG/ASGE quality indicators on GI endoscopic procedures, the most recent of which was published nearly a decade ago.

As in preceding versions, the task force “prioritized indicators that have wide-ranging clinical implications and have been validated in clinical studies.” There are 19 in total, divided into three time periods: Preprocedure (8), intraprocedure (4), and postprocedure (7).

While all 19 indicators are intended to serve as a framework for continual quality improvement efforts among endoscopists and units, the task force recognized a subset of 4 they identified as being a particular priority:

• Frequency with which endoscopy is performed for an indication that is included in a published standard list of appropriate indications and the indication is documented (performance target > 95%) 
• Frequency with which prophylactic antibiotics are administered for appropriate indications (performance target > 98%) 
• Frequency with which a plan for the management of antithrombotic therapy is formulated and documented before the procedure (performance target = 95%) 
• Frequency with which adverse events are documented (performance target > 98%) 

Room for Improvement 

There remains a lack of compliance with some of these indicators, the task force said. 

“Procedures are still performed for questionable indications, adverse events are not always captured and documented, and communication between the endoscopist and patient and/or involved clinicians is sometimes lacking.

“For these reasons, strict attention to the quality indicators in this document and an active plan for improvement in areas of measured deficiency should be a central pillar of the successful practice of endoscopy,” they wrote. 

The task force advised that quality improvement efforts initially focus on the four priority indicators and then progress to include other indicators once it is determined that endoscopists are performing above recommended thresholds, either at baseline or after corrective interventions.

Reached for comment, Ashwin N. Ananthakrishnan, MD, MPH, AGAF, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, Massachusetts, said in an interview that these updated recommendations are “important and commonsense standard procedures that should be followed for all procedures.”

“We recognize endoscopic evaluation plays an important role in the assessment of GI illnesses, but there are also both risks and costs to this as a diagnostic and therapeutic intervention. Thus, it is important to make sure these standards are met, to optimize the outcomes of our patients,” said Dr. Ananthakrishnan, who was not involved in this work.

In a separate statement, the American Gastroenterological Association affirmed that is committed to supporting gastroenterologists in providing high-quality care via improved patients outcomes, increased efficiency and cost-effectiveness. AGA encouraged GIs to visit gastro.org/quality to learn more and find quality measures on topics including Barrett’s esophagus, inflammatory bowel disease, acute pancreatitis, and gastric intestinal metaplasia.

This work had no financial support. Dr. Shaheen and Dr. Ananthakrishnan disclosed having no relevant competing interests.

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

A joint American College of Gastroenterology (ACG) and American Society for Gastrointestinal Endoscopy (ASGE) task force has updated quality indicators considered “fundamental” to all gastrointestinal (GI) endoscopic procedures — most of which have a performance target > 98%, implying they should be achieved in nearly every case. 

The task force’s work was published online in The American Journal of Gastroenterology.

“The purpose of this paper is to delineate all of the steps that the endoscopist should be thinking about before they perform any endoscopy,” task force member Nicholas Shaheen, MD, MPH, Division of Gastroenterology and Hepatology, the University of North Carolina at Chapel Hill, said in an interview. 

“Some of these are straightforward — for instance, did we get informed consent? Others are more nuanced — did we appropriately plan for sedation for the procedure, or did we give the right antibiotics before the procedure to prevent an infectious complication after?

“While the vast majority of endoscopists do these measures with every procedure, especially in unusual circumstances or when the procedure is an emergency, they can be overlooked. Having these quality indicators listed in one place should minimize these omissions,” Dr. Shaheen said.
 

Four Priority Indicators

The update represents the third iteration of the ACG/ASGE quality indicators on GI endoscopic procedures, the most recent of which was published nearly a decade ago.

As in preceding versions, the task force “prioritized indicators that have wide-ranging clinical implications and have been validated in clinical studies.” There are 19 in total, divided into three time periods: Preprocedure (8), intraprocedure (4), and postprocedure (7).

While all 19 indicators are intended to serve as a framework for continual quality improvement efforts among endoscopists and units, the task force recognized a subset of 4 they identified as being a particular priority:

• Frequency with which endoscopy is performed for an indication that is included in a published standard list of appropriate indications and the indication is documented (performance target > 95%) 
• Frequency with which prophylactic antibiotics are administered for appropriate indications (performance target > 98%) 
• Frequency with which a plan for the management of antithrombotic therapy is formulated and documented before the procedure (performance target = 95%) 
• Frequency with which adverse events are documented (performance target > 98%) 

Room for Improvement 

There remains a lack of compliance with some of these indicators, the task force said. 

“Procedures are still performed for questionable indications, adverse events are not always captured and documented, and communication between the endoscopist and patient and/or involved clinicians is sometimes lacking.

“For these reasons, strict attention to the quality indicators in this document and an active plan for improvement in areas of measured deficiency should be a central pillar of the successful practice of endoscopy,” they wrote. 

The task force advised that quality improvement efforts initially focus on the four priority indicators and then progress to include other indicators once it is determined that endoscopists are performing above recommended thresholds, either at baseline or after corrective interventions.

Reached for comment, Ashwin N. Ananthakrishnan, MD, MPH, AGAF, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, Massachusetts, said in an interview that these updated recommendations are “important and commonsense standard procedures that should be followed for all procedures.”

“We recognize endoscopic evaluation plays an important role in the assessment of GI illnesses, but there are also both risks and costs to this as a diagnostic and therapeutic intervention. Thus, it is important to make sure these standards are met, to optimize the outcomes of our patients,” said Dr. Ananthakrishnan, who was not involved in this work.

In a separate statement, the American Gastroenterological Association affirmed that is committed to supporting gastroenterologists in providing high-quality care via improved patients outcomes, increased efficiency and cost-effectiveness. AGA encouraged GIs to visit gastro.org/quality to learn more and find quality measures on topics including Barrett’s esophagus, inflammatory bowel disease, acute pancreatitis, and gastric intestinal metaplasia.

This work had no financial support. Dr. Shaheen and Dr. Ananthakrishnan disclosed having no relevant competing interests.

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

A joint American College of Gastroenterology (ACG) and American Society for Gastrointestinal Endoscopy (ASGE) task force has updated quality indicators considered “fundamental” to all gastrointestinal (GI) endoscopic procedures — most of which have a performance target > 98%, implying they should be achieved in nearly every case. 

The task force’s work was published online in The American Journal of Gastroenterology.

“The purpose of this paper is to delineate all of the steps that the endoscopist should be thinking about before they perform any endoscopy,” task force member Nicholas Shaheen, MD, MPH, Division of Gastroenterology and Hepatology, the University of North Carolina at Chapel Hill, said in an interview. 

“Some of these are straightforward — for instance, did we get informed consent? Others are more nuanced — did we appropriately plan for sedation for the procedure, or did we give the right antibiotics before the procedure to prevent an infectious complication after?

“While the vast majority of endoscopists do these measures with every procedure, especially in unusual circumstances or when the procedure is an emergency, they can be overlooked. Having these quality indicators listed in one place should minimize these omissions,” Dr. Shaheen said.
 

Four Priority Indicators

The update represents the third iteration of the ACG/ASGE quality indicators on GI endoscopic procedures, the most recent of which was published nearly a decade ago.

As in preceding versions, the task force “prioritized indicators that have wide-ranging clinical implications and have been validated in clinical studies.” There are 19 in total, divided into three time periods: Preprocedure (8), intraprocedure (4), and postprocedure (7).

While all 19 indicators are intended to serve as a framework for continual quality improvement efforts among endoscopists and units, the task force recognized a subset of 4 they identified as being a particular priority:

• Frequency with which endoscopy is performed for an indication that is included in a published standard list of appropriate indications and the indication is documented (performance target > 95%) 
• Frequency with which prophylactic antibiotics are administered for appropriate indications (performance target > 98%) 
• Frequency with which a plan for the management of antithrombotic therapy is formulated and documented before the procedure (performance target = 95%) 
• Frequency with which adverse events are documented (performance target > 98%) 

Room for Improvement 

There remains a lack of compliance with some of these indicators, the task force said. 

“Procedures are still performed for questionable indications, adverse events are not always captured and documented, and communication between the endoscopist and patient and/or involved clinicians is sometimes lacking.

“For these reasons, strict attention to the quality indicators in this document and an active plan for improvement in areas of measured deficiency should be a central pillar of the successful practice of endoscopy,” they wrote. 

The task force advised that quality improvement efforts initially focus on the four priority indicators and then progress to include other indicators once it is determined that endoscopists are performing above recommended thresholds, either at baseline or after corrective interventions.

Reached for comment, Ashwin N. Ananthakrishnan, MD, MPH, AGAF, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, Massachusetts, said in an interview that these updated recommendations are “important and commonsense standard procedures that should be followed for all procedures.”

“We recognize endoscopic evaluation plays an important role in the assessment of GI illnesses, but there are also both risks and costs to this as a diagnostic and therapeutic intervention. Thus, it is important to make sure these standards are met, to optimize the outcomes of our patients,” said Dr. Ananthakrishnan, who was not involved in this work.

In a separate statement, the American Gastroenterological Association affirmed that is committed to supporting gastroenterologists in providing high-quality care via improved patients outcomes, increased efficiency and cost-effectiveness. AGA encouraged GIs to visit gastro.org/quality to learn more and find quality measures on topics including Barrett’s esophagus, inflammatory bowel disease, acute pancreatitis, and gastric intestinal metaplasia.

This work had no financial support. Dr. Shaheen and Dr. Ananthakrishnan disclosed having no relevant competing interests.

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