Time-restricted eating – that is, reducing the number of hours a person is allowed to eat during the day – may produce a modest 1%-4% weight loss, even without cutting calories, early studies in humans suggest. But more research is needed to provide definitive evidence.

This type of intermittent fasting also appears to improve blood glucose, blood pressure, and oxidative stress, said Courtney M. Peterson, PhD, a researcher at the University of Alabama at Birmingham, summarizing what is known about the potential weight-loss strategy at the annual scientific sessions of the American Diabetes Association.

The best results were seen with early time-restricted eating (that is, ending the nighttime fasting early in the day) and allowing a person to eat 8-10 hours each day (for example, 8 a.m. to 4 p.m. or 8 a.m. to 6 p.m.), with fasting and only water allowed the remaining hours, she reported.

However, the 3 dozen or so studies in humans to date are mainly small, pilot, or single-arm studies lasting up to 3 months, and there are only three main randomized, controlled trials with 25 or more participants in each group.

Large trials with around 260 participants are needed, Dr. Peterson said, “before drawing definitive conclusions” about the weight-loss and cardiometabolic benefits of time-restricted eating.

Invited to comment, session chair Lisa S. Chow, MD, an associate professor of medicine in the endocrine and diabetes division at the University of Minnesota, Minneapolis, similarly said: “I think time-restricted eating is promising because of its simple message and noted weight-loss benefit, yet more data are needed.”

“Many uncertainties remain,” she added, “including the potential concern that time-restricted eating may be associated with lean [muscle] mass loss and identifying the populations most likely to benefit from time-restricted eating,” she said.
 

36 small studies, a review, a meta-analysis, 3 RCTs

There have been about three dozen small studies of time-restricted eating in humans, which examined 4- to 11-hour eating windows, Dr. Peterson explained.

A systematic review of 23 trials of time-restricted eating reported that, on average, participants lost 3% of their initial weight. And a meta-analysis of 19 trials in 475 participants found a –0.9 kg mean difference effect for weight loss.

However, those two analyses did not compare time-restricted eating with a control treatment, she stressed.

The largest randomized, controlled trial is a 12-week study in 271 adults with nonalcoholic fatty liver disease in China, Dr. Peterson said.

The researchers compared three groups:

• Alternate-day modified fasting: healthy meal provided.
• Time-restricted eating: 8-hour window, healthy meal provided.
• Control: 20% calorie reduction, no meal provided.

At 4 and 12 weeks, adults in the two treatment groups lost more weight than those in the control group, but “this was not a fair comparison” because of the lack of a provided meal in the control group, Dr. Peterson pointed out.

The next largest randomized, controlled study is the 12-week TREAT trial, published online in JAMA Internal Medicine in October 2020.

The researchers, from the University of California, San Francisco, randomized 116 adults into two groups:

• 8-hour time-restricted eating from noon to 8 p.m..
• Control: three meals/day.

Time-restricted eating did not lead to greater weight loss, compared with three structured meals a day, which was not surprising, Dr. Chow said, as “participants just reported whether they were engaged in time-restricted eating in a yes/no answer.”

Moreover, “there was no objective measure of their eating window. From our study, we showed that the extent of eating window restriction matters, not just time-restricted eating participation.”

Also, in TREAT, the eating window was noon to 8 p.m. (considered late for time-restricted eating), and the trial also allowed noncaloric beverages outside the window, whereas most studies only allow water and medications. 

Lastly, TREAT showed that time-restricted eating reduced weight, compared with baseline, but the weight loss was not significant, compared with the control group, and there was a wide spread of effects (that is, some lost a lot of weight, others didn’t lose much weight).

“That being said, the JAMA Internal Medicine paper is the largest paper to date of time-restricted eating randomized versus control, so its findings need to be acknowledged and recognized,” Dr. Chow said.

Peterson reported that her group recently completed a 14-week intervention in 90 adults with obesity divided into two groups:

• Control: Continuous energy restriction, self-selected ≥ 12-hour window.
• Early time-restricted eating: 8-hour window from 7 a.m. to 3 p.m.

The findings will provide further insight into the benefits of time-restricted eating.
 

How might time-restricted eating lead to weight loss?

Dr. Peterson concluded by presenting data suggesting how time-restricted eating may induce weight loss.

In a 4-day crossover study in 11 overweight adults, time-restricted eating did not affect energy expenditure, but it lessened swings in subjective hunger, improved appetite hormones including ghrelin, and increased fat oxidation.

Most trials have reported that time-restricted eating improves one or more cardiometabolic endpoints, she noted.

Early time-restricted eating was associated with improved insulin sensitivity and secretion, blood pressure, and oxidative stress, but not better lipid levels.

In contrast, compared with eating 3 meals/day (control), late time-restricted eating (eating 1 meal/day from 5 p.m. to 9 p.m.) was associated with worsened cardiometabolic health (glucose, insulin, blood pressure, and lipid levels) in an 8-week crossover study in 15 participants.

Dr. Peterson and Dr. Chow reported no relevant financial relationships.

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

Time-restricted eating – that is, reducing the number of hours a person is allowed to eat during the day – may produce a modest 1%-4% weight loss, even without cutting calories, early studies in humans suggest. But more research is needed to provide definitive evidence.

This type of intermittent fasting also appears to improve blood glucose, blood pressure, and oxidative stress, said Courtney M. Peterson, PhD, a researcher at the University of Alabama at Birmingham, summarizing what is known about the potential weight-loss strategy at the annual scientific sessions of the American Diabetes Association.

The best results were seen with early time-restricted eating (that is, ending the nighttime fasting early in the day) and allowing a person to eat 8-10 hours each day (for example, 8 a.m. to 4 p.m. or 8 a.m. to 6 p.m.), with fasting and only water allowed the remaining hours, she reported.

However, the 3 dozen or so studies in humans to date are mainly small, pilot, or single-arm studies lasting up to 3 months, and there are only three main randomized, controlled trials with 25 or more participants in each group.

Large trials with around 260 participants are needed, Dr. Peterson said, “before drawing definitive conclusions” about the weight-loss and cardiometabolic benefits of time-restricted eating.

Invited to comment, session chair Lisa S. Chow, MD, an associate professor of medicine in the endocrine and diabetes division at the University of Minnesota, Minneapolis, similarly said: “I think time-restricted eating is promising because of its simple message and noted weight-loss benefit, yet more data are needed.”

“Many uncertainties remain,” she added, “including the potential concern that time-restricted eating may be associated with lean [muscle] mass loss and identifying the populations most likely to benefit from time-restricted eating,” she said.
 

36 small studies, a review, a meta-analysis, 3 RCTs

There have been about three dozen small studies of time-restricted eating in humans, which examined 4- to 11-hour eating windows, Dr. Peterson explained.

A systematic review of 23 trials of time-restricted eating reported that, on average, participants lost 3% of their initial weight. And a meta-analysis of 19 trials in 475 participants found a –0.9 kg mean difference effect for weight loss.

However, those two analyses did not compare time-restricted eating with a control treatment, she stressed.

The largest randomized, controlled trial is a 12-week study in 271 adults with nonalcoholic fatty liver disease in China, Dr. Peterson said.

The researchers compared three groups:

• Alternate-day modified fasting: healthy meal provided.
• Time-restricted eating: 8-hour window, healthy meal provided.
• Control: 20% calorie reduction, no meal provided.

At 4 and 12 weeks, adults in the two treatment groups lost more weight than those in the control group, but “this was not a fair comparison” because of the lack of a provided meal in the control group, Dr. Peterson pointed out.

The next largest randomized, controlled study is the 12-week TREAT trial, published online in JAMA Internal Medicine in October 2020.

The researchers, from the University of California, San Francisco, randomized 116 adults into two groups:

• 8-hour time-restricted eating from noon to 8 p.m..
• Control: three meals/day.

Time-restricted eating did not lead to greater weight loss, compared with three structured meals a day, which was not surprising, Dr. Chow said, as “participants just reported whether they were engaged in time-restricted eating in a yes/no answer.”

Moreover, “there was no objective measure of their eating window. From our study, we showed that the extent of eating window restriction matters, not just time-restricted eating participation.”

Also, in TREAT, the eating window was noon to 8 p.m. (considered late for time-restricted eating), and the trial also allowed noncaloric beverages outside the window, whereas most studies only allow water and medications. 

Lastly, TREAT showed that time-restricted eating reduced weight, compared with baseline, but the weight loss was not significant, compared with the control group, and there was a wide spread of effects (that is, some lost a lot of weight, others didn’t lose much weight).

“That being said, the JAMA Internal Medicine paper is the largest paper to date of time-restricted eating randomized versus control, so its findings need to be acknowledged and recognized,” Dr. Chow said.

Peterson reported that her group recently completed a 14-week intervention in 90 adults with obesity divided into two groups:

• Control: Continuous energy restriction, self-selected ≥ 12-hour window.
• Early time-restricted eating: 8-hour window from 7 a.m. to 3 p.m.

The findings will provide further insight into the benefits of time-restricted eating.
 

How might time-restricted eating lead to weight loss?

Dr. Peterson concluded by presenting data suggesting how time-restricted eating may induce weight loss.

In a 4-day crossover study in 11 overweight adults, time-restricted eating did not affect energy expenditure, but it lessened swings in subjective hunger, improved appetite hormones including ghrelin, and increased fat oxidation.

Most trials have reported that time-restricted eating improves one or more cardiometabolic endpoints, she noted.

Early time-restricted eating was associated with improved insulin sensitivity and secretion, blood pressure, and oxidative stress, but not better lipid levels.

In contrast, compared with eating 3 meals/day (control), late time-restricted eating (eating 1 meal/day from 5 p.m. to 9 p.m.) was associated with worsened cardiometabolic health (glucose, insulin, blood pressure, and lipid levels) in an 8-week crossover study in 15 participants.

Dr. Peterson and Dr. Chow reported no relevant financial relationships.

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

Time-restricted eating – that is, reducing the number of hours a person is allowed to eat during the day – may produce a modest 1%-4% weight loss, even without cutting calories, early studies in humans suggest. But more research is needed to provide definitive evidence.

This type of intermittent fasting also appears to improve blood glucose, blood pressure, and oxidative stress, said Courtney M. Peterson, PhD, a researcher at the University of Alabama at Birmingham, summarizing what is known about the potential weight-loss strategy at the annual scientific sessions of the American Diabetes Association.

The best results were seen with early time-restricted eating (that is, ending the nighttime fasting early in the day) and allowing a person to eat 8-10 hours each day (for example, 8 a.m. to 4 p.m. or 8 a.m. to 6 p.m.), with fasting and only water allowed the remaining hours, she reported.

However, the 3 dozen or so studies in humans to date are mainly small, pilot, or single-arm studies lasting up to 3 months, and there are only three main randomized, controlled trials with 25 or more participants in each group.

Large trials with around 260 participants are needed, Dr. Peterson said, “before drawing definitive conclusions” about the weight-loss and cardiometabolic benefits of time-restricted eating.

Invited to comment, session chair Lisa S. Chow, MD, an associate professor of medicine in the endocrine and diabetes division at the University of Minnesota, Minneapolis, similarly said: “I think time-restricted eating is promising because of its simple message and noted weight-loss benefit, yet more data are needed.”

“Many uncertainties remain,” she added, “including the potential concern that time-restricted eating may be associated with lean [muscle] mass loss and identifying the populations most likely to benefit from time-restricted eating,” she said.
 

36 small studies, a review, a meta-analysis, 3 RCTs

There have been about three dozen small studies of time-restricted eating in humans, which examined 4- to 11-hour eating windows, Dr. Peterson explained.

A systematic review of 23 trials of time-restricted eating reported that, on average, participants lost 3% of their initial weight. And a meta-analysis of 19 trials in 475 participants found a –0.9 kg mean difference effect for weight loss.

However, those two analyses did not compare time-restricted eating with a control treatment, she stressed.

The largest randomized, controlled trial is a 12-week study in 271 adults with nonalcoholic fatty liver disease in China, Dr. Peterson said.

The researchers compared three groups:

• Alternate-day modified fasting: healthy meal provided.
• Time-restricted eating: 8-hour window, healthy meal provided.
• Control: 20% calorie reduction, no meal provided.

At 4 and 12 weeks, adults in the two treatment groups lost more weight than those in the control group, but “this was not a fair comparison” because of the lack of a provided meal in the control group, Dr. Peterson pointed out.

The next largest randomized, controlled study is the 12-week TREAT trial, published online in JAMA Internal Medicine in October 2020.

The researchers, from the University of California, San Francisco, randomized 116 adults into two groups:

• 8-hour time-restricted eating from noon to 8 p.m..
• Control: three meals/day.

Time-restricted eating did not lead to greater weight loss, compared with three structured meals a day, which was not surprising, Dr. Chow said, as “participants just reported whether they were engaged in time-restricted eating in a yes/no answer.”

Moreover, “there was no objective measure of their eating window. From our study, we showed that the extent of eating window restriction matters, not just time-restricted eating participation.”

Also, in TREAT, the eating window was noon to 8 p.m. (considered late for time-restricted eating), and the trial also allowed noncaloric beverages outside the window, whereas most studies only allow water and medications. 

Lastly, TREAT showed that time-restricted eating reduced weight, compared with baseline, but the weight loss was not significant, compared with the control group, and there was a wide spread of effects (that is, some lost a lot of weight, others didn’t lose much weight).

“That being said, the JAMA Internal Medicine paper is the largest paper to date of time-restricted eating randomized versus control, so its findings need to be acknowledged and recognized,” Dr. Chow said.

Peterson reported that her group recently completed a 14-week intervention in 90 adults with obesity divided into two groups:

• Control: Continuous energy restriction, self-selected ≥ 12-hour window.
• Early time-restricted eating: 8-hour window from 7 a.m. to 3 p.m.

The findings will provide further insight into the benefits of time-restricted eating.
 

How might time-restricted eating lead to weight loss?

Dr. Peterson concluded by presenting data suggesting how time-restricted eating may induce weight loss.

In a 4-day crossover study in 11 overweight adults, time-restricted eating did not affect energy expenditure, but it lessened swings in subjective hunger, improved appetite hormones including ghrelin, and increased fat oxidation.

Most trials have reported that time-restricted eating improves one or more cardiometabolic endpoints, she noted.

Early time-restricted eating was associated with improved insulin sensitivity and secretion, blood pressure, and oxidative stress, but not better lipid levels.

In contrast, compared with eating 3 meals/day (control), late time-restricted eating (eating 1 meal/day from 5 p.m. to 9 p.m.) was associated with worsened cardiometabolic health (glucose, insulin, blood pressure, and lipid levels) in an 8-week crossover study in 15 participants.

Dr. Peterson and Dr. Chow reported no relevant financial relationships.

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

Individuals diagnosed with primary colorectal cancer (CRC) at less than 50 years of age have better survival outcomes than individuals diagnosed at 51-55 years, based on data from more than 750,000 patients.

This finding emphasizes the importance of early CRC detection in younger individuals, reported lead author En Cheng, MD, PhD, of Yale University, New Haven, Conn., and colleagues.

“Early-onset CRC (i.e., CRC diagnosed at age less than 50 years) has been characterized by unique clinical, genetic, and epigenetic characteristics, and thus it may be associated with different survival from CRC diagnosed among individuals older than 50 years,” the investigators wrote in JAMA Network Open. Previous studies comparing survival times across age groups have yielded inconsistent results.

To gain a better understanding, the investigator conducted a retrospective study using data from the National Cancer Database. Excluding patients with primary CRC who had concomitant diagnosis, history of other malignant tumors, noninvasive adenocarcinoma, or missing data, the final dataset included 769,871 patients. Early-onset CRC was defined by age less than 50 years, whereas later-onset CRC was defined by ages 51-55 years.

“Individuals diagnosed at age 50 years were excluded to minimize an apparent screening detection bias at age 50 years in our population, given that these individuals disproportionately presented with earlier stages,” the investigators wrote.

Initial comparisons across groups revealed several significant differences. Individuals in the early-onset group were more often women (47.3% vs. 43.8%; P < .001), members of races in the “other” category (6.9% vs. 5.9%; P < .001), and Medicaid patients (12.3% vs. 10.3%; P < .001). They were also more likely to be diagnosed with stage IV cancer (27.8% vs 24.1%; P < .001) and have rectal tumors (29.3% vs. 28.7%; P = .004).

In the unadjusted Kaplan-Meier analysis, patients with early-onset CRC had a lower 10-year survival rate (53.6%; 95% CI, 53.2%-54.0% vs. 54.3%; 95% CI, 53.8%-54.8%; P < .001). The fully adjusted model revealed significantly higher survival for early-onset patients, compared with later-onset patients (adjusted hazard ratio, 0.95; 95% CI, 0.93-0.96; P < .001) . This disparity deepened when adjusting only for stage (HR, 0.89; 95% CI, 0.88-0.90; P < .001).

Survival was longest among patients 35-39 years (aHR, 0.88; 95% CI, 0.84-0.92; P < .001), compared with those aged 51-55, and among early-onset individuals with stage I disease (a HR, 0.87; 95% CI, 0.81-0.93; P < .001) or stage II disease (a HR, 0.86; 95% CI, 0.82-0.90; P < .001), compared with those having the same stages of later-onset CRC. No survival advantage was observed among patients diagnosed at age 25 or younger or those with stage III or IV disease.

“Interestingly, hereditary nonpolyposis colorectal cancer, owing to underlying mismatch repair deficiency, is associated with superior survival and is often diagnosed in individuals from ages 35-45 years,” the investigators noted. “In contrast, adenomatous polyposis coli syndrome is more common in individuals who are diagnosed with CRC at age younger than 20 years (10%), compared with those diagnosed at later ages (0.1%), and adenomatous polyposis coli syndrome is not associated with a survival advantage. These high penetrance syndromes could partly account for the relative heterogeneity in survival across ages among individuals with early-onset CRC.”
 

Cautious about interpretation

Dr. Cheng and colleagues concluded their publication with a disclaimer: “Our finding of a survival advantage associated with early-onset CRC among younger individuals should be interpreted cautiously, given that the advantage had a small magnitude and was heterogeneous by age and stage,” they wrote. “Further study is needed to understand the underlying heterogeneity of survival by age and stage among individuals with early-onset CRC.”

Kirbi L. Yelorda, MD, of Stanford (Calif.) University, and colleagues, had a similar interpretation.

“These results offer support for effectiveness of treatment in patients diagnosed with CRC at younger ages; however, they must be interpreted within the context of epidemiological and biological factors,” Dr. Yelorda and colleagues wrote in an accompanying editorial.

The findings also suggest that the recent reduction in recommended screening age by the U.S. Preventive Services Task Force – from 50 years to 45 years – is warranted, they added, but screening younger patients remains unnecessary.

“While these results do not suggest that screening should start for patients younger than 45 years, they do support the benefit of early detection in young patients,” Dr. Yelorda and colleagues wrote, noting a “fairly low incidence rate” among individuals younger than 45, which is insufficient to justify the risk-to-benefit ratio and increased costs associated with expanded screening.
 

Important but not surprising

It’s “not surprising” that early-onset patients typically have better survival than later-onset patients, according to Joseph C. Anderson, MD, associate professor at White River Junction Veterans Affairs Medical Center, Hartford, Vt.; Geisel School of Medicine at Dartmouth, Hanover, N.H.; and the University of Connecticut, Farmington.

“They’re younger, have less comorbidities, and can tolerate chemotherapy,” Dr. Anderson said in an interview. “It’s not surprising that people do poorly with later stages. Younger people are no exception.”

Dr. Anderson, who previously coauthored an editorial weighing the pros and cons of earlier screening, noted that earlier screening is needed because of the rising incidence of late-stage diagnoses among younger patients, which, as the study found, are associated with worse outcomes.

Beyond adherence to screening recommendations, Dr. Anderson urged clinicians to be aggressive when doing a workup of CRC symptoms in younger patients, among whom delayed diagnoses are more common.

“We can’t just say it’s something more benign, like hemorrhoids, like we used to,” Dr. Anderson said. “Somebody who’s 30 years old and having rectal bleeding needs to be evaluated promptly – there can’t be a delay.”

The study was supported by the National Institutes of Health and Stand Up To Cancer (grant administered by the American Association for Cancer Research). The investigators disclosed relationships with Evergrande Group, Janssen, Revolution Medicines, and others. One editorialist reported serving as a member of the USPSTF when the guideline for colorectal cancer was developed, and being a coauthor on the guideline. No other disclosures were reported among editorialists. Dr. Anderson reported no relevant conflicts of interest.

Individuals diagnosed with primary colorectal cancer (CRC) at less than 50 years of age have better survival outcomes than individuals diagnosed at 51-55 years, based on data from more than 750,000 patients.

This finding emphasizes the importance of early CRC detection in younger individuals, reported lead author En Cheng, MD, PhD, of Yale University, New Haven, Conn., and colleagues.

“Early-onset CRC (i.e., CRC diagnosed at age less than 50 years) has been characterized by unique clinical, genetic, and epigenetic characteristics, and thus it may be associated with different survival from CRC diagnosed among individuals older than 50 years,” the investigators wrote in JAMA Network Open. Previous studies comparing survival times across age groups have yielded inconsistent results.

To gain a better understanding, the investigator conducted a retrospective study using data from the National Cancer Database. Excluding patients with primary CRC who had concomitant diagnosis, history of other malignant tumors, noninvasive adenocarcinoma, or missing data, the final dataset included 769,871 patients. Early-onset CRC was defined by age less than 50 years, whereas later-onset CRC was defined by ages 51-55 years.

“Individuals diagnosed at age 50 years were excluded to minimize an apparent screening detection bias at age 50 years in our population, given that these individuals disproportionately presented with earlier stages,” the investigators wrote.

Initial comparisons across groups revealed several significant differences. Individuals in the early-onset group were more often women (47.3% vs. 43.8%; P < .001), members of races in the “other” category (6.9% vs. 5.9%; P < .001), and Medicaid patients (12.3% vs. 10.3%; P < .001). They were also more likely to be diagnosed with stage IV cancer (27.8% vs 24.1%; P < .001) and have rectal tumors (29.3% vs. 28.7%; P = .004).

In the unadjusted Kaplan-Meier analysis, patients with early-onset CRC had a lower 10-year survival rate (53.6%; 95% CI, 53.2%-54.0% vs. 54.3%; 95% CI, 53.8%-54.8%; P < .001). The fully adjusted model revealed significantly higher survival for early-onset patients, compared with later-onset patients (adjusted hazard ratio, 0.95; 95% CI, 0.93-0.96; P < .001) . This disparity deepened when adjusting only for stage (HR, 0.89; 95% CI, 0.88-0.90; P < .001).

Survival was longest among patients 35-39 years (aHR, 0.88; 95% CI, 0.84-0.92; P < .001), compared with those aged 51-55, and among early-onset individuals with stage I disease (a HR, 0.87; 95% CI, 0.81-0.93; P < .001) or stage II disease (a HR, 0.86; 95% CI, 0.82-0.90; P < .001), compared with those having the same stages of later-onset CRC. No survival advantage was observed among patients diagnosed at age 25 or younger or those with stage III or IV disease.

“Interestingly, hereditary nonpolyposis colorectal cancer, owing to underlying mismatch repair deficiency, is associated with superior survival and is often diagnosed in individuals from ages 35-45 years,” the investigators noted. “In contrast, adenomatous polyposis coli syndrome is more common in individuals who are diagnosed with CRC at age younger than 20 years (10%), compared with those diagnosed at later ages (0.1%), and adenomatous polyposis coli syndrome is not associated with a survival advantage. These high penetrance syndromes could partly account for the relative heterogeneity in survival across ages among individuals with early-onset CRC.”
 

Cautious about interpretation

Dr. Cheng and colleagues concluded their publication with a disclaimer: “Our finding of a survival advantage associated with early-onset CRC among younger individuals should be interpreted cautiously, given that the advantage had a small magnitude and was heterogeneous by age and stage,” they wrote. “Further study is needed to understand the underlying heterogeneity of survival by age and stage among individuals with early-onset CRC.”

Kirbi L. Yelorda, MD, of Stanford (Calif.) University, and colleagues, had a similar interpretation.

“These results offer support for effectiveness of treatment in patients diagnosed with CRC at younger ages; however, they must be interpreted within the context of epidemiological and biological factors,” Dr. Yelorda and colleagues wrote in an accompanying editorial.

The findings also suggest that the recent reduction in recommended screening age by the U.S. Preventive Services Task Force – from 50 years to 45 years – is warranted, they added, but screening younger patients remains unnecessary.

“While these results do not suggest that screening should start for patients younger than 45 years, they do support the benefit of early detection in young patients,” Dr. Yelorda and colleagues wrote, noting a “fairly low incidence rate” among individuals younger than 45, which is insufficient to justify the risk-to-benefit ratio and increased costs associated with expanded screening.
 

Important but not surprising

It’s “not surprising” that early-onset patients typically have better survival than later-onset patients, according to Joseph C. Anderson, MD, associate professor at White River Junction Veterans Affairs Medical Center, Hartford, Vt.; Geisel School of Medicine at Dartmouth, Hanover, N.H.; and the University of Connecticut, Farmington.

“They’re younger, have less comorbidities, and can tolerate chemotherapy,” Dr. Anderson said in an interview. “It’s not surprising that people do poorly with later stages. Younger people are no exception.”

Dr. Anderson, who previously coauthored an editorial weighing the pros and cons of earlier screening, noted that earlier screening is needed because of the rising incidence of late-stage diagnoses among younger patients, which, as the study found, are associated with worse outcomes.

Beyond adherence to screening recommendations, Dr. Anderson urged clinicians to be aggressive when doing a workup of CRC symptoms in younger patients, among whom delayed diagnoses are more common.

“We can’t just say it’s something more benign, like hemorrhoids, like we used to,” Dr. Anderson said. “Somebody who’s 30 years old and having rectal bleeding needs to be evaluated promptly – there can’t be a delay.”

The study was supported by the National Institutes of Health and Stand Up To Cancer (grant administered by the American Association for Cancer Research). The investigators disclosed relationships with Evergrande Group, Janssen, Revolution Medicines, and others. One editorialist reported serving as a member of the USPSTF when the guideline for colorectal cancer was developed, and being a coauthor on the guideline. No other disclosures were reported among editorialists. Dr. Anderson reported no relevant conflicts of interest.

Individuals diagnosed with primary colorectal cancer (CRC) at less than 50 years of age have better survival outcomes than individuals diagnosed at 51-55 years, based on data from more than 750,000 patients.

This finding emphasizes the importance of early CRC detection in younger individuals, reported lead author En Cheng, MD, PhD, of Yale University, New Haven, Conn., and colleagues.

“Early-onset CRC (i.e., CRC diagnosed at age less than 50 years) has been characterized by unique clinical, genetic, and epigenetic characteristics, and thus it may be associated with different survival from CRC diagnosed among individuals older than 50 years,” the investigators wrote in JAMA Network Open. Previous studies comparing survival times across age groups have yielded inconsistent results.

To gain a better understanding, the investigator conducted a retrospective study using data from the National Cancer Database. Excluding patients with primary CRC who had concomitant diagnosis, history of other malignant tumors, noninvasive adenocarcinoma, or missing data, the final dataset included 769,871 patients. Early-onset CRC was defined by age less than 50 years, whereas later-onset CRC was defined by ages 51-55 years.

“Individuals diagnosed at age 50 years were excluded to minimize an apparent screening detection bias at age 50 years in our population, given that these individuals disproportionately presented with earlier stages,” the investigators wrote.

Initial comparisons across groups revealed several significant differences. Individuals in the early-onset group were more often women (47.3% vs. 43.8%; P < .001), members of races in the “other” category (6.9% vs. 5.9%; P < .001), and Medicaid patients (12.3% vs. 10.3%; P < .001). They were also more likely to be diagnosed with stage IV cancer (27.8% vs 24.1%; P < .001) and have rectal tumors (29.3% vs. 28.7%; P = .004).

In the unadjusted Kaplan-Meier analysis, patients with early-onset CRC had a lower 10-year survival rate (53.6%; 95% CI, 53.2%-54.0% vs. 54.3%; 95% CI, 53.8%-54.8%; P < .001). The fully adjusted model revealed significantly higher survival for early-onset patients, compared with later-onset patients (adjusted hazard ratio, 0.95; 95% CI, 0.93-0.96; P < .001) . This disparity deepened when adjusting only for stage (HR, 0.89; 95% CI, 0.88-0.90; P < .001).

Survival was longest among patients 35-39 years (aHR, 0.88; 95% CI, 0.84-0.92; P < .001), compared with those aged 51-55, and among early-onset individuals with stage I disease (a HR, 0.87; 95% CI, 0.81-0.93; P < .001) or stage II disease (a HR, 0.86; 95% CI, 0.82-0.90; P < .001), compared with those having the same stages of later-onset CRC. No survival advantage was observed among patients diagnosed at age 25 or younger or those with stage III or IV disease.

“Interestingly, hereditary nonpolyposis colorectal cancer, owing to underlying mismatch repair deficiency, is associated with superior survival and is often diagnosed in individuals from ages 35-45 years,” the investigators noted. “In contrast, adenomatous polyposis coli syndrome is more common in individuals who are diagnosed with CRC at age younger than 20 years (10%), compared with those diagnosed at later ages (0.1%), and adenomatous polyposis coli syndrome is not associated with a survival advantage. These high penetrance syndromes could partly account for the relative heterogeneity in survival across ages among individuals with early-onset CRC.”
 

Cautious about interpretation

Dr. Cheng and colleagues concluded their publication with a disclaimer: “Our finding of a survival advantage associated with early-onset CRC among younger individuals should be interpreted cautiously, given that the advantage had a small magnitude and was heterogeneous by age and stage,” they wrote. “Further study is needed to understand the underlying heterogeneity of survival by age and stage among individuals with early-onset CRC.”

Kirbi L. Yelorda, MD, of Stanford (Calif.) University, and colleagues, had a similar interpretation.

“These results offer support for effectiveness of treatment in patients diagnosed with CRC at younger ages; however, they must be interpreted within the context of epidemiological and biological factors,” Dr. Yelorda and colleagues wrote in an accompanying editorial.

The findings also suggest that the recent reduction in recommended screening age by the U.S. Preventive Services Task Force – from 50 years to 45 years – is warranted, they added, but screening younger patients remains unnecessary.

“While these results do not suggest that screening should start for patients younger than 45 years, they do support the benefit of early detection in young patients,” Dr. Yelorda and colleagues wrote, noting a “fairly low incidence rate” among individuals younger than 45, which is insufficient to justify the risk-to-benefit ratio and increased costs associated with expanded screening.
 

Important but not surprising

It’s “not surprising” that early-onset patients typically have better survival than later-onset patients, according to Joseph C. Anderson, MD, associate professor at White River Junction Veterans Affairs Medical Center, Hartford, Vt.; Geisel School of Medicine at Dartmouth, Hanover, N.H.; and the University of Connecticut, Farmington.

“They’re younger, have less comorbidities, and can tolerate chemotherapy,” Dr. Anderson said in an interview. “It’s not surprising that people do poorly with later stages. Younger people are no exception.”

Dr. Anderson, who previously coauthored an editorial weighing the pros and cons of earlier screening, noted that earlier screening is needed because of the rising incidence of late-stage diagnoses among younger patients, which, as the study found, are associated with worse outcomes.

Beyond adherence to screening recommendations, Dr. Anderson urged clinicians to be aggressive when doing a workup of CRC symptoms in younger patients, among whom delayed diagnoses are more common.

“We can’t just say it’s something more benign, like hemorrhoids, like we used to,” Dr. Anderson said. “Somebody who’s 30 years old and having rectal bleeding needs to be evaluated promptly – there can’t be a delay.”

The study was supported by the National Institutes of Health and Stand Up To Cancer (grant administered by the American Association for Cancer Research). The investigators disclosed relationships with Evergrande Group, Janssen, Revolution Medicines, and others. One editorialist reported serving as a member of the USPSTF when the guideline for colorectal cancer was developed, and being a coauthor on the guideline. No other disclosures were reported among editorialists. Dr. Anderson reported no relevant conflicts of interest.

Families with private health insurance pay around $3,000 for newborn delivery and hospitalization, while adding neonatal intensive care can push the bill closer to $5,000, based on a retrospective look at almost 400,000 episodes.

The findings suggest that privately insured families need prenatal financial counseling, as well as screening for financial hardship after delivery, reported lead author Kao-Ping Chua, MD, PhD, assistant professor and health policy researcher in the department of pediatrics and the Susan B. Meister Child Health Evaluation and Research Center at the University of Michigan, Ann Arbor, and colleagues.

“Concern is growing regarding the high and rising financial burden of childbirth for privately insured families,” the investigators wrote in Pediatrics. “Previous studies assessing this burden have focused on out-of-pocket spending for maternal care, including hospitalizations for delivery. However, there are no recent national data on out-of-pocket spending across the childbirth episode, including both deliveries and newborn hospitalizations.”

To address this knowledge gap, Dr. Chua and colleagues turned to Optum’s deidentified Clinformatics Data Mart, comprising 12 million privately insured individuals across the United States. The investigators identified 398,410 childbirth episodes occurring between 2016 and 2019. Each episode was defined as one delivery and at least one newborn hospitalization under the same family plan.

Out-of-pocket cost included copayment plus coinsurance and deductibles. Primary outcomes included mean total out-of-pocket spending and proportion of episodes exceeding $5,000 or $10,000. Subgroup analyses compared differences in spending between episodes involving neonatal intensive care or cesarean birth.

The mean out-of-pocket spending was $2,281 for delivery and $788 for newborn hospitalization, giving a total of $3,068 per childbirth episode. Coinsurance and deductibles accounted for much of that cost, at 55.8% and 42.1%, respectively, whereas copayments accounted for a relatively minor portion (2.2%).

Almost all episodes (95%) cost more than zero dollars, while 17.1% cost more than $5,000 and 1.0% cost more than $10,000. Total mean out-of-pocket spending was higher for episodes involving cesarean birth ($3,389) or neonatal intensive care ($4,969), the latter of which cost more than $10,000 in 8.8% of episodes.

“Because details on plan benefit design were unavailable, the generalizability of findings to all privately insured Americans is unclear,” the investigators noted. “However, the proportion of childbirth episodes covered by high-deductible health plans in this study is consistent with the prevalence of such plans among Americans with employer-sponsored insurance.”

The findings suggest that financial reform is needed, Dr. Chua and colleagues concluded.

“To avoid imposing undue financial burden on families, private insurers should improve childbirth coverage,” they wrote. “An incremental step would be providing first-dollar coverage of deliveries and newborn hospitalizations before deductibles are met. Ideally, however, insurers would waive most or all cost-sharing for these hospitalizations, consistent with the approach taken by Medicaid programs and many developed countries.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, the size of the study is commendable, but some details are lacking.

“Although the overall sample size allows for a robust analysis, deciding to not report the confidence intervals in this report does not allow for understanding of [the findings with] smaller sample sizes,” Dr. Sutton said in an interview.

(Dr. Chua and colleagues noted that they did not report confidence intervals because “all differences between subgroups were significant owing to large sample sizes.”)

“Still,” Dr. Sutton went on, “this is an important study that has implications for financial counseling that may need to be a part of preconceptional, prenatal, and postnatal visits for privately insured families to help with planning and to decrease the chances of childbirth-related financial hardships. Additionally, policy-level changes that decrease or eliminate these private insurance–related childbirth-episode costs that may negatively impact some families with lower incomes, are warranted.”

The study was funded by the National Institutes of Health. Dr. Chua disclosed a grant from the National Institute on Drug Abuse, while Dr. Moniz is supported by the Agency for Healthcare Research and Quality. Dr. Sutton had no relevant disclosures.

Families with private health insurance pay around $3,000 for newborn delivery and hospitalization, while adding neonatal intensive care can push the bill closer to $5,000, based on a retrospective look at almost 400,000 episodes.

The findings suggest that privately insured families need prenatal financial counseling, as well as screening for financial hardship after delivery, reported lead author Kao-Ping Chua, MD, PhD, assistant professor and health policy researcher in the department of pediatrics and the Susan B. Meister Child Health Evaluation and Research Center at the University of Michigan, Ann Arbor, and colleagues.

“Concern is growing regarding the high and rising financial burden of childbirth for privately insured families,” the investigators wrote in Pediatrics. “Previous studies assessing this burden have focused on out-of-pocket spending for maternal care, including hospitalizations for delivery. However, there are no recent national data on out-of-pocket spending across the childbirth episode, including both deliveries and newborn hospitalizations.”

To address this knowledge gap, Dr. Chua and colleagues turned to Optum’s deidentified Clinformatics Data Mart, comprising 12 million privately insured individuals across the United States. The investigators identified 398,410 childbirth episodes occurring between 2016 and 2019. Each episode was defined as one delivery and at least one newborn hospitalization under the same family plan.

Out-of-pocket cost included copayment plus coinsurance and deductibles. Primary outcomes included mean total out-of-pocket spending and proportion of episodes exceeding $5,000 or $10,000. Subgroup analyses compared differences in spending between episodes involving neonatal intensive care or cesarean birth.

The mean out-of-pocket spending was $2,281 for delivery and $788 for newborn hospitalization, giving a total of $3,068 per childbirth episode. Coinsurance and deductibles accounted for much of that cost, at 55.8% and 42.1%, respectively, whereas copayments accounted for a relatively minor portion (2.2%).

Almost all episodes (95%) cost more than zero dollars, while 17.1% cost more than $5,000 and 1.0% cost more than $10,000. Total mean out-of-pocket spending was higher for episodes involving cesarean birth ($3,389) or neonatal intensive care ($4,969), the latter of which cost more than $10,000 in 8.8% of episodes.

“Because details on plan benefit design were unavailable, the generalizability of findings to all privately insured Americans is unclear,” the investigators noted. “However, the proportion of childbirth episodes covered by high-deductible health plans in this study is consistent with the prevalence of such plans among Americans with employer-sponsored insurance.”

The findings suggest that financial reform is needed, Dr. Chua and colleagues concluded.

“To avoid imposing undue financial burden on families, private insurers should improve childbirth coverage,” they wrote. “An incremental step would be providing first-dollar coverage of deliveries and newborn hospitalizations before deductibles are met. Ideally, however, insurers would waive most or all cost-sharing for these hospitalizations, consistent with the approach taken by Medicaid programs and many developed countries.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, the size of the study is commendable, but some details are lacking.

“Although the overall sample size allows for a robust analysis, deciding to not report the confidence intervals in this report does not allow for understanding of [the findings with] smaller sample sizes,” Dr. Sutton said in an interview.

(Dr. Chua and colleagues noted that they did not report confidence intervals because “all differences between subgroups were significant owing to large sample sizes.”)

“Still,” Dr. Sutton went on, “this is an important study that has implications for financial counseling that may need to be a part of preconceptional, prenatal, and postnatal visits for privately insured families to help with planning and to decrease the chances of childbirth-related financial hardships. Additionally, policy-level changes that decrease or eliminate these private insurance–related childbirth-episode costs that may negatively impact some families with lower incomes, are warranted.”

The study was funded by the National Institutes of Health. Dr. Chua disclosed a grant from the National Institute on Drug Abuse, while Dr. Moniz is supported by the Agency for Healthcare Research and Quality. Dr. Sutton had no relevant disclosures.

Families with private health insurance pay around $3,000 for newborn delivery and hospitalization, while adding neonatal intensive care can push the bill closer to $5,000, based on a retrospective look at almost 400,000 episodes.

The findings suggest that privately insured families need prenatal financial counseling, as well as screening for financial hardship after delivery, reported lead author Kao-Ping Chua, MD, PhD, assistant professor and health policy researcher in the department of pediatrics and the Susan B. Meister Child Health Evaluation and Research Center at the University of Michigan, Ann Arbor, and colleagues.

“Concern is growing regarding the high and rising financial burden of childbirth for privately insured families,” the investigators wrote in Pediatrics. “Previous studies assessing this burden have focused on out-of-pocket spending for maternal care, including hospitalizations for delivery. However, there are no recent national data on out-of-pocket spending across the childbirth episode, including both deliveries and newborn hospitalizations.”

To address this knowledge gap, Dr. Chua and colleagues turned to Optum’s deidentified Clinformatics Data Mart, comprising 12 million privately insured individuals across the United States. The investigators identified 398,410 childbirth episodes occurring between 2016 and 2019. Each episode was defined as one delivery and at least one newborn hospitalization under the same family plan.

Out-of-pocket cost included copayment plus coinsurance and deductibles. Primary outcomes included mean total out-of-pocket spending and proportion of episodes exceeding $5,000 or $10,000. Subgroup analyses compared differences in spending between episodes involving neonatal intensive care or cesarean birth.

The mean out-of-pocket spending was $2,281 for delivery and $788 for newborn hospitalization, giving a total of $3,068 per childbirth episode. Coinsurance and deductibles accounted for much of that cost, at 55.8% and 42.1%, respectively, whereas copayments accounted for a relatively minor portion (2.2%).

Almost all episodes (95%) cost more than zero dollars, while 17.1% cost more than $5,000 and 1.0% cost more than $10,000. Total mean out-of-pocket spending was higher for episodes involving cesarean birth ($3,389) or neonatal intensive care ($4,969), the latter of which cost more than $10,000 in 8.8% of episodes.

“Because details on plan benefit design were unavailable, the generalizability of findings to all privately insured Americans is unclear,” the investigators noted. “However, the proportion of childbirth episodes covered by high-deductible health plans in this study is consistent with the prevalence of such plans among Americans with employer-sponsored insurance.”

The findings suggest that financial reform is needed, Dr. Chua and colleagues concluded.

“To avoid imposing undue financial burden on families, private insurers should improve childbirth coverage,” they wrote. “An incremental step would be providing first-dollar coverage of deliveries and newborn hospitalizations before deductibles are met. Ideally, however, insurers would waive most or all cost-sharing for these hospitalizations, consistent with the approach taken by Medicaid programs and many developed countries.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, the size of the study is commendable, but some details are lacking.

“Although the overall sample size allows for a robust analysis, deciding to not report the confidence intervals in this report does not allow for understanding of [the findings with] smaller sample sizes,” Dr. Sutton said in an interview.

(Dr. Chua and colleagues noted that they did not report confidence intervals because “all differences between subgroups were significant owing to large sample sizes.”)

“Still,” Dr. Sutton went on, “this is an important study that has implications for financial counseling that may need to be a part of preconceptional, prenatal, and postnatal visits for privately insured families to help with planning and to decrease the chances of childbirth-related financial hardships. Additionally, policy-level changes that decrease or eliminate these private insurance–related childbirth-episode costs that may negatively impact some families with lower incomes, are warranted.”

The study was funded by the National Institutes of Health. Dr. Chua disclosed a grant from the National Institute on Drug Abuse, while Dr. Moniz is supported by the Agency for Healthcare Research and Quality. Dr. Sutton had no relevant disclosures.

Pfizer is suspending distribution of the antismoking treatment Chantix after heightened levels of the carcinogen N-nitrosodimethylamine (NDMA) were found in some lots of the pills.

The pharmaceutical company is also recalling some lots of Chantix that may have high levels of NDMA, Reuters reported.

Pfizer told Reuters the distribution pause was ordered out of abundance of caution while further testing is conducted. The FDA approved varenicline, which is marketed as Chantix, in 2006.

“The benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime,” Pfizer spokesperson Steven Danehy said in an email, according to Reuters.

The FDA has not issued a recall on Chantix. In Canada, however, health authorities on June 8 instituted a recall for Champix, the name under which the drug is sold in that nation.

The Chantix website says it’s a 3- to 6-month treatment that helps people overcome the need to smoke tobacco. The website says more than 13 million people have been prescribed Chantix.

Other health concerns have been raised about Chantix, such as mental health side effects.

In 2016, however, researchers concluded Chantix did not appear to raise the risk of serious health disorders such as depression, anxiety, and suicidal thoughts.

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

Pfizer is suspending distribution of the antismoking treatment Chantix after heightened levels of the carcinogen N-nitrosodimethylamine (NDMA) were found in some lots of the pills.

The pharmaceutical company is also recalling some lots of Chantix that may have high levels of NDMA, Reuters reported.

Pfizer told Reuters the distribution pause was ordered out of abundance of caution while further testing is conducted. The FDA approved varenicline, which is marketed as Chantix, in 2006.

“The benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime,” Pfizer spokesperson Steven Danehy said in an email, according to Reuters.

The FDA has not issued a recall on Chantix. In Canada, however, health authorities on June 8 instituted a recall for Champix, the name under which the drug is sold in that nation.

The Chantix website says it’s a 3- to 6-month treatment that helps people overcome the need to smoke tobacco. The website says more than 13 million people have been prescribed Chantix.

Other health concerns have been raised about Chantix, such as mental health side effects.

In 2016, however, researchers concluded Chantix did not appear to raise the risk of serious health disorders such as depression, anxiety, and suicidal thoughts.

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

Pfizer is suspending distribution of the antismoking treatment Chantix after heightened levels of the carcinogen N-nitrosodimethylamine (NDMA) were found in some lots of the pills.

The pharmaceutical company is also recalling some lots of Chantix that may have high levels of NDMA, Reuters reported.

Pfizer told Reuters the distribution pause was ordered out of abundance of caution while further testing is conducted. The FDA approved varenicline, which is marketed as Chantix, in 2006.

“The benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime,” Pfizer spokesperson Steven Danehy said in an email, according to Reuters.

The FDA has not issued a recall on Chantix. In Canada, however, health authorities on June 8 instituted a recall for Champix, the name under which the drug is sold in that nation.

The Chantix website says it’s a 3- to 6-month treatment that helps people overcome the need to smoke tobacco. The website says more than 13 million people have been prescribed Chantix.

Other health concerns have been raised about Chantix, such as mental health side effects.

In 2016, however, researchers concluded Chantix did not appear to raise the risk of serious health disorders such as depression, anxiety, and suicidal thoughts.

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

Treating the needs of patients of color requires an understanding of differences that may not be readily apparent, a dermatologist told colleagues. For example, clinicians generally understand what White patients are talking about when they mention acne scarring, but Black patients have a different perception of the term that may be misinterpreted in the doctor’s office.

“Scarring is not usually what they’re talking about, although they may have some of that as well. They’re [typically] talking about what we know as postinflammatory hyperpigmentation, not scarring. So right away, you have to clarify,” Amy McMichael, MD, professor and chair of dermatology at Wake Forest Baptist Medical Center in Winston-Salem, N.C., said in a presentation at the Inaugural Symposium for Inflammatory Skin Disease. “When you’re talking about scarring, do you mean the dark spots? What exactly are you concerned about?”

Dr. McMichael highlighted a 2014 study that reported the results of a survey of 208 women (51% were White; 49% were non-White), which included 51 Black, 23 Hispanic, and 16 Asian women aged 25-45 (mean age, 35) with 25 or more lesions. White women were more troubled by facial acne than were women of color (89% vs. 76%, respectively, P < .05), and they were more likely to say lesion clearance was most important to them (58% vs. 32%, respectively, P < .001).

Meanwhile, non-White women were much more likely than were White women to say that clearance of postinflammatory hyperpigmentation was most important to them (42% vs. 8%, respectively, P < .0001).

“Seventy percent of [non-White women] felt that their race and ethnicity required targeted attention [in treatment], and two-thirds desired acne treatment that was designed to meet the needs of their skin type,” Dr. McMichael said. “If you don’t address the issues, if you don’t talk about the pigmentation with them or explain how you’re going to address it, people don’t feel heard. They don’t feel like they’ve really seen a dermatologist who understands their needs.”

She added that it’s crucial to ask about over-the-counter products. “If you don’t discuss them, they’ll assume that what they’re doing is okay.” She warns her patients against using and exposing their skin and face to cocoa butter and oils such as tea tree oil.

Research has suggested that among people of color, Blacks and Hispanics are most likely to experience dyspigmentation and scarring, Dr. McMichael said. She advised colleagues to be aware of pomade acne in these two groups of patients. Pomade acne appears along the hair line and is caused by the use of hair products. She also cautioned about acne cosmetica, which can be triggered by products such as makeup, used to cover up acne and postinflammatory hyperpigmentation.

As for acne treatments, Dr. McMichael highlighted a long list of familiar topical and oral agents and procedural options. Less familiar strategies include laser and light-based therapies, she said.

As for up-and-coming options, she pointed to topical minocycline, “which allows us to use an anti-inflammatory agent topically rather than orally when we’re trying to get away from using a lot of oral antibiotics.”

Also consider whether female patients have polycystic ovary syndrome, she said. “Then you might consider spironolactone. I certainly use a lot more of that these days to try to avoid long-term oral antibiotics.”

She recommended earlier use of isotretinoin in patients overall, and she urged colleagues to proceed with their standard retinoid approaches. However, she noted that she lets patients know that she’ll focus first on treating the acne itself and then work on the dark spots in later treatments. “If you give people a bleaching agent in the beginning, they’re going to stop using their main products, and they’re going to chase those dark spots. That’s just something that they can’t help doing.”

Dr. McMichael disclosed investigator and consultant relationships with multiple drug makers.

Treating the needs of patients of color requires an understanding of differences that may not be readily apparent, a dermatologist told colleagues. For example, clinicians generally understand what White patients are talking about when they mention acne scarring, but Black patients have a different perception of the term that may be misinterpreted in the doctor’s office.

“Scarring is not usually what they’re talking about, although they may have some of that as well. They’re [typically] talking about what we know as postinflammatory hyperpigmentation, not scarring. So right away, you have to clarify,” Amy McMichael, MD, professor and chair of dermatology at Wake Forest Baptist Medical Center in Winston-Salem, N.C., said in a presentation at the Inaugural Symposium for Inflammatory Skin Disease. “When you’re talking about scarring, do you mean the dark spots? What exactly are you concerned about?”

Dr. McMichael highlighted a 2014 study that reported the results of a survey of 208 women (51% were White; 49% were non-White), which included 51 Black, 23 Hispanic, and 16 Asian women aged 25-45 (mean age, 35) with 25 or more lesions. White women were more troubled by facial acne than were women of color (89% vs. 76%, respectively, P < .05), and they were more likely to say lesion clearance was most important to them (58% vs. 32%, respectively, P < .001).

Meanwhile, non-White women were much more likely than were White women to say that clearance of postinflammatory hyperpigmentation was most important to them (42% vs. 8%, respectively, P < .0001).

“Seventy percent of [non-White women] felt that their race and ethnicity required targeted attention [in treatment], and two-thirds desired acne treatment that was designed to meet the needs of their skin type,” Dr. McMichael said. “If you don’t address the issues, if you don’t talk about the pigmentation with them or explain how you’re going to address it, people don’t feel heard. They don’t feel like they’ve really seen a dermatologist who understands their needs.”

She added that it’s crucial to ask about over-the-counter products. “If you don’t discuss them, they’ll assume that what they’re doing is okay.” She warns her patients against using and exposing their skin and face to cocoa butter and oils such as tea tree oil.

Research has suggested that among people of color, Blacks and Hispanics are most likely to experience dyspigmentation and scarring, Dr. McMichael said. She advised colleagues to be aware of pomade acne in these two groups of patients. Pomade acne appears along the hair line and is caused by the use of hair products. She also cautioned about acne cosmetica, which can be triggered by products such as makeup, used to cover up acne and postinflammatory hyperpigmentation.

As for acne treatments, Dr. McMichael highlighted a long list of familiar topical and oral agents and procedural options. Less familiar strategies include laser and light-based therapies, she said.

As for up-and-coming options, she pointed to topical minocycline, “which allows us to use an anti-inflammatory agent topically rather than orally when we’re trying to get away from using a lot of oral antibiotics.”

Also consider whether female patients have polycystic ovary syndrome, she said. “Then you might consider spironolactone. I certainly use a lot more of that these days to try to avoid long-term oral antibiotics.”

She recommended earlier use of isotretinoin in patients overall, and she urged colleagues to proceed with their standard retinoid approaches. However, she noted that she lets patients know that she’ll focus first on treating the acne itself and then work on the dark spots in later treatments. “If you give people a bleaching agent in the beginning, they’re going to stop using their main products, and they’re going to chase those dark spots. That’s just something that they can’t help doing.”

Dr. McMichael disclosed investigator and consultant relationships with multiple drug makers.

Treating the needs of patients of color requires an understanding of differences that may not be readily apparent, a dermatologist told colleagues. For example, clinicians generally understand what White patients are talking about when they mention acne scarring, but Black patients have a different perception of the term that may be misinterpreted in the doctor’s office.

“Scarring is not usually what they’re talking about, although they may have some of that as well. They’re [typically] talking about what we know as postinflammatory hyperpigmentation, not scarring. So right away, you have to clarify,” Amy McMichael, MD, professor and chair of dermatology at Wake Forest Baptist Medical Center in Winston-Salem, N.C., said in a presentation at the Inaugural Symposium for Inflammatory Skin Disease. “When you’re talking about scarring, do you mean the dark spots? What exactly are you concerned about?”

Dr. McMichael highlighted a 2014 study that reported the results of a survey of 208 women (51% were White; 49% were non-White), which included 51 Black, 23 Hispanic, and 16 Asian women aged 25-45 (mean age, 35) with 25 or more lesions. White women were more troubled by facial acne than were women of color (89% vs. 76%, respectively, P < .05), and they were more likely to say lesion clearance was most important to them (58% vs. 32%, respectively, P < .001).

Meanwhile, non-White women were much more likely than were White women to say that clearance of postinflammatory hyperpigmentation was most important to them (42% vs. 8%, respectively, P < .0001).

“Seventy percent of [non-White women] felt that their race and ethnicity required targeted attention [in treatment], and two-thirds desired acne treatment that was designed to meet the needs of their skin type,” Dr. McMichael said. “If you don’t address the issues, if you don’t talk about the pigmentation with them or explain how you’re going to address it, people don’t feel heard. They don’t feel like they’ve really seen a dermatologist who understands their needs.”

She added that it’s crucial to ask about over-the-counter products. “If you don’t discuss them, they’ll assume that what they’re doing is okay.” She warns her patients against using and exposing their skin and face to cocoa butter and oils such as tea tree oil.

Research has suggested that among people of color, Blacks and Hispanics are most likely to experience dyspigmentation and scarring, Dr. McMichael said. She advised colleagues to be aware of pomade acne in these two groups of patients. Pomade acne appears along the hair line and is caused by the use of hair products. She also cautioned about acne cosmetica, which can be triggered by products such as makeup, used to cover up acne and postinflammatory hyperpigmentation.

As for acne treatments, Dr. McMichael highlighted a long list of familiar topical and oral agents and procedural options. Less familiar strategies include laser and light-based therapies, she said.

As for up-and-coming options, she pointed to topical minocycline, “which allows us to use an anti-inflammatory agent topically rather than orally when we’re trying to get away from using a lot of oral antibiotics.”

Also consider whether female patients have polycystic ovary syndrome, she said. “Then you might consider spironolactone. I certainly use a lot more of that these days to try to avoid long-term oral antibiotics.”

She recommended earlier use of isotretinoin in patients overall, and she urged colleagues to proceed with their standard retinoid approaches. However, she noted that she lets patients know that she’ll focus first on treating the acne itself and then work on the dark spots in later treatments. “If you give people a bleaching agent in the beginning, they’re going to stop using their main products, and they’re going to chase those dark spots. That’s just something that they can’t help doing.”

Dr. McMichael disclosed investigator and consultant relationships with multiple drug makers.

After treatment with ruxolitinib cream for 52 weeks, between 60% and 80% of atopic dermatitis patients maintained clear or almost clear skin, with no safety signals, results from a long-term analysis of clinical trial data showed.

“The incidence of application-site reactions was low, and there were no clinically meaningful changes or trends in hematologic parameters,” Kim Papp, MD, PhD, said during the Revolutionizing Atopic Dermatitis symposium.

Ruxolitinib cream is a selective Janus kinase 1/JAK2 inhibitor being developed by Incyte for the treatment of atopic dermatitis (AD).

According to a press release from the company, the Food and Drug Administration has extended the New Drug Application review period for the agent by 3 months to September 2021. If approved, it would become first topical JAK inhibitor for use in dermatology.

In two phase 3, randomized studies of identical design involving 1,249 patients aged 12 and older with AD – TRuE-AD1 and TRuE-AD2 – ruxolitinib cream demonstrated anti-inflammatory activity, with rapid and sustained antipruritic action, compared with vehicle. To be eligible for the trials patients with an Investigator’s Global Assessment (IGA) score of 2 or 3 and 3%-20% of affected body surface area (BSA) were randomized (2:2:1) to twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 continuous weeks.

A recently published report found that significantly more patients in TRuE-AD1 and TRuE-AD2 achieved IGA treatment success with 0.75% (50% vs. 39%, respectively) and 1.5% ruxolitinib cream (53.8% vs. 51.3%), compared with vehicle (15.1% vs. 7.6%; P < .0001) at week 8. In addition, significant reductions in itch, compared with vehicle, were reported within 12 hours of first applying 1.5% ruxolitinib cream (P < .05).
 

Longterm data

During the symposium, Dr. Papp presented long-term safety data of ruxolitinib cream in patients who were followed for an additional 44 weeks. Those initially randomized to vehicle were rerandomized 1:1 (blinded) to either ruxolitinib cream regimen. They were instructed to treat skin areas with active AD only and to stop treatment 3 days after clearance of lesions, and to restart treatment with ruxolitinib cream at the first sign of recurrence. Safety and tolerability were assessed by frequency and severity of adverse events, while disease control was measured by the proportion of patients with an IGA score of 0 or 1 and the affected BSA.

Dr. Papp, a dermatologist and founder of Probity Medical Research, Waterloo, Ont., reported that 543 patients from TRuE-AD1 and 530 from TRuE-AD2 entered the long-term analysis and that about 78% of these patients completed the study. From weeks 12 to 52, the proportion of patients with an IGA score of 0 or 1 with 0.75% and 1.5% ruxolitinib cream ranged from 62%-77% and 67%-77%, respectively, in TRuE-AD1 to 60%-77% and 72%-80% in TRuE-AD2.

The measured mean total affected BSA was less than 3% throughout the follow-up period in the 1.5% ruxolitinib cream arm in TRuE-AD1 and TRuE-AD2 and was less than 3% in the 0.75% ruxolitinib cream arm during most of the study period.

In a pooled safety analysis, treatment-emergent adverse events (TEAEs) were reported in 60% and 54% of patients who applied 0.75% and 1.5% ruxolitinib cream, respectively, over 44 weeks. The frequency of application-site reactions remained low. Specifically, treatment-related adverse events were reported in 5% of patients who applied 0.75% ruxolitinib cream and in 3% of patients who applied 1.5% ruxolitinib cream; none were serious. TEAEs led to discontinuation in 2% of patients in the 0.75% ruxolitinib cream group, and no patients in the 1.5% ruxolitinib cream group.

“The most common treatment adverse events were upper respiratory tract infections and nasopharyngitis,” Dr. Papp said. “When looking at exposure-adjusted adverse events, we see that there is a high degree of similarity between any of the TEAEs across all of the treatment groups in both studies. We also see that it was patients on the vehicle who experienced the greatest number of application-site reactions.”

Dr. Papp disclosed that he has received honoraria or clinical research grants as a consultant, speaker, scientific officer, advisory board member, and/or steering committee member for several pharmaceutical companies, including Incyte.

[email protected]

After treatment with ruxolitinib cream for 52 weeks, between 60% and 80% of atopic dermatitis patients maintained clear or almost clear skin, with no safety signals, results from a long-term analysis of clinical trial data showed.

“The incidence of application-site reactions was low, and there were no clinically meaningful changes or trends in hematologic parameters,” Kim Papp, MD, PhD, said during the Revolutionizing Atopic Dermatitis symposium.

Ruxolitinib cream is a selective Janus kinase 1/JAK2 inhibitor being developed by Incyte for the treatment of atopic dermatitis (AD).

According to a press release from the company, the Food and Drug Administration has extended the New Drug Application review period for the agent by 3 months to September 2021. If approved, it would become first topical JAK inhibitor for use in dermatology.

In two phase 3, randomized studies of identical design involving 1,249 patients aged 12 and older with AD – TRuE-AD1 and TRuE-AD2 – ruxolitinib cream demonstrated anti-inflammatory activity, with rapid and sustained antipruritic action, compared with vehicle. To be eligible for the trials patients with an Investigator’s Global Assessment (IGA) score of 2 or 3 and 3%-20% of affected body surface area (BSA) were randomized (2:2:1) to twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 continuous weeks.

A recently published report found that significantly more patients in TRuE-AD1 and TRuE-AD2 achieved IGA treatment success with 0.75% (50% vs. 39%, respectively) and 1.5% ruxolitinib cream (53.8% vs. 51.3%), compared with vehicle (15.1% vs. 7.6%; P < .0001) at week 8. In addition, significant reductions in itch, compared with vehicle, were reported within 12 hours of first applying 1.5% ruxolitinib cream (P < .05).
 

Longterm data

During the symposium, Dr. Papp presented long-term safety data of ruxolitinib cream in patients who were followed for an additional 44 weeks. Those initially randomized to vehicle were rerandomized 1:1 (blinded) to either ruxolitinib cream regimen. They were instructed to treat skin areas with active AD only and to stop treatment 3 days after clearance of lesions, and to restart treatment with ruxolitinib cream at the first sign of recurrence. Safety and tolerability were assessed by frequency and severity of adverse events, while disease control was measured by the proportion of patients with an IGA score of 0 or 1 and the affected BSA.

Dr. Papp, a dermatologist and founder of Probity Medical Research, Waterloo, Ont., reported that 543 patients from TRuE-AD1 and 530 from TRuE-AD2 entered the long-term analysis and that about 78% of these patients completed the study. From weeks 12 to 52, the proportion of patients with an IGA score of 0 or 1 with 0.75% and 1.5% ruxolitinib cream ranged from 62%-77% and 67%-77%, respectively, in TRuE-AD1 to 60%-77% and 72%-80% in TRuE-AD2.

The measured mean total affected BSA was less than 3% throughout the follow-up period in the 1.5% ruxolitinib cream arm in TRuE-AD1 and TRuE-AD2 and was less than 3% in the 0.75% ruxolitinib cream arm during most of the study period.

In a pooled safety analysis, treatment-emergent adverse events (TEAEs) were reported in 60% and 54% of patients who applied 0.75% and 1.5% ruxolitinib cream, respectively, over 44 weeks. The frequency of application-site reactions remained low. Specifically, treatment-related adverse events were reported in 5% of patients who applied 0.75% ruxolitinib cream and in 3% of patients who applied 1.5% ruxolitinib cream; none were serious. TEAEs led to discontinuation in 2% of patients in the 0.75% ruxolitinib cream group, and no patients in the 1.5% ruxolitinib cream group.

“The most common treatment adverse events were upper respiratory tract infections and nasopharyngitis,” Dr. Papp said. “When looking at exposure-adjusted adverse events, we see that there is a high degree of similarity between any of the TEAEs across all of the treatment groups in both studies. We also see that it was patients on the vehicle who experienced the greatest number of application-site reactions.”

Dr. Papp disclosed that he has received honoraria or clinical research grants as a consultant, speaker, scientific officer, advisory board member, and/or steering committee member for several pharmaceutical companies, including Incyte.

[email protected]

After treatment with ruxolitinib cream for 52 weeks, between 60% and 80% of atopic dermatitis patients maintained clear or almost clear skin, with no safety signals, results from a long-term analysis of clinical trial data showed.

“The incidence of application-site reactions was low, and there were no clinically meaningful changes or trends in hematologic parameters,” Kim Papp, MD, PhD, said during the Revolutionizing Atopic Dermatitis symposium.

Ruxolitinib cream is a selective Janus kinase 1/JAK2 inhibitor being developed by Incyte for the treatment of atopic dermatitis (AD).

According to a press release from the company, the Food and Drug Administration has extended the New Drug Application review period for the agent by 3 months to September 2021. If approved, it would become first topical JAK inhibitor for use in dermatology.

In two phase 3, randomized studies of identical design involving 1,249 patients aged 12 and older with AD – TRuE-AD1 and TRuE-AD2 – ruxolitinib cream demonstrated anti-inflammatory activity, with rapid and sustained antipruritic action, compared with vehicle. To be eligible for the trials patients with an Investigator’s Global Assessment (IGA) score of 2 or 3 and 3%-20% of affected body surface area (BSA) were randomized (2:2:1) to twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 continuous weeks.

A recently published report found that significantly more patients in TRuE-AD1 and TRuE-AD2 achieved IGA treatment success with 0.75% (50% vs. 39%, respectively) and 1.5% ruxolitinib cream (53.8% vs. 51.3%), compared with vehicle (15.1% vs. 7.6%; P < .0001) at week 8. In addition, significant reductions in itch, compared with vehicle, were reported within 12 hours of first applying 1.5% ruxolitinib cream (P < .05).
 

Longterm data

During the symposium, Dr. Papp presented long-term safety data of ruxolitinib cream in patients who were followed for an additional 44 weeks. Those initially randomized to vehicle were rerandomized 1:1 (blinded) to either ruxolitinib cream regimen. They were instructed to treat skin areas with active AD only and to stop treatment 3 days after clearance of lesions, and to restart treatment with ruxolitinib cream at the first sign of recurrence. Safety and tolerability were assessed by frequency and severity of adverse events, while disease control was measured by the proportion of patients with an IGA score of 0 or 1 and the affected BSA.

Dr. Papp, a dermatologist and founder of Probity Medical Research, Waterloo, Ont., reported that 543 patients from TRuE-AD1 and 530 from TRuE-AD2 entered the long-term analysis and that about 78% of these patients completed the study. From weeks 12 to 52, the proportion of patients with an IGA score of 0 or 1 with 0.75% and 1.5% ruxolitinib cream ranged from 62%-77% and 67%-77%, respectively, in TRuE-AD1 to 60%-77% and 72%-80% in TRuE-AD2.

The measured mean total affected BSA was less than 3% throughout the follow-up period in the 1.5% ruxolitinib cream arm in TRuE-AD1 and TRuE-AD2 and was less than 3% in the 0.75% ruxolitinib cream arm during most of the study period.

In a pooled safety analysis, treatment-emergent adverse events (TEAEs) were reported in 60% and 54% of patients who applied 0.75% and 1.5% ruxolitinib cream, respectively, over 44 weeks. The frequency of application-site reactions remained low. Specifically, treatment-related adverse events were reported in 5% of patients who applied 0.75% ruxolitinib cream and in 3% of patients who applied 1.5% ruxolitinib cream; none were serious. TEAEs led to discontinuation in 2% of patients in the 0.75% ruxolitinib cream group, and no patients in the 1.5% ruxolitinib cream group.

“The most common treatment adverse events were upper respiratory tract infections and nasopharyngitis,” Dr. Papp said. “When looking at exposure-adjusted adverse events, we see that there is a high degree of similarity between any of the TEAEs across all of the treatment groups in both studies. We also see that it was patients on the vehicle who experienced the greatest number of application-site reactions.”

Dr. Papp disclosed that he has received honoraria or clinical research grants as a consultant, speaker, scientific officer, advisory board member, and/or steering committee member for several pharmaceutical companies, including Incyte.

[email protected]

The U.S. Food and Drug Administration has granted breakthrough therapy designation for lecanemab (Eisai/Biogen), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer’s disease.

Lecanemab (formerly BAN2401) is a humanized monoclonal antibody that selectively binds to large, soluble aggregated Abeta protofibrils. The antibody was developed following the discovery of a mutation in amyloid precursor protein that leads to a form of Alzheimer’s disease that is marked by particularly high levels of Abeta protofibrils.

“As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease,” Eisai and Biogen said in a joint news release.

The breakthrough therapy designation for lecanemab is based on results of a randomized, double-blind, phase 2b proof-of-concept study published April 17 in Alzheimer’s Research & Therapy.

The study enrolled 856 patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease with confirmed presence of amyloid pathology.

At the highest doses, treatment with lecanemab led to a reduction in brain amyloid accompanied by a consistent reduction of clinical decline across several clinical and biomarker endpoints.
 

Phase 3 testing underway

In March, Eisai and Biogen completed enrollment in a phase 3 study designed to confirm the safety and efficacy of lecanemab in patients with symptomatic early Alzheimer’s disease. 

The CLARITY AD study includes 1,795 patients with early Alzheimer’s disease, and initial results are expected by the end of September 2022. The core study will compare lecanemab against placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months. The study will also evaluate the long-term safety and tolerability of lecanemab in the extension phase and whether the long-term effects of lecanemab, as measured by the CDR-SB at the end of the core study, are maintained over time.

Additionally, the phase 3 AHEAD 3-45 clinical study is currently exploring lecanemab in adults with preclinical Alzheimer’s disease (clinically normal but with intermediate or elevated brain amyloid).

On June 7, the FDA – amid significant controversy – approved aducanumab (Aduhelm), the first anti-amyloid agent for the treatment Alzheimer’s disease, disregarding the recommendation by its own advisory panel not to approve the drug. Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee subsequently resigned in protest following the agency’s approval of aducanumab.

In addition, the high-profile consumer advocacy group Public Citizen sent a letter to the secretary of the U.S. Department of Health & Human Services demanding the removal of three FDA officials, including acting FDA Commissioner Janet Woodcock, MD. 

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

The U.S. Food and Drug Administration has granted breakthrough therapy designation for lecanemab (Eisai/Biogen), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer’s disease.

Lecanemab (formerly BAN2401) is a humanized monoclonal antibody that selectively binds to large, soluble aggregated Abeta protofibrils. The antibody was developed following the discovery of a mutation in amyloid precursor protein that leads to a form of Alzheimer’s disease that is marked by particularly high levels of Abeta protofibrils.

“As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease,” Eisai and Biogen said in a joint news release.

The breakthrough therapy designation for lecanemab is based on results of a randomized, double-blind, phase 2b proof-of-concept study published April 17 in Alzheimer’s Research & Therapy.

The study enrolled 856 patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease with confirmed presence of amyloid pathology.

At the highest doses, treatment with lecanemab led to a reduction in brain amyloid accompanied by a consistent reduction of clinical decline across several clinical and biomarker endpoints.
 

Phase 3 testing underway

In March, Eisai and Biogen completed enrollment in a phase 3 study designed to confirm the safety and efficacy of lecanemab in patients with symptomatic early Alzheimer’s disease. 

The CLARITY AD study includes 1,795 patients with early Alzheimer’s disease, and initial results are expected by the end of September 2022. The core study will compare lecanemab against placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months. The study will also evaluate the long-term safety and tolerability of lecanemab in the extension phase and whether the long-term effects of lecanemab, as measured by the CDR-SB at the end of the core study, are maintained over time.

Additionally, the phase 3 AHEAD 3-45 clinical study is currently exploring lecanemab in adults with preclinical Alzheimer’s disease (clinically normal but with intermediate or elevated brain amyloid).

On June 7, the FDA – amid significant controversy – approved aducanumab (Aduhelm), the first anti-amyloid agent for the treatment Alzheimer’s disease, disregarding the recommendation by its own advisory panel not to approve the drug. Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee subsequently resigned in protest following the agency’s approval of aducanumab.

In addition, the high-profile consumer advocacy group Public Citizen sent a letter to the secretary of the U.S. Department of Health & Human Services demanding the removal of three FDA officials, including acting FDA Commissioner Janet Woodcock, MD. 

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

The U.S. Food and Drug Administration has granted breakthrough therapy designation for lecanemab (Eisai/Biogen), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer’s disease.

Lecanemab (formerly BAN2401) is a humanized monoclonal antibody that selectively binds to large, soluble aggregated Abeta protofibrils. The antibody was developed following the discovery of a mutation in amyloid precursor protein that leads to a form of Alzheimer’s disease that is marked by particularly high levels of Abeta protofibrils.

“As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease,” Eisai and Biogen said in a joint news release.

The breakthrough therapy designation for lecanemab is based on results of a randomized, double-blind, phase 2b proof-of-concept study published April 17 in Alzheimer’s Research & Therapy.

The study enrolled 856 patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease with confirmed presence of amyloid pathology.

At the highest doses, treatment with lecanemab led to a reduction in brain amyloid accompanied by a consistent reduction of clinical decline across several clinical and biomarker endpoints.
 

Phase 3 testing underway

In March, Eisai and Biogen completed enrollment in a phase 3 study designed to confirm the safety and efficacy of lecanemab in patients with symptomatic early Alzheimer’s disease. 

The CLARITY AD study includes 1,795 patients with early Alzheimer’s disease, and initial results are expected by the end of September 2022. The core study will compare lecanemab against placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months. The study will also evaluate the long-term safety and tolerability of lecanemab in the extension phase and whether the long-term effects of lecanemab, as measured by the CDR-SB at the end of the core study, are maintained over time.

Additionally, the phase 3 AHEAD 3-45 clinical study is currently exploring lecanemab in adults with preclinical Alzheimer’s disease (clinically normal but with intermediate or elevated brain amyloid).

On June 7, the FDA – amid significant controversy – approved aducanumab (Aduhelm), the first anti-amyloid agent for the treatment Alzheimer’s disease, disregarding the recommendation by its own advisory panel not to approve the drug. Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee subsequently resigned in protest following the agency’s approval of aducanumab.

In addition, the high-profile consumer advocacy group Public Citizen sent a letter to the secretary of the U.S. Department of Health & Human Services demanding the removal of three FDA officials, including acting FDA Commissioner Janet Woodcock, MD. 

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

The most comprehensive molecular study to date of brain tissue from people who died of COVID-19 provides clear evidence that SARS-CoV-2 causes profound molecular changes in the brain, despite no molecular trace of the virus in brain tissue.

“The signature the virus leaves in the brain speaks of strong inflammation and disrupted brain circuits and resembles signatures the field has observed in Alzheimer’s or other neurodegenerative diseases,” senior author Tony Wyss-Coray, PhD, professor of neurology and neurological sciences, Stanford (Calif.) University, told this news organization.

The study was published online June 21 in Nature.
 

Signs of distress

“We know that up to a third of SARS-CoV-2-infected people show brain symptoms including brain fog, memory problems, and fatigue, and a growing number of people have such symptoms long after they [have] seemingly recovered from virus infection,” said Dr. Wyss-Coray.

“However, we have very little understanding of how the virus causes these symptoms and what its effects are on the brain at a molecular level,” he added.

Using single-cell RNA sequencing, the researchers profiled the transcriptomes of 65,309 nuclei isolated from frontal cortex and choroid plexus samples from eight patients who died of COVID-19 and 14 controls who died of other causes.

There was no molecular evidence of SARS-CoV-2 in brain tissue samples from the patients who died of COVID-19.

Yet, “we were very surprised to learn that no matter which type of cell we studied (different types of nerve cells, immune cells, or different support cells in the brain) there were prominent changes” compared with brain tissue samples from controls who died of other causes, said Dr. Wyss-Coray.

The changes in the COVID-19 brains showed signatures of inflammation, abnormal nerve cell communication, and chronic neurodegeneration.

“Across cell types, COVID-19 perturbations overlap with those in chronic brain disorders and reside in genetic variants associated with cognition, schizophrenia, and depression,” the researchers report.

“Viral infection appears to trigger inflammatory responses throughout the body that may cause inflammatory signaling across the blood–brain barrier, which in turn could ‘trip off’ neuroinflammation in the brain,” Dr. Wyss-Coray said.

The findings may help explain the brain fog, fatigue, and other neurological and psychiatric symptoms of long COVID.

“While we studied only brains from people who died of COVID-19, we believe it is likely that similar, but hopefully weaker, signs of inflammation and chronic neurodegeneration will be found in COVID-19 survivors, especially those with chronic brain symptoms,” Dr. Wyss-Coray said.

This research was funded by the Nomis Foundation, the National Institutes of Health, Nan Fung Life Sciences, the Wu Tsai Neurosciences Institute and the Stanford Alzheimer’s Disease Research Center. The authors have disclosed no relevant financial relationships.

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

The most comprehensive molecular study to date of brain tissue from people who died of COVID-19 provides clear evidence that SARS-CoV-2 causes profound molecular changes in the brain, despite no molecular trace of the virus in brain tissue.

“The signature the virus leaves in the brain speaks of strong inflammation and disrupted brain circuits and resembles signatures the field has observed in Alzheimer’s or other neurodegenerative diseases,” senior author Tony Wyss-Coray, PhD, professor of neurology and neurological sciences, Stanford (Calif.) University, told this news organization.

The study was published online June 21 in Nature.
 

Signs of distress

“We know that up to a third of SARS-CoV-2-infected people show brain symptoms including brain fog, memory problems, and fatigue, and a growing number of people have such symptoms long after they [have] seemingly recovered from virus infection,” said Dr. Wyss-Coray.

“However, we have very little understanding of how the virus causes these symptoms and what its effects are on the brain at a molecular level,” he added.

Using single-cell RNA sequencing, the researchers profiled the transcriptomes of 65,309 nuclei isolated from frontal cortex and choroid plexus samples from eight patients who died of COVID-19 and 14 controls who died of other causes.

There was no molecular evidence of SARS-CoV-2 in brain tissue samples from the patients who died of COVID-19.

Yet, “we were very surprised to learn that no matter which type of cell we studied (different types of nerve cells, immune cells, or different support cells in the brain) there were prominent changes” compared with brain tissue samples from controls who died of other causes, said Dr. Wyss-Coray.

The changes in the COVID-19 brains showed signatures of inflammation, abnormal nerve cell communication, and chronic neurodegeneration.

“Across cell types, COVID-19 perturbations overlap with those in chronic brain disorders and reside in genetic variants associated with cognition, schizophrenia, and depression,” the researchers report.

“Viral infection appears to trigger inflammatory responses throughout the body that may cause inflammatory signaling across the blood–brain barrier, which in turn could ‘trip off’ neuroinflammation in the brain,” Dr. Wyss-Coray said.

The findings may help explain the brain fog, fatigue, and other neurological and psychiatric symptoms of long COVID.

“While we studied only brains from people who died of COVID-19, we believe it is likely that similar, but hopefully weaker, signs of inflammation and chronic neurodegeneration will be found in COVID-19 survivors, especially those with chronic brain symptoms,” Dr. Wyss-Coray said.

This research was funded by the Nomis Foundation, the National Institutes of Health, Nan Fung Life Sciences, the Wu Tsai Neurosciences Institute and the Stanford Alzheimer’s Disease Research Center. The authors have disclosed no relevant financial relationships.

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

The most comprehensive molecular study to date of brain tissue from people who died of COVID-19 provides clear evidence that SARS-CoV-2 causes profound molecular changes in the brain, despite no molecular trace of the virus in brain tissue.

“The signature the virus leaves in the brain speaks of strong inflammation and disrupted brain circuits and resembles signatures the field has observed in Alzheimer’s or other neurodegenerative diseases,” senior author Tony Wyss-Coray, PhD, professor of neurology and neurological sciences, Stanford (Calif.) University, told this news organization.

The study was published online June 21 in Nature.
 

Signs of distress

“We know that up to a third of SARS-CoV-2-infected people show brain symptoms including brain fog, memory problems, and fatigue, and a growing number of people have such symptoms long after they [have] seemingly recovered from virus infection,” said Dr. Wyss-Coray.

“However, we have very little understanding of how the virus causes these symptoms and what its effects are on the brain at a molecular level,” he added.

Using single-cell RNA sequencing, the researchers profiled the transcriptomes of 65,309 nuclei isolated from frontal cortex and choroid plexus samples from eight patients who died of COVID-19 and 14 controls who died of other causes.

There was no molecular evidence of SARS-CoV-2 in brain tissue samples from the patients who died of COVID-19.

Yet, “we were very surprised to learn that no matter which type of cell we studied (different types of nerve cells, immune cells, or different support cells in the brain) there were prominent changes” compared with brain tissue samples from controls who died of other causes, said Dr. Wyss-Coray.

The changes in the COVID-19 brains showed signatures of inflammation, abnormal nerve cell communication, and chronic neurodegeneration.

“Across cell types, COVID-19 perturbations overlap with those in chronic brain disorders and reside in genetic variants associated with cognition, schizophrenia, and depression,” the researchers report.

“Viral infection appears to trigger inflammatory responses throughout the body that may cause inflammatory signaling across the blood–brain barrier, which in turn could ‘trip off’ neuroinflammation in the brain,” Dr. Wyss-Coray said.

The findings may help explain the brain fog, fatigue, and other neurological and psychiatric symptoms of long COVID.

“While we studied only brains from people who died of COVID-19, we believe it is likely that similar, but hopefully weaker, signs of inflammation and chronic neurodegeneration will be found in COVID-19 survivors, especially those with chronic brain symptoms,” Dr. Wyss-Coray said.

This research was funded by the Nomis Foundation, the National Institutes of Health, Nan Fung Life Sciences, the Wu Tsai Neurosciences Institute and the Stanford Alzheimer’s Disease Research Center. The authors have disclosed no relevant financial relationships.

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

More evidence suggests the severity of internet addiction (IA) is directly related to the severity of sleep problems in youth.

Results from a study of more than 4,000 adolescent students show IA severity was linked to less sleep and to daytime sleepiness. In addition, boys aged 12-14 years who were addicted to computer games versus social media networking were the most affected.

Sleep issues could be “easily detectable manifestations of pathological internet addiction,” investigator Sergey Tereshchenko, PhD, Scientific Research Institute for Medical Problems of the North, Krasnoyask State Medical University, Russia, told this news organization.

These sleep problems require attention and correction, Dr. Tereshchenko added.

The findings were presented at the virtual Congress of the European Academy of Neurology 2021.
 

New phenomenon

IA is a relatively new psychological phenomenon and is most prevalent in “socially vulnerable groups,” such as adolescents, Dr. Tereshchenko said.

He cited numerous studies that have “convincingly demonstrated” IA is comorbid with a broad range of psychopathologic conditions, including depression, anxiety, and attention deficit hyperactivity disorder.

There is also growing evidence, including from systematic reviews in 2014 and 2019, that IA affects a wide range of sleep parameters.

However, most studies in adolescents have used only one psychometric tool to assess addiction, revealing only the “general IA pattern” and not the type of IA, Dr. Tereshchenko noted.

Adolescents may not be addicted to the internet itself but to certain behaviors like gaming or social networking, he said.

The “undoubted advantage” of his team’s research is the use of more than one tool, making it possible to “verify the predominant content of the addiction,” he added.

The investigators previously assessed general prevalence of IA in adolescents in Siberia and found about 6.8% of participants displayed pathological IA behavior – and that gaming addiction is more common in boys whereas addiction to social networking is more common in girls.

This prevalence rate is lower than in the Philippines (21.1%), Hong Kong (16.4%), Malaysia (14.1%), China (11%), and South Korea (9.7%), but slightly higher than in Japan (6.2%).

IA prevalence among adolescents in Europe ranges from 1% to 11%, with an average of 4.4%, said Dr. Tereshchenko.
 

Siberian students’ sleep

The current study included 4,344 students aged 12-18 years (average age, about 15 years) from 10 public schools in three large cities of Central Siberia (Krasnoyarsk, Abakan, and Kyzyl). There were slightly more girls than boys in the study sample.

Participants completed the Russian language version of the Chen Internet Addiction Scale (CIAS), which covers five symptomatic criteria for addictive behavior: withdrawal symptoms, signs of tolerance, compulsive use, psychological or physical problems, and difficulty managing time.

In this questionnaire, respondents rate several statements regarding the effect of internet use, each on a 4-point Likert scale: not at all (1 point), a little bit (2 points), moderately (3 points) and extremely (4). The total score ranges from 26 to 104.

A CIAS score of 26-42 indicates adaptive internet use, 43-64 indicates maladaptive internet use, and 65 and above indicates pathological internet use (PIU), which was classified as “internet-addicted.”

The researchers also used the nine-item Social Media Disorder Scale, as well as the Pittsburgh Sleep Quality Index to assess nighttime sleep.

Among other questions, teens were asked how long it usually took them to fall asleep and when they typically went to bed and woke up on school nights.

For daytime sleepiness, investigators used the targeted Pediatric Daytime Sleepiness Scale questionnaire, making them among the few research groups to use this psychometric instrument, Dr. Tereshchenko noted.

After parental consent was given, students completed the tests at the end of the day’s lessons. Total test time was about 45 minutes.
 

Sleep disturbance

Initial study results showed that compared with the other groups, adolescents with PIU tended to go to bed later, wake up later, take longer to fall asleep, sleep less at night, have more nighttime awakenings, and have more daytime sleepiness.

Sleep quality was the most impaired in boys aged 12-14 years who are addicted to internet computer games.

“In this group, 5 of the 6 sleep assessment parameters we studied were changed,” Dr. Tereshchenko reported.

Decreased total nighttime sleep was more common in older adolescents.

On average, boys and girls aged 15-18 years got less than the recommended 8 hours of sleep per night. Boys with IA got only about 6.4 hours per night and girls with IA got about 6.6 hours.

Interestingly, IA is generally more prevalent among teen girls than boys in Russia, which is not the case in Europe and North America, Dr. Tereshchenko noted.

Mechanisms linking IA and sleep disorders are not clear, but the relationship is probably multifactorial and perhaps interrelated, creating something of a “vicious circle,” he said.

“Sleep disturbances, which reflect psychosocial problems, depression, and anxiety-phobic disorders, can precede and contribute to IA. On the other hand, sleep disturbances such as insomnia can lead to increased use of the internet in the evening and at night, further exacerbating the problem,” said Dr. Tereshchenko.

Research is lacking on useful treatments for youth with IA, but these kids would likely benefit from behavioral therapy approaches, he added.
 

No escape?

Commenting on the study for this news organization, Maurice M. Ohayon, MD, DSc, PhD, director of the Stanford Sleep Epidemiology Research Center, Stanford University, California, said the topic of youth IA is “very important.”

Previous research in this field has shown a major impact from IA not only on sleep but also on mood – with irritability, depression, and even thoughts of suicide being possible red flags, said Dr. Ohayon, who was not involved in the current study.

Interestingly, his own research has also found that young teenage boys are most at risk for gaming addiction.

Although internet gaming has some positive effects, such as fostering leadership skills and relationships, it has become increasingly violent and isolating, with more adult professional gamers preying on younger players, Dr. Ohayon said.

“The major problem is that it’s putting children in a virtual world from which it’s difficult to escape,” he added.

Dr. Ohayon also noted concern about future developmental effects in kids who play video games for hours on end without coming out of their bedroom and with no physical contact with fellow players.

Parents should intervene before this situation occurs and limit the time their children spend on the gaming console, he said.

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

More evidence suggests the severity of internet addiction (IA) is directly related to the severity of sleep problems in youth.

Results from a study of more than 4,000 adolescent students show IA severity was linked to less sleep and to daytime sleepiness. In addition, boys aged 12-14 years who were addicted to computer games versus social media networking were the most affected.

Sleep issues could be “easily detectable manifestations of pathological internet addiction,” investigator Sergey Tereshchenko, PhD, Scientific Research Institute for Medical Problems of the North, Krasnoyask State Medical University, Russia, told this news organization.

These sleep problems require attention and correction, Dr. Tereshchenko added.

The findings were presented at the virtual Congress of the European Academy of Neurology 2021.
 

New phenomenon

IA is a relatively new psychological phenomenon and is most prevalent in “socially vulnerable groups,” such as adolescents, Dr. Tereshchenko said.

He cited numerous studies that have “convincingly demonstrated” IA is comorbid with a broad range of psychopathologic conditions, including depression, anxiety, and attention deficit hyperactivity disorder.

There is also growing evidence, including from systematic reviews in 2014 and 2019, that IA affects a wide range of sleep parameters.

However, most studies in adolescents have used only one psychometric tool to assess addiction, revealing only the “general IA pattern” and not the type of IA, Dr. Tereshchenko noted.

Adolescents may not be addicted to the internet itself but to certain behaviors like gaming or social networking, he said.

The “undoubted advantage” of his team’s research is the use of more than one tool, making it possible to “verify the predominant content of the addiction,” he added.

The investigators previously assessed general prevalence of IA in adolescents in Siberia and found about 6.8% of participants displayed pathological IA behavior – and that gaming addiction is more common in boys whereas addiction to social networking is more common in girls.

This prevalence rate is lower than in the Philippines (21.1%), Hong Kong (16.4%), Malaysia (14.1%), China (11%), and South Korea (9.7%), but slightly higher than in Japan (6.2%).

IA prevalence among adolescents in Europe ranges from 1% to 11%, with an average of 4.4%, said Dr. Tereshchenko.
 

Siberian students’ sleep

The current study included 4,344 students aged 12-18 years (average age, about 15 years) from 10 public schools in three large cities of Central Siberia (Krasnoyarsk, Abakan, and Kyzyl). There were slightly more girls than boys in the study sample.

Participants completed the Russian language version of the Chen Internet Addiction Scale (CIAS), which covers five symptomatic criteria for addictive behavior: withdrawal symptoms, signs of tolerance, compulsive use, psychological or physical problems, and difficulty managing time.

In this questionnaire, respondents rate several statements regarding the effect of internet use, each on a 4-point Likert scale: not at all (1 point), a little bit (2 points), moderately (3 points) and extremely (4). The total score ranges from 26 to 104.

A CIAS score of 26-42 indicates adaptive internet use, 43-64 indicates maladaptive internet use, and 65 and above indicates pathological internet use (PIU), which was classified as “internet-addicted.”

The researchers also used the nine-item Social Media Disorder Scale, as well as the Pittsburgh Sleep Quality Index to assess nighttime sleep.

Among other questions, teens were asked how long it usually took them to fall asleep and when they typically went to bed and woke up on school nights.

For daytime sleepiness, investigators used the targeted Pediatric Daytime Sleepiness Scale questionnaire, making them among the few research groups to use this psychometric instrument, Dr. Tereshchenko noted.

After parental consent was given, students completed the tests at the end of the day’s lessons. Total test time was about 45 minutes.
 

Sleep disturbance

Initial study results showed that compared with the other groups, adolescents with PIU tended to go to bed later, wake up later, take longer to fall asleep, sleep less at night, have more nighttime awakenings, and have more daytime sleepiness.

Sleep quality was the most impaired in boys aged 12-14 years who are addicted to internet computer games.

“In this group, 5 of the 6 sleep assessment parameters we studied were changed,” Dr. Tereshchenko reported.

Decreased total nighttime sleep was more common in older adolescents.

On average, boys and girls aged 15-18 years got less than the recommended 8 hours of sleep per night. Boys with IA got only about 6.4 hours per night and girls with IA got about 6.6 hours.

Interestingly, IA is generally more prevalent among teen girls than boys in Russia, which is not the case in Europe and North America, Dr. Tereshchenko noted.

Mechanisms linking IA and sleep disorders are not clear, but the relationship is probably multifactorial and perhaps interrelated, creating something of a “vicious circle,” he said.

“Sleep disturbances, which reflect psychosocial problems, depression, and anxiety-phobic disorders, can precede and contribute to IA. On the other hand, sleep disturbances such as insomnia can lead to increased use of the internet in the evening and at night, further exacerbating the problem,” said Dr. Tereshchenko.

Research is lacking on useful treatments for youth with IA, but these kids would likely benefit from behavioral therapy approaches, he added.
 

No escape?

Commenting on the study for this news organization, Maurice M. Ohayon, MD, DSc, PhD, director of the Stanford Sleep Epidemiology Research Center, Stanford University, California, said the topic of youth IA is “very important.”

Previous research in this field has shown a major impact from IA not only on sleep but also on mood – with irritability, depression, and even thoughts of suicide being possible red flags, said Dr. Ohayon, who was not involved in the current study.

Interestingly, his own research has also found that young teenage boys are most at risk for gaming addiction.

Although internet gaming has some positive effects, such as fostering leadership skills and relationships, it has become increasingly violent and isolating, with more adult professional gamers preying on younger players, Dr. Ohayon said.

“The major problem is that it’s putting children in a virtual world from which it’s difficult to escape,” he added.

Dr. Ohayon also noted concern about future developmental effects in kids who play video games for hours on end without coming out of their bedroom and with no physical contact with fellow players.

Parents should intervene before this situation occurs and limit the time their children spend on the gaming console, he said.

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

More evidence suggests the severity of internet addiction (IA) is directly related to the severity of sleep problems in youth.

Results from a study of more than 4,000 adolescent students show IA severity was linked to less sleep and to daytime sleepiness. In addition, boys aged 12-14 years who were addicted to computer games versus social media networking were the most affected.

Sleep issues could be “easily detectable manifestations of pathological internet addiction,” investigator Sergey Tereshchenko, PhD, Scientific Research Institute for Medical Problems of the North, Krasnoyask State Medical University, Russia, told this news organization.

These sleep problems require attention and correction, Dr. Tereshchenko added.

The findings were presented at the virtual Congress of the European Academy of Neurology 2021.
 

New phenomenon

IA is a relatively new psychological phenomenon and is most prevalent in “socially vulnerable groups,” such as adolescents, Dr. Tereshchenko said.

He cited numerous studies that have “convincingly demonstrated” IA is comorbid with a broad range of psychopathologic conditions, including depression, anxiety, and attention deficit hyperactivity disorder.

There is also growing evidence, including from systematic reviews in 2014 and 2019, that IA affects a wide range of sleep parameters.

However, most studies in adolescents have used only one psychometric tool to assess addiction, revealing only the “general IA pattern” and not the type of IA, Dr. Tereshchenko noted.

Adolescents may not be addicted to the internet itself but to certain behaviors like gaming or social networking, he said.

The “undoubted advantage” of his team’s research is the use of more than one tool, making it possible to “verify the predominant content of the addiction,” he added.

The investigators previously assessed general prevalence of IA in adolescents in Siberia and found about 6.8% of participants displayed pathological IA behavior – and that gaming addiction is more common in boys whereas addiction to social networking is more common in girls.

This prevalence rate is lower than in the Philippines (21.1%), Hong Kong (16.4%), Malaysia (14.1%), China (11%), and South Korea (9.7%), but slightly higher than in Japan (6.2%).

IA prevalence among adolescents in Europe ranges from 1% to 11%, with an average of 4.4%, said Dr. Tereshchenko.
 

Siberian students’ sleep

The current study included 4,344 students aged 12-18 years (average age, about 15 years) from 10 public schools in three large cities of Central Siberia (Krasnoyarsk, Abakan, and Kyzyl). There were slightly more girls than boys in the study sample.

Participants completed the Russian language version of the Chen Internet Addiction Scale (CIAS), which covers five symptomatic criteria for addictive behavior: withdrawal symptoms, signs of tolerance, compulsive use, psychological or physical problems, and difficulty managing time.

In this questionnaire, respondents rate several statements regarding the effect of internet use, each on a 4-point Likert scale: not at all (1 point), a little bit (2 points), moderately (3 points) and extremely (4). The total score ranges from 26 to 104.

A CIAS score of 26-42 indicates adaptive internet use, 43-64 indicates maladaptive internet use, and 65 and above indicates pathological internet use (PIU), which was classified as “internet-addicted.”

The researchers also used the nine-item Social Media Disorder Scale, as well as the Pittsburgh Sleep Quality Index to assess nighttime sleep.

Among other questions, teens were asked how long it usually took them to fall asleep and when they typically went to bed and woke up on school nights.

For daytime sleepiness, investigators used the targeted Pediatric Daytime Sleepiness Scale questionnaire, making them among the few research groups to use this psychometric instrument, Dr. Tereshchenko noted.

After parental consent was given, students completed the tests at the end of the day’s lessons. Total test time was about 45 minutes.
 

Sleep disturbance

Initial study results showed that compared with the other groups, adolescents with PIU tended to go to bed later, wake up later, take longer to fall asleep, sleep less at night, have more nighttime awakenings, and have more daytime sleepiness.

Sleep quality was the most impaired in boys aged 12-14 years who are addicted to internet computer games.

“In this group, 5 of the 6 sleep assessment parameters we studied were changed,” Dr. Tereshchenko reported.

Decreased total nighttime sleep was more common in older adolescents.

On average, boys and girls aged 15-18 years got less than the recommended 8 hours of sleep per night. Boys with IA got only about 6.4 hours per night and girls with IA got about 6.6 hours.

Interestingly, IA is generally more prevalent among teen girls than boys in Russia, which is not the case in Europe and North America, Dr. Tereshchenko noted.

Mechanisms linking IA and sleep disorders are not clear, but the relationship is probably multifactorial and perhaps interrelated, creating something of a “vicious circle,” he said.

“Sleep disturbances, which reflect psychosocial problems, depression, and anxiety-phobic disorders, can precede and contribute to IA. On the other hand, sleep disturbances such as insomnia can lead to increased use of the internet in the evening and at night, further exacerbating the problem,” said Dr. Tereshchenko.

Research is lacking on useful treatments for youth with IA, but these kids would likely benefit from behavioral therapy approaches, he added.
 

No escape?

Commenting on the study for this news organization, Maurice M. Ohayon, MD, DSc, PhD, director of the Stanford Sleep Epidemiology Research Center, Stanford University, California, said the topic of youth IA is “very important.”

Previous research in this field has shown a major impact from IA not only on sleep but also on mood – with irritability, depression, and even thoughts of suicide being possible red flags, said Dr. Ohayon, who was not involved in the current study.

Interestingly, his own research has also found that young teenage boys are most at risk for gaming addiction.

Although internet gaming has some positive effects, such as fostering leadership skills and relationships, it has become increasingly violent and isolating, with more adult professional gamers preying on younger players, Dr. Ohayon said.

“The major problem is that it’s putting children in a virtual world from which it’s difficult to escape,” he added.

Dr. Ohayon also noted concern about future developmental effects in kids who play video games for hours on end without coming out of their bedroom and with no physical contact with fellow players.

Parents should intervene before this situation occurs and limit the time their children spend on the gaming console, he said.

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

Tardive dyskinesia (TD) can be reasonably managed through telemedicine, but it should be employed as part of a hybrid strategy that ideally includes an office visit at the time of diagnosis and yearly intervals thereafter, according to an expert who spoke at a meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

verbaska_studio/Getty Images

In psychiatry in general and in TD specifically, telepsychiatry is useful, but “is not a one-size-fits-all approach,” according to Rif S. El-Mallakh, MD, director of the mood disorder research program at the University of Louisville (Ky.).

Telepsychiatry was already growing as a strategy to expand psychiatric services to communities with limited resources in mental health when the COVID-19 pandemic arrived. Dependence on this type of patient care then exploded out of necessity but in advance of how it might best be applied in specific circumstances.
 

Best practices panel convened in 2020

The project to develop best practices in TD began in July 2020, when the pandemic was still limiting normal clinician-patient interactions. It was expected from the beginning that recommendations would be applicable to postpandemic circumstances.

There is no reason to expect the forces driving the growth of telepsychiatry, which include convenience of patients and efficiency for clinicians, to dissipate once the pandemic resolves, Dr. El-Mallakh said at the virtual meeting, sponsored by MedscapeLive.

The process of developing best practices for telepsychiatry in TD began with semistructured qualitative interviews of the panelists, which consisted of six neurologists, three psychiatrists, and three psychiatric nurse practitioners. The goal was to gather information about the current practice of TD diagnosis and treatment in real-world settings.

With the information on current practices providing a baseline, a virtual roundtable was then convened to develop best-practices recommendations. The deliberations were performed on the basis of expert opinion. There were no statistical methods applied to data collected from the qualitative interviews.
 

Four key points in recommendations

The panel agreed on four key points: an in-person visit is preferred for initial evaluation and diagnosis; when applied for the evaluation of TD, telepsychiatry should include video; virtual visits cannot completely replace in-person visits; and patients with TD should be evaluated in person at least once per year.

In addition, the panelists recommended specific steps aimed at maximizing the quality of the virtual visit, including confirming that patients have appropriate equipment for video and audio communication. It is also important to recognize that patients or caregivers may require instruction on how to set up the equipment.

Prior to a telemedicine visit, it is appropriate to provide patients with a checklist that includes instructions on adequate lighting and audio. In addition, patient expectations about the goals and processes in the video should be explained.

“Instructional videos prior to the visit might be helpful,” Dr. El-Mallakh said.

Immediately prior to each visit, visual and audio quality should be verified. This allows technical issues, if any, to be resolved.

For the evaluation of TD, the ability to adequately observe body movements is crucial but can pose a challenge in telepsychiatry. To capture hyperkinetic movements and functional impairments with adequate clarity, it might be necessary to engage caregivers to hold the camera or otherwise help the clinician gain an adequate view. Clinicians should consider the limitations of telepsychiatry.

In addition to the challenges of a differential diagnosis for TD that should include such entities as parkinsonism and other drug-induced movement disorders, Dr. El-Mallakh cautioned, “comorbidities add another layer of complexity to TD diagnosis.”
 

Some in-office visits recommended

It is this complexity that led to the recommendation for an in-person evaluation for new-onset TD, although the expert panel did not characterize an initial in-office visit as mandatory.

Once a diagnosis of TD is established, telepsychiatry can be an efficient strategy for education and for confirming that treatments remain effective. However, Dr. El-Mallakh pointed out that patients can and often do have more than one drug-induced movement disorder at the time of diagnosis or develop additional clinical issues over time.

According to the expert panel, telepsychiatry should not be considered an adequate strategy to manage TD by itself, but “it can be an important component” of care of these patients if used judiciously.

“We have all come to recognize the benefits of telepsychiatry and some of the limitations,” said Jonathan M. Meyer, MD, clinical professor of psychiatry, University of California, San Diego. An author or coauthor of several articles on TD, including a recent study of patient awareness of TD symptoms while on vesicular monoamine transporter 2 inhibitors, Dr. Meyer identified technical problems as among the limitations.

Doug Brunk/MDedge News

Tardive dyskinesia (TD) can be reasonably managed through telemedicine, but it should be employed as part of a hybrid strategy that ideally includes an office visit at the time of diagnosis and yearly intervals thereafter, according to an expert who spoke at a meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

verbaska_studio/Getty Images

In psychiatry in general and in TD specifically, telepsychiatry is useful, but “is not a one-size-fits-all approach,” according to Rif S. El-Mallakh, MD, director of the mood disorder research program at the University of Louisville (Ky.).

Telepsychiatry was already growing as a strategy to expand psychiatric services to communities with limited resources in mental health when the COVID-19 pandemic arrived. Dependence on this type of patient care then exploded out of necessity but in advance of how it might best be applied in specific circumstances.
 

Best practices panel convened in 2020

The project to develop best practices in TD began in July 2020, when the pandemic was still limiting normal clinician-patient interactions. It was expected from the beginning that recommendations would be applicable to postpandemic circumstances.

There is no reason to expect the forces driving the growth of telepsychiatry, which include convenience of patients and efficiency for clinicians, to dissipate once the pandemic resolves, Dr. El-Mallakh said at the virtual meeting, sponsored by MedscapeLive.

The process of developing best practices for telepsychiatry in TD began with semistructured qualitative interviews of the panelists, which consisted of six neurologists, three psychiatrists, and three psychiatric nurse practitioners. The goal was to gather information about the current practice of TD diagnosis and treatment in real-world settings.

With the information on current practices providing a baseline, a virtual roundtable was then convened to develop best-practices recommendations. The deliberations were performed on the basis of expert opinion. There were no statistical methods applied to data collected from the qualitative interviews.
 

Four key points in recommendations

The panel agreed on four key points: an in-person visit is preferred for initial evaluation and diagnosis; when applied for the evaluation of TD, telepsychiatry should include video; virtual visits cannot completely replace in-person visits; and patients with TD should be evaluated in person at least once per year.

In addition, the panelists recommended specific steps aimed at maximizing the quality of the virtual visit, including confirming that patients have appropriate equipment for video and audio communication. It is also important to recognize that patients or caregivers may require instruction on how to set up the equipment.

Prior to a telemedicine visit, it is appropriate to provide patients with a checklist that includes instructions on adequate lighting and audio. In addition, patient expectations about the goals and processes in the video should be explained.

“Instructional videos prior to the visit might be helpful,” Dr. El-Mallakh said.

Immediately prior to each visit, visual and audio quality should be verified. This allows technical issues, if any, to be resolved.

For the evaluation of TD, the ability to adequately observe body movements is crucial but can pose a challenge in telepsychiatry. To capture hyperkinetic movements and functional impairments with adequate clarity, it might be necessary to engage caregivers to hold the camera or otherwise help the clinician gain an adequate view. Clinicians should consider the limitations of telepsychiatry.

In addition to the challenges of a differential diagnosis for TD that should include such entities as parkinsonism and other drug-induced movement disorders, Dr. El-Mallakh cautioned, “comorbidities add another layer of complexity to TD diagnosis.”
 

Some in-office visits recommended

It is this complexity that led to the recommendation for an in-person evaluation for new-onset TD, although the expert panel did not characterize an initial in-office visit as mandatory.

Once a diagnosis of TD is established, telepsychiatry can be an efficient strategy for education and for confirming that treatments remain effective. However, Dr. El-Mallakh pointed out that patients can and often do have more than one drug-induced movement disorder at the time of diagnosis or develop additional clinical issues over time.

According to the expert panel, telepsychiatry should not be considered an adequate strategy to manage TD by itself, but “it can be an important component” of care of these patients if used judiciously.

“We have all come to recognize the benefits of telepsychiatry and some of the limitations,” said Jonathan M. Meyer, MD, clinical professor of psychiatry, University of California, San Diego. An author or coauthor of several articles on TD, including a recent study of patient awareness of TD symptoms while on vesicular monoamine transporter 2 inhibitors, Dr. Meyer identified technical problems as among the limitations.

Doug Brunk/MDedge News

Tardive dyskinesia (TD) can be reasonably managed through telemedicine, but it should be employed as part of a hybrid strategy that ideally includes an office visit at the time of diagnosis and yearly intervals thereafter, according to an expert who spoke at a meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

verbaska_studio/Getty Images

In psychiatry in general and in TD specifically, telepsychiatry is useful, but “is not a one-size-fits-all approach,” according to Rif S. El-Mallakh, MD, director of the mood disorder research program at the University of Louisville (Ky.).

Telepsychiatry was already growing as a strategy to expand psychiatric services to communities with limited resources in mental health when the COVID-19 pandemic arrived. Dependence on this type of patient care then exploded out of necessity but in advance of how it might best be applied in specific circumstances.
 

Best practices panel convened in 2020

The project to develop best practices in TD began in July 2020, when the pandemic was still limiting normal clinician-patient interactions. It was expected from the beginning that recommendations would be applicable to postpandemic circumstances.

There is no reason to expect the forces driving the growth of telepsychiatry, which include convenience of patients and efficiency for clinicians, to dissipate once the pandemic resolves, Dr. El-Mallakh said at the virtual meeting, sponsored by MedscapeLive.

The process of developing best practices for telepsychiatry in TD began with semistructured qualitative interviews of the panelists, which consisted of six neurologists, three psychiatrists, and three psychiatric nurse practitioners. The goal was to gather information about the current practice of TD diagnosis and treatment in real-world settings.

With the information on current practices providing a baseline, a virtual roundtable was then convened to develop best-practices recommendations. The deliberations were performed on the basis of expert opinion. There were no statistical methods applied to data collected from the qualitative interviews.
 

Four key points in recommendations

The panel agreed on four key points: an in-person visit is preferred for initial evaluation and diagnosis; when applied for the evaluation of TD, telepsychiatry should include video; virtual visits cannot completely replace in-person visits; and patients with TD should be evaluated in person at least once per year.

In addition, the panelists recommended specific steps aimed at maximizing the quality of the virtual visit, including confirming that patients have appropriate equipment for video and audio communication. It is also important to recognize that patients or caregivers may require instruction on how to set up the equipment.

Prior to a telemedicine visit, it is appropriate to provide patients with a checklist that includes instructions on adequate lighting and audio. In addition, patient expectations about the goals and processes in the video should be explained.

“Instructional videos prior to the visit might be helpful,” Dr. El-Mallakh said.

Immediately prior to each visit, visual and audio quality should be verified. This allows technical issues, if any, to be resolved.

For the evaluation of TD, the ability to adequately observe body movements is crucial but can pose a challenge in telepsychiatry. To capture hyperkinetic movements and functional impairments with adequate clarity, it might be necessary to engage caregivers to hold the camera or otherwise help the clinician gain an adequate view. Clinicians should consider the limitations of telepsychiatry.

In addition to the challenges of a differential diagnosis for TD that should include such entities as parkinsonism and other drug-induced movement disorders, Dr. El-Mallakh cautioned, “comorbidities add another layer of complexity to TD diagnosis.”
 

Some in-office visits recommended

It is this complexity that led to the recommendation for an in-person evaluation for new-onset TD, although the expert panel did not characterize an initial in-office visit as mandatory.

Once a diagnosis of TD is established, telepsychiatry can be an efficient strategy for education and for confirming that treatments remain effective. However, Dr. El-Mallakh pointed out that patients can and often do have more than one drug-induced movement disorder at the time of diagnosis or develop additional clinical issues over time.

According to the expert panel, telepsychiatry should not be considered an adequate strategy to manage TD by itself, but “it can be an important component” of care of these patients if used judiciously.

“We have all come to recognize the benefits of telepsychiatry and some of the limitations,” said Jonathan M. Meyer, MD, clinical professor of psychiatry, University of California, San Diego. An author or coauthor of several articles on TD, including a recent study of patient awareness of TD symptoms while on vesicular monoamine transporter 2 inhibitors, Dr. Meyer identified technical problems as among the limitations.

Doug Brunk/MDedge News