GASTROENTEROLOGY

October 2020
How to incorporate a chief fellow into a gastroenterology fellowship program. Mohammad Bilal et al. 2020 Oct;159(4):1227-30. doi: 10.1053/j.gastro.2020.09.001

Lower adenoma miss rate of computer-aided detection-assisted colonoscopy vs routine white-light colonoscopy in a prospective tandem study. Pu Wang et al. 2020 Oct;159(4):1252-61.e5. doi: 10.1053/j.gastro.2020.06.023

November 2020
Simulation-based mastery learning with virtual coaching: experience in training standardized upper endoscopy to novice endoscopists. Roy Soetikno et al. 2020 Nov;159(5):1632-6. doi: 10.1053/j.gastro.2020.06.096

Risk of small bowel adenocarcinoma, adenomas, and carcinoids in a nationwide cohort of individuals with celiac disease. Louise Emilsson et al. 2020 Nov;159(5):1686-94.e2 doi: 10.1053/j.gastro.2020.07.007

December 2020
Increased intestinal permeability is associated with later development of Crohn’s disease. Williams Turpin et al. 2020 Dec;159(6):2092-100.e5. doi: 10.1053/j.gastro.2020.08.005

January 2021
The role of angiotensin converting enzyme 2 in modulating gut microbiota, intestinal inflammation, and coronavirus infection. Josef M. Penninger et al. 2020 Oct 30:S0016-5085(20)35327-0. doi: 10.1053/j.gastro.2020.07.067

Behavioral and diet therapies in integrated care for patients with irritable bowel syndrome. William D. Chey et al. 2020 Oct 19:S0016-5085(20)35281-1. doi: 10.1053/j.gastro.2020.06.099

Efficacy and safety of tradipitant in patients with diabetic and idiopathic gastroparesis in a randomized, placebo-controlled trial. Jesse L. Carlin et al 2020 Jul 18;S0016-5085(20)34958-1. doi: 10.1053/j.gastro.2020.07.029

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY

November 2020
The virtual gastroenterology clinic. Toyia James-Stevenson. 2020 Nov;18(12):2679-82. doi: 10.1016/j.cgh.2020.06.012

Risk factors associated with early-onset colorectal cancer. Valerie Gausman et al. 2020 Nov;18(12):2752-9.e2. doi: 10.1016/j.cgh.2019.10.009

Association of daily aspirin therapy with hepatocellular carcinoma risk in patients with chronic hepatitis c virus infection. Teng-Yu Lee et al. 2020 Nov;18(12):2784-92.e7. doi: 10.1016/j.cgh.2020.04.036

December 2020
Sensitivity of fecal immunochemical test for colorectal cancer detection differs according to stage and location. Tobias Niedermaier et al. 2020 Dec;18(13):2920-2928.e6. doi: 10.1016/j.cgh.2020.01.025

Effects of colesevelam on bowel symptoms, biomarkers, and colonic mucosal gene expression in patients with bile acid diarrhea in a randomized trial. Priya Vijayvargiya et al. 2020 Dec;18(13):2962-70.e6. doi: 10.1016/j.cgh.2020.02.027

Endoscopy for gastric cancer screening is cost effective for Asian Americans in the United States. Shailja C. Shah et al. 2020 Dec;18(13):3026-39. doi: 10.1016/j.cgh.2020.07.031

January 2021
C.O.V.I.D.: A survival guide for GI fellowship training during the COVID-19 pandemic. Tzu-Hao Lee et al. 2021 Jan;19(1):6-9. doi: 10.1016/j.cgh.2020.10.001

Use of proton pump inhibitors increases risk of incident kidney stones. Michael Simonov et al. 2021 Jan;19(1):72-9.e21. doi: 10.1016/j.cgh.2020.02.053

TECHNIQUES AND INNOVATIONS IN GASTROINTESTINAL ENDOSCOPY

Endoscopic extraction of large foreign bodies utilizing a novel push-pull extraction technique. Koushik K. Das and Michael L. Kochman. 2020 Oct;22(4):172-7. doi: 10.1016/j.tige.2020.06.004

GASTROENTEROLOGY

October 2020
How to incorporate a chief fellow into a gastroenterology fellowship program. Mohammad Bilal et al. 2020 Oct;159(4):1227-30. doi: 10.1053/j.gastro.2020.09.001

Lower adenoma miss rate of computer-aided detection-assisted colonoscopy vs routine white-light colonoscopy in a prospective tandem study. Pu Wang et al. 2020 Oct;159(4):1252-61.e5. doi: 10.1053/j.gastro.2020.06.023

November 2020
Simulation-based mastery learning with virtual coaching: experience in training standardized upper endoscopy to novice endoscopists. Roy Soetikno et al. 2020 Nov;159(5):1632-6. doi: 10.1053/j.gastro.2020.06.096

Risk of small bowel adenocarcinoma, adenomas, and carcinoids in a nationwide cohort of individuals with celiac disease. Louise Emilsson et al. 2020 Nov;159(5):1686-94.e2 doi: 10.1053/j.gastro.2020.07.007

December 2020
Increased intestinal permeability is associated with later development of Crohn’s disease. Williams Turpin et al. 2020 Dec;159(6):2092-100.e5. doi: 10.1053/j.gastro.2020.08.005

January 2021
The role of angiotensin converting enzyme 2 in modulating gut microbiota, intestinal inflammation, and coronavirus infection. Josef M. Penninger et al. 2020 Oct 30:S0016-5085(20)35327-0. doi: 10.1053/j.gastro.2020.07.067

Behavioral and diet therapies in integrated care for patients with irritable bowel syndrome. William D. Chey et al. 2020 Oct 19:S0016-5085(20)35281-1. doi: 10.1053/j.gastro.2020.06.099

Efficacy and safety of tradipitant in patients with diabetic and idiopathic gastroparesis in a randomized, placebo-controlled trial. Jesse L. Carlin et al 2020 Jul 18;S0016-5085(20)34958-1. doi: 10.1053/j.gastro.2020.07.029

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY

November 2020
The virtual gastroenterology clinic. Toyia James-Stevenson. 2020 Nov;18(12):2679-82. doi: 10.1016/j.cgh.2020.06.012

Risk factors associated with early-onset colorectal cancer. Valerie Gausman et al. 2020 Nov;18(12):2752-9.e2. doi: 10.1016/j.cgh.2019.10.009

Association of daily aspirin therapy with hepatocellular carcinoma risk in patients with chronic hepatitis c virus infection. Teng-Yu Lee et al. 2020 Nov;18(12):2784-92.e7. doi: 10.1016/j.cgh.2020.04.036

December 2020
Sensitivity of fecal immunochemical test for colorectal cancer detection differs according to stage and location. Tobias Niedermaier et al. 2020 Dec;18(13):2920-2928.e6. doi: 10.1016/j.cgh.2020.01.025

Effects of colesevelam on bowel symptoms, biomarkers, and colonic mucosal gene expression in patients with bile acid diarrhea in a randomized trial. Priya Vijayvargiya et al. 2020 Dec;18(13):2962-70.e6. doi: 10.1016/j.cgh.2020.02.027

Endoscopy for gastric cancer screening is cost effective for Asian Americans in the United States. Shailja C. Shah et al. 2020 Dec;18(13):3026-39. doi: 10.1016/j.cgh.2020.07.031

January 2021
C.O.V.I.D.: A survival guide for GI fellowship training during the COVID-19 pandemic. Tzu-Hao Lee et al. 2021 Jan;19(1):6-9. doi: 10.1016/j.cgh.2020.10.001

Use of proton pump inhibitors increases risk of incident kidney stones. Michael Simonov et al. 2021 Jan;19(1):72-9.e21. doi: 10.1016/j.cgh.2020.02.053

TECHNIQUES AND INNOVATIONS IN GASTROINTESTINAL ENDOSCOPY

Endoscopic extraction of large foreign bodies utilizing a novel push-pull extraction technique. Koushik K. Das and Michael L. Kochman. 2020 Oct;22(4):172-7. doi: 10.1016/j.tige.2020.06.004

GASTROENTEROLOGY

October 2020
How to incorporate a chief fellow into a gastroenterology fellowship program. Mohammad Bilal et al. 2020 Oct;159(4):1227-30. doi: 10.1053/j.gastro.2020.09.001

Lower adenoma miss rate of computer-aided detection-assisted colonoscopy vs routine white-light colonoscopy in a prospective tandem study. Pu Wang et al. 2020 Oct;159(4):1252-61.e5. doi: 10.1053/j.gastro.2020.06.023

November 2020
Simulation-based mastery learning with virtual coaching: experience in training standardized upper endoscopy to novice endoscopists. Roy Soetikno et al. 2020 Nov;159(5):1632-6. doi: 10.1053/j.gastro.2020.06.096

Risk of small bowel adenocarcinoma, adenomas, and carcinoids in a nationwide cohort of individuals with celiac disease. Louise Emilsson et al. 2020 Nov;159(5):1686-94.e2 doi: 10.1053/j.gastro.2020.07.007

December 2020
Increased intestinal permeability is associated with later development of Crohn’s disease. Williams Turpin et al. 2020 Dec;159(6):2092-100.e5. doi: 10.1053/j.gastro.2020.08.005

January 2021
The role of angiotensin converting enzyme 2 in modulating gut microbiota, intestinal inflammation, and coronavirus infection. Josef M. Penninger et al. 2020 Oct 30:S0016-5085(20)35327-0. doi: 10.1053/j.gastro.2020.07.067

Behavioral and diet therapies in integrated care for patients with irritable bowel syndrome. William D. Chey et al. 2020 Oct 19:S0016-5085(20)35281-1. doi: 10.1053/j.gastro.2020.06.099

Efficacy and safety of tradipitant in patients with diabetic and idiopathic gastroparesis in a randomized, placebo-controlled trial. Jesse L. Carlin et al 2020 Jul 18;S0016-5085(20)34958-1. doi: 10.1053/j.gastro.2020.07.029

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY

November 2020
The virtual gastroenterology clinic. Toyia James-Stevenson. 2020 Nov;18(12):2679-82. doi: 10.1016/j.cgh.2020.06.012

Risk factors associated with early-onset colorectal cancer. Valerie Gausman et al. 2020 Nov;18(12):2752-9.e2. doi: 10.1016/j.cgh.2019.10.009

Association of daily aspirin therapy with hepatocellular carcinoma risk in patients with chronic hepatitis c virus infection. Teng-Yu Lee et al. 2020 Nov;18(12):2784-92.e7. doi: 10.1016/j.cgh.2020.04.036

December 2020
Sensitivity of fecal immunochemical test for colorectal cancer detection differs according to stage and location. Tobias Niedermaier et al. 2020 Dec;18(13):2920-2928.e6. doi: 10.1016/j.cgh.2020.01.025

Effects of colesevelam on bowel symptoms, biomarkers, and colonic mucosal gene expression in patients with bile acid diarrhea in a randomized trial. Priya Vijayvargiya et al. 2020 Dec;18(13):2962-70.e6. doi: 10.1016/j.cgh.2020.02.027

Endoscopy for gastric cancer screening is cost effective for Asian Americans in the United States. Shailja C. Shah et al. 2020 Dec;18(13):3026-39. doi: 10.1016/j.cgh.2020.07.031

January 2021
C.O.V.I.D.: A survival guide for GI fellowship training during the COVID-19 pandemic. Tzu-Hao Lee et al. 2021 Jan;19(1):6-9. doi: 10.1016/j.cgh.2020.10.001

Use of proton pump inhibitors increases risk of incident kidney stones. Michael Simonov et al. 2021 Jan;19(1):72-9.e21. doi: 10.1016/j.cgh.2020.02.053

TECHNIQUES AND INNOVATIONS IN GASTROINTESTINAL ENDOSCOPY

Endoscopic extraction of large foreign bodies utilizing a novel push-pull extraction technique. Koushik K. Das and Michael L. Kochman. 2020 Oct;22(4):172-7. doi: 10.1016/j.tige.2020.06.004

The United States exceeded 2 million reported cases of COVID-19 in children just 6 weeks after recording its 1 millionth case, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of cases in children was 2,000,681 as of Dec. 24, which represents 12.4% of all cases reported by the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA stated Dec. 29.

The case count for just the latest week, 178,935, was actually down 1.7% from the 182,018 reported the week before, marking the second drop since the beginning of December. The first came during the week ending Dec. 3, when the number of cases dropped more than 19% from the previous week, based on data from the AAP/CHA report.

The cumulative national rate of coronavirus infection is now 2,658 cases per 100,000 children, and “13 states have reported more than 4,000 cases per 100,000,” the two groups said.

The highest rate for any state can be found in North Dakota, which has had 7,722 cases of COVID-19 per 100,000 children. Wyoming has the highest proportion of cases in children at 20.5%, and California has reported the most cases overall, 234,174, the report shows.

Data on testing, hospitalization, and mortality were not included in the Dec. 29 report because of the holiday but will be available in the next edition, scheduled for release on Jan. 5, 2021.

rfranki@mdedge.com

The United States exceeded 2 million reported cases of COVID-19 in children just 6 weeks after recording its 1 millionth case, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of cases in children was 2,000,681 as of Dec. 24, which represents 12.4% of all cases reported by the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA stated Dec. 29.

The case count for just the latest week, 178,935, was actually down 1.7% from the 182,018 reported the week before, marking the second drop since the beginning of December. The first came during the week ending Dec. 3, when the number of cases dropped more than 19% from the previous week, based on data from the AAP/CHA report.

The cumulative national rate of coronavirus infection is now 2,658 cases per 100,000 children, and “13 states have reported more than 4,000 cases per 100,000,” the two groups said.

The highest rate for any state can be found in North Dakota, which has had 7,722 cases of COVID-19 per 100,000 children. Wyoming has the highest proportion of cases in children at 20.5%, and California has reported the most cases overall, 234,174, the report shows.

Data on testing, hospitalization, and mortality were not included in the Dec. 29 report because of the holiday but will be available in the next edition, scheduled for release on Jan. 5, 2021.

rfranki@mdedge.com

The United States exceeded 2 million reported cases of COVID-19 in children just 6 weeks after recording its 1 millionth case, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of cases in children was 2,000,681 as of Dec. 24, which represents 12.4% of all cases reported by the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA stated Dec. 29.

The case count for just the latest week, 178,935, was actually down 1.7% from the 182,018 reported the week before, marking the second drop since the beginning of December. The first came during the week ending Dec. 3, when the number of cases dropped more than 19% from the previous week, based on data from the AAP/CHA report.

The cumulative national rate of coronavirus infection is now 2,658 cases per 100,000 children, and “13 states have reported more than 4,000 cases per 100,000,” the two groups said.

The highest rate for any state can be found in North Dakota, which has had 7,722 cases of COVID-19 per 100,000 children. Wyoming has the highest proportion of cases in children at 20.5%, and California has reported the most cases overall, 234,174, the report shows.

Data on testing, hospitalization, and mortality were not included in the Dec. 29 report because of the holiday but will be available in the next edition, scheduled for release on Jan. 5, 2021.

rfranki@mdedge.com

The Department of Agriculture and the Department of Health & Human Services released new dietary guidelines Dec. 29 that for the first time include recommended dietary patterns for infants and toddlers.

LoveTheWind/iStock/Getty Images

Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.

The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.

The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions: 

• Follow a healthy dietary pattern at every life stage.
• Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
• Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
• Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.

The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
 

Proposed cutoffs rejected

The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.

It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.

The agencies published a document explaining why they omitted the advisory committee›s conclusions.

The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.

In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.

“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
 

Guidance for infants and toddlers

The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise. 

At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk. 

The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.

Dr. Elkind highlighted the significance of these additions.

“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
 

For all ages

From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.

According to the guidelines, core elements of a healthy diet include:

• Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
• Fruits (especially whole fruit).
• Grains, at least half of which are whole grain. 
• Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
• Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
• Oils, including vegetable oils and oils in food, such as seafood and nuts.

The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.

Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.

“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”

An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.

The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.

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

The Department of Agriculture and the Department of Health & Human Services released new dietary guidelines Dec. 29 that for the first time include recommended dietary patterns for infants and toddlers.

LoveTheWind/iStock/Getty Images

Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.

The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.

The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions: 

• Follow a healthy dietary pattern at every life stage.
• Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
• Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
• Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.

The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
 

Proposed cutoffs rejected

The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.

It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.

The agencies published a document explaining why they omitted the advisory committee›s conclusions.

The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.

In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.

“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
 

Guidance for infants and toddlers

The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise. 

At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk. 

The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.

Dr. Elkind highlighted the significance of these additions.

“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
 

For all ages

From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.

According to the guidelines, core elements of a healthy diet include:

• Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
• Fruits (especially whole fruit).
• Grains, at least half of which are whole grain. 
• Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
• Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
• Oils, including vegetable oils and oils in food, such as seafood and nuts.

The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.

Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.

“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”

An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.

The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.

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

The Department of Agriculture and the Department of Health & Human Services released new dietary guidelines Dec. 29 that for the first time include recommended dietary patterns for infants and toddlers.

LoveTheWind/iStock/Getty Images

Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.

The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.

The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions: 

• Follow a healthy dietary pattern at every life stage.
• Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
• Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
• Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.

The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
 

Proposed cutoffs rejected

The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.

It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.

The agencies published a document explaining why they omitted the advisory committee›s conclusions.

The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.

In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.

“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
 

Guidance for infants and toddlers

The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise. 

At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk. 

The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.

Dr. Elkind highlighted the significance of these additions.

“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
 

For all ages

From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.

According to the guidelines, core elements of a healthy diet include:

• Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
• Fruits (especially whole fruit).
• Grains, at least half of which are whole grain. 
• Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
• Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
• Oils, including vegetable oils and oils in food, such as seafood and nuts.

The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.

Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.

“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”

An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.

The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.

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

Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.

scyther5/thinkstock

The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.

At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.

In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”

That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.

“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”

Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”

Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”

However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.

The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.


 

COVID-19 vaccines

Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.

But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.

In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.

The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.

“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”

Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.

It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.

According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.

As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?


 

Risk vs. benefit

Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.

“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”

The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”

That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”

Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”

So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.

“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
 

No waiting needed

Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.

“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”

However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”

Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.

The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.

He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.

Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”

He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”


 

Boosting efficacy

Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”

With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”

As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”

There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”

The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”

Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”

Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”

Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”

Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”

He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”

The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”

*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.

scyther5/thinkstock

The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.

At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.

In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”

That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.

“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”

Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”

Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”

However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.

The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.


 

COVID-19 vaccines

Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.

But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.

In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.

The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.

“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”

Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.

It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.

According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.

As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?


 

Risk vs. benefit

Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.

“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”

The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”

That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”

Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”

So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.

“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
 

No waiting needed

Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.

“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”

However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”

Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.

The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.

He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.

Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”

He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”


 

Boosting efficacy

Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”

With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”

As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”

There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”

The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”

Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”

Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”

Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”

Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”

He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”

The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”

*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.

scyther5/thinkstock

The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.

At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.

In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”

That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.

“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”

Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”

Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”

However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.

The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.


 

COVID-19 vaccines

Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.

But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.

In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.

The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.

“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”

Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.

It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.

According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.

As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?


 

Risk vs. benefit

Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.

“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”

The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”

That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”

Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”

So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.

“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
 

No waiting needed

Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.

“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”

However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”

Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.

The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.

He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.

Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”

He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”


 

Boosting efficacy

Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”

With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”

As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”

There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”

The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”

Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”

Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”

Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”

Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”

He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”

The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”

*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

Key studies were presented at the 2020 American Society of Hematology (ASH) meeting on next-generation BTK inhibitors, combination treatments, and CAR-T therapies for chronic lymphocytic leukemia (CLL).

Dr William Wierda of the MD Anderson Cancer Center in Houston, Texas, reviews updated data from the MURANO and CLL14 trials, both of which demonstrated durable and long-term remissions with targeted combination therapies.

Dr Wierda also reviews an analysis of the primary endpoint for the CAPTIVATE study, which examined ibrutinib plus venetoclax, and updated data for LOXO-305, a reversible inhibitor of BTK demonstrating clear activity and good tolerability. 

He discusses two reports on the TRANSCEND anti-CD19 CAR T-cell trial. The first report compares CAR-T monotherapy to a combination of CAR-T therapy and ibrutinib. The second evaluates data from CAR-T monotherapy demonstrating a complete remission rate of 40%-60% along with undetectable MRD in bone marrow.

Finally, Dr Wierda reviews data from the UNITY phase 3 trial evaluating the combination of umbralisib plus ublituximab vs obinutuzumab plus chlorambucil in both the frontline and relapsed settings. The combination targeted therapy resulted in improved survival compared with the chemoimmunotherapy.

--

William G. Wierda, MD, PhD, Professor; Medical Director, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.

William G. Wierda, MD, PhD, has disclosed the following relevant financial relationships:
Contracted research for: GlaxoSmithKline/Novartis; AbbVie; Genentech; Pharmacyclics LLC; Acerta Pharma, Inc.; Gilead Sciences; Juno Therapeutics; KITE Pharma; Sunesis; Miragen; Oncternal Therapeutics, Inc.; Cyclacel; Loxo Oncology, Inc.; Janssen; Xencor.

Key studies were presented at the 2020 American Society of Hematology (ASH) meeting on next-generation BTK inhibitors, combination treatments, and CAR-T therapies for chronic lymphocytic leukemia (CLL).

Dr William Wierda of the MD Anderson Cancer Center in Houston, Texas, reviews updated data from the MURANO and CLL14 trials, both of which demonstrated durable and long-term remissions with targeted combination therapies.

Dr Wierda also reviews an analysis of the primary endpoint for the CAPTIVATE study, which examined ibrutinib plus venetoclax, and updated data for LOXO-305, a reversible inhibitor of BTK demonstrating clear activity and good tolerability. 

He discusses two reports on the TRANSCEND anti-CD19 CAR T-cell trial. The first report compares CAR-T monotherapy to a combination of CAR-T therapy and ibrutinib. The second evaluates data from CAR-T monotherapy demonstrating a complete remission rate of 40%-60% along with undetectable MRD in bone marrow.

Finally, Dr Wierda reviews data from the UNITY phase 3 trial evaluating the combination of umbralisib plus ublituximab vs obinutuzumab plus chlorambucil in both the frontline and relapsed settings. The combination targeted therapy resulted in improved survival compared with the chemoimmunotherapy.

--

William G. Wierda, MD, PhD, Professor; Medical Director, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.

William G. Wierda, MD, PhD, has disclosed the following relevant financial relationships:
Contracted research for: GlaxoSmithKline/Novartis; AbbVie; Genentech; Pharmacyclics LLC; Acerta Pharma, Inc.; Gilead Sciences; Juno Therapeutics; KITE Pharma; Sunesis; Miragen; Oncternal Therapeutics, Inc.; Cyclacel; Loxo Oncology, Inc.; Janssen; Xencor.

Key studies were presented at the 2020 American Society of Hematology (ASH) meeting on next-generation BTK inhibitors, combination treatments, and CAR-T therapies for chronic lymphocytic leukemia (CLL).

Dr William Wierda of the MD Anderson Cancer Center in Houston, Texas, reviews updated data from the MURANO and CLL14 trials, both of which demonstrated durable and long-term remissions with targeted combination therapies.

Dr Wierda also reviews an analysis of the primary endpoint for the CAPTIVATE study, which examined ibrutinib plus venetoclax, and updated data for LOXO-305, a reversible inhibitor of BTK demonstrating clear activity and good tolerability. 

He discusses two reports on the TRANSCEND anti-CD19 CAR T-cell trial. The first report compares CAR-T monotherapy to a combination of CAR-T therapy and ibrutinib. The second evaluates data from CAR-T monotherapy demonstrating a complete remission rate of 40%-60% along with undetectable MRD in bone marrow.

Finally, Dr Wierda reviews data from the UNITY phase 3 trial evaluating the combination of umbralisib plus ublituximab vs obinutuzumab plus chlorambucil in both the frontline and relapsed settings. The combination targeted therapy resulted in improved survival compared with the chemoimmunotherapy.

--

William G. Wierda, MD, PhD, Professor; Medical Director, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.

William G. Wierda, MD, PhD, has disclosed the following relevant financial relationships:
Contracted research for: GlaxoSmithKline/Novartis; AbbVie; Genentech; Pharmacyclics LLC; Acerta Pharma, Inc.; Gilead Sciences; Juno Therapeutics; KITE Pharma; Sunesis; Miragen; Oncternal Therapeutics, Inc.; Cyclacel; Loxo Oncology, Inc.; Janssen; Xencor.

Now that COVID-19 vaccines are being distributed, the American Association for Cancer Research has called for people with cancer to be considered as a high-priority group.

“The available evidence supports the conclusion that patients with cancer, in particular with hematologic malignancies, should be considered among the high-risk groups for priority COVID-19 vaccination,” according to the AACR’s COVID-19 and Cancer Task Force.

A review of literature suggested that COVID-19 fatality rates for patients with cancer were double that of individuals without cancer, the team noted. The higher mortality rates still trended upward, even after adjusting for confounders including age, sex, and comorbidities, indicating that there is a greater risk for severe disease and COVID-19–related mortality.

The new AACR position paper was published online Dec. 19 in Cancer Discovery.

“We conclude that patients with an active cancer should be considered for priority access to COVID-19 vaccination, along other particularly vulnerable populations with risk factors for adverse outcomes with COVID-19,” the team wrote.

However, the authors noted that “it is unclear whether this recommendation should be applicable to patients with a past diagnosis of cancer, as cancer survivors can be considered having the same risk as other persons with matched age and other risk factors. 

“Given that there are nearly 17 million people living with a history of cancer in the United States alone, it is critical to understand whether these individuals are at a higher risk to contract SARS-COV-2 and to experience severe outcomes from COVID-19,” they added.
 

Allocation of initial doses

There has already been much discussion on the allocation of the initial doses of COVID-19 vaccines that have become available in the United States. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommended that the first wave of vaccinations, described as phase 1a, should be administered to health care workers (about 21 million people) and residents of long-term care facilities (about 3 million).

The next priority group, phase 1b, should consist of frontline essential workers, a group of about 30 million, and adults aged 75 years or older, a group of about 21 million. When overlap between the groups is taken into account, phase 1b covers about 49 million people, according to the CDC.

Finally, phase 1c, the third priority group, would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million people.

The AACR task force, led by Antoni Ribas, MD, PhD, of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, noted in their position paper that their recommendation is consistent with ACIP’s guidelines. Those guidelines concluded that patients with cancer are at a higher risk for severe COVID-19, and should be one of the groups considered for early COVID-19 vaccination.
 

Questions remain

Approached for independent comment, Cardinale Smith, MD, PhD, chief quality officer for cancer services for the Mount Sinai Health System in New York, agreed with the AACR task force. “I share that they should be high priority,” she said, “But we don’t know that the efficacy will the same.”

Dr. Smith noted that the impact of cancer therapy on patient immune systems is more related to the type of treatment they’re receiving, and B- and T-cell responses. “But regardless, they should be getting the vaccine, and we just need to follow the guidelines.”

The AACR task force noted that information thus far is quite limited as to the effects of COVID-19 vaccination in patients with cancer. In the Pfizer-BioNTech BNT162b2 COVID vaccine trial, of 43,540 participants, only 3.7% were reported to have cancer. Other large COVID-19 vaccine trials will provide further follow-up information on the effectiveness of the vaccines in patients receiving different cancer treatments, they wrote, but for now, there is “currently not enough data to evaluate the interactions between active oncologic therapy with the ability to induce protective immunity” to COVID-19 with vaccination.

In a recent interview, Nora Disis, MD, a medical oncologist and director of both the Institute of Translational Health Sciences and the Cancer Vaccine Institute, University of Washington, Seattle, also discussed vaccinating cancer patients.

She pointed out that even though there are data suggesting that cancer patients are at higher risk, “they are a bit murky, in part because cancer patients are a heterogeneous group.”

“For example, there are data suggesting that lung and blood cancer patients fare worse,” said Dr. Disis, who is also editor in chief of JAMA Oncology. “There is also a suggestion that, like in the general population, COVID risk in cancer patients remains driven by comorbidities.”

She also pointed out the likelihood that individualized risk factors, including the type of cancer therapy, site of disease, and comorbidities, “will shape individual choices about vaccination among cancer patients.”

It is also reasonable to expect that patients with cancer will respond to the vaccines, even though historically some believed that they would be unable to mount an immune response. “Data on other viral vaccines have shown otherwise,” said Dr. Disis. “For example, there has been a long history of studies of flu vaccination in cancer patients, and in general, those vaccines confer protection.”

Several of the authors of the AACR position paper, including Dr. Ribas, reported relationships with industry as detailed in the paper. Dr. Smith has disclosed no relevant financial relationships.

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

Now that COVID-19 vaccines are being distributed, the American Association for Cancer Research has called for people with cancer to be considered as a high-priority group.

“The available evidence supports the conclusion that patients with cancer, in particular with hematologic malignancies, should be considered among the high-risk groups for priority COVID-19 vaccination,” according to the AACR’s COVID-19 and Cancer Task Force.

A review of literature suggested that COVID-19 fatality rates for patients with cancer were double that of individuals without cancer, the team noted. The higher mortality rates still trended upward, even after adjusting for confounders including age, sex, and comorbidities, indicating that there is a greater risk for severe disease and COVID-19–related mortality.

The new AACR position paper was published online Dec. 19 in Cancer Discovery.

“We conclude that patients with an active cancer should be considered for priority access to COVID-19 vaccination, along other particularly vulnerable populations with risk factors for adverse outcomes with COVID-19,” the team wrote.

However, the authors noted that “it is unclear whether this recommendation should be applicable to patients with a past diagnosis of cancer, as cancer survivors can be considered having the same risk as other persons with matched age and other risk factors. 

“Given that there are nearly 17 million people living with a history of cancer in the United States alone, it is critical to understand whether these individuals are at a higher risk to contract SARS-COV-2 and to experience severe outcomes from COVID-19,” they added.
 

Allocation of initial doses

There has already been much discussion on the allocation of the initial doses of COVID-19 vaccines that have become available in the United States. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommended that the first wave of vaccinations, described as phase 1a, should be administered to health care workers (about 21 million people) and residents of long-term care facilities (about 3 million).

The next priority group, phase 1b, should consist of frontline essential workers, a group of about 30 million, and adults aged 75 years or older, a group of about 21 million. When overlap between the groups is taken into account, phase 1b covers about 49 million people, according to the CDC.

Finally, phase 1c, the third priority group, would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million people.

The AACR task force, led by Antoni Ribas, MD, PhD, of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, noted in their position paper that their recommendation is consistent with ACIP’s guidelines. Those guidelines concluded that patients with cancer are at a higher risk for severe COVID-19, and should be one of the groups considered for early COVID-19 vaccination.
 

Questions remain

Approached for independent comment, Cardinale Smith, MD, PhD, chief quality officer for cancer services for the Mount Sinai Health System in New York, agreed with the AACR task force. “I share that they should be high priority,” she said, “But we don’t know that the efficacy will the same.”

Dr. Smith noted that the impact of cancer therapy on patient immune systems is more related to the type of treatment they’re receiving, and B- and T-cell responses. “But regardless, they should be getting the vaccine, and we just need to follow the guidelines.”

The AACR task force noted that information thus far is quite limited as to the effects of COVID-19 vaccination in patients with cancer. In the Pfizer-BioNTech BNT162b2 COVID vaccine trial, of 43,540 participants, only 3.7% were reported to have cancer. Other large COVID-19 vaccine trials will provide further follow-up information on the effectiveness of the vaccines in patients receiving different cancer treatments, they wrote, but for now, there is “currently not enough data to evaluate the interactions between active oncologic therapy with the ability to induce protective immunity” to COVID-19 with vaccination.

In a recent interview, Nora Disis, MD, a medical oncologist and director of both the Institute of Translational Health Sciences and the Cancer Vaccine Institute, University of Washington, Seattle, also discussed vaccinating cancer patients.

She pointed out that even though there are data suggesting that cancer patients are at higher risk, “they are a bit murky, in part because cancer patients are a heterogeneous group.”

“For example, there are data suggesting that lung and blood cancer patients fare worse,” said Dr. Disis, who is also editor in chief of JAMA Oncology. “There is also a suggestion that, like in the general population, COVID risk in cancer patients remains driven by comorbidities.”

She also pointed out the likelihood that individualized risk factors, including the type of cancer therapy, site of disease, and comorbidities, “will shape individual choices about vaccination among cancer patients.”

It is also reasonable to expect that patients with cancer will respond to the vaccines, even though historically some believed that they would be unable to mount an immune response. “Data on other viral vaccines have shown otherwise,” said Dr. Disis. “For example, there has been a long history of studies of flu vaccination in cancer patients, and in general, those vaccines confer protection.”

Several of the authors of the AACR position paper, including Dr. Ribas, reported relationships with industry as detailed in the paper. Dr. Smith has disclosed no relevant financial relationships.

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

Now that COVID-19 vaccines are being distributed, the American Association for Cancer Research has called for people with cancer to be considered as a high-priority group.

“The available evidence supports the conclusion that patients with cancer, in particular with hematologic malignancies, should be considered among the high-risk groups for priority COVID-19 vaccination,” according to the AACR’s COVID-19 and Cancer Task Force.

A review of literature suggested that COVID-19 fatality rates for patients with cancer were double that of individuals without cancer, the team noted. The higher mortality rates still trended upward, even after adjusting for confounders including age, sex, and comorbidities, indicating that there is a greater risk for severe disease and COVID-19–related mortality.

The new AACR position paper was published online Dec. 19 in Cancer Discovery.

“We conclude that patients with an active cancer should be considered for priority access to COVID-19 vaccination, along other particularly vulnerable populations with risk factors for adverse outcomes with COVID-19,” the team wrote.

However, the authors noted that “it is unclear whether this recommendation should be applicable to patients with a past diagnosis of cancer, as cancer survivors can be considered having the same risk as other persons with matched age and other risk factors. 

“Given that there are nearly 17 million people living with a history of cancer in the United States alone, it is critical to understand whether these individuals are at a higher risk to contract SARS-COV-2 and to experience severe outcomes from COVID-19,” they added.
 

Allocation of initial doses

There has already been much discussion on the allocation of the initial doses of COVID-19 vaccines that have become available in the United States. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommended that the first wave of vaccinations, described as phase 1a, should be administered to health care workers (about 21 million people) and residents of long-term care facilities (about 3 million).

The next priority group, phase 1b, should consist of frontline essential workers, a group of about 30 million, and adults aged 75 years or older, a group of about 21 million. When overlap between the groups is taken into account, phase 1b covers about 49 million people, according to the CDC.

Finally, phase 1c, the third priority group, would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million people.

The AACR task force, led by Antoni Ribas, MD, PhD, of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, noted in their position paper that their recommendation is consistent with ACIP’s guidelines. Those guidelines concluded that patients with cancer are at a higher risk for severe COVID-19, and should be one of the groups considered for early COVID-19 vaccination.
 

Questions remain

Approached for independent comment, Cardinale Smith, MD, PhD, chief quality officer for cancer services for the Mount Sinai Health System in New York, agreed with the AACR task force. “I share that they should be high priority,” she said, “But we don’t know that the efficacy will the same.”

Dr. Smith noted that the impact of cancer therapy on patient immune systems is more related to the type of treatment they’re receiving, and B- and T-cell responses. “But regardless, they should be getting the vaccine, and we just need to follow the guidelines.”

The AACR task force noted that information thus far is quite limited as to the effects of COVID-19 vaccination in patients with cancer. In the Pfizer-BioNTech BNT162b2 COVID vaccine trial, of 43,540 participants, only 3.7% were reported to have cancer. Other large COVID-19 vaccine trials will provide further follow-up information on the effectiveness of the vaccines in patients receiving different cancer treatments, they wrote, but for now, there is “currently not enough data to evaluate the interactions between active oncologic therapy with the ability to induce protective immunity” to COVID-19 with vaccination.

In a recent interview, Nora Disis, MD, a medical oncologist and director of both the Institute of Translational Health Sciences and the Cancer Vaccine Institute, University of Washington, Seattle, also discussed vaccinating cancer patients.

She pointed out that even though there are data suggesting that cancer patients are at higher risk, “they are a bit murky, in part because cancer patients are a heterogeneous group.”

“For example, there are data suggesting that lung and blood cancer patients fare worse,” said Dr. Disis, who is also editor in chief of JAMA Oncology. “There is also a suggestion that, like in the general population, COVID risk in cancer patients remains driven by comorbidities.”

She also pointed out the likelihood that individualized risk factors, including the type of cancer therapy, site of disease, and comorbidities, “will shape individual choices about vaccination among cancer patients.”

It is also reasonable to expect that patients with cancer will respond to the vaccines, even though historically some believed that they would be unable to mount an immune response. “Data on other viral vaccines have shown otherwise,” said Dr. Disis. “For example, there has been a long history of studies of flu vaccination in cancer patients, and in general, those vaccines confer protection.”

Several of the authors of the AACR position paper, including Dr. Ribas, reported relationships with industry as detailed in the paper. Dr. Smith has disclosed no relevant financial relationships.

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

The U.S. has distributed more than 11.4 million doses of the Pfizer and Moderna COVID-19 vaccines, and more than 2.1 million of those had been given to people as of December 28, according to the CDC.

The CDC’s COVID Data Tracker showed the updated numbers as of 9 a.m. on that day. The distribution total is based on the CDC’s Vaccine Tracking System, and the administered total is based on reports from state and local public health departments, as well as updates from five federal agencies: the Bureau of Prisons, Veterans Administration, Department of Defense, Department of State, and Indian Health Services.

Health care providers report to public health agencies up to 72 hours after the vaccine is given, and public health agencies report to the CDC after that, so there may be a lag in the data. The CDC’s numbers will be updated on Mondays, Wednesdays, and Fridays.

“A large difference between the number of doses distributed and the number of doses administered is expected at this point in the COVID vaccination program due to several factors,” the CDC says.

Delays could occur due to the reporting of doses given, how states and local vaccine sites are managing vaccines, and the pending launch of vaccination through the federal Pharmacy Partnership for Long-Term Care Program.

“Numbers reported on other websites may differ from what is posted on CDC’s website because CDC’s overall numbers are validated through a data submission process with each jurisdiction,” the CDC says.

On Dec. 26, the agency’s tally showed that 9.5 million doses had been distributed and 1.9 million had been given, according to Reuters.

Public health officials and health care workers have begun to voice their concerns about the delay in giving the vaccines.

“We certainly are not at the numbers that we wanted to be at the end of December,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told CNNDec. 29.

Operation Warp Speed had planned for 20 million people to be vaccinated by the end of the year. Fauci said he hopes that number will be achieved next month.

“I believe that as we get into January, we are going to see an increase in the momentum,” he said.

Shipment delays have affected other priority groups as well. The New York Police Department anticipated a rollout Dec. 29, but it’s now been delayed since the department hasn’t received enough Moderna doses to start giving the shots, according to the New York Daily News.

“We’ve made numerous attempts to get updated information, and when we get further word on its availability, we will immediately keep our members appraised of the new date and the method of distribution,” Paul DiGiacomo, president of the Detectives’ Endowment Association, wrote in a memo to members on Dec. 28.

“Every detective squad has been crushed with [COVID-19],” he told the newspaper. “Within the last couple of weeks, we’ve had at least two detectives hospitalized.”

President-elect Joe Biden will receive a briefing from his COVID-19 advisory team, provide a general update on the pandemic, and describe his own plan for vaccinating people quickly during an address Dec. 29, a transition official told Axios. Biden has pledged to administer 100 million vaccine doses in his first 100 days in office.
 

A version of this article originally appeared on WebMd.

The U.S. has distributed more than 11.4 million doses of the Pfizer and Moderna COVID-19 vaccines, and more than 2.1 million of those had been given to people as of December 28, according to the CDC.

The CDC’s COVID Data Tracker showed the updated numbers as of 9 a.m. on that day. The distribution total is based on the CDC’s Vaccine Tracking System, and the administered total is based on reports from state and local public health departments, as well as updates from five federal agencies: the Bureau of Prisons, Veterans Administration, Department of Defense, Department of State, and Indian Health Services.

Health care providers report to public health agencies up to 72 hours after the vaccine is given, and public health agencies report to the CDC after that, so there may be a lag in the data. The CDC’s numbers will be updated on Mondays, Wednesdays, and Fridays.

“A large difference between the number of doses distributed and the number of doses administered is expected at this point in the COVID vaccination program due to several factors,” the CDC says.

Delays could occur due to the reporting of doses given, how states and local vaccine sites are managing vaccines, and the pending launch of vaccination through the federal Pharmacy Partnership for Long-Term Care Program.

“Numbers reported on other websites may differ from what is posted on CDC’s website because CDC’s overall numbers are validated through a data submission process with each jurisdiction,” the CDC says.

On Dec. 26, the agency’s tally showed that 9.5 million doses had been distributed and 1.9 million had been given, according to Reuters.

Public health officials and health care workers have begun to voice their concerns about the delay in giving the vaccines.

“We certainly are not at the numbers that we wanted to be at the end of December,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told CNNDec. 29.

Operation Warp Speed had planned for 20 million people to be vaccinated by the end of the year. Fauci said he hopes that number will be achieved next month.

“I believe that as we get into January, we are going to see an increase in the momentum,” he said.

Shipment delays have affected other priority groups as well. The New York Police Department anticipated a rollout Dec. 29, but it’s now been delayed since the department hasn’t received enough Moderna doses to start giving the shots, according to the New York Daily News.

“We’ve made numerous attempts to get updated information, and when we get further word on its availability, we will immediately keep our members appraised of the new date and the method of distribution,” Paul DiGiacomo, president of the Detectives’ Endowment Association, wrote in a memo to members on Dec. 28.

“Every detective squad has been crushed with [COVID-19],” he told the newspaper. “Within the last couple of weeks, we’ve had at least two detectives hospitalized.”

President-elect Joe Biden will receive a briefing from his COVID-19 advisory team, provide a general update on the pandemic, and describe his own plan for vaccinating people quickly during an address Dec. 29, a transition official told Axios. Biden has pledged to administer 100 million vaccine doses in his first 100 days in office.
 

A version of this article originally appeared on WebMd.

The U.S. has distributed more than 11.4 million doses of the Pfizer and Moderna COVID-19 vaccines, and more than 2.1 million of those had been given to people as of December 28, according to the CDC.

The CDC’s COVID Data Tracker showed the updated numbers as of 9 a.m. on that day. The distribution total is based on the CDC’s Vaccine Tracking System, and the administered total is based on reports from state and local public health departments, as well as updates from five federal agencies: the Bureau of Prisons, Veterans Administration, Department of Defense, Department of State, and Indian Health Services.

Health care providers report to public health agencies up to 72 hours after the vaccine is given, and public health agencies report to the CDC after that, so there may be a lag in the data. The CDC’s numbers will be updated on Mondays, Wednesdays, and Fridays.

“A large difference between the number of doses distributed and the number of doses administered is expected at this point in the COVID vaccination program due to several factors,” the CDC says.

Delays could occur due to the reporting of doses given, how states and local vaccine sites are managing vaccines, and the pending launch of vaccination through the federal Pharmacy Partnership for Long-Term Care Program.

“Numbers reported on other websites may differ from what is posted on CDC’s website because CDC’s overall numbers are validated through a data submission process with each jurisdiction,” the CDC says.

On Dec. 26, the agency’s tally showed that 9.5 million doses had been distributed and 1.9 million had been given, according to Reuters.

Public health officials and health care workers have begun to voice their concerns about the delay in giving the vaccines.

“We certainly are not at the numbers that we wanted to be at the end of December,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told CNNDec. 29.

Operation Warp Speed had planned for 20 million people to be vaccinated by the end of the year. Fauci said he hopes that number will be achieved next month.

“I believe that as we get into January, we are going to see an increase in the momentum,” he said.

Shipment delays have affected other priority groups as well. The New York Police Department anticipated a rollout Dec. 29, but it’s now been delayed since the department hasn’t received enough Moderna doses to start giving the shots, according to the New York Daily News.

“We’ve made numerous attempts to get updated information, and when we get further word on its availability, we will immediately keep our members appraised of the new date and the method of distribution,” Paul DiGiacomo, president of the Detectives’ Endowment Association, wrote in a memo to members on Dec. 28.

“Every detective squad has been crushed with [COVID-19],” he told the newspaper. “Within the last couple of weeks, we’ve had at least two detectives hospitalized.”

President-elect Joe Biden will receive a briefing from his COVID-19 advisory team, provide a general update on the pandemic, and describe his own plan for vaccinating people quickly during an address Dec. 29, a transition official told Axios. Biden has pledged to administer 100 million vaccine doses in his first 100 days in office.
 

A version of this article originally appeared on WebMd.

Dermatopathologist Michi M. Shinohara, MD, is often asked why it takes so long to diagnose mycosis fungoides. Her reply: Early histopathologic findings in mycosis fungoides (MF) can be subtle, and accurate diagnosis is aided by taking multiple skin biopsies from different sites sequentially over time when there’s diagnostic uncertainty.

“Take multiple biopsies. There is clear literature that taking multiple biopsies from different areas of the body can really increase the sensitivity and specificity of TCR/PCR [T-cell receptor gene PCR clonality studies],” she said at a virtual forum on cutaneous malignancies jointly presented by the Postgraduate Institute for Medicine and Global Academy for Medical Education.

Patients with MF carry multiple subclones, and by taking multiple skin biopsies, different expression patterns may be revealed.

“MF is incredibly mutationally complex, and that has implications for therapy. There is certainly no single, nor even a few, targetable mutations. There are over 50 driver mutations known in CTCL [cutaneous T-cell lymphoma] involving more than a dozen signaling pathways,” said Dr. Shinohara, codirector of the cutaneous lymphoma clinic at the Seattle Cancer Care Alliance and director of dermatopathology at the University of Washington, Seattle.

MF is a lymphoma of skin-resident memory T-cells, the same T-cells involved in the pathogenesis of fixed drug eruption. MF accounts for about half of primary CTCLs. Traditionally, the average time from appearance of skin lesions to definitive diagnosis of MF is 3-6 years.

The International Society for Cutaneous Lymphomas diagnostic algorithm emphasizes that accurate diagnosis of MF requires clinical and histopathologic correlation supported by immunohistochemistry and TCR/PCR or other molecular studies. In an independent validation study, the algorithm demonstrated a sensitivity of 87.5% and specificity of 60% for diagnosis of MF.

Using this algorithm, a diagnosis of MF requires 4 points or more. A maximum of 2 points is available for the key clinical findings of variably sized persistent patches and/or plaques on non–sun-exposed areas, with poikiloderma. Another maximum of 2 points is awarded for the classic histopathologic findings consistent with MF and other forms of cutaneous T-cell lymphoma – namely, a superficial lymphoid infiltrate with epidermotropic but not spongiotic atypia. A positive immunohistochemical study is worth 1 point, and another point is granted for a positive result from a molecular study; both the immunohistochemical and molecular studies should “almost always” be done in patients with suspected MF, whereas a bone marrow biopsy is almost never appropriate.

The challenge for dermatopathologists in making an early diagnosis of MF is that, in patch-stage disease, many of the patient’s own cytotoxic CD8+ T-cells are present in the biopsy specimen battling the malignancy. These tumor-fighting cells often mask the malignant T-cells, clouding the picture under the microscope and putting the 2-point maximum for histopathologic findings out of reach. However, as the patient progresses to plaques, tumors, and erythroderma, the proportion of malignant T-cells increases and the diagnosis becomes easier, Dr. Shinohara explained.

In cases where histopathologic uncertainty exists, the immunohistochemistry and molecular studies become particularly important because, when positive, they can raise a patient’s score up to the 4-point diagnostic threshold. Dr. Shinohara focused on recent advances in molecular studies because that’s where the action is of late in the field of MF diagnostics.
 

High-throughput sequencing and other molecular studies

Three molecular study options are available for the diagnosis of MF: TCR/PCR, which is the traditional clonality study; next-generation high-throughput DNA sequencing; and flow cytometry.

A TCR/PCR study showing a monoclonal T-cell clone on a more subdued polyclonal background is highly suggestive of MF, as opposed to other inflammatory dermatoses. Early in the disease, however, the pattern can be oligoclonal, an inconclusive result. This point is where taking multiple biopsies from different skin sites becomes extremely helpful to amplify TCR/PCR’s sensitivity and specificity. Indeed, investigators at Stanford (Calif.) University have reported that TCR/PCR analysis showing an identical T-cell clone in biopsy specimens from two different skin sites had 82.6% sensitivity and 95.7% specificity for unequivocal MF.

High-throughput sequencing of the T-cell receptor gene has greater specificity for diagnosis of MF than TCR/PCR, and with similar sensitivity.

“The sensitivity of high-throughput sequencing is okay, but really we want it to be helpful in those wishy washy cases where we get an oligoclonal result on TCR/PCR; that’s, I think, an ideal use for it,” Dr. Shinohara said.

In addition to its role in establishing the diagnosis of MF, high-throughput sequencing shows promise for two other potential applications: detection of residual disease following stem cell transplantation and risk stratification in patients with early-stage disease.

Citing a landmark Stanford retrospective cohort analysis of actuarial disease-specific survival in 525 patients with MF and Sezary syndrome, she noted that the majority of patients had stage IA or IB disease – meaning patches and/or plaques on less than or more than 10% of their body surface area – and the survival curves of these patients with early-stage CTCL were flat.

“Most patients are going to live for decades with their disease if they have early disease, and that’s very reassuring for patients,” the dermatopathologist observed.

And yet, early-stage disease does not follow an indolent lifelong course in a subset of patients; rather, their disease becomes aggressive and resistant to all treatments short of stem cell transplantation. Investigators at Harvard University, Boston, have reported that high-throughput sequencing of the T-cell receptor beta gene in lesional skin biopsies is a powerful tool for early identification of this high-risk subpopulation of patients with early-stage MF. They demonstrated in a cohort of 141 patients with early-stage MF, then again in a validation cohort of 69 others, that a tumor clone frequency (TCF) greater than 25% in lesional skin, as measured by high-throughput sequencing, was a more powerful predictor of disease progression than any of the established prognostic factors.

In the discovery set, a TCF in excess of 25% was associated with a 4.9-fold increased likelihood of reduced progression-free survival; in the validation set, the risk was 10-fold greater than in patients with a lesser TCF. These were significantly greater risks than those seen with other proposed biomarkers of diminished progression-free survival, including the presence of plaques; stage IB, as opposed to IA, disease; large-cell transformation; age greater than 60 years; and elevated lactate dehydrogenase levels.

Although this groundbreaking work requires confirmation in another dataset, “this may be something we evolve towards doing in patients with early disease to pick out those who may have bad outcomes later,” Dr. Shinohara commented.

Still, she stressed, molecular studies will never replace histopathologic analysis for diagnosis of MF. “Judicious use of molecular studies may help in establishing the diagnosis, but I don’t think any one molecular study is ever going to be our home run,” she said.

She reported no financial conflicts regarding her presentation.

Global Academy for Medical Education and this news organization are owned by the same company.

bjancin@mdedge.com

Dermatopathologist Michi M. Shinohara, MD, is often asked why it takes so long to diagnose mycosis fungoides. Her reply: Early histopathologic findings in mycosis fungoides (MF) can be subtle, and accurate diagnosis is aided by taking multiple skin biopsies from different sites sequentially over time when there’s diagnostic uncertainty.

“Take multiple biopsies. There is clear literature that taking multiple biopsies from different areas of the body can really increase the sensitivity and specificity of TCR/PCR [T-cell receptor gene PCR clonality studies],” she said at a virtual forum on cutaneous malignancies jointly presented by the Postgraduate Institute for Medicine and Global Academy for Medical Education.

Patients with MF carry multiple subclones, and by taking multiple skin biopsies, different expression patterns may be revealed.

“MF is incredibly mutationally complex, and that has implications for therapy. There is certainly no single, nor even a few, targetable mutations. There are over 50 driver mutations known in CTCL [cutaneous T-cell lymphoma] involving more than a dozen signaling pathways,” said Dr. Shinohara, codirector of the cutaneous lymphoma clinic at the Seattle Cancer Care Alliance and director of dermatopathology at the University of Washington, Seattle.

MF is a lymphoma of skin-resident memory T-cells, the same T-cells involved in the pathogenesis of fixed drug eruption. MF accounts for about half of primary CTCLs. Traditionally, the average time from appearance of skin lesions to definitive diagnosis of MF is 3-6 years.

The International Society for Cutaneous Lymphomas diagnostic algorithm emphasizes that accurate diagnosis of MF requires clinical and histopathologic correlation supported by immunohistochemistry and TCR/PCR or other molecular studies. In an independent validation study, the algorithm demonstrated a sensitivity of 87.5% and specificity of 60% for diagnosis of MF.

Using this algorithm, a diagnosis of MF requires 4 points or more. A maximum of 2 points is available for the key clinical findings of variably sized persistent patches and/or plaques on non–sun-exposed areas, with poikiloderma. Another maximum of 2 points is awarded for the classic histopathologic findings consistent with MF and other forms of cutaneous T-cell lymphoma – namely, a superficial lymphoid infiltrate with epidermotropic but not spongiotic atypia. A positive immunohistochemical study is worth 1 point, and another point is granted for a positive result from a molecular study; both the immunohistochemical and molecular studies should “almost always” be done in patients with suspected MF, whereas a bone marrow biopsy is almost never appropriate.

The challenge for dermatopathologists in making an early diagnosis of MF is that, in patch-stage disease, many of the patient’s own cytotoxic CD8+ T-cells are present in the biopsy specimen battling the malignancy. These tumor-fighting cells often mask the malignant T-cells, clouding the picture under the microscope and putting the 2-point maximum for histopathologic findings out of reach. However, as the patient progresses to plaques, tumors, and erythroderma, the proportion of malignant T-cells increases and the diagnosis becomes easier, Dr. Shinohara explained.

In cases where histopathologic uncertainty exists, the immunohistochemistry and molecular studies become particularly important because, when positive, they can raise a patient’s score up to the 4-point diagnostic threshold. Dr. Shinohara focused on recent advances in molecular studies because that’s where the action is of late in the field of MF diagnostics.
 

High-throughput sequencing and other molecular studies

Three molecular study options are available for the diagnosis of MF: TCR/PCR, which is the traditional clonality study; next-generation high-throughput DNA sequencing; and flow cytometry.

A TCR/PCR study showing a monoclonal T-cell clone on a more subdued polyclonal background is highly suggestive of MF, as opposed to other inflammatory dermatoses. Early in the disease, however, the pattern can be oligoclonal, an inconclusive result. This point is where taking multiple biopsies from different skin sites becomes extremely helpful to amplify TCR/PCR’s sensitivity and specificity. Indeed, investigators at Stanford (Calif.) University have reported that TCR/PCR analysis showing an identical T-cell clone in biopsy specimens from two different skin sites had 82.6% sensitivity and 95.7% specificity for unequivocal MF.

High-throughput sequencing of the T-cell receptor gene has greater specificity for diagnosis of MF than TCR/PCR, and with similar sensitivity.

“The sensitivity of high-throughput sequencing is okay, but really we want it to be helpful in those wishy washy cases where we get an oligoclonal result on TCR/PCR; that’s, I think, an ideal use for it,” Dr. Shinohara said.

In addition to its role in establishing the diagnosis of MF, high-throughput sequencing shows promise for two other potential applications: detection of residual disease following stem cell transplantation and risk stratification in patients with early-stage disease.

Citing a landmark Stanford retrospective cohort analysis of actuarial disease-specific survival in 525 patients with MF and Sezary syndrome, she noted that the majority of patients had stage IA or IB disease – meaning patches and/or plaques on less than or more than 10% of their body surface area – and the survival curves of these patients with early-stage CTCL were flat.

“Most patients are going to live for decades with their disease if they have early disease, and that’s very reassuring for patients,” the dermatopathologist observed.

And yet, early-stage disease does not follow an indolent lifelong course in a subset of patients; rather, their disease becomes aggressive and resistant to all treatments short of stem cell transplantation. Investigators at Harvard University, Boston, have reported that high-throughput sequencing of the T-cell receptor beta gene in lesional skin biopsies is a powerful tool for early identification of this high-risk subpopulation of patients with early-stage MF. They demonstrated in a cohort of 141 patients with early-stage MF, then again in a validation cohort of 69 others, that a tumor clone frequency (TCF) greater than 25% in lesional skin, as measured by high-throughput sequencing, was a more powerful predictor of disease progression than any of the established prognostic factors.

In the discovery set, a TCF in excess of 25% was associated with a 4.9-fold increased likelihood of reduced progression-free survival; in the validation set, the risk was 10-fold greater than in patients with a lesser TCF. These were significantly greater risks than those seen with other proposed biomarkers of diminished progression-free survival, including the presence of plaques; stage IB, as opposed to IA, disease; large-cell transformation; age greater than 60 years; and elevated lactate dehydrogenase levels.

Although this groundbreaking work requires confirmation in another dataset, “this may be something we evolve towards doing in patients with early disease to pick out those who may have bad outcomes later,” Dr. Shinohara commented.

Still, she stressed, molecular studies will never replace histopathologic analysis for diagnosis of MF. “Judicious use of molecular studies may help in establishing the diagnosis, but I don’t think any one molecular study is ever going to be our home run,” she said.

She reported no financial conflicts regarding her presentation.

Global Academy for Medical Education and this news organization are owned by the same company.

bjancin@mdedge.com

Dermatopathologist Michi M. Shinohara, MD, is often asked why it takes so long to diagnose mycosis fungoides. Her reply: Early histopathologic findings in mycosis fungoides (MF) can be subtle, and accurate diagnosis is aided by taking multiple skin biopsies from different sites sequentially over time when there’s diagnostic uncertainty.

“Take multiple biopsies. There is clear literature that taking multiple biopsies from different areas of the body can really increase the sensitivity and specificity of TCR/PCR [T-cell receptor gene PCR clonality studies],” she said at a virtual forum on cutaneous malignancies jointly presented by the Postgraduate Institute for Medicine and Global Academy for Medical Education.

Patients with MF carry multiple subclones, and by taking multiple skin biopsies, different expression patterns may be revealed.

“MF is incredibly mutationally complex, and that has implications for therapy. There is certainly no single, nor even a few, targetable mutations. There are over 50 driver mutations known in CTCL [cutaneous T-cell lymphoma] involving more than a dozen signaling pathways,” said Dr. Shinohara, codirector of the cutaneous lymphoma clinic at the Seattle Cancer Care Alliance and director of dermatopathology at the University of Washington, Seattle.

MF is a lymphoma of skin-resident memory T-cells, the same T-cells involved in the pathogenesis of fixed drug eruption. MF accounts for about half of primary CTCLs. Traditionally, the average time from appearance of skin lesions to definitive diagnosis of MF is 3-6 years.

The International Society for Cutaneous Lymphomas diagnostic algorithm emphasizes that accurate diagnosis of MF requires clinical and histopathologic correlation supported by immunohistochemistry and TCR/PCR or other molecular studies. In an independent validation study, the algorithm demonstrated a sensitivity of 87.5% and specificity of 60% for diagnosis of MF.

Using this algorithm, a diagnosis of MF requires 4 points or more. A maximum of 2 points is available for the key clinical findings of variably sized persistent patches and/or plaques on non–sun-exposed areas, with poikiloderma. Another maximum of 2 points is awarded for the classic histopathologic findings consistent with MF and other forms of cutaneous T-cell lymphoma – namely, a superficial lymphoid infiltrate with epidermotropic but not spongiotic atypia. A positive immunohistochemical study is worth 1 point, and another point is granted for a positive result from a molecular study; both the immunohistochemical and molecular studies should “almost always” be done in patients with suspected MF, whereas a bone marrow biopsy is almost never appropriate.

The challenge for dermatopathologists in making an early diagnosis of MF is that, in patch-stage disease, many of the patient’s own cytotoxic CD8+ T-cells are present in the biopsy specimen battling the malignancy. These tumor-fighting cells often mask the malignant T-cells, clouding the picture under the microscope and putting the 2-point maximum for histopathologic findings out of reach. However, as the patient progresses to plaques, tumors, and erythroderma, the proportion of malignant T-cells increases and the diagnosis becomes easier, Dr. Shinohara explained.

In cases where histopathologic uncertainty exists, the immunohistochemistry and molecular studies become particularly important because, when positive, they can raise a patient’s score up to the 4-point diagnostic threshold. Dr. Shinohara focused on recent advances in molecular studies because that’s where the action is of late in the field of MF diagnostics.
 

High-throughput sequencing and other molecular studies

Three molecular study options are available for the diagnosis of MF: TCR/PCR, which is the traditional clonality study; next-generation high-throughput DNA sequencing; and flow cytometry.

A TCR/PCR study showing a monoclonal T-cell clone on a more subdued polyclonal background is highly suggestive of MF, as opposed to other inflammatory dermatoses. Early in the disease, however, the pattern can be oligoclonal, an inconclusive result. This point is where taking multiple biopsies from different skin sites becomes extremely helpful to amplify TCR/PCR’s sensitivity and specificity. Indeed, investigators at Stanford (Calif.) University have reported that TCR/PCR analysis showing an identical T-cell clone in biopsy specimens from two different skin sites had 82.6% sensitivity and 95.7% specificity for unequivocal MF.

High-throughput sequencing of the T-cell receptor gene has greater specificity for diagnosis of MF than TCR/PCR, and with similar sensitivity.

“The sensitivity of high-throughput sequencing is okay, but really we want it to be helpful in those wishy washy cases where we get an oligoclonal result on TCR/PCR; that’s, I think, an ideal use for it,” Dr. Shinohara said.

In addition to its role in establishing the diagnosis of MF, high-throughput sequencing shows promise for two other potential applications: detection of residual disease following stem cell transplantation and risk stratification in patients with early-stage disease.

Citing a landmark Stanford retrospective cohort analysis of actuarial disease-specific survival in 525 patients with MF and Sezary syndrome, she noted that the majority of patients had stage IA or IB disease – meaning patches and/or plaques on less than or more than 10% of their body surface area – and the survival curves of these patients with early-stage CTCL were flat.

“Most patients are going to live for decades with their disease if they have early disease, and that’s very reassuring for patients,” the dermatopathologist observed.

And yet, early-stage disease does not follow an indolent lifelong course in a subset of patients; rather, their disease becomes aggressive and resistant to all treatments short of stem cell transplantation. Investigators at Harvard University, Boston, have reported that high-throughput sequencing of the T-cell receptor beta gene in lesional skin biopsies is a powerful tool for early identification of this high-risk subpopulation of patients with early-stage MF. They demonstrated in a cohort of 141 patients with early-stage MF, then again in a validation cohort of 69 others, that a tumor clone frequency (TCF) greater than 25% in lesional skin, as measured by high-throughput sequencing, was a more powerful predictor of disease progression than any of the established prognostic factors.

In the discovery set, a TCF in excess of 25% was associated with a 4.9-fold increased likelihood of reduced progression-free survival; in the validation set, the risk was 10-fold greater than in patients with a lesser TCF. These were significantly greater risks than those seen with other proposed biomarkers of diminished progression-free survival, including the presence of plaques; stage IB, as opposed to IA, disease; large-cell transformation; age greater than 60 years; and elevated lactate dehydrogenase levels.

Although this groundbreaking work requires confirmation in another dataset, “this may be something we evolve towards doing in patients with early disease to pick out those who may have bad outcomes later,” Dr. Shinohara commented.

Still, she stressed, molecular studies will never replace histopathologic analysis for diagnosis of MF. “Judicious use of molecular studies may help in establishing the diagnosis, but I don’t think any one molecular study is ever going to be our home run,” she said.

She reported no financial conflicts regarding her presentation.

Global Academy for Medical Education and this news organization are owned by the same company.

bjancin@mdedge.com

The Centers for Disease Control and Prevention has issued updated guidance for people with underlying medical conditions who are considering getting the coronavirus vaccine.

scyther5/thinkstock

“Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19,” the CDC said in the guidance, posted on Dec. 26. “mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.” 

Both the Pfizer and Moderna vaccines use mRNA, or messenger RNA.

The CDC guidance had specific information for people with HIV, weakened immune systems, and autoimmune conditions such as Guillain-Barré syndrome (GBS) and Bell’s palsy who are thinking of getting the vaccine.

People with HIV and weakened immune systems “may receive a COVID-19 vaccine. However, they should be aware of the limited safety data,” the CDC said.

There’s no information available yet about the safety of the vaccines for people with weakened immune systems. People with HIV were included in clinical trials, but “safety data specific to this group are not yet available at this time,” the CDC said.

Cases of Bell’s palsy, a temporary facial paralysis, were reported in people receiving the Pfizer and Moderna vaccines in clinical trials, the Food and Drug Administration said Dec. 17. 

But the new CDC guidance said that the FDA “does not consider these to be above the rate expected in the general population. They have not concluded these cases were caused by vaccination. Therefore, persons who have previously had Bell’s palsy may receive an mRNA COVID-19 vaccine.”

Researchers have determined the vaccines are safe for people with GBS, a rare autoimmune disorder in which the body’s immune system attacks nerves just as they leave the spinal cord, the CDC said.

“To date, no cases of GBS have been reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials,” the CDC guidance said. “With few exceptions, the independent Advisory Committee on Immunization Practices general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines.”

For months, the CDC and other health authorities have said that people with certain medical conditions are at an increased risk of developing severe cases of COVID-19.

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

The Centers for Disease Control and Prevention has issued updated guidance for people with underlying medical conditions who are considering getting the coronavirus vaccine.

scyther5/thinkstock

“Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19,” the CDC said in the guidance, posted on Dec. 26. “mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.” 

Both the Pfizer and Moderna vaccines use mRNA, or messenger RNA.

The CDC guidance had specific information for people with HIV, weakened immune systems, and autoimmune conditions such as Guillain-Barré syndrome (GBS) and Bell’s palsy who are thinking of getting the vaccine.

People with HIV and weakened immune systems “may receive a COVID-19 vaccine. However, they should be aware of the limited safety data,” the CDC said.

There’s no information available yet about the safety of the vaccines for people with weakened immune systems. People with HIV were included in clinical trials, but “safety data specific to this group are not yet available at this time,” the CDC said.

Cases of Bell’s palsy, a temporary facial paralysis, were reported in people receiving the Pfizer and Moderna vaccines in clinical trials, the Food and Drug Administration said Dec. 17. 

But the new CDC guidance said that the FDA “does not consider these to be above the rate expected in the general population. They have not concluded these cases were caused by vaccination. Therefore, persons who have previously had Bell’s palsy may receive an mRNA COVID-19 vaccine.”

Researchers have determined the vaccines are safe for people with GBS, a rare autoimmune disorder in which the body’s immune system attacks nerves just as they leave the spinal cord, the CDC said.

“To date, no cases of GBS have been reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials,” the CDC guidance said. “With few exceptions, the independent Advisory Committee on Immunization Practices general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines.”

For months, the CDC and other health authorities have said that people with certain medical conditions are at an increased risk of developing severe cases of COVID-19.

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

The Centers for Disease Control and Prevention has issued updated guidance for people with underlying medical conditions who are considering getting the coronavirus vaccine.

scyther5/thinkstock

“Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19,” the CDC said in the guidance, posted on Dec. 26. “mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.” 

Both the Pfizer and Moderna vaccines use mRNA, or messenger RNA.

The CDC guidance had specific information for people with HIV, weakened immune systems, and autoimmune conditions such as Guillain-Barré syndrome (GBS) and Bell’s palsy who are thinking of getting the vaccine.

People with HIV and weakened immune systems “may receive a COVID-19 vaccine. However, they should be aware of the limited safety data,” the CDC said.

There’s no information available yet about the safety of the vaccines for people with weakened immune systems. People with HIV were included in clinical trials, but “safety data specific to this group are not yet available at this time,” the CDC said.

Cases of Bell’s palsy, a temporary facial paralysis, were reported in people receiving the Pfizer and Moderna vaccines in clinical trials, the Food and Drug Administration said Dec. 17. 

But the new CDC guidance said that the FDA “does not consider these to be above the rate expected in the general population. They have not concluded these cases were caused by vaccination. Therefore, persons who have previously had Bell’s palsy may receive an mRNA COVID-19 vaccine.”

Researchers have determined the vaccines are safe for people with GBS, a rare autoimmune disorder in which the body’s immune system attacks nerves just as they leave the spinal cord, the CDC said.

“To date, no cases of GBS have been reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials,” the CDC guidance said. “With few exceptions, the independent Advisory Committee on Immunization Practices general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines.”

For months, the CDC and other health authorities have said that people with certain medical conditions are at an increased risk of developing severe cases of COVID-19.

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

The Food and Drug Administration has approved the EndoRotor System (Interscope, Inc.) for removal of necrotic tissue in patients with walled-off pancreatic necrosis (WOPN).

“This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled-off pancreatic necrosis,” Charles Viviano, MD, PhD, acting director, Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office, FDA Center for Devices and Radiological Health, said in a statement.

“Currently, in order to remove dead tissue from a patient’s necrotic pancreatic cavity, health care providers need to perform an invasive surgery or use other endoscopic tools not specifically indicated to treat this condition. With [this] marketing authorization, patients with walled-off pancreatic necrosis now have a new treatment option,” said Dr. Viviano.

WOPN is a potentially deadly condition that occurs in about 15% of patients with severe pancreatitis. Often, the dead tissue must be removed.

The EndoRotor System is made up of a power console, foot control, specimen trap, and single-use catheter.

The device is used to perform endoscopic necrosectomy. In this procedure, a stent is used to create a portal between the stomach and the necrotic cavity in the pancreas to accommodate a standard endoscope through which the EndoRotor cuts and removes necrotized tissue.

The FDA approved the EndoRotor System on the basis of a clinical trial involving 30 patients with WOPN who underwent a total of 63 direct endoscopic necrosectomies with the EndoRotor System (average, 2.1 procedures per patient).

The effectiveness of the EndoRotor System was determined by how well it cleared pancreatic necrotic tissue measured during CT with contrast before and after the procedure, endoscopy, or MRI 14 to 28 days after the last procedure.

Results showed an average 85% reduction in the amount of necrotic tissue, with half of the patients having 98.5% clearance of necrotic tissue, the FDA said.

Three patients suffered procedure-related serious adverse events (10% complication rate). Two patients experienced gastrointestinal bleeding. One patient had a pneumoperitoneum and later died after suffering from sepsis and multiorgan system failure caused by massive collections of infected pancreatic necrotic tissue.

Other serious adverse events, which were thought to be due to the patient’s underlying condition and not related to the device or procedure, included hematemesis, deep vein thrombosis, and pancreatitis.

The EndoRotor System should not be used for patients with known or suspected pancreatic cancer, and the device will carry a boxed warning stating this.

The FDA said it knows of one patient who died from pancreatic cancer 3 months after having necrotic pancreatic tissue removed with the EndoRotor System.

“This patient did not have a diagnosis of pancreatic cancer prior to treatment, although the patient’s outcome is believed to be unrelated to the device or procedure,” the FDA said.

The EndoRotor System should be used only after patients have undergone other procedures to drain the WOPN.

It is also not appropriate for patients with walled-off necrosis who have a documented pseudoaneurysm greater than 1 cm within the cavity or with intervening gastric varices or unavoidable blood vessels within the access tract.

The EndoRotor System was approved under the de novo premarket review pathway for new low- to moderate-risk devices.

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

The Food and Drug Administration has approved the EndoRotor System (Interscope, Inc.) for removal of necrotic tissue in patients with walled-off pancreatic necrosis (WOPN).

“This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled-off pancreatic necrosis,” Charles Viviano, MD, PhD, acting director, Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office, FDA Center for Devices and Radiological Health, said in a statement.

“Currently, in order to remove dead tissue from a patient’s necrotic pancreatic cavity, health care providers need to perform an invasive surgery or use other endoscopic tools not specifically indicated to treat this condition. With [this] marketing authorization, patients with walled-off pancreatic necrosis now have a new treatment option,” said Dr. Viviano.

WOPN is a potentially deadly condition that occurs in about 15% of patients with severe pancreatitis. Often, the dead tissue must be removed.

The EndoRotor System is made up of a power console, foot control, specimen trap, and single-use catheter.

The device is used to perform endoscopic necrosectomy. In this procedure, a stent is used to create a portal between the stomach and the necrotic cavity in the pancreas to accommodate a standard endoscope through which the EndoRotor cuts and removes necrotized tissue.

The FDA approved the EndoRotor System on the basis of a clinical trial involving 30 patients with WOPN who underwent a total of 63 direct endoscopic necrosectomies with the EndoRotor System (average, 2.1 procedures per patient).

The effectiveness of the EndoRotor System was determined by how well it cleared pancreatic necrotic tissue measured during CT with contrast before and after the procedure, endoscopy, or MRI 14 to 28 days after the last procedure.

Results showed an average 85% reduction in the amount of necrotic tissue, with half of the patients having 98.5% clearance of necrotic tissue, the FDA said.

Three patients suffered procedure-related serious adverse events (10% complication rate). Two patients experienced gastrointestinal bleeding. One patient had a pneumoperitoneum and later died after suffering from sepsis and multiorgan system failure caused by massive collections of infected pancreatic necrotic tissue.

Other serious adverse events, which were thought to be due to the patient’s underlying condition and not related to the device or procedure, included hematemesis, deep vein thrombosis, and pancreatitis.

The EndoRotor System should not be used for patients with known or suspected pancreatic cancer, and the device will carry a boxed warning stating this.

The FDA said it knows of one patient who died from pancreatic cancer 3 months after having necrotic pancreatic tissue removed with the EndoRotor System.

“This patient did not have a diagnosis of pancreatic cancer prior to treatment, although the patient’s outcome is believed to be unrelated to the device or procedure,” the FDA said.

The EndoRotor System should be used only after patients have undergone other procedures to drain the WOPN.

It is also not appropriate for patients with walled-off necrosis who have a documented pseudoaneurysm greater than 1 cm within the cavity or with intervening gastric varices or unavoidable blood vessels within the access tract.

The EndoRotor System was approved under the de novo premarket review pathway for new low- to moderate-risk devices.

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

The Food and Drug Administration has approved the EndoRotor System (Interscope, Inc.) for removal of necrotic tissue in patients with walled-off pancreatic necrosis (WOPN).

“This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled-off pancreatic necrosis,” Charles Viviano, MD, PhD, acting director, Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office, FDA Center for Devices and Radiological Health, said in a statement.

“Currently, in order to remove dead tissue from a patient’s necrotic pancreatic cavity, health care providers need to perform an invasive surgery or use other endoscopic tools not specifically indicated to treat this condition. With [this] marketing authorization, patients with walled-off pancreatic necrosis now have a new treatment option,” said Dr. Viviano.

WOPN is a potentially deadly condition that occurs in about 15% of patients with severe pancreatitis. Often, the dead tissue must be removed.

The EndoRotor System is made up of a power console, foot control, specimen trap, and single-use catheter.

The device is used to perform endoscopic necrosectomy. In this procedure, a stent is used to create a portal between the stomach and the necrotic cavity in the pancreas to accommodate a standard endoscope through which the EndoRotor cuts and removes necrotized tissue.

The FDA approved the EndoRotor System on the basis of a clinical trial involving 30 patients with WOPN who underwent a total of 63 direct endoscopic necrosectomies with the EndoRotor System (average, 2.1 procedures per patient).

The effectiveness of the EndoRotor System was determined by how well it cleared pancreatic necrotic tissue measured during CT with contrast before and after the procedure, endoscopy, or MRI 14 to 28 days after the last procedure.

Results showed an average 85% reduction in the amount of necrotic tissue, with half of the patients having 98.5% clearance of necrotic tissue, the FDA said.

Three patients suffered procedure-related serious adverse events (10% complication rate). Two patients experienced gastrointestinal bleeding. One patient had a pneumoperitoneum and later died after suffering from sepsis and multiorgan system failure caused by massive collections of infected pancreatic necrotic tissue.

Other serious adverse events, which were thought to be due to the patient’s underlying condition and not related to the device or procedure, included hematemesis, deep vein thrombosis, and pancreatitis.

The EndoRotor System should not be used for patients with known or suspected pancreatic cancer, and the device will carry a boxed warning stating this.

The FDA said it knows of one patient who died from pancreatic cancer 3 months after having necrotic pancreatic tissue removed with the EndoRotor System.

“This patient did not have a diagnosis of pancreatic cancer prior to treatment, although the patient’s outcome is believed to be unrelated to the device or procedure,” the FDA said.

The EndoRotor System should be used only after patients have undergone other procedures to drain the WOPN.

It is also not appropriate for patients with walled-off necrosis who have a documented pseudoaneurysm greater than 1 cm within the cavity or with intervening gastric varices or unavoidable blood vessels within the access tract.

The EndoRotor System was approved under the de novo premarket review pathway for new low- to moderate-risk devices.

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