Key clinical point: Atopic dermatitis (AD) was associated with an increased burden of a wide range of psychiatric, dermatologic, and extracutaneous comorbidities, increased awareness of which could help better patient management.

Major finding: Compared with control participants, adults with AD were at an increased risk for psychiatric disorders, such as anxiety (odds ratio [OR] 1.44) and obsessive-compulsive disorder (OR 2.01); autoimmune diseases, such as alopecia areata (OR 6.01) and vitiligo (OR 4.44); dermatologic problems, such as cellulitis (OR 2.52); and systemic conditions, such as lymphoid malignancy (OR 1.91), atherosclerosis (OR 1.69), and metabolic syndrome (OR 1.47; all P < .001).

Study details: Findings are a retrospective analysis of 39,779 patients with AD, who were matched with 353,743 control participants from the general population.

Disclosures: The corresponding author Dr. Kwatra received funding from Pfizer and declared serving as an advisory board member, consultant, and investigator for several sources.

Source: Roh YS et al. J Am Acad Dermatol. 2021 (Nov 17). Doi: 10.1016/j.jaad.2021.11.014.

Key clinical point: Atopic dermatitis (AD) was associated with an increased burden of a wide range of psychiatric, dermatologic, and extracutaneous comorbidities, increased awareness of which could help better patient management.

Major finding: Compared with control participants, adults with AD were at an increased risk for psychiatric disorders, such as anxiety (odds ratio [OR] 1.44) and obsessive-compulsive disorder (OR 2.01); autoimmune diseases, such as alopecia areata (OR 6.01) and vitiligo (OR 4.44); dermatologic problems, such as cellulitis (OR 2.52); and systemic conditions, such as lymphoid malignancy (OR 1.91), atherosclerosis (OR 1.69), and metabolic syndrome (OR 1.47; all P < .001).

Study details: Findings are a retrospective analysis of 39,779 patients with AD, who were matched with 353,743 control participants from the general population.

Disclosures: The corresponding author Dr. Kwatra received funding from Pfizer and declared serving as an advisory board member, consultant, and investigator for several sources.

Source: Roh YS et al. J Am Acad Dermatol. 2021 (Nov 17). Doi: 10.1016/j.jaad.2021.11.014.

Key clinical point: Atopic dermatitis (AD) was associated with an increased burden of a wide range of psychiatric, dermatologic, and extracutaneous comorbidities, increased awareness of which could help better patient management.

Major finding: Compared with control participants, adults with AD were at an increased risk for psychiatric disorders, such as anxiety (odds ratio [OR] 1.44) and obsessive-compulsive disorder (OR 2.01); autoimmune diseases, such as alopecia areata (OR 6.01) and vitiligo (OR 4.44); dermatologic problems, such as cellulitis (OR 2.52); and systemic conditions, such as lymphoid malignancy (OR 1.91), atherosclerosis (OR 1.69), and metabolic syndrome (OR 1.47; all P < .001).

Study details: Findings are a retrospective analysis of 39,779 patients with AD, who were matched with 353,743 control participants from the general population.

Disclosures: The corresponding author Dr. Kwatra received funding from Pfizer and declared serving as an advisory board member, consultant, and investigator for several sources.

Source: Roh YS et al. J Am Acad Dermatol. 2021 (Nov 17). Doi: 10.1016/j.jaad.2021.11.014.

Key clinical point: Phototherapy with narrowband (NB) ultraviolet type B (UV-B) light showed high and long-lasting efficacy in atopic dermatitis (AD) with patients with facial involvement and adverse events (AE) responding poorly to the treatment.

Major finding: Overall, 55.4% patients achieved Investigator’s Global Assessment score of 0 and 1 with an overall median response duration of 12 months. Facial involvement (odds ratio [OR] 2.743; P < .001), adverse events (OR 2.366; P = .015), and lower number of treatments (OR 1.017; P = .089) were related with poor response.

Study details: Findings are from a retrospective cohort study of 390 patients with moderate-to-severe AD who were treated with NB-UV-B therapy and followed up for at least 3 years after completing therapy.

Disclosures: This study did not report any funding. The authors declared no conflict of interests.

Source: Ben Mordehai Y et al. Dermatitis. 2021 (Nov 27). Doi: 10.1097/DER.0000000000000810.

Key clinical point: Phototherapy with narrowband (NB) ultraviolet type B (UV-B) light showed high and long-lasting efficacy in atopic dermatitis (AD) with patients with facial involvement and adverse events (AE) responding poorly to the treatment.

Major finding: Overall, 55.4% patients achieved Investigator’s Global Assessment score of 0 and 1 with an overall median response duration of 12 months. Facial involvement (odds ratio [OR] 2.743; P < .001), adverse events (OR 2.366; P = .015), and lower number of treatments (OR 1.017; P = .089) were related with poor response.

Study details: Findings are from a retrospective cohort study of 390 patients with moderate-to-severe AD who were treated with NB-UV-B therapy and followed up for at least 3 years after completing therapy.

Disclosures: This study did not report any funding. The authors declared no conflict of interests.

Source: Ben Mordehai Y et al. Dermatitis. 2021 (Nov 27). Doi: 10.1097/DER.0000000000000810.

Key clinical point: Phototherapy with narrowband (NB) ultraviolet type B (UV-B) light showed high and long-lasting efficacy in atopic dermatitis (AD) with patients with facial involvement and adverse events (AE) responding poorly to the treatment.

Major finding: Overall, 55.4% patients achieved Investigator’s Global Assessment score of 0 and 1 with an overall median response duration of 12 months. Facial involvement (odds ratio [OR] 2.743; P < .001), adverse events (OR 2.366; P = .015), and lower number of treatments (OR 1.017; P = .089) were related with poor response.

Study details: Findings are from a retrospective cohort study of 390 patients with moderate-to-severe AD who were treated with NB-UV-B therapy and followed up for at least 3 years after completing therapy.

Disclosures: This study did not report any funding. The authors declared no conflict of interests.

Source: Ben Mordehai Y et al. Dermatitis. 2021 (Nov 27). Doi: 10.1097/DER.0000000000000810.

Key clinical point: Ocular surface diseases (OSD), particularly conjunctivitis, are prevalent among patients with atopic dermatitis (AD), with the prevalence increasing with AD severity and childhood onset of AD.

Major finding: Of all OSDs, lifetime prevalence was highest for conjunctivitis (66.6%), followed by other OSDs, such as hordeolum (63.5%), blepharitis (11%), and keratitis (9.7%). The lifetime occurrence of conjunctivitis was higher for mild (adjusted odds ratio [aOR] 1.48; 95% CI 1.02-2.14), moderate (aOR 1.73; 95% CI 1.19-2.53), and severe (aOR 2.17; 95% CI 1.42-3.21) AD vs. inactive AD and for childhood-onset vs. adult-onset AD (aOR 1.34; 95% CI 1.16-1.56).

Study details: Findings are from a nationwide, cross-sectional questionnaire-based survey sent to 16,718 patients with AD, of which 7,044 patients responded.

Disclosures: This study was funded by the Kgl. Hofbundtmager Aage Bang Foundation. The authors declared serving as advisory board members, investigators, and consultants or receiving honoraria, grants, and funding from several sources.

Source: Rønnstad ATM et al. J Eur Acad Dermatol Venereol. 2021 (Nov 23). Doi: 10.1111/jdv.17832.

Key clinical point: Ocular surface diseases (OSD), particularly conjunctivitis, are prevalent among patients with atopic dermatitis (AD), with the prevalence increasing with AD severity and childhood onset of AD.

Major finding: Of all OSDs, lifetime prevalence was highest for conjunctivitis (66.6%), followed by other OSDs, such as hordeolum (63.5%), blepharitis (11%), and keratitis (9.7%). The lifetime occurrence of conjunctivitis was higher for mild (adjusted odds ratio [aOR] 1.48; 95% CI 1.02-2.14), moderate (aOR 1.73; 95% CI 1.19-2.53), and severe (aOR 2.17; 95% CI 1.42-3.21) AD vs. inactive AD and for childhood-onset vs. adult-onset AD (aOR 1.34; 95% CI 1.16-1.56).

Study details: Findings are from a nationwide, cross-sectional questionnaire-based survey sent to 16,718 patients with AD, of which 7,044 patients responded.

Disclosures: This study was funded by the Kgl. Hofbundtmager Aage Bang Foundation. The authors declared serving as advisory board members, investigators, and consultants or receiving honoraria, grants, and funding from several sources.

Source: Rønnstad ATM et al. J Eur Acad Dermatol Venereol. 2021 (Nov 23). Doi: 10.1111/jdv.17832.

Key clinical point: Ocular surface diseases (OSD), particularly conjunctivitis, are prevalent among patients with atopic dermatitis (AD), with the prevalence increasing with AD severity and childhood onset of AD.

Major finding: Of all OSDs, lifetime prevalence was highest for conjunctivitis (66.6%), followed by other OSDs, such as hordeolum (63.5%), blepharitis (11%), and keratitis (9.7%). The lifetime occurrence of conjunctivitis was higher for mild (adjusted odds ratio [aOR] 1.48; 95% CI 1.02-2.14), moderate (aOR 1.73; 95% CI 1.19-2.53), and severe (aOR 2.17; 95% CI 1.42-3.21) AD vs. inactive AD and for childhood-onset vs. adult-onset AD (aOR 1.34; 95% CI 1.16-1.56).

Study details: Findings are from a nationwide, cross-sectional questionnaire-based survey sent to 16,718 patients with AD, of which 7,044 patients responded.

Disclosures: This study was funded by the Kgl. Hofbundtmager Aage Bang Foundation. The authors declared serving as advisory board members, investigators, and consultants or receiving honoraria, grants, and funding from several sources.

Source: Rønnstad ATM et al. J Eur Acad Dermatol Venereol. 2021 (Nov 23). Doi: 10.1111/jdv.17832.

Key clinical point: Treatment with once-daily oral abrocitinib led to significantly greater improvements in patient-reported outcomes than placebo in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the patient-oriented eczema measure score improved significantly for 100 mg abrocitinib (least square mean change from baseline [LSM] −9.2) and 200 mg abrocitinib (LSM −12.5) vs. placebo (−5.0; P for both < .0001). A significantly higher proportion of patients receiving abrocitinib, both 200 mg and 100 mg, than placebo reported clinically meaningful improvement in pruritus and symptoms assessment for AD and patient global assessment response (all P < .05).

Study details: Findings are from a phase 3 JADE COMPARE study including 837 patients with moderate-to-severe AD who were randomly assigned to receive 200 mg abrocitinib, 100 mg abrocitinib, dupilumab, or placebo, with background topical therapy.

Disclosures: This study was funded by Pfizer. The authors declared serving as a consultants, speakers, advisors, and investigators or receiving grants from Pfizer and other sources. Six authors declared being employees and shareholders of Pfizer.

Source: Thyssen JP et al. J Eur Acad Dermatol Venereol. 2021 (Nov 15). Doi: 10.1111/jdv.17813.

Key clinical point: Treatment with once-daily oral abrocitinib led to significantly greater improvements in patient-reported outcomes than placebo in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the patient-oriented eczema measure score improved significantly for 100 mg abrocitinib (least square mean change from baseline [LSM] −9.2) and 200 mg abrocitinib (LSM −12.5) vs. placebo (−5.0; P for both < .0001). A significantly higher proportion of patients receiving abrocitinib, both 200 mg and 100 mg, than placebo reported clinically meaningful improvement in pruritus and symptoms assessment for AD and patient global assessment response (all P < .05).

Study details: Findings are from a phase 3 JADE COMPARE study including 837 patients with moderate-to-severe AD who were randomly assigned to receive 200 mg abrocitinib, 100 mg abrocitinib, dupilumab, or placebo, with background topical therapy.

Disclosures: This study was funded by Pfizer. The authors declared serving as a consultants, speakers, advisors, and investigators or receiving grants from Pfizer and other sources. Six authors declared being employees and shareholders of Pfizer.

Source: Thyssen JP et al. J Eur Acad Dermatol Venereol. 2021 (Nov 15). Doi: 10.1111/jdv.17813.

Key clinical point: Treatment with once-daily oral abrocitinib led to significantly greater improvements in patient-reported outcomes than placebo in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the patient-oriented eczema measure score improved significantly for 100 mg abrocitinib (least square mean change from baseline [LSM] −9.2) and 200 mg abrocitinib (LSM −12.5) vs. placebo (−5.0; P for both < .0001). A significantly higher proportion of patients receiving abrocitinib, both 200 mg and 100 mg, than placebo reported clinically meaningful improvement in pruritus and symptoms assessment for AD and patient global assessment response (all P < .05).

Study details: Findings are from a phase 3 JADE COMPARE study including 837 patients with moderate-to-severe AD who were randomly assigned to receive 200 mg abrocitinib, 100 mg abrocitinib, dupilumab, or placebo, with background topical therapy.

Disclosures: This study was funded by Pfizer. The authors declared serving as a consultants, speakers, advisors, and investigators or receiving grants from Pfizer and other sources. Six authors declared being employees and shareholders of Pfizer.

Source: Thyssen JP et al. J Eur Acad Dermatol Venereol. 2021 (Nov 15). Doi: 10.1111/jdv.17813.

Key clinical point: Atopic dermatitis (AD) was associated with shorter height and higher body mass index (BMI) in early childhood, but these associations attenuated as children approached adolescence.

Major finding: AD was associated with a lower mean z-height score (−0.13; P < .001) and higher mean z-BMI score (0.05; P = .008); however, this association attenuated by age 14 and 5.5 years, respectively. Based on World Health Organization growth tables, children with vs. without AD were 0.5 cm shorter and had 0.2 more BMI units at 2 years of age and 0.6 cm shorter with no difference in BMI at 5 years of age.

Study details: Findings are from TARGet Kids!, a prospective, longitudinal cohort study including 10,611 children, of which 1,834 had AD during follow-up.

Disclosures: This study was funded by Women’s College Hospital and the Canadian Institutes of Health Research. Dr. Drucker reported receiving compensation and serving as a paid consultant for several sources.

Source: Nicholas MN et al. JAMA Dermatol. 2021 (Nov 17). Doi: 10.1001/jamadermatol.2021.4529.

Key clinical point: Atopic dermatitis (AD) was associated with shorter height and higher body mass index (BMI) in early childhood, but these associations attenuated as children approached adolescence.

Major finding: AD was associated with a lower mean z-height score (−0.13; P < .001) and higher mean z-BMI score (0.05; P = .008); however, this association attenuated by age 14 and 5.5 years, respectively. Based on World Health Organization growth tables, children with vs. without AD were 0.5 cm shorter and had 0.2 more BMI units at 2 years of age and 0.6 cm shorter with no difference in BMI at 5 years of age.

Study details: Findings are from TARGet Kids!, a prospective, longitudinal cohort study including 10,611 children, of which 1,834 had AD during follow-up.

Disclosures: This study was funded by Women’s College Hospital and the Canadian Institutes of Health Research. Dr. Drucker reported receiving compensation and serving as a paid consultant for several sources.

Source: Nicholas MN et al. JAMA Dermatol. 2021 (Nov 17). Doi: 10.1001/jamadermatol.2021.4529.

Key clinical point: Atopic dermatitis (AD) was associated with shorter height and higher body mass index (BMI) in early childhood, but these associations attenuated as children approached adolescence.

Major finding: AD was associated with a lower mean z-height score (−0.13; P < .001) and higher mean z-BMI score (0.05; P = .008); however, this association attenuated by age 14 and 5.5 years, respectively. Based on World Health Organization growth tables, children with vs. without AD were 0.5 cm shorter and had 0.2 more BMI units at 2 years of age and 0.6 cm shorter with no difference in BMI at 5 years of age.

Study details: Findings are from TARGet Kids!, a prospective, longitudinal cohort study including 10,611 children, of which 1,834 had AD during follow-up.

Disclosures: This study was funded by Women’s College Hospital and the Canadian Institutes of Health Research. Dr. Drucker reported receiving compensation and serving as a paid consultant for several sources.

Source: Nicholas MN et al. JAMA Dermatol. 2021 (Nov 17). Doi: 10.1001/jamadermatol.2021.4529.

The American Diabetes Association’s updated clinical recommendations for 2022 call for wider population screening, along with furthering the trends toward individualization of care use of diabetes technology.

Courtesy Joslin Diabetes Center

The summary of changes from 2021 spans four pages. “Diabetes is a really dynamic field so there is a lot to update which is good. It means progress,” ADA chief science and medical officer Robert A. Gabbay, MD, PhD, told this news organization.

The ADA Standards of Medical Care in Diabetes – 2022 was published Dec. 20, 2021, online as a supplement to Diabetes Care.
 

Screening widened by age, in pregnancy, and for type 1 diabetes

One dramatic change is a drop in age to begin screening all people for prediabetes and diabetes from 45 years to 35 years, regardless of risk factors such as obesity.

“Sadly, there are increasing numbers of people with diabetes and developing diabetes younger,” Dr. Gabbay said.

In August 2021, the U.S. Preventive Services Task Force dropped its recommended age of diabetes screening from 40 to 35 years for people with overweight or obesity, but not universally, as ADA now has.

The ADA made its recommendation independently, Dr. Gabbay noted.

The recommendation for testing pregnant women early in gestation (<15 weeks) for preexisting diabetes was also expanded, from just those with risk factors to consideration of testing all women for undiagnosed diabetes at the time they’re planning pregnancy, and if not then, at the first prenatal visit. Screening for gestational diabetes is then performed at 24-28 weeks.

Again, this is caused by increasing diabetes onset at younger ages, Dr. Gabbay said. “We’re well aware that the number of women who have diabetes and don’t know it and become pregnant is significant and therefore screening early on is important.”

New guidance regarding autoantibody screening in adults suspected of having type 1 diabetes and genetic testing for those who don’t fit typical criteria for either of the two main types are based on the ADA/European Association for the Study of Diabetes joint consensus statement on type 1 diabetes in adults.
 

Individualization of care based on comorbidities, other factors

The concept of individualization of care in diabetes has been emphasized for several years now, but continues to be enhanced with new data and newly available management tools.

Regarding management of type 2 diabetes, several charts have been included to help guide decision-making.

One lists drug-specific and patient factors, including comorbidities, to consider when selecting glucose-lowering medications. A new table depicts a building with four “pillars,” for complication risk reduction, including management of blood pressure, lipids, and glucose, as well as use of agents with cardiovascular and kidney benefit.

“On the type 2 side, the choice of therapy is really guided by several factors. We lay them out in a nice diagram. ... A lot of useful information there compares classes of drugs in order to help clinicians make decisions on what would be the appropriate therapy for a given individual,” Dr. Gabbay said.

An algorithm for pharmacologic treatment includes considerations of weight, hypoglycemia, and cost. Tables are also provided listing average wholesale prices of insulins and noninsulin medications.

A section now entitled “Obesity and weight management for the prevention and treatment of type 2 diabetes” has added content regarding the importance of addressing obesity in diabetes, particularly in the context of the COVID-19 pandemic, and the addition of semaglutide as an approved obesity treatment.

“What we hope is that this engenders a shared decision-making process with the patient to identify what the goals are and then choose the appropriate therapy for those goals,” Dr. Gabbay said.

New information has also been added about management of nonalcoholic fatty liver disease. “I think that’s one of the unrecognized and unaddressed complications of diabetes that we’ll see in the future, particularly as new therapies come out,” Dr. Gabbay predicted.

The section on cardiovascular disease and risk management, endorsed for the fourth year in a row by the American College of Cardiology, includes several new recommendations, including diagnosis of hypertension at a single visit if blood pressure is 180/110 mm Hg or greater, and individualization of blood pressure targets.

Chronic kidney disease management has now been separated from other microvascular complications into a standalone section, with several new updates. Retinopathy, neuropathy, and foot care remain combined in one section.
 

Diabetes technology: Rapidly evolving, access an issue

The new technology section “doubles down on the time in [normal glucose] range (TIR) concept,” but also emphasizes the importance of time below range.

“When we see that, we need to make a therapeutic change. We were concerned that as there’s more and more information and numbers, users might not pick up on what’s important,” Dr. Gabbay noted.

The new standards also provides greater affirmation of the value of continuous glucose monitoring (CGM) for people with both type 1 and type 2 diabetes at any age, with individualized choice of devices.

Access to technology is a “big issue, and something the ADA has really been fighting for, particularly in terms of health disparities,” Dr. Gabbay said, noting that ADA has a new Health Equity Now platform, which includes a “bill of rights” calling for all patients with diabetes to have access to state-of-the-art technologies, including CGM.

Overall, he said, “I think the big picture is diabetes continues to evolve and advance. After careful review of the literature, the standards of care identifies at least four big areas where there are some changes that clinicians need to know about: screening, how to individualize treatment, considerations of comorbidities, and the important role that technology plays.”

Dr. Gabbay is an employee of the ADA.

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

The American Diabetes Association’s updated clinical recommendations for 2022 call for wider population screening, along with furthering the trends toward individualization of care use of diabetes technology.

Courtesy Joslin Diabetes Center

The summary of changes from 2021 spans four pages. “Diabetes is a really dynamic field so there is a lot to update which is good. It means progress,” ADA chief science and medical officer Robert A. Gabbay, MD, PhD, told this news organization.

The ADA Standards of Medical Care in Diabetes – 2022 was published Dec. 20, 2021, online as a supplement to Diabetes Care.
 

Screening widened by age, in pregnancy, and for type 1 diabetes

One dramatic change is a drop in age to begin screening all people for prediabetes and diabetes from 45 years to 35 years, regardless of risk factors such as obesity.

“Sadly, there are increasing numbers of people with diabetes and developing diabetes younger,” Dr. Gabbay said.

In August 2021, the U.S. Preventive Services Task Force dropped its recommended age of diabetes screening from 40 to 35 years for people with overweight or obesity, but not universally, as ADA now has.

The ADA made its recommendation independently, Dr. Gabbay noted.

The recommendation for testing pregnant women early in gestation (<15 weeks) for preexisting diabetes was also expanded, from just those with risk factors to consideration of testing all women for undiagnosed diabetes at the time they’re planning pregnancy, and if not then, at the first prenatal visit. Screening for gestational diabetes is then performed at 24-28 weeks.

Again, this is caused by increasing diabetes onset at younger ages, Dr. Gabbay said. “We’re well aware that the number of women who have diabetes and don’t know it and become pregnant is significant and therefore screening early on is important.”

New guidance regarding autoantibody screening in adults suspected of having type 1 diabetes and genetic testing for those who don’t fit typical criteria for either of the two main types are based on the ADA/European Association for the Study of Diabetes joint consensus statement on type 1 diabetes in adults.
 

Individualization of care based on comorbidities, other factors

The concept of individualization of care in diabetes has been emphasized for several years now, but continues to be enhanced with new data and newly available management tools.

Regarding management of type 2 diabetes, several charts have been included to help guide decision-making.

One lists drug-specific and patient factors, including comorbidities, to consider when selecting glucose-lowering medications. A new table depicts a building with four “pillars,” for complication risk reduction, including management of blood pressure, lipids, and glucose, as well as use of agents with cardiovascular and kidney benefit.

“On the type 2 side, the choice of therapy is really guided by several factors. We lay them out in a nice diagram. ... A lot of useful information there compares classes of drugs in order to help clinicians make decisions on what would be the appropriate therapy for a given individual,” Dr. Gabbay said.

An algorithm for pharmacologic treatment includes considerations of weight, hypoglycemia, and cost. Tables are also provided listing average wholesale prices of insulins and noninsulin medications.

A section now entitled “Obesity and weight management for the prevention and treatment of type 2 diabetes” has added content regarding the importance of addressing obesity in diabetes, particularly in the context of the COVID-19 pandemic, and the addition of semaglutide as an approved obesity treatment.

“What we hope is that this engenders a shared decision-making process with the patient to identify what the goals are and then choose the appropriate therapy for those goals,” Dr. Gabbay said.

New information has also been added about management of nonalcoholic fatty liver disease. “I think that’s one of the unrecognized and unaddressed complications of diabetes that we’ll see in the future, particularly as new therapies come out,” Dr. Gabbay predicted.

The section on cardiovascular disease and risk management, endorsed for the fourth year in a row by the American College of Cardiology, includes several new recommendations, including diagnosis of hypertension at a single visit if blood pressure is 180/110 mm Hg or greater, and individualization of blood pressure targets.

Chronic kidney disease management has now been separated from other microvascular complications into a standalone section, with several new updates. Retinopathy, neuropathy, and foot care remain combined in one section.
 

Diabetes technology: Rapidly evolving, access an issue

The new technology section “doubles down on the time in [normal glucose] range (TIR) concept,” but also emphasizes the importance of time below range.

“When we see that, we need to make a therapeutic change. We were concerned that as there’s more and more information and numbers, users might not pick up on what’s important,” Dr. Gabbay noted.

The new standards also provides greater affirmation of the value of continuous glucose monitoring (CGM) for people with both type 1 and type 2 diabetes at any age, with individualized choice of devices.

Access to technology is a “big issue, and something the ADA has really been fighting for, particularly in terms of health disparities,” Dr. Gabbay said, noting that ADA has a new Health Equity Now platform, which includes a “bill of rights” calling for all patients with diabetes to have access to state-of-the-art technologies, including CGM.

Overall, he said, “I think the big picture is diabetes continues to evolve and advance. After careful review of the literature, the standards of care identifies at least four big areas where there are some changes that clinicians need to know about: screening, how to individualize treatment, considerations of comorbidities, and the important role that technology plays.”

Dr. Gabbay is an employee of the ADA.

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

The American Diabetes Association’s updated clinical recommendations for 2022 call for wider population screening, along with furthering the trends toward individualization of care use of diabetes technology.

Courtesy Joslin Diabetes Center

The summary of changes from 2021 spans four pages. “Diabetes is a really dynamic field so there is a lot to update which is good. It means progress,” ADA chief science and medical officer Robert A. Gabbay, MD, PhD, told this news organization.

The ADA Standards of Medical Care in Diabetes – 2022 was published Dec. 20, 2021, online as a supplement to Diabetes Care.
 

Screening widened by age, in pregnancy, and for type 1 diabetes

One dramatic change is a drop in age to begin screening all people for prediabetes and diabetes from 45 years to 35 years, regardless of risk factors such as obesity.

“Sadly, there are increasing numbers of people with diabetes and developing diabetes younger,” Dr. Gabbay said.

In August 2021, the U.S. Preventive Services Task Force dropped its recommended age of diabetes screening from 40 to 35 years for people with overweight or obesity, but not universally, as ADA now has.

The ADA made its recommendation independently, Dr. Gabbay noted.

The recommendation for testing pregnant women early in gestation (<15 weeks) for preexisting diabetes was also expanded, from just those with risk factors to consideration of testing all women for undiagnosed diabetes at the time they’re planning pregnancy, and if not then, at the first prenatal visit. Screening for gestational diabetes is then performed at 24-28 weeks.

Again, this is caused by increasing diabetes onset at younger ages, Dr. Gabbay said. “We’re well aware that the number of women who have diabetes and don’t know it and become pregnant is significant and therefore screening early on is important.”

New guidance regarding autoantibody screening in adults suspected of having type 1 diabetes and genetic testing for those who don’t fit typical criteria for either of the two main types are based on the ADA/European Association for the Study of Diabetes joint consensus statement on type 1 diabetes in adults.
 

Individualization of care based on comorbidities, other factors

The concept of individualization of care in diabetes has been emphasized for several years now, but continues to be enhanced with new data and newly available management tools.

Regarding management of type 2 diabetes, several charts have been included to help guide decision-making.

One lists drug-specific and patient factors, including comorbidities, to consider when selecting glucose-lowering medications. A new table depicts a building with four “pillars,” for complication risk reduction, including management of blood pressure, lipids, and glucose, as well as use of agents with cardiovascular and kidney benefit.

“On the type 2 side, the choice of therapy is really guided by several factors. We lay them out in a nice diagram. ... A lot of useful information there compares classes of drugs in order to help clinicians make decisions on what would be the appropriate therapy for a given individual,” Dr. Gabbay said.

An algorithm for pharmacologic treatment includes considerations of weight, hypoglycemia, and cost. Tables are also provided listing average wholesale prices of insulins and noninsulin medications.

A section now entitled “Obesity and weight management for the prevention and treatment of type 2 diabetes” has added content regarding the importance of addressing obesity in diabetes, particularly in the context of the COVID-19 pandemic, and the addition of semaglutide as an approved obesity treatment.

“What we hope is that this engenders a shared decision-making process with the patient to identify what the goals are and then choose the appropriate therapy for those goals,” Dr. Gabbay said.

New information has also been added about management of nonalcoholic fatty liver disease. “I think that’s one of the unrecognized and unaddressed complications of diabetes that we’ll see in the future, particularly as new therapies come out,” Dr. Gabbay predicted.

The section on cardiovascular disease and risk management, endorsed for the fourth year in a row by the American College of Cardiology, includes several new recommendations, including diagnosis of hypertension at a single visit if blood pressure is 180/110 mm Hg or greater, and individualization of blood pressure targets.

Chronic kidney disease management has now been separated from other microvascular complications into a standalone section, with several new updates. Retinopathy, neuropathy, and foot care remain combined in one section.
 

Diabetes technology: Rapidly evolving, access an issue

The new technology section “doubles down on the time in [normal glucose] range (TIR) concept,” but also emphasizes the importance of time below range.

“When we see that, we need to make a therapeutic change. We were concerned that as there’s more and more information and numbers, users might not pick up on what’s important,” Dr. Gabbay noted.

The new standards also provides greater affirmation of the value of continuous glucose monitoring (CGM) for people with both type 1 and type 2 diabetes at any age, with individualized choice of devices.

Access to technology is a “big issue, and something the ADA has really been fighting for, particularly in terms of health disparities,” Dr. Gabbay said, noting that ADA has a new Health Equity Now platform, which includes a “bill of rights” calling for all patients with diabetes to have access to state-of-the-art technologies, including CGM.

Overall, he said, “I think the big picture is diabetes continues to evolve and advance. After careful review of the literature, the standards of care identifies at least four big areas where there are some changes that clinicians need to know about: screening, how to individualize treatment, considerations of comorbidities, and the important role that technology plays.”

Dr. Gabbay is an employee of the ADA.

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

Involvement of the head, neck, face, and hands with atopic dermatitis was associated with a significantly higher impact on health-related quality of life and appeared to be associated with more severe AD, according to a large, cross-sectional study of patients with AD.

“While we know that head, neck, face, and hands seem to be significantly affected by patients with AD, there is a limited evidence basis regarding the prevalence and health-related quality of life impact of AD in these areas,” presenting author Lawrence F. Eichenfield, MD, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium.

For the study, Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues evaluated 533 patients from the TARGET-DERM AD cohort, an ongoing, longitudinal, observational study launched in 2019 that captures patients with AD in 44 community or academic sites in the United States.

Adult, adolescent, and pediatric patients with moderate or severe Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores at enrollment were included in the analysis. The researchers used the Patient-Oriented Scoring AD (PO-SCORAD) index to gather information on involvement of the head, neck, face, hands, or other areas, and the Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index/Children’s DLQI (CDLQI) to measure health-related quality of life outcomes.

Of the 533 study participants, 453 (85%) had AD affecting the head, neck, face, hands, and other areas, while 80 (15%) had AD located in other body regions not including the head, neck, face, or hands. About 38% of all patients were using systemic treatments; most were using topical treatments.

Comorbid immune system disorders (including allergic and hypersensitivity disorders) were noted in 44.8% of patients, infections in 32.5%, asthma in 26.5%, hypertension in 18.6%, depression in 15.8%, and anxiety in 12.4%, with similar proportions observed in those with or without head, neck, face, and hand involvement.

However, patients with head, face, neck, and hand involvement, when compared with patients without those affected areas, were more likely to have severe vIGA scores (28.5% vs. 16.3%, P = .02) and a higher median total body surface area affected (15% vs. 10%, P ≤ .01). Also, while bivariable analyses did not detect statistical differences in POEM and DLQI/CDLQI by body region involvement, multivariable-adjusted models showed that patients with head, neck, face, and hand involvement were more than twice as likely to report higher DLQI/CDLQI (odds ratio, 2.09) and POEM (OR, 2.51) scores than those without head, face, neck, and hand involvement.

“These findings highlight the importance of detailed assessment of specific areas affected by AD to personalize treatment approaches to the needs of patients,” Dr. Eichenfield concluded.

Raj Chovatiya MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that the findings confirm clinical suspicions about the unique and heightened impact of facial, head/neck, and hand dermatitis. “These data show that a detailed skin examination is necessary for a complete assessment of AD,” he said. “Future studies should focus on characterizing the optimal treatment approaches for each of these special sites.”

“This is important data,” added primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington. “We need more high-quality studies like this; we need to create long-term longitudinal data to better understand [the impact of AD on] this and other cohorts.”

TARGET-DERM is sponsored by Target RWE. Dr. Eichenfield disclosed that he has served as a consultant to or investigator for numerous pharmaceutical companies. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

Commentary by Robert Sidbury, MD, MPH

Patients with atopic dermatitis (AD) in “visible” areas such as the head, neck, and hands experience a higher impact on their quality of life than those who do not have these areas of involvement. This is a self-evident and unsurprising result but also a particularly important one to document for several reasons. First, evidence-based demonstration of quality-of-life impact is critical as we petition carriers to support the use of newer, more expensive medications. Second, from a topical therapy standpoint, we often use different medications on the head, neck, face, and hands relative to other areas. On the head and neck area we often use either weaker topical steroids to avoid side effects or nonsteroids like topical calcineurin or phosphodiesterase inhibitors; conversely, on the hands we use stronger steroids and are less likely to use nonsteroidal agents that are perceived to be less potent. These data emphasize the need to tailor therapy but ascertain whether standard approaches are satisfactory. If patients are not responding, particularly in these sensitive areas, providers should consider the outsized impact AD may be having on quality of life.

Dr. Sidbury is chief of dermatology at Seattle Children's Hospital and professor, department of pediatrics, University of Washington, Seattle. He is a site principal investigator for dupilumab trials, for which the hospital has a contract with Regeneron.

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

This article was updated 6/10/22.

Involvement of the head, neck, face, and hands with atopic dermatitis was associated with a significantly higher impact on health-related quality of life and appeared to be associated with more severe AD, according to a large, cross-sectional study of patients with AD.

“While we know that head, neck, face, and hands seem to be significantly affected by patients with AD, there is a limited evidence basis regarding the prevalence and health-related quality of life impact of AD in these areas,” presenting author Lawrence F. Eichenfield, MD, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium.

For the study, Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues evaluated 533 patients from the TARGET-DERM AD cohort, an ongoing, longitudinal, observational study launched in 2019 that captures patients with AD in 44 community or academic sites in the United States.

Adult, adolescent, and pediatric patients with moderate or severe Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores at enrollment were included in the analysis. The researchers used the Patient-Oriented Scoring AD (PO-SCORAD) index to gather information on involvement of the head, neck, face, hands, or other areas, and the Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index/Children’s DLQI (CDLQI) to measure health-related quality of life outcomes.

Of the 533 study participants, 453 (85%) had AD affecting the head, neck, face, hands, and other areas, while 80 (15%) had AD located in other body regions not including the head, neck, face, or hands. About 38% of all patients were using systemic treatments; most were using topical treatments.

Comorbid immune system disorders (including allergic and hypersensitivity disorders) were noted in 44.8% of patients, infections in 32.5%, asthma in 26.5%, hypertension in 18.6%, depression in 15.8%, and anxiety in 12.4%, with similar proportions observed in those with or without head, neck, face, and hand involvement.

However, patients with head, face, neck, and hand involvement, when compared with patients without those affected areas, were more likely to have severe vIGA scores (28.5% vs. 16.3%, P = .02) and a higher median total body surface area affected (15% vs. 10%, P ≤ .01). Also, while bivariable analyses did not detect statistical differences in POEM and DLQI/CDLQI by body region involvement, multivariable-adjusted models showed that patients with head, neck, face, and hand involvement were more than twice as likely to report higher DLQI/CDLQI (odds ratio, 2.09) and POEM (OR, 2.51) scores than those without head, face, neck, and hand involvement.

“These findings highlight the importance of detailed assessment of specific areas affected by AD to personalize treatment approaches to the needs of patients,” Dr. Eichenfield concluded.

Raj Chovatiya MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that the findings confirm clinical suspicions about the unique and heightened impact of facial, head/neck, and hand dermatitis. “These data show that a detailed skin examination is necessary for a complete assessment of AD,” he said. “Future studies should focus on characterizing the optimal treatment approaches for each of these special sites.”

“This is important data,” added primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington. “We need more high-quality studies like this; we need to create long-term longitudinal data to better understand [the impact of AD on] this and other cohorts.”

TARGET-DERM is sponsored by Target RWE. Dr. Eichenfield disclosed that he has served as a consultant to or investigator for numerous pharmaceutical companies. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

Commentary by Robert Sidbury, MD, MPH

Patients with atopic dermatitis (AD) in “visible” areas such as the head, neck, and hands experience a higher impact on their quality of life than those who do not have these areas of involvement. This is a self-evident and unsurprising result but also a particularly important one to document for several reasons. First, evidence-based demonstration of quality-of-life impact is critical as we petition carriers to support the use of newer, more expensive medications. Second, from a topical therapy standpoint, we often use different medications on the head, neck, face, and hands relative to other areas. On the head and neck area we often use either weaker topical steroids to avoid side effects or nonsteroids like topical calcineurin or phosphodiesterase inhibitors; conversely, on the hands we use stronger steroids and are less likely to use nonsteroidal agents that are perceived to be less potent. These data emphasize the need to tailor therapy but ascertain whether standard approaches are satisfactory. If patients are not responding, particularly in these sensitive areas, providers should consider the outsized impact AD may be having on quality of life.

Dr. Sidbury is chief of dermatology at Seattle Children's Hospital and professor, department of pediatrics, University of Washington, Seattle. He is a site principal investigator for dupilumab trials, for which the hospital has a contract with Regeneron.

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

This article was updated 6/10/22.

Involvement of the head, neck, face, and hands with atopic dermatitis was associated with a significantly higher impact on health-related quality of life and appeared to be associated with more severe AD, according to a large, cross-sectional study of patients with AD.

“While we know that head, neck, face, and hands seem to be significantly affected by patients with AD, there is a limited evidence basis regarding the prevalence and health-related quality of life impact of AD in these areas,” presenting author Lawrence F. Eichenfield, MD, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium.

For the study, Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues evaluated 533 patients from the TARGET-DERM AD cohort, an ongoing, longitudinal, observational study launched in 2019 that captures patients with AD in 44 community or academic sites in the United States.

Adult, adolescent, and pediatric patients with moderate or severe Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores at enrollment were included in the analysis. The researchers used the Patient-Oriented Scoring AD (PO-SCORAD) index to gather information on involvement of the head, neck, face, hands, or other areas, and the Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index/Children’s DLQI (CDLQI) to measure health-related quality of life outcomes.

Of the 533 study participants, 453 (85%) had AD affecting the head, neck, face, hands, and other areas, while 80 (15%) had AD located in other body regions not including the head, neck, face, or hands. About 38% of all patients were using systemic treatments; most were using topical treatments.

Comorbid immune system disorders (including allergic and hypersensitivity disorders) were noted in 44.8% of patients, infections in 32.5%, asthma in 26.5%, hypertension in 18.6%, depression in 15.8%, and anxiety in 12.4%, with similar proportions observed in those with or without head, neck, face, and hand involvement.

However, patients with head, face, neck, and hand involvement, when compared with patients without those affected areas, were more likely to have severe vIGA scores (28.5% vs. 16.3%, P = .02) and a higher median total body surface area affected (15% vs. 10%, P ≤ .01). Also, while bivariable analyses did not detect statistical differences in POEM and DLQI/CDLQI by body region involvement, multivariable-adjusted models showed that patients with head, neck, face, and hand involvement were more than twice as likely to report higher DLQI/CDLQI (odds ratio, 2.09) and POEM (OR, 2.51) scores than those without head, face, neck, and hand involvement.

“These findings highlight the importance of detailed assessment of specific areas affected by AD to personalize treatment approaches to the needs of patients,” Dr. Eichenfield concluded.

Raj Chovatiya MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that the findings confirm clinical suspicions about the unique and heightened impact of facial, head/neck, and hand dermatitis. “These data show that a detailed skin examination is necessary for a complete assessment of AD,” he said. “Future studies should focus on characterizing the optimal treatment approaches for each of these special sites.”

“This is important data,” added primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington. “We need more high-quality studies like this; we need to create long-term longitudinal data to better understand [the impact of AD on] this and other cohorts.”

TARGET-DERM is sponsored by Target RWE. Dr. Eichenfield disclosed that he has served as a consultant to or investigator for numerous pharmaceutical companies. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

Commentary by Robert Sidbury, MD, MPH

Patients with atopic dermatitis (AD) in “visible” areas such as the head, neck, and hands experience a higher impact on their quality of life than those who do not have these areas of involvement. This is a self-evident and unsurprising result but also a particularly important one to document for several reasons. First, evidence-based demonstration of quality-of-life impact is critical as we petition carriers to support the use of newer, more expensive medications. Second, from a topical therapy standpoint, we often use different medications on the head, neck, face, and hands relative to other areas. On the head and neck area we often use either weaker topical steroids to avoid side effects or nonsteroids like topical calcineurin or phosphodiesterase inhibitors; conversely, on the hands we use stronger steroids and are less likely to use nonsteroidal agents that are perceived to be less potent. These data emphasize the need to tailor therapy but ascertain whether standard approaches are satisfactory. If patients are not responding, particularly in these sensitive areas, providers should consider the outsized impact AD may be having on quality of life.

Dr. Sidbury is chief of dermatology at Seattle Children's Hospital and professor, department of pediatrics, University of Washington, Seattle. He is a site principal investigator for dupilumab trials, for which the hospital has a contract with Regeneron.

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

This article was updated 6/10/22.

Field cancerization and subsequent second cancer in squamous cell carcinoma (SCC) patients was significantly associated with cigarette and alcohol use, based on data from more than 300 individuals.

Cigarette and alcohol use are established risk factors for SCCs of the esophagus, head, and neck, Manabu Moto, MD, of Kyoto University, and colleagues wrote. “In addition, squamous cell carcinoma and squamous dysplastic epithelium develop multifocally in these organs,” in a phenomenon known as field cancerization, but the interaction of multiple dysplastic epithelium with other factors, notably whether cessation of cigarette and alcohol use would reduce risk of SCC, has not been well studied.

In a study published in Gastro Hep Advances, the researchers identified 331 adults with newly diagnosed superficial esophageal SCC who underwent endoscopic resection, and 1,022 healthy controls. Field cancerization was based on the number of Lugol-voiding lesions (LVLs) per endoscopic view according to three groups: grade A, 0 LVLs; grade B, 1-9; or grade C, at least 10. The primary study outcome was a measure of risk factors for the development of LVLs.

“Multiple LVLs are closely associated with inactive aldehyde dehydrogenase 2 (ALDH2) and field cancerization,” the researchers wrote. Before assessing their human subjects, they used a mouse model to investigate whether alcohol intake and abstinence would affect acetaldehyde-induced DNA damage to the esophageal epithelium among individuals with ALDH2 dysfunction.

The researchers found that DNA damage, measured by acetaldehyde-derived DNA adduct levels (via N²-ethylidene-dG), accumulated with alcohol consumption over time, but decreased with alcohol cessation in the mouse model.

For the human part of the study, participants completed a lifestyle survey at entry, with questions about alcohol consumption history, alcohol flushing response, smoking, consumption of high-temperature foods, and consumption of green and yellow vegetables and fruit. Drinking status was divided into five groups: never/rarely (of less than 1 unit/week), light (1-8.9 units/week), moderate (9-17.9 units/week), heavy (18 or more units/week), and ex-drinker, with 1 unit defined as 22 g of ethanol. Smoking was divided into three groups: never (0 pack-years), light (less than 30 pack-years), and heavy (30 or more pack-years). Patients were given educational materials at study entry about the importance of alcohol and smoking cessation, as well as verbal advice to cease these behaviors.

Participants underwent endoscopic surveillance at 3-month intervals for up to 6 months following endoscopic resection.

Overall, increased alcohol consumption was associated with increased risk in development of LVL across all LVL grades; higher grades of LVLs were positively associated with high-intensity alcohol consumption, smoking, flushing, and high-temperature foods, and negatively associated with eating vegetables and fruit.

The risk of LVL grade progression was most strongly associated with increased alcohol consumption and with reported flushing. “The greatest risk was observed in the patients with flushing reactions who consumed an average of 30 units per week in grade C LVL,” with an odds ratio of 534, compared with healthy controls. “Since flushing reaction is caused by accumulation of acetaldehyde due to ALDH2 deficient, our result also means that acetaldehyde is a strong carcinogen in field cancerization.”

Secondary outcomes included the incidence of second primary esophageal SCC and head/neck SCC; these were significantly more prevalent in patients with grade C LVL (cumulative 5-year incidence of 47.1% for ESCC and 13.3% for head and neck SCC). However, alcohol and smoking cessation significantly reduced the development of second primary esophageal SCC (adjusted hazard ratios, 0.47 for alcohol and 0.49 for smoking).

The study findings were limited by several factors including the lack of randomization to noncessation and cessation groups and the inclusion of cancer patients, but not long-term cancer survivors, the researchers noted.

“We believe that our data will be useful to establish a prevention and surveillance strategy for cancer survivors, because the overall prognosis of esophageal cancer and head and neck cancer is still poor,” with a 5-year survival rate of less than 20%, and the results highlight the need to educate cancer survivors on the value of smoking and alcohol cessation, they added.

The study was supported by the National Cancer Center Research and Development Fund 36 by the Ministry of Health, Labour, and Welfare of Japan. The researchers had no financial conflicts to disclose.

Field cancerization and subsequent second cancer in squamous cell carcinoma (SCC) patients was significantly associated with cigarette and alcohol use, based on data from more than 300 individuals.

Cigarette and alcohol use are established risk factors for SCCs of the esophagus, head, and neck, Manabu Moto, MD, of Kyoto University, and colleagues wrote. “In addition, squamous cell carcinoma and squamous dysplastic epithelium develop multifocally in these organs,” in a phenomenon known as field cancerization, but the interaction of multiple dysplastic epithelium with other factors, notably whether cessation of cigarette and alcohol use would reduce risk of SCC, has not been well studied.

In a study published in Gastro Hep Advances, the researchers identified 331 adults with newly diagnosed superficial esophageal SCC who underwent endoscopic resection, and 1,022 healthy controls. Field cancerization was based on the number of Lugol-voiding lesions (LVLs) per endoscopic view according to three groups: grade A, 0 LVLs; grade B, 1-9; or grade C, at least 10. The primary study outcome was a measure of risk factors for the development of LVLs.

“Multiple LVLs are closely associated with inactive aldehyde dehydrogenase 2 (ALDH2) and field cancerization,” the researchers wrote. Before assessing their human subjects, they used a mouse model to investigate whether alcohol intake and abstinence would affect acetaldehyde-induced DNA damage to the esophageal epithelium among individuals with ALDH2 dysfunction.

The researchers found that DNA damage, measured by acetaldehyde-derived DNA adduct levels (via N²-ethylidene-dG), accumulated with alcohol consumption over time, but decreased with alcohol cessation in the mouse model.

For the human part of the study, participants completed a lifestyle survey at entry, with questions about alcohol consumption history, alcohol flushing response, smoking, consumption of high-temperature foods, and consumption of green and yellow vegetables and fruit. Drinking status was divided into five groups: never/rarely (of less than 1 unit/week), light (1-8.9 units/week), moderate (9-17.9 units/week), heavy (18 or more units/week), and ex-drinker, with 1 unit defined as 22 g of ethanol. Smoking was divided into three groups: never (0 pack-years), light (less than 30 pack-years), and heavy (30 or more pack-years). Patients were given educational materials at study entry about the importance of alcohol and smoking cessation, as well as verbal advice to cease these behaviors.

Participants underwent endoscopic surveillance at 3-month intervals for up to 6 months following endoscopic resection.

Overall, increased alcohol consumption was associated with increased risk in development of LVL across all LVL grades; higher grades of LVLs were positively associated with high-intensity alcohol consumption, smoking, flushing, and high-temperature foods, and negatively associated with eating vegetables and fruit.

The risk of LVL grade progression was most strongly associated with increased alcohol consumption and with reported flushing. “The greatest risk was observed in the patients with flushing reactions who consumed an average of 30 units per week in grade C LVL,” with an odds ratio of 534, compared with healthy controls. “Since flushing reaction is caused by accumulation of acetaldehyde due to ALDH2 deficient, our result also means that acetaldehyde is a strong carcinogen in field cancerization.”

Secondary outcomes included the incidence of second primary esophageal SCC and head/neck SCC; these were significantly more prevalent in patients with grade C LVL (cumulative 5-year incidence of 47.1% for ESCC and 13.3% for head and neck SCC). However, alcohol and smoking cessation significantly reduced the development of second primary esophageal SCC (adjusted hazard ratios, 0.47 for alcohol and 0.49 for smoking).

The study findings were limited by several factors including the lack of randomization to noncessation and cessation groups and the inclusion of cancer patients, but not long-term cancer survivors, the researchers noted.

“We believe that our data will be useful to establish a prevention and surveillance strategy for cancer survivors, because the overall prognosis of esophageal cancer and head and neck cancer is still poor,” with a 5-year survival rate of less than 20%, and the results highlight the need to educate cancer survivors on the value of smoking and alcohol cessation, they added.

The study was supported by the National Cancer Center Research and Development Fund 36 by the Ministry of Health, Labour, and Welfare of Japan. The researchers had no financial conflicts to disclose.

Field cancerization and subsequent second cancer in squamous cell carcinoma (SCC) patients was significantly associated with cigarette and alcohol use, based on data from more than 300 individuals.

Cigarette and alcohol use are established risk factors for SCCs of the esophagus, head, and neck, Manabu Moto, MD, of Kyoto University, and colleagues wrote. “In addition, squamous cell carcinoma and squamous dysplastic epithelium develop multifocally in these organs,” in a phenomenon known as field cancerization, but the interaction of multiple dysplastic epithelium with other factors, notably whether cessation of cigarette and alcohol use would reduce risk of SCC, has not been well studied.

In a study published in Gastro Hep Advances, the researchers identified 331 adults with newly diagnosed superficial esophageal SCC who underwent endoscopic resection, and 1,022 healthy controls. Field cancerization was based on the number of Lugol-voiding lesions (LVLs) per endoscopic view according to three groups: grade A, 0 LVLs; grade B, 1-9; or grade C, at least 10. The primary study outcome was a measure of risk factors for the development of LVLs.

“Multiple LVLs are closely associated with inactive aldehyde dehydrogenase 2 (ALDH2) and field cancerization,” the researchers wrote. Before assessing their human subjects, they used a mouse model to investigate whether alcohol intake and abstinence would affect acetaldehyde-induced DNA damage to the esophageal epithelium among individuals with ALDH2 dysfunction.

The researchers found that DNA damage, measured by acetaldehyde-derived DNA adduct levels (via N²-ethylidene-dG), accumulated with alcohol consumption over time, but decreased with alcohol cessation in the mouse model.

For the human part of the study, participants completed a lifestyle survey at entry, with questions about alcohol consumption history, alcohol flushing response, smoking, consumption of high-temperature foods, and consumption of green and yellow vegetables and fruit. Drinking status was divided into five groups: never/rarely (of less than 1 unit/week), light (1-8.9 units/week), moderate (9-17.9 units/week), heavy (18 or more units/week), and ex-drinker, with 1 unit defined as 22 g of ethanol. Smoking was divided into three groups: never (0 pack-years), light (less than 30 pack-years), and heavy (30 or more pack-years). Patients were given educational materials at study entry about the importance of alcohol and smoking cessation, as well as verbal advice to cease these behaviors.

Participants underwent endoscopic surveillance at 3-month intervals for up to 6 months following endoscopic resection.

Overall, increased alcohol consumption was associated with increased risk in development of LVL across all LVL grades; higher grades of LVLs were positively associated with high-intensity alcohol consumption, smoking, flushing, and high-temperature foods, and negatively associated with eating vegetables and fruit.

The risk of LVL grade progression was most strongly associated with increased alcohol consumption and with reported flushing. “The greatest risk was observed in the patients with flushing reactions who consumed an average of 30 units per week in grade C LVL,” with an odds ratio of 534, compared with healthy controls. “Since flushing reaction is caused by accumulation of acetaldehyde due to ALDH2 deficient, our result also means that acetaldehyde is a strong carcinogen in field cancerization.”

Secondary outcomes included the incidence of second primary esophageal SCC and head/neck SCC; these were significantly more prevalent in patients with grade C LVL (cumulative 5-year incidence of 47.1% for ESCC and 13.3% for head and neck SCC). However, alcohol and smoking cessation significantly reduced the development of second primary esophageal SCC (adjusted hazard ratios, 0.47 for alcohol and 0.49 for smoking).

The study findings were limited by several factors including the lack of randomization to noncessation and cessation groups and the inclusion of cancer patients, but not long-term cancer survivors, the researchers noted.

“We believe that our data will be useful to establish a prevention and surveillance strategy for cancer survivors, because the overall prognosis of esophageal cancer and head and neck cancer is still poor,” with a 5-year survival rate of less than 20%, and the results highlight the need to educate cancer survivors on the value of smoking and alcohol cessation, they added.

The study was supported by the National Cancer Center Research and Development Fund 36 by the Ministry of Health, Labour, and Welfare of Japan. The researchers had no financial conflicts to disclose.

According to the Centers for Disease Control and Prevention, lung cancer is the third-most common cancer in the United States and the leading cause of cancer deaths in both men and women. Approximately, 150,000 Americans die every year from this disease.

For many years, no effective screening tests were available for lung cancer. This has changed with the advent of low-dose CT scanning as a screening method. In fact, it has been shown that low-dose CT scan screening can reduce lung cancer deaths by 20%-30% in high-risk populations.

In the United States, low-dose CT scan screening for lung cancer has largely become the norm. In July 2021, CHEST released new clinical guidelines. These guidelines cover 18 evidence-based recommendations as well as inclusion of further evidence regarding the benefits, risks, and use of CT screening.

In doing the risk assessment of low-dose CT scan as a method of lung cancer screening, meta-analyses were performed on evidence obtained through a literature search using PubMed, Embase, and the Cochrane Library. It was concluded that the benefits outweigh the risks as a method of lung cancer screening and can be utilized in reducing lung cancer deaths.

Low-dose CT scan screening was recommended for the following patients:

• Asymptomatic individuals aged 55-77 years with a history of smoking 30 or more pack-years. (This includes those who continue to smoke or who have quit in the previous 15 years. Annual screening is advised.)
• Asymptomatic individuals aged 55-80 years with a history of smoking 20-30 pack-years who either continue to smoke or have quit in the previous 15 years.
• For asymptomatic individuals who do not meet the above criteria but are predicted to benefit based on life-year gained calculations.

Don’t screen these patients

CT scan screening should not be performed on any person who does not meet any of the above three criteria.

Additionally, if a person has significant comorbidities that would limit their life expectancy, it is recommended not to do CT scan screening. Symptomatic patients should have appropriate diagnostic testing rather than screening.

Additional recommendations from the updated guidelines include developing appropriate counseling strategies as well as deciding what constitutes a positive test.

A positive test should be anything that warrants further evaluation rather than a return to annual screening. It was also advised that overtreatment strategies should be implemented. Additionally, smoking cessation treatment should be provided.

CHEST suggested undertaking a comprehensive approach involving multiple specialists including pulmonologists, radiologists, oncologists, etc. Strategies to ensure compliance with annual screening should also be devised, the guidelines say.
 

USPSTF’s updated guidelines

It should be noted that the U.S. Preventative Task Force released their own set of updated guidelines in March 2021. In these guidelines, the age at which lung cancer screening should be started was lowered from 55 years to 50 years.

Also, the USPSTF lowered the minimum required smoking history in order to be screened from 30 to 20 pack-years. Their purpose for doing this was to include more high-risk women as well as minorities.

With the changes, 14.5 million individuals living in the United States would be eligible for lung cancer screening by low-dose CT scan, an increase of 6.5 million people, compared with the previous guidelines.

While only small differences exist between the set of guidelines issued by CHEST and the ones issues by the USPSTF, lung cancer screening is still largely underutilized.

One of the barriers to screening may be patients’ lacking insurance coverage for it. As physicians, we need to advocate for these screening tools to be covered.

Other barriers include lack of patient knowledge regarding low-dose CT scans as a screening tool, patient time, and patient visits with their doctors being too short.
 

Key message

Part of the duties of physicians is to give our patients the best information. We can reduce lung cancer mortality in high risk patients by performing annual low-dose CT scans.

Whichever set of guidelines we chose to follow, we fail our patients if we don’t follow either set of them. The evidence is clear that a low-dose CT scan is a valuable screening tool to add to our practice of medicine.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

According to the Centers for Disease Control and Prevention, lung cancer is the third-most common cancer in the United States and the leading cause of cancer deaths in both men and women. Approximately, 150,000 Americans die every year from this disease.

For many years, no effective screening tests were available for lung cancer. This has changed with the advent of low-dose CT scanning as a screening method. In fact, it has been shown that low-dose CT scan screening can reduce lung cancer deaths by 20%-30% in high-risk populations.

In the United States, low-dose CT scan screening for lung cancer has largely become the norm. In July 2021, CHEST released new clinical guidelines. These guidelines cover 18 evidence-based recommendations as well as inclusion of further evidence regarding the benefits, risks, and use of CT screening.

In doing the risk assessment of low-dose CT scan as a method of lung cancer screening, meta-analyses were performed on evidence obtained through a literature search using PubMed, Embase, and the Cochrane Library. It was concluded that the benefits outweigh the risks as a method of lung cancer screening and can be utilized in reducing lung cancer deaths.

Low-dose CT scan screening was recommended for the following patients:

• Asymptomatic individuals aged 55-77 years with a history of smoking 30 or more pack-years. (This includes those who continue to smoke or who have quit in the previous 15 years. Annual screening is advised.)
• Asymptomatic individuals aged 55-80 years with a history of smoking 20-30 pack-years who either continue to smoke or have quit in the previous 15 years.
• For asymptomatic individuals who do not meet the above criteria but are predicted to benefit based on life-year gained calculations.

Don’t screen these patients

CT scan screening should not be performed on any person who does not meet any of the above three criteria.

Additionally, if a person has significant comorbidities that would limit their life expectancy, it is recommended not to do CT scan screening. Symptomatic patients should have appropriate diagnostic testing rather than screening.

Additional recommendations from the updated guidelines include developing appropriate counseling strategies as well as deciding what constitutes a positive test.

A positive test should be anything that warrants further evaluation rather than a return to annual screening. It was also advised that overtreatment strategies should be implemented. Additionally, smoking cessation treatment should be provided.

CHEST suggested undertaking a comprehensive approach involving multiple specialists including pulmonologists, radiologists, oncologists, etc. Strategies to ensure compliance with annual screening should also be devised, the guidelines say.
 

USPSTF’s updated guidelines

It should be noted that the U.S. Preventative Task Force released their own set of updated guidelines in March 2021. In these guidelines, the age at which lung cancer screening should be started was lowered from 55 years to 50 years.

Also, the USPSTF lowered the minimum required smoking history in order to be screened from 30 to 20 pack-years. Their purpose for doing this was to include more high-risk women as well as minorities.

With the changes, 14.5 million individuals living in the United States would be eligible for lung cancer screening by low-dose CT scan, an increase of 6.5 million people, compared with the previous guidelines.

While only small differences exist between the set of guidelines issued by CHEST and the ones issues by the USPSTF, lung cancer screening is still largely underutilized.

One of the barriers to screening may be patients’ lacking insurance coverage for it. As physicians, we need to advocate for these screening tools to be covered.

Other barriers include lack of patient knowledge regarding low-dose CT scans as a screening tool, patient time, and patient visits with their doctors being too short.
 

Key message

Part of the duties of physicians is to give our patients the best information. We can reduce lung cancer mortality in high risk patients by performing annual low-dose CT scans.

Whichever set of guidelines we chose to follow, we fail our patients if we don’t follow either set of them. The evidence is clear that a low-dose CT scan is a valuable screening tool to add to our practice of medicine.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

According to the Centers for Disease Control and Prevention, lung cancer is the third-most common cancer in the United States and the leading cause of cancer deaths in both men and women. Approximately, 150,000 Americans die every year from this disease.

For many years, no effective screening tests were available for lung cancer. This has changed with the advent of low-dose CT scanning as a screening method. In fact, it has been shown that low-dose CT scan screening can reduce lung cancer deaths by 20%-30% in high-risk populations.

In the United States, low-dose CT scan screening for lung cancer has largely become the norm. In July 2021, CHEST released new clinical guidelines. These guidelines cover 18 evidence-based recommendations as well as inclusion of further evidence regarding the benefits, risks, and use of CT screening.

In doing the risk assessment of low-dose CT scan as a method of lung cancer screening, meta-analyses were performed on evidence obtained through a literature search using PubMed, Embase, and the Cochrane Library. It was concluded that the benefits outweigh the risks as a method of lung cancer screening and can be utilized in reducing lung cancer deaths.

Low-dose CT scan screening was recommended for the following patients:

• Asymptomatic individuals aged 55-77 years with a history of smoking 30 or more pack-years. (This includes those who continue to smoke or who have quit in the previous 15 years. Annual screening is advised.)
• Asymptomatic individuals aged 55-80 years with a history of smoking 20-30 pack-years who either continue to smoke or have quit in the previous 15 years.
• For asymptomatic individuals who do not meet the above criteria but are predicted to benefit based on life-year gained calculations.

Don’t screen these patients

CT scan screening should not be performed on any person who does not meet any of the above three criteria.

Additionally, if a person has significant comorbidities that would limit their life expectancy, it is recommended not to do CT scan screening. Symptomatic patients should have appropriate diagnostic testing rather than screening.

Additional recommendations from the updated guidelines include developing appropriate counseling strategies as well as deciding what constitutes a positive test.

A positive test should be anything that warrants further evaluation rather than a return to annual screening. It was also advised that overtreatment strategies should be implemented. Additionally, smoking cessation treatment should be provided.

CHEST suggested undertaking a comprehensive approach involving multiple specialists including pulmonologists, radiologists, oncologists, etc. Strategies to ensure compliance with annual screening should also be devised, the guidelines say.
 

USPSTF’s updated guidelines

It should be noted that the U.S. Preventative Task Force released their own set of updated guidelines in March 2021. In these guidelines, the age at which lung cancer screening should be started was lowered from 55 years to 50 years.

Also, the USPSTF lowered the minimum required smoking history in order to be screened from 30 to 20 pack-years. Their purpose for doing this was to include more high-risk women as well as minorities.

With the changes, 14.5 million individuals living in the United States would be eligible for lung cancer screening by low-dose CT scan, an increase of 6.5 million people, compared with the previous guidelines.

While only small differences exist between the set of guidelines issued by CHEST and the ones issues by the USPSTF, lung cancer screening is still largely underutilized.

One of the barriers to screening may be patients’ lacking insurance coverage for it. As physicians, we need to advocate for these screening tools to be covered.

Other barriers include lack of patient knowledge regarding low-dose CT scans as a screening tool, patient time, and patient visits with their doctors being too short.
 

Key message

Part of the duties of physicians is to give our patients the best information. We can reduce lung cancer mortality in high risk patients by performing annual low-dose CT scans.

Whichever set of guidelines we chose to follow, we fail our patients if we don’t follow either set of them. The evidence is clear that a low-dose CT scan is a valuable screening tool to add to our practice of medicine.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

The Food and Drug Administration has granted emergency use authorization to Merck’s antiviral drug to treat adults with mild to moderate COVID-19 who are at risk for severe disease.

Similar to FDA authorization of another antiviral pill regimen – ritonavir plus nirmatrelvir, or Paxlovid – granted to Pfizer on Wednesday, molnupiravir (brand name Lagevrio) should be taken early in the course of COVID-19 illness.

Pfizer’s drug is authorized for anyone aged 12 and up. But Merck’s is only for adults aged 18 and older.

Merck filed an application for emergency use authorization with the FDA in October. The company included results of its phase 3 study showing the treatment could lead to a 50% reduction in COVID-19 hospitalizations. Data later showed this efficacy at closer to a 30% reduction. In November, an FDA advisory panel narrowly recommended the agency grant authorization by a 13-10 vote.

Animal studies found the drug may harm a fetus, so it is not recommended for pregnant people, the FDA says. It may be prescribed to a pregnant person only after their doctor determines the benefits outweigh the risks and the patient is told of those risks.

Women who may get pregnant should use a reliable method of birth control if being treated with molnupiravir and for 4 days after the final dose.

Two weapons against COVID

Two antiviral pills could be better than one, at least in terms of making more COVID-19 treatments available in early 2022. It is yet to be seen if the drugmakers will be able to keep up with demand, which could substantially increase with an expected surge in Omicron variant cases.

Ritonavir and molnupiravir join remdesivir (brand name Veklury) as available antivirals to treat COVID-19. Remdesivir is fully approved by the FDA but is given only through an IV to people in the hospital.

Officials point out that COVID-19 treatments in tablet form are more convenient for patients in the United States and across the globe, particularly where IV infusion services may be limited.

In March 2021, experts accurately predicted that the molnupiravir pill would be available by year’s end.

Interestingly, in September, Merck announced the findings of laboratory studies suggesting that molnupiravir would work against variants of SARS-CoV-2 because the agent does not target the virus’s spike protein.

Perhaps in part because of early promising results, the U.S. government announced in November intentions to purchase $1 billion worth of molnupiravir. That new order came on top of $1.2 billion worth of the pills the U.S. ordered in June.

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

The Food and Drug Administration has granted emergency use authorization to Merck’s antiviral drug to treat adults with mild to moderate COVID-19 who are at risk for severe disease.

Similar to FDA authorization of another antiviral pill regimen – ritonavir plus nirmatrelvir, or Paxlovid – granted to Pfizer on Wednesday, molnupiravir (brand name Lagevrio) should be taken early in the course of COVID-19 illness.

Pfizer’s drug is authorized for anyone aged 12 and up. But Merck’s is only for adults aged 18 and older.

Merck filed an application for emergency use authorization with the FDA in October. The company included results of its phase 3 study showing the treatment could lead to a 50% reduction in COVID-19 hospitalizations. Data later showed this efficacy at closer to a 30% reduction. In November, an FDA advisory panel narrowly recommended the agency grant authorization by a 13-10 vote.

Animal studies found the drug may harm a fetus, so it is not recommended for pregnant people, the FDA says. It may be prescribed to a pregnant person only after their doctor determines the benefits outweigh the risks and the patient is told of those risks.

Women who may get pregnant should use a reliable method of birth control if being treated with molnupiravir and for 4 days after the final dose.

Two weapons against COVID

Two antiviral pills could be better than one, at least in terms of making more COVID-19 treatments available in early 2022. It is yet to be seen if the drugmakers will be able to keep up with demand, which could substantially increase with an expected surge in Omicron variant cases.

Ritonavir and molnupiravir join remdesivir (brand name Veklury) as available antivirals to treat COVID-19. Remdesivir is fully approved by the FDA but is given only through an IV to people in the hospital.

Officials point out that COVID-19 treatments in tablet form are more convenient for patients in the United States and across the globe, particularly where IV infusion services may be limited.

In March 2021, experts accurately predicted that the molnupiravir pill would be available by year’s end.

Interestingly, in September, Merck announced the findings of laboratory studies suggesting that molnupiravir would work against variants of SARS-CoV-2 because the agent does not target the virus’s spike protein.

Perhaps in part because of early promising results, the U.S. government announced in November intentions to purchase $1 billion worth of molnupiravir. That new order came on top of $1.2 billion worth of the pills the U.S. ordered in June.

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

The Food and Drug Administration has granted emergency use authorization to Merck’s antiviral drug to treat adults with mild to moderate COVID-19 who are at risk for severe disease.

Similar to FDA authorization of another antiviral pill regimen – ritonavir plus nirmatrelvir, or Paxlovid – granted to Pfizer on Wednesday, molnupiravir (brand name Lagevrio) should be taken early in the course of COVID-19 illness.

Pfizer’s drug is authorized for anyone aged 12 and up. But Merck’s is only for adults aged 18 and older.

Merck filed an application for emergency use authorization with the FDA in October. The company included results of its phase 3 study showing the treatment could lead to a 50% reduction in COVID-19 hospitalizations. Data later showed this efficacy at closer to a 30% reduction. In November, an FDA advisory panel narrowly recommended the agency grant authorization by a 13-10 vote.

Animal studies found the drug may harm a fetus, so it is not recommended for pregnant people, the FDA says. It may be prescribed to a pregnant person only after their doctor determines the benefits outweigh the risks and the patient is told of those risks.

Women who may get pregnant should use a reliable method of birth control if being treated with molnupiravir and for 4 days after the final dose.

Two weapons against COVID

Two antiviral pills could be better than one, at least in terms of making more COVID-19 treatments available in early 2022. It is yet to be seen if the drugmakers will be able to keep up with demand, which could substantially increase with an expected surge in Omicron variant cases.

Ritonavir and molnupiravir join remdesivir (brand name Veklury) as available antivirals to treat COVID-19. Remdesivir is fully approved by the FDA but is given only through an IV to people in the hospital.

Officials point out that COVID-19 treatments in tablet form are more convenient for patients in the United States and across the globe, particularly where IV infusion services may be limited.

In March 2021, experts accurately predicted that the molnupiravir pill would be available by year’s end.

Interestingly, in September, Merck announced the findings of laboratory studies suggesting that molnupiravir would work against variants of SARS-CoV-2 because the agent does not target the virus’s spike protein.

Perhaps in part because of early promising results, the U.S. government announced in November intentions to purchase $1 billion worth of molnupiravir. That new order came on top of $1.2 billion worth of the pills the U.S. ordered in June.

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