Key clinical point: The risk for overall infection was not higher in children and adolescents with moderate-to-severe or severe atopic dermatitis (AD) treated with dupilumab vs. placebo; however, the risk for skin infections was significantly lower with dupilumab.

Major finding: Dupilumab did not increase the risk for overall infections (risk ratio [RR] 0.76; P = .051) and was associated with a reduced risk for total skin infections (RR 0.45; P = .003) compared with placebo.

Study details: This was a pooled analysis of 2 phase 3 trials including 612 adolescents or children with moderate-to-severe/severe AD who received dupilumab either as monotherapy (LIBERTY AD ADOL) or with concomitant topical corticosteroids (LIBERTY AD PEDS).

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. The authors declared serving as investigators, speakers, consultants, and scientific advisors or clinical study investigators, and advisory board members or receiving honoraria and grants from several sources. Six authors declared being employees or shareholders of Sanofi and Regeneron Pharmaceuticals.

Source: Paller AS et al. Pediatr Dermatol. 2022 (Jan 26). Doi: 10.1111/pde.14909

Key clinical point: The risk for overall infection was not higher in children and adolescents with moderate-to-severe or severe atopic dermatitis (AD) treated with dupilumab vs. placebo; however, the risk for skin infections was significantly lower with dupilumab.

Major finding: Dupilumab did not increase the risk for overall infections (risk ratio [RR] 0.76; P = .051) and was associated with a reduced risk for total skin infections (RR 0.45; P = .003) compared with placebo.

Study details: This was a pooled analysis of 2 phase 3 trials including 612 adolescents or children with moderate-to-severe/severe AD who received dupilumab either as monotherapy (LIBERTY AD ADOL) or with concomitant topical corticosteroids (LIBERTY AD PEDS).

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. The authors declared serving as investigators, speakers, consultants, and scientific advisors or clinical study investigators, and advisory board members or receiving honoraria and grants from several sources. Six authors declared being employees or shareholders of Sanofi and Regeneron Pharmaceuticals.

Source: Paller AS et al. Pediatr Dermatol. 2022 (Jan 26). Doi: 10.1111/pde.14909

Key clinical point: The risk for overall infection was not higher in children and adolescents with moderate-to-severe or severe atopic dermatitis (AD) treated with dupilumab vs. placebo; however, the risk for skin infections was significantly lower with dupilumab.

Major finding: Dupilumab did not increase the risk for overall infections (risk ratio [RR] 0.76; P = .051) and was associated with a reduced risk for total skin infections (RR 0.45; P = .003) compared with placebo.

Study details: This was a pooled analysis of 2 phase 3 trials including 612 adolescents or children with moderate-to-severe/severe AD who received dupilumab either as monotherapy (LIBERTY AD ADOL) or with concomitant topical corticosteroids (LIBERTY AD PEDS).

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. The authors declared serving as investigators, speakers, consultants, and scientific advisors or clinical study investigators, and advisory board members or receiving honoraria and grants from several sources. Six authors declared being employees or shareholders of Sanofi and Regeneron Pharmaceuticals.

Source: Paller AS et al. Pediatr Dermatol. 2022 (Jan 26). Doi: 10.1111/pde.14909

Key clinical point: Salivary cortisol levels were neither associated with the severity of atopic dermatitis (AD) nor could measure the stress associated with it.

Major finding: Salivary cortisol levels increased in both symptomatic and asymptomatic patients, but the levels were significantly lower in symptomatic vs. asymptomatic patients (P = .011) and those with severe vs. moderate and mild disease (P = .042). However, the severity of perceived stress could neither be measured by cortisol levels nor by disease severity.

Study details: Findings are from a prospective study including symptomatic (n = 42) and asymptomatic (n =               42) patients with AD.

Disclosures: The study did not report any source of funding. The authors declared no conflicts of interest.

Source: Meštrović-Štefekov  J et al. Dermatitis. 2022 (Jan 25). Doi: 10.1097/DER.0000000000000834.

Key clinical point: Salivary cortisol levels were neither associated with the severity of atopic dermatitis (AD) nor could measure the stress associated with it.

Major finding: Salivary cortisol levels increased in both symptomatic and asymptomatic patients, but the levels were significantly lower in symptomatic vs. asymptomatic patients (P = .011) and those with severe vs. moderate and mild disease (P = .042). However, the severity of perceived stress could neither be measured by cortisol levels nor by disease severity.

Study details: Findings are from a prospective study including symptomatic (n = 42) and asymptomatic (n =               42) patients with AD.

Disclosures: The study did not report any source of funding. The authors declared no conflicts of interest.

Source: Meštrović-Štefekov  J et al. Dermatitis. 2022 (Jan 25). Doi: 10.1097/DER.0000000000000834.

Key clinical point: Salivary cortisol levels were neither associated with the severity of atopic dermatitis (AD) nor could measure the stress associated with it.

Major finding: Salivary cortisol levels increased in both symptomatic and asymptomatic patients, but the levels were significantly lower in symptomatic vs. asymptomatic patients (P = .011) and those with severe vs. moderate and mild disease (P = .042). However, the severity of perceived stress could neither be measured by cortisol levels nor by disease severity.

Study details: Findings are from a prospective study including symptomatic (n = 42) and asymptomatic (n =               42) patients with AD.

Disclosures: The study did not report any source of funding. The authors declared no conflicts of interest.

Source: Meštrović-Štefekov  J et al. Dermatitis. 2022 (Jan 25). Doi: 10.1097/DER.0000000000000834.

Key clinical point: Moderate-to-severe lower respiratory tract infection (LRTI) before 18 months of age is a significant risk factor for developing atopic dermatitis (AD) in later childhood.

Major finding: The group of infants with moderate-severe vs. no or mild LRTI had significantly higher rates of AD at age 3 years (P = .001) and 5 years (P = .006) with moderate-to-severe vs. no LRTI in the first 18 months of life being significantly associated with increased odds of AD in later childhood (odds ratio [OR] 2.19; P < .001) independent of both-parent history of asthma and both-parent genetic predisposition.

Study details: Findings are from the Canadian Healthy Infant Longitudinal Development (CHILD) Cohort Study, comprising a longitudinal birth cohort of 3,272 parents and infants recruited during pregnancy and followed from birth onwards.

Disclosures: This study was funded by the Canadian Institutes of Health Research and Allergy, Genes, and Environment Network of Centers of Excellence. The authors declared no conflicts of interest.

Source: Medeleanu M et al. J Allergy Clin Immunol. 2022 (Jan 16). Doi: 10.1016/j.jacig.2021.12.005

Key clinical point: Moderate-to-severe lower respiratory tract infection (LRTI) before 18 months of age is a significant risk factor for developing atopic dermatitis (AD) in later childhood.

Major finding: The group of infants with moderate-severe vs. no or mild LRTI had significantly higher rates of AD at age 3 years (P = .001) and 5 years (P = .006) with moderate-to-severe vs. no LRTI in the first 18 months of life being significantly associated with increased odds of AD in later childhood (odds ratio [OR] 2.19; P < .001) independent of both-parent history of asthma and both-parent genetic predisposition.

Study details: Findings are from the Canadian Healthy Infant Longitudinal Development (CHILD) Cohort Study, comprising a longitudinal birth cohort of 3,272 parents and infants recruited during pregnancy and followed from birth onwards.

Disclosures: This study was funded by the Canadian Institutes of Health Research and Allergy, Genes, and Environment Network of Centers of Excellence. The authors declared no conflicts of interest.

Source: Medeleanu M et al. J Allergy Clin Immunol. 2022 (Jan 16). Doi: 10.1016/j.jacig.2021.12.005

Key clinical point: Moderate-to-severe lower respiratory tract infection (LRTI) before 18 months of age is a significant risk factor for developing atopic dermatitis (AD) in later childhood.

Major finding: The group of infants with moderate-severe vs. no or mild LRTI had significantly higher rates of AD at age 3 years (P = .001) and 5 years (P = .006) with moderate-to-severe vs. no LRTI in the first 18 months of life being significantly associated with increased odds of AD in later childhood (odds ratio [OR] 2.19; P < .001) independent of both-parent history of asthma and both-parent genetic predisposition.

Study details: Findings are from the Canadian Healthy Infant Longitudinal Development (CHILD) Cohort Study, comprising a longitudinal birth cohort of 3,272 parents and infants recruited during pregnancy and followed from birth onwards.

Disclosures: This study was funded by the Canadian Institutes of Health Research and Allergy, Genes, and Environment Network of Centers of Excellence. The authors declared no conflicts of interest.

Source: Medeleanu M et al. J Allergy Clin Immunol. 2022 (Jan 16). Doi: 10.1016/j.jacig.2021.12.005

Key clinical point: Infections in early life increase the risk of developing atopic dermatitis (AD) later in infancy and early childhood.

Major finding: Prior to AD diagnosis, all infections including skin infection up to 2 years of age were more frequent in patients who subsequently developed AD vs. healthy controls (P < .001), with a significant association observed between having any infection before AD diagnosis and subsequent development of AD (adjusted odds ratio, 1.40; P < .001), which persisted up to 2 years of age.

Study details: Findings are from a population-based, nationwide case-control study including 5,454 patients (mean age 2.6±2.9 years) with AD matched with 16,362 healthy controls without AD.

Disclosures: This study is supported by the Ministry of Science and Technology and Taichung Veterans General Hospital. The authors declared no conflicts of interest.

Source: Lin T-L et al. J Eur Acad Dermatol Venereol. 2022 (Jan 9). Doi: 10.1111/jdv.17908

Key clinical point: Infections in early life increase the risk of developing atopic dermatitis (AD) later in infancy and early childhood.

Major finding: Prior to AD diagnosis, all infections including skin infection up to 2 years of age were more frequent in patients who subsequently developed AD vs. healthy controls (P < .001), with a significant association observed between having any infection before AD diagnosis and subsequent development of AD (adjusted odds ratio, 1.40; P < .001), which persisted up to 2 years of age.

Study details: Findings are from a population-based, nationwide case-control study including 5,454 patients (mean age 2.6±2.9 years) with AD matched with 16,362 healthy controls without AD.

Disclosures: This study is supported by the Ministry of Science and Technology and Taichung Veterans General Hospital. The authors declared no conflicts of interest.

Source: Lin T-L et al. J Eur Acad Dermatol Venereol. 2022 (Jan 9). Doi: 10.1111/jdv.17908

Key clinical point: Infections in early life increase the risk of developing atopic dermatitis (AD) later in infancy and early childhood.

Major finding: Prior to AD diagnosis, all infections including skin infection up to 2 years of age were more frequent in patients who subsequently developed AD vs. healthy controls (P < .001), with a significant association observed between having any infection before AD diagnosis and subsequent development of AD (adjusted odds ratio, 1.40; P < .001), which persisted up to 2 years of age.

Study details: Findings are from a population-based, nationwide case-control study including 5,454 patients (mean age 2.6±2.9 years) with AD matched with 16,362 healthy controls without AD.

Disclosures: This study is supported by the Ministry of Science and Technology and Taichung Veterans General Hospital. The authors declared no conflicts of interest.

Source: Lin T-L et al. J Eur Acad Dermatol Venereol. 2022 (Jan 9). Doi: 10.1111/jdv.17908

Key clinical point: Atopic dermatitis (AD) is prevalent among young adults, with men being at increased odds of having AD in early life and decreased odds of having AD at adolescence and young adulthood.

Major finding: At 24 years, the 12-month prevalence of AD was 17.8%, with the prevalence being higher in women vs. men (20.5% vs. 14.8%; P < .0001). Men vs. women were more likely to have AD in the first year of life (odds ratio [OR] 1.31; 95% CI 1.10-1.56) but less likely to have AD at 24 years (OR 0.66; 95% CI 0.55-0.80).

Study details: This study included 3,055 individuals from the population-based BAMSE cohort, who were followed for 24 years after birth, and responded to a questionnaire regarding AD at the 24-year follow-up.

Disclosures: This study was funded by the European Research Council, Swedish Research Council, Åke Wiberg foundation, and other sources. Some of the authors declared serving as meeting experts or receiving consultancy fees and lecture fees from various sources.

Source: Johansson EK et al. J Eur Acad Dermatol Venereol. 2022 (Jan 15). Doi: 10.1111/jdv.17929

Key clinical point: Atopic dermatitis (AD) is prevalent among young adults, with men being at increased odds of having AD in early life and decreased odds of having AD at adolescence and young adulthood.

Major finding: At 24 years, the 12-month prevalence of AD was 17.8%, with the prevalence being higher in women vs. men (20.5% vs. 14.8%; P < .0001). Men vs. women were more likely to have AD in the first year of life (odds ratio [OR] 1.31; 95% CI 1.10-1.56) but less likely to have AD at 24 years (OR 0.66; 95% CI 0.55-0.80).

Study details: This study included 3,055 individuals from the population-based BAMSE cohort, who were followed for 24 years after birth, and responded to a questionnaire regarding AD at the 24-year follow-up.

Disclosures: This study was funded by the European Research Council, Swedish Research Council, Åke Wiberg foundation, and other sources. Some of the authors declared serving as meeting experts or receiving consultancy fees and lecture fees from various sources.

Source: Johansson EK et al. J Eur Acad Dermatol Venereol. 2022 (Jan 15). Doi: 10.1111/jdv.17929

Key clinical point: Atopic dermatitis (AD) is prevalent among young adults, with men being at increased odds of having AD in early life and decreased odds of having AD at adolescence and young adulthood.

Major finding: At 24 years, the 12-month prevalence of AD was 17.8%, with the prevalence being higher in women vs. men (20.5% vs. 14.8%; P < .0001). Men vs. women were more likely to have AD in the first year of life (odds ratio [OR] 1.31; 95% CI 1.10-1.56) but less likely to have AD at 24 years (OR 0.66; 95% CI 0.55-0.80).

Study details: This study included 3,055 individuals from the population-based BAMSE cohort, who were followed for 24 years after birth, and responded to a questionnaire regarding AD at the 24-year follow-up.

Disclosures: This study was funded by the European Research Council, Swedish Research Council, Åke Wiberg foundation, and other sources. Some of the authors declared serving as meeting experts or receiving consultancy fees and lecture fees from various sources.

Source: Johansson EK et al. J Eur Acad Dermatol Venereol. 2022 (Jan 15). Doi: 10.1111/jdv.17929

Key clinical point: Children with inadequately controlled moderate-to-severe atopic dermatitis (AD) presented with a high disease burden characterized by itch, impaired quality of life (QoL), and disturbed sleep, which may be attributed to lower use of systemic therapies.

Major finding: Most of the children were receiving nonsystemic medications (77.2%) and reported a mean Eczema Area and Severity Index of 14.4 and Patient-Oriented Eczema Measure score of 15.6. Patients aged 6 to <12 years reported an itch score of 4.9; infants (0-3 years) and children (4 to <12 years) reported QoL scores of 10.3 and 10.8, respectively, and 31% of patients reported disturbed sleep because of AD.

Study details: Findings are based on interim baseline data from an ongoing, longitudinal study including 732 children aged <12 years with moderate-to-severe AD.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. The authors declared serving as investigators, consultants, speakers, and advisory board members or receiving research grants and honoraria from various sources. Some authors declared being employees or stockholders of Sanofi Genzyme or Regeneron Pharmaceuticals.

Source: Paller AS et al. J Am Acad Dermatol. 2022 (Jan 23). Doi: 10.1016/j.jaad.2022.01.018

Key clinical point: Children with inadequately controlled moderate-to-severe atopic dermatitis (AD) presented with a high disease burden characterized by itch, impaired quality of life (QoL), and disturbed sleep, which may be attributed to lower use of systemic therapies.

Major finding: Most of the children were receiving nonsystemic medications (77.2%) and reported a mean Eczema Area and Severity Index of 14.4 and Patient-Oriented Eczema Measure score of 15.6. Patients aged 6 to <12 years reported an itch score of 4.9; infants (0-3 years) and children (4 to <12 years) reported QoL scores of 10.3 and 10.8, respectively, and 31% of patients reported disturbed sleep because of AD.

Study details: Findings are based on interim baseline data from an ongoing, longitudinal study including 732 children aged <12 years with moderate-to-severe AD.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. The authors declared serving as investigators, consultants, speakers, and advisory board members or receiving research grants and honoraria from various sources. Some authors declared being employees or stockholders of Sanofi Genzyme or Regeneron Pharmaceuticals.

Source: Paller AS et al. J Am Acad Dermatol. 2022 (Jan 23). Doi: 10.1016/j.jaad.2022.01.018

Key clinical point: Children with inadequately controlled moderate-to-severe atopic dermatitis (AD) presented with a high disease burden characterized by itch, impaired quality of life (QoL), and disturbed sleep, which may be attributed to lower use of systemic therapies.

Major finding: Most of the children were receiving nonsystemic medications (77.2%) and reported a mean Eczema Area and Severity Index of 14.4 and Patient-Oriented Eczema Measure score of 15.6. Patients aged 6 to <12 years reported an itch score of 4.9; infants (0-3 years) and children (4 to <12 years) reported QoL scores of 10.3 and 10.8, respectively, and 31% of patients reported disturbed sleep because of AD.

Study details: Findings are based on interim baseline data from an ongoing, longitudinal study including 732 children aged <12 years with moderate-to-severe AD.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. The authors declared serving as investigators, consultants, speakers, and advisory board members or receiving research grants and honoraria from various sources. Some authors declared being employees or stockholders of Sanofi Genzyme or Regeneron Pharmaceuticals.

Source: Paller AS et al. J Am Acad Dermatol. 2022 (Jan 23). Doi: 10.1016/j.jaad.2022.01.018

Key clinical point: Adults with atopic dermatitis (AD) who received COVID-19 vaccination did not show a higher risk for any assessed adverse events (AE) than those without AD; however, a minimal risk persisted among patients with a 1-year history of immunosuppressive or immunomodulatory therapy.

Major finding: The risk for 1-day immediate AEs, AEs at 30/60/90-day follow-up, and breakthrough infections was similar between vaccinated adults with vs. without AD; however, those who had a 1-year history of immunosuppressant or immunomodulatory therapy were at a higher risk for all-cause hospitalization at 30 days (adjusted hazard ratio [aHR] 2.14; 95% CI 1.27-3.59), 60 days (aHR 1.77; 95% CI 1.22-2.56), and 90 days (aHR 1.68; 95% CI 1.25-2.27) after vaccination.

Study details: Findings are from a retrospective cohort study including 1,262,306 vaccinated adults, of which 1.2% of adults had a history of AD.

Disclosures: This study did not report any source of funding. Some of the authors declared serving as consultants, honoraria speakers, and receiving research funding from several sources.

Source: Pakhchanian H et al. Br J Dermatol. 2022 (Jan 27). Doi: 10.1111/bjd.21038

Key clinical point: Adults with atopic dermatitis (AD) who received COVID-19 vaccination did not show a higher risk for any assessed adverse events (AE) than those without AD; however, a minimal risk persisted among patients with a 1-year history of immunosuppressive or immunomodulatory therapy.

Major finding: The risk for 1-day immediate AEs, AEs at 30/60/90-day follow-up, and breakthrough infections was similar between vaccinated adults with vs. without AD; however, those who had a 1-year history of immunosuppressant or immunomodulatory therapy were at a higher risk for all-cause hospitalization at 30 days (adjusted hazard ratio [aHR] 2.14; 95% CI 1.27-3.59), 60 days (aHR 1.77; 95% CI 1.22-2.56), and 90 days (aHR 1.68; 95% CI 1.25-2.27) after vaccination.

Study details: Findings are from a retrospective cohort study including 1,262,306 vaccinated adults, of which 1.2% of adults had a history of AD.

Disclosures: This study did not report any source of funding. Some of the authors declared serving as consultants, honoraria speakers, and receiving research funding from several sources.

Source: Pakhchanian H et al. Br J Dermatol. 2022 (Jan 27). Doi: 10.1111/bjd.21038

Key clinical point: Adults with atopic dermatitis (AD) who received COVID-19 vaccination did not show a higher risk for any assessed adverse events (AE) than those without AD; however, a minimal risk persisted among patients with a 1-year history of immunosuppressive or immunomodulatory therapy.

Major finding: The risk for 1-day immediate AEs, AEs at 30/60/90-day follow-up, and breakthrough infections was similar between vaccinated adults with vs. without AD; however, those who had a 1-year history of immunosuppressant or immunomodulatory therapy were at a higher risk for all-cause hospitalization at 30 days (adjusted hazard ratio [aHR] 2.14; 95% CI 1.27-3.59), 60 days (aHR 1.77; 95% CI 1.22-2.56), and 90 days (aHR 1.68; 95% CI 1.25-2.27) after vaccination.

Study details: Findings are from a retrospective cohort study including 1,262,306 vaccinated adults, of which 1.2% of adults had a history of AD.

Disclosures: This study did not report any source of funding. Some of the authors declared serving as consultants, honoraria speakers, and receiving research funding from several sources.

Source: Pakhchanian H et al. Br J Dermatol. 2022 (Jan 27). Doi: 10.1111/bjd.21038

Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.

The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.

“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.

“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.

The study was published Feb. 1 in JCO Oncology Practice.

Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.

To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.

White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.

Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.

The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.

Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).

Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.

For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).

Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
 

Risky business?

This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.

“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.

“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.

Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.

“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.

The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.

“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.

Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.

The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.

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

Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.

The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.

“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.

“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.

The study was published Feb. 1 in JCO Oncology Practice.

Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.

To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.

White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.

Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.

The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.

Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).

Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.

For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).

Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
 

Risky business?

This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.

“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.

“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.

Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.

“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.

The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.

“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.

Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.

The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.

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

Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.

The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.

“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.

“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.

The study was published Feb. 1 in JCO Oncology Practice.

Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.

To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.

White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.

Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.

The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.

Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).

Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.

For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).

Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
 

Risky business?

This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.

“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.

“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.

Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.

“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.

The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.

“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.

Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.

The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.

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

In the 2022 Medicare Physician Fee Schedule, the Centers for Medicare and Medicaid Services (CMS) further refined E/M billing by addressing split/shared visits between nonphysician practitioners (such as nurse practitioners and physician assistants) (see https://www.govinfo.gov/content/pkg/FR-2021-11-19/pdf/2021-23972.pdf, pp. 65150-9).

A split/shared visit is “an E/M visit in the facility setting that is performed in part by both a physician and an NPP who are in the same group, in accordance with applicable laws and regulations.” CMS recognized team-based care increased utilization of NPPs in the inpatient setting, typically under physician supervision rather than completely independent NPP practice. NPP-physician team-based care is widely prevalent on critical care, hospitalist, and specialty consultation services.

These new changes from CMS went into effect January 1, 2022. CMS now mandates the practitioner providing the “substantive portion” of the service must bill for the service. For the past 20 years, the substantive portion was largely defined by medical decision making (MDM): the physician often spent less face-to-face and/or non-face-to-face time than the NPP, but the physician could bill for the service based on MDM including a nuanced synthesis of data, and final approvals or revisions to decisions on additional evaluation and treatment. Beginning January 1, 2023, CMS will no longer define MDM as the substantive portion of the visit “because MDM is not necessarily quantifiable and can depend on patient characteristics (for example, risk).” Thus, CMS will define the “substantive portion” of the visit as the practitioner who spent >50% of the total of both face-to-face and non-face-to-face time, on the calendar day. 2022 is a transitional year allowing “the practitioner who spends more than half of the total time, or performs the history, exam, or MDM to be considered to have performed the substantive portion and can bill for the split (or shared) E/M visit.” During 2022, the visit level can be chosen based on MDM or time. In 2023, the visit level can still be chosen based upon MDM, but the billing provider is determined by who performed the “substantive portion” of the visit, which will be exclusively based upon which provider spent the most amount of time.

During 2022, when billing based on time, the practitioner spending the most time (the NPP or the physician) dictates who will be the billing provider. Alternatively, billing based on the substantive portion of the visit allows billing by the provider (NPP or physician) who completely performs the key component (history, physical examination, or medical decision making) that determines the level of the visit. With the new documentation guidelines, MDM is the only key component that can determine the visit level in the office setting. In 2023, only time-based billing will be in effect for choosing the billing provider in the inpatient hospital setting. Most importantly, time-based billing is already the only method for determining the billing provider for billing critical care services, based on the provider (NPP or physician) with the greater individual total of time.

This change represents a major shift in reimbursement for physician-NPP teams. Many physician compensation plans are based on a work relative value unit (wRVU) system. This time-based billing may shift attribution to the NPP and, thereby, disadvantage the physicians working with NPPs as they will no longer receive wRVU credit for team-based care delivery. This shift demands we all reexamine our compensation models, and how organizations attribute work value across their providers (both NPPs and physicians), with special consideration for how to credit physicians for their essential supervision of team-based care delivered and now billed by NPPs. Ideally, options for revising compensation models without changing the care delivery model would preserve the essential partnership between physicians and NPPs.
 

*The CHEST Health Policy and Advocacy Work Group includes Nikki Augustyn, Geoffrey D. Bass, MD, Jamie Cummings, Ian Nathanson, MD, FCCP, Emily Petraglia, Gulshan Sharma, MD, FCCP, Kelly Shriner, and John E. Studdard, MD, FCCP.

In the 2022 Medicare Physician Fee Schedule, the Centers for Medicare and Medicaid Services (CMS) further refined E/M billing by addressing split/shared visits between nonphysician practitioners (such as nurse practitioners and physician assistants) (see https://www.govinfo.gov/content/pkg/FR-2021-11-19/pdf/2021-23972.pdf, pp. 65150-9).

A split/shared visit is “an E/M visit in the facility setting that is performed in part by both a physician and an NPP who are in the same group, in accordance with applicable laws and regulations.” CMS recognized team-based care increased utilization of NPPs in the inpatient setting, typically under physician supervision rather than completely independent NPP practice. NPP-physician team-based care is widely prevalent on critical care, hospitalist, and specialty consultation services.

These new changes from CMS went into effect January 1, 2022. CMS now mandates the practitioner providing the “substantive portion” of the service must bill for the service. For the past 20 years, the substantive portion was largely defined by medical decision making (MDM): the physician often spent less face-to-face and/or non-face-to-face time than the NPP, but the physician could bill for the service based on MDM including a nuanced synthesis of data, and final approvals or revisions to decisions on additional evaluation and treatment. Beginning January 1, 2023, CMS will no longer define MDM as the substantive portion of the visit “because MDM is not necessarily quantifiable and can depend on patient characteristics (for example, risk).” Thus, CMS will define the “substantive portion” of the visit as the practitioner who spent >50% of the total of both face-to-face and non-face-to-face time, on the calendar day. 2022 is a transitional year allowing “the practitioner who spends more than half of the total time, or performs the history, exam, or MDM to be considered to have performed the substantive portion and can bill for the split (or shared) E/M visit.” During 2022, the visit level can be chosen based on MDM or time. In 2023, the visit level can still be chosen based upon MDM, but the billing provider is determined by who performed the “substantive portion” of the visit, which will be exclusively based upon which provider spent the most amount of time.

During 2022, when billing based on time, the practitioner spending the most time (the NPP or the physician) dictates who will be the billing provider. Alternatively, billing based on the substantive portion of the visit allows billing by the provider (NPP or physician) who completely performs the key component (history, physical examination, or medical decision making) that determines the level of the visit. With the new documentation guidelines, MDM is the only key component that can determine the visit level in the office setting. In 2023, only time-based billing will be in effect for choosing the billing provider in the inpatient hospital setting. Most importantly, time-based billing is already the only method for determining the billing provider for billing critical care services, based on the provider (NPP or physician) with the greater individual total of time.

This change represents a major shift in reimbursement for physician-NPP teams. Many physician compensation plans are based on a work relative value unit (wRVU) system. This time-based billing may shift attribution to the NPP and, thereby, disadvantage the physicians working with NPPs as they will no longer receive wRVU credit for team-based care delivery. This shift demands we all reexamine our compensation models, and how organizations attribute work value across their providers (both NPPs and physicians), with special consideration for how to credit physicians for their essential supervision of team-based care delivered and now billed by NPPs. Ideally, options for revising compensation models without changing the care delivery model would preserve the essential partnership between physicians and NPPs.
 

*The CHEST Health Policy and Advocacy Work Group includes Nikki Augustyn, Geoffrey D. Bass, MD, Jamie Cummings, Ian Nathanson, MD, FCCP, Emily Petraglia, Gulshan Sharma, MD, FCCP, Kelly Shriner, and John E. Studdard, MD, FCCP.

In the 2022 Medicare Physician Fee Schedule, the Centers for Medicare and Medicaid Services (CMS) further refined E/M billing by addressing split/shared visits between nonphysician practitioners (such as nurse practitioners and physician assistants) (see https://www.govinfo.gov/content/pkg/FR-2021-11-19/pdf/2021-23972.pdf, pp. 65150-9).

A split/shared visit is “an E/M visit in the facility setting that is performed in part by both a physician and an NPP who are in the same group, in accordance with applicable laws and regulations.” CMS recognized team-based care increased utilization of NPPs in the inpatient setting, typically under physician supervision rather than completely independent NPP practice. NPP-physician team-based care is widely prevalent on critical care, hospitalist, and specialty consultation services.

These new changes from CMS went into effect January 1, 2022. CMS now mandates the practitioner providing the “substantive portion” of the service must bill for the service. For the past 20 years, the substantive portion was largely defined by medical decision making (MDM): the physician often spent less face-to-face and/or non-face-to-face time than the NPP, but the physician could bill for the service based on MDM including a nuanced synthesis of data, and final approvals or revisions to decisions on additional evaluation and treatment. Beginning January 1, 2023, CMS will no longer define MDM as the substantive portion of the visit “because MDM is not necessarily quantifiable and can depend on patient characteristics (for example, risk).” Thus, CMS will define the “substantive portion” of the visit as the practitioner who spent >50% of the total of both face-to-face and non-face-to-face time, on the calendar day. 2022 is a transitional year allowing “the practitioner who spends more than half of the total time, or performs the history, exam, or MDM to be considered to have performed the substantive portion and can bill for the split (or shared) E/M visit.” During 2022, the visit level can be chosen based on MDM or time. In 2023, the visit level can still be chosen based upon MDM, but the billing provider is determined by who performed the “substantive portion” of the visit, which will be exclusively based upon which provider spent the most amount of time.

During 2022, when billing based on time, the practitioner spending the most time (the NPP or the physician) dictates who will be the billing provider. Alternatively, billing based on the substantive portion of the visit allows billing by the provider (NPP or physician) who completely performs the key component (history, physical examination, or medical decision making) that determines the level of the visit. With the new documentation guidelines, MDM is the only key component that can determine the visit level in the office setting. In 2023, only time-based billing will be in effect for choosing the billing provider in the inpatient hospital setting. Most importantly, time-based billing is already the only method for determining the billing provider for billing critical care services, based on the provider (NPP or physician) with the greater individual total of time.

This change represents a major shift in reimbursement for physician-NPP teams. Many physician compensation plans are based on a work relative value unit (wRVU) system. This time-based billing may shift attribution to the NPP and, thereby, disadvantage the physicians working with NPPs as they will no longer receive wRVU credit for team-based care delivery. This shift demands we all reexamine our compensation models, and how organizations attribute work value across their providers (both NPPs and physicians), with special consideration for how to credit physicians for their essential supervision of team-based care delivered and now billed by NPPs. Ideally, options for revising compensation models without changing the care delivery model would preserve the essential partnership between physicians and NPPs.
 

*The CHEST Health Policy and Advocacy Work Group includes Nikki Augustyn, Geoffrey D. Bass, MD, Jamie Cummings, Ian Nathanson, MD, FCCP, Emily Petraglia, Gulshan Sharma, MD, FCCP, Kelly Shriner, and John E. Studdard, MD, FCCP.

Innovative technologies for obesity management, emerging noninvasive diagnostic tools, and the AI revolution in health care are just some of the topics featured at the 2022 AGA Tech Summit, April 14-15, in San Francisco. Registration is now open.

This year’s Summit features a keynote lecture from Rajni Natesan, MD, MBA, chief medical officer for Braid Health, on how the power of data connectivity is being used in the transformation of health care.

The 2022 Summit continues to feature ancillary programs for physician innovators and trainees interested in innovation.

See the next big idea in gastroenterology. The Shark Tank competition is where GI innovators pitch their concepts to a panel of judges. Have an idea you think has potential

Get an exclusive behind-the-scenes tour of the MedTech world through the AGA Innovation Fellows Program. The program connects GI fellows in their third and fourth year, as well as those in advanced endoscopy fellowship programs, with successful physician innovators and industry thought leaders with the goals of sharpening their entrepreneurial talents and introducing careers in GI innovation.

Join the GI innovation community at the AGA Tech Summit and be part of it yourself.

Innovative technologies for obesity management, emerging noninvasive diagnostic tools, and the AI revolution in health care are just some of the topics featured at the 2022 AGA Tech Summit, April 14-15, in San Francisco. Registration is now open.

This year’s Summit features a keynote lecture from Rajni Natesan, MD, MBA, chief medical officer for Braid Health, on how the power of data connectivity is being used in the transformation of health care.

The 2022 Summit continues to feature ancillary programs for physician innovators and trainees interested in innovation.

See the next big idea in gastroenterology. The Shark Tank competition is where GI innovators pitch their concepts to a panel of judges. Have an idea you think has potential

Get an exclusive behind-the-scenes tour of the MedTech world through the AGA Innovation Fellows Program. The program connects GI fellows in their third and fourth year, as well as those in advanced endoscopy fellowship programs, with successful physician innovators and industry thought leaders with the goals of sharpening their entrepreneurial talents and introducing careers in GI innovation.

Join the GI innovation community at the AGA Tech Summit and be part of it yourself.

Innovative technologies for obesity management, emerging noninvasive diagnostic tools, and the AI revolution in health care are just some of the topics featured at the 2022 AGA Tech Summit, April 14-15, in San Francisco. Registration is now open.

This year’s Summit features a keynote lecture from Rajni Natesan, MD, MBA, chief medical officer for Braid Health, on how the power of data connectivity is being used in the transformation of health care.

The 2022 Summit continues to feature ancillary programs for physician innovators and trainees interested in innovation.

See the next big idea in gastroenterology. The Shark Tank competition is where GI innovators pitch their concepts to a panel of judges. Have an idea you think has potential

Get an exclusive behind-the-scenes tour of the MedTech world through the AGA Innovation Fellows Program. The program connects GI fellows in their third and fourth year, as well as those in advanced endoscopy fellowship programs, with successful physician innovators and industry thought leaders with the goals of sharpening their entrepreneurial talents and introducing careers in GI innovation.

Join the GI innovation community at the AGA Tech Summit and be part of it yourself.