Key clinical point: The risk for all-cause and atopic dermatitis (AD)-related hospitalization was significantly lower in adult patients with moderate-to-severe AD who received dupilumab vs. placebo.

Major finding: Risk for all-cause hospitalizations was lower by 62% (risk ratio [RR] 0.38; P < .001) and AD-related hospitalizations by 79% (RR 0.21; P < .001) in patients who received dupilumab vs. placebo.

Study details: Findings are from a post hoc analysis of pooled data from 7 phase 2/3 trials including 2,932 patients with moderate-to-severe AD who were randomly assigned to 300 mg dupilumab (every 2 weeks or weekly) with or without topical corticosteroids or placebo for 12, 16, or 52 weeks.

Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals. The authors declared serving as consultants or receiving grants and honoraria from several sources. Six authors declared being employees or shareholders of Sanofi or Regeneron or Sanofi Genzyme.

Source: Silverberg JI et al. J Allergy Clin Immunol Pract. 2022 (Jan 12). Doi:  10.1016/j.jaip.2021.11.034.

Key clinical point: The risk for all-cause and atopic dermatitis (AD)-related hospitalization was significantly lower in adult patients with moderate-to-severe AD who received dupilumab vs. placebo.

Major finding: Risk for all-cause hospitalizations was lower by 62% (risk ratio [RR] 0.38; P < .001) and AD-related hospitalizations by 79% (RR 0.21; P < .001) in patients who received dupilumab vs. placebo.

Study details: Findings are from a post hoc analysis of pooled data from 7 phase 2/3 trials including 2,932 patients with moderate-to-severe AD who were randomly assigned to 300 mg dupilumab (every 2 weeks or weekly) with or without topical corticosteroids or placebo for 12, 16, or 52 weeks.

Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals. The authors declared serving as consultants or receiving grants and honoraria from several sources. Six authors declared being employees or shareholders of Sanofi or Regeneron or Sanofi Genzyme.

Source: Silverberg JI et al. J Allergy Clin Immunol Pract. 2022 (Jan 12). Doi:  10.1016/j.jaip.2021.11.034.

Key clinical point: The risk for all-cause and atopic dermatitis (AD)-related hospitalization was significantly lower in adult patients with moderate-to-severe AD who received dupilumab vs. placebo.

Major finding: Risk for all-cause hospitalizations was lower by 62% (risk ratio [RR] 0.38; P < .001) and AD-related hospitalizations by 79% (RR 0.21; P < .001) in patients who received dupilumab vs. placebo.

Study details: Findings are from a post hoc analysis of pooled data from 7 phase 2/3 trials including 2,932 patients with moderate-to-severe AD who were randomly assigned to 300 mg dupilumab (every 2 weeks or weekly) with or without topical corticosteroids or placebo for 12, 16, or 52 weeks.

Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals. The authors declared serving as consultants or receiving grants and honoraria from several sources. Six authors declared being employees or shareholders of Sanofi or Regeneron or Sanofi Genzyme.

Source: Silverberg JI et al. J Allergy Clin Immunol Pract. 2022 (Jan 12). Doi:  10.1016/j.jaip.2021.11.034.

Key clinical point: Under real-world settings, dupilumab was an effective and safe therapeutic option for adolescents and adults with moderate-to-severe atopic dermatitis (AD).

Major finding: At least 75% improvement in the Eczema Area and Severity Index was achieved by 53.3% and 79.4% of patients at weeks 12 and 48, respectively. Overall, mild adverse events were reported by 32% of patients, with the most frequent being conjunctivitis, persistent facial erythema, and arthritis/arthralgia.

Study details: Findings are from a nationwide, retrospective 48-week study including 169 patients aged 12 years or older with moderate-to-severe AD who received dupilumab.

Disclosures: This study did not report any source of funding. Some authors declared serving as a speakers and principal investigators or receiving consulting fees, research grants, and honoraria from several sources.

Source: Torres T et al. J Dermatolog Treat. 2022 (Jan 31). Doi: 10.1080/09546634.2022.2035309

Key clinical point: Under real-world settings, dupilumab was an effective and safe therapeutic option for adolescents and adults with moderate-to-severe atopic dermatitis (AD).

Major finding: At least 75% improvement in the Eczema Area and Severity Index was achieved by 53.3% and 79.4% of patients at weeks 12 and 48, respectively. Overall, mild adverse events were reported by 32% of patients, with the most frequent being conjunctivitis, persistent facial erythema, and arthritis/arthralgia.

Study details: Findings are from a nationwide, retrospective 48-week study including 169 patients aged 12 years or older with moderate-to-severe AD who received dupilumab.

Disclosures: This study did not report any source of funding. Some authors declared serving as a speakers and principal investigators or receiving consulting fees, research grants, and honoraria from several sources.

Source: Torres T et al. J Dermatolog Treat. 2022 (Jan 31). Doi: 10.1080/09546634.2022.2035309

Key clinical point: Under real-world settings, dupilumab was an effective and safe therapeutic option for adolescents and adults with moderate-to-severe atopic dermatitis (AD).

Major finding: At least 75% improvement in the Eczema Area and Severity Index was achieved by 53.3% and 79.4% of patients at weeks 12 and 48, respectively. Overall, mild adverse events were reported by 32% of patients, with the most frequent being conjunctivitis, persistent facial erythema, and arthritis/arthralgia.

Study details: Findings are from a nationwide, retrospective 48-week study including 169 patients aged 12 years or older with moderate-to-severe AD who received dupilumab.

Disclosures: This study did not report any source of funding. Some authors declared serving as a speakers and principal investigators or receiving consulting fees, research grants, and honoraria from several sources.

Source: Torres T et al. J Dermatolog Treat. 2022 (Jan 31). Doi: 10.1080/09546634.2022.2035309

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.