Atopic Dermatitis

Key clinical point: Children who were hospitalized for atopic dermatitis (AD) exacerbation had significantly higher serum total IgE levels than those hospitalized for AD-associated infectious complications.

Major finding: Children with AD exacerbation vs an infectious complication had significantly higher mean serum total IgE levels (9603 ± 15,873 vs 3167 ± 5486 kU/L; P = .029). The likelihood of AD exacerbation vs an infectious complication was significantly greater in children with an age-adjusted IgE level (serum total IgE level/maximum reference IgE value for their age) of >4.

Study details: This retrospective chart review study included 68 children hospitalized for AD exacerbations (n = 34) or AD-associated infectious complications (n = 34) over a 17-year period.

Disclosures: This study did not report the source of funding. PY Ong declared serving as a consultant for and receiving research funding from various organizations.

Source: Atwal S, Ong PY. Elevated serum total IgE is associated with eczema exacerbation in children hospitalized for atopic dermatitis. Pediatr Dermatol. 2023 (Jan 19). Doi: 10.1111/pde.15245

Key clinical point: Children who were hospitalized for atopic dermatitis (AD) exacerbation had significantly higher serum total IgE levels than those hospitalized for AD-associated infectious complications.

Major finding: Children with AD exacerbation vs an infectious complication had significantly higher mean serum total IgE levels (9603 ± 15,873 vs 3167 ± 5486 kU/L; P = .029). The likelihood of AD exacerbation vs an infectious complication was significantly greater in children with an age-adjusted IgE level (serum total IgE level/maximum reference IgE value for their age) of >4.

Study details: This retrospective chart review study included 68 children hospitalized for AD exacerbations (n = 34) or AD-associated infectious complications (n = 34) over a 17-year period.

Disclosures: This study did not report the source of funding. PY Ong declared serving as a consultant for and receiving research funding from various organizations.

Source: Atwal S, Ong PY. Elevated serum total IgE is associated with eczema exacerbation in children hospitalized for atopic dermatitis. Pediatr Dermatol. 2023 (Jan 19). Doi: 10.1111/pde.15245

Key clinical point: Children who were hospitalized for atopic dermatitis (AD) exacerbation had significantly higher serum total IgE levels than those hospitalized for AD-associated infectious complications.

Major finding: Children with AD exacerbation vs an infectious complication had significantly higher mean serum total IgE levels (9603 ± 15,873 vs 3167 ± 5486 kU/L; P = .029). The likelihood of AD exacerbation vs an infectious complication was significantly greater in children with an age-adjusted IgE level (serum total IgE level/maximum reference IgE value for their age) of >4.

Study details: This retrospective chart review study included 68 children hospitalized for AD exacerbations (n = 34) or AD-associated infectious complications (n = 34) over a 17-year period.

Disclosures: This study did not report the source of funding. PY Ong declared serving as a consultant for and receiving research funding from various organizations.

Source: Atwal S, Ong PY. Elevated serum total IgE is associated with eczema exacerbation in children hospitalized for atopic dermatitis. Pediatr Dermatol. 2023 (Jan 19). Doi: 10.1111/pde.15245

Key clinical point: Dupilumab demonstrated good 4-year drug survival in patients with moderate-to-severe atopic dermatitis (AD); however, early-onset AD (at <18 years of age) was a risk factor for a shorter drug survival.

Major finding: The 1-, 2-, 3-, and 4-year overall dupilumab drug survival rates were 90.5%, 82.9%, 78.8%, and 76.4%, respectively. Early onset of AD may serve as a significant predictor of shorter overall drug survival (hazard ratio, 1.32; P = .04).

Study details: This real-world prospective cohort study included 363 patients with moderate-to-severe AD who had received dupilumab for ≥4 weeks.

Disclosures: This study did not receive any funding. Some authors declared serving as consultants and/or speakers for various organizations.

Source: Pezzolo E et al. Long-term drug survival of dupilumab and associated predictors in moderate to severe atopic dermatitis: A real-world prospective cohort study. J Eur Acad Dermatol Venereol. 2023 (Jan 20). Doi: 10.1111/jdv.18889

Key clinical point: Dupilumab demonstrated good 4-year drug survival in patients with moderate-to-severe atopic dermatitis (AD); however, early-onset AD (at <18 years of age) was a risk factor for a shorter drug survival.

Major finding: The 1-, 2-, 3-, and 4-year overall dupilumab drug survival rates were 90.5%, 82.9%, 78.8%, and 76.4%, respectively. Early onset of AD may serve as a significant predictor of shorter overall drug survival (hazard ratio, 1.32; P = .04).

Study details: This real-world prospective cohort study included 363 patients with moderate-to-severe AD who had received dupilumab for ≥4 weeks.

Disclosures: This study did not receive any funding. Some authors declared serving as consultants and/or speakers for various organizations.

Source: Pezzolo E et al. Long-term drug survival of dupilumab and associated predictors in moderate to severe atopic dermatitis: A real-world prospective cohort study. J Eur Acad Dermatol Venereol. 2023 (Jan 20). Doi: 10.1111/jdv.18889

Key clinical point: Dupilumab demonstrated good 4-year drug survival in patients with moderate-to-severe atopic dermatitis (AD); however, early-onset AD (at <18 years of age) was a risk factor for a shorter drug survival.

Major finding: The 1-, 2-, 3-, and 4-year overall dupilumab drug survival rates were 90.5%, 82.9%, 78.8%, and 76.4%, respectively. Early onset of AD may serve as a significant predictor of shorter overall drug survival (hazard ratio, 1.32; P = .04).

Study details: This real-world prospective cohort study included 363 patients with moderate-to-severe AD who had received dupilumab for ≥4 weeks.

Disclosures: This study did not receive any funding. Some authors declared serving as consultants and/or speakers for various organizations.

Source: Pezzolo E et al. Long-term drug survival of dupilumab and associated predictors in moderate to severe atopic dermatitis: A real-world prospective cohort study. J Eur Acad Dermatol Venereol. 2023 (Jan 20). Doi: 10.1111/jdv.18889

Key clinical point: Coadjuvant treatment with a specific probiotic preparation reduced disease severity in children and adolescents with atopic dermatitis (AD), as evidenced by a decrease in Scoring of Atopic Dermatitis (SCORAD) and Investigator’s Global Assessment (IGA) scores.

Major finding: At 12 weeks, patients receiving the probiotic preparation vs placebo had a significantly higher rate of achieving at least a 1-point improvement in IGA score (90.5% vs 56.7%; P < .002) and lower SCORAD score (13.52 vs 18.96; P = .041).

Study details: This study included 70 patients aged 4-17 years with AD who were randomly assigned to receive the probiotic preparation (containing Bifidobacterium lactis, Bifidobacterium longum, and Lactobacillus casei; n = 35) or placebo (n = 35) daily for 12 weeks.

Disclosures: This study was funded by Biopolis SL. The authors declared no conflicts of interest.

Source: Feíto-Rodríguez M et al. Randomised double blind placebo controlled clinical trial to evaluate the effect of a mixture of probiotic strains on symptom severity and the use of corticosteroids in children and adolescents with atopic dermatitis. Clin Exp Dermatol. 2023 (Jan 13). Doi: 10.1093/ced/llad007

Key clinical point: Coadjuvant treatment with a specific probiotic preparation reduced disease severity in children and adolescents with atopic dermatitis (AD), as evidenced by a decrease in Scoring of Atopic Dermatitis (SCORAD) and Investigator’s Global Assessment (IGA) scores.

Major finding: At 12 weeks, patients receiving the probiotic preparation vs placebo had a significantly higher rate of achieving at least a 1-point improvement in IGA score (90.5% vs 56.7%; P < .002) and lower SCORAD score (13.52 vs 18.96; P = .041).

Study details: This study included 70 patients aged 4-17 years with AD who were randomly assigned to receive the probiotic preparation (containing Bifidobacterium lactis, Bifidobacterium longum, and Lactobacillus casei; n = 35) or placebo (n = 35) daily for 12 weeks.

Disclosures: This study was funded by Biopolis SL. The authors declared no conflicts of interest.

Source: Feíto-Rodríguez M et al. Randomised double blind placebo controlled clinical trial to evaluate the effect of a mixture of probiotic strains on symptom severity and the use of corticosteroids in children and adolescents with atopic dermatitis. Clin Exp Dermatol. 2023 (Jan 13). Doi: 10.1093/ced/llad007

Key clinical point: Coadjuvant treatment with a specific probiotic preparation reduced disease severity in children and adolescents with atopic dermatitis (AD), as evidenced by a decrease in Scoring of Atopic Dermatitis (SCORAD) and Investigator’s Global Assessment (IGA) scores.

Major finding: At 12 weeks, patients receiving the probiotic preparation vs placebo had a significantly higher rate of achieving at least a 1-point improvement in IGA score (90.5% vs 56.7%; P < .002) and lower SCORAD score (13.52 vs 18.96; P = .041).

Study details: This study included 70 patients aged 4-17 years with AD who were randomly assigned to receive the probiotic preparation (containing Bifidobacterium lactis, Bifidobacterium longum, and Lactobacillus casei; n = 35) or placebo (n = 35) daily for 12 weeks.

Disclosures: This study was funded by Biopolis SL. The authors declared no conflicts of interest.

Source: Feíto-Rodríguez M et al. Randomised double blind placebo controlled clinical trial to evaluate the effect of a mixture of probiotic strains on symptom severity and the use of corticosteroids in children and adolescents with atopic dermatitis. Clin Exp Dermatol. 2023 (Jan 13). Doi: 10.1093/ced/llad007

Key clinical point: Upadacitinib can serve as an effective treatment option for atopic dermatitis (AD) and concomitant hand eczema (HE) in daily practice.

Major finding: At week 16, the mean Eczema Area and Severity Index (EASI) score decreased significantly from 17.2 (at baseline) to 4.8 (P < .001) and 50.0%, 40.6%, 59.3%, and 74.1% of patients achieved EASI-75, an Investigator’s Global Assessment score of (almost) clear, Hand Eczema Severity Index-75, and a score of (almost) clear on the photographic guide, respectively. Adverse events were generally mild in severity.

Study details: This multicenter prospective observational study included 38 patients with AD from the BioDay registry who received once-daily upadacitinib over 16 weeks, of which 32 patients had concomitant HE.

Disclosures: The BioDay registry is funded by Sanofi/Regeneron and others. Some authors declared serving as advisors, speakers, or consultants for or receiving consulting fees from various sources, including the registry funders.

Source: Kamphuis E, Loman L, et al. Experiences from daily practice of upadacitinib treatment on atopic dermatitis with a focus on hand eczema: Results from the BioDay registry. Contact Dermatitis. 2023 (Jan 9). Doi: 10.1111/cod.14276

Key clinical point: Upadacitinib can serve as an effective treatment option for atopic dermatitis (AD) and concomitant hand eczema (HE) in daily practice.

Major finding: At week 16, the mean Eczema Area and Severity Index (EASI) score decreased significantly from 17.2 (at baseline) to 4.8 (P < .001) and 50.0%, 40.6%, 59.3%, and 74.1% of patients achieved EASI-75, an Investigator’s Global Assessment score of (almost) clear, Hand Eczema Severity Index-75, and a score of (almost) clear on the photographic guide, respectively. Adverse events were generally mild in severity.

Study details: This multicenter prospective observational study included 38 patients with AD from the BioDay registry who received once-daily upadacitinib over 16 weeks, of which 32 patients had concomitant HE.

Disclosures: The BioDay registry is funded by Sanofi/Regeneron and others. Some authors declared serving as advisors, speakers, or consultants for or receiving consulting fees from various sources, including the registry funders.

Source: Kamphuis E, Loman L, et al. Experiences from daily practice of upadacitinib treatment on atopic dermatitis with a focus on hand eczema: Results from the BioDay registry. Contact Dermatitis. 2023 (Jan 9). Doi: 10.1111/cod.14276

Key clinical point: Upadacitinib can serve as an effective treatment option for atopic dermatitis (AD) and concomitant hand eczema (HE) in daily practice.

Major finding: At week 16, the mean Eczema Area and Severity Index (EASI) score decreased significantly from 17.2 (at baseline) to 4.8 (P < .001) and 50.0%, 40.6%, 59.3%, and 74.1% of patients achieved EASI-75, an Investigator’s Global Assessment score of (almost) clear, Hand Eczema Severity Index-75, and a score of (almost) clear on the photographic guide, respectively. Adverse events were generally mild in severity.

Study details: This multicenter prospective observational study included 38 patients with AD from the BioDay registry who received once-daily upadacitinib over 16 weeks, of which 32 patients had concomitant HE.

Disclosures: The BioDay registry is funded by Sanofi/Regeneron and others. Some authors declared serving as advisors, speakers, or consultants for or receiving consulting fees from various sources, including the registry funders.

Source: Kamphuis E, Loman L, et al. Experiences from daily practice of upadacitinib treatment on atopic dermatitis with a focus on hand eczema: Results from the BioDay registry. Contact Dermatitis. 2023 (Jan 9). Doi: 10.1111/cod.14276

Key clinical point: Dupilumab provides rapid improvement in atopic dermatitis (AD) signs and symptoms and is well tolerated in patients with moderate-to-severe AD in a real-world setting.

Major finding: At week 12, the percentages of patients who achieved ≥75% improvement in the Eczema Area and Severity Index, an Investigator’s Global Assessment score of 0/1 with a ≥2-point reduction from baseline, and a ≥4-point decrease in itch-numerical rating scale score were 59.4%, 33.0%, and 57.0%, respectively. Adverse event rates were lower than those reported in previous phase 3 trials.

Study details: Findings are from a 12-week analysis of the multicenter prospective real-life study PROLEAD including 828 dupilumab-naive adult patients with moderate-to-severe AD who received dupilumab.

Disclosures: This study was funded by Sanofi. Some authors reported ties with various organizations, including Sanofi. Three authors declared being employees of or holding stock or stock options in Sanofi.

Source: Augustin M et al. Dupilumab demonstrates rapid onset of action in improving signs, symptoms and quality of life in adults with atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Feb 4). Doi: 10.1007/s13555-023-00894-3

Key clinical point: Dupilumab provides rapid improvement in atopic dermatitis (AD) signs and symptoms and is well tolerated in patients with moderate-to-severe AD in a real-world setting.

Major finding: At week 12, the percentages of patients who achieved ≥75% improvement in the Eczema Area and Severity Index, an Investigator’s Global Assessment score of 0/1 with a ≥2-point reduction from baseline, and a ≥4-point decrease in itch-numerical rating scale score were 59.4%, 33.0%, and 57.0%, respectively. Adverse event rates were lower than those reported in previous phase 3 trials.

Study details: Findings are from a 12-week analysis of the multicenter prospective real-life study PROLEAD including 828 dupilumab-naive adult patients with moderate-to-severe AD who received dupilumab.

Disclosures: This study was funded by Sanofi. Some authors reported ties with various organizations, including Sanofi. Three authors declared being employees of or holding stock or stock options in Sanofi.

Source: Augustin M et al. Dupilumab demonstrates rapid onset of action in improving signs, symptoms and quality of life in adults with atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Feb 4). Doi: 10.1007/s13555-023-00894-3

Key clinical point: Dupilumab provides rapid improvement in atopic dermatitis (AD) signs and symptoms and is well tolerated in patients with moderate-to-severe AD in a real-world setting.

Major finding: At week 12, the percentages of patients who achieved ≥75% improvement in the Eczema Area and Severity Index, an Investigator’s Global Assessment score of 0/1 with a ≥2-point reduction from baseline, and a ≥4-point decrease in itch-numerical rating scale score were 59.4%, 33.0%, and 57.0%, respectively. Adverse event rates were lower than those reported in previous phase 3 trials.

Study details: Findings are from a 12-week analysis of the multicenter prospective real-life study PROLEAD including 828 dupilumab-naive adult patients with moderate-to-severe AD who received dupilumab.

Disclosures: This study was funded by Sanofi. Some authors reported ties with various organizations, including Sanofi. Three authors declared being employees of or holding stock or stock options in Sanofi.

Source: Augustin M et al. Dupilumab demonstrates rapid onset of action in improving signs, symptoms and quality of life in adults with atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Feb 4). Doi: 10.1007/s13555-023-00894-3

Key clinical point: Tralokinumab was effective and safe in a real-world cohort of patients with moderate-to-severe atopic dermatitis (AD) who had failed prior systemic therapy.

Major finding: At last review (24 weeks of maximum follow-up), 59% of patients were still on tralokinumab therapy and showed a decrease in the median Numeric Rating Scale Peak Pruritus Score over the past 7 days (from 5 at baseline to 2) but without any change in the median Investigator Global Assessment score. Treatment-related adverse events were mostly mild in severity.

Study details: Findings are from an observational, prospective cohort study including 37 patients aged ≥15 years with moderate-to-severe AD who had failed prior therapy with immunosuppressants, biologics, or a Janus kinase inhibitor and received subcutaneous tralokinumab.

Disclosures: This study did not receive any funding. DJ Hijnen declared serving as an investigator for and receiving consulting fees from various sources.

Source: Schlösser AR et al. Tralokinumab for moderate-to-severe atopic dermatitis patients: First daily practice results. Clin Exp Dermatol. 2023 (Jan 26). Doi: 10.1093/ced/llad038

Key clinical point: Tralokinumab was effective and safe in a real-world cohort of patients with moderate-to-severe atopic dermatitis (AD) who had failed prior systemic therapy.

Major finding: At last review (24 weeks of maximum follow-up), 59% of patients were still on tralokinumab therapy and showed a decrease in the median Numeric Rating Scale Peak Pruritus Score over the past 7 days (from 5 at baseline to 2) but without any change in the median Investigator Global Assessment score. Treatment-related adverse events were mostly mild in severity.

Study details: Findings are from an observational, prospective cohort study including 37 patients aged ≥15 years with moderate-to-severe AD who had failed prior therapy with immunosuppressants, biologics, or a Janus kinase inhibitor and received subcutaneous tralokinumab.

Disclosures: This study did not receive any funding. DJ Hijnen declared serving as an investigator for and receiving consulting fees from various sources.

Source: Schlösser AR et al. Tralokinumab for moderate-to-severe atopic dermatitis patients: First daily practice results. Clin Exp Dermatol. 2023 (Jan 26). Doi: 10.1093/ced/llad038

Key clinical point: Tralokinumab was effective and safe in a real-world cohort of patients with moderate-to-severe atopic dermatitis (AD) who had failed prior systemic therapy.

Major finding: At last review (24 weeks of maximum follow-up), 59% of patients were still on tralokinumab therapy and showed a decrease in the median Numeric Rating Scale Peak Pruritus Score over the past 7 days (from 5 at baseline to 2) but without any change in the median Investigator Global Assessment score. Treatment-related adverse events were mostly mild in severity.

Study details: Findings are from an observational, prospective cohort study including 37 patients aged ≥15 years with moderate-to-severe AD who had failed prior therapy with immunosuppressants, biologics, or a Janus kinase inhibitor and received subcutaneous tralokinumab.

Disclosures: This study did not receive any funding. DJ Hijnen declared serving as an investigator for and receiving consulting fees from various sources.

Source: Schlösser AR et al. Tralokinumab for moderate-to-severe atopic dermatitis patients: First daily practice results. Clin Exp Dermatol. 2023 (Jan 26). Doi: 10.1093/ced/llad038

Key clinical point: Tralokinumab was effective and safe in a real-world cohort of patients with moderate-to-severe atopic dermatitis (AD) who had failed prior systemic therapy.

Major finding: At last review (24 weeks of maximum follow-up), 59% of patients were still on tralokinumab therapy and showed a decrease in the median Numeric Rating Scale Peak Pruritus Score over the past 7 days (from 5 at baseline to 2) but without any change in the median Investigator Global Assessment score. Treatment-related adverse events were mostly mild in severity.

Study details: Findings are from an observational, prospective cohort study including 37 patients aged ≥15 years with moderate-to-severe AD who had failed prior therapy with immunosuppressants, biologics, or a Janus kinase inhibitor and received subcutaneous tralokinumab.

Disclosures: This study did not receive any funding. DJ Hijnen declared serving as an investigator for and receiving consulting fees from various sources.

Source: Schlösser AR et al. Tralokinumab for moderate-to-severe atopic dermatitis patients: First daily practice results. Clin Exp Dermatol. 2023 (Jan 26). Doi: 10.1093/ced/llad038

Key clinical point: Tralokinumab was effective and safe in a real-world cohort of patients with moderate-to-severe atopic dermatitis (AD) who had failed prior systemic therapy.

Major finding: At last review (24 weeks of maximum follow-up), 59% of patients were still on tralokinumab therapy and showed a decrease in the median Numeric Rating Scale Peak Pruritus Score over the past 7 days (from 5 at baseline to 2) but without any change in the median Investigator Global Assessment score. Treatment-related adverse events were mostly mild in severity.

Study details: Findings are from an observational, prospective cohort study including 37 patients aged ≥15 years with moderate-to-severe AD who had failed prior therapy with immunosuppressants, biologics, or a Janus kinase inhibitor and received subcutaneous tralokinumab.

Disclosures: This study did not receive any funding. DJ Hijnen declared serving as an investigator for and receiving consulting fees from various sources.

Source: Schlösser AR et al. Tralokinumab for moderate-to-severe atopic dermatitis patients: First daily practice results. Clin Exp Dermatol. 2023 (Jan 26). Doi: 10.1093/ced/llad038

Key clinical point: Tralokinumab was effective and safe in a real-world cohort of patients with moderate-to-severe atopic dermatitis (AD) who had failed prior systemic therapy.

Major finding: At last review (24 weeks of maximum follow-up), 59% of patients were still on tralokinumab therapy and showed a decrease in the median Numeric Rating Scale Peak Pruritus Score over the past 7 days (from 5 at baseline to 2) but without any change in the median Investigator Global Assessment score. Treatment-related adverse events were mostly mild in severity.

Study details: Findings are from an observational, prospective cohort study including 37 patients aged ≥15 years with moderate-to-severe AD who had failed prior therapy with immunosuppressants, biologics, or a Janus kinase inhibitor and received subcutaneous tralokinumab.

Disclosures: This study did not receive any funding. DJ Hijnen declared serving as an investigator for and receiving consulting fees from various sources.

Source: Schlösser AR et al. Tralokinumab for moderate-to-severe atopic dermatitis patients: First daily practice results. Clin Exp Dermatol. 2023 (Jan 26). Doi: 10.1093/ced/llad038

Key clinical point: Children born by cesarean section or instrumental vaginal delivery are at a greater risk of developing atopic dermatitis (AD) compared with those born by uncomplicated vaginal delivery.

Major finding: Children aged <1 year born by instrumental vaginal delivery (adjusted hazard ratio [aHR] 1.10; 95% CI 1.07-1.13), emergency cesarean section (aHR 1.12; 95% CI 1.10-1.15), and elective caesarean section (aHR 1.13; 95% CI 1.10-1.16) were at a higher risk for AD compared with those born by uncomplicated vaginal delivery, with the risk being similar in children aged ≥1 year.

Study details: This prospective population-based study included 1,399,406 children aged ≤5 years with available information on the mode of delivery and mother's identity.

Disclosures: This study was supported by the Swedish Research Council, Swedish Heart-Lung Foundation, and Stiftelsen Frimurare Barnhuset i Stockholm. The authors declared no conflicts of interest.

Source: Mubanga M et al. Mode of delivery and offspring atopic dermatitis in a Swedish nationwide study. Pediatr Allergy Immunol. 2023;34(1):e13904 (Jan 11). Doi: 10.1111/pai.13904

Key clinical point: Children born by cesarean section or instrumental vaginal delivery are at a greater risk of developing atopic dermatitis (AD) compared with those born by uncomplicated vaginal delivery.

Major finding: Children aged <1 year born by instrumental vaginal delivery (adjusted hazard ratio [aHR] 1.10; 95% CI 1.07-1.13), emergency cesarean section (aHR 1.12; 95% CI 1.10-1.15), and elective caesarean section (aHR 1.13; 95% CI 1.10-1.16) were at a higher risk for AD compared with those born by uncomplicated vaginal delivery, with the risk being similar in children aged ≥1 year.

Study details: This prospective population-based study included 1,399,406 children aged ≤5 years with available information on the mode of delivery and mother's identity.

Disclosures: This study was supported by the Swedish Research Council, Swedish Heart-Lung Foundation, and Stiftelsen Frimurare Barnhuset i Stockholm. The authors declared no conflicts of interest.

Source: Mubanga M et al. Mode of delivery and offspring atopic dermatitis in a Swedish nationwide study. Pediatr Allergy Immunol. 2023;34(1):e13904 (Jan 11). Doi: 10.1111/pai.13904

Key clinical point: Children born by cesarean section or instrumental vaginal delivery are at a greater risk of developing atopic dermatitis (AD) compared with those born by uncomplicated vaginal delivery.

Major finding: Children aged <1 year born by instrumental vaginal delivery (adjusted hazard ratio [aHR] 1.10; 95% CI 1.07-1.13), emergency cesarean section (aHR 1.12; 95% CI 1.10-1.15), and elective caesarean section (aHR 1.13; 95% CI 1.10-1.16) were at a higher risk for AD compared with those born by uncomplicated vaginal delivery, with the risk being similar in children aged ≥1 year.

Study details: This prospective population-based study included 1,399,406 children aged ≤5 years with available information on the mode of delivery and mother's identity.

Disclosures: This study was supported by the Swedish Research Council, Swedish Heart-Lung Foundation, and Stiftelsen Frimurare Barnhuset i Stockholm. The authors declared no conflicts of interest.

Source: Mubanga M et al. Mode of delivery and offspring atopic dermatitis in a Swedish nationwide study. Pediatr Allergy Immunol. 2023;34(1):e13904 (Jan 11). Doi: 10.1111/pai.13904

Key clinical point: Dupilumab with or without concomitant topical corticosteroids (TCS) was safe and provided rapid and sustained improvements in atopic dermatitis (AD) signs and symptoms in patients with erythrodermic AD.

Major finding: At week 16, dupilumab without and with concomitant TCS vs placebo provided significant improvements in the percentage of AD-affected body surface area (P = .02 and P < .001, respectively), Eczema Area and Severity Index score (P = .002 and P < .001, respectively), and Peak Pruritus Numerical Rating Scale score (P < .001 and P = .002, respectively), with improvements observed from week 1. Most treatment-emergent adverse events were mild or moderate in severity.

Study details: This post hoc analysis of six multicenter randomized trials included 209 patients with erythrodermic AD who were randomly assigned to receive dupilumab or placebo (both with or without concomitant TCS).

Disclosures: This study was funded by Sanofi-Regeneron Pharmaceuticals Inc. Some authors reported ties with various organizations, including Sanofi/Regeneron. Four authors declared being employees of or holding stock or stock options in Sanofi/Regeneron.

Source: Paller AS et al. Efficacy and safety of dupilumab in patients with erythrodermic atopic dermatitis: A post hoc analysis of 6 randomized clinical trials. JAMA Dermatol. 2023 (Feb 1). Doi: 10.1001/jamadermatol.2022.6192

Key clinical point: Dupilumab with or without concomitant topical corticosteroids (TCS) was safe and provided rapid and sustained improvements in atopic dermatitis (AD) signs and symptoms in patients with erythrodermic AD.

Major finding: At week 16, dupilumab without and with concomitant TCS vs placebo provided significant improvements in the percentage of AD-affected body surface area (P = .02 and P < .001, respectively), Eczema Area and Severity Index score (P = .002 and P < .001, respectively), and Peak Pruritus Numerical Rating Scale score (P < .001 and P = .002, respectively), with improvements observed from week 1. Most treatment-emergent adverse events were mild or moderate in severity.

Study details: This post hoc analysis of six multicenter randomized trials included 209 patients with erythrodermic AD who were randomly assigned to receive dupilumab or placebo (both with or without concomitant TCS).

Disclosures: This study was funded by Sanofi-Regeneron Pharmaceuticals Inc. Some authors reported ties with various organizations, including Sanofi/Regeneron. Four authors declared being employees of or holding stock or stock options in Sanofi/Regeneron.

Source: Paller AS et al. Efficacy and safety of dupilumab in patients with erythrodermic atopic dermatitis: A post hoc analysis of 6 randomized clinical trials. JAMA Dermatol. 2023 (Feb 1). Doi: 10.1001/jamadermatol.2022.6192

Key clinical point: Dupilumab with or without concomitant topical corticosteroids (TCS) was safe and provided rapid and sustained improvements in atopic dermatitis (AD) signs and symptoms in patients with erythrodermic AD.

Major finding: At week 16, dupilumab without and with concomitant TCS vs placebo provided significant improvements in the percentage of AD-affected body surface area (P = .02 and P < .001, respectively), Eczema Area and Severity Index score (P = .002 and P < .001, respectively), and Peak Pruritus Numerical Rating Scale score (P < .001 and P = .002, respectively), with improvements observed from week 1. Most treatment-emergent adverse events were mild or moderate in severity.

Study details: This post hoc analysis of six multicenter randomized trials included 209 patients with erythrodermic AD who were randomly assigned to receive dupilumab or placebo (both with or without concomitant TCS).

Disclosures: This study was funded by Sanofi-Regeneron Pharmaceuticals Inc. Some authors reported ties with various organizations, including Sanofi/Regeneron. Four authors declared being employees of or holding stock or stock options in Sanofi/Regeneron.

Source: Paller AS et al. Efficacy and safety of dupilumab in patients with erythrodermic atopic dermatitis: A post hoc analysis of 6 randomized clinical trials. JAMA Dermatol. 2023 (Feb 1). Doi: 10.1001/jamadermatol.2022.6192

The U.S. Food and Drug Administration today expanded the indication for Pfizer’s oral Janus kinase (JAK) inhibitor for atopic dermatitis (AD), abrocitinib (Cibinqo), to include adolescents aged 12 through 17 years.

Abrocitinib, taken once daily, previously was approved only for treating adults aged 18 and older.

It joins upadacitinib (Rinvoq), previously the only oral JAK inhibitor to be approved for use by adolescents aged 12 through 17 with refractory moderate to severe AD.

The indication has been expanded for teens whose disease is not adequately controlled with other systemic drugs, including biologics, or those for whom use of those drugs is not advised.

Prescribing information was updated to reflect data from JADE TEEN, a phase 3, randomized, placebo-controlled trial that supported the indication for adolescents. That trial evaluated both the 100-mg and 200-mg doses of abrocitinib in comparison with placebo in 285 adolescents aged 12-18 who had moderate to severe AD and who were also receiving background therapy with topical medications.

The most common toxicities that were reported in at least 1% of patients treated with abrocitinib for up to 16 weeks included nasopharyngitis, nausea, and headache.

Efficacy measures included improvements in itch, skin clearance, and disease severity using the Investigator Global Assessment (IGA), the Peak Pruritus Numerical Rating Scale (PP-NRS), and the Eczema Area and Severity Index (EASI), according to the Pfizer statement announcing the expanded approval.

Select JADE TEEN findings include the following:

• IGA response rate of 0 or 1 at week 12: 39% with abrocitinib 100 mg; 46% with abrocitinib 200 mg; and 24% with placebo.
• EASI-75 response rate at week 12: 64%, 71%, and 41%, respectively.
• Proportion of participants achieving PP-NRS with at least a 4-point decrease from baseline at week 2: 13%, 25%, and 8%, respectively.

Data included in the prescribing information now encompass five randomized, placebo-controlled clinical trials and a long-term extension study with more than 1,600 patients treated with abrocitinib, according to the statement from Pfizer.

In a 2021 story, when JADE TEEN trial results were presented, Lawrence Eichenfield, MD, professor of dermatology and pediatrics, University of California, San Diego, and Rady Children’s Hospital, San Diego, told this news organization that he welcomed oral JAKs as a weapon against atopic dermatitis.

He noted that moderate to severe AD can have a tremendous impact on adolescents. “Traditionally, we have treated it with intermittent topical corticosteroids, but this has left a significant percentage of patients without long-term disease control,” he said.

Abrocitinib is not recommended for use with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

AD, one of the most common inflammatory skin diseases, affects approximately 5%-10% of adults in the United States and approximately 11% of children. About one in three adults and one in three children and adolescents aged 17 and younger with AD have moderate to severe disease.

JAK inhibition is thought to modulate multiple cytokines involved in AD, including interleukin (IL)–4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin.

Prescribing information includes a warning that use of abrocitinib should be avoided by patients with an active, serious infection, including localized infections. A boxed warning is included in the labels of JAK inhibitors regarding the risk of serious infections, mortality, major cardiovascular events, and thrombosis.

Treatment risks and benefits should be carefully considered for patients with chronic or recurrent infections or those who have lived in or traveled in areas of endemic tuberculosis or endemic mycoses, the information states.

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

The U.S. Food and Drug Administration today expanded the indication for Pfizer’s oral Janus kinase (JAK) inhibitor for atopic dermatitis (AD), abrocitinib (Cibinqo), to include adolescents aged 12 through 17 years.

Abrocitinib, taken once daily, previously was approved only for treating adults aged 18 and older.

It joins upadacitinib (Rinvoq), previously the only oral JAK inhibitor to be approved for use by adolescents aged 12 through 17 with refractory moderate to severe AD.

The indication has been expanded for teens whose disease is not adequately controlled with other systemic drugs, including biologics, or those for whom use of those drugs is not advised.

Prescribing information was updated to reflect data from JADE TEEN, a phase 3, randomized, placebo-controlled trial that supported the indication for adolescents. That trial evaluated both the 100-mg and 200-mg doses of abrocitinib in comparison with placebo in 285 adolescents aged 12-18 who had moderate to severe AD and who were also receiving background therapy with topical medications.

The most common toxicities that were reported in at least 1% of patients treated with abrocitinib for up to 16 weeks included nasopharyngitis, nausea, and headache.

Efficacy measures included improvements in itch, skin clearance, and disease severity using the Investigator Global Assessment (IGA), the Peak Pruritus Numerical Rating Scale (PP-NRS), and the Eczema Area and Severity Index (EASI), according to the Pfizer statement announcing the expanded approval.

Select JADE TEEN findings include the following:

• IGA response rate of 0 or 1 at week 12: 39% with abrocitinib 100 mg; 46% with abrocitinib 200 mg; and 24% with placebo.
• EASI-75 response rate at week 12: 64%, 71%, and 41%, respectively.
• Proportion of participants achieving PP-NRS with at least a 4-point decrease from baseline at week 2: 13%, 25%, and 8%, respectively.

Data included in the prescribing information now encompass five randomized, placebo-controlled clinical trials and a long-term extension study with more than 1,600 patients treated with abrocitinib, according to the statement from Pfizer.

In a 2021 story, when JADE TEEN trial results were presented, Lawrence Eichenfield, MD, professor of dermatology and pediatrics, University of California, San Diego, and Rady Children’s Hospital, San Diego, told this news organization that he welcomed oral JAKs as a weapon against atopic dermatitis.

He noted that moderate to severe AD can have a tremendous impact on adolescents. “Traditionally, we have treated it with intermittent topical corticosteroids, but this has left a significant percentage of patients without long-term disease control,” he said.

Abrocitinib is not recommended for use with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

AD, one of the most common inflammatory skin diseases, affects approximately 5%-10% of adults in the United States and approximately 11% of children. About one in three adults and one in three children and adolescents aged 17 and younger with AD have moderate to severe disease.

JAK inhibition is thought to modulate multiple cytokines involved in AD, including interleukin (IL)–4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin.

Prescribing information includes a warning that use of abrocitinib should be avoided by patients with an active, serious infection, including localized infections. A boxed warning is included in the labels of JAK inhibitors regarding the risk of serious infections, mortality, major cardiovascular events, and thrombosis.

Treatment risks and benefits should be carefully considered for patients with chronic or recurrent infections or those who have lived in or traveled in areas of endemic tuberculosis or endemic mycoses, the information states.

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

The U.S. Food and Drug Administration today expanded the indication for Pfizer’s oral Janus kinase (JAK) inhibitor for atopic dermatitis (AD), abrocitinib (Cibinqo), to include adolescents aged 12 through 17 years.

Abrocitinib, taken once daily, previously was approved only for treating adults aged 18 and older.

It joins upadacitinib (Rinvoq), previously the only oral JAK inhibitor to be approved for use by adolescents aged 12 through 17 with refractory moderate to severe AD.

The indication has been expanded for teens whose disease is not adequately controlled with other systemic drugs, including biologics, or those for whom use of those drugs is not advised.

Prescribing information was updated to reflect data from JADE TEEN, a phase 3, randomized, placebo-controlled trial that supported the indication for adolescents. That trial evaluated both the 100-mg and 200-mg doses of abrocitinib in comparison with placebo in 285 adolescents aged 12-18 who had moderate to severe AD and who were also receiving background therapy with topical medications.

The most common toxicities that were reported in at least 1% of patients treated with abrocitinib for up to 16 weeks included nasopharyngitis, nausea, and headache.

Efficacy measures included improvements in itch, skin clearance, and disease severity using the Investigator Global Assessment (IGA), the Peak Pruritus Numerical Rating Scale (PP-NRS), and the Eczema Area and Severity Index (EASI), according to the Pfizer statement announcing the expanded approval.

Select JADE TEEN findings include the following:

• IGA response rate of 0 or 1 at week 12: 39% with abrocitinib 100 mg; 46% with abrocitinib 200 mg; and 24% with placebo.
• EASI-75 response rate at week 12: 64%, 71%, and 41%, respectively.
• Proportion of participants achieving PP-NRS with at least a 4-point decrease from baseline at week 2: 13%, 25%, and 8%, respectively.

Data included in the prescribing information now encompass five randomized, placebo-controlled clinical trials and a long-term extension study with more than 1,600 patients treated with abrocitinib, according to the statement from Pfizer.

In a 2021 story, when JADE TEEN trial results were presented, Lawrence Eichenfield, MD, professor of dermatology and pediatrics, University of California, San Diego, and Rady Children’s Hospital, San Diego, told this news organization that he welcomed oral JAKs as a weapon against atopic dermatitis.

He noted that moderate to severe AD can have a tremendous impact on adolescents. “Traditionally, we have treated it with intermittent topical corticosteroids, but this has left a significant percentage of patients without long-term disease control,” he said.

Abrocitinib is not recommended for use with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

AD, one of the most common inflammatory skin diseases, affects approximately 5%-10% of adults in the United States and approximately 11% of children. About one in three adults and one in three children and adolescents aged 17 and younger with AD have moderate to severe disease.

JAK inhibition is thought to modulate multiple cytokines involved in AD, including interleukin (IL)–4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin.

Prescribing information includes a warning that use of abrocitinib should be avoided by patients with an active, serious infection, including localized infections. A boxed warning is included in the labels of JAK inhibitors regarding the risk of serious infections, mortality, major cardiovascular events, and thrombosis.

Treatment risks and benefits should be carefully considered for patients with chronic or recurrent infections or those who have lived in or traveled in areas of endemic tuberculosis or endemic mycoses, the information states.

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