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Dupilumab shows long-term safety and efficacy in severe pediatric atopic dermatitis
Key clinical point: Long-term dupilumab treatment provides sustained clinical benefits and acceptable safety in children age 6-11 years with uncontrolled severe atopic dermatitis (AD).
Major finding: By week 52, 41% of patients achieved an Investigator’s Global Assessment score of 0 or 1, and 82% of patients achieved ≥75% improvement in the Eczema Area and Severity Index scores compared with the LIBERTY AD PEDS baseline. Treatment-emergent adverse events were mostly of mild or moderate severity.
Study details: This analysis of data from the LIBERTY AD PED-OLE study included 321 children (age 6-11 years) with severe AD who previously participated in LIBERTY AD PEDS and received 300 mg dupilumab every 4 weeks or an up-titrated weight-tiered dose of 200 or 300 mg dupilumab every 2 weeks.
Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Seven authors declared being employees of or holding stocks or stock options in Sanofi or Regeneron. The other authors declared ties with various sources, including Sanofi and Regeneron.
Source: Cork MJ et al. Dupilumab safety and efficacy in a phase III open-label extension trial in children 6-11 years of age with severe atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Sep 26). doi: 10.1007/s13555-023-01016-9
Key clinical point: Long-term dupilumab treatment provides sustained clinical benefits and acceptable safety in children age 6-11 years with uncontrolled severe atopic dermatitis (AD).
Major finding: By week 52, 41% of patients achieved an Investigator’s Global Assessment score of 0 or 1, and 82% of patients achieved ≥75% improvement in the Eczema Area and Severity Index scores compared with the LIBERTY AD PEDS baseline. Treatment-emergent adverse events were mostly of mild or moderate severity.
Study details: This analysis of data from the LIBERTY AD PED-OLE study included 321 children (age 6-11 years) with severe AD who previously participated in LIBERTY AD PEDS and received 300 mg dupilumab every 4 weeks or an up-titrated weight-tiered dose of 200 or 300 mg dupilumab every 2 weeks.
Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Seven authors declared being employees of or holding stocks or stock options in Sanofi or Regeneron. The other authors declared ties with various sources, including Sanofi and Regeneron.
Source: Cork MJ et al. Dupilumab safety and efficacy in a phase III open-label extension trial in children 6-11 years of age with severe atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Sep 26). doi: 10.1007/s13555-023-01016-9
Key clinical point: Long-term dupilumab treatment provides sustained clinical benefits and acceptable safety in children age 6-11 years with uncontrolled severe atopic dermatitis (AD).
Major finding: By week 52, 41% of patients achieved an Investigator’s Global Assessment score of 0 or 1, and 82% of patients achieved ≥75% improvement in the Eczema Area and Severity Index scores compared with the LIBERTY AD PEDS baseline. Treatment-emergent adverse events were mostly of mild or moderate severity.
Study details: This analysis of data from the LIBERTY AD PED-OLE study included 321 children (age 6-11 years) with severe AD who previously participated in LIBERTY AD PEDS and received 300 mg dupilumab every 4 weeks or an up-titrated weight-tiered dose of 200 or 300 mg dupilumab every 2 weeks.
Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Seven authors declared being employees of or holding stocks or stock options in Sanofi or Regeneron. The other authors declared ties with various sources, including Sanofi and Regeneron.
Source: Cork MJ et al. Dupilumab safety and efficacy in a phase III open-label extension trial in children 6-11 years of age with severe atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Sep 26). doi: 10.1007/s13555-023-01016-9
Tralokinumab improves clinical responses at week 16 in moderate-to-severe AD despite IGA 0/1 nonachievement
Key clinical point: Tralokinumab led to clinically meaningful responses in adults with moderate-to-severe atopic dermatitis (AD) who failed to achieve an Investigator’s Global Assessment (IGA) score of 0 or 1 at 16 weeks without rescue medication.
Major finding: At week 16, a significantly greater proportion of patients receiving tralokinumab vs placebo achieved ≥ 50% improvement in the Eczema Area and Severity Index scores (33.0% vs 13.0%; P < .0001) and ≥ 3-point improvement in the itch Numerical Rating Scale scores (22.6% vs 9.4%; P < .0001).
Study details: This post hoc analysis of data from ECZTRA 1 and 2 trials included adults with moderate-to-severe AD who were randomized to receive tralokinumab (n = 966) or placebo (n = 362) and failed to achieve an IGA score of 0 or 1 at week 16 without rescue medication.
Disclosures: ECZTRA 1 and 2 were sponsored by LEO Pharma A/S, Denmark. Several authors declared ties with LEO Pharma, among others. T Mark declared being an employee and stockholder of LEO Pharma A/S.
Source: Simpson EL et al. Tralokinumab provides clinically meaningful responses at week 16 in adults with moderate-to-severe atopic dermatitis who do not achieve IGA 0/1. Am J Clin Dermatol. 2023 (Oct 7). doi: 10.1007/s40257-023-00817-0
Key clinical point: Tralokinumab led to clinically meaningful responses in adults with moderate-to-severe atopic dermatitis (AD) who failed to achieve an Investigator’s Global Assessment (IGA) score of 0 or 1 at 16 weeks without rescue medication.
Major finding: At week 16, a significantly greater proportion of patients receiving tralokinumab vs placebo achieved ≥ 50% improvement in the Eczema Area and Severity Index scores (33.0% vs 13.0%; P < .0001) and ≥ 3-point improvement in the itch Numerical Rating Scale scores (22.6% vs 9.4%; P < .0001).
Study details: This post hoc analysis of data from ECZTRA 1 and 2 trials included adults with moderate-to-severe AD who were randomized to receive tralokinumab (n = 966) or placebo (n = 362) and failed to achieve an IGA score of 0 or 1 at week 16 without rescue medication.
Disclosures: ECZTRA 1 and 2 were sponsored by LEO Pharma A/S, Denmark. Several authors declared ties with LEO Pharma, among others. T Mark declared being an employee and stockholder of LEO Pharma A/S.
Source: Simpson EL et al. Tralokinumab provides clinically meaningful responses at week 16 in adults with moderate-to-severe atopic dermatitis who do not achieve IGA 0/1. Am J Clin Dermatol. 2023 (Oct 7). doi: 10.1007/s40257-023-00817-0
Key clinical point: Tralokinumab led to clinically meaningful responses in adults with moderate-to-severe atopic dermatitis (AD) who failed to achieve an Investigator’s Global Assessment (IGA) score of 0 or 1 at 16 weeks without rescue medication.
Major finding: At week 16, a significantly greater proportion of patients receiving tralokinumab vs placebo achieved ≥ 50% improvement in the Eczema Area and Severity Index scores (33.0% vs 13.0%; P < .0001) and ≥ 3-point improvement in the itch Numerical Rating Scale scores (22.6% vs 9.4%; P < .0001).
Study details: This post hoc analysis of data from ECZTRA 1 and 2 trials included adults with moderate-to-severe AD who were randomized to receive tralokinumab (n = 966) or placebo (n = 362) and failed to achieve an IGA score of 0 or 1 at week 16 without rescue medication.
Disclosures: ECZTRA 1 and 2 were sponsored by LEO Pharma A/S, Denmark. Several authors declared ties with LEO Pharma, among others. T Mark declared being an employee and stockholder of LEO Pharma A/S.
Source: Simpson EL et al. Tralokinumab provides clinically meaningful responses at week 16 in adults with moderate-to-severe atopic dermatitis who do not achieve IGA 0/1. Am J Clin Dermatol. 2023 (Oct 7). doi: 10.1007/s40257-023-00817-0
Methotrexate reduces epidermal hyperplasia and alters cutaneous IL-31 and IL-31RA expression in AD
Key clinical point: Methotrexate treatment decreased epidermal hyperplasia and altered the cutaneous expression of pruritus-related inflammatory cytokines and receptors, including interleukin-31 (IL-31) and IL-31 alpha receptor subunits (RA), in adults with moderate-to-severe refractory atopic dermatitis (AD).
Major finding: At 24 weeks of treatment, methotrexate led to a significant increase in IL-31RA expression in the epidermis (P = .016), decrease in IL-31 gene expression in lesional skin (P = .019), and reduction in the mean epidermal thickness (P = .021).
Study details: Findings are from a prospective cohort study including 12 adults with moderate-to-severe refractory AD who orally received 15 mg methotrexate per week and were matched with 10 control individuals without AD.
Disclosures: This study was supported by Fundo de Apoio à Dermatologia de São Paulo, Brazil. The authors declared no conflicts of interest.
Source: Samorano LP et al. Methotrexate for refractory adult atopic dermatitis leads to alterations in cutaneous IL-31 and IL-31RA expression. An Bras Dermatol. 2023 (Sep 18). doi: 10.1016/j.abd.2023.01.002
Key clinical point: Methotrexate treatment decreased epidermal hyperplasia and altered the cutaneous expression of pruritus-related inflammatory cytokines and receptors, including interleukin-31 (IL-31) and IL-31 alpha receptor subunits (RA), in adults with moderate-to-severe refractory atopic dermatitis (AD).
Major finding: At 24 weeks of treatment, methotrexate led to a significant increase in IL-31RA expression in the epidermis (P = .016), decrease in IL-31 gene expression in lesional skin (P = .019), and reduction in the mean epidermal thickness (P = .021).
Study details: Findings are from a prospective cohort study including 12 adults with moderate-to-severe refractory AD who orally received 15 mg methotrexate per week and were matched with 10 control individuals without AD.
Disclosures: This study was supported by Fundo de Apoio à Dermatologia de São Paulo, Brazil. The authors declared no conflicts of interest.
Source: Samorano LP et al. Methotrexate for refractory adult atopic dermatitis leads to alterations in cutaneous IL-31 and IL-31RA expression. An Bras Dermatol. 2023 (Sep 18). doi: 10.1016/j.abd.2023.01.002
Key clinical point: Methotrexate treatment decreased epidermal hyperplasia and altered the cutaneous expression of pruritus-related inflammatory cytokines and receptors, including interleukin-31 (IL-31) and IL-31 alpha receptor subunits (RA), in adults with moderate-to-severe refractory atopic dermatitis (AD).
Major finding: At 24 weeks of treatment, methotrexate led to a significant increase in IL-31RA expression in the epidermis (P = .016), decrease in IL-31 gene expression in lesional skin (P = .019), and reduction in the mean epidermal thickness (P = .021).
Study details: Findings are from a prospective cohort study including 12 adults with moderate-to-severe refractory AD who orally received 15 mg methotrexate per week and were matched with 10 control individuals without AD.
Disclosures: This study was supported by Fundo de Apoio à Dermatologia de São Paulo, Brazil. The authors declared no conflicts of interest.
Source: Samorano LP et al. Methotrexate for refractory adult atopic dermatitis leads to alterations in cutaneous IL-31 and IL-31RA expression. An Bras Dermatol. 2023 (Sep 18). doi: 10.1016/j.abd.2023.01.002
Tacrolimus tops hydrocortisone in pediatric atopic dermatitis treatment
Key clinical point: Topical treatment with tacrolimus vs hydrocortisone was more efficacious in reducing inflammatory marker levels and had a better safety profile in children with atopic dermatitis (AD).
Major finding: After 3 weeks, patients receiving tacrolimus vs hydrocortisone showed a significantly greater decrease in the mean serum levels of IL-10 (P = .05), IL-17 (P = .021), and IL-23 (P = .03), lower rates of skin atrophy (P < .05), and higher but manageable incidences of mild-to-moderate transient stinging and erythema (P < .05).
Study details: Findings are from a prospective randomized clinical trial including 200 children with AD (age 2-16 years) who were randomly assigned in a 1:1 ratio to receive either 0.03% topical tacrolimus ointment or 1% hydrocortisone cream twice daily.
Disclosures: This study did not disclose any funding source. The authors declared no conflicts of interest.
Source: Mohamed AA et al. A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children. Front Pharmacol. 2023;14:1202325 (Sep 20). doi: 10.3389/fphar.2023.1202325
Key clinical point: Topical treatment with tacrolimus vs hydrocortisone was more efficacious in reducing inflammatory marker levels and had a better safety profile in children with atopic dermatitis (AD).
Major finding: After 3 weeks, patients receiving tacrolimus vs hydrocortisone showed a significantly greater decrease in the mean serum levels of IL-10 (P = .05), IL-17 (P = .021), and IL-23 (P = .03), lower rates of skin atrophy (P < .05), and higher but manageable incidences of mild-to-moderate transient stinging and erythema (P < .05).
Study details: Findings are from a prospective randomized clinical trial including 200 children with AD (age 2-16 years) who were randomly assigned in a 1:1 ratio to receive either 0.03% topical tacrolimus ointment or 1% hydrocortisone cream twice daily.
Disclosures: This study did not disclose any funding source. The authors declared no conflicts of interest.
Source: Mohamed AA et al. A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children. Front Pharmacol. 2023;14:1202325 (Sep 20). doi: 10.3389/fphar.2023.1202325
Key clinical point: Topical treatment with tacrolimus vs hydrocortisone was more efficacious in reducing inflammatory marker levels and had a better safety profile in children with atopic dermatitis (AD).
Major finding: After 3 weeks, patients receiving tacrolimus vs hydrocortisone showed a significantly greater decrease in the mean serum levels of IL-10 (P = .05), IL-17 (P = .021), and IL-23 (P = .03), lower rates of skin atrophy (P < .05), and higher but manageable incidences of mild-to-moderate transient stinging and erythema (P < .05).
Study details: Findings are from a prospective randomized clinical trial including 200 children with AD (age 2-16 years) who were randomly assigned in a 1:1 ratio to receive either 0.03% topical tacrolimus ointment or 1% hydrocortisone cream twice daily.
Disclosures: This study did not disclose any funding source. The authors declared no conflicts of interest.
Source: Mohamed AA et al. A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children. Front Pharmacol. 2023;14:1202325 (Sep 20). doi: 10.3389/fphar.2023.1202325
Atopic dermatitis affects outcomes in occupational contact dermatitis
Key clinical point: Atopic dermatitis (AD) negatively affects the prognosis, quality of life (QoL), and work life in young workers with occupational contact dermatitis (OCD).
Major finding: The prevalence of previously diagnosed AD was 41.8%. A higher proportion of workers with vs without AD experienced eczema during the last 3 months of response submission (adjusted odds ratio [aOR] 1.7; P < .001) and reported that OCD had negatively affected their choice of jobs and occupations (aOR 1.4; P < .001). Workers with vs without AD had significantly higher mean scores in the emotions (P < .01) and symptoms (P < .001) subscales of the Skindex-29 assessment of QoL.
Study details: Findings are from a retrospective questionnaire-based study including 2392 workers age < 35 years with OCD who answered a question about being previously diagnosed with AD.
Disclosures: This study was funded by the Danish Working Environment Research Fund. The authors declared no conflicts of interest.
Source: Dietz JB et al. Impact of atopic dermatitis on occupational contact dermatitis among young people: A retrospective cohort study. Contact Dermatitis. 2023 (Sep 26). doi: 10.1111/cod.14426
Key clinical point: Atopic dermatitis (AD) negatively affects the prognosis, quality of life (QoL), and work life in young workers with occupational contact dermatitis (OCD).
Major finding: The prevalence of previously diagnosed AD was 41.8%. A higher proportion of workers with vs without AD experienced eczema during the last 3 months of response submission (adjusted odds ratio [aOR] 1.7; P < .001) and reported that OCD had negatively affected their choice of jobs and occupations (aOR 1.4; P < .001). Workers with vs without AD had significantly higher mean scores in the emotions (P < .01) and symptoms (P < .001) subscales of the Skindex-29 assessment of QoL.
Study details: Findings are from a retrospective questionnaire-based study including 2392 workers age < 35 years with OCD who answered a question about being previously diagnosed with AD.
Disclosures: This study was funded by the Danish Working Environment Research Fund. The authors declared no conflicts of interest.
Source: Dietz JB et al. Impact of atopic dermatitis on occupational contact dermatitis among young people: A retrospective cohort study. Contact Dermatitis. 2023 (Sep 26). doi: 10.1111/cod.14426
Key clinical point: Atopic dermatitis (AD) negatively affects the prognosis, quality of life (QoL), and work life in young workers with occupational contact dermatitis (OCD).
Major finding: The prevalence of previously diagnosed AD was 41.8%. A higher proportion of workers with vs without AD experienced eczema during the last 3 months of response submission (adjusted odds ratio [aOR] 1.7; P < .001) and reported that OCD had negatively affected their choice of jobs and occupations (aOR 1.4; P < .001). Workers with vs without AD had significantly higher mean scores in the emotions (P < .01) and symptoms (P < .001) subscales of the Skindex-29 assessment of QoL.
Study details: Findings are from a retrospective questionnaire-based study including 2392 workers age < 35 years with OCD who answered a question about being previously diagnosed with AD.
Disclosures: This study was funded by the Danish Working Environment Research Fund. The authors declared no conflicts of interest.
Source: Dietz JB et al. Impact of atopic dermatitis on occupational contact dermatitis among young people: A retrospective cohort study. Contact Dermatitis. 2023 (Sep 26). doi: 10.1111/cod.14426
Xyloglucan-pea protein a possible steroid-sparing alternative for treating pediatric AD
Key clinical point: Xyloglucan and pea protein (XG-PP)-based topical treatment shows safety and efficacy outcomes comparable with those of hydrocortisone in pediatric patients with atopic dermatitis (AD).
Major finding: At 8 and 15 days of treatment, both XG-PP and hydrocortisone led to significant decreases in the AD Severity Index (ADSI) score (all P = .00001). Both treatment arms showed similar decrease in ADSI scores at 8 (P = .91) and 15 (P = .92) days. No adverse events were reported in the XG-PP treatment arm.
Study details: Findings are from a prospective multicenter study including 42 pediatric patients with mild-to-moderate AD (age 6 months-12 years) who were randomly assigned to receive either topical XG-PP-based cream or hydrocortisone twice daily for 14 consecutive days.
Disclosures: This study was sponsored by Novintethical Pharma SA. The authors declared no conflicts of interest.
Source: Sowlati M et al. Efficacy and tolerability of a novel topical treatment containing pea protein and xyloglucan in the management of atopic dermatitis in children: A prospective, multicenter clinical study. Dermatol Ther (Heidelb). 2023 (Sep 23). doi: 10.1007/s13555-023-01035-6
Key clinical point: Xyloglucan and pea protein (XG-PP)-based topical treatment shows safety and efficacy outcomes comparable with those of hydrocortisone in pediatric patients with atopic dermatitis (AD).
Major finding: At 8 and 15 days of treatment, both XG-PP and hydrocortisone led to significant decreases in the AD Severity Index (ADSI) score (all P = .00001). Both treatment arms showed similar decrease in ADSI scores at 8 (P = .91) and 15 (P = .92) days. No adverse events were reported in the XG-PP treatment arm.
Study details: Findings are from a prospective multicenter study including 42 pediatric patients with mild-to-moderate AD (age 6 months-12 years) who were randomly assigned to receive either topical XG-PP-based cream or hydrocortisone twice daily for 14 consecutive days.
Disclosures: This study was sponsored by Novintethical Pharma SA. The authors declared no conflicts of interest.
Source: Sowlati M et al. Efficacy and tolerability of a novel topical treatment containing pea protein and xyloglucan in the management of atopic dermatitis in children: A prospective, multicenter clinical study. Dermatol Ther (Heidelb). 2023 (Sep 23). doi: 10.1007/s13555-023-01035-6
Key clinical point: Xyloglucan and pea protein (XG-PP)-based topical treatment shows safety and efficacy outcomes comparable with those of hydrocortisone in pediatric patients with atopic dermatitis (AD).
Major finding: At 8 and 15 days of treatment, both XG-PP and hydrocortisone led to significant decreases in the AD Severity Index (ADSI) score (all P = .00001). Both treatment arms showed similar decrease in ADSI scores at 8 (P = .91) and 15 (P = .92) days. No adverse events were reported in the XG-PP treatment arm.
Study details: Findings are from a prospective multicenter study including 42 pediatric patients with mild-to-moderate AD (age 6 months-12 years) who were randomly assigned to receive either topical XG-PP-based cream or hydrocortisone twice daily for 14 consecutive days.
Disclosures: This study was sponsored by Novintethical Pharma SA. The authors declared no conflicts of interest.
Source: Sowlati M et al. Efficacy and tolerability of a novel topical treatment containing pea protein and xyloglucan in the management of atopic dermatitis in children: A prospective, multicenter clinical study. Dermatol Ther (Heidelb). 2023 (Sep 23). doi: 10.1007/s13555-023-01035-6
Increased risk for neuropsychiatric disorders in adults with AD
Key clinical point: Patients with atopic dermatitis (AD) have an increased risk for multiple neuropsychiatric conditions; however, the risk profiles for specific neuropsychiatric conditions differ with AD severity.
Major finding: Adults with AD (of any severity level) vs without AD had a higher risk for anxiety (adjusted hazard ratio [aHR] 1.14, 95% CI 1.13-1.15), depression (aHR 1.14, 95% CI 1.13-1.15), and obsessive-compulsive disorder (aHR 1.48, 95% CI 1.38-1.58); the risk for autism increased in patients with mild (aHR 1.55; 95% CI 1.26-1.89) and moderate (aHR 1.40; 95% CI 1.07-1.83) AD and that for attention-deficit/hyperactivity disorder increased in those with mild AD (aHR 1.27; 95% CI 1.03-1.55].
Study details: This population-based cohort study included 625,083 adults with AD who were matched with 2,678,888 control adults without AD.
Disclosures: This study was supported by a contract from Pfizer, Inc. Some authors declared receiving research or fellowship funding or consultation honoraria from various sources, including Pfizer. AR Lemeshow declared being an employee of Pfizer.
Source: Wan J et al. Neuropsychiatric disorders in adults with atopic dermatitis: A population-based cohort study. J Eur Acad Dermatol Venereol. 2023 (Sep 20). doi: 10.1111/jdv.19518
Key clinical point: Patients with atopic dermatitis (AD) have an increased risk for multiple neuropsychiatric conditions; however, the risk profiles for specific neuropsychiatric conditions differ with AD severity.
Major finding: Adults with AD (of any severity level) vs without AD had a higher risk for anxiety (adjusted hazard ratio [aHR] 1.14, 95% CI 1.13-1.15), depression (aHR 1.14, 95% CI 1.13-1.15), and obsessive-compulsive disorder (aHR 1.48, 95% CI 1.38-1.58); the risk for autism increased in patients with mild (aHR 1.55; 95% CI 1.26-1.89) and moderate (aHR 1.40; 95% CI 1.07-1.83) AD and that for attention-deficit/hyperactivity disorder increased in those with mild AD (aHR 1.27; 95% CI 1.03-1.55].
Study details: This population-based cohort study included 625,083 adults with AD who were matched with 2,678,888 control adults without AD.
Disclosures: This study was supported by a contract from Pfizer, Inc. Some authors declared receiving research or fellowship funding or consultation honoraria from various sources, including Pfizer. AR Lemeshow declared being an employee of Pfizer.
Source: Wan J et al. Neuropsychiatric disorders in adults with atopic dermatitis: A population-based cohort study. J Eur Acad Dermatol Venereol. 2023 (Sep 20). doi: 10.1111/jdv.19518
Key clinical point: Patients with atopic dermatitis (AD) have an increased risk for multiple neuropsychiatric conditions; however, the risk profiles for specific neuropsychiatric conditions differ with AD severity.
Major finding: Adults with AD (of any severity level) vs without AD had a higher risk for anxiety (adjusted hazard ratio [aHR] 1.14, 95% CI 1.13-1.15), depression (aHR 1.14, 95% CI 1.13-1.15), and obsessive-compulsive disorder (aHR 1.48, 95% CI 1.38-1.58); the risk for autism increased in patients with mild (aHR 1.55; 95% CI 1.26-1.89) and moderate (aHR 1.40; 95% CI 1.07-1.83) AD and that for attention-deficit/hyperactivity disorder increased in those with mild AD (aHR 1.27; 95% CI 1.03-1.55].
Study details: This population-based cohort study included 625,083 adults with AD who were matched with 2,678,888 control adults without AD.
Disclosures: This study was supported by a contract from Pfizer, Inc. Some authors declared receiving research or fellowship funding or consultation honoraria from various sources, including Pfizer. AR Lemeshow declared being an employee of Pfizer.
Source: Wan J et al. Neuropsychiatric disorders in adults with atopic dermatitis: A population-based cohort study. J Eur Acad Dermatol Venereol. 2023 (Sep 20). doi: 10.1111/jdv.19518
Methotrexate is a safe and efficacious alternative to ciclosporin in children with severe AD
Key clinical point: Both ciclosporin and methotrexate were effective against severe atopic dermatitis (AD) in children, but ciclosporin resulted in a more rapid response whereas methotrexate led to more sustained disease control even after treatment discontinuation.
Major finding: At 12 weeks, a significantly higher proportion of patients achieved 50% improvement in Objective Severity Scoring of Atopic Dermatitis scores (o-SCORAD-50) with ciclosporin vs methotrexate (P = .012). However, at 60 weeks, the proportion of patients who achieved o-SCORAD-50 was higher with methotrexate vs ciclosporin (P = .022). Adverse event rates were comparable in both groups.
Study details: The TREatment of severe Atopic Eczema Trial included 103 children with severe AD (age 2-16 years) who were unresponsive to topical treatments and were randomly assigned to receive ciclosporin or methotrexate.
Disclosures: This study was funded by the UK Medical Research Council/National Institute for Health Research (NIHR). Some authors, including the lead author, declared receiving consulting fees, advisory fees, or research funding from various sources, including UK NIHR.
Source: Flohr C et al and the TREAT Trial Investigators. Efficacy and safety of ciclosporin versus methotrexate in the treatment of severe atopic dermatitis in children and young people (TREAT): A multicentre, parallel group, assessor-blinded clinical trial. Br J Dermatol. 2023 (Sep 19). doi: 10.1093/bjd/ljad281
Key clinical point: Both ciclosporin and methotrexate were effective against severe atopic dermatitis (AD) in children, but ciclosporin resulted in a more rapid response whereas methotrexate led to more sustained disease control even after treatment discontinuation.
Major finding: At 12 weeks, a significantly higher proportion of patients achieved 50% improvement in Objective Severity Scoring of Atopic Dermatitis scores (o-SCORAD-50) with ciclosporin vs methotrexate (P = .012). However, at 60 weeks, the proportion of patients who achieved o-SCORAD-50 was higher with methotrexate vs ciclosporin (P = .022). Adverse event rates were comparable in both groups.
Study details: The TREatment of severe Atopic Eczema Trial included 103 children with severe AD (age 2-16 years) who were unresponsive to topical treatments and were randomly assigned to receive ciclosporin or methotrexate.
Disclosures: This study was funded by the UK Medical Research Council/National Institute for Health Research (NIHR). Some authors, including the lead author, declared receiving consulting fees, advisory fees, or research funding from various sources, including UK NIHR.
Source: Flohr C et al and the TREAT Trial Investigators. Efficacy and safety of ciclosporin versus methotrexate in the treatment of severe atopic dermatitis in children and young people (TREAT): A multicentre, parallel group, assessor-blinded clinical trial. Br J Dermatol. 2023 (Sep 19). doi: 10.1093/bjd/ljad281
Key clinical point: Both ciclosporin and methotrexate were effective against severe atopic dermatitis (AD) in children, but ciclosporin resulted in a more rapid response whereas methotrexate led to more sustained disease control even after treatment discontinuation.
Major finding: At 12 weeks, a significantly higher proportion of patients achieved 50% improvement in Objective Severity Scoring of Atopic Dermatitis scores (o-SCORAD-50) with ciclosporin vs methotrexate (P = .012). However, at 60 weeks, the proportion of patients who achieved o-SCORAD-50 was higher with methotrexate vs ciclosporin (P = .022). Adverse event rates were comparable in both groups.
Study details: The TREatment of severe Atopic Eczema Trial included 103 children with severe AD (age 2-16 years) who were unresponsive to topical treatments and were randomly assigned to receive ciclosporin or methotrexate.
Disclosures: This study was funded by the UK Medical Research Council/National Institute for Health Research (NIHR). Some authors, including the lead author, declared receiving consulting fees, advisory fees, or research funding from various sources, including UK NIHR.
Source: Flohr C et al and the TREAT Trial Investigators. Efficacy and safety of ciclosporin versus methotrexate in the treatment of severe atopic dermatitis in children and young people (TREAT): A multicentre, parallel group, assessor-blinded clinical trial. Br J Dermatol. 2023 (Sep 19). doi: 10.1093/bjd/ljad281
Children with atopic dermatitis more prone to allergic contact dermatitis
Key clinical point: Compared with children without atopic dermatitis (AD), those with AD are significantly more likely to have positive patch tests (PPT) and respond to ≥1 allergen on patch testing.
Major finding: Children with vs without AD were significantly more likely to have a longer duration of dermatitis (P < .0001), >1 PPT result (P = .005), a greater number of PPT overall (P = .012), and a more generalized distribution of dermatitis (P = .001) as well as PPT to bacitracin (P = .030), carba mix (diphenylguanidine, zinc dibutyldithiocarbamate, and zinc diethyldithiocarbamate) (P = .025), and cocamidopropyl betaine (P = .0007).
Study details: This retrospective case-control study included 615 children with AD and 297 children without AD.
Disclosures: This study was supported by the Dermatology Foundation, Evanston, IL. The authors declared no conflicts of interest.
Source: Johnson H et al. Prevalence of allergic contact dermatitis in children with and without atopic dermatitis: A multicenter retrospective case-control study. J Am Acad Dermatol. 2023;89(5):1007-1014 (Sep 25). doi: 10.1016/j.jaad.2023.06.048
Key clinical point: Compared with children without atopic dermatitis (AD), those with AD are significantly more likely to have positive patch tests (PPT) and respond to ≥1 allergen on patch testing.
Major finding: Children with vs without AD were significantly more likely to have a longer duration of dermatitis (P < .0001), >1 PPT result (P = .005), a greater number of PPT overall (P = .012), and a more generalized distribution of dermatitis (P = .001) as well as PPT to bacitracin (P = .030), carba mix (diphenylguanidine, zinc dibutyldithiocarbamate, and zinc diethyldithiocarbamate) (P = .025), and cocamidopropyl betaine (P = .0007).
Study details: This retrospective case-control study included 615 children with AD and 297 children without AD.
Disclosures: This study was supported by the Dermatology Foundation, Evanston, IL. The authors declared no conflicts of interest.
Source: Johnson H et al. Prevalence of allergic contact dermatitis in children with and without atopic dermatitis: A multicenter retrospective case-control study. J Am Acad Dermatol. 2023;89(5):1007-1014 (Sep 25). doi: 10.1016/j.jaad.2023.06.048
Key clinical point: Compared with children without atopic dermatitis (AD), those with AD are significantly more likely to have positive patch tests (PPT) and respond to ≥1 allergen on patch testing.
Major finding: Children with vs without AD were significantly more likely to have a longer duration of dermatitis (P < .0001), >1 PPT result (P = .005), a greater number of PPT overall (P = .012), and a more generalized distribution of dermatitis (P = .001) as well as PPT to bacitracin (P = .030), carba mix (diphenylguanidine, zinc dibutyldithiocarbamate, and zinc diethyldithiocarbamate) (P = .025), and cocamidopropyl betaine (P = .0007).
Study details: This retrospective case-control study included 615 children with AD and 297 children without AD.
Disclosures: This study was supported by the Dermatology Foundation, Evanston, IL. The authors declared no conflicts of interest.
Source: Johnson H et al. Prevalence of allergic contact dermatitis in children with and without atopic dermatitis: A multicenter retrospective case-control study. J Am Acad Dermatol. 2023;89(5):1007-1014 (Sep 25). doi: 10.1016/j.jaad.2023.06.048
Atopic Dermatitis Triggered by Omalizumab and Treated With Dupilumab
To the Editor:
A 16-year-old adolescent boy presented to our pediatric dermatology clinic for evaluation of long-standing mild atopic dermatitis (AD) that had become severe over the last year after omalizumab was initiated for severe asthma. The patient had a history of multiple hospitalizations for severe asthma. Despite excellent control of asthma with omalizumab given every 2 weeks, he developed widespread eczematous plaques on the neck, trunk, and extremities over the course of a year. The AD often was complicated by superimposed folliculitis due to scratching from severe pruritus. Treatment with topical corticosteroids including triamcinolone ointment 0.1% to AD on the body, plus clobetasol ointment 0.05% for prurigolike lesions on the legs resulted in modest improvement; however, the AD consistently recurred within a few days after the biweekly omalizumab injection (Figure 1). When the omalizumab injections were delayed, the flares temporarily improved, and when injections were decreased to once monthly, the exacerbations subsided partially but not fully.
Because omalizumab resulted in dramatic improvement in the patient’s asthma, there was hesitation to discontinue it initially; however, the patient and his parents in conjunction with the dermatology and pulmonary teams decided to transition to dupilumab. The patient reported vast improvement of AD 1 month after initiation of dupilumab (Figure 2), which remained well controlled more than 1 year later. Mid-potency topical corticosteroids for the treatment of occasional mild eczematous flares on the extremities were used. The patient’s asthma has remained well controlled on dupilumab without any exacerbations.
Omalizumab is a recombinant DNA-derived humanized monoclonal antibody that binds both circulating and membrane-bound IgE. It has been proposed as a possible treatment for severe and/or recalcitrant AD, with mixed treatment results.1 A case series and review of 174 patients demonstrated a moderate to complete AD response to treatment with omalizumab in 74.1% of patients.2 The Atopic Dermatitis Anti-IgE Pediatric Trial (ADAPT) showed a statistically significant reduction in the Scoring Atopic Dermatitis (SCORAD) index (P=.01), along with improved quality of life in children treated with omalizumab vs those treated with placebo.3 However, a prior randomized, placebo-controlled, double-blind study did not show a significant difference in clinical disease parameters in patients treated with omalizumab.4
The humanized monoclonal antibody dupilumab, an anti–IL-4/IL-13 agent, has demonstrated more consistent efficacy for the treatment of AD in children and adults.1 Dupilumab is effective for both intrinsic and extrinsic AD1 because its clinical efficacy is unrelated to circulating levels of IgE in the bloodstream. Although IgE may have a role in childhood AD, our case demonstrated a different pathophysiologic mechanism independent of IgE. Our patient’s AD flares occurred within a few days of omalizumab injection, which may have resulted in a paradoxical increase in basophil sensitivity to other cytokines such as IL-335 and led to an increase in IL-4/IL-13 production within the skin. In our patient, this increase was successfully blocked by dupilumab. Furthermore, omalizumab has been shown to modulate helper T cell (TH2) cytokine response such as thymic stromal lymphopoietin.6 A cytokine imbalance could have exacerbated AD in our case.
Although additional work to clarify the pathogenesis of AD is needed, it is important to recognize the potential for the occurrence of paradoxical AD flares in patients treated with omalizumab, which is analogous to the well-documented entity of tumor necrosis factor α inhibitor–induced psoriasis. It is equally important to recognize the potential benefit for patients treated with dupilumab.
- Nygaard U, Vestergaard C, Deleuran M. Emerging treatment options in atopic dermatitis: systemic therapies. Dermatology. 2017;233:344-357.
- Holm JG, Agner T, Sand C, et al. Omalizumab for atopic dermatitis: case series and a systematic review of the literature. Int J Dermatol. 2017;56:18-26.
- Chan S, Cornelius V, Cro S, et al. Treatment effect of omalizumab on severe pediatric atopic dermatitis: the ADAPT randomized clinical trial. JAMA Pediatr. 2020;174:29-37.
- Heil PM, Maurer D, Klein B, et al. Omalizumab therapy in atopic dermatitis: depletion of IgE does not improve the clinical course – a randomized placebo-controlled and double blind pilot study. J Dtsch Dermatol Ges. 2010;8:990-998.
- Imai Y. Interleukin-33 in atopic dermatitis. J Dermatol Sci. 2019;96:2-7.
- Iyengar SR, Hoyte EG, Loza A, et al. Immunologic effects of omalizumab in children with severe refractory atopic dermatitis: a randomized, placebo-controlled clinical trial. Int Arch Allergy Immunol. 2013;162:89-93.
To the Editor:
A 16-year-old adolescent boy presented to our pediatric dermatology clinic for evaluation of long-standing mild atopic dermatitis (AD) that had become severe over the last year after omalizumab was initiated for severe asthma. The patient had a history of multiple hospitalizations for severe asthma. Despite excellent control of asthma with omalizumab given every 2 weeks, he developed widespread eczematous plaques on the neck, trunk, and extremities over the course of a year. The AD often was complicated by superimposed folliculitis due to scratching from severe pruritus. Treatment with topical corticosteroids including triamcinolone ointment 0.1% to AD on the body, plus clobetasol ointment 0.05% for prurigolike lesions on the legs resulted in modest improvement; however, the AD consistently recurred within a few days after the biweekly omalizumab injection (Figure 1). When the omalizumab injections were delayed, the flares temporarily improved, and when injections were decreased to once monthly, the exacerbations subsided partially but not fully.
Because omalizumab resulted in dramatic improvement in the patient’s asthma, there was hesitation to discontinue it initially; however, the patient and his parents in conjunction with the dermatology and pulmonary teams decided to transition to dupilumab. The patient reported vast improvement of AD 1 month after initiation of dupilumab (Figure 2), which remained well controlled more than 1 year later. Mid-potency topical corticosteroids for the treatment of occasional mild eczematous flares on the extremities were used. The patient’s asthma has remained well controlled on dupilumab without any exacerbations.
Omalizumab is a recombinant DNA-derived humanized monoclonal antibody that binds both circulating and membrane-bound IgE. It has been proposed as a possible treatment for severe and/or recalcitrant AD, with mixed treatment results.1 A case series and review of 174 patients demonstrated a moderate to complete AD response to treatment with omalizumab in 74.1% of patients.2 The Atopic Dermatitis Anti-IgE Pediatric Trial (ADAPT) showed a statistically significant reduction in the Scoring Atopic Dermatitis (SCORAD) index (P=.01), along with improved quality of life in children treated with omalizumab vs those treated with placebo.3 However, a prior randomized, placebo-controlled, double-blind study did not show a significant difference in clinical disease parameters in patients treated with omalizumab.4
The humanized monoclonal antibody dupilumab, an anti–IL-4/IL-13 agent, has demonstrated more consistent efficacy for the treatment of AD in children and adults.1 Dupilumab is effective for both intrinsic and extrinsic AD1 because its clinical efficacy is unrelated to circulating levels of IgE in the bloodstream. Although IgE may have a role in childhood AD, our case demonstrated a different pathophysiologic mechanism independent of IgE. Our patient’s AD flares occurred within a few days of omalizumab injection, which may have resulted in a paradoxical increase in basophil sensitivity to other cytokines such as IL-335 and led to an increase in IL-4/IL-13 production within the skin. In our patient, this increase was successfully blocked by dupilumab. Furthermore, omalizumab has been shown to modulate helper T cell (TH2) cytokine response such as thymic stromal lymphopoietin.6 A cytokine imbalance could have exacerbated AD in our case.
Although additional work to clarify the pathogenesis of AD is needed, it is important to recognize the potential for the occurrence of paradoxical AD flares in patients treated with omalizumab, which is analogous to the well-documented entity of tumor necrosis factor α inhibitor–induced psoriasis. It is equally important to recognize the potential benefit for patients treated with dupilumab.
To the Editor:
A 16-year-old adolescent boy presented to our pediatric dermatology clinic for evaluation of long-standing mild atopic dermatitis (AD) that had become severe over the last year after omalizumab was initiated for severe asthma. The patient had a history of multiple hospitalizations for severe asthma. Despite excellent control of asthma with omalizumab given every 2 weeks, he developed widespread eczematous plaques on the neck, trunk, and extremities over the course of a year. The AD often was complicated by superimposed folliculitis due to scratching from severe pruritus. Treatment with topical corticosteroids including triamcinolone ointment 0.1% to AD on the body, plus clobetasol ointment 0.05% for prurigolike lesions on the legs resulted in modest improvement; however, the AD consistently recurred within a few days after the biweekly omalizumab injection (Figure 1). When the omalizumab injections were delayed, the flares temporarily improved, and when injections were decreased to once monthly, the exacerbations subsided partially but not fully.
Because omalizumab resulted in dramatic improvement in the patient’s asthma, there was hesitation to discontinue it initially; however, the patient and his parents in conjunction with the dermatology and pulmonary teams decided to transition to dupilumab. The patient reported vast improvement of AD 1 month after initiation of dupilumab (Figure 2), which remained well controlled more than 1 year later. Mid-potency topical corticosteroids for the treatment of occasional mild eczematous flares on the extremities were used. The patient’s asthma has remained well controlled on dupilumab without any exacerbations.
Omalizumab is a recombinant DNA-derived humanized monoclonal antibody that binds both circulating and membrane-bound IgE. It has been proposed as a possible treatment for severe and/or recalcitrant AD, with mixed treatment results.1 A case series and review of 174 patients demonstrated a moderate to complete AD response to treatment with omalizumab in 74.1% of patients.2 The Atopic Dermatitis Anti-IgE Pediatric Trial (ADAPT) showed a statistically significant reduction in the Scoring Atopic Dermatitis (SCORAD) index (P=.01), along with improved quality of life in children treated with omalizumab vs those treated with placebo.3 However, a prior randomized, placebo-controlled, double-blind study did not show a significant difference in clinical disease parameters in patients treated with omalizumab.4
The humanized monoclonal antibody dupilumab, an anti–IL-4/IL-13 agent, has demonstrated more consistent efficacy for the treatment of AD in children and adults.1 Dupilumab is effective for both intrinsic and extrinsic AD1 because its clinical efficacy is unrelated to circulating levels of IgE in the bloodstream. Although IgE may have a role in childhood AD, our case demonstrated a different pathophysiologic mechanism independent of IgE. Our patient’s AD flares occurred within a few days of omalizumab injection, which may have resulted in a paradoxical increase in basophil sensitivity to other cytokines such as IL-335 and led to an increase in IL-4/IL-13 production within the skin. In our patient, this increase was successfully blocked by dupilumab. Furthermore, omalizumab has been shown to modulate helper T cell (TH2) cytokine response such as thymic stromal lymphopoietin.6 A cytokine imbalance could have exacerbated AD in our case.
Although additional work to clarify the pathogenesis of AD is needed, it is important to recognize the potential for the occurrence of paradoxical AD flares in patients treated with omalizumab, which is analogous to the well-documented entity of tumor necrosis factor α inhibitor–induced psoriasis. It is equally important to recognize the potential benefit for patients treated with dupilumab.
- Nygaard U, Vestergaard C, Deleuran M. Emerging treatment options in atopic dermatitis: systemic therapies. Dermatology. 2017;233:344-357.
- Holm JG, Agner T, Sand C, et al. Omalizumab for atopic dermatitis: case series and a systematic review of the literature. Int J Dermatol. 2017;56:18-26.
- Chan S, Cornelius V, Cro S, et al. Treatment effect of omalizumab on severe pediatric atopic dermatitis: the ADAPT randomized clinical trial. JAMA Pediatr. 2020;174:29-37.
- Heil PM, Maurer D, Klein B, et al. Omalizumab therapy in atopic dermatitis: depletion of IgE does not improve the clinical course – a randomized placebo-controlled and double blind pilot study. J Dtsch Dermatol Ges. 2010;8:990-998.
- Imai Y. Interleukin-33 in atopic dermatitis. J Dermatol Sci. 2019;96:2-7.
- Iyengar SR, Hoyte EG, Loza A, et al. Immunologic effects of omalizumab in children with severe refractory atopic dermatitis: a randomized, placebo-controlled clinical trial. Int Arch Allergy Immunol. 2013;162:89-93.
- Nygaard U, Vestergaard C, Deleuran M. Emerging treatment options in atopic dermatitis: systemic therapies. Dermatology. 2017;233:344-357.
- Holm JG, Agner T, Sand C, et al. Omalizumab for atopic dermatitis: case series and a systematic review of the literature. Int J Dermatol. 2017;56:18-26.
- Chan S, Cornelius V, Cro S, et al. Treatment effect of omalizumab on severe pediatric atopic dermatitis: the ADAPT randomized clinical trial. JAMA Pediatr. 2020;174:29-37.
- Heil PM, Maurer D, Klein B, et al. Omalizumab therapy in atopic dermatitis: depletion of IgE does not improve the clinical course – a randomized placebo-controlled and double blind pilot study. J Dtsch Dermatol Ges. 2010;8:990-998.
- Imai Y. Interleukin-33 in atopic dermatitis. J Dermatol Sci. 2019;96:2-7.
- Iyengar SR, Hoyte EG, Loza A, et al. Immunologic effects of omalizumab in children with severe refractory atopic dermatitis: a randomized, placebo-controlled clinical trial. Int Arch Allergy Immunol. 2013;162:89-93.
Practice Points
- Monoclonal antibodies are promising therapies for atopic conditions, although its efficacy for atopic dermatitis (AD) is debated and the side-effect profile is not entirely known.
- Omalizumab may cause a paradoxical exacerbation of AD in select patients analogous to tumor necrosis factor α inhibitor–induced psoriasis.