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Dupilumab Boosts Clinical and Molecular Responses in Pediatric Atopic Dermatitis
Key clinical point: Dupilumab treatment was well-tolerated and demonstrated improved clinical and molecular responses in pediatric patients with moderate to severe atopic dermatitis (AD).
Major finding: Dupilumab significantly reduced Eczema Area and Severity Index, SCORing Atopic Dermatitis index, and Investigator’s Global Assessment scores at 3 and 6 months (all P < .05), along with significant reduction in AD-associated stratum corneum biomarker levels at 3 months (P < .01). Dupilumab showed good tolerability, with adverse events reported in only four patients.
Study details: This study included 314 pediatric patients with moderate to severe AD from the German TREATkids registry, of whom 87 received dupilumab.
Disclosures: TREATkids is the child and adolescent section of the TREATgermany registry, which is supported by AbbVie Deutschland GmbH & Co. KG, Almirall Hermal GmbH, Galderma S.A., LEO Pharma GmbH, Lilly Deutschland GmbH, Pfizer Inc., and Sanofi. Several authors declared receiving research grants, lecture, or consultancy fees from or having other ties with various sources, including the supporters of TREATgermany.
Source: Stölzl D, Sander N, Siegels D, et al, and the TREATgermany study group. Clinical and molecular response to dupilumab treatment in pediatric atopic dermatitis: Results of the German TREATkids registry. Allergy. 2024 (May 7). doi: 0.1111/all.16147 Source
Key clinical point: Dupilumab treatment was well-tolerated and demonstrated improved clinical and molecular responses in pediatric patients with moderate to severe atopic dermatitis (AD).
Major finding: Dupilumab significantly reduced Eczema Area and Severity Index, SCORing Atopic Dermatitis index, and Investigator’s Global Assessment scores at 3 and 6 months (all P < .05), along with significant reduction in AD-associated stratum corneum biomarker levels at 3 months (P < .01). Dupilumab showed good tolerability, with adverse events reported in only four patients.
Study details: This study included 314 pediatric patients with moderate to severe AD from the German TREATkids registry, of whom 87 received dupilumab.
Disclosures: TREATkids is the child and adolescent section of the TREATgermany registry, which is supported by AbbVie Deutschland GmbH & Co. KG, Almirall Hermal GmbH, Galderma S.A., LEO Pharma GmbH, Lilly Deutschland GmbH, Pfizer Inc., and Sanofi. Several authors declared receiving research grants, lecture, or consultancy fees from or having other ties with various sources, including the supporters of TREATgermany.
Source: Stölzl D, Sander N, Siegels D, et al, and the TREATgermany study group. Clinical and molecular response to dupilumab treatment in pediatric atopic dermatitis: Results of the German TREATkids registry. Allergy. 2024 (May 7). doi: 0.1111/all.16147 Source
Key clinical point: Dupilumab treatment was well-tolerated and demonstrated improved clinical and molecular responses in pediatric patients with moderate to severe atopic dermatitis (AD).
Major finding: Dupilumab significantly reduced Eczema Area and Severity Index, SCORing Atopic Dermatitis index, and Investigator’s Global Assessment scores at 3 and 6 months (all P < .05), along with significant reduction in AD-associated stratum corneum biomarker levels at 3 months (P < .01). Dupilumab showed good tolerability, with adverse events reported in only four patients.
Study details: This study included 314 pediatric patients with moderate to severe AD from the German TREATkids registry, of whom 87 received dupilumab.
Disclosures: TREATkids is the child and adolescent section of the TREATgermany registry, which is supported by AbbVie Deutschland GmbH & Co. KG, Almirall Hermal GmbH, Galderma S.A., LEO Pharma GmbH, Lilly Deutschland GmbH, Pfizer Inc., and Sanofi. Several authors declared receiving research grants, lecture, or consultancy fees from or having other ties with various sources, including the supporters of TREATgermany.
Source: Stölzl D, Sander N, Siegels D, et al, and the TREATgermany study group. Clinical and molecular response to dupilumab treatment in pediatric atopic dermatitis: Results of the German TREATkids registry. Allergy. 2024 (May 7). doi: 0.1111/all.16147 Source
Lebrikizumab Shows Prompt Clinical Response in Moderate to Severe Atopic Dermatitis
Key clinical point: Lebrikizumab monotherapy rapidly and consistently reduced atopic dermatitis (AD) extent and severity in patients with moderate to severe AD across all Eczema Area and Severity Index (EASI) clinical signs and body regions.
Major finding: At week 16, lebrikizumab vs placebo led to greater improvements in EASI scores and clinical signs (both P < .001) across all body regions in ADvocate1 and ADvocate2, with improvements observed as early as week 2 for all signs except erythema on head/neck (P < .05) and lower extremity erythema, edema/papulation, and lichenification (all P < .001), which improved significantly only by week 4 in ADvocate2.
Study details: This post hoc analysis of ADvocate1 (n = 424) and ADvocate2 (n = 427) included adolescent and adult patients with moderate to severe AD who were randomly assigned to receive 250 mg lebrikizumab biweekly or placebo.
Disclosures: This study was funded by Dermira, Inc., a wholly owned subsidiary of Eli Lilly and Company. Several authors declared having various ties with Dermira, Eli Lilly, and others. Five authors declared being employees or stockholders of Eli Lilly.
Source: Simpson EL, de Bruin-Weller M, Hong HC, et al. Lebrikizumab provides rapid clinical responses across all Eczema Area and Severity Index body regions and clinical signs in adolescents and adults with moderate-to-severe atopic dermatitis. Dermatol Ther (Heidelb). 2024 (May 3). doi: 10.1007/s13555-024-01158-4 Source
Key clinical point: Lebrikizumab monotherapy rapidly and consistently reduced atopic dermatitis (AD) extent and severity in patients with moderate to severe AD across all Eczema Area and Severity Index (EASI) clinical signs and body regions.
Major finding: At week 16, lebrikizumab vs placebo led to greater improvements in EASI scores and clinical signs (both P < .001) across all body regions in ADvocate1 and ADvocate2, with improvements observed as early as week 2 for all signs except erythema on head/neck (P < .05) and lower extremity erythema, edema/papulation, and lichenification (all P < .001), which improved significantly only by week 4 in ADvocate2.
Study details: This post hoc analysis of ADvocate1 (n = 424) and ADvocate2 (n = 427) included adolescent and adult patients with moderate to severe AD who were randomly assigned to receive 250 mg lebrikizumab biweekly or placebo.
Disclosures: This study was funded by Dermira, Inc., a wholly owned subsidiary of Eli Lilly and Company. Several authors declared having various ties with Dermira, Eli Lilly, and others. Five authors declared being employees or stockholders of Eli Lilly.
Source: Simpson EL, de Bruin-Weller M, Hong HC, et al. Lebrikizumab provides rapid clinical responses across all Eczema Area and Severity Index body regions and clinical signs in adolescents and adults with moderate-to-severe atopic dermatitis. Dermatol Ther (Heidelb). 2024 (May 3). doi: 10.1007/s13555-024-01158-4 Source
Key clinical point: Lebrikizumab monotherapy rapidly and consistently reduced atopic dermatitis (AD) extent and severity in patients with moderate to severe AD across all Eczema Area and Severity Index (EASI) clinical signs and body regions.
Major finding: At week 16, lebrikizumab vs placebo led to greater improvements in EASI scores and clinical signs (both P < .001) across all body regions in ADvocate1 and ADvocate2, with improvements observed as early as week 2 for all signs except erythema on head/neck (P < .05) and lower extremity erythema, edema/papulation, and lichenification (all P < .001), which improved significantly only by week 4 in ADvocate2.
Study details: This post hoc analysis of ADvocate1 (n = 424) and ADvocate2 (n = 427) included adolescent and adult patients with moderate to severe AD who were randomly assigned to receive 250 mg lebrikizumab biweekly or placebo.
Disclosures: This study was funded by Dermira, Inc., a wholly owned subsidiary of Eli Lilly and Company. Several authors declared having various ties with Dermira, Eli Lilly, and others. Five authors declared being employees or stockholders of Eli Lilly.
Source: Simpson EL, de Bruin-Weller M, Hong HC, et al. Lebrikizumab provides rapid clinical responses across all Eczema Area and Severity Index body regions and clinical signs in adolescents and adults with moderate-to-severe atopic dermatitis. Dermatol Ther (Heidelb). 2024 (May 3). doi: 10.1007/s13555-024-01158-4 Source
Causal Relationship Exists Between Atopic Dermatitis and Brain Cancer
Key clinical point: A causal relationship was observed between genetically related atopic dermatitis (AD) and brain cancer, delineating AD as a potential risk factor for brain cancer.
Major finding: The presence of AD led to an increased risk for brain cancer (odds ratio 1.0005; P = .0096); however, no significant causal association was observed on conducting reverse Mendelian randomization analysis.
Study details: This cohort study analyzed the data on AD-associated single nucleotide polymorphisms of patients with AD (n = 15,208) and control individuals without AD (n = 367,046) from the FinnGen database (10th release) and the summary data of patients with brain cancer (n = 606) and control individuals without cancer (n = 372,016) from the IEU Open GWAS database.
Disclosures: This study did not disclose any funding source. The authors declared no conflicts of interest.
Source: Xin Y, Yuan T, Wang J. The causal relationship between atopic dermatitis and brain cancer: A bidirectional Mendelian randomization study. Skin Res Technol. 2024;30(4):e13715. doi: 10.1111/srt.13715 Source
Key clinical point: A causal relationship was observed between genetically related atopic dermatitis (AD) and brain cancer, delineating AD as a potential risk factor for brain cancer.
Major finding: The presence of AD led to an increased risk for brain cancer (odds ratio 1.0005; P = .0096); however, no significant causal association was observed on conducting reverse Mendelian randomization analysis.
Study details: This cohort study analyzed the data on AD-associated single nucleotide polymorphisms of patients with AD (n = 15,208) and control individuals without AD (n = 367,046) from the FinnGen database (10th release) and the summary data of patients with brain cancer (n = 606) and control individuals without cancer (n = 372,016) from the IEU Open GWAS database.
Disclosures: This study did not disclose any funding source. The authors declared no conflicts of interest.
Source: Xin Y, Yuan T, Wang J. The causal relationship between atopic dermatitis and brain cancer: A bidirectional Mendelian randomization study. Skin Res Technol. 2024;30(4):e13715. doi: 10.1111/srt.13715 Source
Key clinical point: A causal relationship was observed between genetically related atopic dermatitis (AD) and brain cancer, delineating AD as a potential risk factor for brain cancer.
Major finding: The presence of AD led to an increased risk for brain cancer (odds ratio 1.0005; P = .0096); however, no significant causal association was observed on conducting reverse Mendelian randomization analysis.
Study details: This cohort study analyzed the data on AD-associated single nucleotide polymorphisms of patients with AD (n = 15,208) and control individuals without AD (n = 367,046) from the FinnGen database (10th release) and the summary data of patients with brain cancer (n = 606) and control individuals without cancer (n = 372,016) from the IEU Open GWAS database.
Disclosures: This study did not disclose any funding source. The authors declared no conflicts of interest.
Source: Xin Y, Yuan T, Wang J. The causal relationship between atopic dermatitis and brain cancer: A bidirectional Mendelian randomization study. Skin Res Technol. 2024;30(4):e13715. doi: 10.1111/srt.13715 Source
Preventive Effect of Maternal Probiotic Supplementation in Atopic Dermatitis
Key clinical point: Maternal probiotic supplementation was effective in preventing atopic dermatitis (AD) in children regardless of their filaggrin (FLG) gene mutation status.
Major finding: Heterozygous FLG mutations were observed in 7% of children. The risk for AD after maternal probiotic supplementation was similar between children who expressed a FLG mutation (risk ratio [RR] 0.6; 95% CI 0.1-4.1) and those having a wild-type FLG (RR 0.6; 95% CI 0.4-0.9).
Study details: This exploratory study included the data of 228 children from the Probiotic in the Prevention of Allergy among Children in Trondheim (ProPACT) study who did or did not have FLG mutations and whose mothers received probiotic or placebo milk from 36 weeks of gestation until 3 months post delivery while breastfeeding.
Disclosures: This study was funded by the Liaison Committee between the Central Norway Regional Health Authority and the Norwegian University of Science and Technology, and the Norwegian Research Council. The authors declared no conflicts of interest.
Source: Zakiudin DP, Thyssen JP, Zachariae C, Videm V, Øien T, Simpson MR. Filaggrin mutation status and prevention of atopic dermatitis with maternal probiotic supplementation. Acta Derm Venereol. 2024;104:adv24360 (Apr 24). doi: 10.2340/actadv.v104.24360 Source
Key clinical point: Maternal probiotic supplementation was effective in preventing atopic dermatitis (AD) in children regardless of their filaggrin (FLG) gene mutation status.
Major finding: Heterozygous FLG mutations were observed in 7% of children. The risk for AD after maternal probiotic supplementation was similar between children who expressed a FLG mutation (risk ratio [RR] 0.6; 95% CI 0.1-4.1) and those having a wild-type FLG (RR 0.6; 95% CI 0.4-0.9).
Study details: This exploratory study included the data of 228 children from the Probiotic in the Prevention of Allergy among Children in Trondheim (ProPACT) study who did or did not have FLG mutations and whose mothers received probiotic or placebo milk from 36 weeks of gestation until 3 months post delivery while breastfeeding.
Disclosures: This study was funded by the Liaison Committee between the Central Norway Regional Health Authority and the Norwegian University of Science and Technology, and the Norwegian Research Council. The authors declared no conflicts of interest.
Source: Zakiudin DP, Thyssen JP, Zachariae C, Videm V, Øien T, Simpson MR. Filaggrin mutation status and prevention of atopic dermatitis with maternal probiotic supplementation. Acta Derm Venereol. 2024;104:adv24360 (Apr 24). doi: 10.2340/actadv.v104.24360 Source
Key clinical point: Maternal probiotic supplementation was effective in preventing atopic dermatitis (AD) in children regardless of their filaggrin (FLG) gene mutation status.
Major finding: Heterozygous FLG mutations were observed in 7% of children. The risk for AD after maternal probiotic supplementation was similar between children who expressed a FLG mutation (risk ratio [RR] 0.6; 95% CI 0.1-4.1) and those having a wild-type FLG (RR 0.6; 95% CI 0.4-0.9).
Study details: This exploratory study included the data of 228 children from the Probiotic in the Prevention of Allergy among Children in Trondheim (ProPACT) study who did or did not have FLG mutations and whose mothers received probiotic or placebo milk from 36 weeks of gestation until 3 months post delivery while breastfeeding.
Disclosures: This study was funded by the Liaison Committee between the Central Norway Regional Health Authority and the Norwegian University of Science and Technology, and the Norwegian Research Council. The authors declared no conflicts of interest.
Source: Zakiudin DP, Thyssen JP, Zachariae C, Videm V, Øien T, Simpson MR. Filaggrin mutation status and prevention of atopic dermatitis with maternal probiotic supplementation. Acta Derm Venereol. 2024;104:adv24360 (Apr 24). doi: 10.2340/actadv.v104.24360 Source
Pharmacological Interventions in Atopic Dermatitis Reduce Anxiety and Depression
Key clinical point: Pharmacological interventions aimed at reducing disease severity in patients with moderate to severe atopic dermatitis (AD) are also effective for improving anxiety and depression.
Major finding: Pharmacologic interventions for AD led to significant improvements in anxiety levels (standardized mean difference [SMD] −0.29; 95% CI −0.49 to −0.09) and depression severity (SMD −0.27; 95% CI −0.45 to −0.08) and an overall significant improvement in Hospital Anxiety and Depression scale scores (SMD −0.50; 95% CI −0.064 to −0.35).
Study details: This meta-analysis of seven phase 2b or 3 randomized controlled trials included 4723 patients with AD who were treated with either abrocitinib, baricitinib, dupilumab, tralokinumab, or placebo.
Disclosures: This study did not disclose any funding source. The authors declared no conflicts of interest.
Source: Hartono SP, Chatrath S, Aktas ON, et al. Interventions for anxiety and depression in patients with atopic dermatitis: A systematic review and meta-analysis. Sci Rep. 2024;14:8844 (Apr 17). Source
Key clinical point: Pharmacological interventions aimed at reducing disease severity in patients with moderate to severe atopic dermatitis (AD) are also effective for improving anxiety and depression.
Major finding: Pharmacologic interventions for AD led to significant improvements in anxiety levels (standardized mean difference [SMD] −0.29; 95% CI −0.49 to −0.09) and depression severity (SMD −0.27; 95% CI −0.45 to −0.08) and an overall significant improvement in Hospital Anxiety and Depression scale scores (SMD −0.50; 95% CI −0.064 to −0.35).
Study details: This meta-analysis of seven phase 2b or 3 randomized controlled trials included 4723 patients with AD who were treated with either abrocitinib, baricitinib, dupilumab, tralokinumab, or placebo.
Disclosures: This study did not disclose any funding source. The authors declared no conflicts of interest.
Source: Hartono SP, Chatrath S, Aktas ON, et al. Interventions for anxiety and depression in patients with atopic dermatitis: A systematic review and meta-analysis. Sci Rep. 2024;14:8844 (Apr 17). Source
Key clinical point: Pharmacological interventions aimed at reducing disease severity in patients with moderate to severe atopic dermatitis (AD) are also effective for improving anxiety and depression.
Major finding: Pharmacologic interventions for AD led to significant improvements in anxiety levels (standardized mean difference [SMD] −0.29; 95% CI −0.49 to −0.09) and depression severity (SMD −0.27; 95% CI −0.45 to −0.08) and an overall significant improvement in Hospital Anxiety and Depression scale scores (SMD −0.50; 95% CI −0.064 to −0.35).
Study details: This meta-analysis of seven phase 2b or 3 randomized controlled trials included 4723 patients with AD who were treated with either abrocitinib, baricitinib, dupilumab, tralokinumab, or placebo.
Disclosures: This study did not disclose any funding source. The authors declared no conflicts of interest.
Source: Hartono SP, Chatrath S, Aktas ON, et al. Interventions for anxiety and depression in patients with atopic dermatitis: A systematic review and meta-analysis. Sci Rep. 2024;14:8844 (Apr 17). Source
Comparable Efficacy of Tralokinumab and Dupilumab in Moderate to Severe Atopic Dermatitis
Key clinical point: When combined with topical corticosteroids (TCS), tralokinumab and dupilumab demonstrate similar efficacy in the treatment of patients with moderate to severe atopic dermatitis (AD) at 32 weeks of therapy.
Major finding: At week 32, tralokinumab and dupilumab treatment, both in combination with TCS, led to a similar proportion of patients achieving an Investigator's Global Assessment score of 0 or 1 (49.9% vs 39.3%; P = .95) or 75% improvement in the Eczema Area Severity Index scores (71.5% vs 71.9%; P = .95).
Study details: This unanchored matching-adjusted indirect comparison study analyzed the individual patient data of adults with moderate to severe AD (sample size 123.4) treated with tralokinumab plus TCS in ECZTRA 3, which were matched with the aggregate data of 106 patients treated with dupilumab plus TCS in the LIBERTY AD CHRONOS trial.
Disclosures: This study was funded by LEO Pharma. Four authors declared being employees of LEO Pharma. The other authors declared receiving consultancy or speaker honoraria from or having other ties with various sources, including LEO Pharma.
Source: Torres T, Sohrt Petersen A, Ivens U, et al. Matching-adjusted indirect comparison of the efficacy at week 32 of tralokinumab and dupilumab in the treatment of moderate-to-severe atopic dermatitis. Dermatol Ther (Heidelb). 2024;14:983-992 (Apr 13). doi: 10.1007/s13555-024-01143-x Source
Key clinical point: When combined with topical corticosteroids (TCS), tralokinumab and dupilumab demonstrate similar efficacy in the treatment of patients with moderate to severe atopic dermatitis (AD) at 32 weeks of therapy.
Major finding: At week 32, tralokinumab and dupilumab treatment, both in combination with TCS, led to a similar proportion of patients achieving an Investigator's Global Assessment score of 0 or 1 (49.9% vs 39.3%; P = .95) or 75% improvement in the Eczema Area Severity Index scores (71.5% vs 71.9%; P = .95).
Study details: This unanchored matching-adjusted indirect comparison study analyzed the individual patient data of adults with moderate to severe AD (sample size 123.4) treated with tralokinumab plus TCS in ECZTRA 3, which were matched with the aggregate data of 106 patients treated with dupilumab plus TCS in the LIBERTY AD CHRONOS trial.
Disclosures: This study was funded by LEO Pharma. Four authors declared being employees of LEO Pharma. The other authors declared receiving consultancy or speaker honoraria from or having other ties with various sources, including LEO Pharma.
Source: Torres T, Sohrt Petersen A, Ivens U, et al. Matching-adjusted indirect comparison of the efficacy at week 32 of tralokinumab and dupilumab in the treatment of moderate-to-severe atopic dermatitis. Dermatol Ther (Heidelb). 2024;14:983-992 (Apr 13). doi: 10.1007/s13555-024-01143-x Source
Key clinical point: When combined with topical corticosteroids (TCS), tralokinumab and dupilumab demonstrate similar efficacy in the treatment of patients with moderate to severe atopic dermatitis (AD) at 32 weeks of therapy.
Major finding: At week 32, tralokinumab and dupilumab treatment, both in combination with TCS, led to a similar proportion of patients achieving an Investigator's Global Assessment score of 0 or 1 (49.9% vs 39.3%; P = .95) or 75% improvement in the Eczema Area Severity Index scores (71.5% vs 71.9%; P = .95).
Study details: This unanchored matching-adjusted indirect comparison study analyzed the individual patient data of adults with moderate to severe AD (sample size 123.4) treated with tralokinumab plus TCS in ECZTRA 3, which were matched with the aggregate data of 106 patients treated with dupilumab plus TCS in the LIBERTY AD CHRONOS trial.
Disclosures: This study was funded by LEO Pharma. Four authors declared being employees of LEO Pharma. The other authors declared receiving consultancy or speaker honoraria from or having other ties with various sources, including LEO Pharma.
Source: Torres T, Sohrt Petersen A, Ivens U, et al. Matching-adjusted indirect comparison of the efficacy at week 32 of tralokinumab and dupilumab in the treatment of moderate-to-severe atopic dermatitis. Dermatol Ther (Heidelb). 2024;14:983-992 (Apr 13). doi: 10.1007/s13555-024-01143-x Source
Topical Ruxolitinib Provides Long-Term Disease Control in Adolescents With Atopic Dermatitis
Key clinical point: Topical 1.5% ruxolitinib was effective and well-tolerated and offered long-term disease control with as-needed use in adolescents with atopic dermatitis (AD).
Major finding: At week 8, a substantially higher number of patients receiving 1.5% ruxolitinib vs vehicle achieved an Investigator's Global Assessment (IGA) score of 0 or 1 with ≥2 grade improvement from baseline (50.6% vs 14.0%) and ≥75% improvement in the Eczema Area and Severity Index score (60.9% vs 34.9%), with sustained or increased proportion of patients achieving an IGA score of 0 or 1 during the long-term safety (LTS) period. No serious adverse events were reported.
Study details: This study used pooled data from two phase 3 trials (TRuE-AD1 and TRuE-AD2) and included 137 adolescents (age, 12-17 years) with AD who were randomly assigned to receive 0.75% or 1.5% ruxolitinib cream or vehicle twice daily for 8 weeks, followed by an LTS period lasting up to 52 weeks.
Disclosures: This study was funded by Incyte Corporation. Four authors declared being employees or shareholders of Incyte Corporation. Several authors declared ties with various sources, including Incyte Corporation.
Source: Eichenfield LF, Simpson EL, Papp K, et al. Efficacy, safety, and long-term disease control of ruxolitinib cream among adolescents with atopic dermatitis: Pooled results from two randomized phase 3 studies. Am J Clin Dermatol. 2024 (May 2). doi: 10.1007/s40257-024-00855-2 Source
Key clinical point: Topical 1.5% ruxolitinib was effective and well-tolerated and offered long-term disease control with as-needed use in adolescents with atopic dermatitis (AD).
Major finding: At week 8, a substantially higher number of patients receiving 1.5% ruxolitinib vs vehicle achieved an Investigator's Global Assessment (IGA) score of 0 or 1 with ≥2 grade improvement from baseline (50.6% vs 14.0%) and ≥75% improvement in the Eczema Area and Severity Index score (60.9% vs 34.9%), with sustained or increased proportion of patients achieving an IGA score of 0 or 1 during the long-term safety (LTS) period. No serious adverse events were reported.
Study details: This study used pooled data from two phase 3 trials (TRuE-AD1 and TRuE-AD2) and included 137 adolescents (age, 12-17 years) with AD who were randomly assigned to receive 0.75% or 1.5% ruxolitinib cream or vehicle twice daily for 8 weeks, followed by an LTS period lasting up to 52 weeks.
Disclosures: This study was funded by Incyte Corporation. Four authors declared being employees or shareholders of Incyte Corporation. Several authors declared ties with various sources, including Incyte Corporation.
Source: Eichenfield LF, Simpson EL, Papp K, et al. Efficacy, safety, and long-term disease control of ruxolitinib cream among adolescents with atopic dermatitis: Pooled results from two randomized phase 3 studies. Am J Clin Dermatol. 2024 (May 2). doi: 10.1007/s40257-024-00855-2 Source
Key clinical point: Topical 1.5% ruxolitinib was effective and well-tolerated and offered long-term disease control with as-needed use in adolescents with atopic dermatitis (AD).
Major finding: At week 8, a substantially higher number of patients receiving 1.5% ruxolitinib vs vehicle achieved an Investigator's Global Assessment (IGA) score of 0 or 1 with ≥2 grade improvement from baseline (50.6% vs 14.0%) and ≥75% improvement in the Eczema Area and Severity Index score (60.9% vs 34.9%), with sustained or increased proportion of patients achieving an IGA score of 0 or 1 during the long-term safety (LTS) period. No serious adverse events were reported.
Study details: This study used pooled data from two phase 3 trials (TRuE-AD1 and TRuE-AD2) and included 137 adolescents (age, 12-17 years) with AD who were randomly assigned to receive 0.75% or 1.5% ruxolitinib cream or vehicle twice daily for 8 weeks, followed by an LTS period lasting up to 52 weeks.
Disclosures: This study was funded by Incyte Corporation. Four authors declared being employees or shareholders of Incyte Corporation. Several authors declared ties with various sources, including Incyte Corporation.
Source: Eichenfield LF, Simpson EL, Papp K, et al. Efficacy, safety, and long-term disease control of ruxolitinib cream among adolescents with atopic dermatitis: Pooled results from two randomized phase 3 studies. Am J Clin Dermatol. 2024 (May 2). doi: 10.1007/s40257-024-00855-2 Source
Obesity Associated With Disease Severity in Moderate to Severe Atopic Dermatitis
Key clinical point: Obesity is significantly associated with patient- and physician-assessed measures of atopic dermatitis (AD) disease severity.
Major finding: Increased body mass index (BMI) values were associated with higher disease severity as assessed by objective Scoring AD (adjusted β 1.24; P = .013) and patient-oriented eczema measure (adjusted β 1.09; P = .038) scores.
Study details: This study based on data from the prospective observational TREATgermany registry included 1416 patients with moderate to severe AD who were either underweight (BMI < 18.5 kg/m2; n = 33), normal weight or overweight (nonobese; BMI ≥ 18.5 and < 30 kg/m2; n = 1149), or obese (BMI ≥ 30 kg/m2; n = 234).
Disclosures: The TREATgermany registry is supported by AbbVie Deutschland GmbH & Co. KG, Galderma SA, LEO Pharma GmbH, Lilly Deutschland GmbH, Pfizer Inc., and Sanofi. Eight authors declared serving as consultants or lecturers for or receiving research grants, personal fees, or lecture or consulting honoraria from various sources, including some of the supporters of TREATgermany.
Source: Traidl S, Hollstein MM, Kroeger N, et al, and The TREATgermany Study Group. Obesity is linked to disease severity in moderate to severe atopic dermatitis—Data from the prospective observational TREATgermany registry. J Eur Acad Dermatol Venereol. 2024 (Apr 25). doi: 10.1111/jdv.20042 Source
Key clinical point: Obesity is significantly associated with patient- and physician-assessed measures of atopic dermatitis (AD) disease severity.
Major finding: Increased body mass index (BMI) values were associated with higher disease severity as assessed by objective Scoring AD (adjusted β 1.24; P = .013) and patient-oriented eczema measure (adjusted β 1.09; P = .038) scores.
Study details: This study based on data from the prospective observational TREATgermany registry included 1416 patients with moderate to severe AD who were either underweight (BMI < 18.5 kg/m2; n = 33), normal weight or overweight (nonobese; BMI ≥ 18.5 and < 30 kg/m2; n = 1149), or obese (BMI ≥ 30 kg/m2; n = 234).
Disclosures: The TREATgermany registry is supported by AbbVie Deutschland GmbH & Co. KG, Galderma SA, LEO Pharma GmbH, Lilly Deutschland GmbH, Pfizer Inc., and Sanofi. Eight authors declared serving as consultants or lecturers for or receiving research grants, personal fees, or lecture or consulting honoraria from various sources, including some of the supporters of TREATgermany.
Source: Traidl S, Hollstein MM, Kroeger N, et al, and The TREATgermany Study Group. Obesity is linked to disease severity in moderate to severe atopic dermatitis—Data from the prospective observational TREATgermany registry. J Eur Acad Dermatol Venereol. 2024 (Apr 25). doi: 10.1111/jdv.20042 Source
Key clinical point: Obesity is significantly associated with patient- and physician-assessed measures of atopic dermatitis (AD) disease severity.
Major finding: Increased body mass index (BMI) values were associated with higher disease severity as assessed by objective Scoring AD (adjusted β 1.24; P = .013) and patient-oriented eczema measure (adjusted β 1.09; P = .038) scores.
Study details: This study based on data from the prospective observational TREATgermany registry included 1416 patients with moderate to severe AD who were either underweight (BMI < 18.5 kg/m2; n = 33), normal weight or overweight (nonobese; BMI ≥ 18.5 and < 30 kg/m2; n = 1149), or obese (BMI ≥ 30 kg/m2; n = 234).
Disclosures: The TREATgermany registry is supported by AbbVie Deutschland GmbH & Co. KG, Galderma SA, LEO Pharma GmbH, Lilly Deutschland GmbH, Pfizer Inc., and Sanofi. Eight authors declared serving as consultants or lecturers for or receiving research grants, personal fees, or lecture or consulting honoraria from various sources, including some of the supporters of TREATgermany.
Source: Traidl S, Hollstein MM, Kroeger N, et al, and The TREATgermany Study Group. Obesity is linked to disease severity in moderate to severe atopic dermatitis—Data from the prospective observational TREATgermany registry. J Eur Acad Dermatol Venereol. 2024 (Apr 25). doi: 10.1111/jdv.20042 Source
Antibiotics in Early Infancy Disrupt Gut Microbiome and Increase Risk for Atopic Dermatitis
Key clinical point: Antibiotic use early in life, especially within one year of age, disrupts the gut microbiome and increases the risk for atopic dermatitis (AD) at 5 years of age.
Major finding: Children who received antibiotics during the first year of life vs later were significantly more likely to develop AD at 5 years of age (adjusted odds ratio [aOR] 1.81; P < .001), with an increased number of antibiotic courses leading to a dose-response-like increased risk for AD (1 course: aOR 1.67; P = .0044; ≥ 2 courses: aOR 2.16; P = .0030).
Study details: This study analyzed the clinical data for AD diagnosis at age 5 years of 2484 children from the prospective, general population CHILD birth cohort, which enrolled pregnant women and infants with no congenital abnormalities born at ≥ 34 weeks of gestation.
Disclosures: The CHILD Study is funded by the Canadian Institutes of Health Research, the Allergy, Genes, and Environment Network of Centres of Excellence, Debbie and Don Morrison, and others. The authors declared no conflicts of interest.
Source: Hoskinson C, Medeleanu MV, Reyna ME, et al. Antibiotics within first year are linked to infant gut microbiome disruption and elevated atopic dermatitis risk. J Allergy Clin Immunol. 2024 (Apr 24). doi: 10.1016/j.jaci.2024.03.025 Source
Key clinical point: Antibiotic use early in life, especially within one year of age, disrupts the gut microbiome and increases the risk for atopic dermatitis (AD) at 5 years of age.
Major finding: Children who received antibiotics during the first year of life vs later were significantly more likely to develop AD at 5 years of age (adjusted odds ratio [aOR] 1.81; P < .001), with an increased number of antibiotic courses leading to a dose-response-like increased risk for AD (1 course: aOR 1.67; P = .0044; ≥ 2 courses: aOR 2.16; P = .0030).
Study details: This study analyzed the clinical data for AD diagnosis at age 5 years of 2484 children from the prospective, general population CHILD birth cohort, which enrolled pregnant women and infants with no congenital abnormalities born at ≥ 34 weeks of gestation.
Disclosures: The CHILD Study is funded by the Canadian Institutes of Health Research, the Allergy, Genes, and Environment Network of Centres of Excellence, Debbie and Don Morrison, and others. The authors declared no conflicts of interest.
Source: Hoskinson C, Medeleanu MV, Reyna ME, et al. Antibiotics within first year are linked to infant gut microbiome disruption and elevated atopic dermatitis risk. J Allergy Clin Immunol. 2024 (Apr 24). doi: 10.1016/j.jaci.2024.03.025 Source
Key clinical point: Antibiotic use early in life, especially within one year of age, disrupts the gut microbiome and increases the risk for atopic dermatitis (AD) at 5 years of age.
Major finding: Children who received antibiotics during the first year of life vs later were significantly more likely to develop AD at 5 years of age (adjusted odds ratio [aOR] 1.81; P < .001), with an increased number of antibiotic courses leading to a dose-response-like increased risk for AD (1 course: aOR 1.67; P = .0044; ≥ 2 courses: aOR 2.16; P = .0030).
Study details: This study analyzed the clinical data for AD diagnosis at age 5 years of 2484 children from the prospective, general population CHILD birth cohort, which enrolled pregnant women and infants with no congenital abnormalities born at ≥ 34 weeks of gestation.
Disclosures: The CHILD Study is funded by the Canadian Institutes of Health Research, the Allergy, Genes, and Environment Network of Centres of Excellence, Debbie and Don Morrison, and others. The authors declared no conflicts of interest.
Source: Hoskinson C, Medeleanu MV, Reyna ME, et al. Antibiotics within first year are linked to infant gut microbiome disruption and elevated atopic dermatitis risk. J Allergy Clin Immunol. 2024 (Apr 24). doi: 10.1016/j.jaci.2024.03.025 Source
Commentary: Studies Often Do Not Answer Clinical Questions in AD, May 2024
In "Atopic Dermatitis in Early Childhood and Risk of Inflammatory Bowel Disease: A Scandinavian Birth Cohort Study," Lerchova and colleagues found a statistically significant increased risk for inflammatory bowel disease (IBD) in children with atopic dermatitis. The study had a large patient population, giving it the power to identify very small differences. The researchers found increased risks for IBD, Crohn's disease, and ulcerative colitis (UC) in children with atopic dermatitis; UC had the greatest relative risk. But I don't think this risk was clinically meaningful. About 2 in every 1000 children with atopic dermatitis had UC, whereas about 1 in every 1000 children without atopic dermatitis had UC. Even if the increased absolute risk of 1 in 1000 children was due to atopic dermatitis and not to other factors, I don't think it justifies the authors' conclusion that "these findings might be useful in identifying at-risk individuals for IBD."
Sometimes reviewing articles makes me feel like a crotchety old man. A study by Guttman-Yassky and colleagues, "Targeting IL-13 With Tralokinumab Normalizes Type 2 Inflammation in Atopic Dermatitis Both Early and at 2 Years," didn't seem to test any specific hypothesis. The researchers just looked at a variety of inflammation markers in patients with atopic dermatitis treated with tralokinumab, an interleukin-13 (IL-13) antagonist. In these patients, as expected, the atopic dermatitis improved; so did the inflammatory markers. Did we learn anything clinically useful? I don't think so. We already know that IL-13 is important in atopic dermatitis because when we block IL-13, atopic dermatitis improves.
Vitamin D supplementation doesn't appear to improve atopic dermatitis, as reported by Borzutzky and colleagues in "Effect of Weekly Vitamin D Supplementation on the Severity of Atopic Dermatitis and Type 2 Immunity Biomarkers in Children: A Randomized Controlled Trial." A group of 101 children with atopic dermatitis were randomly assigned to receive oral vitamin D supplementation or placebo. The two groups improved to a similar extent. If you know me, you know I'm wondering whether they took the medication. It appears that they did, because at baseline most of the children were vitamin D deficient, and vitamin D levels improved greatly in the group treated with vitamin D but not in the placebo group.
Journals such as the Journal of the American Academy of Dermatology should require articles to report absolute risk. In "Risk of Lymphoma in Patients With Atopic Dermatitis: A Case-Control Study in the All of Us Database," Powers and colleagues tell us that atopic dermatitis is associated with a statistically significantly increased risk for lymphoma. This means that increased risk wasn't likely due to chance alone. The article says nothing, as far as I could tell, about how big the risk is. Does everyone get lymphoma? Or is it a one in a million risk? Without knowing the absolute risk, the relative risk doesn't tell us whether there is a clinically meaningful increased risk or not. I suspect the increased risk is small. If the incidence of lymphoma is about 2 in 10,000 and peripheral T-cell lymphomas (PTCL) account for 10% of those, even a fourfold increase in the risk for PTCL (the form of lymphoma with the highest relative risk) would not amount to much.
Traidl and colleagues report in "Treatment of Moderate-to-Severe Atopic Dermatitis With Baricitinib: Results From an Interim Analysis of the TREATgermany Registry" that the Janus kinase inhibitor baricitinib makes atopic dermatitis better.
In "Dupilumab Therapy for Atopic Dermatitis Is Associated With Increased Risk of Cutaneous T Cell Lymphoma," Hasan and colleagues report that "it requires 738 prescriptions of dupilumab to produce one case of CTCL [cutaneous T-cell lymphoma]." It seems that this finding could easily be due to 1 in 738 people with a rash thought to be severe atopic dermatitis needing dupilumab having CTCL, not atopic dermatitis, to begin with. If we were to wonder whether dupilumab causes CTCL, perhaps it would be better to study asthma patients treated with or without dupilumab.
In "Atopic Dermatitis in Early Childhood and Risk of Inflammatory Bowel Disease: A Scandinavian Birth Cohort Study," Lerchova and colleagues found a statistically significant increased risk for inflammatory bowel disease (IBD) in children with atopic dermatitis. The study had a large patient population, giving it the power to identify very small differences. The researchers found increased risks for IBD, Crohn's disease, and ulcerative colitis (UC) in children with atopic dermatitis; UC had the greatest relative risk. But I don't think this risk was clinically meaningful. About 2 in every 1000 children with atopic dermatitis had UC, whereas about 1 in every 1000 children without atopic dermatitis had UC. Even if the increased absolute risk of 1 in 1000 children was due to atopic dermatitis and not to other factors, I don't think it justifies the authors' conclusion that "these findings might be useful in identifying at-risk individuals for IBD."
Sometimes reviewing articles makes me feel like a crotchety old man. A study by Guttman-Yassky and colleagues, "Targeting IL-13 With Tralokinumab Normalizes Type 2 Inflammation in Atopic Dermatitis Both Early and at 2 Years," didn't seem to test any specific hypothesis. The researchers just looked at a variety of inflammation markers in patients with atopic dermatitis treated with tralokinumab, an interleukin-13 (IL-13) antagonist. In these patients, as expected, the atopic dermatitis improved; so did the inflammatory markers. Did we learn anything clinically useful? I don't think so. We already know that IL-13 is important in atopic dermatitis because when we block IL-13, atopic dermatitis improves.
Vitamin D supplementation doesn't appear to improve atopic dermatitis, as reported by Borzutzky and colleagues in "Effect of Weekly Vitamin D Supplementation on the Severity of Atopic Dermatitis and Type 2 Immunity Biomarkers in Children: A Randomized Controlled Trial." A group of 101 children with atopic dermatitis were randomly assigned to receive oral vitamin D supplementation or placebo. The two groups improved to a similar extent. If you know me, you know I'm wondering whether they took the medication. It appears that they did, because at baseline most of the children were vitamin D deficient, and vitamin D levels improved greatly in the group treated with vitamin D but not in the placebo group.
Journals such as the Journal of the American Academy of Dermatology should require articles to report absolute risk. In "Risk of Lymphoma in Patients With Atopic Dermatitis: A Case-Control Study in the All of Us Database," Powers and colleagues tell us that atopic dermatitis is associated with a statistically significantly increased risk for lymphoma. This means that increased risk wasn't likely due to chance alone. The article says nothing, as far as I could tell, about how big the risk is. Does everyone get lymphoma? Or is it a one in a million risk? Without knowing the absolute risk, the relative risk doesn't tell us whether there is a clinically meaningful increased risk or not. I suspect the increased risk is small. If the incidence of lymphoma is about 2 in 10,000 and peripheral T-cell lymphomas (PTCL) account for 10% of those, even a fourfold increase in the risk for PTCL (the form of lymphoma with the highest relative risk) would not amount to much.
Traidl and colleagues report in "Treatment of Moderate-to-Severe Atopic Dermatitis With Baricitinib: Results From an Interim Analysis of the TREATgermany Registry" that the Janus kinase inhibitor baricitinib makes atopic dermatitis better.
In "Dupilumab Therapy for Atopic Dermatitis Is Associated With Increased Risk of Cutaneous T Cell Lymphoma," Hasan and colleagues report that "it requires 738 prescriptions of dupilumab to produce one case of CTCL [cutaneous T-cell lymphoma]." It seems that this finding could easily be due to 1 in 738 people with a rash thought to be severe atopic dermatitis needing dupilumab having CTCL, not atopic dermatitis, to begin with. If we were to wonder whether dupilumab causes CTCL, perhaps it would be better to study asthma patients treated with or without dupilumab.
In "Atopic Dermatitis in Early Childhood and Risk of Inflammatory Bowel Disease: A Scandinavian Birth Cohort Study," Lerchova and colleagues found a statistically significant increased risk for inflammatory bowel disease (IBD) in children with atopic dermatitis. The study had a large patient population, giving it the power to identify very small differences. The researchers found increased risks for IBD, Crohn's disease, and ulcerative colitis (UC) in children with atopic dermatitis; UC had the greatest relative risk. But I don't think this risk was clinically meaningful. About 2 in every 1000 children with atopic dermatitis had UC, whereas about 1 in every 1000 children without atopic dermatitis had UC. Even if the increased absolute risk of 1 in 1000 children was due to atopic dermatitis and not to other factors, I don't think it justifies the authors' conclusion that "these findings might be useful in identifying at-risk individuals for IBD."
Sometimes reviewing articles makes me feel like a crotchety old man. A study by Guttman-Yassky and colleagues, "Targeting IL-13 With Tralokinumab Normalizes Type 2 Inflammation in Atopic Dermatitis Both Early and at 2 Years," didn't seem to test any specific hypothesis. The researchers just looked at a variety of inflammation markers in patients with atopic dermatitis treated with tralokinumab, an interleukin-13 (IL-13) antagonist. In these patients, as expected, the atopic dermatitis improved; so did the inflammatory markers. Did we learn anything clinically useful? I don't think so. We already know that IL-13 is important in atopic dermatitis because when we block IL-13, atopic dermatitis improves.
Vitamin D supplementation doesn't appear to improve atopic dermatitis, as reported by Borzutzky and colleagues in "Effect of Weekly Vitamin D Supplementation on the Severity of Atopic Dermatitis and Type 2 Immunity Biomarkers in Children: A Randomized Controlled Trial." A group of 101 children with atopic dermatitis were randomly assigned to receive oral vitamin D supplementation or placebo. The two groups improved to a similar extent. If you know me, you know I'm wondering whether they took the medication. It appears that they did, because at baseline most of the children were vitamin D deficient, and vitamin D levels improved greatly in the group treated with vitamin D but not in the placebo group.
Journals such as the Journal of the American Academy of Dermatology should require articles to report absolute risk. In "Risk of Lymphoma in Patients With Atopic Dermatitis: A Case-Control Study in the All of Us Database," Powers and colleagues tell us that atopic dermatitis is associated with a statistically significantly increased risk for lymphoma. This means that increased risk wasn't likely due to chance alone. The article says nothing, as far as I could tell, about how big the risk is. Does everyone get lymphoma? Or is it a one in a million risk? Without knowing the absolute risk, the relative risk doesn't tell us whether there is a clinically meaningful increased risk or not. I suspect the increased risk is small. If the incidence of lymphoma is about 2 in 10,000 and peripheral T-cell lymphomas (PTCL) account for 10% of those, even a fourfold increase in the risk for PTCL (the form of lymphoma with the highest relative risk) would not amount to much.
Traidl and colleagues report in "Treatment of Moderate-to-Severe Atopic Dermatitis With Baricitinib: Results From an Interim Analysis of the TREATgermany Registry" that the Janus kinase inhibitor baricitinib makes atopic dermatitis better.
In "Dupilumab Therapy for Atopic Dermatitis Is Associated With Increased Risk of Cutaneous T Cell Lymphoma," Hasan and colleagues report that "it requires 738 prescriptions of dupilumab to produce one case of CTCL [cutaneous T-cell lymphoma]." It seems that this finding could easily be due to 1 in 738 people with a rash thought to be severe atopic dermatitis needing dupilumab having CTCL, not atopic dermatitis, to begin with. If we were to wonder whether dupilumab causes CTCL, perhaps it would be better to study asthma patients treated with or without dupilumab.