Atopic dermatitis: Inadequate disease control and QoL impairments among patients receiving topical therapy

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Key clinical point: Almost a fifth of patients with atopic dermatitis (AD) receiving topical therapy had an uncontrolled disease and reported impairment in work productivity along with a lower quality of life (QoL).

Major finding: Overall, physicians identified 24.5% of patients as having uncontrolled disease. Patients with uncontrolled vs controlled disease had higher impairment in QoL (Dermatology Life Quality Index, 8.8 vs 6.0; P = .0003) and work productivity (Work Productivity and Activity Impairment, 23.5 vs 16.2; P = .0488).

Study details: Findings are from a retrospective, point-in-time study including 394 adults and 144 adolescent patients with moderate-to-severe AD who received topical therapy for at least 1 month.

Disclosures: This study was funded by Incyte Corporation. JH Lofland and VN Joish declared being employees and shareholders of Incyte Corporation. Three of the other authors declared being employees of Adelphi Real World.

Source: Anderson P et al. Dermatol Ther (Heidelb). 2021 Jul 15. doi: 10.1007/s13555-021-00580-2.

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Key clinical point: Almost a fifth of patients with atopic dermatitis (AD) receiving topical therapy had an uncontrolled disease and reported impairment in work productivity along with a lower quality of life (QoL).

Major finding: Overall, physicians identified 24.5% of patients as having uncontrolled disease. Patients with uncontrolled vs controlled disease had higher impairment in QoL (Dermatology Life Quality Index, 8.8 vs 6.0; P = .0003) and work productivity (Work Productivity and Activity Impairment, 23.5 vs 16.2; P = .0488).

Study details: Findings are from a retrospective, point-in-time study including 394 adults and 144 adolescent patients with moderate-to-severe AD who received topical therapy for at least 1 month.

Disclosures: This study was funded by Incyte Corporation. JH Lofland and VN Joish declared being employees and shareholders of Incyte Corporation. Three of the other authors declared being employees of Adelphi Real World.

Source: Anderson P et al. Dermatol Ther (Heidelb). 2021 Jul 15. doi: 10.1007/s13555-021-00580-2.

Key clinical point: Almost a fifth of patients with atopic dermatitis (AD) receiving topical therapy had an uncontrolled disease and reported impairment in work productivity along with a lower quality of life (QoL).

Major finding: Overall, physicians identified 24.5% of patients as having uncontrolled disease. Patients with uncontrolled vs controlled disease had higher impairment in QoL (Dermatology Life Quality Index, 8.8 vs 6.0; P = .0003) and work productivity (Work Productivity and Activity Impairment, 23.5 vs 16.2; P = .0488).

Study details: Findings are from a retrospective, point-in-time study including 394 adults and 144 adolescent patients with moderate-to-severe AD who received topical therapy for at least 1 month.

Disclosures: This study was funded by Incyte Corporation. JH Lofland and VN Joish declared being employees and shareholders of Incyte Corporation. Three of the other authors declared being employees of Adelphi Real World.

Source: Anderson P et al. Dermatol Ther (Heidelb). 2021 Jul 15. doi: 10.1007/s13555-021-00580-2.

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Atopic dermatitis: Rapid improvement in skin pain with baricitinib

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Key clinical point: Baricitinib monotherapy improved clinically burdensome symptom of skin pain on the first day itself after the first dose in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: By day 2, skin pain numerical rating scale scores changed significantly from baseline with baricitinib vs placebo in BREEZE-AD1 (baricitinib 4 mg, 11.9%; 2 mg, 6.4%; 1 mg, 6.2%; all P less than .05), BREEZE-AD2 (baricitinib 4 mg, 12.6%; 2 mg, 5.6%; 1 mg, 6.9%; all P less than .05), and BREEZE-AD7 (baricitinib 4 mg, 6.9%; 2 mg, 7.9%; both P less than .05).

Study details: Findings are from an analysis of 3 phase 3 trials (BREEZE-AD1, BREEZE-AD2, and BREEZE-AD7) including 1,568 patients with moderate-to-severe AD with inadequate response to existing topical therapies who were randomly assigned to baricitinib or placebo with or without topical corticosteroids.

Disclosures: This work was funded by Eli Lilly and Company. Some of the authors declared receiving grants, honoraria, consulting, and/or lecturing fees from and/or serving as advisory board member, speaker, and/or investigator for various sources including Eli Lilly. Two authors declared being employees and shareholders of Eli Lilly.

Source: Thyssen JP et al. Dermatol Ther (Heidelb). 2021 Jul 18. doi: 10.1007/s13555-021-00577-x.

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Key clinical point: Baricitinib monotherapy improved clinically burdensome symptom of skin pain on the first day itself after the first dose in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: By day 2, skin pain numerical rating scale scores changed significantly from baseline with baricitinib vs placebo in BREEZE-AD1 (baricitinib 4 mg, 11.9%; 2 mg, 6.4%; 1 mg, 6.2%; all P less than .05), BREEZE-AD2 (baricitinib 4 mg, 12.6%; 2 mg, 5.6%; 1 mg, 6.9%; all P less than .05), and BREEZE-AD7 (baricitinib 4 mg, 6.9%; 2 mg, 7.9%; both P less than .05).

Study details: Findings are from an analysis of 3 phase 3 trials (BREEZE-AD1, BREEZE-AD2, and BREEZE-AD7) including 1,568 patients with moderate-to-severe AD with inadequate response to existing topical therapies who were randomly assigned to baricitinib or placebo with or without topical corticosteroids.

Disclosures: This work was funded by Eli Lilly and Company. Some of the authors declared receiving grants, honoraria, consulting, and/or lecturing fees from and/or serving as advisory board member, speaker, and/or investigator for various sources including Eli Lilly. Two authors declared being employees and shareholders of Eli Lilly.

Source: Thyssen JP et al. Dermatol Ther (Heidelb). 2021 Jul 18. doi: 10.1007/s13555-021-00577-x.

Key clinical point: Baricitinib monotherapy improved clinically burdensome symptom of skin pain on the first day itself after the first dose in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: By day 2, skin pain numerical rating scale scores changed significantly from baseline with baricitinib vs placebo in BREEZE-AD1 (baricitinib 4 mg, 11.9%; 2 mg, 6.4%; 1 mg, 6.2%; all P less than .05), BREEZE-AD2 (baricitinib 4 mg, 12.6%; 2 mg, 5.6%; 1 mg, 6.9%; all P less than .05), and BREEZE-AD7 (baricitinib 4 mg, 6.9%; 2 mg, 7.9%; both P less than .05).

Study details: Findings are from an analysis of 3 phase 3 trials (BREEZE-AD1, BREEZE-AD2, and BREEZE-AD7) including 1,568 patients with moderate-to-severe AD with inadequate response to existing topical therapies who were randomly assigned to baricitinib or placebo with or without topical corticosteroids.

Disclosures: This work was funded by Eli Lilly and Company. Some of the authors declared receiving grants, honoraria, consulting, and/or lecturing fees from and/or serving as advisory board member, speaker, and/or investigator for various sources including Eli Lilly. Two authors declared being employees and shareholders of Eli Lilly.

Source: Thyssen JP et al. Dermatol Ther (Heidelb). 2021 Jul 18. doi: 10.1007/s13555-021-00577-x.

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Abrocitinib emerges as a potential treatment option for moderate-to-severe atopic dermatitis

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Key clinical point: Preliminary evidence from a meta-analysis suggests that abrocitinib was significantly beneficial with a tolerable adverse event profile in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At 12 weeks, patients treated with abrocitinib achieved a significantly higher Investigator’s Global Assessment response vs those treated with placebo (risk ratio [RR], 3.52; P less than .00001). Treatment-emergent adverse effects were mostly mild and manageable, with a higher risk in the abrocitinib vs placebo group (RR, 1.17; P = .002).

Study details: Findings are from a meta-analysis of 4 randomized controlled trials, which assessed clinical outcomes in 1,175 patients with moderate-to-severe AD with inadequate response to topical medications who received abrocitinib 100 or 200 mg and 334 control participants who received placebo.

Disclosures: The study did not receive any funding. No conflict of interests was reported.

Source: Meher BR et al. J Dermatol Treat. 2021 Jul 27. doi: 10.1080/09546634.2021.1961997.

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Key clinical point: Preliminary evidence from a meta-analysis suggests that abrocitinib was significantly beneficial with a tolerable adverse event profile in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At 12 weeks, patients treated with abrocitinib achieved a significantly higher Investigator’s Global Assessment response vs those treated with placebo (risk ratio [RR], 3.52; P less than .00001). Treatment-emergent adverse effects were mostly mild and manageable, with a higher risk in the abrocitinib vs placebo group (RR, 1.17; P = .002).

Study details: Findings are from a meta-analysis of 4 randomized controlled trials, which assessed clinical outcomes in 1,175 patients with moderate-to-severe AD with inadequate response to topical medications who received abrocitinib 100 or 200 mg and 334 control participants who received placebo.

Disclosures: The study did not receive any funding. No conflict of interests was reported.

Source: Meher BR et al. J Dermatol Treat. 2021 Jul 27. doi: 10.1080/09546634.2021.1961997.

Key clinical point: Preliminary evidence from a meta-analysis suggests that abrocitinib was significantly beneficial with a tolerable adverse event profile in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At 12 weeks, patients treated with abrocitinib achieved a significantly higher Investigator’s Global Assessment response vs those treated with placebo (risk ratio [RR], 3.52; P less than .00001). Treatment-emergent adverse effects were mostly mild and manageable, with a higher risk in the abrocitinib vs placebo group (RR, 1.17; P = .002).

Study details: Findings are from a meta-analysis of 4 randomized controlled trials, which assessed clinical outcomes in 1,175 patients with moderate-to-severe AD with inadequate response to topical medications who received abrocitinib 100 or 200 mg and 334 control participants who received placebo.

Disclosures: The study did not receive any funding. No conflict of interests was reported.

Source: Meher BR et al. J Dermatol Treat. 2021 Jul 27. doi: 10.1080/09546634.2021.1961997.

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Atopic dermatitis tied to increased risk for hypertension

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Key clinical point: Patients with atopic dermatitis (AD), particularly those with a moderate-to-severe form of the disease, had significantly higher odds of hypertension than healthy controls.

Major finding: Overall, odds of hypertension was significantly higher in patients with AD than healthy controls (odds ratio [OR], 1.16; 95% confidence interval [CI], 1.04-1.30), particularly in those with moderate-to-severe AD (OR, 2.33; 95% CI, 1.10-4.94). Hypertension was mainly reported as an adverse event from cyclosporine A (pooled prevalence, 7.8%).

Study details: Findings are from a meta-analysis of 19 studies involving 269,861 adults with AD and 718,873 healthy controls, including 52,530 children with AD and 340,356 children as healthy controls.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Yousaf M et al. Br J Dermatol. 2021 Jul 28. doi: 10.1111/bjd.20661.

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Key clinical point: Patients with atopic dermatitis (AD), particularly those with a moderate-to-severe form of the disease, had significantly higher odds of hypertension than healthy controls.

Major finding: Overall, odds of hypertension was significantly higher in patients with AD than healthy controls (odds ratio [OR], 1.16; 95% confidence interval [CI], 1.04-1.30), particularly in those with moderate-to-severe AD (OR, 2.33; 95% CI, 1.10-4.94). Hypertension was mainly reported as an adverse event from cyclosporine A (pooled prevalence, 7.8%).

Study details: Findings are from a meta-analysis of 19 studies involving 269,861 adults with AD and 718,873 healthy controls, including 52,530 children with AD and 340,356 children as healthy controls.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Yousaf M et al. Br J Dermatol. 2021 Jul 28. doi: 10.1111/bjd.20661.

Key clinical point: Patients with atopic dermatitis (AD), particularly those with a moderate-to-severe form of the disease, had significantly higher odds of hypertension than healthy controls.

Major finding: Overall, odds of hypertension was significantly higher in patients with AD than healthy controls (odds ratio [OR], 1.16; 95% confidence interval [CI], 1.04-1.30), particularly in those with moderate-to-severe AD (OR, 2.33; 95% CI, 1.10-4.94). Hypertension was mainly reported as an adverse event from cyclosporine A (pooled prevalence, 7.8%).

Study details: Findings are from a meta-analysis of 19 studies involving 269,861 adults with AD and 718,873 healthy controls, including 52,530 children with AD and 340,356 children as healthy controls.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Yousaf M et al. Br J Dermatol. 2021 Jul 28. doi: 10.1111/bjd.20661.

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Comorbidities account for higher incidence of hospitalization in patients with AD

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Key clinical point: Over 20 years of evidence indicates an increased incidence of hospitalizations among patients with atopic dermatitis (AD) in the United States, mainly attributed to increased burden of medical comorbidities rather than AD itself, highlighting the need for increased screening and management of comorbidities.

Major finding: The number of hospitalizations among patients with AD increased from 1.0 to 2.3 per 100,000 persons from 1998 to 2018 (adjusted P-trend less than .0001). However, the proportion of hospitalizations with AD as the principal diagnosis reduced from 11.5% in 1998 to 3.7% in 2018 (adjusted P-trend = .001). A higher proportion of patients reported Charlson Comorbidity Index score of 3 or higher in 2018 vs 1998 (27.8% vs 10.5%; adjusted P-trend less than .0001).

Study details: Findings are from a longitudinal study including 23,410 adults hospitalized with any form of AD between 1998 and 2018.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Edigin E et al. J Am Acad Dermatol. 2021 Jul 9. doi: 10.1016/j.jaad.2021.06.882.

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Key clinical point: Over 20 years of evidence indicates an increased incidence of hospitalizations among patients with atopic dermatitis (AD) in the United States, mainly attributed to increased burden of medical comorbidities rather than AD itself, highlighting the need for increased screening and management of comorbidities.

Major finding: The number of hospitalizations among patients with AD increased from 1.0 to 2.3 per 100,000 persons from 1998 to 2018 (adjusted P-trend less than .0001). However, the proportion of hospitalizations with AD as the principal diagnosis reduced from 11.5% in 1998 to 3.7% in 2018 (adjusted P-trend = .001). A higher proportion of patients reported Charlson Comorbidity Index score of 3 or higher in 2018 vs 1998 (27.8% vs 10.5%; adjusted P-trend less than .0001).

Study details: Findings are from a longitudinal study including 23,410 adults hospitalized with any form of AD between 1998 and 2018.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Edigin E et al. J Am Acad Dermatol. 2021 Jul 9. doi: 10.1016/j.jaad.2021.06.882.

Key clinical point: Over 20 years of evidence indicates an increased incidence of hospitalizations among patients with atopic dermatitis (AD) in the United States, mainly attributed to increased burden of medical comorbidities rather than AD itself, highlighting the need for increased screening and management of comorbidities.

Major finding: The number of hospitalizations among patients with AD increased from 1.0 to 2.3 per 100,000 persons from 1998 to 2018 (adjusted P-trend less than .0001). However, the proportion of hospitalizations with AD as the principal diagnosis reduced from 11.5% in 1998 to 3.7% in 2018 (adjusted P-trend = .001). A higher proportion of patients reported Charlson Comorbidity Index score of 3 or higher in 2018 vs 1998 (27.8% vs 10.5%; adjusted P-trend less than .0001).

Study details: Findings are from a longitudinal study including 23,410 adults hospitalized with any form of AD between 1998 and 2018.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Edigin E et al. J Am Acad Dermatol. 2021 Jul 9. doi: 10.1016/j.jaad.2021.06.882.

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Methylation on golli-MBP locus serves as an indicator of atopic dermatitis severity in children

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Key clinical point: Reduced DNA methylation of golli-myelin basic protein (MBP) locus could serve as an important biomarker to determine the severity of atopic dermatitis (AD) in pediatric patients.

Major finding: Loss of DNA methylation and higher golli-MBP mRNA expression were observed in pediatric patients with AD (both P less than .0001). The score in the intensity of symptoms increased with decreasing methylation levels in cg27400313, the differentially methylated CpG cluster of MBP gene (P = .012).

Study details: The study used a discovery cohort of 24 pediatric patients with AD and 24 control participants to screen for DNA methylation. The results were further validated in an additional cohort of 224 pediatric patients with AD and 44 control participants.

Disclosures: The study was supported by grants from Ministry of Health and Welfare and Chang Gung Memorial Hospital. The authors declared no conflict of interests.

Source: Chen KD et al. J Invest Dermatol. 2021 Jul 19. doi: 10.1016/j.jid.2021.06.025.

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Key clinical point: Reduced DNA methylation of golli-myelin basic protein (MBP) locus could serve as an important biomarker to determine the severity of atopic dermatitis (AD) in pediatric patients.

Major finding: Loss of DNA methylation and higher golli-MBP mRNA expression were observed in pediatric patients with AD (both P less than .0001). The score in the intensity of symptoms increased with decreasing methylation levels in cg27400313, the differentially methylated CpG cluster of MBP gene (P = .012).

Study details: The study used a discovery cohort of 24 pediatric patients with AD and 24 control participants to screen for DNA methylation. The results were further validated in an additional cohort of 224 pediatric patients with AD and 44 control participants.

Disclosures: The study was supported by grants from Ministry of Health and Welfare and Chang Gung Memorial Hospital. The authors declared no conflict of interests.

Source: Chen KD et al. J Invest Dermatol. 2021 Jul 19. doi: 10.1016/j.jid.2021.06.025.

Key clinical point: Reduced DNA methylation of golli-myelin basic protein (MBP) locus could serve as an important biomarker to determine the severity of atopic dermatitis (AD) in pediatric patients.

Major finding: Loss of DNA methylation and higher golli-MBP mRNA expression were observed in pediatric patients with AD (both P less than .0001). The score in the intensity of symptoms increased with decreasing methylation levels in cg27400313, the differentially methylated CpG cluster of MBP gene (P = .012).

Study details: The study used a discovery cohort of 24 pediatric patients with AD and 24 control participants to screen for DNA methylation. The results were further validated in an additional cohort of 224 pediatric patients with AD and 44 control participants.

Disclosures: The study was supported by grants from Ministry of Health and Welfare and Chang Gung Memorial Hospital. The authors declared no conflict of interests.

Source: Chen KD et al. J Invest Dermatol. 2021 Jul 19. doi: 10.1016/j.jid.2021.06.025.

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Sleep disturbance and geriatric age in atopic dermatitis: Is there a link?

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Key clinical point: Geriatric patients experienced more profound sleep disturbance (SD) despite having similar severity of atopic dermatitis (AD) as younger adult patients with AD.

Major finding: Geriatric age was not associated with severity of AD as measured by Eczema Area and Severity Index score (adjusted odds ratio [aOR], 1.47; P = .3269). However, geriatric patients with AD spent an increased number of nights with SD from eczema (aOR, 2.14; P = .0142), experienced fatigue (aOR, 1.81; P = .0313), and had trouble staying asleep (aOR, 2.26; P = .0030).

Study details: Findings are from a cross-sectional, dermatology practice-based study conducted between 2014 and 2019 and included adults diagnosed with AD.

Disclosures: This study was supported by Agency for Healthcare Research and Quality, the Dermatology Foundation, and an unrestricted research grant from Galderma. The authors declared no conflict of interests.

Source: Manjunath J and Silverberg JI. J Am Acad Dermatol. 2021 Jul 29. doi: 10.1016/j.jaad.2021.07.039.

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Key clinical point: Geriatric patients experienced more profound sleep disturbance (SD) despite having similar severity of atopic dermatitis (AD) as younger adult patients with AD.

Major finding: Geriatric age was not associated with severity of AD as measured by Eczema Area and Severity Index score (adjusted odds ratio [aOR], 1.47; P = .3269). However, geriatric patients with AD spent an increased number of nights with SD from eczema (aOR, 2.14; P = .0142), experienced fatigue (aOR, 1.81; P = .0313), and had trouble staying asleep (aOR, 2.26; P = .0030).

Study details: Findings are from a cross-sectional, dermatology practice-based study conducted between 2014 and 2019 and included adults diagnosed with AD.

Disclosures: This study was supported by Agency for Healthcare Research and Quality, the Dermatology Foundation, and an unrestricted research grant from Galderma. The authors declared no conflict of interests.

Source: Manjunath J and Silverberg JI. J Am Acad Dermatol. 2021 Jul 29. doi: 10.1016/j.jaad.2021.07.039.

Key clinical point: Geriatric patients experienced more profound sleep disturbance (SD) despite having similar severity of atopic dermatitis (AD) as younger adult patients with AD.

Major finding: Geriatric age was not associated with severity of AD as measured by Eczema Area and Severity Index score (adjusted odds ratio [aOR], 1.47; P = .3269). However, geriatric patients with AD spent an increased number of nights with SD from eczema (aOR, 2.14; P = .0142), experienced fatigue (aOR, 1.81; P = .0313), and had trouble staying asleep (aOR, 2.26; P = .0030).

Study details: Findings are from a cross-sectional, dermatology practice-based study conducted between 2014 and 2019 and included adults diagnosed with AD.

Disclosures: This study was supported by Agency for Healthcare Research and Quality, the Dermatology Foundation, and an unrestricted research grant from Galderma. The authors declared no conflict of interests.

Source: Manjunath J and Silverberg JI. J Am Acad Dermatol. 2021 Jul 29. doi: 10.1016/j.jaad.2021.07.039.

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Cold atmospheric plasma alleviates AD severity without any safety issues

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Key clinical point: Cold atmospheric plasma (CAP) can potentially improve the clinical severity of atopic dermatitis (AD) by recovering the diversity of skin microbiome and promoting wound healing for damaged skin barriers without any safety issues.

Major finding: At the end of treatment, reduction in Staphylococcus aureus count was significantly higher for the CAP vs sham group (10.14% vs 15.29%; P = .047). In the CAP group, mean modified AD antecubital severity score reduced significantly at week 4 vs baseline (13.12 vs 33.73; P less than .001), whereas reduction in the sham group was not statistically significant (P = .114). No severe adverse events were reported.

Study details: Findings are from a prospective analysis of 22 adults with mild-to-moderate AD having symmetric lesions. For each patient, the symmetric lesions were randomly assigned to either CAP or sham treatment.

Disclosures: The study did not report any source of funding. No conflicts of interest were reported.

Source: Kim YJ et al. Sci Rep. 2021 Jul 14. doi: 10.1038/s41598-021-93941-y.

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Key clinical point: Cold atmospheric plasma (CAP) can potentially improve the clinical severity of atopic dermatitis (AD) by recovering the diversity of skin microbiome and promoting wound healing for damaged skin barriers without any safety issues.

Major finding: At the end of treatment, reduction in Staphylococcus aureus count was significantly higher for the CAP vs sham group (10.14% vs 15.29%; P = .047). In the CAP group, mean modified AD antecubital severity score reduced significantly at week 4 vs baseline (13.12 vs 33.73; P less than .001), whereas reduction in the sham group was not statistically significant (P = .114). No severe adverse events were reported.

Study details: Findings are from a prospective analysis of 22 adults with mild-to-moderate AD having symmetric lesions. For each patient, the symmetric lesions were randomly assigned to either CAP or sham treatment.

Disclosures: The study did not report any source of funding. No conflicts of interest were reported.

Source: Kim YJ et al. Sci Rep. 2021 Jul 14. doi: 10.1038/s41598-021-93941-y.

Key clinical point: Cold atmospheric plasma (CAP) can potentially improve the clinical severity of atopic dermatitis (AD) by recovering the diversity of skin microbiome and promoting wound healing for damaged skin barriers without any safety issues.

Major finding: At the end of treatment, reduction in Staphylococcus aureus count was significantly higher for the CAP vs sham group (10.14% vs 15.29%; P = .047). In the CAP group, mean modified AD antecubital severity score reduced significantly at week 4 vs baseline (13.12 vs 33.73; P less than .001), whereas reduction in the sham group was not statistically significant (P = .114). No severe adverse events were reported.

Study details: Findings are from a prospective analysis of 22 adults with mild-to-moderate AD having symmetric lesions. For each patient, the symmetric lesions were randomly assigned to either CAP or sham treatment.

Disclosures: The study did not report any source of funding. No conflicts of interest were reported.

Source: Kim YJ et al. Sci Rep. 2021 Jul 14. doi: 10.1038/s41598-021-93941-y.

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Difamilast ointment shows promise for pediatric atopic dermatitis in phase 3

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Key clinical point: Difamilast 0.3% and 1% ointments demonstrated superiority over vehicle along with a favorable safety profile when applied twice daily for up to 4 weeks in pediatric patients with atopic dermatitis (AD).

Major finding: At week 4, the success rate in investigator global assessment score was significantly higher with difamilast 0.3% (44.6%; P = .0005) and 1% (47.1%; P less than .0001) vs vehicle (18.1%) group. Treatment-emergent adverse effects were mostly mild or moderate in severity, with adverse event profiles similar between treatment and vehicle groups.

Study details: Findings are from a double-blind phase 3 trial including 251 patients aged 2-14 years with mild-to-moderate AD who were randomly assigned to receive difamilast 0.3%, difamilast 1%, or vehicle ointment twice daily for 4 weeks.

Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd. Dr. Saeki and Dr. Baba declared receiving consultation fees from Otsuka Pharmaceutical Co., Ltd. Dr. Ito, Dr. Yokota, and Dr. Tsubouchi declared being employees of Otsuka Pharmaceutical Co., Ltd.

Source: Saeki H et al. Br J Dermatol. 2021 Jul 21. doi: 10.1111/bjd.20655.

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Key clinical point: Difamilast 0.3% and 1% ointments demonstrated superiority over vehicle along with a favorable safety profile when applied twice daily for up to 4 weeks in pediatric patients with atopic dermatitis (AD).

Major finding: At week 4, the success rate in investigator global assessment score was significantly higher with difamilast 0.3% (44.6%; P = .0005) and 1% (47.1%; P less than .0001) vs vehicle (18.1%) group. Treatment-emergent adverse effects were mostly mild or moderate in severity, with adverse event profiles similar between treatment and vehicle groups.

Study details: Findings are from a double-blind phase 3 trial including 251 patients aged 2-14 years with mild-to-moderate AD who were randomly assigned to receive difamilast 0.3%, difamilast 1%, or vehicle ointment twice daily for 4 weeks.

Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd. Dr. Saeki and Dr. Baba declared receiving consultation fees from Otsuka Pharmaceutical Co., Ltd. Dr. Ito, Dr. Yokota, and Dr. Tsubouchi declared being employees of Otsuka Pharmaceutical Co., Ltd.

Source: Saeki H et al. Br J Dermatol. 2021 Jul 21. doi: 10.1111/bjd.20655.

Key clinical point: Difamilast 0.3% and 1% ointments demonstrated superiority over vehicle along with a favorable safety profile when applied twice daily for up to 4 weeks in pediatric patients with atopic dermatitis (AD).

Major finding: At week 4, the success rate in investigator global assessment score was significantly higher with difamilast 0.3% (44.6%; P = .0005) and 1% (47.1%; P less than .0001) vs vehicle (18.1%) group. Treatment-emergent adverse effects were mostly mild or moderate in severity, with adverse event profiles similar between treatment and vehicle groups.

Study details: Findings are from a double-blind phase 3 trial including 251 patients aged 2-14 years with mild-to-moderate AD who were randomly assigned to receive difamilast 0.3%, difamilast 1%, or vehicle ointment twice daily for 4 weeks.

Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd. Dr. Saeki and Dr. Baba declared receiving consultation fees from Otsuka Pharmaceutical Co., Ltd. Dr. Ito, Dr. Yokota, and Dr. Tsubouchi declared being employees of Otsuka Pharmaceutical Co., Ltd.

Source: Saeki H et al. Br J Dermatol. 2021 Jul 21. doi: 10.1111/bjd.20655.

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Upadacitinib shows superior efficacy over dupilumab for moderate-to-severe atopic dermatitis in phase 3b

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Key clinical point: Upadacitinib demonstrated superior efficacy over dupilumab for treatment of adults with moderate-to-severe atopic dermatitis (AD) with no new safety signals identified.

Major finding: At week 16, a higher proportion of patients achieved 75% improvement in Eczema Area and Severity Index with upadacitinib vs dupilumab (71.0% vs 61.1%; P = .006). Rates of serious treatment-emergent adverse events leading to drug discontinuation in upadacitinib vs dupilumab were 2.9% vs 1.2%, with no new safety risks observed for upadacitinib.

Study details: Findings are 24-week results of Heads up, a phase 3b trial including 692 adults with moderate-to-severe AD who were randomly assigned to receive oral upadacitinib, 30 mg once daily, or subcutaneous dupilumab, 300 mg every alternate week.

Disclosures: This study was funded by AbbVie. The authors declared serving as speaker, consultant, scientific advisor, clinical study investigator, and/or receiving personal fees and grants from various sources including AbbVie. Four authors declared being employees and/or shareholders of AbbVie.

Source: Blauvelt A et al. JAMA Dermatol. 2021 Aug 4. doi: 10.1001/jamadermatol.2021.3023.

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Key clinical point: Upadacitinib demonstrated superior efficacy over dupilumab for treatment of adults with moderate-to-severe atopic dermatitis (AD) with no new safety signals identified.

Major finding: At week 16, a higher proportion of patients achieved 75% improvement in Eczema Area and Severity Index with upadacitinib vs dupilumab (71.0% vs 61.1%; P = .006). Rates of serious treatment-emergent adverse events leading to drug discontinuation in upadacitinib vs dupilumab were 2.9% vs 1.2%, with no new safety risks observed for upadacitinib.

Study details: Findings are 24-week results of Heads up, a phase 3b trial including 692 adults with moderate-to-severe AD who were randomly assigned to receive oral upadacitinib, 30 mg once daily, or subcutaneous dupilumab, 300 mg every alternate week.

Disclosures: This study was funded by AbbVie. The authors declared serving as speaker, consultant, scientific advisor, clinical study investigator, and/or receiving personal fees and grants from various sources including AbbVie. Four authors declared being employees and/or shareholders of AbbVie.

Source: Blauvelt A et al. JAMA Dermatol. 2021 Aug 4. doi: 10.1001/jamadermatol.2021.3023.

Key clinical point: Upadacitinib demonstrated superior efficacy over dupilumab for treatment of adults with moderate-to-severe atopic dermatitis (AD) with no new safety signals identified.

Major finding: At week 16, a higher proportion of patients achieved 75% improvement in Eczema Area and Severity Index with upadacitinib vs dupilumab (71.0% vs 61.1%; P = .006). Rates of serious treatment-emergent adverse events leading to drug discontinuation in upadacitinib vs dupilumab were 2.9% vs 1.2%, with no new safety risks observed for upadacitinib.

Study details: Findings are 24-week results of Heads up, a phase 3b trial including 692 adults with moderate-to-severe AD who were randomly assigned to receive oral upadacitinib, 30 mg once daily, or subcutaneous dupilumab, 300 mg every alternate week.

Disclosures: This study was funded by AbbVie. The authors declared serving as speaker, consultant, scientific advisor, clinical study investigator, and/or receiving personal fees and grants from various sources including AbbVie. Four authors declared being employees and/or shareholders of AbbVie.

Source: Blauvelt A et al. JAMA Dermatol. 2021 Aug 4. doi: 10.1001/jamadermatol.2021.3023.

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