Atopic Dermatitis

Key clinical point: Dupilumab rapidly improves the severity of atopic dermatitis (AD) symptoms and shows a favorable safety profile in children with moderate-to-severe AD.

Major finding: Dupilumab significantly reduced the mean Eczema Area and Severity Index (EASI) score at weeks 16, 24, and 52 (all P < .0001) and from weeks 16 to 24 (P < .01) and weeks 16 to 52 (P < .001). By week 52, 86.8% of patients had achieved a ≥ 75% improvement in the EASI score. No serious adverse events were observed, and none of the children discontinued treatment.

Study details: Findings are from a retrospective, observational, real-life study including 96 children (age 6-11 years) with moderate-to-severe AD inadequately controlled with conventional topical therapies who received dupilumab (300 mg on days 1 and 15 and 300 mg every 4 weeks).

Disclosures: This study did not receive any funding. Several authors reported receiving honoraria, travel support, or personal fees from or serving as consultants, investigators, speakers, or advisory board members for or having other ties with various sources.

Source: Patruno C et al. A 52-week multicenter retrospective real-world study on effectiveness and safety of dupilumab in children with atopic dermatitis aged from 6 to 11 years. J Dermatolog Treat. 2023;34:2246602 (Aug 14). doi: 10.1080/09546634.2023.2246602

Key clinical point: Dupilumab rapidly improves the severity of atopic dermatitis (AD) symptoms and shows a favorable safety profile in children with moderate-to-severe AD.

Major finding: Dupilumab significantly reduced the mean Eczema Area and Severity Index (EASI) score at weeks 16, 24, and 52 (all P < .0001) and from weeks 16 to 24 (P < .01) and weeks 16 to 52 (P < .001). By week 52, 86.8% of patients had achieved a ≥ 75% improvement in the EASI score. No serious adverse events were observed, and none of the children discontinued treatment.

Study details: Findings are from a retrospective, observational, real-life study including 96 children (age 6-11 years) with moderate-to-severe AD inadequately controlled with conventional topical therapies who received dupilumab (300 mg on days 1 and 15 and 300 mg every 4 weeks).

Disclosures: This study did not receive any funding. Several authors reported receiving honoraria, travel support, or personal fees from or serving as consultants, investigators, speakers, or advisory board members for or having other ties with various sources.

Source: Patruno C et al. A 52-week multicenter retrospective real-world study on effectiveness and safety of dupilumab in children with atopic dermatitis aged from 6 to 11 years. J Dermatolog Treat. 2023;34:2246602 (Aug 14). doi: 10.1080/09546634.2023.2246602

Key clinical point: Dupilumab rapidly improves the severity of atopic dermatitis (AD) symptoms and shows a favorable safety profile in children with moderate-to-severe AD.

Major finding: Dupilumab significantly reduced the mean Eczema Area and Severity Index (EASI) score at weeks 16, 24, and 52 (all P < .0001) and from weeks 16 to 24 (P < .01) and weeks 16 to 52 (P < .001). By week 52, 86.8% of patients had achieved a ≥ 75% improvement in the EASI score. No serious adverse events were observed, and none of the children discontinued treatment.

Study details: Findings are from a retrospective, observational, real-life study including 96 children (age 6-11 years) with moderate-to-severe AD inadequately controlled with conventional topical therapies who received dupilumab (300 mg on days 1 and 15 and 300 mg every 4 weeks).

Disclosures: This study did not receive any funding. Several authors reported receiving honoraria, travel support, or personal fees from or serving as consultants, investigators, speakers, or advisory board members for or having other ties with various sources.

Source: Patruno C et al. A 52-week multicenter retrospective real-world study on effectiveness and safety of dupilumab in children with atopic dermatitis aged from 6 to 11 years. J Dermatolog Treat. 2023;34:2246602 (Aug 14). doi: 10.1080/09546634.2023.2246602

Key clinical point: Severe atopic dermatitis (AD) is associated with higher risks for venous thromboembolism and cardiovascular diseases in both children and adults.

Major finding: Children with severe AD vs those without AD had a significantly increased risk (adjusted hazard ratio; 95% CI) for cerebrovascular accidents (2.43; 1.13-5.22), diabetes (1.46; 1.06-2.01), and deep vein thrombosis (DVT; 2.13; 1.17-3.87). Among adults, the severe AD vs non-AD group had a significantly higher risk for cerebrovascular accidents (1.21; 1.13-1.30), diabetes (1.15; 1.09-1.22), dyslipidemia (1.11; 1.06-1.17), myocardial infarction (1.27; 1.15-1.39), DVT (1.64; 1.49-1.82), and pulmonary embolism (1.39; 1.21-1.60).

Study details: This population-based cohort study included 409,431 children (age < 18 years) and 625,083 adults with AD who were matched with 1,809,029 children and 2,678,888 adults without AD, respectively.

Disclosures: This study was supported by a contract from Pfizer, Inc. Some authors declared serving as consultants for or receiving research grants, honoraria, or consulting fees from various sources, including Pfizer. AR Lemeshow declared being an employee of Pfizer, Inc.

Source: Wan J, Chiesa Fuxench  ZC, et al. Incidence of cardiovascular disease and venous thromboembolism in patients with atopic dermatitis. J Allergy Clin Immunol Pract. 2023 (Aug 10). doi: 10.1016/j.jaip.2023.08.007

Key clinical point: Severe atopic dermatitis (AD) is associated with higher risks for venous thromboembolism and cardiovascular diseases in both children and adults.

Major finding: Children with severe AD vs those without AD had a significantly increased risk (adjusted hazard ratio; 95% CI) for cerebrovascular accidents (2.43; 1.13-5.22), diabetes (1.46; 1.06-2.01), and deep vein thrombosis (DVT; 2.13; 1.17-3.87). Among adults, the severe AD vs non-AD group had a significantly higher risk for cerebrovascular accidents (1.21; 1.13-1.30), diabetes (1.15; 1.09-1.22), dyslipidemia (1.11; 1.06-1.17), myocardial infarction (1.27; 1.15-1.39), DVT (1.64; 1.49-1.82), and pulmonary embolism (1.39; 1.21-1.60).

Study details: This population-based cohort study included 409,431 children (age < 18 years) and 625,083 adults with AD who were matched with 1,809,029 children and 2,678,888 adults without AD, respectively.

Disclosures: This study was supported by a contract from Pfizer, Inc. Some authors declared serving as consultants for or receiving research grants, honoraria, or consulting fees from various sources, including Pfizer. AR Lemeshow declared being an employee of Pfizer, Inc.

Source: Wan J, Chiesa Fuxench  ZC, et al. Incidence of cardiovascular disease and venous thromboembolism in patients with atopic dermatitis. J Allergy Clin Immunol Pract. 2023 (Aug 10). doi: 10.1016/j.jaip.2023.08.007

Key clinical point: Severe atopic dermatitis (AD) is associated with higher risks for venous thromboembolism and cardiovascular diseases in both children and adults.

Major finding: Children with severe AD vs those without AD had a significantly increased risk (adjusted hazard ratio; 95% CI) for cerebrovascular accidents (2.43; 1.13-5.22), diabetes (1.46; 1.06-2.01), and deep vein thrombosis (DVT; 2.13; 1.17-3.87). Among adults, the severe AD vs non-AD group had a significantly higher risk for cerebrovascular accidents (1.21; 1.13-1.30), diabetes (1.15; 1.09-1.22), dyslipidemia (1.11; 1.06-1.17), myocardial infarction (1.27; 1.15-1.39), DVT (1.64; 1.49-1.82), and pulmonary embolism (1.39; 1.21-1.60).

Study details: This population-based cohort study included 409,431 children (age < 18 years) and 625,083 adults with AD who were matched with 1,809,029 children and 2,678,888 adults without AD, respectively.

Disclosures: This study was supported by a contract from Pfizer, Inc. Some authors declared serving as consultants for or receiving research grants, honoraria, or consulting fees from various sources, including Pfizer. AR Lemeshow declared being an employee of Pfizer, Inc.

Source: Wan J, Chiesa Fuxench  ZC, et al. Incidence of cardiovascular disease and venous thromboembolism in patients with atopic dermatitis. J Allergy Clin Immunol Pract. 2023 (Aug 10). doi: 10.1016/j.jaip.2023.08.007

Key clinical point: Adults with newly diagnosed atopic dermatitis (AD) have a 44% increased risk of subsequently developing type 2 diabetes (T2D).

Major finding: The risk for new-onset T2D was significantly higher in adults with newly diagnosed AD vs control individuals without AD (adjusted hazard ratio 1.44; P < .001), with the risk being significantly greater in both men and women with AD (both P < .001).

Study details: Findings are from a retrospective cohort study including 36,692 adult patients with AD and 36,692 matched control individuals who had never been diagnosed with AD.

Disclosures: This study was supported by the National Research Foundation of Korea funded by the Ministry of Education, Science, and Technology and others. The authors declared no conflicts of interest.

Source: Won Lee S et al. Risk of type 2 diabetes mellitus in adult patients with atopic dermatitis. Diabetes Res Clin Pract. 2023;110883 (Aug 16). doi: 10.1016/j.diabres.2023.110883

Key clinical point: Adults with newly diagnosed atopic dermatitis (AD) have a 44% increased risk of subsequently developing type 2 diabetes (T2D).

Major finding: The risk for new-onset T2D was significantly higher in adults with newly diagnosed AD vs control individuals without AD (adjusted hazard ratio 1.44; P < .001), with the risk being significantly greater in both men and women with AD (both P < .001).

Study details: Findings are from a retrospective cohort study including 36,692 adult patients with AD and 36,692 matched control individuals who had never been diagnosed with AD.

Disclosures: This study was supported by the National Research Foundation of Korea funded by the Ministry of Education, Science, and Technology and others. The authors declared no conflicts of interest.

Source: Won Lee S et al. Risk of type 2 diabetes mellitus in adult patients with atopic dermatitis. Diabetes Res Clin Pract. 2023;110883 (Aug 16). doi: 10.1016/j.diabres.2023.110883

Key clinical point: Adults with newly diagnosed atopic dermatitis (AD) have a 44% increased risk of subsequently developing type 2 diabetes (T2D).

Major finding: The risk for new-onset T2D was significantly higher in adults with newly diagnosed AD vs control individuals without AD (adjusted hazard ratio 1.44; P < .001), with the risk being significantly greater in both men and women with AD (both P < .001).

Study details: Findings are from a retrospective cohort study including 36,692 adult patients with AD and 36,692 matched control individuals who had never been diagnosed with AD.

Disclosures: This study was supported by the National Research Foundation of Korea funded by the Ministry of Education, Science, and Technology and others. The authors declared no conflicts of interest.

Source: Won Lee S et al. Risk of type 2 diabetes mellitus in adult patients with atopic dermatitis. Diabetes Res Clin Pract. 2023;110883 (Aug 16). doi: 10.1016/j.diabres.2023.110883

Key clinical point: Tralokinumab is well tolerated and effective in older adults with moderate-to-severe atopic dermatitis (AD).

Major finding: Compared with the placebo group, a significantly higher proportion of patients in ECZTRA 1 and 2 achieved ≥ 75% improvement in the Eczema Area and Severity Index score (33.9% vs 4.76%; P < .001) and an Investigator’s Global Assessment 0 or 1 score (16.95% vs 0%; P < .001) in the tralokinumab group at week 16. The adverse event (AE) rate was comparable between the groups; however, fewer patients discontinued treatment due to AE in the tralokinumab vs placebo group (5.3% vs 6.9%).

Study details: Findings are from a post hoc analysis of ECZTRA 1, 2, and 3 trials and included 104 older patients (≥65 years) with AD who received tralokinumab (n = 75) or placebo (n = 29).

Disclosures: This study was supported by LEO Pharma. Two authors declared being employees of LEO Pharma. Some authors declared receiving grants, personal fees, or consulting fees from LEO Pharma and other sources.

Source: Merola JF et al. Safety and efficacy of tralokinumab in older adults with moderate-to-severe atopic dermatitis: A secondary analysis. JAMA Dermatol. 2023 (Aug 23). doi: 10.1001/jamadermatol.2023.2626

Key clinical point: Tralokinumab is well tolerated and effective in older adults with moderate-to-severe atopic dermatitis (AD).

Major finding: Compared with the placebo group, a significantly higher proportion of patients in ECZTRA 1 and 2 achieved ≥ 75% improvement in the Eczema Area and Severity Index score (33.9% vs 4.76%; P < .001) and an Investigator’s Global Assessment 0 or 1 score (16.95% vs 0%; P < .001) in the tralokinumab group at week 16. The adverse event (AE) rate was comparable between the groups; however, fewer patients discontinued treatment due to AE in the tralokinumab vs placebo group (5.3% vs 6.9%).

Study details: Findings are from a post hoc analysis of ECZTRA 1, 2, and 3 trials and included 104 older patients (≥65 years) with AD who received tralokinumab (n = 75) or placebo (n = 29).

Disclosures: This study was supported by LEO Pharma. Two authors declared being employees of LEO Pharma. Some authors declared receiving grants, personal fees, or consulting fees from LEO Pharma and other sources.

Source: Merola JF et al. Safety and efficacy of tralokinumab in older adults with moderate-to-severe atopic dermatitis: A secondary analysis. JAMA Dermatol. 2023 (Aug 23). doi: 10.1001/jamadermatol.2023.2626

Key clinical point: Tralokinumab is well tolerated and effective in older adults with moderate-to-severe atopic dermatitis (AD).

Major finding: Compared with the placebo group, a significantly higher proportion of patients in ECZTRA 1 and 2 achieved ≥ 75% improvement in the Eczema Area and Severity Index score (33.9% vs 4.76%; P < .001) and an Investigator’s Global Assessment 0 or 1 score (16.95% vs 0%; P < .001) in the tralokinumab group at week 16. The adverse event (AE) rate was comparable between the groups; however, fewer patients discontinued treatment due to AE in the tralokinumab vs placebo group (5.3% vs 6.9%).

Study details: Findings are from a post hoc analysis of ECZTRA 1, 2, and 3 trials and included 104 older patients (≥65 years) with AD who received tralokinumab (n = 75) or placebo (n = 29).

Disclosures: This study was supported by LEO Pharma. Two authors declared being employees of LEO Pharma. Some authors declared receiving grants, personal fees, or consulting fees from LEO Pharma and other sources.

Source: Merola JF et al. Safety and efficacy of tralokinumab in older adults with moderate-to-severe atopic dermatitis: A secondary analysis. JAMA Dermatol. 2023 (Aug 23). doi: 10.1001/jamadermatol.2023.2626

Key clinical point: Children and adults with atopic dermatitis (AD) have a significantly increased risk of developing inflammatory bowel disease (IBD), including Crohn’s disease (CD).

Major finding: Children with vs without AD had a significantly higher risk for IBD (adjusted HR [aHR] 1.44; 95% CI 1.31-1.58) and CD (aHR 1.74; 95% CI 1.54-1.97), but the risk for ulcerative colitis (UC; aHR 1.65; 95% CI 1.02-2.67) was higher only in children with severe AD. Adults with vs without AD had a significantly increased risk for IBD (aHR 1.34; 95% CI 1.27-1.40), CD (aHR 1.36; 95% CI 1.26-1.47), and UC (aHR 1.32; 95% CI 1.24-1.41).

Study details: This population-based cohort study matched children (n = 409,431; age < 18 years) and adults (n = 625,083) with AD with control children (n = 1,809,029) and adults (n = 2,678,888) without AD, respectively.

Disclosures: This study was supported by a contract from Pfizer Inc. Five authors declared receiving grants, personal fees, and fellowship funding from various sources, including Pfizer Inc.

Source: Chiesa Fuxench ZC et al. Risk of inflammatory bowel disease in patients with atopic dermatitis. JAMA Dermatol. 2023 (Aug 30). doi: 10.1001/jamadermatol.2023.2875

Key clinical point: Children and adults with atopic dermatitis (AD) have a significantly increased risk of developing inflammatory bowel disease (IBD), including Crohn’s disease (CD).

Major finding: Children with vs without AD had a significantly higher risk for IBD (adjusted HR [aHR] 1.44; 95% CI 1.31-1.58) and CD (aHR 1.74; 95% CI 1.54-1.97), but the risk for ulcerative colitis (UC; aHR 1.65; 95% CI 1.02-2.67) was higher only in children with severe AD. Adults with vs without AD had a significantly increased risk for IBD (aHR 1.34; 95% CI 1.27-1.40), CD (aHR 1.36; 95% CI 1.26-1.47), and UC (aHR 1.32; 95% CI 1.24-1.41).

Study details: This population-based cohort study matched children (n = 409,431; age < 18 years) and adults (n = 625,083) with AD with control children (n = 1,809,029) and adults (n = 2,678,888) without AD, respectively.

Disclosures: This study was supported by a contract from Pfizer Inc. Five authors declared receiving grants, personal fees, and fellowship funding from various sources, including Pfizer Inc.

Source: Chiesa Fuxench ZC et al. Risk of inflammatory bowel disease in patients with atopic dermatitis. JAMA Dermatol. 2023 (Aug 30). doi: 10.1001/jamadermatol.2023.2875

Key clinical point: Children and adults with atopic dermatitis (AD) have a significantly increased risk of developing inflammatory bowel disease (IBD), including Crohn’s disease (CD).

Major finding: Children with vs without AD had a significantly higher risk for IBD (adjusted HR [aHR] 1.44; 95% CI 1.31-1.58) and CD (aHR 1.74; 95% CI 1.54-1.97), but the risk for ulcerative colitis (UC; aHR 1.65; 95% CI 1.02-2.67) was higher only in children with severe AD. Adults with vs without AD had a significantly increased risk for IBD (aHR 1.34; 95% CI 1.27-1.40), CD (aHR 1.36; 95% CI 1.26-1.47), and UC (aHR 1.32; 95% CI 1.24-1.41).

Study details: This population-based cohort study matched children (n = 409,431; age < 18 years) and adults (n = 625,083) with AD with control children (n = 1,809,029) and adults (n = 2,678,888) without AD, respectively.

Disclosures: This study was supported by a contract from Pfizer Inc. Five authors declared receiving grants, personal fees, and fellowship funding from various sources, including Pfizer Inc.

Source: Chiesa Fuxench ZC et al. Risk of inflammatory bowel disease in patients with atopic dermatitis. JAMA Dermatol. 2023 (Aug 30). doi: 10.1001/jamadermatol.2023.2875

Key clinical point: Dupilumab significantly improved the overall sleep continuity and quality, itch, and other signs and symptoms of atopic dermatitis (AD) in patients with moderate-to-severe AD.

Major finding: At week 12, dupilumab vs placebo led to a significant improvement in the sleep Numeric Rating Scale (NRS), peak pruritus NRS, SCORing Atopic Dermatitis (SCORAD), SCORAD sleep visual analog scale, Eczema Area and Severity Index, Epworth Sleepiness Scale, and sleep-related impairment T-scores (all P < .001) and a lower overall treatment-emergent adverse event rate (56.7% vs 67.2%).

Study details: Findings are from the prospective phase 4 DUPISTAD study including patients with moderate-to-severe AD who were randomly assigned to receive 300 mg dupilumab every 2 weeks (n = 127) or placebo (n = 61).

Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Three authors declared being employees of and holding stocks or stock options in Sanofi or Regeneron. Other authors declared receiving grant support, travel grants, or speaker fees from or serving as principal investigators, advisory board members, or consultants for various sources.

Source: Merola JF et al. Dupilumab significantly improves sleep in adults with atopic dermatitis: Results from the 12-week placebo-controlled period of the 24-week phase 4 randomized double-blinded placebo-controlled DUPISTAD study. Br J Dermatol. 2023 (Aug 10). doi: 10.1093/bjd/ljad284

Key clinical point: Dupilumab significantly improved the overall sleep continuity and quality, itch, and other signs and symptoms of atopic dermatitis (AD) in patients with moderate-to-severe AD.

Major finding: At week 12, dupilumab vs placebo led to a significant improvement in the sleep Numeric Rating Scale (NRS), peak pruritus NRS, SCORing Atopic Dermatitis (SCORAD), SCORAD sleep visual analog scale, Eczema Area and Severity Index, Epworth Sleepiness Scale, and sleep-related impairment T-scores (all P < .001) and a lower overall treatment-emergent adverse event rate (56.7% vs 67.2%).

Study details: Findings are from the prospective phase 4 DUPISTAD study including patients with moderate-to-severe AD who were randomly assigned to receive 300 mg dupilumab every 2 weeks (n = 127) or placebo (n = 61).

Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Three authors declared being employees of and holding stocks or stock options in Sanofi or Regeneron. Other authors declared receiving grant support, travel grants, or speaker fees from or serving as principal investigators, advisory board members, or consultants for various sources.

Source: Merola JF et al. Dupilumab significantly improves sleep in adults with atopic dermatitis: Results from the 12-week placebo-controlled period of the 24-week phase 4 randomized double-blinded placebo-controlled DUPISTAD study. Br J Dermatol. 2023 (Aug 10). doi: 10.1093/bjd/ljad284

Key clinical point: Dupilumab significantly improved the overall sleep continuity and quality, itch, and other signs and symptoms of atopic dermatitis (AD) in patients with moderate-to-severe AD.

Major finding: At week 12, dupilumab vs placebo led to a significant improvement in the sleep Numeric Rating Scale (NRS), peak pruritus NRS, SCORing Atopic Dermatitis (SCORAD), SCORAD sleep visual analog scale, Eczema Area and Severity Index, Epworth Sleepiness Scale, and sleep-related impairment T-scores (all P < .001) and a lower overall treatment-emergent adverse event rate (56.7% vs 67.2%).

Study details: Findings are from the prospective phase 4 DUPISTAD study including patients with moderate-to-severe AD who were randomly assigned to receive 300 mg dupilumab every 2 weeks (n = 127) or placebo (n = 61).

Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Three authors declared being employees of and holding stocks or stock options in Sanofi or Regeneron. Other authors declared receiving grant support, travel grants, or speaker fees from or serving as principal investigators, advisory board members, or consultants for various sources.

Source: Merola JF et al. Dupilumab significantly improves sleep in adults with atopic dermatitis: Results from the 12-week placebo-controlled period of the 24-week phase 4 randomized double-blinded placebo-controlled DUPISTAD study. Br J Dermatol. 2023 (Aug 10). doi: 10.1093/bjd/ljad284

Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children aged 6 years and older.

Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.

According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children aged 6 years and older.

Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.

According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children aged 6 years and older.

Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.

According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

Almonds and almond oil are known to exhibit anti-inflammatory, antihepatotoxicity, and immunity-boosting activity.¹ The seed from the deciduous almond tree (Oleum amygdalae), which is native to Iran and parts of the Levant, almonds contain copious amounts of phenols and polyphenols, fatty acids, and vitamin E, all of which are known to exert antioxidant activity.^2-5 These seeds have been found to have a substantial impact on serum lipids.⁴ Emollient and sclerosant characteristics have also been linked to almond oil, which has been found to ameliorate complexion and skin tone.⁵ Significantly, in vitro and in vivo studies have shown that UVB-induced photoaging can be attenuated through the use of almond oil and almond skin extract.² Further, in traditional Chinese Medicine, Ayurveda, and ancient Greco-Persian medicine, almond oil was used to treat cutaneous conditions, including eczema and psoriasis.¹The focus of this column is to provide an update on the use of almonds and almond oil for skincare since covering the topic in July 2014.

Antiphotoaging activity

In 2019, Foolad and Vaughn conducted a prospective, investigator-blind, randomized controlled trial to determine the effects of almond consumption on facial sebum production and wrinkles. Participants (28 postmenopausal women with Fitzpatrick skin types I and II completed the study) consumed 20% of their daily energy intake in almonds or a calorie-matched snack over 16 weeks through the UC Davis Dermatology Clinic. Photographic analysis revealed that the almond group experienced significantly diminished wrinkle severity, compared with the control group. The investigators concluded that daily almond consumption has the potential to decrease wrinkle severity in postmenopausal women and that almonds may confer natural antiaging effects.⁴

In a similar investigation 2 years later, Rybak et al. reported on a prospective, randomized controlled study to ascertain the effects of almond consumption on photoaging in postmenopausal women with Fitzpatrick skin types I or II who obtained 20% of their daily energy consumption via almonds or a calorie-matched snack for 24 weeks. Results demonstrated significant effects conferred by almond consumption, with average wrinkle severity substantially diminished in the almond group at weeks 16 (by 15%) and 24 (by 16%), compared with baseline. In addition, facial pigment intensity was reduced by 20% in the almond group by week 16 and this was maintained through the end of the study. Further, sebum excretion was higher in the control group. The investigators concluded that the daily consumption of almonds may have the potential to enhance protection against photoaging, particularly in terms of facial wrinkles and pigment intensity, in postmenopausal women.³

Later in 2021, Li et al. conducted a study in 39 healthy Asian women (18-45 years old) with Fitzpatrick skin types II to IV to investigate the effects of almond consumption on UVB resistance. The researchers randomized participants to eat either 1.5 oz of almonds or 1.8 oz of pretzels daily for 12 weeks. Results showed that the minimal erythema dose was higher in the almond group as compared with the control group. No differences were observed in hydration, melanin, roughness, or sebum on facial skin. The authors concluded that daily oral almond intake may improve photoprotection by raising the minimal erythema dose.²

In a 2022 review on the cutaneous benefits of sweet almond, evening primrose, and jojoba oils, Blaak and Staib noted that all three have been used for hundreds if not thousands of years in traditional medicine to treat various conditions, including skin disorders. Further, they concluded that the longstanding uses of these oils has been borne out by contemporary data, which reveal cutaneous benefits for adult and young skin, particularly in bolstering stratum corneum integrity, recovery, and lipid ratio.⁶

Later that year, Sanju et al., reporting on the development and assessment of a broad-spectrum polyherbal sunscreen delivered through solid lipid nanoparticles, noted that almond oil was among the natural ingredients used because of its photoprotective characteristics. Overall, the sunscreen formulation, Safranal, was found to impart robust protection against UV radiation.⁷

Wound healing

In 2020, Borzou et al. conducted a single-blind randomized clinical trial to ascertain the impact of topical almond oil in preventing pressure injuries. Data collection occurred over 8 months in a hospital setting, with 108 patients randomly assigned to receive almond oil, placebo (liquid paraffin), or the control (standard of care). The researchers found that topically applied almond oil was linked to a lower incidence of pressure injuries, and they arose later in the study as compared with those injuries in the groups receiving paraffin or standard of care. Pressure injury incidence was 5.6% in the almond oil group, 13.9% in the placebo group, and 25.1% in the control group.⁸

That same year, Caglar et al. completed a randomized controlled trial in 90 preterm infants to assess the effects of sunflower seed oil and almond oil on the stratum corneum. Infants were randomly selected for treatment with either oil or control. A nurse researcher applied oils to the whole body except for the head and face four times daily for 5 days. Investigators determined that stratum corneum hydration was better in the oil groups as compared with control, with no difference found between sunflower seed and almond oils.⁹

Eczema, hand dermatitis, and striae

In 2018, Simon et al. performed a randomized, double-blind study to determine the short- and long-term effects of two emollients on pruritus and skin restoration in xerotic eczema. The emollients contained lactic acid and refined almond oil, with one also including polidocanol. Both emollients were effective in reducing the severity of itching, with skin moisture and lipid content found to have risen after the initial administration and yielding steady improvement over 2 weeks.¹⁰

Earlier that year, Zeichner et al. found that the use of an OTC sweet almond oil, rich in fatty acids and a standard-bearing treatment for eczema and psoriasis for centuries, was effective in treating hand dermatitis. Specifically, the moisturizer, which contained 7% sweet almond oil and 2% colloidal oatmeal, was identified as safe and effective in resolving moderate to severe hand dermatitis.¹¹

Some studies have also shown almond oil to be effective against striae gravidarum. Hajhashemi et al. conducted a double-blind clinical trial in 160 nulliparous women to compare the effects of aloe vera gel and sweet almond oil on striae gravidarum in 2018. Volunteers were randomly assigned to one of three case groups (Aloe vera, sweet almond oil, or base cream) who received topical treatment on the abdomen, or the fourth group, which received no treatment. Results showed that both treatment creams were effective in decreasing erythema and the pruritus associated with striae as well as in preventing their expansion.¹² Previously, Tashan and Kafkasli showed in a nonrandomized study that massage with bitter almond oil may diminish the visibility of present striae gravidarum and prevent the emergence of new striae.¹³

Conclusion

Almonds and almond oil have been used as food and in traditional medical practices dating back several centuries. In the last decade, intriguing results have emerged regarding the effects of almond consumption or topical almond oil administration on skin health. While much more research is necessary, the recent data seem to support the traditional uses of this tree seed for dermatologic purposes.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology” (New York: McGraw Hill), was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as an e-commerce solution. Write to her at [email protected].

References

1. Ahmad Z. Complement Ther Clin Pract. 2010 Feb;16(1):10-2.

2. Li JN et al. J Cosmet Dermatol. 2021 Sep;20(9):2975-80.

3. Rybak I et al. Nutrients. 2021 Feb 27;13(3):785.

4. Foolad N et al. Phytother Res. 2019 Dec;33(12):3212-7.

5. Lin TK et al. Int J Mol Sci. 2017 Dec 27;19(1):70.

6. Blaak J, Staib P. Int J Cosmet Sci. 2022 Feb;44(1):1-9.

7. Sanju N et al. J Cosmet Dermatol. 2022 Oct;21(10):4433-46.

8. Borzou SR et al. J Wound Ostomy Continence Nurs. 2020 Jul/Aug;47(4):336-42.

9. Caglar S et al. Adv Skin Wound Care. 2020 Aug;33(8):1-6.

10. Simon D et al. Dermatol Ther. 2018 Nov;31(6):e12692.

11. Zeichner JA at al. J Drugs Dermatol. 2018 Jan 1;17(1):78-82.

12. Hajhashemi M et al. J Matern Fetal Neonatal Med. 2018 Jul;31(13):1703-8.

13. Timur Tashan S and Kafkasli A. J Clin Nurs. 2012 Jun;21(11-12):1570-6.
 

Almonds and almond oil are known to exhibit anti-inflammatory, antihepatotoxicity, and immunity-boosting activity.¹ The seed from the deciduous almond tree (Oleum amygdalae), which is native to Iran and parts of the Levant, almonds contain copious amounts of phenols and polyphenols, fatty acids, and vitamin E, all of which are known to exert antioxidant activity.^2-5 These seeds have been found to have a substantial impact on serum lipids.⁴ Emollient and sclerosant characteristics have also been linked to almond oil, which has been found to ameliorate complexion and skin tone.⁵ Significantly, in vitro and in vivo studies have shown that UVB-induced photoaging can be attenuated through the use of almond oil and almond skin extract.² Further, in traditional Chinese Medicine, Ayurveda, and ancient Greco-Persian medicine, almond oil was used to treat cutaneous conditions, including eczema and psoriasis.¹The focus of this column is to provide an update on the use of almonds and almond oil for skincare since covering the topic in July 2014.

Antiphotoaging activity

In 2019, Foolad and Vaughn conducted a prospective, investigator-blind, randomized controlled trial to determine the effects of almond consumption on facial sebum production and wrinkles. Participants (28 postmenopausal women with Fitzpatrick skin types I and II completed the study) consumed 20% of their daily energy intake in almonds or a calorie-matched snack over 16 weeks through the UC Davis Dermatology Clinic. Photographic analysis revealed that the almond group experienced significantly diminished wrinkle severity, compared with the control group. The investigators concluded that daily almond consumption has the potential to decrease wrinkle severity in postmenopausal women and that almonds may confer natural antiaging effects.⁴

In a similar investigation 2 years later, Rybak et al. reported on a prospective, randomized controlled study to ascertain the effects of almond consumption on photoaging in postmenopausal women with Fitzpatrick skin types I or II who obtained 20% of their daily energy consumption via almonds or a calorie-matched snack for 24 weeks. Results demonstrated significant effects conferred by almond consumption, with average wrinkle severity substantially diminished in the almond group at weeks 16 (by 15%) and 24 (by 16%), compared with baseline. In addition, facial pigment intensity was reduced by 20% in the almond group by week 16 and this was maintained through the end of the study. Further, sebum excretion was higher in the control group. The investigators concluded that the daily consumption of almonds may have the potential to enhance protection against photoaging, particularly in terms of facial wrinkles and pigment intensity, in postmenopausal women.³

Later in 2021, Li et al. conducted a study in 39 healthy Asian women (18-45 years old) with Fitzpatrick skin types II to IV to investigate the effects of almond consumption on UVB resistance. The researchers randomized participants to eat either 1.5 oz of almonds or 1.8 oz of pretzels daily for 12 weeks. Results showed that the minimal erythema dose was higher in the almond group as compared with the control group. No differences were observed in hydration, melanin, roughness, or sebum on facial skin. The authors concluded that daily oral almond intake may improve photoprotection by raising the minimal erythema dose.²

In a 2022 review on the cutaneous benefits of sweet almond, evening primrose, and jojoba oils, Blaak and Staib noted that all three have been used for hundreds if not thousands of years in traditional medicine to treat various conditions, including skin disorders. Further, they concluded that the longstanding uses of these oils has been borne out by contemporary data, which reveal cutaneous benefits for adult and young skin, particularly in bolstering stratum corneum integrity, recovery, and lipid ratio.⁶

Later that year, Sanju et al., reporting on the development and assessment of a broad-spectrum polyherbal sunscreen delivered through solid lipid nanoparticles, noted that almond oil was among the natural ingredients used because of its photoprotective characteristics. Overall, the sunscreen formulation, Safranal, was found to impart robust protection against UV radiation.⁷

Wound healing

In 2020, Borzou et al. conducted a single-blind randomized clinical trial to ascertain the impact of topical almond oil in preventing pressure injuries. Data collection occurred over 8 months in a hospital setting, with 108 patients randomly assigned to receive almond oil, placebo (liquid paraffin), or the control (standard of care). The researchers found that topically applied almond oil was linked to a lower incidence of pressure injuries, and they arose later in the study as compared with those injuries in the groups receiving paraffin or standard of care. Pressure injury incidence was 5.6% in the almond oil group, 13.9% in the placebo group, and 25.1% in the control group.⁸

That same year, Caglar et al. completed a randomized controlled trial in 90 preterm infants to assess the effects of sunflower seed oil and almond oil on the stratum corneum. Infants were randomly selected for treatment with either oil or control. A nurse researcher applied oils to the whole body except for the head and face four times daily for 5 days. Investigators determined that stratum corneum hydration was better in the oil groups as compared with control, with no difference found between sunflower seed and almond oils.⁹

Eczema, hand dermatitis, and striae

In 2018, Simon et al. performed a randomized, double-blind study to determine the short- and long-term effects of two emollients on pruritus and skin restoration in xerotic eczema. The emollients contained lactic acid and refined almond oil, with one also including polidocanol. Both emollients were effective in reducing the severity of itching, with skin moisture and lipid content found to have risen after the initial administration and yielding steady improvement over 2 weeks.¹⁰

Earlier that year, Zeichner et al. found that the use of an OTC sweet almond oil, rich in fatty acids and a standard-bearing treatment for eczema and psoriasis for centuries, was effective in treating hand dermatitis. Specifically, the moisturizer, which contained 7% sweet almond oil and 2% colloidal oatmeal, was identified as safe and effective in resolving moderate to severe hand dermatitis.¹¹

Some studies have also shown almond oil to be effective against striae gravidarum. Hajhashemi et al. conducted a double-blind clinical trial in 160 nulliparous women to compare the effects of aloe vera gel and sweet almond oil on striae gravidarum in 2018. Volunteers were randomly assigned to one of three case groups (Aloe vera, sweet almond oil, or base cream) who received topical treatment on the abdomen, or the fourth group, which received no treatment. Results showed that both treatment creams were effective in decreasing erythema and the pruritus associated with striae as well as in preventing their expansion.¹² Previously, Tashan and Kafkasli showed in a nonrandomized study that massage with bitter almond oil may diminish the visibility of present striae gravidarum and prevent the emergence of new striae.¹³

Conclusion

Almonds and almond oil have been used as food and in traditional medical practices dating back several centuries. In the last decade, intriguing results have emerged regarding the effects of almond consumption or topical almond oil administration on skin health. While much more research is necessary, the recent data seem to support the traditional uses of this tree seed for dermatologic purposes.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology” (New York: McGraw Hill), was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as an e-commerce solution. Write to her at [email protected].

References

1. Ahmad Z. Complement Ther Clin Pract. 2010 Feb;16(1):10-2.

2. Li JN et al. J Cosmet Dermatol. 2021 Sep;20(9):2975-80.

3. Rybak I et al. Nutrients. 2021 Feb 27;13(3):785.

4. Foolad N et al. Phytother Res. 2019 Dec;33(12):3212-7.

5. Lin TK et al. Int J Mol Sci. 2017 Dec 27;19(1):70.

6. Blaak J, Staib P. Int J Cosmet Sci. 2022 Feb;44(1):1-9.

7. Sanju N et al. J Cosmet Dermatol. 2022 Oct;21(10):4433-46.

8. Borzou SR et al. J Wound Ostomy Continence Nurs. 2020 Jul/Aug;47(4):336-42.

9. Caglar S et al. Adv Skin Wound Care. 2020 Aug;33(8):1-6.

10. Simon D et al. Dermatol Ther. 2018 Nov;31(6):e12692.

11. Zeichner JA at al. J Drugs Dermatol. 2018 Jan 1;17(1):78-82.

12. Hajhashemi M et al. J Matern Fetal Neonatal Med. 2018 Jul;31(13):1703-8.

13. Timur Tashan S and Kafkasli A. J Clin Nurs. 2012 Jun;21(11-12):1570-6.
 

Almonds and almond oil are known to exhibit anti-inflammatory, antihepatotoxicity, and immunity-boosting activity.¹ The seed from the deciduous almond tree (Oleum amygdalae), which is native to Iran and parts of the Levant, almonds contain copious amounts of phenols and polyphenols, fatty acids, and vitamin E, all of which are known to exert antioxidant activity.^2-5 These seeds have been found to have a substantial impact on serum lipids.⁴ Emollient and sclerosant characteristics have also been linked to almond oil, which has been found to ameliorate complexion and skin tone.⁵ Significantly, in vitro and in vivo studies have shown that UVB-induced photoaging can be attenuated through the use of almond oil and almond skin extract.² Further, in traditional Chinese Medicine, Ayurveda, and ancient Greco-Persian medicine, almond oil was used to treat cutaneous conditions, including eczema and psoriasis.¹The focus of this column is to provide an update on the use of almonds and almond oil for skincare since covering the topic in July 2014.

Antiphotoaging activity

In 2019, Foolad and Vaughn conducted a prospective, investigator-blind, randomized controlled trial to determine the effects of almond consumption on facial sebum production and wrinkles. Participants (28 postmenopausal women with Fitzpatrick skin types I and II completed the study) consumed 20% of their daily energy intake in almonds or a calorie-matched snack over 16 weeks through the UC Davis Dermatology Clinic. Photographic analysis revealed that the almond group experienced significantly diminished wrinkle severity, compared with the control group. The investigators concluded that daily almond consumption has the potential to decrease wrinkle severity in postmenopausal women and that almonds may confer natural antiaging effects.⁴

In a similar investigation 2 years later, Rybak et al. reported on a prospective, randomized controlled study to ascertain the effects of almond consumption on photoaging in postmenopausal women with Fitzpatrick skin types I or II who obtained 20% of their daily energy consumption via almonds or a calorie-matched snack for 24 weeks. Results demonstrated significant effects conferred by almond consumption, with average wrinkle severity substantially diminished in the almond group at weeks 16 (by 15%) and 24 (by 16%), compared with baseline. In addition, facial pigment intensity was reduced by 20% in the almond group by week 16 and this was maintained through the end of the study. Further, sebum excretion was higher in the control group. The investigators concluded that the daily consumption of almonds may have the potential to enhance protection against photoaging, particularly in terms of facial wrinkles and pigment intensity, in postmenopausal women.³

Later in 2021, Li et al. conducted a study in 39 healthy Asian women (18-45 years old) with Fitzpatrick skin types II to IV to investigate the effects of almond consumption on UVB resistance. The researchers randomized participants to eat either 1.5 oz of almonds or 1.8 oz of pretzels daily for 12 weeks. Results showed that the minimal erythema dose was higher in the almond group as compared with the control group. No differences were observed in hydration, melanin, roughness, or sebum on facial skin. The authors concluded that daily oral almond intake may improve photoprotection by raising the minimal erythema dose.²

In a 2022 review on the cutaneous benefits of sweet almond, evening primrose, and jojoba oils, Blaak and Staib noted that all three have been used for hundreds if not thousands of years in traditional medicine to treat various conditions, including skin disorders. Further, they concluded that the longstanding uses of these oils has been borne out by contemporary data, which reveal cutaneous benefits for adult and young skin, particularly in bolstering stratum corneum integrity, recovery, and lipid ratio.⁶

Later that year, Sanju et al., reporting on the development and assessment of a broad-spectrum polyherbal sunscreen delivered through solid lipid nanoparticles, noted that almond oil was among the natural ingredients used because of its photoprotective characteristics. Overall, the sunscreen formulation, Safranal, was found to impart robust protection against UV radiation.⁷

Wound healing

In 2020, Borzou et al. conducted a single-blind randomized clinical trial to ascertain the impact of topical almond oil in preventing pressure injuries. Data collection occurred over 8 months in a hospital setting, with 108 patients randomly assigned to receive almond oil, placebo (liquid paraffin), or the control (standard of care). The researchers found that topically applied almond oil was linked to a lower incidence of pressure injuries, and they arose later in the study as compared with those injuries in the groups receiving paraffin or standard of care. Pressure injury incidence was 5.6% in the almond oil group, 13.9% in the placebo group, and 25.1% in the control group.⁸

That same year, Caglar et al. completed a randomized controlled trial in 90 preterm infants to assess the effects of sunflower seed oil and almond oil on the stratum corneum. Infants were randomly selected for treatment with either oil or control. A nurse researcher applied oils to the whole body except for the head and face four times daily for 5 days. Investigators determined that stratum corneum hydration was better in the oil groups as compared with control, with no difference found between sunflower seed and almond oils.⁹

Eczema, hand dermatitis, and striae

In 2018, Simon et al. performed a randomized, double-blind study to determine the short- and long-term effects of two emollients on pruritus and skin restoration in xerotic eczema. The emollients contained lactic acid and refined almond oil, with one also including polidocanol. Both emollients were effective in reducing the severity of itching, with skin moisture and lipid content found to have risen after the initial administration and yielding steady improvement over 2 weeks.¹⁰

Earlier that year, Zeichner et al. found that the use of an OTC sweet almond oil, rich in fatty acids and a standard-bearing treatment for eczema and psoriasis for centuries, was effective in treating hand dermatitis. Specifically, the moisturizer, which contained 7% sweet almond oil and 2% colloidal oatmeal, was identified as safe and effective in resolving moderate to severe hand dermatitis.¹¹

Some studies have also shown almond oil to be effective against striae gravidarum. Hajhashemi et al. conducted a double-blind clinical trial in 160 nulliparous women to compare the effects of aloe vera gel and sweet almond oil on striae gravidarum in 2018. Volunteers were randomly assigned to one of three case groups (Aloe vera, sweet almond oil, or base cream) who received topical treatment on the abdomen, or the fourth group, which received no treatment. Results showed that both treatment creams were effective in decreasing erythema and the pruritus associated with striae as well as in preventing their expansion.¹² Previously, Tashan and Kafkasli showed in a nonrandomized study that massage with bitter almond oil may diminish the visibility of present striae gravidarum and prevent the emergence of new striae.¹³

Conclusion

Almonds and almond oil have been used as food and in traditional medical practices dating back several centuries. In the last decade, intriguing results have emerged regarding the effects of almond consumption or topical almond oil administration on skin health. While much more research is necessary, the recent data seem to support the traditional uses of this tree seed for dermatologic purposes.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology” (New York: McGraw Hill), was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as an e-commerce solution. Write to her at [email protected].

References

1. Ahmad Z. Complement Ther Clin Pract. 2010 Feb;16(1):10-2.

2. Li JN et al. J Cosmet Dermatol. 2021 Sep;20(9):2975-80.

3. Rybak I et al. Nutrients. 2021 Feb 27;13(3):785.

4. Foolad N et al. Phytother Res. 2019 Dec;33(12):3212-7.

5. Lin TK et al. Int J Mol Sci. 2017 Dec 27;19(1):70.

6. Blaak J, Staib P. Int J Cosmet Sci. 2022 Feb;44(1):1-9.

7. Sanju N et al. J Cosmet Dermatol. 2022 Oct;21(10):4433-46.

8. Borzou SR et al. J Wound Ostomy Continence Nurs. 2020 Jul/Aug;47(4):336-42.

9. Caglar S et al. Adv Skin Wound Care. 2020 Aug;33(8):1-6.

10. Simon D et al. Dermatol Ther. 2018 Nov;31(6):e12692.

11. Zeichner JA at al. J Drugs Dermatol. 2018 Jan 1;17(1):78-82.

12. Hajhashemi M et al. J Matern Fetal Neonatal Med. 2018 Jul;31(13):1703-8.

13. Timur Tashan S and Kafkasli A. J Clin Nurs. 2012 Jun;21(11-12):1570-6.
 

Pregnant women with atopic dermatitis (AD) are more likely to be colonized with group B streptococcus (GBS), compared with other pregnant women, results from a large cross-sectional study suggest.

“The rate of GBS colonization among pregnant females with a history of AD has not been previously reported, but AD could be a risk factor for maternal carriage of GBS,” corresponding author David J. Margolis, MD, PhD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and colleagues wrote in the study, which was published as a letter to the editor online in the Journal of Investigative Dermatology. “GBS reporting in a large administrative database represents a unique opportunity to conduct a population-based evaluation of GBS carriage with AD. Understanding this association could expand our understanding of microbial changes associated with AD,” they noted.

To determine if an association between GBS and AD in pregnant women exists, the researchers performed a cross-sectional study using a random sample from an Optum administrative database of pregnant women who had vaginal deliveries between May of 2007 and September 2021. The primary outcome of interest was the presence of GBS based on American College of Obstetricians and Gynecologists–recommended codes for GBS during 36 0/7 to 37 6/7 weeks of pregnancy. They used descriptive statistics to summarize categorical and continuous variables as proportions and means, and logistic regression to examine the association between AD and GBS status.

The cohort included 566,467 pregnant women with an average age of 38.8 years. Of these, 2.9% had a diagnosis of AD or a history of AD, and 24.9% had diagnoses of asthma, seasonal allergies, or both. Women with AD had an increased odds ratio of asthma (OR, 2.55), seasonal allergies (OR, 3.39), or both (OR, 5.35), compared with those without AD.

GBS was reported in 20.6% of the cohort. The median time of follow-up for those with and without GBS was 494 days and 468 days, respectively (P = .134). Among the women with AD, 24.1% had GBS, compared with 20.51% of the women without AD (P <.0001), which translated into an OR of 1.23 (95% confidence interval, 1.18-1.27).

Among the women with GBS, the OR of asthma was 1.08 (95% CI, 1.06-1.10) and was 1.07 (95% CI, 1.05-1.09) among those with seasonal allergies. When adjusted for potential confounders, these findings did not change substantively.

“It is not apparent why pregnant females with AD are more likely to specifically carry GBS,” the authors wrote. “However, several studies have shown that individuals with AD are more likely to carry [Staphylococcus] aureus and that individuals with AD might be deficient in host defenses against S. aureus and other pathogens,” they added.

“Individuals with AD frequently receive antibiotics as part of their AD treatment and this might alter their resident microbiome. Carriage rates may be enhanced by the inhibition of an important barrier protein called filaggrin (FLG) and FLG loss of function genetic variation is known to decrease barrier proteins thought to inhibit the colonization of S. aureus and other pathogens,” the researchers wrote.

They acknowledged certain limitations of their study, including its reliance on an administrative database that does not contain information on past disease.

Asked to comment on the results, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was not involved with the study, characterized AD as “the poster child for cutaneous dysbiosis – an altered petri dish, so to speak, [that] facilitates survival of the few, leading to decreased microbial diversity that can both enable potential pathogen invasion and immune dysregulation.”

Though it’s not surprising that pregnant AD patients have dysbiosis, the focus on GBS, “which can be a bad actor in the perinatal period, is an interesting connection,” he said. “Will this change practices? Pregnant women should be screened for GBS regardless, but maybe more attention or counseling can be offered to AD patients about the importance of screening. Would decolonization regimens be employed early in pregnancy? This study can’t answer that but certainly raises good questions.”

Dr. Margolis disclosed that he is or recently has been a consultant for Pfizer, Leo, and Sanofi with respect to studies of atopic dermatitis and served on an advisory board for the National Eczema Association. Another author disclosed receiving grants from companies related to work with AD; other authors had no disclosures. Dr. Friedman reported having no relevant disclosures.

Pregnant women with atopic dermatitis (AD) are more likely to be colonized with group B streptococcus (GBS), compared with other pregnant women, results from a large cross-sectional study suggest.

“The rate of GBS colonization among pregnant females with a history of AD has not been previously reported, but AD could be a risk factor for maternal carriage of GBS,” corresponding author David J. Margolis, MD, PhD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and colleagues wrote in the study, which was published as a letter to the editor online in the Journal of Investigative Dermatology. “GBS reporting in a large administrative database represents a unique opportunity to conduct a population-based evaluation of GBS carriage with AD. Understanding this association could expand our understanding of microbial changes associated with AD,” they noted.

To determine if an association between GBS and AD in pregnant women exists, the researchers performed a cross-sectional study using a random sample from an Optum administrative database of pregnant women who had vaginal deliveries between May of 2007 and September 2021. The primary outcome of interest was the presence of GBS based on American College of Obstetricians and Gynecologists–recommended codes for GBS during 36 0/7 to 37 6/7 weeks of pregnancy. They used descriptive statistics to summarize categorical and continuous variables as proportions and means, and logistic regression to examine the association between AD and GBS status.

The cohort included 566,467 pregnant women with an average age of 38.8 years. Of these, 2.9% had a diagnosis of AD or a history of AD, and 24.9% had diagnoses of asthma, seasonal allergies, or both. Women with AD had an increased odds ratio of asthma (OR, 2.55), seasonal allergies (OR, 3.39), or both (OR, 5.35), compared with those without AD.

GBS was reported in 20.6% of the cohort. The median time of follow-up for those with and without GBS was 494 days and 468 days, respectively (P = .134). Among the women with AD, 24.1% had GBS, compared with 20.51% of the women without AD (P <.0001), which translated into an OR of 1.23 (95% confidence interval, 1.18-1.27).

Among the women with GBS, the OR of asthma was 1.08 (95% CI, 1.06-1.10) and was 1.07 (95% CI, 1.05-1.09) among those with seasonal allergies. When adjusted for potential confounders, these findings did not change substantively.

“It is not apparent why pregnant females with AD are more likely to specifically carry GBS,” the authors wrote. “However, several studies have shown that individuals with AD are more likely to carry [Staphylococcus] aureus and that individuals with AD might be deficient in host defenses against S. aureus and other pathogens,” they added.

“Individuals with AD frequently receive antibiotics as part of their AD treatment and this might alter their resident microbiome. Carriage rates may be enhanced by the inhibition of an important barrier protein called filaggrin (FLG) and FLG loss of function genetic variation is known to decrease barrier proteins thought to inhibit the colonization of S. aureus and other pathogens,” the researchers wrote.

They acknowledged certain limitations of their study, including its reliance on an administrative database that does not contain information on past disease.

Asked to comment on the results, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was not involved with the study, characterized AD as “the poster child for cutaneous dysbiosis – an altered petri dish, so to speak, [that] facilitates survival of the few, leading to decreased microbial diversity that can both enable potential pathogen invasion and immune dysregulation.”

Though it’s not surprising that pregnant AD patients have dysbiosis, the focus on GBS, “which can be a bad actor in the perinatal period, is an interesting connection,” he said. “Will this change practices? Pregnant women should be screened for GBS regardless, but maybe more attention or counseling can be offered to AD patients about the importance of screening. Would decolonization regimens be employed early in pregnancy? This study can’t answer that but certainly raises good questions.”

Dr. Margolis disclosed that he is or recently has been a consultant for Pfizer, Leo, and Sanofi with respect to studies of atopic dermatitis and served on an advisory board for the National Eczema Association. Another author disclosed receiving grants from companies related to work with AD; other authors had no disclosures. Dr. Friedman reported having no relevant disclosures.

Pregnant women with atopic dermatitis (AD) are more likely to be colonized with group B streptococcus (GBS), compared with other pregnant women, results from a large cross-sectional study suggest.

“The rate of GBS colonization among pregnant females with a history of AD has not been previously reported, but AD could be a risk factor for maternal carriage of GBS,” corresponding author David J. Margolis, MD, PhD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and colleagues wrote in the study, which was published as a letter to the editor online in the Journal of Investigative Dermatology. “GBS reporting in a large administrative database represents a unique opportunity to conduct a population-based evaluation of GBS carriage with AD. Understanding this association could expand our understanding of microbial changes associated with AD,” they noted.

To determine if an association between GBS and AD in pregnant women exists, the researchers performed a cross-sectional study using a random sample from an Optum administrative database of pregnant women who had vaginal deliveries between May of 2007 and September 2021. The primary outcome of interest was the presence of GBS based on American College of Obstetricians and Gynecologists–recommended codes for GBS during 36 0/7 to 37 6/7 weeks of pregnancy. They used descriptive statistics to summarize categorical and continuous variables as proportions and means, and logistic regression to examine the association between AD and GBS status.

The cohort included 566,467 pregnant women with an average age of 38.8 years. Of these, 2.9% had a diagnosis of AD or a history of AD, and 24.9% had diagnoses of asthma, seasonal allergies, or both. Women with AD had an increased odds ratio of asthma (OR, 2.55), seasonal allergies (OR, 3.39), or both (OR, 5.35), compared with those without AD.

GBS was reported in 20.6% of the cohort. The median time of follow-up for those with and without GBS was 494 days and 468 days, respectively (P = .134). Among the women with AD, 24.1% had GBS, compared with 20.51% of the women without AD (P <.0001), which translated into an OR of 1.23 (95% confidence interval, 1.18-1.27).

Among the women with GBS, the OR of asthma was 1.08 (95% CI, 1.06-1.10) and was 1.07 (95% CI, 1.05-1.09) among those with seasonal allergies. When adjusted for potential confounders, these findings did not change substantively.

“It is not apparent why pregnant females with AD are more likely to specifically carry GBS,” the authors wrote. “However, several studies have shown that individuals with AD are more likely to carry [Staphylococcus] aureus and that individuals with AD might be deficient in host defenses against S. aureus and other pathogens,” they added.

“Individuals with AD frequently receive antibiotics as part of their AD treatment and this might alter their resident microbiome. Carriage rates may be enhanced by the inhibition of an important barrier protein called filaggrin (FLG) and FLG loss of function genetic variation is known to decrease barrier proteins thought to inhibit the colonization of S. aureus and other pathogens,” the researchers wrote.

They acknowledged certain limitations of their study, including its reliance on an administrative database that does not contain information on past disease.

Asked to comment on the results, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was not involved with the study, characterized AD as “the poster child for cutaneous dysbiosis – an altered petri dish, so to speak, [that] facilitates survival of the few, leading to decreased microbial diversity that can both enable potential pathogen invasion and immune dysregulation.”

Though it’s not surprising that pregnant AD patients have dysbiosis, the focus on GBS, “which can be a bad actor in the perinatal period, is an interesting connection,” he said. “Will this change practices? Pregnant women should be screened for GBS regardless, but maybe more attention or counseling can be offered to AD patients about the importance of screening. Would decolonization regimens be employed early in pregnancy? This study can’t answer that but certainly raises good questions.”

Dr. Margolis disclosed that he is or recently has been a consultant for Pfizer, Leo, and Sanofi with respect to studies of atopic dermatitis and served on an advisory board for the National Eczema Association. Another author disclosed receiving grants from companies related to work with AD; other authors had no disclosures. Dr. Friedman reported having no relevant disclosures.

Amlitelimab is a monoclonal antibody that targets the OX40 ligand (Weidinger et al). It is predicted to have broad potential therapeutic application for multiple immune diseases, including atopic dermatitis. I'm not looking for that. I've been spoiled by drugs that have narrow therapeutic application (like IL-23 blockade and IL-4/IL-13 blockade) that target a specific disease very effectively with very little in the way of side effects.

The OX40 ligand/receptor interaction may be too important. When I Google "OX40 deficiency," the first thing that pops up is a combined T- and B-cell immunodeficiency associated with possible aggressive, childhood-onset, disseminated, cutaneous, and systemic Kaposi sarcoma. That doesn't mean that such a horrible outcome will come with the level of pharmacologic OX40 blockade that we would try to achieve in our patients. Clinical trials don't show horrible adverse events — so far. I'm in no hurry to find out in my patients whether real-life efficacy in large numbers of people treated for long periods of time matches up with the short-term safety profiles seen in relatively small clinical trial populations.

It might be nice to give patients upadacitinib only as needed, for example for a flare of their atopic dermatitis, then cut down the dose or stop altogether until the next flare. The study by Guttman-Yassky and colleagues found that atopic dermatitis came back quickly when upadacitinib was stopped. However, their study looked at patients with chronically bad atopic dermatitis. If we have a patient who tends to flare only intermittently, it may be that we could use upadacitinib or other systemic treatments on an intermittent basis. I know when it came to my son's mild atopic dermatitis, intermittent use of a little triamcinolone ointment was all that was needed. Yes, I know that's a "reactive," roller-coaster approach. Yes, I know that a "proactive" keep-the-disease-away approach sounds better. But I'm realistic when it comes to patients' adherence behaviors. I think there's a lot to be said for minimizing drug exposure and just using treatments as needed. Guttman-Yassky's work makes me believe that a lot of patients will need continuous treatment to keep their severe disease under control. I'm not convinced that everyone will need continuous treatment to be happy with their treatment.

O'Connor and colleagues found that emollient bathing is associated with later development of atopic dermatitis. They defined emollient bathing as baths with oil or emulsifier-based additives. This study illustrates the importance of randomization in a controlled trial. Because their study was not randomized, we don't know whether the emollient bathing caused atopic dermatitis or whether families that had more dry skin or more family history of atopic dermatitis were more likely to use emollient bathing.

When dupilumab was first approved, I prescribed it to my patients to take every 2 weeks as recommended on the label. I'm not so sure how many patients actually used it that way. I suspect that a lot of them took the medicine less often than recommended, especially when they were doing well. This report by Sánchez-García and colleagues suggests that patients who are doing very well on dupilumab may be able to take the drug less often. That's probably not news to my patients who are already taking the drug less often than I told them to.

I think less frequent dosing may become even more common over time, particularly for drugs that may have more safety risks than dupilumab. Many patients with atopic dermatitis probably don't need to be taking drugs all the time. Patients who tend to have flare-ups but who do very well for a long period of time between flares may only need drugs intermittently. It will be interesting to see if our patients can use oral treatments for atopic dermatitis that way.

Siegfried and colleagues assessed how well dupilumab worked in children with atopic dermatitis in different areas of the body: head and neck, trunk, upper extremities, lower extremities. Dupilumab worked well in all these areas, as expected.

Xu and colleagues did a meta-analysis of studies of dupilumab for atopic dermatitis and concluded, not shockingly, that dupilumab is safe and effective for atopic dermatitis. Okay, I believe that. They further concluded: "More long-term, high-quality, controlled studies in different regions are needed for further verification." I don't think so. I think the evidence is clear already.

Studies that measure the levels of things are generally not particularly helpful. The study by García-Reyes and colleagues studied the levels of serum thymic stromal lymphopoietin (TSLP) in patients with atopic dermatitis. TSLP levels were higher in patients with atopic dermatitis compared with patients without atopic dermatitis. This basically tells us nothing about the role of TSLP in atopic dermatitis. The elevated levels could be causing atopic dermatitis or they could be the body's response to having atopic dermatitis.

To tell whether something is causal we have to look at either genetic studies or studies with specific inhibitors. A specific inhibitor study was done by atopic dermatitis expert Eric Simpson and colleagues.1 This was a randomized, placebo-controlled study in which an anti-TSLP antibody was given to patients with atopic dermatitis. Both the anti-TSLP antibody and placebo groups were permitted to use topical steroids. While the anti-TSLP antibody–treated patients did better than placebo-treated patients, the difference did not achieve statistical significance, probably, I believe, because the placebo-treated patients used more topical steroids. When you want to assess whether a drug for atopic dermatitis is better than placebo, you must be careful about how much topical steroid you let patients in the study use!

Additional Reference

1. Simpson EL, Parnes JR, She D, et al. Tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis: A randomized phase 2a clinical trial. J Am Acad Dermatol. 2019;80(4):1013-1021. doi: 10.1016/j.jaad.2018.11.059

Amlitelimab is a monoclonal antibody that targets the OX40 ligand (Weidinger et al). It is predicted to have broad potential therapeutic application for multiple immune diseases, including atopic dermatitis. I'm not looking for that. I've been spoiled by drugs that have narrow therapeutic application (like IL-23 blockade and IL-4/IL-13 blockade) that target a specific disease very effectively with very little in the way of side effects.

The OX40 ligand/receptor interaction may be too important. When I Google "OX40 deficiency," the first thing that pops up is a combined T- and B-cell immunodeficiency associated with possible aggressive, childhood-onset, disseminated, cutaneous, and systemic Kaposi sarcoma. That doesn't mean that such a horrible outcome will come with the level of pharmacologic OX40 blockade that we would try to achieve in our patients. Clinical trials don't show horrible adverse events — so far. I'm in no hurry to find out in my patients whether real-life efficacy in large numbers of people treated for long periods of time matches up with the short-term safety profiles seen in relatively small clinical trial populations.

It might be nice to give patients upadacitinib only as needed, for example for a flare of their atopic dermatitis, then cut down the dose or stop altogether until the next flare. The study by Guttman-Yassky and colleagues found that atopic dermatitis came back quickly when upadacitinib was stopped. However, their study looked at patients with chronically bad atopic dermatitis. If we have a patient who tends to flare only intermittently, it may be that we could use upadacitinib or other systemic treatments on an intermittent basis. I know when it came to my son's mild atopic dermatitis, intermittent use of a little triamcinolone ointment was all that was needed. Yes, I know that's a "reactive," roller-coaster approach. Yes, I know that a "proactive" keep-the-disease-away approach sounds better. But I'm realistic when it comes to patients' adherence behaviors. I think there's a lot to be said for minimizing drug exposure and just using treatments as needed. Guttman-Yassky's work makes me believe that a lot of patients will need continuous treatment to keep their severe disease under control. I'm not convinced that everyone will need continuous treatment to be happy with their treatment.

O'Connor and colleagues found that emollient bathing is associated with later development of atopic dermatitis. They defined emollient bathing as baths with oil or emulsifier-based additives. This study illustrates the importance of randomization in a controlled trial. Because their study was not randomized, we don't know whether the emollient bathing caused atopic dermatitis or whether families that had more dry skin or more family history of atopic dermatitis were more likely to use emollient bathing.

When dupilumab was first approved, I prescribed it to my patients to take every 2 weeks as recommended on the label. I'm not so sure how many patients actually used it that way. I suspect that a lot of them took the medicine less often than recommended, especially when they were doing well. This report by Sánchez-García and colleagues suggests that patients who are doing very well on dupilumab may be able to take the drug less often. That's probably not news to my patients who are already taking the drug less often than I told them to.

I think less frequent dosing may become even more common over time, particularly for drugs that may have more safety risks than dupilumab. Many patients with atopic dermatitis probably don't need to be taking drugs all the time. Patients who tend to have flare-ups but who do very well for a long period of time between flares may only need drugs intermittently. It will be interesting to see if our patients can use oral treatments for atopic dermatitis that way.

Siegfried and colleagues assessed how well dupilumab worked in children with atopic dermatitis in different areas of the body: head and neck, trunk, upper extremities, lower extremities. Dupilumab worked well in all these areas, as expected.

Xu and colleagues did a meta-analysis of studies of dupilumab for atopic dermatitis and concluded, not shockingly, that dupilumab is safe and effective for atopic dermatitis. Okay, I believe that. They further concluded: "More long-term, high-quality, controlled studies in different regions are needed for further verification." I don't think so. I think the evidence is clear already.

Studies that measure the levels of things are generally not particularly helpful. The study by García-Reyes and colleagues studied the levels of serum thymic stromal lymphopoietin (TSLP) in patients with atopic dermatitis. TSLP levels were higher in patients with atopic dermatitis compared with patients without atopic dermatitis. This basically tells us nothing about the role of TSLP in atopic dermatitis. The elevated levels could be causing atopic dermatitis or they could be the body's response to having atopic dermatitis.

To tell whether something is causal we have to look at either genetic studies or studies with specific inhibitors. A specific inhibitor study was done by atopic dermatitis expert Eric Simpson and colleagues.1 This was a randomized, placebo-controlled study in which an anti-TSLP antibody was given to patients with atopic dermatitis. Both the anti-TSLP antibody and placebo groups were permitted to use topical steroids. While the anti-TSLP antibody–treated patients did better than placebo-treated patients, the difference did not achieve statistical significance, probably, I believe, because the placebo-treated patients used more topical steroids. When you want to assess whether a drug for atopic dermatitis is better than placebo, you must be careful about how much topical steroid you let patients in the study use!

Additional Reference

1. Simpson EL, Parnes JR, She D, et al. Tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis: A randomized phase 2a clinical trial. J Am Acad Dermatol. 2019;80(4):1013-1021. doi: 10.1016/j.jaad.2018.11.059

Amlitelimab is a monoclonal antibody that targets the OX40 ligand (Weidinger et al). It is predicted to have broad potential therapeutic application for multiple immune diseases, including atopic dermatitis. I'm not looking for that. I've been spoiled by drugs that have narrow therapeutic application (like IL-23 blockade and IL-4/IL-13 blockade) that target a specific disease very effectively with very little in the way of side effects.

The OX40 ligand/receptor interaction may be too important. When I Google "OX40 deficiency," the first thing that pops up is a combined T- and B-cell immunodeficiency associated with possible aggressive, childhood-onset, disseminated, cutaneous, and systemic Kaposi sarcoma. That doesn't mean that such a horrible outcome will come with the level of pharmacologic OX40 blockade that we would try to achieve in our patients. Clinical trials don't show horrible adverse events — so far. I'm in no hurry to find out in my patients whether real-life efficacy in large numbers of people treated for long periods of time matches up with the short-term safety profiles seen in relatively small clinical trial populations.

It might be nice to give patients upadacitinib only as needed, for example for a flare of their atopic dermatitis, then cut down the dose or stop altogether until the next flare. The study by Guttman-Yassky and colleagues found that atopic dermatitis came back quickly when upadacitinib was stopped. However, their study looked at patients with chronically bad atopic dermatitis. If we have a patient who tends to flare only intermittently, it may be that we could use upadacitinib or other systemic treatments on an intermittent basis. I know when it came to my son's mild atopic dermatitis, intermittent use of a little triamcinolone ointment was all that was needed. Yes, I know that's a "reactive," roller-coaster approach. Yes, I know that a "proactive" keep-the-disease-away approach sounds better. But I'm realistic when it comes to patients' adherence behaviors. I think there's a lot to be said for minimizing drug exposure and just using treatments as needed. Guttman-Yassky's work makes me believe that a lot of patients will need continuous treatment to keep their severe disease under control. I'm not convinced that everyone will need continuous treatment to be happy with their treatment.

O'Connor and colleagues found that emollient bathing is associated with later development of atopic dermatitis. They defined emollient bathing as baths with oil or emulsifier-based additives. This study illustrates the importance of randomization in a controlled trial. Because their study was not randomized, we don't know whether the emollient bathing caused atopic dermatitis or whether families that had more dry skin or more family history of atopic dermatitis were more likely to use emollient bathing.

When dupilumab was first approved, I prescribed it to my patients to take every 2 weeks as recommended on the label. I'm not so sure how many patients actually used it that way. I suspect that a lot of them took the medicine less often than recommended, especially when they were doing well. This report by Sánchez-García and colleagues suggests that patients who are doing very well on dupilumab may be able to take the drug less often. That's probably not news to my patients who are already taking the drug less often than I told them to.

I think less frequent dosing may become even more common over time, particularly for drugs that may have more safety risks than dupilumab. Many patients with atopic dermatitis probably don't need to be taking drugs all the time. Patients who tend to have flare-ups but who do very well for a long period of time between flares may only need drugs intermittently. It will be interesting to see if our patients can use oral treatments for atopic dermatitis that way.

Siegfried and colleagues assessed how well dupilumab worked in children with atopic dermatitis in different areas of the body: head and neck, trunk, upper extremities, lower extremities. Dupilumab worked well in all these areas, as expected.

Xu and colleagues did a meta-analysis of studies of dupilumab for atopic dermatitis and concluded, not shockingly, that dupilumab is safe and effective for atopic dermatitis. Okay, I believe that. They further concluded: "More long-term, high-quality, controlled studies in different regions are needed for further verification." I don't think so. I think the evidence is clear already.

Studies that measure the levels of things are generally not particularly helpful. The study by García-Reyes and colleagues studied the levels of serum thymic stromal lymphopoietin (TSLP) in patients with atopic dermatitis. TSLP levels were higher in patients with atopic dermatitis compared with patients without atopic dermatitis. This basically tells us nothing about the role of TSLP in atopic dermatitis. The elevated levels could be causing atopic dermatitis or they could be the body's response to having atopic dermatitis.

To tell whether something is causal we have to look at either genetic studies or studies with specific inhibitors. A specific inhibitor study was done by atopic dermatitis expert Eric Simpson and colleagues.1 This was a randomized, placebo-controlled study in which an anti-TSLP antibody was given to patients with atopic dermatitis. Both the anti-TSLP antibody and placebo groups were permitted to use topical steroids. While the anti-TSLP antibody–treated patients did better than placebo-treated patients, the difference did not achieve statistical significance, probably, I believe, because the placebo-treated patients used more topical steroids. When you want to assess whether a drug for atopic dermatitis is better than placebo, you must be careful about how much topical steroid you let patients in the study use!

Additional Reference

1. Simpson EL, Parnes JR, She D, et al. Tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis: A randomized phase 2a clinical trial. J Am Acad Dermatol. 2019;80(4):1013-1021. doi: 10.1016/j.jaad.2018.11.059