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Does Dupilumab Treatment in Atopic Dermatitis Increase Infection Risk in Infants and Children?
Key clinical point: In infants and young children with atopic dermatitis (AD), dupilumab treatment with concomitant low-potency topical corticosteroids (TCS) does not increase infection rates and is associated with a reduced risk for bacterial and non-herpetic skin infections.
Major finding: Patients receiving dupilumab vs placebo had similar total infection rates week 16 (rate ratio [RR] 0.75; P = .223) and a significantly lower frequency of non-herpetic skin infections (RR 0.46; P = .047) and bacterial infections (RR 0.09; P = .019).
Study details: This post hoc analysis of the phase 3 LIBERTY AD PRESCHOOL trial included 162 patients (age 6 months to 5 years) with moderate to severe AD who were randomly assigned to receive 200 or 300 mg dupilumab (n = 83) or placebo (n = 79) every 4 weeks with concomitant low-potency TCS.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Four authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors declared having ties with Sanofi, Regeneron, or others.
Source: Paller AS, Siegfried EC, Cork MJ, et al. Infections in children aged 6 months to 5 years treated with dupilumab in a placebo-controlled clinical trial of moderate-to-severe atopic dermatitis. Paediatr Drugs. 2024 (Jan 24). doi: 10.1007/s40272-023-00611-9 Source
Key clinical point: In infants and young children with atopic dermatitis (AD), dupilumab treatment with concomitant low-potency topical corticosteroids (TCS) does not increase infection rates and is associated with a reduced risk for bacterial and non-herpetic skin infections.
Major finding: Patients receiving dupilumab vs placebo had similar total infection rates week 16 (rate ratio [RR] 0.75; P = .223) and a significantly lower frequency of non-herpetic skin infections (RR 0.46; P = .047) and bacterial infections (RR 0.09; P = .019).
Study details: This post hoc analysis of the phase 3 LIBERTY AD PRESCHOOL trial included 162 patients (age 6 months to 5 years) with moderate to severe AD who were randomly assigned to receive 200 or 300 mg dupilumab (n = 83) or placebo (n = 79) every 4 weeks with concomitant low-potency TCS.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Four authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors declared having ties with Sanofi, Regeneron, or others.
Source: Paller AS, Siegfried EC, Cork MJ, et al. Infections in children aged 6 months to 5 years treated with dupilumab in a placebo-controlled clinical trial of moderate-to-severe atopic dermatitis. Paediatr Drugs. 2024 (Jan 24). doi: 10.1007/s40272-023-00611-9 Source
Key clinical point: In infants and young children with atopic dermatitis (AD), dupilumab treatment with concomitant low-potency topical corticosteroids (TCS) does not increase infection rates and is associated with a reduced risk for bacterial and non-herpetic skin infections.
Major finding: Patients receiving dupilumab vs placebo had similar total infection rates week 16 (rate ratio [RR] 0.75; P = .223) and a significantly lower frequency of non-herpetic skin infections (RR 0.46; P = .047) and bacterial infections (RR 0.09; P = .019).
Study details: This post hoc analysis of the phase 3 LIBERTY AD PRESCHOOL trial included 162 patients (age 6 months to 5 years) with moderate to severe AD who were randomly assigned to receive 200 or 300 mg dupilumab (n = 83) or placebo (n = 79) every 4 weeks with concomitant low-potency TCS.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Four authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors declared having ties with Sanofi, Regeneron, or others.
Source: Paller AS, Siegfried EC, Cork MJ, et al. Infections in children aged 6 months to 5 years treated with dupilumab in a placebo-controlled clinical trial of moderate-to-severe atopic dermatitis. Paediatr Drugs. 2024 (Jan 24). doi: 10.1007/s40272-023-00611-9 Source
Dupilumab Dose Reduction Achievable in Persistently Controlled Atopic Dermatitis
Key clinical point: Dose reduction of 300 mg dupilumab was successfully achieved by dose spacing to >2 weeks without loss of efficacy in most patients with persistently controlled atopic dermatitis (AD), regardless of previous exposure to biologics and Janus kinase inhibitors (JAKi).
Major finding: At a median follow-up of 10 months, dose spacing of 300 mg dupilumab without loss in efficacy was achieved in 35 of 37 patients with controlled AD receiving dupilumab treatment for a median duration of 20.1 months. Similar findings were observed in patients with vs without previous exposure to biologics or JAKi (P > .05).
Study details: Findings are from a retrospective cohort study including 37 patients with controlled AD for more than a year, who were treated with 300 mg dupilumab at intervals > 2 weeks, and of whom 7 patients were classified as non-naive to biologics and JAKi.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lasheras-Pérez MA, Palacios-Diaz RD, González-Delgado VA, et al. Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: A Spanish multicenter cohort study. Int J Dermatol. 2024 (Jan 16). doi: 10.1111/ijd.17030 Source
Key clinical point: Dose reduction of 300 mg dupilumab was successfully achieved by dose spacing to >2 weeks without loss of efficacy in most patients with persistently controlled atopic dermatitis (AD), regardless of previous exposure to biologics and Janus kinase inhibitors (JAKi).
Major finding: At a median follow-up of 10 months, dose spacing of 300 mg dupilumab without loss in efficacy was achieved in 35 of 37 patients with controlled AD receiving dupilumab treatment for a median duration of 20.1 months. Similar findings were observed in patients with vs without previous exposure to biologics or JAKi (P > .05).
Study details: Findings are from a retrospective cohort study including 37 patients with controlled AD for more than a year, who were treated with 300 mg dupilumab at intervals > 2 weeks, and of whom 7 patients were classified as non-naive to biologics and JAKi.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lasheras-Pérez MA, Palacios-Diaz RD, González-Delgado VA, et al. Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: A Spanish multicenter cohort study. Int J Dermatol. 2024 (Jan 16). doi: 10.1111/ijd.17030 Source
Key clinical point: Dose reduction of 300 mg dupilumab was successfully achieved by dose spacing to >2 weeks without loss of efficacy in most patients with persistently controlled atopic dermatitis (AD), regardless of previous exposure to biologics and Janus kinase inhibitors (JAKi).
Major finding: At a median follow-up of 10 months, dose spacing of 300 mg dupilumab without loss in efficacy was achieved in 35 of 37 patients with controlled AD receiving dupilumab treatment for a median duration of 20.1 months. Similar findings were observed in patients with vs without previous exposure to biologics or JAKi (P > .05).
Study details: Findings are from a retrospective cohort study including 37 patients with controlled AD for more than a year, who were treated with 300 mg dupilumab at intervals > 2 weeks, and of whom 7 patients were classified as non-naive to biologics and JAKi.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lasheras-Pérez MA, Palacios-Diaz RD, González-Delgado VA, et al. Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: A Spanish multicenter cohort study. Int J Dermatol. 2024 (Jan 16). doi: 10.1111/ijd.17030 Source
Dupilumab Effective in Patients With Atopic Dermatitis and Comorbidities Including Malignancies
Key clinical point: In real-world settings, dupilumab is safe and leads to significant and sustained improvements in the severity of atopic dermatitis (AD) in patients with moderate-to-severe AD, including those with malignancies and other comorbidities.
Major finding: At week 52, 64% of patients showed a decrease in disease severity, achieving a Physician Global Assessment score of 0 or 1 compared with a score of 3 or 4 at baseline. No adverse effect on current malignancy or recurrence of prior malignancy was reported with dupilumab use.
Study details: This real-world retrospective study analyzed the data of 155 adult patients with moderate-to-severe AD, including those with other significant comorbidities like malignancies, who were treated with dupilumab.
Disclosures: This study did not receive any funding. Mohannad Abu-Hilal declared serving as an advisor, consultant, or speaker for or receiving grants or honoraria from various sources.
Source: Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11 (Jan 15). doi: 10.1016/j.jdin.2024.01.002 Source
Key clinical point: In real-world settings, dupilumab is safe and leads to significant and sustained improvements in the severity of atopic dermatitis (AD) in patients with moderate-to-severe AD, including those with malignancies and other comorbidities.
Major finding: At week 52, 64% of patients showed a decrease in disease severity, achieving a Physician Global Assessment score of 0 or 1 compared with a score of 3 or 4 at baseline. No adverse effect on current malignancy or recurrence of prior malignancy was reported with dupilumab use.
Study details: This real-world retrospective study analyzed the data of 155 adult patients with moderate-to-severe AD, including those with other significant comorbidities like malignancies, who were treated with dupilumab.
Disclosures: This study did not receive any funding. Mohannad Abu-Hilal declared serving as an advisor, consultant, or speaker for or receiving grants or honoraria from various sources.
Source: Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11 (Jan 15). doi: 10.1016/j.jdin.2024.01.002 Source
Key clinical point: In real-world settings, dupilumab is safe and leads to significant and sustained improvements in the severity of atopic dermatitis (AD) in patients with moderate-to-severe AD, including those with malignancies and other comorbidities.
Major finding: At week 52, 64% of patients showed a decrease in disease severity, achieving a Physician Global Assessment score of 0 or 1 compared with a score of 3 or 4 at baseline. No adverse effect on current malignancy or recurrence of prior malignancy was reported with dupilumab use.
Study details: This real-world retrospective study analyzed the data of 155 adult patients with moderate-to-severe AD, including those with other significant comorbidities like malignancies, who were treated with dupilumab.
Disclosures: This study did not receive any funding. Mohannad Abu-Hilal declared serving as an advisor, consultant, or speaker for or receiving grants or honoraria from various sources.
Source: Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11 (Jan 15). doi: 10.1016/j.jdin.2024.01.002 Source
Atopic Dermatitis Remission in Children Unaffected by Washing With Water or Cleanser During Summer
Key clinical point: Skin care by washing with water alone is not inferior to washing with a cleanser for the maintenance of remission in children with atopic dermatitis (AD) during the summer.
Major finding: The mean modified Eczema Area and Severity Index scores at 8 ± 4 weeks were similar in children who washed their upper and lower limbs with water and those who used a cleanser (0.00 and 0.15, respectively; P = .74). No difference was observed in the occurrence of skin infection, Patient-Oriented Eczema Measure, and other secondary outcomes with water vs cleanser use (all P > .05).
Study details: This noninferiority study included 43 children (age < 15 years) with AD having controlled eczema following regular steroid ointment application, who washed the randomly assigned left or right limb with a cleanser and the other limb with water alone.
Disclosures: This study was funded by the Maruho Scholarship Donations Support Program, Japan. Osamu Natsume declared receiving grants from several sources. The other authors declared no conflicts of interest.
Source: Katoh Y, Natsume O, Yasuoka R, et al. Skin care by washing with water is not inferior to washing with a cleanser in children with atopic dermatitis in remission in summer: WASH study. Allergol Int. 2024 (Feb 2). doi: 10.1016/j.alit.2024.01.007 Source
Key clinical point: Skin care by washing with water alone is not inferior to washing with a cleanser for the maintenance of remission in children with atopic dermatitis (AD) during the summer.
Major finding: The mean modified Eczema Area and Severity Index scores at 8 ± 4 weeks were similar in children who washed their upper and lower limbs with water and those who used a cleanser (0.00 and 0.15, respectively; P = .74). No difference was observed in the occurrence of skin infection, Patient-Oriented Eczema Measure, and other secondary outcomes with water vs cleanser use (all P > .05).
Study details: This noninferiority study included 43 children (age < 15 years) with AD having controlled eczema following regular steroid ointment application, who washed the randomly assigned left or right limb with a cleanser and the other limb with water alone.
Disclosures: This study was funded by the Maruho Scholarship Donations Support Program, Japan. Osamu Natsume declared receiving grants from several sources. The other authors declared no conflicts of interest.
Source: Katoh Y, Natsume O, Yasuoka R, et al. Skin care by washing with water is not inferior to washing with a cleanser in children with atopic dermatitis in remission in summer: WASH study. Allergol Int. 2024 (Feb 2). doi: 10.1016/j.alit.2024.01.007 Source
Key clinical point: Skin care by washing with water alone is not inferior to washing with a cleanser for the maintenance of remission in children with atopic dermatitis (AD) during the summer.
Major finding: The mean modified Eczema Area and Severity Index scores at 8 ± 4 weeks were similar in children who washed their upper and lower limbs with water and those who used a cleanser (0.00 and 0.15, respectively; P = .74). No difference was observed in the occurrence of skin infection, Patient-Oriented Eczema Measure, and other secondary outcomes with water vs cleanser use (all P > .05).
Study details: This noninferiority study included 43 children (age < 15 years) with AD having controlled eczema following regular steroid ointment application, who washed the randomly assigned left or right limb with a cleanser and the other limb with water alone.
Disclosures: This study was funded by the Maruho Scholarship Donations Support Program, Japan. Osamu Natsume declared receiving grants from several sources. The other authors declared no conflicts of interest.
Source: Katoh Y, Natsume O, Yasuoka R, et al. Skin care by washing with water is not inferior to washing with a cleanser in children with atopic dermatitis in remission in summer: WASH study. Allergol Int. 2024 (Feb 2). doi: 10.1016/j.alit.2024.01.007 Source
Air Quality Index Tied to the Incidence of Atopic Dermatitis
Key clinical point: A significant positive, dose-dependent association was observed between air quality index (AQI) and the incidence of atopic dermatitis (AD).
Major finding: The participants were classified into four AQI value quantiles (Q), with the mean AQI values from the lowest Q1 to the highest Q4 being 69.0, 78.9, 89.8, and 104.0, respectively. Compared with Q1, the risk for AD increased significantly in Q2 (adjusted hazard ratio [aHR] 1.29; 95% CI 1.04-1.65), Q3 (aHR 4.71; 95% CI 3.78-6.04), and Q4 (aHR 13.20; 95% CI 10.86-16.60). An increase of one unit in the AQI value increased the risk for AD by 7%.
Study details: This cohort study included 21,278,938 individuals without AD, with the long-term average AQI value before AD diagnosis being calculated and linked for each of the individuals.
Disclosures: This study was sponsored by grants from the Ministry of Science and Technology, Taiwan, Republic of China. The authors declared no conflicts of interest.
Source: Wu CY, Wu CY, Li MC, Ho HJ, Ao CK. Association of air quality index (AQI) with incidence of atopic dermatitis in Taiwan: A nationwide population-based cohort study. J Am Acad Dermatol. 2024 (Feb 1). doi: 10.1016/j.jaad.2024.01.058 Source
Key clinical point: A significant positive, dose-dependent association was observed between air quality index (AQI) and the incidence of atopic dermatitis (AD).
Major finding: The participants were classified into four AQI value quantiles (Q), with the mean AQI values from the lowest Q1 to the highest Q4 being 69.0, 78.9, 89.8, and 104.0, respectively. Compared with Q1, the risk for AD increased significantly in Q2 (adjusted hazard ratio [aHR] 1.29; 95% CI 1.04-1.65), Q3 (aHR 4.71; 95% CI 3.78-6.04), and Q4 (aHR 13.20; 95% CI 10.86-16.60). An increase of one unit in the AQI value increased the risk for AD by 7%.
Study details: This cohort study included 21,278,938 individuals without AD, with the long-term average AQI value before AD diagnosis being calculated and linked for each of the individuals.
Disclosures: This study was sponsored by grants from the Ministry of Science and Technology, Taiwan, Republic of China. The authors declared no conflicts of interest.
Source: Wu CY, Wu CY, Li MC, Ho HJ, Ao CK. Association of air quality index (AQI) with incidence of atopic dermatitis in Taiwan: A nationwide population-based cohort study. J Am Acad Dermatol. 2024 (Feb 1). doi: 10.1016/j.jaad.2024.01.058 Source
Key clinical point: A significant positive, dose-dependent association was observed between air quality index (AQI) and the incidence of atopic dermatitis (AD).
Major finding: The participants were classified into four AQI value quantiles (Q), with the mean AQI values from the lowest Q1 to the highest Q4 being 69.0, 78.9, 89.8, and 104.0, respectively. Compared with Q1, the risk for AD increased significantly in Q2 (adjusted hazard ratio [aHR] 1.29; 95% CI 1.04-1.65), Q3 (aHR 4.71; 95% CI 3.78-6.04), and Q4 (aHR 13.20; 95% CI 10.86-16.60). An increase of one unit in the AQI value increased the risk for AD by 7%.
Study details: This cohort study included 21,278,938 individuals without AD, with the long-term average AQI value before AD diagnosis being calculated and linked for each of the individuals.
Disclosures: This study was sponsored by grants from the Ministry of Science and Technology, Taiwan, Republic of China. The authors declared no conflicts of interest.
Source: Wu CY, Wu CY, Li MC, Ho HJ, Ao CK. Association of air quality index (AQI) with incidence of atopic dermatitis in Taiwan: A nationwide population-based cohort study. J Am Acad Dermatol. 2024 (Feb 1). doi: 10.1016/j.jaad.2024.01.058 Source
Dupilumab Monotherapy Safe and Effective Against Hand and Foot Atopic Dermatitis
Key clinical point: Dupilumab monotherapy is safe and leads to rapid and significant improvements in disease signs and symptoms in patients with hand and foot (HF) atopic dermatitis (AD).
Major finding: At week 16, a significantly higher number of patients receiving dupilumab vs placebo achieved an HF Investigator’s Global Assessment score of 0 or 1 (P = .003) and ≥4-point reduction in HF Peak Pruritus Numeric Rating Scale score (P < .0001), with the difference between groups evident from weeks 4 and 1, respectively. Safety was consistent with the known dupilumab profile.
Study details: Findings are from the phase 3 LIBERTY-AD-HAFT study, which included 106 adults and 27 adolescents (≥ 12 to < 18 years) with moderate to severe HF AD who were randomized (1:1) to receive dupilumab or placebo.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Ten authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors, except Ewa Sygula, declared serving as investigators, consultants, etc., for or receiving personal fees, grants, honoraria, etc., from Sanofi, Regeneron, or others.
Source: Simpson E, Silverberg JI, Worm M, et al. Dupilumab treatment improves signs, symptoms, quality of life and work productivity in patients with atopic hand and foot dermatitis: Results from a phase 3, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2024 (Jan 29). doi: 10.1016/j.jaad.2023.12.066 Source
Key clinical point: Dupilumab monotherapy is safe and leads to rapid and significant improvements in disease signs and symptoms in patients with hand and foot (HF) atopic dermatitis (AD).
Major finding: At week 16, a significantly higher number of patients receiving dupilumab vs placebo achieved an HF Investigator’s Global Assessment score of 0 or 1 (P = .003) and ≥4-point reduction in HF Peak Pruritus Numeric Rating Scale score (P < .0001), with the difference between groups evident from weeks 4 and 1, respectively. Safety was consistent with the known dupilumab profile.
Study details: Findings are from the phase 3 LIBERTY-AD-HAFT study, which included 106 adults and 27 adolescents (≥ 12 to < 18 years) with moderate to severe HF AD who were randomized (1:1) to receive dupilumab or placebo.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Ten authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors, except Ewa Sygula, declared serving as investigators, consultants, etc., for or receiving personal fees, grants, honoraria, etc., from Sanofi, Regeneron, or others.
Source: Simpson E, Silverberg JI, Worm M, et al. Dupilumab treatment improves signs, symptoms, quality of life and work productivity in patients with atopic hand and foot dermatitis: Results from a phase 3, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2024 (Jan 29). doi: 10.1016/j.jaad.2023.12.066 Source
Key clinical point: Dupilumab monotherapy is safe and leads to rapid and significant improvements in disease signs and symptoms in patients with hand and foot (HF) atopic dermatitis (AD).
Major finding: At week 16, a significantly higher number of patients receiving dupilumab vs placebo achieved an HF Investigator’s Global Assessment score of 0 or 1 (P = .003) and ≥4-point reduction in HF Peak Pruritus Numeric Rating Scale score (P < .0001), with the difference between groups evident from weeks 4 and 1, respectively. Safety was consistent with the known dupilumab profile.
Study details: Findings are from the phase 3 LIBERTY-AD-HAFT study, which included 106 adults and 27 adolescents (≥ 12 to < 18 years) with moderate to severe HF AD who were randomized (1:1) to receive dupilumab or placebo.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Ten authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors, except Ewa Sygula, declared serving as investigators, consultants, etc., for or receiving personal fees, grants, honoraria, etc., from Sanofi, Regeneron, or others.
Source: Simpson E, Silverberg JI, Worm M, et al. Dupilumab treatment improves signs, symptoms, quality of life and work productivity in patients with atopic hand and foot dermatitis: Results from a phase 3, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2024 (Jan 29). doi: 10.1016/j.jaad.2023.12.066 Source
Atopic Dermatitis Increases the Risk for Subsequent Autoimmune Disease
Key clinical point: A significant causal relationship was observed between atopic dermatitis (AD) and autoimmune diseases in children, and this was supported by the presence of shared genetic factors.
Major finding: At a follow-up of 12 years, children with vs without AD had a significantly increased risk for autoimmune diseases (adjusted hazard ratio [aHR] 1.27; 95% CI 1.23-1.32), particularly psoriasis vulgaris (aHR 2.55; 95% CI 2.25-2.80). Boys were significantly more susceptible to autoimmune diseases than girls (P for interaction = .04). Sixteen shared genes were identified between AD and autoimmune diseases and were associated with comorbidities, such as asthma and bronchiolitis.
Study details: This large-scale cohort study included 39,832 children with AD born between 2002 and 2018, who were matched with 159,328 children without AD.
Disclosures: This study was supported by the Korea Health Technology R&D. The authors declared no conflicts of interest.
Source: Ahn J, Shin S, Lee GC, et al. Unraveling the link between atopic dermatitis and autoimmune diseases in children: Insights from a large-scale cohort study with 15-year follow-up and shared gene ontology analysis. Allergol Int. 2024 (Jan 17). doi: 10.1016/j.alit.2023.12.005 Source
Key clinical point: A significant causal relationship was observed between atopic dermatitis (AD) and autoimmune diseases in children, and this was supported by the presence of shared genetic factors.
Major finding: At a follow-up of 12 years, children with vs without AD had a significantly increased risk for autoimmune diseases (adjusted hazard ratio [aHR] 1.27; 95% CI 1.23-1.32), particularly psoriasis vulgaris (aHR 2.55; 95% CI 2.25-2.80). Boys were significantly more susceptible to autoimmune diseases than girls (P for interaction = .04). Sixteen shared genes were identified between AD and autoimmune diseases and were associated with comorbidities, such as asthma and bronchiolitis.
Study details: This large-scale cohort study included 39,832 children with AD born between 2002 and 2018, who were matched with 159,328 children without AD.
Disclosures: This study was supported by the Korea Health Technology R&D. The authors declared no conflicts of interest.
Source: Ahn J, Shin S, Lee GC, et al. Unraveling the link between atopic dermatitis and autoimmune diseases in children: Insights from a large-scale cohort study with 15-year follow-up and shared gene ontology analysis. Allergol Int. 2024 (Jan 17). doi: 10.1016/j.alit.2023.12.005 Source
Key clinical point: A significant causal relationship was observed between atopic dermatitis (AD) and autoimmune diseases in children, and this was supported by the presence of shared genetic factors.
Major finding: At a follow-up of 12 years, children with vs without AD had a significantly increased risk for autoimmune diseases (adjusted hazard ratio [aHR] 1.27; 95% CI 1.23-1.32), particularly psoriasis vulgaris (aHR 2.55; 95% CI 2.25-2.80). Boys were significantly more susceptible to autoimmune diseases than girls (P for interaction = .04). Sixteen shared genes were identified between AD and autoimmune diseases and were associated with comorbidities, such as asthma and bronchiolitis.
Study details: This large-scale cohort study included 39,832 children with AD born between 2002 and 2018, who were matched with 159,328 children without AD.
Disclosures: This study was supported by the Korea Health Technology R&D. The authors declared no conflicts of interest.
Source: Ahn J, Shin S, Lee GC, et al. Unraveling the link between atopic dermatitis and autoimmune diseases in children: Insights from a large-scale cohort study with 15-year follow-up and shared gene ontology analysis. Allergol Int. 2024 (Jan 17). doi: 10.1016/j.alit.2023.12.005 Source
Tapinarof Cream Under FDA Review for Atopic Dermatitis Indication
On February 14, Dermavant Sciences announced that the company had submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for tapinarof cream, 1%, for treating atopic dermatitis (AD) in adults and children 2 years of age and older.
Tapinarof cream, 1%, is an aryl hydrocarbon receptor agonist marketed under the brand name VTAMA that was approved in 2022 for treating plaque psoriasis in adults.
According to a Dermavant press release, the sNDA is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the phase 3 ADORING 3 open-label, long-term extension 48-week trial. In ADORING 1 and ADORING 2, tapinarof cream demonstrated statistically significant improvements in the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) treatment success, defined as a vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline; demonstrated treatment success over vehicle at week 8; and met all key secondary endpoints with statistical significance, according to the company.
The most common adverse reactions in patients treated with VTAMA cream include folliculitis, nasopharyngitis, contact dermatitis, headache, and pruritus.
On February 14, Dermavant Sciences announced that the company had submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for tapinarof cream, 1%, for treating atopic dermatitis (AD) in adults and children 2 years of age and older.
Tapinarof cream, 1%, is an aryl hydrocarbon receptor agonist marketed under the brand name VTAMA that was approved in 2022 for treating plaque psoriasis in adults.
According to a Dermavant press release, the sNDA is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the phase 3 ADORING 3 open-label, long-term extension 48-week trial. In ADORING 1 and ADORING 2, tapinarof cream demonstrated statistically significant improvements in the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) treatment success, defined as a vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline; demonstrated treatment success over vehicle at week 8; and met all key secondary endpoints with statistical significance, according to the company.
The most common adverse reactions in patients treated with VTAMA cream include folliculitis, nasopharyngitis, contact dermatitis, headache, and pruritus.
On February 14, Dermavant Sciences announced that the company had submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for tapinarof cream, 1%, for treating atopic dermatitis (AD) in adults and children 2 years of age and older.
Tapinarof cream, 1%, is an aryl hydrocarbon receptor agonist marketed under the brand name VTAMA that was approved in 2022 for treating plaque psoriasis in adults.
According to a Dermavant press release, the sNDA is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the phase 3 ADORING 3 open-label, long-term extension 48-week trial. In ADORING 1 and ADORING 2, tapinarof cream demonstrated statistically significant improvements in the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) treatment success, defined as a vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline; demonstrated treatment success over vehicle at week 8; and met all key secondary endpoints with statistical significance, according to the company.
The most common adverse reactions in patients treated with VTAMA cream include folliculitis, nasopharyngitis, contact dermatitis, headache, and pruritus.
Dupilumab Improves AD Affecting the Hands, Feet
TOPLINE:
compared with placebo.
METHODOLOGY:
- The multinational phase 3 LIBERTY-AD-HAFT trial of adults and adolescents with moderate to severe chronic atopic dermatitis (AD) of the hands, feet, or both included 67 participants at 48 sites randomized to dupilumab monotherapy and 66 to placebo.
- The primary endpoint was the proportion of patients scoring 0 or 1 on Hand and Foot Investigator’s Global Assessment (HF-IGA) at week 16.
- Secondary endpoints were severity and extent of signs, symptom intensity (itch and pain), sleep, and quality of life.
TAKEAWAY:
- At week 16, 27 patients receiving dupilumab vs 11 receiving placebo achieved an HF-IGA score of 0 or 1 (40.3% vs 16.7%; P = .003).
- At week 16, 35 participants receiving dupilumab vs nine receiving placebo improved at least four points in the weekly average of daily HF-Peak Pruritus Numeric Rating Scale (52.2% vs 13.6%; P < .0001).
- At week 16, Quality of Life Hand Eczema Questionnaire results improved in the dupilumab group compared with controls (P < .0001), and weekly average of daily Sleep Numeric Rating Scale results improved in the dupilumab group compared with controls (P < .05).
- The safety profile was similar to the known profile in adults and adolescents with moderate to severe AD.
IN PRACTICE:
The results of the study “support dupilumab” as an “efficacious systemic therapy for moderate to severe H/F AD,” the authors wrote.
SOURCE:
The study, led by Eric L. Simpson, MD, MCR, professor of dermatology at the Oregon Health & Science University in Portland, was published on January 29, 2024, in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The short duration of the study and the large proportion of patients with positive patch tests (31 of 133) suggested that some participants may have had concurrent AD and allergic contact dermatitis, so the effect of dupilumab on those patients needs further evaluation.
DISCLOSURES:
The study was sponsored by Sanofi and Regeneron. All but one author had financial relationships with Sanofi, Regeneron, or both. Several authors were employees of, and may hold stocks or stock options in, Sanofi or Regeneron.
TOPLINE:
compared with placebo.
METHODOLOGY:
- The multinational phase 3 LIBERTY-AD-HAFT trial of adults and adolescents with moderate to severe chronic atopic dermatitis (AD) of the hands, feet, or both included 67 participants at 48 sites randomized to dupilumab monotherapy and 66 to placebo.
- The primary endpoint was the proportion of patients scoring 0 or 1 on Hand and Foot Investigator’s Global Assessment (HF-IGA) at week 16.
- Secondary endpoints were severity and extent of signs, symptom intensity (itch and pain), sleep, and quality of life.
TAKEAWAY:
- At week 16, 27 patients receiving dupilumab vs 11 receiving placebo achieved an HF-IGA score of 0 or 1 (40.3% vs 16.7%; P = .003).
- At week 16, 35 participants receiving dupilumab vs nine receiving placebo improved at least four points in the weekly average of daily HF-Peak Pruritus Numeric Rating Scale (52.2% vs 13.6%; P < .0001).
- At week 16, Quality of Life Hand Eczema Questionnaire results improved in the dupilumab group compared with controls (P < .0001), and weekly average of daily Sleep Numeric Rating Scale results improved in the dupilumab group compared with controls (P < .05).
- The safety profile was similar to the known profile in adults and adolescents with moderate to severe AD.
IN PRACTICE:
The results of the study “support dupilumab” as an “efficacious systemic therapy for moderate to severe H/F AD,” the authors wrote.
SOURCE:
The study, led by Eric L. Simpson, MD, MCR, professor of dermatology at the Oregon Health & Science University in Portland, was published on January 29, 2024, in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The short duration of the study and the large proportion of patients with positive patch tests (31 of 133) suggested that some participants may have had concurrent AD and allergic contact dermatitis, so the effect of dupilumab on those patients needs further evaluation.
DISCLOSURES:
The study was sponsored by Sanofi and Regeneron. All but one author had financial relationships with Sanofi, Regeneron, or both. Several authors were employees of, and may hold stocks or stock options in, Sanofi or Regeneron.
TOPLINE:
compared with placebo.
METHODOLOGY:
- The multinational phase 3 LIBERTY-AD-HAFT trial of adults and adolescents with moderate to severe chronic atopic dermatitis (AD) of the hands, feet, or both included 67 participants at 48 sites randomized to dupilumab monotherapy and 66 to placebo.
- The primary endpoint was the proportion of patients scoring 0 or 1 on Hand and Foot Investigator’s Global Assessment (HF-IGA) at week 16.
- Secondary endpoints were severity and extent of signs, symptom intensity (itch and pain), sleep, and quality of life.
TAKEAWAY:
- At week 16, 27 patients receiving dupilumab vs 11 receiving placebo achieved an HF-IGA score of 0 or 1 (40.3% vs 16.7%; P = .003).
- At week 16, 35 participants receiving dupilumab vs nine receiving placebo improved at least four points in the weekly average of daily HF-Peak Pruritus Numeric Rating Scale (52.2% vs 13.6%; P < .0001).
- At week 16, Quality of Life Hand Eczema Questionnaire results improved in the dupilumab group compared with controls (P < .0001), and weekly average of daily Sleep Numeric Rating Scale results improved in the dupilumab group compared with controls (P < .05).
- The safety profile was similar to the known profile in adults and adolescents with moderate to severe AD.
IN PRACTICE:
The results of the study “support dupilumab” as an “efficacious systemic therapy for moderate to severe H/F AD,” the authors wrote.
SOURCE:
The study, led by Eric L. Simpson, MD, MCR, professor of dermatology at the Oregon Health & Science University in Portland, was published on January 29, 2024, in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The short duration of the study and the large proportion of patients with positive patch tests (31 of 133) suggested that some participants may have had concurrent AD and allergic contact dermatitis, so the effect of dupilumab on those patients needs further evaluation.
DISCLOSURES:
The study was sponsored by Sanofi and Regeneron. All but one author had financial relationships with Sanofi, Regeneron, or both. Several authors were employees of, and may hold stocks or stock options in, Sanofi or Regeneron.
Survey: Dermatology Residents Shortchanged on Sensitive Skin Education
Although sensitive skin affects an estimated 40%-70% of the population, knowledge of the pathophysiology of sensitive skin is incomplete, and consensus is lacking as to the best diagnosis and treatment strategies, and the inclusion of sensitive skin education in dermatology curricula has not been examined, according to Erika T. McCormick, BS, and Adam Friedman, MD, of George Washington University, Washington, DC.
For the study, published in the Journal of Drugs in Dermatology, they developed a 26-question survey for dermatology residents that asked about sensitive skin in dermatology residency training. Participants came from the Orlando Dermatology, Aesthetic, and Surgical Conference email list.
Survey respondents included 214 residents at various levels of training at programs across the United States; 67.1% were female, 92.1% were aged 25-34 years, and 85.5% were in academic or university programs.
Overall, 99% of respondents believed that sensitive skin issues should be part of their residency training to some extent, and 84% reported experiences with patients for whom the chief presenting complaint was sensitive skin.
However, fewer than half (48%) of the residents reported specific resident education in sensitive skin, while 51% reported nonspecific education about sensitive skin education in the context of other skin diseases, and 1% reported no education about sensitive skin.
Less than one-quarter of the respondents who received any sensitive skin education reported feeling comfortable in their ability to diagnose, evaluate, and manage sensitive skin, while those with sensitive skin–specific education were significantly more likely to describe themselves as “very knowledgeable.”
As for treatment approaches, residents with specific sensitive skin education were more likely than were those without sensitive skin–specific training to ask patients about allergies and past reactions to skin products, and to counsel them about environmental triggers.
Notably, 96% of the respondents were not familiar with the Sensitive Skin (SS) Scale–10, a validated measure of sensitive skin severity.
The most common challenges in care of patients with sensitive skin were assessing improvement over time, reported by 25% of respondents, recommending products (23%), and prescribing/medical management (22%). The topics residents expressed most interest in learning about were product recommendations (78%), patient counseling (77%), reviewing research on sensitive skin (70%), diagnosing sensitive skin (67%), using the SS-10 (48%), and clinical research updates (40%).
The findings were limited by several factors including the reliance on self-reports, the researchers noted. However, the results highlight the lack of consensus in treatment of sensitive skin and the need to address this knowledge gap at the residency level, they said.
Improving Tools for Practice
“Many practice patterns and approaches are forged in the fires of training,” corresponding author Dr. Friedman, professor and chair of dermatology and residency program director at George Washington University, said in an interview. “Identifying gaps, especially for heavily prevalent issues, questions, and concerns such as sensitive skin that residents will encounter in practice is important to ensure an educated workforce,” he said.
Education on sensitive skin is lacking because, until recently, research and clinical guidance have been lacking, Dr. Friedman said. The root of the problem is that sensitive skin is mainly considered a symptom, rather than an independent condition, he explained. “Depending on the study, the prevalence of sensitive skin has been reported as high as 70%, with roughly 40% of these patients having no primary skin condition,” he said. This means sensitive skin can be both a symptom and a condition, which causes confusion for clinicians and patients, he added.
“Therefore, in order to overcome this gap, the condition itself at a minimum needs a standard definition and a way to diagnosis, which we fortunately have in the validated research tool known as the SS-10,” said Dr. Friedman.
Almost all residents surveyed in the current study had never heard of the SS-10, but more than half found it to be useful after learning of it through the study survey, he noted.
Looking ahead, greater elucidation of the pathophysiology of sensitive skin is needed to effectively pursue studies of products and treatments for these patients, but the SS-10 can be used to define and monitor the condition to evaluate improvement, he added.
The study was funded by an independent fellowship grant from Galderma. Ms. McCormick is supported by an unrestricted fellowship grant funded by Galderma. Dr. Friedman has served as a consultant for Galderma.
Although sensitive skin affects an estimated 40%-70% of the population, knowledge of the pathophysiology of sensitive skin is incomplete, and consensus is lacking as to the best diagnosis and treatment strategies, and the inclusion of sensitive skin education in dermatology curricula has not been examined, according to Erika T. McCormick, BS, and Adam Friedman, MD, of George Washington University, Washington, DC.
For the study, published in the Journal of Drugs in Dermatology, they developed a 26-question survey for dermatology residents that asked about sensitive skin in dermatology residency training. Participants came from the Orlando Dermatology, Aesthetic, and Surgical Conference email list.
Survey respondents included 214 residents at various levels of training at programs across the United States; 67.1% were female, 92.1% were aged 25-34 years, and 85.5% were in academic or university programs.
Overall, 99% of respondents believed that sensitive skin issues should be part of their residency training to some extent, and 84% reported experiences with patients for whom the chief presenting complaint was sensitive skin.
However, fewer than half (48%) of the residents reported specific resident education in sensitive skin, while 51% reported nonspecific education about sensitive skin education in the context of other skin diseases, and 1% reported no education about sensitive skin.
Less than one-quarter of the respondents who received any sensitive skin education reported feeling comfortable in their ability to diagnose, evaluate, and manage sensitive skin, while those with sensitive skin–specific education were significantly more likely to describe themselves as “very knowledgeable.”
As for treatment approaches, residents with specific sensitive skin education were more likely than were those without sensitive skin–specific training to ask patients about allergies and past reactions to skin products, and to counsel them about environmental triggers.
Notably, 96% of the respondents were not familiar with the Sensitive Skin (SS) Scale–10, a validated measure of sensitive skin severity.
The most common challenges in care of patients with sensitive skin were assessing improvement over time, reported by 25% of respondents, recommending products (23%), and prescribing/medical management (22%). The topics residents expressed most interest in learning about were product recommendations (78%), patient counseling (77%), reviewing research on sensitive skin (70%), diagnosing sensitive skin (67%), using the SS-10 (48%), and clinical research updates (40%).
The findings were limited by several factors including the reliance on self-reports, the researchers noted. However, the results highlight the lack of consensus in treatment of sensitive skin and the need to address this knowledge gap at the residency level, they said.
Improving Tools for Practice
“Many practice patterns and approaches are forged in the fires of training,” corresponding author Dr. Friedman, professor and chair of dermatology and residency program director at George Washington University, said in an interview. “Identifying gaps, especially for heavily prevalent issues, questions, and concerns such as sensitive skin that residents will encounter in practice is important to ensure an educated workforce,” he said.
Education on sensitive skin is lacking because, until recently, research and clinical guidance have been lacking, Dr. Friedman said. The root of the problem is that sensitive skin is mainly considered a symptom, rather than an independent condition, he explained. “Depending on the study, the prevalence of sensitive skin has been reported as high as 70%, with roughly 40% of these patients having no primary skin condition,” he said. This means sensitive skin can be both a symptom and a condition, which causes confusion for clinicians and patients, he added.
“Therefore, in order to overcome this gap, the condition itself at a minimum needs a standard definition and a way to diagnosis, which we fortunately have in the validated research tool known as the SS-10,” said Dr. Friedman.
Almost all residents surveyed in the current study had never heard of the SS-10, but more than half found it to be useful after learning of it through the study survey, he noted.
Looking ahead, greater elucidation of the pathophysiology of sensitive skin is needed to effectively pursue studies of products and treatments for these patients, but the SS-10 can be used to define and monitor the condition to evaluate improvement, he added.
The study was funded by an independent fellowship grant from Galderma. Ms. McCormick is supported by an unrestricted fellowship grant funded by Galderma. Dr. Friedman has served as a consultant for Galderma.
Although sensitive skin affects an estimated 40%-70% of the population, knowledge of the pathophysiology of sensitive skin is incomplete, and consensus is lacking as to the best diagnosis and treatment strategies, and the inclusion of sensitive skin education in dermatology curricula has not been examined, according to Erika T. McCormick, BS, and Adam Friedman, MD, of George Washington University, Washington, DC.
For the study, published in the Journal of Drugs in Dermatology, they developed a 26-question survey for dermatology residents that asked about sensitive skin in dermatology residency training. Participants came from the Orlando Dermatology, Aesthetic, and Surgical Conference email list.
Survey respondents included 214 residents at various levels of training at programs across the United States; 67.1% were female, 92.1% were aged 25-34 years, and 85.5% were in academic or university programs.
Overall, 99% of respondents believed that sensitive skin issues should be part of their residency training to some extent, and 84% reported experiences with patients for whom the chief presenting complaint was sensitive skin.
However, fewer than half (48%) of the residents reported specific resident education in sensitive skin, while 51% reported nonspecific education about sensitive skin education in the context of other skin diseases, and 1% reported no education about sensitive skin.
Less than one-quarter of the respondents who received any sensitive skin education reported feeling comfortable in their ability to diagnose, evaluate, and manage sensitive skin, while those with sensitive skin–specific education were significantly more likely to describe themselves as “very knowledgeable.”
As for treatment approaches, residents with specific sensitive skin education were more likely than were those without sensitive skin–specific training to ask patients about allergies and past reactions to skin products, and to counsel them about environmental triggers.
Notably, 96% of the respondents were not familiar with the Sensitive Skin (SS) Scale–10, a validated measure of sensitive skin severity.
The most common challenges in care of patients with sensitive skin were assessing improvement over time, reported by 25% of respondents, recommending products (23%), and prescribing/medical management (22%). The topics residents expressed most interest in learning about were product recommendations (78%), patient counseling (77%), reviewing research on sensitive skin (70%), diagnosing sensitive skin (67%), using the SS-10 (48%), and clinical research updates (40%).
The findings were limited by several factors including the reliance on self-reports, the researchers noted. However, the results highlight the lack of consensus in treatment of sensitive skin and the need to address this knowledge gap at the residency level, they said.
Improving Tools for Practice
“Many practice patterns and approaches are forged in the fires of training,” corresponding author Dr. Friedman, professor and chair of dermatology and residency program director at George Washington University, said in an interview. “Identifying gaps, especially for heavily prevalent issues, questions, and concerns such as sensitive skin that residents will encounter in practice is important to ensure an educated workforce,” he said.
Education on sensitive skin is lacking because, until recently, research and clinical guidance have been lacking, Dr. Friedman said. The root of the problem is that sensitive skin is mainly considered a symptom, rather than an independent condition, he explained. “Depending on the study, the prevalence of sensitive skin has been reported as high as 70%, with roughly 40% of these patients having no primary skin condition,” he said. This means sensitive skin can be both a symptom and a condition, which causes confusion for clinicians and patients, he added.
“Therefore, in order to overcome this gap, the condition itself at a minimum needs a standard definition and a way to diagnosis, which we fortunately have in the validated research tool known as the SS-10,” said Dr. Friedman.
Almost all residents surveyed in the current study had never heard of the SS-10, but more than half found it to be useful after learning of it through the study survey, he noted.
Looking ahead, greater elucidation of the pathophysiology of sensitive skin is needed to effectively pursue studies of products and treatments for these patients, but the SS-10 can be used to define and monitor the condition to evaluate improvement, he added.
The study was funded by an independent fellowship grant from Galderma. Ms. McCormick is supported by an unrestricted fellowship grant funded by Galderma. Dr. Friedman has served as a consultant for Galderma.
FROM THE JOURNAL OF DRUGS IN DERMATOLOGY