Atopic Dermatitis

Key clinical point: Treatment with dupilumab vs cyclosporine or mycophenolate is not associated with an increased risk for arthralgia in patients with atopic dermatitis (AD).

Major finding: The pooled 180-day incidence rate of arthralgia for dupilumab vs cyclosporine or mycophenolate was 100.7 vs 65.4/1000 person-years (adjusted hazard ratio 1.27; 95% CI 0.93-1.72).

Study details: Findings are from a cohort study that included patients age < 50 years with AD who initiated treatment with either dupilumab (n = 4011) or cyclosporine/mycophenolate (n = 2220).

Disclosures: This study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, USA. Some authors declared serving as consultants or investigators for or receiving research grants from various sources.

Source: Schneeweiss MC et al. Joint pain in patients with atopic dermatitis receiving treatment with dupilumab: A US nation-wide cohort study. J Am Acad Dermatol. 2023 (Aug 18). doi: 10.1016/j.jaad.2023.08.025

Key clinical point: Treatment with dupilumab vs cyclosporine or mycophenolate is not associated with an increased risk for arthralgia in patients with atopic dermatitis (AD).

Major finding: The pooled 180-day incidence rate of arthralgia for dupilumab vs cyclosporine or mycophenolate was 100.7 vs 65.4/1000 person-years (adjusted hazard ratio 1.27; 95% CI 0.93-1.72).

Study details: Findings are from a cohort study that included patients age < 50 years with AD who initiated treatment with either dupilumab (n = 4011) or cyclosporine/mycophenolate (n = 2220).

Disclosures: This study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, USA. Some authors declared serving as consultants or investigators for or receiving research grants from various sources.

Source: Schneeweiss MC et al. Joint pain in patients with atopic dermatitis receiving treatment with dupilumab: A US nation-wide cohort study. J Am Acad Dermatol. 2023 (Aug 18). doi: 10.1016/j.jaad.2023.08.025

Key clinical point: Treatment with dupilumab vs cyclosporine or mycophenolate is not associated with an increased risk for arthralgia in patients with atopic dermatitis (AD).

Major finding: The pooled 180-day incidence rate of arthralgia for dupilumab vs cyclosporine or mycophenolate was 100.7 vs 65.4/1000 person-years (adjusted hazard ratio 1.27; 95% CI 0.93-1.72).

Study details: Findings are from a cohort study that included patients age < 50 years with AD who initiated treatment with either dupilumab (n = 4011) or cyclosporine/mycophenolate (n = 2220).

Disclosures: This study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, USA. Some authors declared serving as consultants or investigators for or receiving research grants from various sources.

Source: Schneeweiss MC et al. Joint pain in patients with atopic dermatitis receiving treatment with dupilumab: A US nation-wide cohort study. J Am Acad Dermatol. 2023 (Aug 18). doi: 10.1016/j.jaad.2023.08.025

Key clinical point: Patients with non-alcoholic fatty liver disease (NAFLD), especially younger patients, have a significantly decreased risk of developing atopic dermatitis (AD).

Major finding: The risk for AD was significantly lower among patients with NAFLD (adjusted hazard ratio [aHR] 0.93; P = .024), particularly those age ≤ 40 years (aHR 0.80; P < .001), compared with control individuals without NAFLD.

Study details: This retrospective cohort study included 307,743 patients with NAFLD and 1,230,972 matched control individuals without NAFLD.

Disclosures: This study was funded by the Chung Shan Medical University Hospital and China Medical University, Taiwan. The authors declared no conflicts of interest.

Source: Gau SY et al. The association between non-alcoholic fatty liver disease and atopic dermatitis: A population-based cohort study. Front Immunol. 2023;14:1171804 (Aug 18). doi: 10.3389/fimmu.2023.1171804

Key clinical point: Patients with non-alcoholic fatty liver disease (NAFLD), especially younger patients, have a significantly decreased risk of developing atopic dermatitis (AD).

Major finding: The risk for AD was significantly lower among patients with NAFLD (adjusted hazard ratio [aHR] 0.93; P = .024), particularly those age ≤ 40 years (aHR 0.80; P < .001), compared with control individuals without NAFLD.

Study details: This retrospective cohort study included 307,743 patients with NAFLD and 1,230,972 matched control individuals without NAFLD.

Disclosures: This study was funded by the Chung Shan Medical University Hospital and China Medical University, Taiwan. The authors declared no conflicts of interest.

Source: Gau SY et al. The association between non-alcoholic fatty liver disease and atopic dermatitis: A population-based cohort study. Front Immunol. 2023;14:1171804 (Aug 18). doi: 10.3389/fimmu.2023.1171804

Key clinical point: Patients with non-alcoholic fatty liver disease (NAFLD), especially younger patients, have a significantly decreased risk of developing atopic dermatitis (AD).

Major finding: The risk for AD was significantly lower among patients with NAFLD (adjusted hazard ratio [aHR] 0.93; P = .024), particularly those age ≤ 40 years (aHR 0.80; P < .001), compared with control individuals without NAFLD.

Study details: This retrospective cohort study included 307,743 patients with NAFLD and 1,230,972 matched control individuals without NAFLD.

Disclosures: This study was funded by the Chung Shan Medical University Hospital and China Medical University, Taiwan. The authors declared no conflicts of interest.

Source: Gau SY et al. The association between non-alcoholic fatty liver disease and atopic dermatitis: A population-based cohort study. Front Immunol. 2023;14:1171804 (Aug 18). doi: 10.3389/fimmu.2023.1171804

Key clinical point: Among patients with atopic dermatitis (AD), those with vs without a history of Staphylococcus aureus skin infections have significantly higher odds of having a history of eczema herpeticum (EH).

Major finding: Patients with AD and with vs without a history of S aureus skin infections had a 6.60-fold increased risk of having a history of EH (adjusted odds ratio 6.60; P = .002).

Study details: This multicenter, clinical registry study included 112 patients with AD and with (n = 56) or without (n = 56) a history of EH, matched by age and AD severity.

Disclosures: This study was supported partly by a National Eczema Association Engagement Research Grant. Several authors declared serving as consultants or investigator for or receiving grants, personal fees, or clinical trial support from various organizations.

Source: Moran MC et al. History of S. aureus skin infection significantly associates with history of eczema herpeticum in patients with atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Aug 24). doi: 10.1007/s13555-023-00996-y

Key clinical point: Among patients with atopic dermatitis (AD), those with vs without a history of Staphylococcus aureus skin infections have significantly higher odds of having a history of eczema herpeticum (EH).

Major finding: Patients with AD and with vs without a history of S aureus skin infections had a 6.60-fold increased risk of having a history of EH (adjusted odds ratio 6.60; P = .002).

Study details: This multicenter, clinical registry study included 112 patients with AD and with (n = 56) or without (n = 56) a history of EH, matched by age and AD severity.

Disclosures: This study was supported partly by a National Eczema Association Engagement Research Grant. Several authors declared serving as consultants or investigator for or receiving grants, personal fees, or clinical trial support from various organizations.

Source: Moran MC et al. History of S. aureus skin infection significantly associates with history of eczema herpeticum in patients with atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Aug 24). doi: 10.1007/s13555-023-00996-y

Key clinical point: Among patients with atopic dermatitis (AD), those with vs without a history of Staphylococcus aureus skin infections have significantly higher odds of having a history of eczema herpeticum (EH).

Major finding: Patients with AD and with vs without a history of S aureus skin infections had a 6.60-fold increased risk of having a history of EH (adjusted odds ratio 6.60; P = .002).

Study details: This multicenter, clinical registry study included 112 patients with AD and with (n = 56) or without (n = 56) a history of EH, matched by age and AD severity.

Disclosures: This study was supported partly by a National Eczema Association Engagement Research Grant. Several authors declared serving as consultants or investigator for or receiving grants, personal fees, or clinical trial support from various organizations.

Source: Moran MC et al. History of S. aureus skin infection significantly associates with history of eczema herpeticum in patients with atopic dermatitis. Dermatol Ther (Heidelb). 2023 (Aug 24). doi: 10.1007/s13555-023-00996-y

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%).