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CHMP recommends marketing of biologic for atopic dermatitis
The who are candidates for systemic therapy.
Lebrikizumab is an investigational, monoclonal antibody that binds to cytokine interleukin (IL)-13, which has been implicated in driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening, and infection. The biologic is being developed by Almirall and is designed to be administered once per month. Lebrikizumab is not yet available in the United States.
According to a press release from Almirall, the CHMP opinion was based on three pivotal phase 3 studies that showed long-term response in skin clearance and itch control. ADvocate 1 and ADvocate 2 evaluated lebrikizumab as monotherapy, while ADhere assessed lebrikizumab in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate to severe AD. At week 16, more than 50% of patients with moderate to severe AD experienced at least a 75% reduction in disease severity (EASI-75) when receiving lebrikizumab monotherapy in the ADvocate studies and nearly 70% of patients receiving lebrikizumab combined with standard-of-care TCS achieved EASI-75 in the ADhere trial.
Most adverse events across the studies were mild or moderate. The most common reactions were conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.
The who are candidates for systemic therapy.
Lebrikizumab is an investigational, monoclonal antibody that binds to cytokine interleukin (IL)-13, which has been implicated in driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening, and infection. The biologic is being developed by Almirall and is designed to be administered once per month. Lebrikizumab is not yet available in the United States.
According to a press release from Almirall, the CHMP opinion was based on three pivotal phase 3 studies that showed long-term response in skin clearance and itch control. ADvocate 1 and ADvocate 2 evaluated lebrikizumab as monotherapy, while ADhere assessed lebrikizumab in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate to severe AD. At week 16, more than 50% of patients with moderate to severe AD experienced at least a 75% reduction in disease severity (EASI-75) when receiving lebrikizumab monotherapy in the ADvocate studies and nearly 70% of patients receiving lebrikizumab combined with standard-of-care TCS achieved EASI-75 in the ADhere trial.
Most adverse events across the studies were mild or moderate. The most common reactions were conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.
The who are candidates for systemic therapy.
Lebrikizumab is an investigational, monoclonal antibody that binds to cytokine interleukin (IL)-13, which has been implicated in driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening, and infection. The biologic is being developed by Almirall and is designed to be administered once per month. Lebrikizumab is not yet available in the United States.
According to a press release from Almirall, the CHMP opinion was based on three pivotal phase 3 studies that showed long-term response in skin clearance and itch control. ADvocate 1 and ADvocate 2 evaluated lebrikizumab as monotherapy, while ADhere assessed lebrikizumab in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate to severe AD. At week 16, more than 50% of patients with moderate to severe AD experienced at least a 75% reduction in disease severity (EASI-75) when receiving lebrikizumab monotherapy in the ADvocate studies and nearly 70% of patients receiving lebrikizumab combined with standard-of-care TCS achieved EASI-75 in the ADhere trial.
Most adverse events across the studies were mild or moderate. The most common reactions were conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.
Upadacitinib an effective treatment option in AD patients with recent discontinuation of dupilumab
Key clinical point: Upadacitinib was safe and effective in patients with atopic dermatitis (AD) who recently discontinued dupilumab therapy due to lack of desired efficacy or an adverse event (AE).
Major finding: By week 16, a ≥75% improvement in the Eczema Area and Severity Index score or an Investigator’s Global Assessment score of 0 or 1 was achieved by 75% and 81.8% of patients receiving 15 mg and 30 mg upadacitinib, respectively. The treatment-related AE rate was 30.7%, and none of the patients discontinued treatment during the 16-week treatment period.
Study details: Findings are from a real-world multicenter retrospective study that included 39 adult patients with AD who were treated with upadacitinib after discontinuing treatment with dupilumab due to inefficacy or an AE.
Disclosures: This study did not receive any funding. Two authors declared serving as advisors, consultants, speakers, or investigators for various organizations. The other authors declared no conflicts of interest.
Source: Georgakopoulos JR et al. Real-world effectiveness and safety of upadacitinib for the treatment of atopic dermatitis in adult patients switched from dupilumab: A multicenter retrospective study. J Am Acad Dermatol. 2023 (Aug 28). doi: 10.1016/j.jaad.2023.08.059
Key clinical point: Upadacitinib was safe and effective in patients with atopic dermatitis (AD) who recently discontinued dupilumab therapy due to lack of desired efficacy or an adverse event (AE).
Major finding: By week 16, a ≥75% improvement in the Eczema Area and Severity Index score or an Investigator’s Global Assessment score of 0 or 1 was achieved by 75% and 81.8% of patients receiving 15 mg and 30 mg upadacitinib, respectively. The treatment-related AE rate was 30.7%, and none of the patients discontinued treatment during the 16-week treatment period.
Study details: Findings are from a real-world multicenter retrospective study that included 39 adult patients with AD who were treated with upadacitinib after discontinuing treatment with dupilumab due to inefficacy or an AE.
Disclosures: This study did not receive any funding. Two authors declared serving as advisors, consultants, speakers, or investigators for various organizations. The other authors declared no conflicts of interest.
Source: Georgakopoulos JR et al. Real-world effectiveness and safety of upadacitinib for the treatment of atopic dermatitis in adult patients switched from dupilumab: A multicenter retrospective study. J Am Acad Dermatol. 2023 (Aug 28). doi: 10.1016/j.jaad.2023.08.059
Key clinical point: Upadacitinib was safe and effective in patients with atopic dermatitis (AD) who recently discontinued dupilumab therapy due to lack of desired efficacy or an adverse event (AE).
Major finding: By week 16, a ≥75% improvement in the Eczema Area and Severity Index score or an Investigator’s Global Assessment score of 0 or 1 was achieved by 75% and 81.8% of patients receiving 15 mg and 30 mg upadacitinib, respectively. The treatment-related AE rate was 30.7%, and none of the patients discontinued treatment during the 16-week treatment period.
Study details: Findings are from a real-world multicenter retrospective study that included 39 adult patients with AD who were treated with upadacitinib after discontinuing treatment with dupilumab due to inefficacy or an AE.
Disclosures: This study did not receive any funding. Two authors declared serving as advisors, consultants, speakers, or investigators for various organizations. The other authors declared no conflicts of interest.
Source: Georgakopoulos JR et al. Real-world effectiveness and safety of upadacitinib for the treatment of atopic dermatitis in adult patients switched from dupilumab: A multicenter retrospective study. J Am Acad Dermatol. 2023 (Aug 28). doi: 10.1016/j.jaad.2023.08.059
No association between dupilumab treatment and risk for arthralgia in 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
Patients with non-alcoholic fatty liver disease have a lower risk for atopic dermatitis
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
Reduction in S aureus skin infections may reduce the risk for eczema herpeticum in atopic dermatitis
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
Dupilumab rapidly controls atopic dermatitis symptoms in children
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
Severe atopic dermatitis raises risks for cardiovascular disease and venous thromboembolism
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
Atopic dermatitis increases the risk for type 2 diabetes mellitus in adults
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
Tralokinumab is safe and effective in older patients with atopic dermatitis
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
Atopic dermatitis tied to a higher risk for inflammatory bowel disease in children and adults
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