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Atopic dermatitis and immune abnormalities in children born to mothers with nickel exposure
Key clinical point: Maternal exposure to nickel was associated with increased serum interleukin (IL)-2 levels but decreased serum eotaxin-1 levels and was negatively associated with the development of atopic dermatitis (AD) in children aged 3 years.
Major finding: Maternal nickel exposure was associated with increased serum levels of IL-2 (β 16.820; P < .001) but decreased serum levels of eotaxin-1 (β −5.065; P < .01) and was negatively associated with the development of AD (P = .024) in children aged 3 years.
Study details: Findings are from the analysis of an ongoing birth cohort study including 140 mother-child pairs.
Disclosures: This work was supported by grants from the Ministry of Science and Technology, Taiwan, and National Health Research Institutes. The authors declared no conflicts of interest.
Source: Ho JC et al. Prenatal exposure to nickel and atopic dermatitis at age 3 years: A birth cohort study with cytokine profiles. J Eur Acad Dermatol Venereol. 2022 (Jul 16). Doi: 10.1111/jdv.18425
Key clinical point: Maternal exposure to nickel was associated with increased serum interleukin (IL)-2 levels but decreased serum eotaxin-1 levels and was negatively associated with the development of atopic dermatitis (AD) in children aged 3 years.
Major finding: Maternal nickel exposure was associated with increased serum levels of IL-2 (β 16.820; P < .001) but decreased serum levels of eotaxin-1 (β −5.065; P < .01) and was negatively associated with the development of AD (P = .024) in children aged 3 years.
Study details: Findings are from the analysis of an ongoing birth cohort study including 140 mother-child pairs.
Disclosures: This work was supported by grants from the Ministry of Science and Technology, Taiwan, and National Health Research Institutes. The authors declared no conflicts of interest.
Source: Ho JC et al. Prenatal exposure to nickel and atopic dermatitis at age 3 years: A birth cohort study with cytokine profiles. J Eur Acad Dermatol Venereol. 2022 (Jul 16). Doi: 10.1111/jdv.18425
Key clinical point: Maternal exposure to nickel was associated with increased serum interleukin (IL)-2 levels but decreased serum eotaxin-1 levels and was negatively associated with the development of atopic dermatitis (AD) in children aged 3 years.
Major finding: Maternal nickel exposure was associated with increased serum levels of IL-2 (β 16.820; P < .001) but decreased serum levels of eotaxin-1 (β −5.065; P < .01) and was negatively associated with the development of AD (P = .024) in children aged 3 years.
Study details: Findings are from the analysis of an ongoing birth cohort study including 140 mother-child pairs.
Disclosures: This work was supported by grants from the Ministry of Science and Technology, Taiwan, and National Health Research Institutes. The authors declared no conflicts of interest.
Source: Ho JC et al. Prenatal exposure to nickel and atopic dermatitis at age 3 years: A birth cohort study with cytokine profiles. J Eur Acad Dermatol Venereol. 2022 (Jul 16). Doi: 10.1111/jdv.18425
Meta-analysis demonstrates efficacy and safety of IL-13 inhibitors in atopic dermatitis
Key clinical point: Interleukin (IL)-13 inhibitors, such as lebrikizumab and tralokinumab, rapidly reduced disease severity and were well tolerated in patients with moderate-to-severe atopic dermatitis (AD).
Major finding: A significantly higher proportion of patients receiving lebrikizumab or tralokinumab vs placebo achieved ≥75% improvement in the Eczema Area and Severity Index as early as week 4 (risk ratio [RR] 2.09; P = .006) and ≥4-point improvement in the Pruritus Numerical Rating Scale score (RR 1.59; 95% CI 1.23-2.05). Lebrikizumab/tralokinumab was associated with a higher risk for conjunctivitis than placebo (RR 2.318; P < .001).
Study details: Findings are from a meta-analysis of 7 randomized controlled trials including 2946 adults with moderate-to-severe AD who were randomly assigned to receive lebrikizumab, tralokinumab, or placebo for 12-16 weeks.
Disclosures: This study was supported by the Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.
Source: Zhang Y et al. The efficacy and safety of IL-13 inhibitors in atopic dermatitis: A systematic review and meta-analysis. Front Immunol. 2022;13:923362 (Jul 27). Doi: 10.3389/fimmu.2022.923362
Key clinical point: Interleukin (IL)-13 inhibitors, such as lebrikizumab and tralokinumab, rapidly reduced disease severity and were well tolerated in patients with moderate-to-severe atopic dermatitis (AD).
Major finding: A significantly higher proportion of patients receiving lebrikizumab or tralokinumab vs placebo achieved ≥75% improvement in the Eczema Area and Severity Index as early as week 4 (risk ratio [RR] 2.09; P = .006) and ≥4-point improvement in the Pruritus Numerical Rating Scale score (RR 1.59; 95% CI 1.23-2.05). Lebrikizumab/tralokinumab was associated with a higher risk for conjunctivitis than placebo (RR 2.318; P < .001).
Study details: Findings are from a meta-analysis of 7 randomized controlled trials including 2946 adults with moderate-to-severe AD who were randomly assigned to receive lebrikizumab, tralokinumab, or placebo for 12-16 weeks.
Disclosures: This study was supported by the Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.
Source: Zhang Y et al. The efficacy and safety of IL-13 inhibitors in atopic dermatitis: A systematic review and meta-analysis. Front Immunol. 2022;13:923362 (Jul 27). Doi: 10.3389/fimmu.2022.923362
Key clinical point: Interleukin (IL)-13 inhibitors, such as lebrikizumab and tralokinumab, rapidly reduced disease severity and were well tolerated in patients with moderate-to-severe atopic dermatitis (AD).
Major finding: A significantly higher proportion of patients receiving lebrikizumab or tralokinumab vs placebo achieved ≥75% improvement in the Eczema Area and Severity Index as early as week 4 (risk ratio [RR] 2.09; P = .006) and ≥4-point improvement in the Pruritus Numerical Rating Scale score (RR 1.59; 95% CI 1.23-2.05). Lebrikizumab/tralokinumab was associated with a higher risk for conjunctivitis than placebo (RR 2.318; P < .001).
Study details: Findings are from a meta-analysis of 7 randomized controlled trials including 2946 adults with moderate-to-severe AD who were randomly assigned to receive lebrikizumab, tralokinumab, or placebo for 12-16 weeks.
Disclosures: This study was supported by the Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.
Source: Zhang Y et al. The efficacy and safety of IL-13 inhibitors in atopic dermatitis: A systematic review and meta-analysis. Front Immunol. 2022;13:923362 (Jul 27). Doi: 10.3389/fimmu.2022.923362
Pseudoceramide+steroid cream rapidly improved skin barrier function in atopic dermatitis
Key clinical point: A 2-week treatment with a test cream (TC) containing a steroid and pseudoceramide rapidly improved skin barrier function compared with a control cream (CC) containing only steroids in patients with mild-to-moderate atopic dermatitis (AD).
Major finding: In the TC group, the mean skin hydration value (48.0; P < .01) and transepidermal water loss (−2.1; P < .05) improved significantly as early as at 1 week after application, with similar improvements observed at 2 weeks; however, no significant improvements were observed in the CC group.
Study details: Findings are from a parallel, double-blind study including 36 patients with mild-to-moderate AD skin symptoms on the inner forearm who were randomly assigned to receive a TC containing 0.15% prednisolone valerate acetate (PVA)+3% synthetic pseudoceramide or a CC containing 0.15% PVA for 2 weeks.
Disclosures: This study was fully funded by Kao Corporation, Japan. The authors declared no conflicts of interest.
Source: Okoshi K et al. Efficacy of pseudo-ceramide-containing steroid lamellar cream in patients with mild to moderate atopic dermatitis: A randomized, double-blind study. Dermatol Ther (Heidelb). 2022;12:1823–1834 (Jul 19). Doi: 10.1007/s13555-022-00766-2
Key clinical point: A 2-week treatment with a test cream (TC) containing a steroid and pseudoceramide rapidly improved skin barrier function compared with a control cream (CC) containing only steroids in patients with mild-to-moderate atopic dermatitis (AD).
Major finding: In the TC group, the mean skin hydration value (48.0; P < .01) and transepidermal water loss (−2.1; P < .05) improved significantly as early as at 1 week after application, with similar improvements observed at 2 weeks; however, no significant improvements were observed in the CC group.
Study details: Findings are from a parallel, double-blind study including 36 patients with mild-to-moderate AD skin symptoms on the inner forearm who were randomly assigned to receive a TC containing 0.15% prednisolone valerate acetate (PVA)+3% synthetic pseudoceramide or a CC containing 0.15% PVA for 2 weeks.
Disclosures: This study was fully funded by Kao Corporation, Japan. The authors declared no conflicts of interest.
Source: Okoshi K et al. Efficacy of pseudo-ceramide-containing steroid lamellar cream in patients with mild to moderate atopic dermatitis: A randomized, double-blind study. Dermatol Ther (Heidelb). 2022;12:1823–1834 (Jul 19). Doi: 10.1007/s13555-022-00766-2
Key clinical point: A 2-week treatment with a test cream (TC) containing a steroid and pseudoceramide rapidly improved skin barrier function compared with a control cream (CC) containing only steroids in patients with mild-to-moderate atopic dermatitis (AD).
Major finding: In the TC group, the mean skin hydration value (48.0; P < .01) and transepidermal water loss (−2.1; P < .05) improved significantly as early as at 1 week after application, with similar improvements observed at 2 weeks; however, no significant improvements were observed in the CC group.
Study details: Findings are from a parallel, double-blind study including 36 patients with mild-to-moderate AD skin symptoms on the inner forearm who were randomly assigned to receive a TC containing 0.15% prednisolone valerate acetate (PVA)+3% synthetic pseudoceramide or a CC containing 0.15% PVA for 2 weeks.
Disclosures: This study was fully funded by Kao Corporation, Japan. The authors declared no conflicts of interest.
Source: Okoshi K et al. Efficacy of pseudo-ceramide-containing steroid lamellar cream in patients with mild to moderate atopic dermatitis: A randomized, double-blind study. Dermatol Ther (Heidelb). 2022;12:1823–1834 (Jul 19). Doi: 10.1007/s13555-022-00766-2
Dupilumab effective and safe in special populations
Key clinical point: Dupilumab demonstrated comparable long-term efficacy and safety in patients with moderate-to-severe atopic dermatitis (AD) and other major comorbidities (special population) as well as patients with only AD.
Major finding: Patients with AD and concomitant comorbidities achieved significant improvements in the Eczema Area and Severity Index at weeks 4, 16, and 52 (all P < .0001), with comparable outcomes observed in patients with only AD. Patients with vs without concomitant comorbidities reported injection site reactions (12.0% vs 17.22%) and conjunctivitis (8.0% vs 11.34%) as the main adverse events.
Study details: Findings are from a 52-week retrospective study including 263 adults with moderate-to-severe AD who received dupilumab for 16 weeks, including 25 patients with severe kidney failure, hepatitis B/C, neurological diseases, AIDS, or a history of cancer or organ transplantation who were classified as the special population.
Disclosures: This study did not receive any funding. Some authors declared serving as investigators, speakers, consultants, or advisory board members for several sources.
Source: Patruno C et al. Dupilumab for the treatment of adult atopic dermatitis in special populations. J Dermatolog Treat. 2022 (Jul 19). Doi: 10.1080/09546634.2022.2102121
Key clinical point: Dupilumab demonstrated comparable long-term efficacy and safety in patients with moderate-to-severe atopic dermatitis (AD) and other major comorbidities (special population) as well as patients with only AD.
Major finding: Patients with AD and concomitant comorbidities achieved significant improvements in the Eczema Area and Severity Index at weeks 4, 16, and 52 (all P < .0001), with comparable outcomes observed in patients with only AD. Patients with vs without concomitant comorbidities reported injection site reactions (12.0% vs 17.22%) and conjunctivitis (8.0% vs 11.34%) as the main adverse events.
Study details: Findings are from a 52-week retrospective study including 263 adults with moderate-to-severe AD who received dupilumab for 16 weeks, including 25 patients with severe kidney failure, hepatitis B/C, neurological diseases, AIDS, or a history of cancer or organ transplantation who were classified as the special population.
Disclosures: This study did not receive any funding. Some authors declared serving as investigators, speakers, consultants, or advisory board members for several sources.
Source: Patruno C et al. Dupilumab for the treatment of adult atopic dermatitis in special populations. J Dermatolog Treat. 2022 (Jul 19). Doi: 10.1080/09546634.2022.2102121
Key clinical point: Dupilumab demonstrated comparable long-term efficacy and safety in patients with moderate-to-severe atopic dermatitis (AD) and other major comorbidities (special population) as well as patients with only AD.
Major finding: Patients with AD and concomitant comorbidities achieved significant improvements in the Eczema Area and Severity Index at weeks 4, 16, and 52 (all P < .0001), with comparable outcomes observed in patients with only AD. Patients with vs without concomitant comorbidities reported injection site reactions (12.0% vs 17.22%) and conjunctivitis (8.0% vs 11.34%) as the main adverse events.
Study details: Findings are from a 52-week retrospective study including 263 adults with moderate-to-severe AD who received dupilumab for 16 weeks, including 25 patients with severe kidney failure, hepatitis B/C, neurological diseases, AIDS, or a history of cancer or organ transplantation who were classified as the special population.
Disclosures: This study did not receive any funding. Some authors declared serving as investigators, speakers, consultants, or advisory board members for several sources.
Source: Patruno C et al. Dupilumab for the treatment of adult atopic dermatitis in special populations. J Dermatolog Treat. 2022 (Jul 19). Doi: 10.1080/09546634.2022.2102121
Dupilumab effective against pruritus in atopic dermatitis in real-life settings
Key clinical point: Dupilumab was effective against pruritus and improved itch and sleep scores in patients with atopic dermatitis (AD).
Major finding: By 36 months, the mean numerical rating scale peak of pruritus (NRSpp) score dropped from 8.6 to 1.7 and the mean NRS sleep disturbance (NRSsd) score dropped from 7 to 0. The Eczema Area and Severity Index and Dermatology Life Quality Index scores were significantly correlated with both NRSpp and NRSsd scores (P < .001).
Study details: Findings are from a retrospective, observational study including 356 patients with AD who received dupilumab.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Mastorino L et al. Chronic pruritus in atopic patients treated with dupilumab: Real life response and related parameters in 354 patients. Pharmaceuticals (Basel). 2022;15(7):883 (Jul 17). Doi: 10.3390/ph15070883
Key clinical point: Dupilumab was effective against pruritus and improved itch and sleep scores in patients with atopic dermatitis (AD).
Major finding: By 36 months, the mean numerical rating scale peak of pruritus (NRSpp) score dropped from 8.6 to 1.7 and the mean NRS sleep disturbance (NRSsd) score dropped from 7 to 0. The Eczema Area and Severity Index and Dermatology Life Quality Index scores were significantly correlated with both NRSpp and NRSsd scores (P < .001).
Study details: Findings are from a retrospective, observational study including 356 patients with AD who received dupilumab.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Mastorino L et al. Chronic pruritus in atopic patients treated with dupilumab: Real life response and related parameters in 354 patients. Pharmaceuticals (Basel). 2022;15(7):883 (Jul 17). Doi: 10.3390/ph15070883
Key clinical point: Dupilumab was effective against pruritus and improved itch and sleep scores in patients with atopic dermatitis (AD).
Major finding: By 36 months, the mean numerical rating scale peak of pruritus (NRSpp) score dropped from 8.6 to 1.7 and the mean NRS sleep disturbance (NRSsd) score dropped from 7 to 0. The Eczema Area and Severity Index and Dermatology Life Quality Index scores were significantly correlated with both NRSpp and NRSsd scores (P < .001).
Study details: Findings are from a retrospective, observational study including 356 patients with AD who received dupilumab.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Mastorino L et al. Chronic pruritus in atopic patients treated with dupilumab: Real life response and related parameters in 354 patients. Pharmaceuticals (Basel). 2022;15(7):883 (Jul 17). Doi: 10.3390/ph15070883
Progressive and sustained improvement in atopic dermatitis with tralokinumab plus TCS as needed
Key clinical point: Adults with moderate-to-severe atopic dermatitis (AD) who continued tralokinumab and topical corticosteroids (TCS) as needed showed progressive and sustained improvement in disease extent and severity and quality-of-life over 32 weeks.
Major finding: Longer use of tralokinumab was associated with a higher proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (week 16: 56%; week 32: 70.2%) and sustained improvement in the Dermatology Life Quality Index scores (week 16: 65.4%; week 32: 66.8%).
Study details: This post hoc analysis of the phase 3 ECZTRA 3 trial included 380 patients with moderate-to-severe AD who were randomized to receive tralokinumab or placebo every 2 weeks, both with TCS as needed, for 16 weeks followed by tralokinumab every 2-4 weeks with TCS until week 32 after re-randomization.
Disclosures: The ECZTRA 3 trial was sponsored by LEO Pharma A/S. Two authors declared being employees and owning stocks in LEO Pharma. The other authors reported ties with several sources, including LEO Pharma.
Source: Silverberg JI et al. Tralokinumab plus topical corticosteroids as needed provides progressive and sustained efficacy in adults with moderate-to-severe atopic dermatitis over a 32-week period: An ECZTRA 3 post hoc analysis. Am J Clin Dermatol. 2022;23:547–559 (Jul 20). Doi: 10.1007/s40257-022-00702-2
Key clinical point: Adults with moderate-to-severe atopic dermatitis (AD) who continued tralokinumab and topical corticosteroids (TCS) as needed showed progressive and sustained improvement in disease extent and severity and quality-of-life over 32 weeks.
Major finding: Longer use of tralokinumab was associated with a higher proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (week 16: 56%; week 32: 70.2%) and sustained improvement in the Dermatology Life Quality Index scores (week 16: 65.4%; week 32: 66.8%).
Study details: This post hoc analysis of the phase 3 ECZTRA 3 trial included 380 patients with moderate-to-severe AD who were randomized to receive tralokinumab or placebo every 2 weeks, both with TCS as needed, for 16 weeks followed by tralokinumab every 2-4 weeks with TCS until week 32 after re-randomization.
Disclosures: The ECZTRA 3 trial was sponsored by LEO Pharma A/S. Two authors declared being employees and owning stocks in LEO Pharma. The other authors reported ties with several sources, including LEO Pharma.
Source: Silverberg JI et al. Tralokinumab plus topical corticosteroids as needed provides progressive and sustained efficacy in adults with moderate-to-severe atopic dermatitis over a 32-week period: An ECZTRA 3 post hoc analysis. Am J Clin Dermatol. 2022;23:547–559 (Jul 20). Doi: 10.1007/s40257-022-00702-2
Key clinical point: Adults with moderate-to-severe atopic dermatitis (AD) who continued tralokinumab and topical corticosteroids (TCS) as needed showed progressive and sustained improvement in disease extent and severity and quality-of-life over 32 weeks.
Major finding: Longer use of tralokinumab was associated with a higher proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (week 16: 56%; week 32: 70.2%) and sustained improvement in the Dermatology Life Quality Index scores (week 16: 65.4%; week 32: 66.8%).
Study details: This post hoc analysis of the phase 3 ECZTRA 3 trial included 380 patients with moderate-to-severe AD who were randomized to receive tralokinumab or placebo every 2 weeks, both with TCS as needed, for 16 weeks followed by tralokinumab every 2-4 weeks with TCS until week 32 after re-randomization.
Disclosures: The ECZTRA 3 trial was sponsored by LEO Pharma A/S. Two authors declared being employees and owning stocks in LEO Pharma. The other authors reported ties with several sources, including LEO Pharma.
Source: Silverberg JI et al. Tralokinumab plus topical corticosteroids as needed provides progressive and sustained efficacy in adults with moderate-to-severe atopic dermatitis over a 32-week period: An ECZTRA 3 post hoc analysis. Am J Clin Dermatol. 2022;23:547–559 (Jul 20). Doi: 10.1007/s40257-022-00702-2
Patients with controlled atopic dermatitis can opt for dupilumab dose reduction
Key clinical point: A patient-centered dose reduction after 52 weeks of dupilumab therapy helped maintain low disease activity in a subgroup of patients with persistently controlled atopic dermatitis (AD).
Major finding: After ≥3 months of dupilumab dose reduction, >80% and 93.3% of patients receiving dupilumab every 4 weeks (Q4W) and every 6-8 weeks (Q6W/Q8W) maintained an Eczema Area and Severity Index score of ≤7, respectively.
Study details: Findings are from an observational cohort study including 90 adult patients with AD from the BioDay registry who were treated with dupilumab every 2 weeks (Q2W) for 52 weeks, after which the dosing interval was prolonged to Q4W (n = 60) and subsequently to Q6W/Q8W (n = 30) in patients with controlled disease.
Disclosures: The BioDay registry was sponsored by Sanofi Genzyme. Some authors declared receiving research funding or grants from or serving as advisors, consultants, speakers, investigators, or advisory board members for several sources, including Sanofi Genzyme.
Source: Spekhorst LS et al. Patient-centered dupilumab dosing regimen leads to successful dose reduction in persistently controlled atopic dermatitis. Allergy. 2022 (Jul 15). Doi: 10.1111/all.15439
Key clinical point: A patient-centered dose reduction after 52 weeks of dupilumab therapy helped maintain low disease activity in a subgroup of patients with persistently controlled atopic dermatitis (AD).
Major finding: After ≥3 months of dupilumab dose reduction, >80% and 93.3% of patients receiving dupilumab every 4 weeks (Q4W) and every 6-8 weeks (Q6W/Q8W) maintained an Eczema Area and Severity Index score of ≤7, respectively.
Study details: Findings are from an observational cohort study including 90 adult patients with AD from the BioDay registry who were treated with dupilumab every 2 weeks (Q2W) for 52 weeks, after which the dosing interval was prolonged to Q4W (n = 60) and subsequently to Q6W/Q8W (n = 30) in patients with controlled disease.
Disclosures: The BioDay registry was sponsored by Sanofi Genzyme. Some authors declared receiving research funding or grants from or serving as advisors, consultants, speakers, investigators, or advisory board members for several sources, including Sanofi Genzyme.
Source: Spekhorst LS et al. Patient-centered dupilumab dosing regimen leads to successful dose reduction in persistently controlled atopic dermatitis. Allergy. 2022 (Jul 15). Doi: 10.1111/all.15439
Key clinical point: A patient-centered dose reduction after 52 weeks of dupilumab therapy helped maintain low disease activity in a subgroup of patients with persistently controlled atopic dermatitis (AD).
Major finding: After ≥3 months of dupilumab dose reduction, >80% and 93.3% of patients receiving dupilumab every 4 weeks (Q4W) and every 6-8 weeks (Q6W/Q8W) maintained an Eczema Area and Severity Index score of ≤7, respectively.
Study details: Findings are from an observational cohort study including 90 adult patients with AD from the BioDay registry who were treated with dupilumab every 2 weeks (Q2W) for 52 weeks, after which the dosing interval was prolonged to Q4W (n = 60) and subsequently to Q6W/Q8W (n = 30) in patients with controlled disease.
Disclosures: The BioDay registry was sponsored by Sanofi Genzyme. Some authors declared receiving research funding or grants from or serving as advisors, consultants, speakers, investigators, or advisory board members for several sources, including Sanofi Genzyme.
Source: Spekhorst LS et al. Patient-centered dupilumab dosing regimen leads to successful dose reduction in persistently controlled atopic dermatitis. Allergy. 2022 (Jul 15). Doi: 10.1111/all.15439
Moderate-to-severe atopic dermatitis: Long-term safety and effectiveness of tralokinumab
Key clinical point: Tralokinumab was well tolerated and maintained long-term disease control for up to 2 years in patients with moderate-to-severe atopic dermatitis (AD).
Major finding: In the safety analysis set (n = 1174), the exposure-adjusted incidence rate of adverse events (AE) was 237.8 events/100 patient-years of exposure and 71.9% of participants reported ≥1 AE of mostly mild or moderate severity. In the efficacy analysis set (n = 345), 82.5% of patients treated with tralokinumab for 2 years maintained ≥75% improvement in the Eczema Area and Severity Index.
Study details: Findings are from the 2-year post hoc interim analysis of the ongoing, 5-year open-label extension trial, ECZTEND, including adult participants with moderate-to-severe AD from previous parent trials who received 300 mg tralokinumab every 2 weeks with or without topical corticosteroids.
Disclosures: The ECZTEND trial was sponsored by LEO Pharma A/S. Three authors declared being employees of LEO Pharma, and other authors reported ties with several sources, including LEO Pharma.
Source: Blauvelt A et al. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022 (Jul 18). Doi: 10.1016/j.jaad.2022.07.019
Key clinical point: Tralokinumab was well tolerated and maintained long-term disease control for up to 2 years in patients with moderate-to-severe atopic dermatitis (AD).
Major finding: In the safety analysis set (n = 1174), the exposure-adjusted incidence rate of adverse events (AE) was 237.8 events/100 patient-years of exposure and 71.9% of participants reported ≥1 AE of mostly mild or moderate severity. In the efficacy analysis set (n = 345), 82.5% of patients treated with tralokinumab for 2 years maintained ≥75% improvement in the Eczema Area and Severity Index.
Study details: Findings are from the 2-year post hoc interim analysis of the ongoing, 5-year open-label extension trial, ECZTEND, including adult participants with moderate-to-severe AD from previous parent trials who received 300 mg tralokinumab every 2 weeks with or without topical corticosteroids.
Disclosures: The ECZTEND trial was sponsored by LEO Pharma A/S. Three authors declared being employees of LEO Pharma, and other authors reported ties with several sources, including LEO Pharma.
Source: Blauvelt A et al. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022 (Jul 18). Doi: 10.1016/j.jaad.2022.07.019
Key clinical point: Tralokinumab was well tolerated and maintained long-term disease control for up to 2 years in patients with moderate-to-severe atopic dermatitis (AD).
Major finding: In the safety analysis set (n = 1174), the exposure-adjusted incidence rate of adverse events (AE) was 237.8 events/100 patient-years of exposure and 71.9% of participants reported ≥1 AE of mostly mild or moderate severity. In the efficacy analysis set (n = 345), 82.5% of patients treated with tralokinumab for 2 years maintained ≥75% improvement in the Eczema Area and Severity Index.
Study details: Findings are from the 2-year post hoc interim analysis of the ongoing, 5-year open-label extension trial, ECZTEND, including adult participants with moderate-to-severe AD from previous parent trials who received 300 mg tralokinumab every 2 weeks with or without topical corticosteroids.
Disclosures: The ECZTEND trial was sponsored by LEO Pharma A/S. Three authors declared being employees of LEO Pharma, and other authors reported ties with several sources, including LEO Pharma.
Source: Blauvelt A et al. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022 (Jul 18). Doi: 10.1016/j.jaad.2022.07.019
Abrocitinib more promising than dupilumab in moderate-to-severe atopic dermatitis
Key clinical point: Abrocitinib was more effective than dupilumab in inducing early itch reduction and controlling disease severity in adults with moderate-to-severe atopic dermatitis (AD) on background topical therapy.
Major finding: A significantly higher proportion of patients in the abrocitinib vs dupilumab group achieved ≥4-point improvement in the Peak Pruritus Numerical Rating Scale score at week 2 (48% vs 26%; P < .0001) and ≥90% improvement in the Eczema Area and Severity Index at week 4 (29% vs 15%; P < .0001). Treatment-emergent adverse events were more frequent in the abrocitinib vs dupilumab group (74% vs 65%).
Study details: Findings are from a phase 3 trial including 727 adults with moderate-to-severe AD who showed inadequate response to medicated topical therapy and were randomly assigned to receive oral abrocitinib or subcutaneous dupilumab for 26 weeks.
Disclosures: This study was funded by Pfizer. Seven authors declared being current or former employees or shareholders of Pfizer or Pfizer Pharma. The other authors reported ties with several sources.
Source: Reich K et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A randomised, double-blind, multicentre phase 3 trial. Lancet. 2022;400(10348):273-282 (Jul 23). Doi: 10.1016/S0140-6736(22)01199-0
Key clinical point: Abrocitinib was more effective than dupilumab in inducing early itch reduction and controlling disease severity in adults with moderate-to-severe atopic dermatitis (AD) on background topical therapy.
Major finding: A significantly higher proportion of patients in the abrocitinib vs dupilumab group achieved ≥4-point improvement in the Peak Pruritus Numerical Rating Scale score at week 2 (48% vs 26%; P < .0001) and ≥90% improvement in the Eczema Area and Severity Index at week 4 (29% vs 15%; P < .0001). Treatment-emergent adverse events were more frequent in the abrocitinib vs dupilumab group (74% vs 65%).
Study details: Findings are from a phase 3 trial including 727 adults with moderate-to-severe AD who showed inadequate response to medicated topical therapy and were randomly assigned to receive oral abrocitinib or subcutaneous dupilumab for 26 weeks.
Disclosures: This study was funded by Pfizer. Seven authors declared being current or former employees or shareholders of Pfizer or Pfizer Pharma. The other authors reported ties with several sources.
Source: Reich K et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A randomised, double-blind, multicentre phase 3 trial. Lancet. 2022;400(10348):273-282 (Jul 23). Doi: 10.1016/S0140-6736(22)01199-0
Key clinical point: Abrocitinib was more effective than dupilumab in inducing early itch reduction and controlling disease severity in adults with moderate-to-severe atopic dermatitis (AD) on background topical therapy.
Major finding: A significantly higher proportion of patients in the abrocitinib vs dupilumab group achieved ≥4-point improvement in the Peak Pruritus Numerical Rating Scale score at week 2 (48% vs 26%; P < .0001) and ≥90% improvement in the Eczema Area and Severity Index at week 4 (29% vs 15%; P < .0001). Treatment-emergent adverse events were more frequent in the abrocitinib vs dupilumab group (74% vs 65%).
Study details: Findings are from a phase 3 trial including 727 adults with moderate-to-severe AD who showed inadequate response to medicated topical therapy and were randomly assigned to receive oral abrocitinib or subcutaneous dupilumab for 26 weeks.
Disclosures: This study was funded by Pfizer. Seven authors declared being current or former employees or shareholders of Pfizer or Pfizer Pharma. The other authors reported ties with several sources.
Source: Reich K et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A randomised, double-blind, multicentre phase 3 trial. Lancet. 2022;400(10348):273-282 (Jul 23). Doi: 10.1016/S0140-6736(22)01199-0
Words, now actions: How medical associations try to fulfill pledges to combat racism in health care
– from health care outcomes, from the level and quality of patient treatment, from their own memberships. How have those pronouncements translated into programs that could have, or even have had, positive impacts?
For this article, this news organization asked several associations about tangible actions behind their vows to combat racism in health care. Meanwhile, a recent Medscape report focused on the degree to which physicians prioritize racial disparities as a leading social issue.
American Academy of Family Physicians
The American Academy of Family Physicians’ approach is to integrate diversity, equity, and inclusion (DEI) efforts into all existing and new projects rather than tackle racial disparities as a discrete problem.
“Our policies, our advocacy efforts, everything our commissions and staff do ... is through a lens of diversity, equity, and inclusiveness,” said AAFP Board Chair Ada D. Stewart, MD, FAAP.
That lens is ground by a DEI center the AAFP created in 2017. Run by AAFP staff, members, and chapters, the center focuses on five areas: policy, education and training, practice, diversifying the workplace, and strategic partnerships.
The center has established a special project called EveryONE to provide AAFP members with relevant research, policy templates, and other resources to address patient needs. One example is the Neighborhood Navigator, an online tool that shows food, housing, transportation, and other needs in a patient’s neighborhood.
Meanwhile, the DEI center has created training programs for AAFP members on topics like unconscious and implicit racial biases. And the AAFP has implemented several relevant governing policies regarding pushes to improve childbirth conditions and limit race-based treatment, among other areas.
In January, the AAFP established a new DEI commission for family medicine to set the academy’s agenda on racial issues moving forward. “We only had 10 physician positions available on the commission, and over 100 individuals applied, which gave us comfort that we were going in the right direction,” Dr. Stewart said.
Association of American Medical Colleges
The Association of American Medical Colleges, which represents nearly 600 U.S. and Canadian medical schools and teaching hospitals, has a “longstanding” focus on racial equity, said Philip Alberti, founder of the AAMC Center for Health Justice. However, in 2020 that focus became more detailed and layered.
Those layers include:
- Encouraging self-reflection by members on how personal racial biases and stereotypes can lead to systemic racism in health care.
- Working on the AAMC organizational structure. Priorities range from hiring a consultant to help guide antiracism efforts, to establishing a DEI council and advisors, to regularly seeking input from staff. In 2021, the AAMC launched a Center for Health Justice to work more closely with communities.
- Ramping up collaboration with national and local academic medicine organizations and partners. As one example, the AAMC and American Medical Association released a guide for physicians and health care professionals on language that could be interpreted as racist or disrespectful.
- Continuing to be outspoken about racial disparities in health care in society generally.
Meanwhile, the AAMC is supporting more specific, localized health equity efforts in cities such as Cincinnati and Boston.
Cincinnati Children’s Hospital research has found that children in poor neighborhoods are five times more likely to need hospital stays. AAMC members have helped identify “hot spots” for social needs among children and focused specifically on two neighborhoods in the city. The initiative has roped in partnerships with community and social service organizations as well as health care providers, and proponents say the number of child hospital stays in those neighborhoods has dropped by 20%.
Boston Medical Center researchers learned that Black and Latino patients experiencing problems with heart failure were less likely to be referred to a cardiologist. AAMC members assisted with a program to encourage physicians to make medically necessary referrals more often.
National Health Council
The National Health Council, an umbrella association of health organizations, similarly has made a “commitment, not just around policy work but anytime and anything the NHC is doing, to build around trying to identify and solve issues of health equity,” CEO Randall Rutta said.
The NHC has identified four strategic policy areas including race and in 2021 issued a statement signed by 45 other health care organizations vowing to take on systemic racism and advance equity, through public policy and law.
In relation to policy, Mr. Rutta said his organization is lobbying Congress and federal agencies to diversify clinical trials.
“We want to make sure that clinical trials are inclusive of people from different racial and ethnic groups, in order to understand how [they are] affected by a particular condition,” he said. “As you would imagine, some conditions hit certain groups harder than others for genetic or other reasons, or it may just be a reflection of other disparities that occur across health care.”
The organization has issued suggestions for policy change in the Food and Drug Administration’s clinical trial policy and separately targeted telemedicine policy to promote equity and greater patient access. For example, one initiative aims to ensure patients’ privacy and civil rights as telemedicine’s popularity grows after the COVID-19 pandemic. The NHC presented the initiative in a congressional briefing last year.
American Public Health Association
The American Public Health Association says it started focusing on racial disparities in health care in 2015, following a series of racially fueled violent acts. The APHA started with a four-part webinar series on racism in health (more than 10,000 live participants and 40,000 replays to date).
Shortly afterward, then-APHA President Camara Jones, MD, MPH, PhD, launched a national campaign encouraging APHA members, affiliates, and partners to name and address racism as a determinant of health.
More recently in 2021, the APHA adopted a “Truth, Racial Healing & Transformation” guiding framework and “Healing Through Policy” initiative that offer local leaders policy templates and best practices.
“We have identified a suite of policies that have actually been implemented successfully and are advancing racial equity,” said Regina Davis Moss, APHA’s associate executive director of health policy and practice. “You can’t advance health without having a policy that supports it.”
Montgomery County, Md., is one community that has used the framework (for racial equity training of county employees). Leaders in Evanston, Ill., also used it in crafting a resolution to end structural racism in the city.
A version of this article first appeared on Medscape.com.
– from health care outcomes, from the level and quality of patient treatment, from their own memberships. How have those pronouncements translated into programs that could have, or even have had, positive impacts?
For this article, this news organization asked several associations about tangible actions behind their vows to combat racism in health care. Meanwhile, a recent Medscape report focused on the degree to which physicians prioritize racial disparities as a leading social issue.
American Academy of Family Physicians
The American Academy of Family Physicians’ approach is to integrate diversity, equity, and inclusion (DEI) efforts into all existing and new projects rather than tackle racial disparities as a discrete problem.
“Our policies, our advocacy efforts, everything our commissions and staff do ... is through a lens of diversity, equity, and inclusiveness,” said AAFP Board Chair Ada D. Stewart, MD, FAAP.
That lens is ground by a DEI center the AAFP created in 2017. Run by AAFP staff, members, and chapters, the center focuses on five areas: policy, education and training, practice, diversifying the workplace, and strategic partnerships.
The center has established a special project called EveryONE to provide AAFP members with relevant research, policy templates, and other resources to address patient needs. One example is the Neighborhood Navigator, an online tool that shows food, housing, transportation, and other needs in a patient’s neighborhood.
Meanwhile, the DEI center has created training programs for AAFP members on topics like unconscious and implicit racial biases. And the AAFP has implemented several relevant governing policies regarding pushes to improve childbirth conditions and limit race-based treatment, among other areas.
In January, the AAFP established a new DEI commission for family medicine to set the academy’s agenda on racial issues moving forward. “We only had 10 physician positions available on the commission, and over 100 individuals applied, which gave us comfort that we were going in the right direction,” Dr. Stewart said.
Association of American Medical Colleges
The Association of American Medical Colleges, which represents nearly 600 U.S. and Canadian medical schools and teaching hospitals, has a “longstanding” focus on racial equity, said Philip Alberti, founder of the AAMC Center for Health Justice. However, in 2020 that focus became more detailed and layered.
Those layers include:
- Encouraging self-reflection by members on how personal racial biases and stereotypes can lead to systemic racism in health care.
- Working on the AAMC organizational structure. Priorities range from hiring a consultant to help guide antiracism efforts, to establishing a DEI council and advisors, to regularly seeking input from staff. In 2021, the AAMC launched a Center for Health Justice to work more closely with communities.
- Ramping up collaboration with national and local academic medicine organizations and partners. As one example, the AAMC and American Medical Association released a guide for physicians and health care professionals on language that could be interpreted as racist or disrespectful.
- Continuing to be outspoken about racial disparities in health care in society generally.
Meanwhile, the AAMC is supporting more specific, localized health equity efforts in cities such as Cincinnati and Boston.
Cincinnati Children’s Hospital research has found that children in poor neighborhoods are five times more likely to need hospital stays. AAMC members have helped identify “hot spots” for social needs among children and focused specifically on two neighborhoods in the city. The initiative has roped in partnerships with community and social service organizations as well as health care providers, and proponents say the number of child hospital stays in those neighborhoods has dropped by 20%.
Boston Medical Center researchers learned that Black and Latino patients experiencing problems with heart failure were less likely to be referred to a cardiologist. AAMC members assisted with a program to encourage physicians to make medically necessary referrals more often.
National Health Council
The National Health Council, an umbrella association of health organizations, similarly has made a “commitment, not just around policy work but anytime and anything the NHC is doing, to build around trying to identify and solve issues of health equity,” CEO Randall Rutta said.
The NHC has identified four strategic policy areas including race and in 2021 issued a statement signed by 45 other health care organizations vowing to take on systemic racism and advance equity, through public policy and law.
In relation to policy, Mr. Rutta said his organization is lobbying Congress and federal agencies to diversify clinical trials.
“We want to make sure that clinical trials are inclusive of people from different racial and ethnic groups, in order to understand how [they are] affected by a particular condition,” he said. “As you would imagine, some conditions hit certain groups harder than others for genetic or other reasons, or it may just be a reflection of other disparities that occur across health care.”
The organization has issued suggestions for policy change in the Food and Drug Administration’s clinical trial policy and separately targeted telemedicine policy to promote equity and greater patient access. For example, one initiative aims to ensure patients’ privacy and civil rights as telemedicine’s popularity grows after the COVID-19 pandemic. The NHC presented the initiative in a congressional briefing last year.
American Public Health Association
The American Public Health Association says it started focusing on racial disparities in health care in 2015, following a series of racially fueled violent acts. The APHA started with a four-part webinar series on racism in health (more than 10,000 live participants and 40,000 replays to date).
Shortly afterward, then-APHA President Camara Jones, MD, MPH, PhD, launched a national campaign encouraging APHA members, affiliates, and partners to name and address racism as a determinant of health.
More recently in 2021, the APHA adopted a “Truth, Racial Healing & Transformation” guiding framework and “Healing Through Policy” initiative that offer local leaders policy templates and best practices.
“We have identified a suite of policies that have actually been implemented successfully and are advancing racial equity,” said Regina Davis Moss, APHA’s associate executive director of health policy and practice. “You can’t advance health without having a policy that supports it.”
Montgomery County, Md., is one community that has used the framework (for racial equity training of county employees). Leaders in Evanston, Ill., also used it in crafting a resolution to end structural racism in the city.
A version of this article first appeared on Medscape.com.
– from health care outcomes, from the level and quality of patient treatment, from their own memberships. How have those pronouncements translated into programs that could have, or even have had, positive impacts?
For this article, this news organization asked several associations about tangible actions behind their vows to combat racism in health care. Meanwhile, a recent Medscape report focused on the degree to which physicians prioritize racial disparities as a leading social issue.
American Academy of Family Physicians
The American Academy of Family Physicians’ approach is to integrate diversity, equity, and inclusion (DEI) efforts into all existing and new projects rather than tackle racial disparities as a discrete problem.
“Our policies, our advocacy efforts, everything our commissions and staff do ... is through a lens of diversity, equity, and inclusiveness,” said AAFP Board Chair Ada D. Stewart, MD, FAAP.
That lens is ground by a DEI center the AAFP created in 2017. Run by AAFP staff, members, and chapters, the center focuses on five areas: policy, education and training, practice, diversifying the workplace, and strategic partnerships.
The center has established a special project called EveryONE to provide AAFP members with relevant research, policy templates, and other resources to address patient needs. One example is the Neighborhood Navigator, an online tool that shows food, housing, transportation, and other needs in a patient’s neighborhood.
Meanwhile, the DEI center has created training programs for AAFP members on topics like unconscious and implicit racial biases. And the AAFP has implemented several relevant governing policies regarding pushes to improve childbirth conditions and limit race-based treatment, among other areas.
In January, the AAFP established a new DEI commission for family medicine to set the academy’s agenda on racial issues moving forward. “We only had 10 physician positions available on the commission, and over 100 individuals applied, which gave us comfort that we were going in the right direction,” Dr. Stewart said.
Association of American Medical Colleges
The Association of American Medical Colleges, which represents nearly 600 U.S. and Canadian medical schools and teaching hospitals, has a “longstanding” focus on racial equity, said Philip Alberti, founder of the AAMC Center for Health Justice. However, in 2020 that focus became more detailed and layered.
Those layers include:
- Encouraging self-reflection by members on how personal racial biases and stereotypes can lead to systemic racism in health care.
- Working on the AAMC organizational structure. Priorities range from hiring a consultant to help guide antiracism efforts, to establishing a DEI council and advisors, to regularly seeking input from staff. In 2021, the AAMC launched a Center for Health Justice to work more closely with communities.
- Ramping up collaboration with national and local academic medicine organizations and partners. As one example, the AAMC and American Medical Association released a guide for physicians and health care professionals on language that could be interpreted as racist or disrespectful.
- Continuing to be outspoken about racial disparities in health care in society generally.
Meanwhile, the AAMC is supporting more specific, localized health equity efforts in cities such as Cincinnati and Boston.
Cincinnati Children’s Hospital research has found that children in poor neighborhoods are five times more likely to need hospital stays. AAMC members have helped identify “hot spots” for social needs among children and focused specifically on two neighborhoods in the city. The initiative has roped in partnerships with community and social service organizations as well as health care providers, and proponents say the number of child hospital stays in those neighborhoods has dropped by 20%.
Boston Medical Center researchers learned that Black and Latino patients experiencing problems with heart failure were less likely to be referred to a cardiologist. AAMC members assisted with a program to encourage physicians to make medically necessary referrals more often.
National Health Council
The National Health Council, an umbrella association of health organizations, similarly has made a “commitment, not just around policy work but anytime and anything the NHC is doing, to build around trying to identify and solve issues of health equity,” CEO Randall Rutta said.
The NHC has identified four strategic policy areas including race and in 2021 issued a statement signed by 45 other health care organizations vowing to take on systemic racism and advance equity, through public policy and law.
In relation to policy, Mr. Rutta said his organization is lobbying Congress and federal agencies to diversify clinical trials.
“We want to make sure that clinical trials are inclusive of people from different racial and ethnic groups, in order to understand how [they are] affected by a particular condition,” he said. “As you would imagine, some conditions hit certain groups harder than others for genetic or other reasons, or it may just be a reflection of other disparities that occur across health care.”
The organization has issued suggestions for policy change in the Food and Drug Administration’s clinical trial policy and separately targeted telemedicine policy to promote equity and greater patient access. For example, one initiative aims to ensure patients’ privacy and civil rights as telemedicine’s popularity grows after the COVID-19 pandemic. The NHC presented the initiative in a congressional briefing last year.
American Public Health Association
The American Public Health Association says it started focusing on racial disparities in health care in 2015, following a series of racially fueled violent acts. The APHA started with a four-part webinar series on racism in health (more than 10,000 live participants and 40,000 replays to date).
Shortly afterward, then-APHA President Camara Jones, MD, MPH, PhD, launched a national campaign encouraging APHA members, affiliates, and partners to name and address racism as a determinant of health.
More recently in 2021, the APHA adopted a “Truth, Racial Healing & Transformation” guiding framework and “Healing Through Policy” initiative that offer local leaders policy templates and best practices.
“We have identified a suite of policies that have actually been implemented successfully and are advancing racial equity,” said Regina Davis Moss, APHA’s associate executive director of health policy and practice. “You can’t advance health without having a policy that supports it.”
Montgomery County, Md., is one community that has used the framework (for racial equity training of county employees). Leaders in Evanston, Ill., also used it in crafting a resolution to end structural racism in the city.
A version of this article first appeared on Medscape.com.