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Aim: Abrocitinib is a JAK-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD). We conducted a 16-week multicenter retrospective study to assess the short-term effectiveness and safety of abrocitinib in patients with moderate-to-severe AD. Our retrospective study included 85 adult patients from 14 Italian Dermatology Units affected by moderate-to-severe AD treated with abrocitinib 100/200 mg. Methods: Effectiveness of abrocitinib at weeks 4 and 16 was assessed by using the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA), the peak pruritus and sleep- Numerical Rating Scale (PP-NRS and S-NRS, respectively). Results: At week 16, improvement of at least 90% in EASI (EASI90) and IGA 0/1 was observed in 49.4% and 61.2% of patients, respectively. A reduction of at least 4 points in PP-NRS and S-NRS compared with baseline was achieved by 70.6% of patients for both endpoints. No significant safety reports were observed during the study period. Naïve patients had better rates of EASI 90 compared to patients who previously failed dupilumab. Conclusion: Our data confirm the effectiveness of abrocitinib in a real-world setting with better clinical responses at weeks 4 and 16, compared with Phase-III clinical trials. Longer analyses are required to further establish the safety profile of abrocitinib. [ABSTRACT FROM AUTHOR]

Background and Objective: AtopyReg® is a multicenter, prospective, observational, non-profit cohort study on moderate-to-severe atopic dermatitis in adults promoted in 2018 by the Italian Society of Dermatology and Venereology (SIDeMaST). We aimed to describe baseline demographics, disease characteristics, comorbidities, and therapeutic data of adult patients affected by moderate-to-severe atopic dermatitis. Methods: Patients were selected based on the following inclusion criteria: age ≥ 18 years; Eczema Area and Severity Index score ≥ 16 or localization in visible or sensitive areas (face, neck, hands, or genitalia), or a Numeric Rating Scale itch score ≥ 7 or a Numeric Rating Scale sleep loss score ≥ 7, or a Dermatology Life Quality Index score ≥ 10. Demographic and clinical data at baseline were recorded and analyzed. Results: A total of 1170 patients (male 51.1%; mean age: 44.7 years; range 18–90 years) were enrolled by 12 Italian Dermatology Units between January 2019 and November 2022. Skin lesions were eczematous in 83.2% of patients, the most involved site were the flexures (53.9%), face (50.9%), and neck (48.0%). Mean Eczema Area and Severity Index score was 22.3, mean Dermatology Life Quality Index value was 17.6, mean Patient Oriented Eczema Measure score was 13.1, and mean Numeric Rating Scale itch and sleep loss scores were 7.6 and 5.9, respectively. Previous systemic therapies were corticosteroids in 77.7% of patients, antihistamines in 50.3% of patients, and cyclosporine A in 42.6% of patients. Conclusions: This baseline data analysis deriving from AtopyReg® provides real-life evidence on patients with moderate-to-severe atopic dermatitis in Italy confirming the high burden of atopic dermatitis with a significant impact on patients' quality of life. [ABSTRACT FROM AUTHOR]

This article explores the use of Dupilumab as a treatment for chronic urticaria (CU), a condition characterized by recurrent, itchy wheals and/or angioedema lasting more than 6 weeks. The study focuses on seven patients with severe atopic dermatitis and CU who were treated with Dupilumab, a monoclonal antibody inhibiting interleukin (IL)-4 and IL-13 signaling. The results showed positive outcomes, including improvements in urticarial control, eczema severity, quality of life, and sleep scores. However, larger controlled studies are needed to fully understand the effectiveness of Dupilumab and determine the best treatment approach for different types of CU. [Extracted from the article]

Introduction The GLOBOSTAD study aims to capture long-term dupilumab effectiveness in real-world atopic dermatitis (AD) treatment. Objective To present patient-reported outcomes, that complement clinical AD assessments and guide healthcare decision-making, and a summary of adverse events one year after dupilumab initiation. Methods The GLOBOSTAD five-year, multinational, prospective, observational study (NCT03992417) enrolled patients aged ≥12 years with moderate-to-severe AD. Patients received dupilumab based on country-specific prescribing information. Assessments were performed at baseline, 3 months (M; ±1M), 6M (±2M), and 12M (±2M). Data are reported as observed for enrollment/safety (N = 955; data cutoff: March 2023) and follow-up (N = 903) populations. Results 758/863/705 patients completed ≥1 follow-up assessment at 3M/6M/12M, respectively. During the study, patients reported rapid improvements in mean (SD) patient-oriented eczema measure from 19.7 (6.4) at baseline to 8.7 (6.6) at 3M to 7.1 (5.8) at end of observation period (12M); pruritus numerical rating scale from 6.3 (2.2) to 2.5 (2.4) to 1.7 (2.0); scoring of atopic dermatitis sleep loss score from 5.6 (3.0) to 1.7 (2.3) to 1.0 (1.8); dermatology life quality index (DLQI) from 13.7 (7.1) to 5.3 (5.1) to 3.9 (4.2); and children's DLQI from 12.2 (6.2) to 2.7 (2.9) to 4.8 (4.8). Adverse events considered related to dupilumab by the investigator were reported in 187 (19.6%) patients. Adverse events leading to permanent dupilumab discontinuation were reported in 23 (2.4%) patients. Conclusion On initiating dupilumab treatment, patients reported rapid improvements in skin lesions, itch, sleep, and overall quality of life, from severe/very large effect scores to mild/small effect scores, which were sustained for up to one year. Safety data were consistent with previous studies. [ABSTRACT FROM AUTHOR]

Introduction Dupilumab demonstrated robust efficacy in patients with moderate-to-severe atopic dermatitis (AD) in randomized controlled trials. Long-term effectiveness of dupilumab in real-world AD treatment is one of the main objectives of the ongoing GLOBOSTAD study. Objective To report dupilumab effectiveness, through physician-assessed AD clinical tools that measure disease severity over time, and a summary of adverse events in patients one year after initiating treatment. Methods The GLOBOSTAD five-year, multinational, prospective, observational study (NCT03992417) enrolled patients aged ≥12 years with moderate-to-severe AD. Patients received dupilumab based on country-specific prescribing information. Assessments were performed at baseline, 3 months (M; ±1M), 6M (±2M), and 12M (±2M). Data are reported as observed for enrollment/safety (N = 955; data cutoff: March 2023) and follow-up (N = 903) populations. Results 758/863/705 patients completed ≥1 follow-up assessment at 3M/6M/12M, respectively. During the study, mean (SD) eczema area and severity index (EASI; >21 = severe; ≤7 = mild/no disease) score rapidly improved from 25.1 (12.8) at baseline to 6.1 (8.0) at 3M, and was sustained until the end of observation period [12M; 4.2 (8.4)]. Similarly, scoring of atopic dermatitis (SCORAD; >50 = severe; <25 = mild/no disease) score improved from 59.3 (16.6) at baseline to 25.3 (16.4) at 3M, further improving to [17.6 (13.0)] at 12M. Adverse events considered related to dupilumab by the investigator were reported in 187 (19.6%) patients. Adverse events leading to permanent dupilumab discontinuation were reported in 23 (2.4%) patients. Conclusion In a real-world scenario, clinical AD assessments rapidly improved upon initiating dupilumab treatment, and were sustained through the end of the one-year observation period. Safety data were consistent with previous studies. [ABSTRACT FROM AUTHOR]

Patch testing with textile dye mix in Italy: A 2-year multicenter SIDAPA study Azo-dyes, patch test, SIDAPA baseline series, skin tests, textile dye mix Keywords: azo-dyes; patch test; SIDAPA baseline series; skin tests; textile dye mix EN azo-dyes patch test SIDAPA baseline series skin tests textile dye mix 265 268 4 03/22/21 20210401 NES 210401 Disperse dyes (DDs), mostly represented by azo dyes, are small and lipophilic molecules characterized by low cost and simple application on clothing. [Extracted from the article]

Introduction The GLOBOSTAD study aims to assess the extended realworld effectiveness of dupilumab in patients with atopic dermatitis (AD) receiving dupilumab as part of their normal care. Objectives: To report patient-reported outcomes and physician-assessed AD clinical measures for evaluating disease characteristics, severity, and treatment effectiveness 1 year after initiating dupilumab treatment. Methods: This 5-year, multinational, prospective, observational study (NCT03992417) enrolled patients aged =12 years with moderate-to-severe AD. Patients received dupilumab based on country-specific prescribing information. Assessments were performed at baseline, 3 months (± 1 month), 6 months (± 2 months), and 12 months (± 2 months). Data are reported as observed for enrollment/safety (N = 955; data cutoff: March 2023) and follow-up (N = 903) populations including 13 adolescent patients with AD (=12 and <18 years old). Results: In this study, 758/863/705 patients completed =1 follow-up assessment at 3 months/6 months/12 months, respectively. During the study the mean (standard deviation [SD]) Eczema Area and Severity Index (EASI; >21 = severe; =7 = mild/no disease) scores decreased from 25.1 (12.8) at baseline to 6.1 (8.0) at 3 months, 4.6 (6.4) at 6 months and sustaining throughout the observation period [12 months; 4.2 (8.4)]. Mean Patient-Oriented Eczema Measure (SD) improved from 19.7 (6.4) at baseline descending to 8.7 (6.6) at 3 months, 7.7 (6.0) at 6 months and 7.1 (5.8) at 12 months. A significant improvement was also observed in Dermatology Life Quality Index (DLQI) from 13.7 (7.1) to 5.3 (5.1) to 4.4 (4.4) to 3.9 (4.2); and children's DLQI from 12.2 (6.2) to 2.7 (2.9) to 2.9 (3.0) to 4.8 (4.8) by the end of the 3, 6 and 12-months observational period respectively. Dupilumab-related adverse events were reported in 187 (20.8%) patients. Conclusions: In a real-world scenario, the initiation of dupilumab treatment led to early and sustained improvements in AD outcome measures throughout the 1-year observational period. Safety data remained consistent with findings from previous studies. [ABSTRACT FROM AUTHOR]

The article discusses a case study of a 46-year-old Caucasian man with atopic dermatitis and psoriasis who was treated with a combination of dupilumab and risankizumab. Despite initial challenges with individual treatments exacerbating the conditions, the combination therapy led to complete resolution of both atopic dermatitis and psoriasis. The study highlights the potential effectiveness of using both biologic agents concurrently to manage concomitant atopic dermatitis and psoriasis, although further research is needed to confirm long-term safety and efficacy. [Extracted from the article]

This document presents a study on the effectiveness and safety of dupilumab, a systemic treatment for atopic dermatitis, in adolescents. The study followed 94 adolescents over a period of up to 3 years and found that dupilumab consistently improved clinical scores and maintained minimal disease activity in the majority of patients. Adverse events were rare, with only a small percentage of patients experiencing temporary eosinophilia or mild conjunctivitis. The study concludes that dupilumab is a safe and effective long-term option for adolescents with severe atopic dermatitis. [Extracted from the article]

This article discusses the effectiveness of dupilumab, a dual inhibitor of interleukin (IL)-4 and IL-13, in patients with atopic dermatitis (AD) who have not responded to tralokinumab, a selective IL-13 inhibitor. The study included seven patients with moderate-to-severe AD who showed limited response to tralokinumab before switching to dupilumab. After starting dupilumab, all patients demonstrated significant improvement, with a 50% reduction in Eczema Area and Severity Index (EASI) within an average of 1.7 months. The study suggests that dupilumab may be a promising therapeutic option for tralokinumab-resistant patients with AD. [Extracted from the article]

This article discusses a case study of a patient with atopic dermatitis who experienced a relapse of psoriasis after being treated with tralokinumab, a monoclonal antibody targeting interleukin-13. The patient initially had a history of childhood psoriasis and was diagnosed with late-onset atopic dermatitis. Tralokinumab significantly improved the patient's atopic dermatitis symptoms but led to a severe exacerbation of psoriasis. The article highlights the complex interactions within the cytokine network and the need for further research to understand and manage these paradoxical reactions to biological therapies. [Extracted from the article]

Competing Interests: Conflicts of interest: S.M.F. is principal investigator in clinical trial to Amgen, Sanofi, Novartis, Lilly, Leo Pharma and AbbVie, and she is advisory board or speaker to Novartis, Menarini, Sanofi, AbbVie and Leo Pharma. F.B. has a conflict of interest with Leo Pharma and Almirall. The other authors declare no conflicts of interest.

Background: There is limited epidemiological evidence on outcomes associated with dupilumab exposure during pregnancy; monitoring pregnancy outcomes in large populations is required., Objective: To investigate the potential association between exposure to dupilumab in pregnant women with atopic dermatitis and any adverse pregnancy, neonatal, congenital and post-partum outcomes., Methods: We performed a multicentre retrospective cohort study across 19 Italian tertiary referral hospital. Childbearing women were eligible if aged 18-49 years and carried out the pregnancy between 1 October 2018 and 1 September 2022., Results: We retrospectively screened records of 5062 patients receiving dupilumab regardless of age and gender, identifying 951 female atopic dermatitis patients of childbearing age, 29 of whom had been exposed to the drug during pregnancy (3%). The median duration of dupilumab treatment prior to conception was 22.5 weeks (range: 3-118). The median time of exposure to the drug during pregnancy was 6 weeks (range: 2-24). All the documented pregnancies were unplanned, and the drug was discontinued in all cases once pregnancy status was reported. The comparison of the study cohort and the control group found no significant drug-associated risk for adverse pregnancy, congenital, neonatal or post-partum outcomes. The absence of a statistically significant effect of exposure on the event was confirmed by bivariate analysis and multivariate analysis adjusted for other confounding factors., Conclusions: This cohort of pregnant patients exposed to dupilumab adds to the existing evidence concerning the safety of biologic agents in pregnancy. No safety issues were identified regarding the primary outcome assessed. In clinical practice, these data provide reassurance in case of dupilumab exposure during the first trimester. However, the continuous use of dupilumab throughout pregnancy warrants further research., (© 2024 European Academy of Dermatology and Venereology.)