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Background: Limited real-world data are available on upadacitinib drug survival in patients with atopic dermatitis (AD). Objectives: To investigate upadacitinib drug survival, and the reasons and predictors of drug discontinuation in AD patients. Methods: All consecutive patients aged 18–75 years, affected by moderate-to-severe AD, and treated with upadacitinib for more than 1 month at dermatological clinics were included during November 2020–August 2023. Upadacitinib survival was investigated through Kaplan–Meier survival analysis and the predictors through multivariable logistic regression analysis. Results: Overall, 325 adult AD patients (mean (SD) age, 38.6(15.6) years) had a 1-year and 1.5-year upadacitinib drug survival of 91.5% and 80.2%, respectively. The main reasons for drug discontinuation (25/325, 7.7%) were adverse events (4.9%), including cutaneous or infectious diseases (1.5%), such as acne and herpes zoster; blood test changes (1.2%), including hypercholesterolemia, creatine phosphokinase or liver enzyme elevation, and lymphopenia; urinary or respiratory infections (0.9%); deep venous thrombosis (0.3%); malignancies (0.3%); loss of consciousness (0.3%); and arthralgias (0.3%); followed by ineffectiveness (0.6%). No specific characteristic was significantly associated with an increased risk of upadacitinib discontinuation. Conclusions: Our findings show that upadacitinib was effective in moderate-to-severe AD after more than 1 year of continuous treatment but point to the need for clinical and laboratory monitoring of patients. [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]

Purpose: Dupilumab, a fully human monoclonal antibody that inhibits the signaling pathways of interleukin (IL)-4 and IL-13, has demonstrated remarkable efficacy in the treatment of atopic dermatitis (AD). Dupilumab has been reported to attenuate itch and reduce several serum markers, including blood lactate dehydrogenase (LDH), blood eosinophil count, and serum total immunoglobulin E (IgE).Patients and Methods: The present study investigated retrospectively changes in clinical scores and serum biomarker from 175 adults with moderate-to-severe AD treated with dupilumab. Clinical manifestations were assessed using eczema area and severity index (EASI) and visual analogue scale (VAS) for itch at baseline and subsequently at 16-week intervals up to a duration of 48 weeks. Total IgE, LDH and blood eosinophil count were also collected.Results: The dupilumab treatment significantly improved EASI and VAS scores and decreased serum levels of IgE, LDH, and total eosinophil count. The EASI scores were positively correlated with VAS for itch at all recorded time points, whereas serum biomarkers did not exhibit a strong correlation with EASI scores.Conclusion: These findings highlight the close relationship between the extent and severity of eczema and the intensity of itch experienced by patients and suggest that factors beyond the measured serum biomarkers play a significant role in the clinical manifestations of AD, emphasizing the complex nature of the disease. [ABSTRACT FROM AUTHOR]

This article reports on a study that investigated the long-term efficacy and safety of tralokinumab, a treatment for moderate-to-severe atopic dermatitis (AD), in adult patients. The study followed 171 AD patients for up to 52 weeks and found that 96.5% of patients were still using tralokinumab at the end of the study. There was a significant improvement in AD symptoms, including a decrease in Eczema Area and Severity Index (EASI) scores, itch, sleep loss, and improvement in quality of life. Adverse events were generally mild, with conjunctivitis being the most common. The study suggests that tralokinumab is a well-tolerated and effective long-term treatment option for AD. [Extracted from the article]

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]

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]

Narrow-band (NB) UVB and UVA1 have been successfully used for the treatment of atopic dermatitis (AD) since the 1980s, but the clinical indications for their use "at the age of biologics" remain to be assessed. From 2013 to 2017, 145 patients underwent a first treatment cycle with phototherapy. They achieved a median final EASI score of 9.90 with UVA1 and 13.70 with NB-UVB. The rates of patients achieving an IGA score of 0/1 persistent for at least 6 months were 33% with UVA1 and 28% with NB-UVB, and the rates with an EASI90 improvement were 10.9% with UVA1 and 11.0% with NB-UVB. The cut-off baseline EASI values for a good probability to achieve a 0/1 IGA were 24.4 with UVA1 and 24.7 with NB-UVB. A 0/1 IGA persistent for at least 6 months was more likely to be achieved by patients with a history of flares interspersed with periods of mild or no disease. From 2018, we only enrolled patients with the above-mentioned characteristics. The number of treated patients was lower, but the final EASI score, the rate of patients achieving IGA 0/1 persistent for at least 6 months, and EASI90 were significantly higher. Medium-dose UVA1 and NB-UVB phototherapies remain useful for the treatment of AD patients with a baseline EASI score lower than 24.4 and 24.7, respectively, and a medical history of flares followed by prolonged periods of complete or near-complete remission. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) represents the most common dermatosis in humans with a lifetime prevalence of up to 20% and a significant impact on health-related quality of life.[1] Several systemic treatments are available for moderate-to-severe AD, including cyclosporin, methotrexate, glucocorticoids, azathioprine, mycophenolate mofetil and dupilumab.[2] Dupilumab, a fully human monoclonal antibody that binds interleukin (IL)-4Ra, because of its very favourable efficacy and safety profile is rapidly replacing the traditional systemics.[[3]] Real-life data on dupilumab long-term survival and the associated predictors are scarce,[[5], [7]] and no studies have analysed dupilumab drug survival for longer than 3 years yet. By the data lock, 319 patients (87.9%) were still using dupilumab, 44 patients (12.1%) had discontinued dupilumab treatment, 11 of whom due to ineffectiveness, 20 due to adverse effects, 5 owing to pregnancy, 8 owing to AD remission and 5 patients (1.3%) were lost to follow up. [Extracted from the article]

Background: Since the best clinical response to dupilumab is achieved after 12–16 weeks, a combination therapy at the beginning of the treatment could be a helpful strategy to reach a faster response in patients with severe atopic dermatitis (AD). Objectives: To quantify the benefit of a combination of dupilumab treatment with a short course of narrow-band ultraviolet B (NB-UVB) phototherapy. Methods: In the present pilot study adult patients suffering from severe AD were enrolled with a 2:1 ratio to receive treatment with dupilumab alone or dupilumab plus NB-UVB phototherapy, for 12 weeks. After the twelfth week, all patients received dupilumab only. A follow-up visit took place after 16 weeks. Both clinician-oriented and patient-oriented scores were assessed at baseline (T0) and after 4 (T1), 12 (T2) and 16 (T3) weeks. Results: Forty-five adult patients were enrolled in the study. Both treatment regimens were well tolerated and very effective on all measured scores (EASI, SCORAD, BSA, NRS of itching, NRS of sleep loss, DLQI, POEM and HADS), but the combined regimen led to a more robust clinical improvement of lesions and relief of symptoms after 4 weeks. However, after 12 and 16 weeks, the additional therapeutic effect of phototherapy weakened. Conclusion: NB-UVB phototherapy can provide a faster remission of severe AD in the first few weeks of dupilumab therapy. [ABSTRACT FROM AUTHOR]

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 efficacy and safety of dupilumab have been reported previously based on data from controlled clinical trials. The GLOBOSTAD study extends the scope of these trials by providing real-world data. This analysis reports baseline demographics and family disease history in patients with atopic dermatitis (AD) who received treatment with dupilumab in a real-world setting. This 5-year, international, multicentre, non-interventional study (GLOBOSTAD; NCT03992417) included patients ≥12 years old with moderate-to-severe AD (Investigator’s Global Assessment score ≥3) who received dupilumab treatment based on country-specific prescribing criteria. Data reported are for the population at baseline (N=952; data cut-off: March 2022) in 22 countries. In the 952 patients included at baseline, mean (standard deviation) age at AD onset was 11.1 (16.0) years. Male patients represented 57.8% of patients and White patients 65.2%. The majority of patients were enrolled from Italy (17.2%), Japan (12.4%) and Spain (11.3%). Family history of type 2 inflammatory conditions (number of patients [%]) was prevalent, including AD (364 [38.2%]), asthma (238 [25%]), allergic rhinitis (219 [23%]), food allergies (74 [7.8%]), recurrent or chronic urticaria (31 [3.3%]), nasal polyposis (21 [2.2%]), eosinophilic esophagitis (11 [1.2%]) and other atopic/allergic conditions (39 [4.1%]). Most cases of type 2 inflammatory conditions were reported in first-degree relatives. Most patients enrolled in the GLOBOSTAD study developed AD during pre-adolescence. Family history of select type 2 inflammatory conditions, including AD, asthma and allergic rhinitis, was present in a moderate proportion of patients. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) therapeutic approach calls for a long‐term treatment. Treatment options for AD have recently undergone a revolutionary change by the introduction of the first biologic drug. Availability in daily practice of the last version of international AD guidelines, taking peculiarities of the country into account, can contribute to good clinical practice in Italy. To adapt European Dermatology Forum (EDF) guidelines for AD to the Italian medical–legal context, the EDF guidelines were assessed independently by two independent Italian renowned experts in the field and further integrated with articles published and systematically reviewed before May 2019. The first draft was collegially corrected and updated by the members of the SIDEMAST, ADOI, and SIDAPA. Recommendation levels (A; B; C; D) were graded based on the evidence levels (1–4). The adapted guidelines presented here focus on topical and systemic therapies in AD patients, both children and adults. As opposed to previous Italian guidelines, they include indications about biologics. New relevant evidence available from very recent literature and peculiarities of the Italian medical and legal context have been integrated in the revision process. If compared to general guidelines for AD not adapted to a specific national and cultural context, a revision for specific Italian needs is now available: It comprises the option of implementing the new biologic treatments and is likely to provide an important contribution to the improvement of clinical practice in Italy. Cooperation between patients, dermatologists, allergologists, and pediatricians remains mandatory in AD management. The authors of the present revision recommend an update of the Italian guidelines to be performed at least every second year. [ABSTRACT FROM AUTHOR]