Moderate-severe Atopic Dermatitis Research Articles

Hematological Markers in Children and Adults with Atopic Dermatitis: A Retrospective Cohort Study.

Atopic dermatitis (AD) is a common chronic skin disease with an inflammatory pathophysiology that includes the activation of the innate and adaptive immune systems. We aimed to investigate the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), eosinophil-to-lymphocyte ratio (ELR), and eosinophil-to-neutrophil ratio (ENR) in AD patients, according to age and disease severity. This is a retrospective, population-based cohort study conducted between the years 2005 and 2020, comparing hematological markers of AD patients and sex-age-ethnicity-matched controls. AD patients were further divided by age and disease severity (mild, moderate-to-severe AD). We created a decision tree to predict moderate-severe AD. A total of 13,928 patients with AD were included in this study: 6,828 adults and 7,100 children, with 13,548 controls. NLR, PLR, and ELR were lower in children compared to adults (p values <0.001). NLR, PLR, ELR, and ENR were increased in moderate-severe AD patients compared to mild AD patients (p values <0.001). PLR, ELR, and ENR were increased in AD patients versus controls (p values <0.001), with an additional increase in the NLR of moderate-to-severe AD patients. Patients with an ELR <0.21, a PLR >161, and ENR ≤0.016 should be considered high risk for developing severe AD, as well as patients with an ELR >0.21 and age at diagnosis <30 or age >30 years and mean platelet volume ≤9. Hematological ratios were significantly higher in moderate-to-severe AD patients, compared to mild AD patients. Hematological markers were lower in children with AD compared to adults, except for ENR, likely reflecting age-related changes in blood count parameters. These markers can assist in the management and follow-up of AD patients.

Association Between Increased Body Mass Index (BMI) and Atopic Dermatitis in Children Attending a Tertiary Referral Center: A Case-Control Study.

Background Atopic dermatitis (AD) and obesity represent chronic diseases, with growing worldwideprevalence, that rely on a common pathophysiological background: perpetual inflammation. Moreover, AD is considered more and more to be a beyond-the-skin disease with various associated comorbidities. This study aimed to investigate a potential link between overweight/obese status and AD in children. Methods A case-control study was performed on 130 AD patients and 130 exact age and sex match controls that attended the Pediatric Dermatology Department of Colentina Clinical Hospital. Based on the weight (in kilograms) and height (in centimeters), the body mass index (BMI), and the corresponding age and gender percentiles were assessed in both groups; study participants were divided as normal-weight, underweight, overweight, or obese. AD severity was evaluated using the Scoring Atopic Dermatitis Index (SCORAD), and quality of life impairment was assessed with the Dermatology Life Quality Index (DLQI).Descriptive statistics, t-tests, and logistic regression with odds ratios (OR) and associated 95% confidence intervals (CI) were used for data analysis. Results A statistically significantly higher BMI was identified in the AD group compared to controls (p=0.027). The relative risk for overweight/obese status in the AD group compared to controls was three times more frequent (OR 3.61, 95% CI 1.45-10.3, p<0.01). Additionally, the increased BMI in the AD group correlated significantly with disease severity as determined by SCORAD (p<0.05), with a relative risk for overweight/obese status in the moderate-severe AD subgroup being 20 times more frequent as compared to mild AD (OR 20.4, 95% CI 6.53-90.7, p<0.001). Conclusions To our knowledge, this is the first study to evaluate the correlation between AD and BMI in Romanian children. Statistically significant correlations between increased BMI, AD development, and AD severity in children were identified in our study population. This study's small sample size and single-center study design represent possible limitations. Additional, larger, multicentric studies are required to establish a more precise correlation between AD and obesity. Physicians should be aware of this potential association in order to perform obesity screening in AD children for more appropriate multidisciplinary management of such patients.

Efficacy of JAK inhibitors in the treatment of psoriasiform atopic dermatitis.

Atopic dermatitis (AD) is a common inflammatory skin disease with multiple clinical manifestations. Among AD phenotypes, psoriasiform AD shows the coexisting of eczematous itching lesions in flexural areas with psoriasiform plaques. The use of anti-IL-4 and anti-IL-13 in psoriasiform AD may lead to therapeutic failure or worsening of manifestations. A recent Delphi consensus proposed JAK inhibitors (JAKi) as a viable alternative, even in the first line, in patients with different clinical phenotypes of AD, including psoriasiform AD. A retrospective analysis of patients in our dermatology clinic with moderate-severe AD and treated with JAKi was performed. Among the 192 overall patients, 21 had psoriasiform AD. EASI, p-NRS and DLQI were the severity scores considered and their reduction was observed in all 21 patients at weeks 4, 16 and 24 of treatment. At week 16 the percentage of patients achieving EASI-75 and EASI-90 was 80.95% and 66.67%, respectively. While at week 24 95.23% of patients achieved EASI-75 and 85.71% obtained EASI-90. No adverse event lead to treatment interruption. This study confirmed the clinical effectiveness of JAKi treatment in adult patients with moderate-to-severe psoriasiform AD, with a good safety profile. These drugs are proposed as the first choice for the treatment of this form of AD, although further studies with larger cohorts are required.

Efficacy and safety of tralokinumab in the treatment of head and neck pattern atopic dermatitis: A multicentre study of 12 patients.

The evaluation of the efficacy and safety of new molecules for atopic dermatitis (AD) in real clinical practice is very important to obtain information that clinical trials (EECC) lack. The pattern of AD in the head and neck (H&N) continues to be a challenge in treatment today, despite the new molecules, and real-life data on the use of tralokinumab is still missing. This is the first daily practice study of tralokinumab treatment in patients with H&N AD pattern. The objective is to evaluate the efficacy and safety of tralokinumab in the short term (16 weeks) in patients with AD with H&N pattern, for the first time. A multicentre prospective observational study was conducted, including patients with moderate-severe AD and H&N pattern who started tralokinumab treatment in four hospitals in Andalusia. Values of severity and quality of life scales, as well as patient-reported outcomes (PROs), were collected at baseline and at Weeks 4 and 16. Safety events were also recorded. Twelve patients were included. An improvement was observed in all efficacy and quality of life parameters evaluated at 16 weeks with respect to the baseline. No serious adverse events were recorded. In real clinical practice, tralokinumab is demonstrated to be an effective and safe treatment for patients with AD and H&N pattern at short term.

Loading-Dose Dupilumab May Function as a Prophylactic Agent for Food-Induced Anaphylaxis: A Case and Review of the Literature

Recent advances in targeted therapy using monoclonal antibodies have revolutionized care in many fields, and dupilumab for the treatment of moderate-severe atopic dermatitis is no exception. While on a trial of loading dose dupilumab, a 25-year-old white male with a past medical history significant for anaphylaxis after ingesting peanuts and tree nuts did not experience anaphylaxis after accidentally consuming almonds. Similarly to anti-IgE, the large-scale inhibition of IL-4 and IL-13 signaling to various immune cells involved with type II hypersensitivity reactions using loading dose dupilumab may have played a role in preventing anaphylaxis in this patient. The role of loading dose dupilumab as a potential prophylactic agent against food-induced anaphylaxis could be explored cautiously as a novel way to reduce both morbidity and mortality in patients with these allergies.

Cost per NNT for upadacitinib in the treatment of patients with moderate-severe atopic dermatitis in Italy

Background: Targeted systemic therapies, including abrocitinib, baricitinib, dupilumab, tralokinumab and upadacitinib, are new treatments for moderate to severe atopic dermatitis (AD). We evaluated the efficacy and the costs of these targeted systemic therapies in the treatment of adult patients with moderate to severe AD. Methods: The clinical efficacy was assessed considering the results of a previous network meta-analysis (NMA). The analysis involved five therapies approved in Italy for the treatment of moderate to severe AD: abrocitinib (ABR), baricitinib (BAR), dupilumab (DUP), tralokinumab (TRA) and upadacitinib (UPA). According to the NMA, the cost of the treatment was based on the number of administrations dispensed at 16 weeks and the clinical efficacy was measured by the number needed to treat (NNT) compared to placebo using the improvement ≥ 75% (EASI-75) or ≥ 90 (EASI-90) from baseline of the eczema area and severity index (EASI). Only the ex-factory price of the targeted systemic therapies was considered. The cost per NNT was adopted as a cost-effectiveness indicator. Results: At 16 weeks, the cost per NNT based on EASI-75 was lower for UPA 15 mg (€ 6,384.00) compared to BAR 4 mg (€ 11,619.73) and 2 mg (€ 14,524.66), ABR 100 mg (€ 16,265.22), DUP 300 mg (€ 16,115.04) and TRA 300 mg (€ 31,710.24). UPA 15 (€ 8,512.00) also showed the lower cost per NNT based on EASI-90 at 16 weeks compared to BAR 4 mg (€ 14,788.75) and 2 mg (€ 20,862.70), ABR 100 mg (€ 25,922.69), DUP 300 mg (€ 25,992.00) and TRA 300 mg (€ 41,067.36). Conclusions: The findings show that upadacitinib is the most cost-effective option (cost per NNT) for the treatment of moderate to severe atopic dermatitis.

509 - Dupilumab improves disease severity in children less than 12 years of age with moderate-severe AD: interim results from PEDISTAD real-world registry

Abstract Introduction In phase 3 studies, dupilumab significantly improved disease severity in children with moderate-to-severe atopic dermatitis (AD). However, the impact of this systemic treatment on children in real-world treatment settings is yet to be investigated. Objectives To report the real-world effectiveness and safety of dupilumab in children the PEDISTAD registry. Methods PEDISTAD (NCT03687359) is an ongoing, international, longitudinal, observational 10-year registry study in patients aged from 6 months to 11 years at enrollment with moderate-to-severe AD, whose disease is not adequately controlled by topical prescription therapies or for whom those therapies are medically inadvisable. This interim analysis measures the effect of dupilumab on Eczema Area and Severity Index (EASI) total score and %-affected body surface area (BSA) from therapy start to up to 3 years’ follow up. Safety was also evaluated. Results A total of 214 patients received dupilumab (median treatment observation period: 16.1 months; accumulated 3-year discontinuation rate: 13.3%). The proportion of patients with clear/mild AD (EASI score &amp;lt;7 [range 0–28]) increased from 20.8% at therapy start to 76.7% at last observation. The mean (±SE) EASI score decreased with dupilumab use, from 19.7±1.0 at therapy start to 6.1±0.8 at last observation. The proportion of patients with &amp;lt;10% BSA affected by AD increased from 12.6% at therapy start to 46.5% at last observation. The mean (± SE) BSA affected decreased from 38.3%±1.7 at therapy start to 17.1%±2.0 at last observation. 24.2% of patients had adverse events, including 2.4% serious adverse events. Conclusions Dupilumab treatment significantly improved disease severity in patients aged from 6 months to 11 years in real-world practice.

Burden of Disease in the Real-Life Setting of Patients with Atopic Dermatitis: Italian Data From the MEASURE-AD Study.

Atopic dermatitis (AD) is a chronic inflammatory skin disease that negatively impacts the quality of life and work productivity of patients. We sought to evaluate the real-world burden of AD patients in Italy. This sub-analysis of the MEASURE-AD multicountry study conducted between December 2019-2020 included patients diagnosed with moderate-to-severe AD eligible for or receiving systemic therapy in the previous 6 months. During a single visit, physician and patient-reported questionnaires were used. A total of 118 adult patients were enrolled and 57.6% (N = 68) of patients had moderate-to-severe AD at the time of enrolment according to the Eczema Area and Severity Index. Sleep disorders interfered with daily function in the previous week in 58.5% (N = 69) of patients, pruritus was severe in 50% (N = 59) and 42.4% (N = 50) reported a flare lasting >7 days in the previous 6 months. According to the Dermatology Quality of Life Index, 37.3% (N = 44) of patients reported a severe impact of AD and approximately 10% had clinical depression/anxiety. Current drug therapy was considered inadequate in controlling AD in 26.3% (N=31) of patients. Work activity impairment was 38.6±31.7% and monthly AD-related expenses were 148.6±134.6 Euros per patient. This real-life study documents a high burden of disease in patients with moderate-severe AD in Italy.

Incremental Risk of Adverse Events with Oral Janus Kinase Inhibitor Use in Atopic Dermatitis and Other Indications: A Systematic Review and Meta-Analysis

Introduction: The number of treatment opportunities for patients with moderate-severe atopic dermatitis (AD) is increasing, however with varying treatment safety profiles. The safety profile of oral JAKis remains a concern because of their ubiquitous mechanism of action inhibiting many cytokines. Safety warnings for these products have combined data across indications, making it difficult to assess risk for specific populations.&#x0D; Objective: We aimed to estimate the incremental risk of pre-specified adverse events (AEs) per patient-year (PY) of oral JAKi compared with standard of care (SoC), incl. topical corticosteroids, biologic agents, and other treatments, among those with AD or with other diagnoses.&#x0D; Methods: A systematic literature review was conducted on 17 preselected AEs based on randomized controlled trials of oral JAKis.&#x0D; Meta-analyses (MA) estimated the incidence rate difference (IRD) for each AE between oral JAKis and SoC, both in AD and non-AD populations. Number needed to harm (NNH) was calculated as the inverse of the IRD for each AE. &#x0D; Results: We identified 82 studies, including 19 in AD population, for use in the MA.&#x0D; In the AD population, the estimated NNH in PY for acne was 5, indicating 1 additional acne event for every 5 patients treated with oral JAKis vs SoC per year. Moreover, the NNH was 33 for herpes zoster, 62 for anemia, 94 for serious adverse events (SAEs), and 452 for malignancies. In the non-AD population, the NNH was 52 for HZ, 56 for hyperlipidemia, 58 for SAEs, 113 for anemia, 153 for acne, and 254 for malignancies.&#x0D; Conclusions: The MA identified an increased risk with oral JAKis compared with SoC for multiple AEs, spanning from less to more severe AE, including malignancies in both AD and non-AD populations. As safety risks are observed in both the AD and non-AD populations, the use of oral JAKis should be carefully considered.

O02 Assessing SleeP in INfants with moderate-severe atopic Dermatitis by Longitudinal Evaluation (The SPINDLE study)

Abstract Introduction Atopic dermatitis (AD) is associated with sleep disruption due to pruritus, inflammation, increased transepidermal water loss (TEWL) and circadian alterations. Little is known about the impact of AD on sleep in early infancy, a critical time for neurodevelopment. The aim of this study was to deeply characterise the sleep architecture of 6-month-old infants with moderate-severe AD, compared to controls. Methods Overnight movements (defined as 10-15 seconds of movement) were measured for five consecutive nights using a novel wearable movement sensor. Infantile and parental sleep measures were reported by parents. Daytime sleep quality and quantity was measured by electroencephalogram (EEG) polysomnography. AD was assessed using clinical severity scoring, skin barrier assessment (TEWL, natural moisturising factor levels, and filaggrin mutational analysis) and inflammatory cytokine analysis by tape stripping. Results 57 controls and 33 cases were recruited. Average EASI at time of 6-month assessment was 7.2 (range 0.8-34.8). Infants with AD recorded almost twice as many overnight movements as controls (19.2 versus 11.2, p&amp;lt;0.05). Infants with AD slept for 13.1 hours versus 13.8 (p&amp;lt;0.05), and woke 3.5 times versus 1.9 (p&amp;lt;0.05). Infants with AD had differences in EEG sleep measures, including sleep spindle power and frequency. Mothers of cases had worse total sleep time (6.3 versus 7.1 hours, p&amp;lt;0.05), sleep-­onset latency (27.1 versus 12.8 minutes, p&amp;lt;0.05), and sleep ­efficiency. Conclusion This is the most detailed study ever performed on sleep in infants with AD using objective sleep measures, and has revealed significant effects on sleep architecture, sleep duration, and overnight movement.

Current treatment goals are achieved by the majority of patients with atopic dermatitis treated with tralokinumab: results from a multicentric, multinational, retrospective, cohort study

ABSTRACT Background Tralokinumab is a human monoclonal antibody targeting interleukin-13 that is approved for the treatment of moderate-severe atopic dermatitis. Studies analyzing the efficacy and safety of tralokinumab in a real-world setting are scarce. Research design and methods A European, multicentric, real-world, retrospective cohort study was defined to assess the effectiveness and safeness profile of tralokinumab, investigating the achievement of pre-specified treatment goals; and to detect potential differences in terms of effectiveness and safeness across some selected patient subcohorts. Results A total of 194 adult patients were included in this study. A significant improvement in physician-assessed disease severity was detected at each follow-up visit as compared with baseline and similar trend was observed for patient-reported outcomes and quality of life. No meaningful difference in effectiveness was found when considering patient age (<65 versus ≥65 years), neither dissecting patient cohort in dupilumab-naive vs dupilumab-treated subjects. Among tralokinumab-treated patients, 88% achieved at least one currently identified real-world therapeutic goal at week 16. Conclusions This retrospective multicenter study confirmed the effectiveness and safeness of tralokinumab throughout 32 weeks of observation, showing the achievement of therapeutic goals identified in both trial and real-world settings in a large proportion of tralokinumab-treated patients.

Dupilumab therapy reduces urinary biopyrrin levels in atopic patients: a new possible biomarker of oxidative status in atopic dermatitis.

Accumulating evidence suggests that oxidative stress is involved in the inflammatory process of atopic dermatitis (AD). Biopyrrins are the end products of the oxidative reaction of bilirubin with reactive oxygen species. The aim of our study was to explore the correlation between urinary biopyrrin levels and AD severity as well as to assess the possible modification of them in AD patients during biologic therapy with human monoclonal antibody dupilumab. For this purpose, 25 adult patients with moderate-severe AD who were candidates for dupilumab therapy independently from the study, and 15 healthy control subjects, matched by sex and age, were enrolled. Morning urine samples were collected from all study participants. For AD patients, a collection was planned before starting therapy with dupilumab (WO), after 8, 16, 52 weeks (W8, W16, W52, respectively), and two years (Y2) of treatment. The analysis of urinary levels of biopyrrins was performed by ELISA assay. Our results demonstrated that urinary biopyrrin levels were significantly augmented in AD patients, and interestingly they correlated with disease severity. Furthermore, dupilumab therapy decreased levels of urinary biopyrrins in AD patients after eight and 16 weeks, maintaining the result after 52 weeks as well as after two years of treatment. The correlation analysis showed a statistically significant positive correlation between the urinary concentration of biopyrrins and EASI Index, circulating total IgE as well as plasma C reactive protein levels. Dupilumab therapy was able to ameliorate oxidative state in AD patients.

Prediction of Food Sensitization in Children with Atopic Dermatitis Based on Disease Severity and Epidermal Layer Impairment

Plain Language SummaryThe study has revealed notable associations between food sensitizations (FSs) and the disease severity as well as epidermal barrier impairment in children with atopic dermatitis (AD). Specifically, the findings indicate that children with AD who were sensitized to higher numbers of food allergens (FAs) had higher SCORAD scores and greater epidermal barrier impairment. In addition, SCORAD score and stratum corneum hydration (SCH) levels at lesional skin could be predictive factors for FS in children with AD. The findings of this study suggest that clinicians should consider screening for food sensitization in children with moderate-severe AD and/or low SCH levels at lesional skins.

Real-World Clinical Experience of Dupilumab in the Treatment of Chronic Palmo-Plantar Eczema in Patients with Moderate-Severe Atopic Dermatitis: 52-Week Follow-Up.

Background: Hand-foot eczema (HFE) are special locations of dermatitis, which are often associated with atopic dermatitis (AD) and have a significant negative impact on the quality of life, demanding a clinically relevant improvement. Objectives: To evaluate the effectiveness and safety of dupilumab in the treatment of eczema localized in hands and/or feet in patients with moderate-to-severe AD. Methods: Retrospective multicenter study of adult patients with HFE treated with dupilumab for their AD. Patients with other concomitantly systemic immunosuppressive treatments did not undergo a washout period. The severity of palmar and/or plantar involvement was assessed using the Physician Global Assessment (PGA) scale on a scale of 0 ( = clear) to 5 ( = very severe). Eczema Area and Severity Index (EASI) and NRS-pruritus scales were also evaluated. One hundred percent of patients reached week 16, while 67/84 reached week 52 of follow-up. Results: A total of 84 patients were included 86.69% of patients showed a reduction in PGA-Hand, and 80.34% in PGA-Foot at week 52, EASI improvement was reached by 83.55% of patients at week 16 and 87.35% at week 52. Reduction of pruritus (≥4 points in NRS-pruritus scale) was 73.01% at week 16 and 80.67% at week 52. No differences in response to dupilumab were observed in the different subtypes of palmo-plantar dermatitis. Conclusions: The results obtained in our study suggest that dupilumab may be an effective and safe therapeutic option for the treatment of dermatitis localized in hands and/or feet.

Dupilumab in Children and Adolescents with Severe Atopic Dermatitis and Severe Asthma: A Case Series

The increasing incidence and common specific inflammatory type 2 intracellular pathways have recently allowed for the rise of new biologic therapies in two inflammatory chronic diseases in children: atopic dermatitis (AD) and severe asthma. Such therapies aim at relieving symptoms and reducing inflammation by treating the underlying molecular causes. Dupilumab is a monoclonal antibody indicated in children with moderate–severe AD and severe asthma ineffectively responsive to standard treatments. Here, we report a case series of seven consecutive children with moderate–severe AD, with three of them also affected by asthma and treated with dupilumab. The children experienced a reduction in the extent and severity of lesions and decreased intensity of symptoms, leading to better asthma control, a general improvement in sleep and quality of life (QoL), with a good safety profile. Notwithstanding the observed clinical improvement, further larger prospective studies are needed to better tailor the treatment duration and the potential preventive and long-lasting effects.

42999 Rocatinlimab demonstrates a significant reduction in IgE concentrations in addition to clinical efficacy measures in patients with moderate–severe atopic dermatitis (msAD) in a randomised, double-blind, placebo-controlled Phase 2 trial

42999 Rocatinlimab demonstrates a significant reduction in IgE concentrations in addition to clinical efficacy measures in patients with moderate–severe atopic dermatitis (msAD) in a randomised, double-blind, placebo-controlled Phase 2 trial

42942 Rocatinlimab demonstrates improvements in patient-reported outcomes in adult patients with moderate–severe atopic dermatitis in a Phase 2 trial

42942 Rocatinlimab demonstrates improvements in patient-reported outcomes in adult patients with moderate–severe atopic dermatitis in a Phase 2 trial

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study

BackgroundDupilumab is a monoclonal antibody against the IL-4/IL-13 receptor-subunit approved for the treatment of moderate-severe atopic dermatitis (AD). Some attempts to increase dose interval have been described in both trial and real-world settings.ObjectiveThis study aimed to identify predictive clinical and demographic factors affecting patient selection for dose spacing or treatment withdrawal due to satisfactory response.Materials and methodsThis retrospective study included adult patients with moderate-to-severe AD treated with dupilumab for at least 16 weeks. Descriptive statistics were performed to analyze demographic and clinical variables. Logistic regression models were used to identify predictor variables.ResultsA total of 818 adult patients with moderate-to-severe AD was included in the study and 12% (97/818) of them performed dose spacing to 3–4 weeks or treatment withdrawal (8%, 67/818). The presence of non-cutaneous atopic manifestations (OR = 1.59, 95%CI = 1.06–2.38, p = 0.024), prurigo nodularis phenotype (OR = 4.5, 95%CI = 1.87–10.9, p = 0.001) and the age at treatment initiation (OR = 1.82, 95%CI = 1.12–2.94, p = 0.015) were confirmed as the strongest predictors of dose spacing or treatment withdrawal while maintaining dupilumab effectiveness.ConclusionOur findings contribute to define the patient profile that could maintain the therapeutic response after dose spacing or treatment withdrawal.

Association between yearlong air pollution and moderate-severe atopic dermatitis: A United States cross-sectional claims analysis

Association between yearlong air pollution and moderate-severe atopic dermatitis: A United States cross-sectional claims analysis

Long-term Effectiveness and Safety of Upadacitinib for Atopic Dermatitisin a Real-world Setting: An Interim Analysis Through 48 Weeks of Observation.

Janus kinase (JAK) inhibitors, including upadacitinib, have been recently approved for the treatment of moderate-severe atopic dermatitis (AD) and real-world data on upadacitinib effectiveness and safety are limited. This interim analysis aimed to assess effectiveness and safety of upadacitinib throughout 48 weeks of observation in a real-world adult AD population. This prospective study collected data on adult patients affected by moderate-to-severe AD and treated with upadacitinib at the dosage of either 15 mg or 30 mg daily based on the physician decision. Upadacitinib was prescribed in the context of a national compassionate use programme. In this interim analysis, within patient comparisons of continuous scores of different scales (namely Eczema Area andSeverity Index [EASI], body surface area [BSA], Dermatology Life Quality Index [DLQI], Patient Oriented Eczema Measure [POEM], Numeric Rating Scale [NRS] subtests) were performed. The percentage of patients achieving EASI 75, EASI 90 and EASI 100 at Week 16, 32 and 48 was also evaluated. One hundred and forty-six patients were included in the analysis. Upadacitinib 15 mg or 30 mg daily was prescribed as monotherapy in most cases (127/146, 87.0%). Upadacitinib was initially prescribed at the dosage of 30 mg daily in 118 of 146 (80.8%) patients and 15 mg daily in 28/146 (19.2%) patients. A significant improvement in the clinical signs and symptoms of AD was detected by Week 16 andthroughout the study period. EASI 75, EASI 90 and EASI 100 responses were achieved by 87.6%, 69.1% and 44.3% at Week 48, associated with a sustained reduction in the mean values of all physician-reported (EASI and BSA) and patient-reported (Itch- Sleep- and Pain-NRS, DLQI, and POEM) disease severity outcomes, up to 48 weeks of treatment. Treatment response observed in 15 mg upadacitinib-treated patients was comparable with that detected in 30 mg upadacitinib-treated patients, revealing no statistical difference between the two patient sub-cohorts. Through the observation period, dose reduction or escalation was observed in 38/146 (26%) of treated cases. Overall, 26 of 146 (17.8%) patients experienced at least one adverse event (AE) during the treatment period. In total, 29 AEs were recorded and most of them were evaluated as mild to moderate, while in 4 cases the occurrence of AE led to drug discontinuation, for a total of 7/146 (4.8%) dropouts. This study provides strong evidence of a sustained response obtained by upadacitinib in AD patients, who had failed to respond to conventional or biological systemic agents, through 48 weeks of observation. Upadacitinib wasalso demonstrated to be advantageous in terms of flexibility in dose reduction or escalation as upadacitinib dose was shaped on clinical needs that, in a real-world setting, might frequently change.