Purpose:This multicentre cross-sectional study aimed to quantify caregiver burden among elderly patients with atopic dermatitis (AD) and to identify its principal clinical, functional, and symptomatic determinants. Specifically, we evaluated the relative contributions of functional impairment, caregiving intensity, and inflammatory severity to overall caregiver burden. Patients and Methods:A total of 213 patient-caregiver dyads were consecutively recruited from four tertiary dermatology centers in Italy. Eligible patients were aged ≥65 years with dermatologist-confirmed AD. Clinical assessments were performed by board-certified dermatologists at each participating centre and included the Eczema Area and Severity Index (EASI), body surface area (BSA), pruritus and sleep disturbance (numeric rating scales), comorbidities, and functional status measured by Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL). Caregivers completed a structured questionnaire on caregiving responsibilities and the Caregiver Burden Inventory (CBI). Associations were examined using Spearman correlation and multivariable linear regression models. Results:Patients had a mean age of 73.3 ± 7.3 years and moderate disease severity (mean EASI 13.3 ± 11.2). Functional impairment was common (median ADL 4.0), and caregivers reported a median of 2.5 daily hours of assistance. Overall burden was moderate (mean CBI 32.0 ± 14.0). CBI correlated most strongly with ADL impairment (ρ = -0.50) and daily caregiving hours (ρ = 0.47), with additional associations for sleep disturbance (ρ = 0.35) and EASI (ρ = 0.31). In multivariable analysis, ADL impairment (p < 0.001), caregiving hours (p = 0.031), sleep disturbance (p < 0.001), and EASI (p = 0.005) remained independently associated with burden; pruritus was not significant after adjustment. Conclusion:Caregiver burden in elderly AD is primarily driven by functional dependence and caregiving intensity, with additional contributions from sleep disturbance and inflammatory severity. Integrating functional assessment and caregiver-focused strategies into routine care may improve outcomes for both patients and caregivers.

Understanding how treatment responses evolve over time is essential for optimising therapeutic strategies in moderate-to-severe atopic dermatitis (AD). While clinical trials have demonstrated the efficacy of targeted therapies, real-world evidence describing longitudinal response trajectories remains limited. This study aimed to characterise temporal patterns of clinical response in patients with AD treated with dupilumab or upadacitinib in routine clinical practice. A multicentre real-world observational study was conducted using data from the Italian AD-Landscape platform, a structured clinical database collecting longitudinal information on patients receiving advanced systemic therapies for AD. Adult patients initiating dupilumab or upadacitinib between July 2019 and January 2026 were included if baseline and at least week-4 assessments were available. Disease severity and patient-reported outcomes were evaluated using the Eczema Area and Severity Index (EASI), Investigator’s Global Assessment (IGA), Pruritus Numerical Rating Scale (P-NRS) and Sleep Numerical Rating Scale (S-NRS) at baseline and at weeks 4, 16, 36 and 52. Categorical response thresholds (EASI75, EASI90 and EASI100) and safety outcomes were analysed descriptively. A total of 2625 patients were included (dupilumab n=2085; upadacitinib n=540). Both treatments produced rapid and sustained improvements in clinician-reported and patient-reported outcomes throughout the 52-week follow-up. Mean EASI scores decreased from 25.6 ± 6.5 to 2.2 ± 2.9 in the dupilumab group and from 19.1 ± 9.2 to 2.9 ± 5.7 in the upadacitinib group at week 52, respectively. Upadacitinib demonstrated faster early response kinetics, whereas dupilumab showed a progressive accumulation of clinical benefit over time, resulting in convergence of response rates during long-term follow-up. Safety findings were consistent with known mechanism-specific profiles. In this large real-world cohort, both dupilumab and upadacitinib provided substantial and sustained clinical improvements in moderate-to-severe AD. Distinct response kinetics were observed, with faster early responses with upadacitinib and progressively increasing responses with dupilumab, supporting a personalised approach to treatment selection in routine clinical practice.

BACKGROUND:Prurigo nodularis (PN) is a chronic, intensely pruritic skin disorder that markedly impairs quality of life. Dupilumab, an interleukin-4Rα antagonist, is approved for moderate-to-severe PN, but long-term real-world evidence remains limited. OBJECTIVES:To evaluate the long-term effectiveness and safety of dupilumab in adults with PN, including those with multiple comorbidities, in a real-world multicentre setting. METHODS:Clinical data were collected from 26 Italian dermatology centres [the Dupilumab Italian Prurigo Nodularis (DUPItaPN) study]. Adults with PN refractory to topical therapies and/or phototherapy, and/or prior systemic treatments who received dupilumab for a minimum treatment duration of 12 weeks were included. Outcomes routinely assessed in practice - Worst Itch (WI) Numeric Rating Scale (NRS) (WI-NRS), Investigator Global Assessment for PN-Stage (IGA PN-S), Sleep-NRS, Skin Pain-NRS and Dermatology Life Quality Index (DLQI) - were analysed at baseline and weeks 12, 24, 52, 76 and 104. Main endpoints were ≥ 4-point WI-NRS reduction and IGA PN-S 0/1 status. Predictors of response and safety were also evaluated. RESULTS:In total, 543 patients [mean age 65.7 (SD 15.8) years; 63.7% (346/543) female] were included. Dupilumab induced rapid and sustained improvements: mean WI-NRS decreased from 8.69 (SD 1.41) to 2.67 (SD 2.59) at week 24 and to 1.72 (SD 2.44) at week 104 (P < 0.001); ≥ 4-point WI-NRS reduction was achieved by 78.6% (408/519) and by 86.9% (258/297) of patients at 24 and 104 weeks, respectively; and IGA PN-S 0/1 achieved by 62.8% (326/519) and 81.1% (241/297) of patients at 24 and 104 weeks. DLQI improved from 17.40 (SD 6.94) to 2.57 (SD 4.89) (P < 0.001). Higher baseline WI-NRS predicted better outcomes, whereas psychiatric comorbidities and prior tricyclic antidepressant use predicted lower response. Dupilumab was well tolerated; discontinuation because of adverse events occurred in 2.9% (16/543), with no cancer progression or viral reactivation. CONCLUSIONS:Dupilumab provided sustained, clinically meaningful benefits and a favourable safety profile over 104 weeks, supporting its role as a long-term treatment for moderate-to-severe PN, including in older adults and patients with comorbidities.

Introduction: Atopic dermatitis (AD) and inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic immune-mediated disorders with overlapping immunopathogenic mechanisms. Limited research has investigated clinical features of AD and concomitant IBD. Objectives: This study aimed to evaluate the clinical presentation of adult patients with concomitant moderate-to-severe AD and IBD. Methods: Adult patients with moderate-to-severe AD and confirmed IBD were identified across 12 hospital-based dermatology centers between 2022 and 2024 by using electronic records. Results: Thirty-eight out of 4,236 (0.9%) patients with moderate-to-severe AD had verified IBD (19 CD and 19 UC), with a prevalence higher than that expected in the general Italian population (0.9% vs 0.41%). The mean age at AD diagnosis was 25 years, with AD preceding IBD diagnosis with a median interval of 10 years in 71% of cases. At the time of the study, 40% of CD patients and 63% of UC patients were in clinical remission. AD clinical presentation in patients with IBD was typical, with 68% of patients presenting with flexural phenotype, and associated with personal (34%) or family (40%) history of atopy. Conclusions: IBD is not frequent in AD patients, but the prevalence seems to be higher compared to the general population. AD occurring with IBD had a typical clinical presentation. Interestingly, occurrence of AD preceded IBD onset in most patients, putting dermatologists in the position to make early IBD diagnosis. However, no direct causal relationship can be drawn from these findings. Larger, controlled prospective studies are needed to clarify the relationship between AD and IBD.

Abrocitinib, an oral selective Janus kinase 1 inhibitor, is approved for the treatment of moderate-tosevere atopic dermatitis (AD) in adults, but realworld evidence remains limited. We retrospectively collected data from 187 adult patients (mean age:37.9 years; 60.4% male), with AD and up to oneyear exposure to abrocitinib either 100 or 200 mg, between 2023 and 2025 across 22 Italian dermatology centres. Nearly half of patients were bio-experienced and 80 % had difficult-to-treat areas. Beginning at week 8, with either 100 (59%) or 200 mg, 52 % achieved Investigator Global Assessment 0/1, significantly increasing to 88 % at week 52. Similarly, Eczema Area and Severity Index (EASI) and itch had significantly higher 1-year response: increasing from 27.8% and 34.7%, respectively, at week 8, 79.6 % achieved EASI-90 and 73.5% reached Peak Pruritus-Numerical Rating Scale 0/1. Minimal disease activity, a stringent composite endpoint, was met by 18 % at week 8 and by 66 % at week 52. Safety was good, with mild adverse events mostly including abdominal pain, upper respiratory infections and headache. The 100 mg dose had a significantly better safety profile, with efficacy similar to 200 mg. These data confirm the efficacy and safety of abrocitinib, with early, progressive clinical benefits sustained through 1 year.

Ritlecitinib, an oral selective inhibitor of Janus kinase 3 and the TEC family of kinases, has recently been approved for the treatment of severe alopecia areata, but real-world data are still limited. The aim was to evaluate the effectiveness and tolerability of ritlecitinib 50 mg/day after 24 weeks in patients with severe alopecia areata in clinical practice. We performed an Italian observational, retrospective, multicentre study with 24 weeks of follow-up. Patients ≥ 12 years of age with severe alopecia areata (Severity of Alopecia Tool [SALT] ≥ 50) and a disease duration ≥ 6 months who were candidates for systemic therapy were enrolled. Ritlecitinib 50 mg/day was administered according to national guidelines. The primary endpoint was to evaluate the achievement of SALT ≤ 20 at week 24. Secondary endpoints included achievement of SALT ≤ 10; mean change in SALT; trichoscopic improvement; quality of life; psychological impact; efficacy in eyebrows, eyelashes, and nails; and safety profile. A total of 102 patients were included. At week 24, 40.2

Lebrikizumab, a monoclonal antibody targeting interleukin-13, has demonstrated efficacy and safety in adults with moderate-to-severe atopic dermatitis (AD), but data in elderly patients remain limited. We conducted a retrospective multicentre study including 90 patients aged ≥60 years with moderate-to-severe AD treated with lebrikizumab across 23 Italian dermatology centres. Clinical outcomes were assessed at baseline and at weeks (W)16, W24 and W52. Mean EASI decreased from 23.24 ± 7.93 at baseline to 6.33 ± 6.54 at W16, 3.57 ± 3.74 at W24 and 2.70 ± 4.83 at W52 (p < 0.0001). EASI75 was achieved by 58.4%, 82.0% and 87.0% of patients at W16, W24 and W52, respectively. Clinical responses were similar across age groups and independent of prior biologic or JAK inhibitor exposure. Adverse events occurred in 7.8% of patients and were mainly mild. These findings support the effectiveness and safety of lebrikizumab in elderly patients with AD in real-world clinical practice.

INTRODUCTION:Real-world evidence on the long-term use of dupilumab in very young children with moderate-to-severe atopic dermatitis (AD) remains limited. Observational data are needed to complement clinical trial findings by describing treatment outcomes in routine clinical practice. METHODS:This multicenter retrospective study included children aged 6 months to 5 years with moderate-to-severe AD treated with dupilumab through the Italian Named Patient Program. Clinical assessments were performed at baseline and at weeks (W) 16, 24, 36, and 52. Disease severity, quality of life, and symptom burden were evaluated using the Eczema Area and Severity Index (EASI), Children's Dermatology Life Quality Index (c-DLQI), pruritus-numeric rating scale (P-NRS), and sleep-numeric rating scale (S-NRS). EASI-50/75/90 responder rates were calculated at each time point. Safety data were collected throughout treatment. Growth parameters were monitored between baseline and W52. RESULTS:Forty-seven children were included. Dupilumab led to rapid and progressive improvement of AD severity, with mean EASI decreasing from 26.1 at baseline to 2.7 at W52 (-89.7%). Marked improvements were also observed in quality of life (-91.3% in c-DLQI), itch intensity (-82.5% in P-NRS), and sleep disturbance (-82.7% in S-NRS). At W52, EASI-75 and EASI-90 responses were achieved by 79.5% and 59.0% of evaluable patients, respectively. Dupilumab was well tolerated, with treatment-emergent adverse events occurring in 10.6% of patients, all mild or moderate and none leading to discontinuation. Weight- and height-for-age z-scores significantly increased over 52 weeks; no child newly developed values below -2 standard deviations, although 1 child remained below this threshold at W52. Percentile-based analyses yielded consistent results, confirming the absence of negative effects on growth. CONCLUSION:Dupilumab was effective and well tolerated over 52 weeks in children aged 6 months to 5 years with moderate-to-severe AD, providing sustained skin clearance, symptom relief, and quality-of-life improvement. These findings support dupilumab as a valuable long-term therapeutic option in very young children with uncontrolled AD in clinical practice.

BACKGROUND:Biologic therapies such as dupilumab and tralokinumab have greatly impacted the management of moderate-to-severe atopic dermatitis (AD). However, recent clinical observations have reported paradoxical adverse events, including psoriasis and seronegative spondyloarthropathy (SpA). OBJECTIVES:To assess the incidence, clinical characteristics and management of psoriasis and SpA in patients with AD treated with dupilumab or tralokinumab in a real-world setting. METHODS:We conducted a multicentre retrospective observational study involving patients with AD receiving dupilumab or tralokinumab for ≥ 16 weeks between January 2019 and May 2025. Data were collected on patients developing psoriasis and/or SpA, including demographics, time to onset, severity, management strategies and treatment outcomes. RESULTS:Psoriasis developed in 78 of 5899 patients (1.3%) receiving dupilumab and 16 of 769 (2.1%) on tralokinumab, with respective mean times to onset of 57.7 (SD 66.5) and 28.3 (28.9) weeks. SpA occurred in 17 patients (0.3%) on dupilumab and 1 (0.1%) on tralokinumab. Topical calcipotriol/betamethasone was the most frequent treatment for psoriasis, while systemic agents, including methotrexate and corticosteroids, were required in refractory cases. In addition, a proportion of patients required switching to alternative biologics due to poor disease control. For SpA, management often involved systemic corticosteroids, nonsteroidal anti-inflammatory drugs or methotrexate, and upadacitinib was introduced in 41% of cases of dupilumab requiring therapeutic escalation. CONCLUSIONS:Although rare, psoriasis and SpA are adverse events emerging during dupilumab or tralokinumab therapy in patients with AD. Close monitoring and prompt differential diagnosis are essential to optimize patient outcomes.

Background: Dupilumab, a monoclonal antibody targeting the interleukin-4 receptor α, is approved for moderate-to-severe atopic dermatitis (AD). However, its safety profile in patients with concomitant hematologic disorders remains unclear, as such populations were excluded from pivotal trials. Objective: To evaluate the safety and effectiveness of dupilumab in adolescents and adults with AD and underlying hematologic comorbidities. Methods: This retrospective, multicenter study included 139 patients aged ≥15 years with moderate-to-severe AD and at least one hematologic disorder, treated with dupilumab across 21 dermatology centers. Data on disease severity, laboratory markers, and hematologic outcomes were collected over a median follow-up of 52 weeks (range 4–156). Results: The most common hematologic conditions included monoclonal gammopathies, leukemias, lymphomas, myeloproliferative neoplasms, and immune cytopenias. Clinical response to dupilumab was sustained across all endpoints, with median EASI scores decreasing from 26.0 at the baseline to 1.0 at week 52. NRS pruritus and sleep scores similarly declined to 0.0 by week 52. Serum IgE levels and eosinophil counts progressively decreased. The clinical response to dupilumab was sustained across all endpoints, with significant and progressive improvements in EASI, pruritus NRS, and sleep NRS observed up to week 52, followed by long-term stability through week 156. Serum IgE levels decreased steadily at all timepoints, while eosinophil counts declined after week 4 and stabilized beyond week 52. Hematologic conditions remained stable in 82.7% of patients, resolved in 16.5%, and progressed in only one case. Twelve patients (8.6%) received a new hematologic diagnosis during follow-up; no causal relationship could be established due to the retrospective design and absence of systematic screening, and these findings should be interpreted as descriptive associations only. Conclusions: Dupilumab appears to be safe and effective in AD patients with a broad range of hematologic comorbidities, including malignancies. These findings support its use in real-world settings, though prospective studies are warranted to further assess long-term safety in this population.

Atopic dermatitis (AD) is a chronic inflammatory skin condition that significantly affects the quality of life (QoL). Lebrikizumab, a biologic drug targeting interleukin-13, demonstrated efficacy and safety in clinical trials. However, real-world data remain limited, largely restricted to Asian populations. This 16-week retrospective multicenter study included 78 adults from a predominantly white cohort with moderate-to-severe AD treated with lebrikizumab throughout 2024. Patients were both naïve and experienced with biologics or Janus kinase inhibitors (bio/JAKi-naïve or -experienced). The primary outcome for disease severity and therapeutic response was measured using the Eczema Area and Severity Index (EASI). Secondary outcomes included the Dermatology Life Quality Index (DLQI), itch- and sleep-numerical rating scales (NRS), body surface area (BSA), Investigator Global Assessment (IGA), SCORing Atopic Dermatitis (SCORAD), and Patient-Oriented Eczema Measure (POEM). Atopic Dermatitis Control Tool (ADCT) and minimal disease activity (MDA) were used to estimate disease control, and Hospital Anxiety and Depression Scales to monitor mental health status. At week 16, benefits in disease severity were observed for EASI (− 15.8 ± 9.4, p < 0.0001) and EASI head and neck (− 2.0 ± 1.7, p < 0.0001). QoL significantly improved in 70