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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. [ABSTRACT FROM AUTHOR]

Introduction: Even if mild forms of atopic dermatitis (AD) are usually well controlled with topical prescription drugs and emollients, the management of severe forms of the disease may be challenging, especially in special populations (SPs). These patients include groups of disadvantaged people (elderly, patients with disabilities and serious medical conditions) who are usually excluded from clinical trials. As a consequence, most of the data about the efficacy and safety of a drug in these patients derives from post-marketing experiences. In this context, the aim of our study was to retrospectively investigate the effectiveness and safety of tralokinumab in the management of AD in SPs. Methods: A 24-weeks retrospective, dual-center study was performed enrolling patients with a diagnosis of moderate-to-severe AD undergoing treatment with tralokinumab at labelled dosage. Disease severity was assessed using Eczema Area Severity Index (EASI), Pruritus–Numerical Rating Scale (P-NRS), and Dermatology Life Quality Index (DLQI) score at baseline and after 4 weeks (W4), W16, and W24. Adverse events (AEs) were monitored at the same timepoints. Statistical significance of clinical improvement (EASI, P-NRS, DLQI) at week 4, week 16, and week 24 as compared with baseline was evaluated by using Student's t-test, considering significant a p-value < 0.05. Results: Our study enrolling 27 SPs patients showed a significant improvement in EASI and P-NRS since week 4, continuing to improve up to week 24. Similarly, DLQI significantly decreases at each timepoint as compared with baseline. Finally, no AEs were reported during the study period. Of interest, our cohort included oncologic patients, a patient with a history of severe infection, as well as subjects affected by severe neurological, psychiatric, pulmonary, and/or cardiovascular disease. Discussion: Our experience showed that tralokinumab is effective and safe in elderly patients and subjects affected by severe comorbidities. [ABSTRACT FROM AUTHOR]

Dermatologists' burnout is a growing phenomenon. During the last years, an important role on medical stress is played by the ever‐increasing use of common technological devices (smartphones, smartwatches, PCs and tablets). The aim of the study was to investigate whether digital technology use causes burnout among Italian dermatologists, using a survey conducted among a group of Italian dermatologists. The final sample contained 194 responses valid for analysis. A positive and significant relationship between technostress, assessed through Technostress Inventory and burnout, assessed through Maslach Burnout Inventory, among Italian dermatologists was found. Our data seems suggesting a close relationship between technostress and dermatologist burnout. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) is a common inflammatory skin disease with multiple clinical manifestations. Among AD phenotypes, psoriasiform AD shows the coexistence of eczematous itching lesions in flexural areas with psoriasiform plaques. The use of anti-interleukin (IL)-4 and anti-IL-13 in psoriasiform AD may lead to therapeutic failure or worsening of manifestations. A recent Delphi consensus proposed Janus kinase inhibitors (JAKi) as a viable alternative, even as a first-line treatment, in patients with different clinical phenotypes of AD, including psoriasiform AD. We performed a retrospective analysis of patients in our dermatology clinic with moderate-to-severe AD who were treated with JAKi. Among 192 patients overall, 21 had psoriasiform AD. We used the Eczema Area and Severity Index (EASI), Pruritus-Numerical Rating Scale and Dermatology Life Quality Index for considering severity scores, and reduction was observed in all 21 patients at week (W) 4, W16 and W24 of treatment. At W16, 81% and 67% achieved EASI-75 and EASI-90, respectively, while at W24 95% of patients achieved EASI-75 and 86% obtained EASI-90. No adverse event led 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 treating this form of AD, although further studies with larger cohorts are required. [ABSTRACT FROM AUTHOR]

Background: Eyelid dermatitis is a frequent reason of dermatological consultation. Its aetiology is not univocal, being contact dermatitis, both allergic and irritant, the most frequent. The primary sources of allergen exposure include cosmetics, metals, and topical medications, from direct, indirect, or airborne contact. Objectives: To define the frequency of positive patch test reactions to SIDAPA baseline series allergens, to document positive allergens, and to precise the final diagnosis in patients with eyelid involvement. Methods: A total of 8557 consecutive patients from 12 Italian Dermatology Clinics underwent patch testing with SIDAPA baseline series in 2018 and 2019. Patients were divided into two groups: (i) with eyelid involvement with or without other involved sites (E‐Group) and (ii) without eyelid involvement (NE‐Group). The final diagnosis and the frequency of positive relevant patch test reactions were evaluated. Results: E‐Group consisted of 688 patients (females 78.6%, mean age 45.3 years), 8.0% of 8557 consecutively patch‐tested patients. The final diagnosis in E‐Group was ADC in 42.4%, ICD in 34.2%, and AD in 30.5%. The highest reaction rates were elicited by nickel sulphate and methylchloroisothiazolinone/methylisothiazolinone in both E‐Group and NE‐Group, even if these allergens were significantly more frequently positive in NE‐Group patients than in E‐Group ones. Positive patch test reactions to fragrance Mix II, dimethylaminopropylamine, and sorbitan sesquiolate were significantly more frequent in E‐Group patients than in NE‐Group ones. Conclusions: Eyelid dermatitis is a frequent dermatological complaint. Allergic contact dermatitis is the most frequent diagnosis commonly caused by nickel sulphate, isothiazolinones, and fragrances. The surfactants dimethylaminopropylamine and sorbitan sesquioleate are emerging causes of eyelid allergic contact dermatitis. [ABSTRACT FROM AUTHOR]

Background Managing a pregnant patient with chronic spontaneous urticaria (CSU) is often challenging. Recent data have shown that most CSU treatments in pregnant patients are second-generation H1 antihistamines (sgAHs), while data on the safety of omalizumab are scant. Objectives To evaluate, in a routine clinical practice setting, the efficacy and safety of omalizumab in patients with severe CSU refractory to sgAHs who either became pregnant during treatment or who started the drug during pregnancy. Methods We conducted a retrospective study of women aged ≥ 18 years who were pregnant, who received one or more doses of omalizumab at any time during their pregnancy or who were taking omalizumab at the time of, or in the 8 weeks before, conception. Results Twenty-nine pregnant patients were evaluated: 23 (79%) conceived a child while taking omalizumab (group A), while 6 (21%) started omalizumab treatment during pregnancy (group B). Among patients in group A, we observed 23 births (21 liveborn singletons and 1 liveborn twin pair) and 1 miscarriage. Fifteen (65%) patients discontinued omalizumab after confirming their pregnancy, while eight (35%) were exposed to omalizumab during their entire pregnancy. In group B, omalizumab was introduced at a mean (SD) 10.83 (3.60) weeks' gestation and all patients were exposed to it until the end of pregnancy. In this group, there were seven liveborn infants (five singletons and one twin pair). No adverse events, pregnancy complications or congenital anomalies in newborns were recorded in either group. Conclusions Omalizumab for CSU treatment before and during pregnancy does not appear to have negative effects on maternal or fetal outcomes. [ABSTRACT FROM AUTHOR]

Dupilumab is a fully human monoclonal antibody that acts by inhibiting the interleukin (IL)-4 receptor subunit α, and hence the IL-4 and IL-13 signalling pathway. Dupilumab treatment has been linked to the onset of T helper 17-driven inflammatory diseases, including cases of seronegative arthritis and enthesitis. To date, dupilumab-associated inflammatory arthritis (DAIA) represents a relatively unknown adverse event, initially reported in single cases or case series reports. Indeed, the onset of DAIA may not be promptly recognized, and is probably underestimated. Here we have reviewed the available English literature regarding arthritis and enthesitis onset during dupilumab treatment for atopic dermatitis, aiming to improve rapid recognition and thus prompt treatment of these diseases. [ABSTRACT FROM AUTHOR]

Background: Tralokinumab has been recently approved for the management of moderate-to-severe atopic dermatitis (AD). Despite its effectiveness and safety have been widely reported, there are no studies investigating factors that may affect clinical outcomes. Objective: To evaluate the effectiveness and safety of tralokinumab, also to investigate possible predictive response factors that may affect the time of onset of treatment response. Methods: A monocentric retrospective real-life study was performed enrolling AD patients undergoing treatment with tralokinumab for at least 24 weeks. AD severity was assessed at baseline and at week (W)16, and W24. Similarly, treatment-related adverse events (AEs) were evaluated at each follow-up visit. Results: A total of 57 patients were enrolled. AD severity started to improve at W4, continued to improve at W16 and W24. In our cohort, we found out that gender, age, atopic comorbidities, and previous treatments did not affect treatment outcomes. However, we observed that patients with higher Pruritus-Numerical Rating Scale (‡8), relapsing form of AD, Eczema Area and Severity Index (EASI) £24, and Investigator Global Assessment (IGA) £3 achieved more frequently EASI75 response at W16. No significant AEs were collected. Conclusions: Our study confirmed the effectiveness and safety of tralokinumab. In particular, a higher pruritus, a relapsing course of the disease, a reduced EASI, a reduced IGA, and a brief duration of the disease seem to be associated with the fastest onset of treatment effectiveness. [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]

The article discusses the efficacy and tolerance of dupilumab in patients with moderate-to-severe atopic dermatitis and obesity. It compares the outcomes of treatment in obese and non-obese patients, highlighting differences in response rates and effectiveness based on body mass index. The study suggests that a higher BMI may be associated with a lower effectiveness of dupilumab, especially in the short term, but long-term results are contradictory. Further research is needed to understand the impact of dupilumab on body weight and its effectiveness in different patient populations. [Extracted from the article]

This article discusses the occurrence of parapsoriasis in three patients with a long history of atopic dermatitis who were undergoing treatment with the drug dupilumab. Parapsoriasis is a rare skin disease that can potentially progress into mycosis fungoides, a type of cutaneous T-cell lymphoma. The patients experienced the development of irregular, slightly itchy patches on their trunk and lower limbs during dupilumab treatment. The drug was discontinued, and the patients started a new therapy with partial remission of their skin manifestations. The article highlights the importance of correctly diagnosing atopic dermatitis before administering dupilumab and the need for continuous monitoring of patients undergoing this treatment. It also suggests that patients with a long history of severe atopic dermatitis and previous use of immunosuppressive agents may be at higher risk for lymphomatous disorders. [Extracted from the article]

The article presents a case study of a 14-year-old man who developed allergic contact dermatitis following the implantation of a subcutaneous implantable cardioverter-defibrillator (ICD). It mentions that patch testing identified a sensitivity to cobalt chloride, leading to the replacement of the ICD with a titanium-based device, which successfully resolved his symptoms.

This article is a reply to a previous article titled "Omalizumab for the management of refractory aquagenic pruritus." The authors of this reply express their interest in the previous article and share their own experience with treating aquagenic pruritus using omalizumab. They report that their experience did not yield significant improvement in aquagenic pruritus, and they discontinued treatment after six months. They also disagree with the previous authors' statement about the role of omalizumab in treating aquagenic pruritus, citing a lack of supporting evidence. The authors conclude by stating that while omalizumab is approved for the treatment of chronic spontaneous urticaria, its role in other types of urticaria, including aquagenic pruritus, is still unknown. [Extracted from the article]

Background Objectives Methods Results Conclusions Hand eczema (HE) is a common skin disease with a negative impact on patients' quality of life in occupational and non‐occupational settings. Up‐to‐date, data on HE in Italian patients referred for patch testing are lacking.To characterise the profile in terms of demographics, aetiology and patch test results of Italian patients affected by HE referred for patch testing.A retrospective descriptive study on consecutive patients affected by HE who underwent patch testing from 2016 to 2023 in eight dermatology clinics was performed. HE patients were divided into two groups according to the exclusive (HE‐only group) and not‐exclusive (HE+ group) hand involvement, and compared to patients with eczema localised in body areas other than hands (NHE group).One thousand five hundred and ninety‐seven patients were affected by HE (35.3% males; mean age 42.7 years), 60.2% belonging to the HE‐only group and 39.8% to the HE+ group. Occupational dermatitis was diagnosed in 33.2% of HE‐only patients, 25.0% of HE+ patients and 5.2% of NHE patients (p < 0.001). HE‐only patients presented: Allergic Contact Dermatitis (ACD), Irritant Contact Dermatitis (ICD), atopic HE in 48.1%, 47.5% and 7.1%, respectively; hyperkeratotic palmar, acute recurrent vesicular and nummular clinical subtypes in 52.2%, 43.9% and 11.9%, respectively; relevant positive patch test reactions in 48.1% (nickel sulphate 18.9%, methylchloroisothiazolinone/methylisothiazolinone 10.6%, methylisothiazolinone 8.6%, p‐phenylenediamine 6.0% and potassium dichromate 4.7%).HE patients, and particularly those with exclusive hand involvement, show a particular profile in terms of demographic and clinical characteristics, etiologies and relevant positive patch test reactions. [ABSTRACT FROM AUTHOR]

Background: Prurigo nodularis (PN) is a chronic, inflammatory skin disease characterized by intense itch. Little evidence exists on the burden of PN in Italy. This real-world analysis aimed to investigate the healthcare resource consumption and related direct costs of patients hospitalized for PN., Methods: The analysis utilized the administrative databases of healthcare units that cover approximately 12 million inhabitants across Italy. Adult patients were included by ICD-9-CM=698.3 (lichen simplex chronicus; neurodermatitis circumscripta; PN) as proxy of PN diagnosis, from 01/2010 to 09/2021, and had 1 year of data availability before (baseline) and after (follow-up) hospitalization (index date). These patients were 1:2 matched by age, sex, and index date (year) to adults without such hospitalization in the baseline period (matched non-PN controls)., Results: The analysis comprised 295 PN-hospitalized patients, matched with 590 non-PN individuals (mean age 63.2 years, 43.7% female). At baseline, patients had a greater comorbidity burden than non-PN controls, including higher prevalence of hypertension (56.6% vs. 36.6%, respectively), dyslipidemia (26.4% vs. 18.0%), diabetes (24.4% vs. 12.5%) and mental health conditions (14.9% vs. 7.8%). During 1-year follow-up, PN-hospitalized patients had significantly higher resource consumption than matched controls, in terms of mean number of prescriptions most commonly prescribed in PN patients (5.1 vs. 1.9, P<0.001), other drugs (11.7 vs. 6.5, P<0.001), all-cause hospitalization (1.4 vs. 0.1, P<0.001) and outpatient services (5.4 vs. 2.5, P<0.001). Mean annual all-cause healthcare costs for patients over 1-year follow-up were € 3847 total (€ 875 drugs, € 2652 hospitalization, € 320 outpatient services), higher than those for the matched controls, of € 711 total (P<0.001) (€ 353 drugs, € 228 hospitalization, € 130 outpatient services)., Conclusions: Patients hospitalized for PN had a higher comorbidity burden at baseline and greater healthcare resource consumption during 1-year follow-up compared to matched controls, with a 5.4-fold increase in all-cause healthcare costs, indicating substantial clinical burden and remaining unmet need in these patients.

Background: Atopic dermatitis (AD) is a heterogeneous disease, associated with comorbidities, and high healthcare consumptions and costs. This study assessed the burden before and after treatment with dupilumab in adults with severe AD from 2018 to 2020, from the perspective of the Italian National Health Service (SSN)., Methods: From Fondazione Ricerca e Salute's administrative healthcare database (~5 million inhabitants/year), adults treated with dupilumab from 09/01/2018 to 31/12/2020 (index date) and a five-year lookback were identified. Age, sex and comorbidities at baseline, concomitant drugs, overnight hospitalizations, outpatient specialist services and direct costs charged to the SSN one year before/after index date were assessed., Results: Of 337 adults treated with dupilumab (5.8x100,000 adult inhabitants/2019; 8.0x100,000/2020; 55% males; mean age 43±19), 68% (228/337) had ≥12-month follow-up available. Asthma was a common comorbidity (23% patients). Rates of patients treated with nearly all concomitant AD-related therapies reduced from 12 months before to 12 months after dupilumab treatment: antibacterials (from 59% to 50%), systemic corticosteroids (55% to 29%), antihistamines (54% to 38%) and cyclosporine (52% to 7%). A similar trend was observed among patients with asthma as comorbidity. Within 12 months before/after dupilumab, patients hospitalized halved from 14% to 7%, and patients receiving outpatient specialist care reduced from 72% to 65%. Annual mean direct total costs per patient treated with dupilumab charged to the SSN, net of dupilumab cost, were €1384 and €773, before and after dupilumab dispensation, respectively., Conclusions: Before dupilumab, observed patients had higher healthcare resource consumptions and direct SSN costs than after dupilumab.

Allergic contact dermatitis (ACD) is a common inflammatory skin disease caused by delayed hypersensitivity to chemical and biotic contact allergens. ACD significantly affects the patients' quality of life negatively impacting both occupational and non-occupational settings. Patch testing is the gold standard diagnostic in vivo test to precise the ACD etiology and to correctly perform prevention. According to the Italian Medicines Agency (AIFA) legislative decree no. 178 of 29 th May 1991, allergens are defined as medicines and therefore they are subject to strict regulation. In 2017, AIFA (decree no. 2130/2017) started a procedure to regulate contact allergens on the Italian market and actually the contact allergens temporarily authorized are reported in AIFA decree no. 98/2022, valid until November 2023. The availability on the market of contact allergens to diagnose ACD and continuous updating on the basis of new epidemiological trends are mandatory, jointly with the continuous update of the baseline and integrative series for patch testing. For this reason, the scientific community represented in Italy by the Skin Allergies Study Group of SIDeMaST (Italian Society of Dermatology and Venereology) and SIDAPA (Italian Society of Allergological, Occupational and Environmental Dermatology) are constantly working, in close relationship with the European scientific communities with large expertise in this important sector of the modern Dermatology. Herein, we report the setting up of regulatory legislation by AIFA and the new Italian Adult Baseline Series for patch testing.

Background: Tralokinumab has been recently approved for the management of moderate-to-severe atopic dermatitis (AD). Despite its effectiveness and safety have been widely reported, there are no studies investigating factors that may affect clinical outcomes. Objective: To evaluate the effectiveness and safety of tralokinumab, also to investigate possible predictive response factors that may affect the time of onset of treatment response. Methods: A monocentric retrospective real-life study was performed enrolling AD patients undergoing treatment with tralokinumab for at least 24 weeks. AD severity was assessed at baseline and at week (W)16, and W24. Similarly, treatment-related adverse events (AEs) were evaluated at each follow-up visit. Results: A total of 57 patients were enrolled. AD severity started to improve at W4, continued to improve at W16 and W24. In our cohort, we found out that gender, age, atopic comorbidities, and previous treatments did not affect treatment outcomes. However, we observed that patients with higher Pruritus-Numerical Rating Scale (≥8), relapsing form of AD, Eczema Area and Severity Index (EASI) ≤24, and Investigator Global Assessment (IGA) ≤3 achieved more frequently EASI75 response at W16. No significant AEs were collected. Conclusions: Our study confirmed the effectiveness and safety of tralokinumab. In particular, a higher pruritus, a relapsing course of the disease, a reduced EASI, a reduced IGA, and a brief duration of the disease seem to be associated with the fastest onset of treatment effectiveness.