Short-, mid- and long-term efficacy of dupilumab in moderate to severe atopic dermatitis: a real life multicenter Italian study on 2576 patients.

BACKGROUND: The efficacy and safety of dupilumab in atopic dermatitis (AD) have been defined in clinical trials but limited real-world evidence on long term treatment outcomes are currently available to inform clinical decisions. OBJECTIVES: to describe long-term effectiveness and safety of dupilumab up to 48 months in patients with moderate-to-severe AD. METHODS: a multicenter, retrospective, dynamic cohort study was conducted to assess long term effectiveness and safety of dupilumab in patients with moderate to severe AD in a real-world setting. Predictors of minimal disease activity (MDA) optimal treatment target criteria (defined as the simultaneous achievement of EASI90, itch NRS score ≤1, sleep NRS score ≤1 and DLQI ≤1) were investigated. RESULTS: 2576 patients were enrolled from June 2018 to July 2022. MDA optimal treatment target criteria were achieved by 506 (21.91%), 769 (40.63%), 628 (50.36%), 330 (55.37%) and 58 (54.72%) of those that reached 4, 12, 24, 36 and 48 months of follow-up, respectively. Logistic regression revealed a negative effect on MDA achievement for conjunctivitis and food allergy at all timepoints. Adverse events (AE) were mild and were observed in 373 (15.78%), 166 (7.02%), 83 (6.43%), 27 (4.50%) and 5 (4.55%) of those that reached 4, 12, 24, 36 and 48 months of follow-up. Conjunctivitis was the most frequently reported AE during the available follow-up. AE led to treatment discontinuation in <1% of patients during the evaluated time periods. CONCLUSION: High long-term effectiveness and safety of dupilumab were confirmed in this dynamic cohort of patients with moderate to severe AD, regardless of clinical phenotype and course at baseline. Further research will be needed to investigate the effect of Th2 comorbidities and disease duration on the response to dupilumab and other newer therapeutics for AD.

Contact allergy to SIDAPA baseline series allergens in patients with eyelid dermatitis: An Italian multicentre study.

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.

Safety of SARS-CoV-2 vaccines in psoriatic patients treated with biologics: A real life experience.

Vaccination is the most effective method to prevent and control the SARS-CoV-2 infection and biologics are not considered a contraindication for vaccination. The burning question is that safety data are lacking since patients taking drugs affecting the immune system were excluded from clinical trials leading to vaccine approbation. Moreover, it seems that vaccination could worsen psoriasis. We conducted a survey to investigate the safety of SARS-CoV-2 vaccines in psoriatic patients treated with biologics. A total of 150 patients with stable plaque psoriasis treated with biologics for at least 2 months were evaluated in a 3 months period. Fifty patients (22 F/28 M; age: 33-83 years) only underwent the first and second doses of SARS-CoV-2 vaccines. All patients discontinued their biological agents 10 days before and 10 days after each dose of vaccine. Of these, 24 patients were treated with anti-TNF, 14 with anti-IL17, 7 with anti-IL12-23, and 5 with anti-IL23. After the vaccines, all patients were evaluated at day 2, 7, and 14 for local and/or systemic side effects and/or adverse drug reactions to SARS-CoV-2 vaccines. None of the patients experienced any side effects or a psoriatic flare. Only one patient treated with infliximab biosimilar referred an exacerbation of psoriasis after vaccine. The remaining 100 patients reported that they did not get the vaccine yet. Our preliminary data confirm that SARS-CoV-2 mRNA vaccines are safe for patients with chronic plaque psoriasis treated with biologics and did not trigger psoriasis, although these data should be validated in a larger population. We encourage an early SARS-CoV-2 vaccines administration in all psoriatic patients on immunosuppressant drugs.

Long lasting response to anti-tumor necrosis factor α agents in psoriasis: A real life experience.

Psoriasis is a chronic, immune-mediated inflammatory disease for which no definitive cure exists and patients difficult to treat with moderate to severe psoriasis often require life-long therapy. In general, the use of any biologic agent as monotherapy allows a long-term efficacy, however survival response may progressively decrease over time. We report real-world long lasting response data in psoriatic patients on treatment with anti-TNFα evaluating those on the same anti-TNFα agent (infliximab, etanercept, adalimumab) from January 2011 and December 2013 to December 31, 2021 as monotherapy. On 210 treated patients, 69 were found to maintain the same anti-TNFα agent. The median survival rate for etanercept, infliximab and adalimumab was 10, 9.6, and 9.5 years respectively and the efficacy rate was similar (mean PASI96). Our results demonstrate that anti-TNFα agents are a long-term effective and safe therapeutic option for a satisfying proportion (33%) of patients with moderate-to-severe chronic plaque psoriasis. Further long-term real life studies are needed to better understand which are the causes of drug failure or persistent response and why these may occur at different time intervals in patients on the same drug.

DECISA Project (DErmatology Clinics in Italy: Survey on Alitretinoin): A real-life retrospective cohort multicenter study on 438 subjects with chronic hand eczema.

Alitretinoin is the only systemic agent approved to treat moderate-severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids. No nationwide Italian data regarding real-life efficacy, safety, and tolerability of treatment are available. The DECISA project (DErmatology Clinics in Italy: Survey on Alitretinoin) retrospectively examined data from a registry including 15 Dermatology Clinics authorized to prescription of alitretinoin for CHE patients. Disease severity was assessed at baseline, and after 3 and 6 months of treatment, using the 5-point Physician Global Assessment (PGA) and the modified Total Lesion-Symptoms-Severity (mTLSS) scores. Between November 2010 and July 2018, data of 248 male and 190 female patients (mean age 49.71 ± 13.20 years) treated with alitretinoin were collected. Of them, 43.2% had irritant contact dermatitis, 22.2% allergic contact dermatitis, 18.0% atopic dermatitis, 16.7% mixed (irritant/allergic) type of eczema. At 3 months, the 420 re-evaluated patients showed significantly reduced mTLSS and PGA (P < .0000001 vs baseline for both); PGA was clear/almost clear in 35.6% of cases. At 6 months, the 341 re-evaluated patients showed significant (P < .0000001) improvement of mTLSS and PGA vs baseline and 3 months (PGA clear/almost clear: 41.4%). Relapses occurred in 125 patients; 58 underwent an additional course of alitretinoin, with similarly good results. No relevant safety issues were reported; 86 patients experienced adverse effects, which forced 40 to prematurely stop treatment. The DECISA project results confirm the real-life efficacy, safety and tolerability of alitretinoin in the treatment of moderate to severe CHE refractory to standard topical therapies.

Secukinumab Exhibits Sustained and Stable Response in Patients with Moderate-to-Severe Psoriasis: Results from the SUPREME Study.

Secukinumab, a fully human monoclonal antibody, neutralizes interleukin-17A, a cornerstone cytokine driving the multiple manifestations of psoriasis. This post-hoc analysis of the SUPREME study was performed to determine the sustainability of response to secukinumab in terms of Psoriasis Area and Severity Index (PASI) 90 in patients with moderate-to-severe plaque psoriasis. Based on PASI 90 response at week 16, patients were stratified as PASI 90 responders (PASI90R, n = 337) or non-responders (PASI90NR, n = 72). At week 20, 94.2% (n = 295/313) achieved PASI 90/100 response in PASI90R, with response maintained through week 48 (89.6%, n = 189/211). An increased proportion of patients achieved PASI 90/100 response in PASI90NR (week 20: 29.9%, n = 20/67; week 48: 57.1%, n = 20/35). Overall, 64.4% patients achieved absolute PASI score = 0 at week 24 with response sustained to week 48 (66.9%). Secukinumab showed sustained and stable efficacy in maintaining PASI 90 response in patients with moderate-to-severe plaque psoriasis up to week 48.

Patch testing of budesonide in Italy: The SIDAPA baseline series experience, 2018-2019.

BACKGROUND: Budesonide was included in the European Baseline Series in 2000 as the most suitable marker forcorticosteroid hypersensitivity. In the last two decades, a decreasing trend of budesonide allergy has been observed. OBJECTIVES: To estimate the prevalence of positive patch test reactions to budesonide in a large, Italian patch test population, characterizing patients according to MOAHLFA index and evaluating the benefit with extended readings of budesonide patch test. METHODS: Retrospective analysis of patient demographics and patch test results over a 2-year period (2018-2019) was performed at 14 patch test clinics in Italy. RESULTS: Ninety out of 14 544 (0.6%) patients reacted to budesonide 0.01% pet.. Positive reactions were mild in 54.4% and late readings at day 7 showed new positive reactions in 37.8% of patients. The MOAHLFA index showed a significant positive association with male gender, atopic dermatitis, and age >40 years and a significant negative association with hand and face dermatitis. CONCLUSIONS: We documented a low prevalence of budesonide allergy in Italy, confirming its decreasing trend recently reported in the literature. Nevertheless, budesonide needs to be maintained in the baseline series for its good ability to detect corticosteroid sensitization.

History of urea as a dermatological agent in clinical practice.

Urea, also known as carbamide, is a polar, hygroscopic molecule produced by the human body that was first discovered in urine in 1773 by the French chemist Hilaire Rouelle and was artificially synthesised from inorganic precursors in 1828 by the German chemist Friedrich Wöhler. The importance of urea in dermatology is twofold: it primarily has a physiological key role for the maintenance of skin hydration, and it secondarily has been used for more than a century in different topical preparation and concentration in various skin conditions. One of the first uses of urea was the topical treatment of wounds because of its antibacterial and proteolytic properties. Since the second part of the 20th century, urea became one of the most common moisturisers and keratolytic agents, useful for the treatment of xerosis, atopic dermatitis, ichthyosis and psoriasis.

Depression and sleep quality in psoriatic patients: impact of psoriasis severity.

Background: Psoriatic patients often display depression and sleep disturbances. In previous research, we found high rates of depression and poor sleep quality among psoriatic patients, unrelated to psoriasis severity. However, these results referred to a sample mainly composed of patients under remission.Aim: To compared the prevalence of depression and sleep disturbances in patients suffering from mild versus moderate-tosevere plaque psoriasis, also investigating the association between psoriasis severity and psychopathological variables.KeypointsPsoriasis affects the patients' psychophysical health.Depressive symptoms and/or sleep disturbances are frequent among psoriatic patients.This study investigates these issues comparing the sub-populations of mild and moderate-to-severe psoriatic patients, with special attention to the association between sleep and pruritus.In clinical practice, the link between psychopathological disturbances and psoriasis should not be underestimated.

Reflectance Confocal Microscopy Features of Plaque Psoriasis Overlap With Horizontal Histopathological Sections: A Case Series.

Reflectance confocal microscopy (RCM) displays horizontal, en face tissue sections of the epidermis and upper dermis, and interpretation of its features is classically based on the comparison with vertical conventional histopathological sections that, as known, do not reflect the same plane of observation. In 10 patients affected by psoriasis, we correlated RCM images with horizontal histopathological sections from skin biopsies, observing in all cases marked overlaps between the 2 techniques. Although vertical section examination remains the gold standard for the diagnosis of psoriasis, this novel comparative approach may contribute to a more precise definition of RCM findings and could represent the drive for further research as well as an innovative tool for educational purposes.

Adult female acne and associated risk factors: Results of a multicenter case-control study in Italy.

BACKGROUND: The reasons for the appearance of acne in adulthood are largely unknown. OBJECTIVE: We explored the role of personal and environmental factors in adult female acne. METHODS: We conducted a multicenter case-control study in the outpatient departments of 12 Italian cities. Cases (n = 248) were consecutive women ≥25 years of age with newly diagnosed acne of any grade. Controls (n = 270) were females diagnosed with conditions other than acne. RESULTS: In multivariate analysis, a history of acne in parents (odds ratio [OR] = 3.02) or siblings (OR = 2.40), history of acne during adolescence (OR = 5.44), having no previous pregnancies (OR = 1.71), having hirsutism (OR = 3.50), being an office worker versus being unemployed or being a housewife (OR = 2.24), and having a high level of reported psychological stress (OR = 2.95) were all associated with acne. A low weekly intake of fruits or vegetables (OR = 2.33) and low consumption of fresh fish (OR = 2.76) were also associated with acne. LIMITATIONS: We did not establish an onset date for acne. Some of our associations may reflect consequences of established acne. CONCLUSION: Lifestyle factors may play an important role for acne development in adulthood, but their role should be further assessed in prospective studies.

Psychopathological Variables and Sleep Quality in Psoriatic Patients.

Psoriasis is an inflammatory disease frequently associated with psychiatric disturbances and sleep disorders. The aim of the study was to assess the prevalence of depression, interaction anxiety, audience anxiety, and sleep quality in psoriatic patients. One hundred and two psoriatic patients were enrolled and underwent the following questionnaires: Zung Self-Rating Depression Scale (SDS), Interaction Anxiousness Scale (IAS), Audience Anxiousness Scale (AAS), Pittsburgh Sleep Quality Index (PSQI). The severity of skin lesions was assessed by Psoriasis Area Severity Index (PASI). The presence of a link between clinical variables and with demographic data has been investigated. Psoriasis was linked to depression, interaction and audience anxiety, as well as to poor sleep quality; 37.5% of patients were depressed, 46.1% scored above 37 at the IAS, 47.1% scored above 33 at the AAS. Thirty-nine subjects (38.2%) presented a PSQI ≥ 5. An association between interaction anxiety and lower limbs psoriasis-related erythema as well as between PSQI and head psoriasis-related erythema was found, particularly among male patients. Hence, psoriatic patients should be assessed from a holistic point of view, in order to identify associated disorders that could benefit from targeted treatments.

To what extent is quality of life impaired in vitiligo? A multicenter study on Italian patients using the dermatology life quality index.

BACKGROUND: It is believed that vitiligo has an impact on the overall patient quality of life (QoL). OBJECTIVE: To estimate QoL in a fairly large sample of Italian vitiligo patients by using the Dermatology Life Quality Index (DLQI) questionnaire. METHODS: One hundred and sixty-one vitiligo patients referred to 9 dermatological centers were offered to participate by filling in the Italian version of the DLQI questionnaire. RESULTS: The mean total DLQI score was 4.3 (SD ±4.9; range: 0-22). In multivariate analysis, DLQI >5 was associated with female gender, stability of the disease over time and involvement of the face at disease onset. CONCLUSIONS: The impairment of QoL is overall limited in Italian vitiligo patients, especially if it is compared with results from other available studies. This could be due to cultural and ethnic characteristics of the sample.

Circulating autoantibodies and autoimmune comorbidities in vitiligo patients: a multicenter Italian study.

BACKGROUND: Autoimmune comorbidities and circulating autoantibodies have been observed in vitiligo patients, but differences in rate are present according to countries in which the studies were performed, perhaps owing to ethnic diversities or different trigger factors. OBJECTIVE: To estimate the prevalence of circulating autoantibodies and overt autoimmune diseases in a fairly large sample of Italian vitiligo patients. METHODS: 175 outpatients affected by vitiligo and referred to nine dermatological centers were included in the study. Patients were offered routine blood test, serological testing for thyroid function and search for autoantibodies. RESULTS: At least one circulating autoantibody was detected in 61 (41.8%) of 146 subjects who underwent laboratory tests. Anti-thyroperoxidase (25.6%), anti-thyroglobulin (23.4%), antinuclear antibodies (16.8%) and anti-gastric parietal cell antibodies (7.8%) were the most noticed autoantibodies. 74 (41.5%) autoimmune comorbidities, mainly autoimmune thyroiditis (37%), were reported. CONCLUSION: The prevalence of autoimmune comorbidities and circulating autoantibodies in this study was in agreement with other surveys conducted on Caucasian patients.

Evaluation of the vascular pattern in psoriatic plaques in children using videodermatoscopy: an open comparative study.

Psoriasis is a common erythematous desquamative dermatosis. The diagnosis may sometimes be troublesome in children, especially if clinical presentation is mild or atypical. Videodermatoscopy has been suggested as a new noninvasive aid for the diagnosis of psoriasis, prognostic evaluation, and treatment monitoring. An open comparative study in children aimed at assessing the correlation between the vascular pattern evaluated using videodermatoscopy and the clinical diagnosis of psoriasis and other erythematous desquamative disorders was designed and performed. Sixty Caucasian children were enrolled and subdivided into two groups: group A, 24 patients with multiple plaque psoriasis; group B, 36 patients with other erythematous desquamative disorders. At least two lesions were examined in each patient using videodermatoscopy at 150× magnification and the superficial vascular pattern of each lesion was evaluated in three different fields. In group A, the presence of dilated capillaries with a "bushy" aspect, homogeneously distributed in all examined fields, was seen in all considered plaques. In group B, videodermatoscopic findings were not specific, showing normal-looking capillaries, slightly dilated vessels, or a few isolated "bushes." Videodermatoscopy may be considered an important adjunct diagnostic tool in clinically doubtful erythematous desquamative lesions in children, allowing a psoriatic vascular pattern to be confirmed or excluded, with some distinct advantages over skin biopsy.

Impact of Attachment Style and Temperament Traits on the Quality of Life of Patients with Psoriasis.

BACKGROUND: Psoriasis is a chronic inflammatory skin disease with manifestations that go beyond the visual manifestation, and include psychological aspects. Some mental disorders or personality traits in psoriasis patients have also been highlighted, such as a negative or problematic attitude towards life, impulsive or avoidant behavior, and lower satisfaction with life. The aim of our cross-sectional study was to explore the associations between adult attachment, temperament, and quality of life of patients with psoriasis. METHODS: A sample of 75 patients with psoriasis was evaluated with the Attachment Style Questionnaire (ASQ) to study adult attachment, the Temperament Evaluation of Memphis, Pisa, and San Diego Auto-questionnaire (TEMPS-A) to study temperament traits, and the Dermatology Life Quality Index (DLQI) to study the impact of dermatological diseases on patients' lives. RESULTS: Depressive, cyclothymic, and irritable temperaments were found to be significantly positively associated with a need for approval and preoccupation with relationships subscales of the ASQ. The severity of skin disease effect on the patient's life was higher in women than in men. Moreover, a statistically significant effect of the need for approval subscale of the ASQ was found. The positive correlation between the severity of skin disease effect on the patient's life with a need for approval was statistically significant and stronger in women than in men. CONCLUSIONS: A better understanding of the impact of mental comorbidities on psoriasis and vice versa places an ever-greater responsibility on dermatologists involved in the management of psoriasis to recognize these problems and collaborate with psychologists and psychiatrists to help these patients.

Effectiveness and Safety After a Switch to Tildrakizumab: A Real World Multicenter Italian Study in Psoriasis.

INTRODUCTION: Tildrakizumab is a humanized IgG1κ monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, approved in 2018 for the treatment of patients with moderate-to-severe chronic plaque psoriasis. OBJECTIVES: This study aimed to evaluate the effectiveness, safety and survival of tildrakizumab in the medium term (48 weeks) in psoriatic patients failure to previous biologic treatment in a real world setting. METHODS: This was a retrospective, multicenter observational study that included adult patients with moderate-to-severe plaque psoriasis, failure to previous biologic therapy, consecutively treated with tildrakizumab. Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA) values were recorded at baseline, at 12 and 48 weeks of treatment. Safety and tolerability of tildrakizumab were investigated by examining the presence of any adverse events. RESULTS: Overall 51 patients were enrolled. Baseline disease severity was moderate to severe with a mean PASI score of 19.2 ± 8.5, mean BSA of 16 ± 10.4, and mean Dermatology Life Quality Index (DLQI) of 18.2 ± 6.8. A significant reduction in the mean PASI score was detected at 12 weeks of tildrakizumab therapy (3.5 ± 2.7, P < 0.001), with a further improvement at week 48 (0.6 ± 1.5, P < 0.001). At week 12, there was a great improvement in BSA score for all groups (P <0.001) with further increase at week 48. The effectiveness was confirmed also by DLQI assessment, with a significant decrease at week 12 and even more at week 48 (P <0.001). CONCLUSIONS: This study confirms the effectiveness of tildrakizumab in daily clinical practice in patients with moderate-to-severe plaque psoriasis.

Efficacy of Secukinumab in Psoriasis: Post Hoc Gender-Wise Analysis of the SUPREME Study.

Purpose: Psoriasis, a common systemic inflammatory disorder, presents with gender-related differences in the quality of life (QoL) and treatment outcomes. This post hoc analysis from the Phase 3b SUPREME study explored gender-related differences in patient characteristics and efficacy of secukinumab 300 mg on Psoriasis Area and Severity Index (PASI) 75/90/100 and impact on QoL using the Dermatology Life Quality Index (DLQI) in patients with moderate to severe psoriasis through week 24. Patients and Methods: The proportion of patients achieving PASI 75/90/100 was computed using a nonresponder imputation approach. Differences between cohorts were analyzed using a logistic regression model. The mean change from baseline in DLQI was computed using the Wilcoxon test. Results: Among the 433 patients (males: 71.6%), females had a higher DLQI than males at baseline (13.1 vs 9.5; P<0.0001). Males had a slightly higher response for PASI 90 than females at week 16 (80.7% vs 78.1%; P=0.0779) and 24 (83.2% vs 79.7%; P=0.0319). No differences were observed between genders in PASI 100/75 responses at week 24. Both genders showed an improvement in DLQI with secukinumab at week 24 (-10.9 vs -8.1, respectively, in females vs males; P=0.0004). Conclusion: In summary, secukinumab was effective in the treatment of psoriasis, irrespective of gender.