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Purpose of the article: The aim of this multicenter observational study is to report data from real world on the use of bimekizumab in patients aged ≥ 65 years with moderate-to-severe plaque psoriasis. Elderly patients are poorly represented in clinical trials on bimekizumab for plaque psoriasis, and real-world studies are important to guide clinical choices., Materials and methods: A retrospective multicenter study was conducted in 33 dermatological outpatient clinics in Italy. Patients aged ≥ 65 years, with moderate-to-severe plaque psoriasis and treated with bimekizumab were enrolled. No exclusion criteria were applied. Bimekizumab was administered following the Italian Guidelines for the management of plaque psoriasis and according to the summary of product characteristics, in adult patients who were candidates for systemic treatments. Overall, 98 subjects were included, and received bimekizumab up to week 36. Clinical and demographic data were collected before the initiation of treatment with bimekizumab. At baseline and each dermatological examination (4, 16, and 36 weeks), clinical outcomes were measured by the following parameters: (1) PASI score; (2) site-specific (scalp, palmoplantar, genital, nail) Psoriasis Global Assessment (PGA). At each visit, the occurrence of any adverse events (AEs) was recorded, including serious AEs and AEs leading to bimekizumab discontinuation., Results: The mean PASI score was 16.6 ± 9.4 at baseline and significantly decreased to 4.3 ± 5.2 after 4 weeks ( p  < 0.001), and 1.1 ± 1.7 after 16 week ( p  < 0.001). This level of improvement was maintained after 36 weeks ( p  < 0.001). PASI ≤2 was recorded in 36 (36.7%) at week 4, 68% and 69.4% at week 16 and 36, respectively. By week 16, 86/98 (87.8%) patients reached PASI75, 71/98 (72.4%) obtained PASI90, and 52/98 (53.1%) PASI100. Binary logistic regression tests showed a significant association of PASI100 by week 4 with lower PASI at baseline. PASI 100 at 16 or 36 weeks was not associated with baseline PASI, obesity, age, gender, previously naïve state, and presence of psoriatic arthritis. Patients naïve to biologics at baseline had similar response to bimekizumab as non-naïve subjects., Conclusions: Bimekizumab is a suitable option for elder patients as it is effective, tolerated and has a convenient schedule.

Aim: Abrocitinib is a JAK-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD). We conducted a 16-week multicenter retrospective study to assess the short-term effectiveness and safety of abrocitinib in patients with moderate-to-severe AD., Our retrospective study included 85 adult patients from 14 Italian Dermatology Units affected by moderate-to-severe AD treated with abrocitinib 100/200 mg., Methods: Effectiveness of abrocitinib at weeks 4 and 16 was assessed by using the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA), the peak pruritus and sleep- Numerical Rating Scale (PP-NRS and S-NRS, respectively)., Results: At week 16, improvement of at least 90% in EASI (EASI90) and IGA 0/1 was observed in 49.4% and 61.2% of patients, respectively. A reduction of at least 4 points in PP-NRS and S-NRS compared with baseline was achieved by 70.6% of patients for both endpoints. No significant safety reports were observed during the study period. Naïve patients had better rates of EASI 90 compared to patients who previously failed dupilumab. Conclusion: Our data confirm the effectiveness of abrocitinib in a real-world setting with better clinical responses at weeks 4 and 16, compared with Phase-III clinical trials. Longer analyses are required to further establish the safety profile of abrocitinib.

Purpose: Tildrakizumab is a selective inhibitor of IL-23 approved for the treatment of moderate-to-severe plaque psoriasis in two dosages. We conducted a 16-week multicenter retrospective study to compare the effectiveness and safety of tildrakizumab 200 mg versus tildrakizumab 100 mg in patients with a high disease burden or high body weight., Materials and Methods: Our retrospective study included 134 patients treated with tildrakizumab 200 mg and 364 patients treated with tildrakizumab 100 mg from 28 Italian Dermatology Units affected by moderate-to-severe plaque psoriasis. The patients had a body weight above 90 kg or a high disease burden (Psoriasis Area and Severity Index [PASI] ≥ 16 or the involvement of difficult-to-treat areas). We evaluated the effectiveness of tildrakizumab at the week-16 visit in terms of PASI90, PASI100 and absolute PASI ≤ 2., Results: After 16 weeks of treatment with tildrakizumab 200 mg, PASI90 was reached by 57.5% of patients and PASI100 by 39.6% of patients. At the same time point, 34.3% and 24.2% of patients treated with tildrakizumab 100 mg achieved PASI90 and PASI100, respectively., Conclusions: Our data suggest that tildrakizumab 200 mg has better effectiveness than tildrakizumab 100 mg in patients with a body weight ≥ 90 kg and a high disease burden.

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 is currently available to inform clinical decisions., Objectives: To describe the long-term effectiveness and safety of dupilumab up to 48 months in patients with moderate-to-severe AD., Methods: A multicentre, 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 a 90% reduction in Eczema Area and Severity Index score, itch-numeric rating scale (NRS) score ≤ 1, sleep-NRS score ≤ 1 and Dermatology Life Quality Index ≤ 1] were investigated., Results: In total, 2576 patients were enrolled from June 2018 to July 2022. MDA optimal treatment target criteria were achieved by 506/2309 (21.9%), 769/1959 (39.3%), 628/1247 (50.4%), 330/596 (55.4%) and 58/106 (54.7%) 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 (AEs) were mild and were observed in 373/2364 (15.8%), 166/2066 (8.0%), 83/1291 (6.4%), 27/601 (4.5%) and 5/110 (4.5%) 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. AEs led to treatment discontinuation in < 1% of patients during the evaluated time periods., Conclusions: The 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 (persisting or relapsing) at baseline. Further research will be needed to investigate the effect of T helper cell 2 comorbidities and disease duration on the response to dupilumab and other newer therapeutics for AD., Competing Interests: Conflicts of interest The authors declare no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists.)

Introduction: Patients with psoriasis who have failed multiple biologic drugs have been defined as "multi-failure," although there are no clear data on the characteristics, comorbidities, and best treatment strategies for this population. Nowadays, given the next generation and the number of biologics available, patients are considered multi-failure when ≥4 biologics fail to achieve a good response., Methods: Demographic characteristics and efficacy of anti-interleukin drugs in multi-failure patients were compared to a cohort of general psoriatic patients treated with IL-23 or IL-17 inhibitors., Results: In total 97 multi-failure patients (≥4 lines of biologics) were compared with 1,057 patients in the general cohort. The current drugs in the multi-failure group were risankizumab (34), ixekizumab (23), guselkumab (21), brodalumab (7), tildrakizumab (5), ustekinumab (4), secukinumab (2), and certolizumab pegol (1). A significant difference was found in the multi-failure cohort for age of psoriasis onset (mean 29.7 vs. 35.1, P < 0.001), concurrent psoriatic arthritis (45.4 vs. 26.9%, P < 0.001), diabetes mellitus (30.9 vs. 10.9%, P < 0.001), and cardiovascular comorbidity (54.6 vs. 39.8%, P = 0.005). In multi-failure patients, current biological therapy showed a good initial response (PASI 90 and 100 of 41.24 and 27.84%, respectively, at 16 weeks); the response tended to decline after 40 weeks. Anti-IL-17 agents showed clinical superiority over IL-23 agents in terms of achieving PASI90 at 28 weeks (P < 0.001) and 40 weeks (P = 0.007), after which they reached a plateau. In contrast, IL-23 agents showed a slower but progressive improvement that was maintained for up to 52 weeks. A similar trend was also seen for PASI100 (28 weeks P = 0.032; 40 weeks P = 0.121)., Conclusions: The multi-failure patient is characterized by many comorbidities and longstanding inflammatory disease that frequently precedes the introduction of systemic biologic therapy. Further studies are needed to identify more specific criteria that could be applied as a guideline by clinicians., (© 2024 The Authors. International Journal of Dermatology published by Wiley Periodicals LLC on behalf of the International Society of Dermatology.)

Introduction: The development of several effective biological drugs for moderate-to-severe plaque psoriasis has dramatically changed the lives of patients. Despite the wide use of interleukin (IL) inhibitors, limited data are available to date regarding long-term treatment persistence., Method: This multicenter retrospective real-world study evaluated 5932 treatment courses across 5300 patients, all treated with interleukin inhibitors. Drug survival was expressed by using the Kaplan-Meier estimator for each biological drug at 6, 12, 24, 36 and 48 months. We also stratified by discontinuation associated with primary or secondary ineffectiveness., Results: In our study, the most prescribed drugs were secukinumab (1412), ixekizumab (1183), and risankizumab (977). After four years of follow-up, risankizumab emerged as the treatment with the highest drug survival overall, as 91.6% of patients were still on treatment. The overall probability of drug survival at four years was comparable for tildrakizumab (83.5%), ixekizumab (82.6%), guselkumab (82.4%) and brodalumab (81.8%). When evaluating only patients who discontinued the treatment because of ineffectiveness, once again risankizumab was the molecule with the highest drug survival at 4 years (93.4%), this time followed by ixekizumab (87%). Our study, in which all IL inhibitors were adequately represented, confirmed a slightly better treatment persistence for IL-23 inhibitors, consistent with other real-world studies., Conclusion: Our experience showed that IL-23 inhibitors, and risankizumab in particular, had a higher probability of drug survival overall during a 4-year follow-up. Risankizumab and ixekizumab were less likely to be discontinued because of ineffectiveness after four years., Competing Interests: LG has been a consultant for Almirall. LI has been a consultant for Almirall. PM has been a speaker for AbbVie, Lilly, Novartis, Janssen-Cilag, Celgene, Leopharma and Almirall. AB has received honoraria for participation in advisory boards, meetings or as speaker for AbbVie, Celgene, Janssen-Cilag, Eli Lilly, Novartis Pharma, Pfizer, Sanofi-Genzyme and UCB Pharma. FB has been a consultant advisor and clinical study investigator for Eli Lilly, Abbvie, Novartis, Leo Pharma, Sandoz, Bristol Myers, Abiogen-Pharma, Celgene and Janssen. MB has acted as a speaker and consultant for AbbVie, Janssen, Amgen, Novartis, Eli Lilly and UCB Pharma. CC has served as a board participant or speaker for Abbvie, Lilly, Janssen, Novartis, Celgene, Almirall and Leopharma. GD served as consultant and/or speaker for AbbVie, Almirall, Bristol-Meyers Squibb, LeoPharma, Novartis, Pfizer, Sanofi and UCB and received unrestricted grants from Pfizer and Almirall. PD has been a speaker for Novartis, Abbvie, Sanofi, UCB, Janssen, Lilly and LeoPharma. FG acted as a speaker or consultant for Novartis, Abbvie, Eli Lilly, Celgene, LeoPharma and Almirall. GG served as consultant and/or speaker for AbbVie, Almirall, Amgen, Biogen, Boehringer-Ingelheim, Bristol-Meyers Squibb, Eli-Lilly, LeoPharma, Novartis, Pfizer, Samsung, Sanofi and UCB. CG has been a scientific consultant/speaker/clinical study investigator for Abbvie, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, Sanofi, Almirall and LEO Pharma. CL declares a conflict of interest with Abbvie, Novartis, Lilly and Almirall. FL served on advisory boards and/or received honoraria for lectures from Abbvie, Janssen-Cilag, Novartis, Lilly and Sanofi. AM reports consultancy/advisory boards disease-relevant honoraria from AbbVie, Boehringer-Ingelheim, Novartis, Pfizer, Sanofi and UCB. MM acted as a speaker or consultant for Abbvie, Eli Lilly, Janssen, Leo-Pharma, UCB and Novartis. AC has served as an advisory board member, consultant and has received fees and speaker’s honoraria or has participated in clinical trials for Abbvie, Almirall, Biogen, LEO Pharma, Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme and UCB-Pharma. AN has served on advisory boards, received honoraria for lectures and research grants from Almirall, Abbvie, Leo Pharma, Celgene, Eli Lilly, Janssen, Novartis, Sanofi-Genzyme, Amgen and Boehringer Ingelheim. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Gargiulo, Ibba, Malagoli, Balato, Bardazzi, Burlando, Carrera, Damiani, Dapavo, Dini, Gaiani, Girolomoni, Guarneri, Lasagni, Loconsole, Marzano, Megna, Mercuri, Travaglini, Costanzo and Narcisi.)

Purpose: Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A approved for the treatment of moderate-to-severe plaque psoriasis. The objective of this study was to describe the real-world long-term effectiveness of ixekizumab in patients with plaque psoriasis in Italy., Materials and Methods: A retrospective study was conducted in patients affected by moderate-to-severe plaque psoriasis who were continuously treated with ixekizumab for at least 12 months. Patient data was obtained at 4-weeks, 12-weeks and 6-, 12-, 18- and 24-months after baseline (June 2017 and September 2019) from 10 sites. Results were analyzed by complete case approach, with sensitivity analysis performed to evaluate the impact of missing data., Results: A total of 198 patients were enrolled in the study. At Month 24, 94.3% of patients achieved PASI75 response, while 85.1 and 71.8% achieved PASI90 and PASI100, respectively; and 91.1% of the patients achieved absolute PASI score ≤2. Patients experienced psoriasis improvement at 4 weeks after starting treatment, and improvement was maintained with continued ixekizumab use. The quality of life of patients also improved significantly starting at Week 12, with sustained effect in the long term., Conclusion: This 24-month observational cohort study confirmed that ixekizumab is effective in the long-term management of patients with moderate-to-severe plaque psoriasis.

Background: Tildrakizumab is a humanized monoclonal antibody that binds selectively the p19 subunit of interleukin-23. It is approved for treatment of moderate-severe chronic plaque psoriasis., Objectives: We conducted a 52-week retrospective study to assess the effectiveness and safety of tildrakizumab in a real-life setting., Methods: Our retrospective study included 237 consecutive adults with moderate-to-severe plaque psoriasis, enrolled in 10 different Italian centres, treated with tildrakizumab up to Week 52. Patient characteristics, comorbidities, previous treatments and the PASI (Psoriasis Area and Severity Index) score at each visit (baseline, Week 16, Week 28 and Week 52) were retrieved from the electronic medical records. The percentages of patients achieving 75%, 90% and 100% (PASI 75, PASI 90 and PASI 100) improvement in PASI with respect to baseline PASI were registered., Results: At Week 52, 90.91%, 73.55% and 58.68% of patients achieved a PASI reduction ≥75% (PASI 75), PASI 90 and PASI 100, respectively. An absolute PASI ≤ 2 was reached by 85.95% at Week 52. Compared with Phase 3 clinical trials, we observed similar rates of PASI 75/90 responses and higher percentages of patients achieving PASI 100. Patients who had not responded to previous biologic treatments and patients with cardio-metabolic comorbidities were significantly more likely to achieve PASI 100 at Week 28 and PASI 90 at Week 52. The higher body mass index did not interfere with the odds of reaching PASI 75/90/100 at each time point. No significant safety findings were recorded throughout the study, and none of the patients had to interrupt the treatment because of adverse events., Conclusion: Our data suggest that the efficacy of tildrakizumab for plaque psoriasis in 'real-life' clinical practice is comparable with Phase 3 clinical trials with higher percentages of patients achieving complete skin clearance (PASI 100) at Weeks 16, 28 and 52., (© 2022 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Background: Psoriasis is a chronic immune-mediated inflammatory skin disease which can also involve joints. It is often associated with burdensome comorbidities which negatively impact prognosis and quality of life (QoL). Biologic agents have been shown to be effective in controlling disease progression, but their use is associated with higher costs compared with traditional systemic treatments. The economic analysis of the CANOVA (EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: an obserVAtional longitudinal study of real-life clinical practice) study aims to assess the costs and cost-effectiveness of biologics in a real-world context in Italy., Methods: The annualised overall direct costs of moderate-to-severe plaque psoriasis management, the annualised cost of biologic drugs and the cost per responder in the Italian National Health System perspective were assessed. More specifically, the cost per response and cost per sustained response of the most prescribed biologic therapies for the treatment of moderate-to-severe plaque psoriasis within the CANOVA study were assessed using the Psoriasis Area Severity Index (PASI) at several score levels (75, 90 and 100%)., Results: The most frequently used biologic therapies for plaque psoriasis were secukinumab, ustekinumab, adalimumab originator, and ixekizumab. Cost of biologics was the driver of expenditure, accounting for about 98% of total costs. Adalimumab originator was the biologic with the lowest cost per responder ratio (range: €7848 - €31,378), followed by secukinumab (range: €9015 - €33,419). Ustekinumab (range: €11,689 - €39,280) and ixekizumab (range: €11,092 - €34,289) ranked respectively third and fourth, in terms of cost-effectiveness ratio. As concerns the cost per sustained response analysis, secukinumab showed the lowest value observed (€21,375) over the other options, because of its high response rate (86% vs. 60-80%), which was achieved early in time., Conclusion: Biologic therapy is a valuable asset for the treatment of moderate-to-severe plaque psoriasis. Concomitant assessment of treatment costs against the expected therapeutic response over time can provide physicians and payers additional insights which can complement the traditional risk-benefit profile assessment and drive treatment decisions., (© 2021. The Author(s).)

Background: During the recent COVID-19 outbreak, masks became mandatory and shortages frequent, therefore the prevalence of non-CE (European Conformity Mark) approved masks increased in the general population. We aimed to quantify the prevalence of mask-related cutaneous side effects and the differences between CE and non-CE approved masks., Methods: In this multicenter prospective observational study conducted from March 20, 2020 to May 12, 2020(during and after quarantine), patients attending emergency departments for a dermatological consult were clinically assessed and their masks were inspected to detect CE marks and UNI (Italian National Unification Entity) norms. Patients with history of facial dermatoses or under current treatment for facial dermatoses were excluded., Results: We enrolled 412 patients (318 during quarantine and 94 after quarantine). CE-approved masks were observed 52.8% vs. 24.5%, whilst subsets of non-CE approved masks were 9.7% vs. 14.9% (Personal protective equipment (PPE)-masks), 16.4% vs. 12.8% (surgical masks [SM]), and 21.1% vs. 47.9%(non-PPE) and (non-SM masks), respectively during and after quarantine. Remarkably, non-CE-approved masks resulted in patients displaying a statistically significant higher incidence of facial dermatoses and irritant contact dermatitis compared to CE-approved masks, and these differences were mainly driven by non-PPE non-SM masks. Comparing quarantine and after quarantine periods, no statistically significant differences were found for CE-approved masks, whilst differences were detected in non-CE-approved masks regarding incidence of facial dermatoses (P<0.0001)and irritant contact dermatitis (P=0.0041)., Conclusions: Masks are essential to prevent COVID-19 but at the same time higher awareness regarding mask specifications should be promoted in the general population. Non-PPE and non-SM masks should undergo more rigorous testing to prevent the occurrence of cutaneous side effects and future patients' lawsuit damages.

Geographic tongue (GT) represents a localized type of psoriasis inversa and its burden of dermatological and oral comorbidities frequently conditions its severity and diagnosis. Currently, no epidemiological studies have evaluated GT muco-cutaneous comorbidities. We aimed to study oral and dermatological comorbidities in a large sample of GT patients. In this multicenter, cross-sectional study, involving 4 primary referral centers in Italy, we evaluated adult GT patients, who were assessed by board certified dermatologists and dentists for 5 months and collected demographics and medical history. GT was evaluated using Hume's classification together with Geographic tongue severity index (GTASI) to score its severity. The prevalence of oral and dermatological comorbidities was recorded. In the sample we enrolled 137 GT patients (M/F= 5:1) with a mean age of 48,2 ± 14,7 yoa and 33.6% had GT family history. The clinical evaluation found 96 (70.1%) GT type I, 7 (5.1%) type II, 13 (9.5%) type IIIa, 19 (13.9%) type IIIb, 2 (1.5%) type IV, following Hume's classification. The mean GTASI score was 23,7 ± 14,2 and the vast majority displayed a severe form of GT. Eighty-nine patients had oral comorbidities (burning mouth syndrome, caries, parulid and lichen planus) and 80 had dermatological concurrent conditions (plaque psoriasis, inverse psoriasis and atopic dermatitis). In GT patients, both dermatological and dental evaluation should be mandatory to identify previously undiagnosed mucocutaneous comorbidities., (Copyright 2020 Biolife Sas. www.biolifesas.org.)

Introduction: Whether biologic therapies enhance the risk of coronavirus 2019 (COVID-19) or affect the disease outcome in patients with chronic plaque psoriasis remains to be ascertained., Objective: We sought to investigate the incidence of hospitalization and death for COVID-19 in a large sample of patients with plaque psoriasis receiving biologic therapies compared with the general population., Methods: This is a retrospective multicenter cohort study including patients with chronic plaque psoriasis (n = 6501) being treated with biologic therapy and regularly followed up at the divisions of dermatology of several main hospitals in the Northern Italian cities of Verona, Padua, Vicenza, Modena, Bologna, Piacenza, Turin, and Milan. Incidence rates of hospitalization and death per 10,000 person-months with exact mid-p 95% CIs and standardized incidence ratios were estimated in the patients with psoriasis and compared with those in the general population in the same geographic areas., Results: The incidence rate of hospitalization for COVID-19 was 11.7 (95% CI, 7.2-18.1) per 10,000 person-months in patients with psoriasis and 14.4 (95% CI, 14.3-14.5) in the general population; the incidence rate of death from COVID-19 was 1.3 (95% CI, 0.2-4.3) and 4.7 (95% CI, 4.6-4.7) in patients with psoriasis and the general population, respectively. The standardized incidence ratio of hospitalization and death in patients with psoriasis compared with those in the general population was 0.94 (95% CI, 0.57-1.45; P = .82) and 0.42 (95% CI, 0.07-1.38; P = .19), respectively., Conclusions: Our data did not show any adverse impact of biologics on COVID-19 outcome in patients with psoriasis. We would not advise biologic discontinuation in patients on treatment since more than 6 months and not infected with severe acute respiratory syndrome coronavirus 2 to prevent hospitalization and death from COVID-19., (Copyright © 2020 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Knowledge regarding differences in care for psoriatic patients is limited. The aim of this study was to investigate factors influencing prescription of systemic treatments for patients with psoriasis with a special focus on socioeconomic factors., Methods and Findings: This was a non-interventional, cross-sectional study, conducted in 18 Italian University and/or hospital centers with psoriasis-specialized units. Questionnaires evaluating demographic and socioeconomic characteristics were administered to participants. Overall, 1880 consecutive patients affected by mild-to-severe psoriasis were recruited. Univariate and multivariable logistic regression analyses of systemic therapy prescription, with a special focus on biologics, accounting for the above mentioned characteristics were performed. Our analysis showed that all analyzed patients' characteristics were significantly associated with biological therapy compared to non-biological systemic one. Particularly, women were less likely to receive biologics than men (OR = 0.66; 95% CI, 0.57-0.77). Elderly patients (≥65 years) and subjects with a BMI ≥30 had lower odds to receive biologics respect to adults (≥35-64 years) (OR = 0.33; 95% CI, 0.25-0.40), and subjects with BMI≥25<30 (OR = 0.64; 95% CI, 0.53-0.77), respectively. Northern and Southern patients were both less likely to receive biologics than Central patients (OR = 0.75; 95% CI, 0.63-0.89, and OR = 0.56; 95% CI,0.47-0.68, respectively). Lower economic profile and never reading books were both associated with decreased odds of receiving biological therapy., Conclusions: This study shows that sex, age, comorbidities, and socioeconomic characteristics influence the prescription of systemic treatments in psoriasis, highlighting that there are still unmet needs influencing the therapeutic decision-making process that have to be addressed., Competing Interests: P. Amerio has been a scientific consultant for Abbvie, Eli-Lilly, Jannsen, Celgene, Galderma, LEO-Pharma, Sanofi Genzyme and Alfa Wasserman. F. Bardazzi has been a scientific consultant/speaker/clinical study investigator for AbbVie, Celgene, Janssen, LEOPharma, Eli-Lilly, MSD, Novartis and Pfizer. L. Bianchi has been a scientific consultant/speaker for Abbvie, Janssen, Celgene, Pfizer, UCB, Novartis, Sanofi Genzyme and LEO-Pharma. A. Campanati has been a scientific consultant/speaker/clinical study investigator for AbbVie, Celgene, Janssen, LEO-Pharma, Eli-Lilly, MSD, Novartis, Pfizer and Sanofi. S.P. Cannavò has been a scientific consultant/speaker for AbbVie, Celgene, Eli-Lilly, Janssen, LEO-Pharma, Novartis and Sanofi. A. Chiricozzi has been a scientific consultant/speaker/clinical study investigator for Abbvie, Biogen, Fresenius Kabi, LEO-Pharma, Eli-Lilly, Novartis, UCB, Sanofi and Janssen. A. Conti has been a scientific consultant for Abbvie, Eli-Lilly, Janssen Cilag, LEO-Pharma, UCB and Sandoz. P. Dapavo has been a scientific consultant/speaker for Novartis, Abbvie, Eli-Lilly, Celgene, LEOpharma and Janssen. C. De Simone has been a scientific consultant/speaker/clinical study investigator for AbbVie, Almirall, Amgen, Celgene, Janssen, LEO-Pharma, Eli-Lilly, MSD, Novartis, Pfizer, Sanofi and Sun Pharma. M. Esposito has been a scientific consultant/speaker for Abbvie, Novartis, Eli-Lilly, Biogen, LEO-Pharma. M.C. Fargnoli has been a scientific consultant/speaker/clinical study investigator for AbbVie, Celgene, Janssen, LEO-Pharma, Eli- Lilly, Novartis, Pfizer, Sanofi, Galderma, Almirall, Mylan, UCB and Regeneron. C. Guarneri has been a scientific consultant/speaker/clinical study investigator for Wyeth-Pfizer, Abbott Immunology-Abbvie, Janssen-Cilag, Novartis, LEO-Pharma, Eli-Lilly, Celgene and Merck-Serono. K. Hansel has been a scientific consultant/speaker/clinical study investigator for AbbVie, Eli- Lilly, Novartis, Sanofi and Admiral. P. Malagoli has been a scientific consultant/speaker/clinical study investigator for AbbVie, Amgen, Biogen, Celgene, Janssen, LEO-Pharma, Eli-Lilly, Novartis. G. Micali has been a scientific consultant/clinical study investigator for Abbvie, Eli-Lilly, Janssen- Cilag, LEO-Pharma and Novartis. C. Mugheddu has been a speaker/clinical study investigator for Abbvie, Celgene, Boehringer Ingelheim, Janseen, Novartis and LEO-Pharma. A. Offidani has been a scientific consultant/speaker/clinical study investigator for AbbVie, Celgene, Janssen, LEOPharma, Eli-Lilly, MSD, Novartis, Pfizer, Sanofi, Alfasigma and Almirall. F. Prignano has been a scientific consultant/adviser/clinical study investigator for Eli-Lilly, Abbvie, Novartis, LEOPharma, Abiogen-Pharma, Celgene and Janssen-Cilag. F. Rongioletti has been a scientific consultant/speaker/clinical study investigator for AbbVie, Boehringer, Celgene, Janssen, LEOPharma, Eli-Lilly, Novartis and Sanofi. L. Stingeni has been a scientific consultant/speaker/clinical study investigator for AbbVie, Celgene, Eli-Lilly, Novartis, Almirall and Sanofi. A. Balato has been a scientific consultant/speaker/clinical study investigator for AbbVie, Celgene, Janssen, Eli-Lilly, Novartis, Pfizer, Sanofi and UCB. The remaining authors declare no conflicts of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

SARS-CoV-2 become pandemics and there is still a dearth of data about its the potentially among dermatological patients under biologics. We aimed to assess health literacy, disease knowledge, treatment dissatisfaction and biologics attitudes toward COVID-19. We performed a cross-sectional, questionnaire-based survey on 98/105 consecutive dermatological patients treated with biologics-51 suffering from plaque psoriasis, 22 from atopic dermatitis, and 25 from hidradenitis suppurativa. An ad hoc, validated questionnaire has 44 items investigating the following domains: knowledge of COVID-19 related to (a) epidemiology, (b) pathogenesis, (c) clinical symptoms, (d) preventive measures, and (e) attitudes. Patients data and questionnaires were collected. Despite only 8.1% thought that biologics may increase the risk of COVID-19, 18.4% and 21.4% of the patients were evaluating the possibility to discontinue or modify the dosage of the current biologic therapy, respectively. Globally, male patients (P = .001) with higher scholarity level (P = .005) displayed higher knowledge of COVID-19. Patients with lower DLQI (P = .006), longer disease duration (P = .051) and lower scholarity (P = .007) have thought to discontinue/modify autonomously their biologic therapy. At the multivariate logistic regression, only the knowledge of epidemiology and preventive measures resulted independent predictors of continuation vs discontinuation and modification vs no modification, respectively. Dermatologists should promote COVID-19 knowledge to prevent biologics disruption., (© 2020 Wiley Periodicals LLC.)

Background: Ixekizumab (anti-IL-17A) is a biological agent used for the treatment of moderate-to-severe psoriasis. Real-life data on the effectiveness and safety of ixekizumab are currently scarce., Objective: The objective of this study was to evaluate the effectiveness and safety of ixekizumab in a cohort of psoriatic and psoriatic arthritis patients., Methods: We conducted a retrospective study involving 201 patients affected by moderate-to-severe psoriasis and treated with ixekizumab at seven Italian University centers. Data analysis focused on 110 patients who started ixekizumab at baseline and completed at least 24 weeks of treatment., Results: Significant reduction of mean (± standard deviation) baseline Psoriasis Area Severity Index (PASI) score (14.3 ± 5.8) was detected at 4 weeks of ixekizumab therapy (4.9 ± 4.2, p < 0.001), with a further significant improvement at weeks 12 and 24 (1.9 ± 2.9 and 0.9 ± 1.6, respectively) (p < 0.001). Our analysis showed 90%, 72%, and 57% of patients achieving PASI 75, 90, and 100 responses (75%, 90%, and 100% reduction in PASI score), respectively, after 24 weeks' therapy. For patients with arthritis (28%), a significant reduction in the mean (± standard deviation) baseline Disease Activity Score (DAS)-28 score (4.6 ± 5.1) was detected at week 4 (2.5 ± 3.9, p < 0.01), with a further significant improvement at weeks 12 and 24 (2.1 ± 1.2 and 1.4 ± 0.9, respectively) (p < 0.001). The bio-naïve group showed significantly higher PASI 90 and 100 response rates at week 12 than the bio-exposed one (p < 0.05). This trend in terms of PASI 100 response was also maintained at week 24 (p < 0.05). Furthermore, PASI 90 responses were significantly higher in anti-interleukin (IL)-17A-naïve patients at week 24 than in anti-IL-17A-experienced ones (p < 0.05). The dropout rate for adverse events (AEs) was as low as 2% (2/110), while AEs that did not cause treatment interruption were observed in 6% (7/110). Patients withdrawing from the study were defined as non-responders according to the non-responder imputation method. The retrospective design of the study does not allow missing data to be retrieved or homogeneous patient selection., Conclusions: The present study illustrates ixekizumab in real-world clinical practice, confirming its usefulness and safety in the management of psoriasis and psoriatic arthritis.

Background: Switching between biologics is commonly performed for the management of plaque psoriasis. However, no evidence about switching from secukinumab to ustekinumab has been reported., Methods: This retrospective observational multicenter study aimed to describe efficacy and safety of ustekinumab in secukinumab nonresponder patients., Results: A total of 21 patients unresponsive to secukinumab were treated with ustekinumab for a mean period of 53.3 weeks. Ustekinumab was effective in reducing disease severity, with significant improvements of both psoriasis area severity index (PASI) and dermatology quality of life index (DLQI) scores. PASI score improvements of 31.8, 44, 77.8, 80.3, 80.5, and 89.6%, at week 4, 12, 24, 36, 48, and above 60 weeks, respectively, were detected (p < 0.05), achieving PASI 50, 75, and > 90 responses in 93.8, 87.5, and 50% of patients at week 48. Four patients withdrew from ustekinumab treatment because of inefficacy, and failure of multiple biologic agents (> 2) seemed to affect ustekinumab drug survival. No serious adverse events (AEs) were reported while 38.1% of patients experienced mild AEs., Conclusion: Ustekinumab was safe and effective in treating patients unresponsive to secukinumab., (© 2019 S. Karger AG, Basel.)

Purpose of the article: Baricitinib, a JAK 1/2 inhibitor, is approved for treating severe alopecia areata (AA). This study aimed to evaluate the long-term effectiveness and safety of baricitinib in a real-world setting over 52 weeks., Materials and methods: This multicenter retrospective study included 96 adult patients diagnosed with severe AA from 11 Italian Dermatology Units. All patients received 4 mg of baricitinib daily. Effectiveness was assessed using the Severity of Alopecia Tool (SALT) score, with the primary endpoint defined as achieving a SALT score ≤ 20 at week 52. Secondary endpoints included achieving a Clinician-Reported Outcome (ClinRO) score of 0 or 1 for eyebrow (ClinRO EB) and eyelash hair loss (ClinRO EL), with a ≥ 2-point improvement from baseline., Results: After 52 weeks, 61.5% of patients achieved a SALT score ≤ 20. Additionally, 67.6% and 69.7% of patients attained ClinRO EB and ClinRO EL scores of 0 or 1, respectively, with a ≥ 2-point improvement. No significant adverse safety events were reported during the study., Conclusions: The study confirms the long-term effectiveness and safety of baricitinib for severe AA in a real-world setting. These findings align with clinical trial results and reinforce baricitinib's role as a viable treatment option for severe AA.

HLA polymorphisms of class I (HLA-A, B, C) of class II (HLA-DR, DQ) and of class III (C4A, C4B, BF) were investigated in 93 Northern Italian patients affected with vitiligo and in 388 controls. Vitiligo patients had significant increases in HLA-A30 (corrected p, pc = 0.0144), Cw6 (pc = 0.0189), DQw3 (pc less than 0.0003) and a significant decrease in C4AQ0 (pc = 0.003). Nonfamilial vitiligo is marked by increases in HLA-A30 and DQw3. Extensive vitiligo is marked by increases in HLA-A30 and Cw6. These findings suggest that immunogenetic mechanisms may be responsible for vitiligo and that unique HLA phenotypes may influence the expression of vitiligo in this population.