Search

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.

Real-world data on the effectiveness and safety of tildrakizumab, an interleukin 23p19 inhibitor, in Switzerland is limited. The objectives of this analysis were to assess the effectiveness and safety of tildrakizumab in patients with moderate-to-severe plaque psoriasis in Switzerland. Twenty-eight adults from the Swiss Dermatology Network for Targeted Therapies registry (SDNTT), who were on tildrakizumab treatment and had at least 3 months' follow-up, were enrolled in this prospective, multicentre study. No missing data imputation was performed. The median Psoriasis Area and Severity Index (PASI) decreased from 9.5 at baseline to 2.1 and 0.3 (both p < 0.001) after 3 and 18 months, respectively, of tildrakizumab treatment. After 3 months, 76.9%/30.8% patients reached an absolute PASI <  3/ < 1. These rates increased to 85.7%/57.1% after 18 months of treatment. The proportions of patients achieving PASI 90/100 responses were 47.8%/30.4% at month 6 and 42.9%/14.3% at month 18. A significant improvement in quality of life up to 18 months of follow-up was observed as measured by the Dermatology Life Quality Index. There were no treatment discontinuations due to adverse events. This real-world registry provides robust evidence supporting the long-term effectiveness and favourable safety profile of tildrakizumab in treating patients with moderate-to-severe psoriasis.

(1) Background/Objectives: Nail psoriasis (NP) is a chronic and difficult-to-treat disease, which causes significant social stigma and impairs the patients' quality of life. Moreover, nail psoriasis is a true therapeutic challenge for clinicians. The presence of nail psoriasis can be part of a severe form of psoriasis and can have predictive value for the development of psoriatic arthritis. Our real-world-evidence multicenter study aims to evaluate the efficacy of bimekizumab in nail psoriasis. (2) Methods: A retrospective analysis of a multicenter observational study included 834 patients affected by moderate-to-severe psoriasis, in 33 Dermatologic Units in Italy, treated with bimekizumab from December 2022 to September 2023. Clinimetric assessments were based on Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and Physician's Global Assessment of Fingernail Psoriasis (PGA-F) for the severity of nail psoriasis at 0, 12, 24, and 36 weeks. (3) Results: Psoriatic nail involvement was present in 27.95% of patients. The percentage of patients who achieved a complete clearance of NP in terms of PGA-F 0 was 31.7%, 57%, and 88.5% at week 4, 16, and 36, respectively. PASI 100 was achieved by 32.03% of patients at week 4, by 61.8% at week 16, and by 78.92% of patients at week 36. The mean baseline PASI was 16.24. The mean DLQI values for the entire group of patients at baseline, at week 4, at week 16, and at week 36 were 14.62, 3.02, 0.83, and 0.5, respectively. (4) Conclusions: Therapies that promote the healing of both the skin and nails in a short time can also ensure a lower risk of subsequently developing arthritis which is disabling over time. Bimekizumab proved to be particularly effective to treat NP, with a fast response in terms of complete clearance, with over 88.5% of patients free from NP after 36 weeks. The findings of our real-world study showed that patients with moderate-to-severe PsO and concomitant NP had significantly faster and more substantial improvements in NP up to 36 weeks with respect to previous research findings. Considering the rapid healing of the nail, the dual inhibition of IL17 A and F might have a great value in re-establishing the dysregulation of keratin 17 at the nail level.

Introduction: The efficacy and safety of tildrakizumab for the treatment of plaque psoriasis were demonstrated by randomized clinical studies, but the reappraisal of prolonged experiences in the clinical practice helps to optimize the use of this biologic drug. The aim of this study was to evaluate the long-term efficacy of tildrakizumab in patients with moderate-to-severe psoriasis in the real world., Methods: This is a long-term retrospective observational study in a real-life setting. Overall, 136 adult patients with moderate-to-severe plaque psoriasis and treated with tildrakizumab were included., Results: One hundred percent reduction of Psoriasis Area Severity Index (PASI100) was reached by 21.7% of patients at 4 weeks of therapy and by 51.2% at week 16, and the proportion of patients with this improvement was between 66.9% and 64.5% from 36 weeks to 3 years. The mean PASI of the cohort progressively improved from 12.6 at baseline to 1.8 at week 36 and was stable at 1 year, 2 years and 3 years. We could not confirm a previous observation that patients naïve to biologic had a better response, but we observed that those with a short history of psoriasis had a higher probability of 90% PASI reduction (PASI90) or PASI 100 within 36 weeks, suggesting that early treatment could be useful., Conclusion: This long-term observation in the real life of patients with moderate-to-severe plaque psoriasis receiving tildrakizumab 100 mg showed that PASI100 can be obtained in a high proportion of patients by week 36 and be maintained for up to 3 years., (© 2024. The Author(s).)

Immune-mediated comorbidities in patients with psoriasiform eczema are common. It can be challenging to manage multiple immune-mediated diseases, especially considering that biologic treatments are prone to causing paradoxical effects. The aim of this retrospective observational case series was to describe the course of both psoriasiform eczema and immune-mediated comorbidities in five patients treated with upadacitinib for psoriasiform dermatitis. Five patients, all male, were included. All the patients suffered from psoriasiform eczema. Moreover, two of the patients suffered from alopecia areata, two from vitiligo, one from ulcerative colitis and one from hidradenitis suppurativa. In all cases, the treatment with upadacitinib was rapidly effective on the eczema. The effectiveness on alopecia areata was good in both cases, while the results on vitiligo were only partial. The only case of ulcerative colitis achieved complete remission, while the case of hidradenitis suppurativa experience partial improvement. In conclusion, upadacitinib was effective in treating not only psoriasiform eczema, but also several immune mediated comorbidities. Additional studies are necessary to determine the efficacy of upadacitinib in alopecia areata, vitiligo and hidradenitis suppurativa., Competing Interests: The 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 Salvi, Parodi, Cozzani and Burlando.)

Background: Trypanophobia or "needle phobia" represents a potential hindrance to the effective management of chronic diseases whenever an injectable therapy might be required, especially in case of frequent administrations. Psoriasis, a chronic dermatologic disease, can be effectively treated with biologic drugs administered subcutaneously. Thankfully, anti-IL-23 drugs require few administrations per year and are available in prefilled pens that hide the needle, thus representing a convenient option in patients with trypanophobia., Methods: An observational multicentric study was conducted on patients with moderate-to-severe psoriasis who were treated with 75 mg × 2 risankizumab prefilled syringe therapy for more than 6 months and reported a loss of efficacy measured by the Psoriasis Area and Severity Index (PASI) from PASI 90 to PASI 75 attributed to a reduction of adherence due to trypanophobia. The patients were switched to 1 prefilled pen of risankizumab 150 mg and asked to fill out the Self-Injection Assessment Questionnaire (SIAQ) before and after the injection at week 0 and at the following administration after 12 weeks. Subjects scored each item of the SIAQ on a 5-point scale, scores were later transformed from 0 (worst experience) to 10 (best experience)., Results: Twenty-two patients were enrolled. The mean SIAQ predose domain scores were 5.5 for feelings about injection, 6.2 for self-confidence, and 6.4 for satisfaction with self-injection. After dose scores were higher (> 8.5) for each of the six domains at Week 0 and even higher after 12 weeks (> 9.0)., Conclusions: User-friendly devices, such as prefilled pens, and a lower number of injections improved patient satisfaction in a group of patients with psoriasis on treatment with biologic drugs. We believe that treatment adherence could be positively influenced by such changes in the way of administration of a biologic treatment., (© 2024 The Author(s). Skin Research and Technology published by John Wiley & Sons Ltd.)

Background: Psoriasis is a chronic inflammatory skin condition that affects millions of individuals worldwide, impacting their physical and emotional well-being. The management of psoriasis requires effective communication and a strong physician-patient relationship. Objective: We aim to develop a novel algorithm to enhance patient well-being and care in moderate-to-severe psoriasis, considering the time constraints that dermatologists have in public hospitals. Methods: This project employed a multidisciplinary approach, involving collaboration between 14 experienced dermatologists (referred to as Key Opinion Leaders: KOLs) and a psychologist. During three separate meetings (an initial virtual session, a face-to-face meeting, and a final virtual meeting), an algorithm (Embracing Patients' Well-being in their Journey of Moderate-to-Severe psoriasis: EMPATHY), describing the patient's reception through the entire first visit and follow-up visits, was developed and refined. Results: The EMPATHY algorithm provides a step-by-step approach from the moment the patient arrives at reception, through the first visit and on to subsequent visits. This algorithm fills a critical gap in the existing guidelines by specifically addressing how to foster empathy during psoriasis patient visits within time-limited consultations. The algorithm outlines patient-centered strategies at each visit. Key aspects include creating a welcoming environment, active listening, respecting privacy, tailoring communication styles, and managing patient expectations. Conclusions: The EMPATHY algorithm represents a novel and promising approach to improving patient care and well-being in moderate-to-severe psoriasis. Developed together by dermatologists and a psychologist, this algorithm offers healthcare providers practical guidance for managing both initial and follow-up patient visits. While further validation is necessary, the potential for adapting the EMPATHY algorithm to diverse healthcare settings and patient populations holds promise for improving patient outcomes across various chronic conditions.

Background : Psoriatic disease, a chronic immune-mediated systemic inflammatory condition, significantly impairs patients' quality of life. The advent of highly targeted biological therapies has transformed treatment strategies, emphasizing the importance of selecting the most effective and cost-efficient option. Secukinumab, an IL-17A inhibitor, has demonstrated efficacy and safety in treating moderate-to-severe plaque psoriasis (PsO). However, long-term real-world data on its effectiveness and persistence rate are limited. Methods : This retrospective study, conducted across eight Italian dermatology centers, aimed to evaluate the 6-year persistence rate and effectiveness of secukinumab in patients with PsO. Additionally, the study investigated the onset of psoriatic arthritis during treatment. Results : Overall, 166 adult patients were analyzed. Their median age was 53.9 years. The mean BMI was 26.5. Of the 166 patients, 64 were bio-experienced while 102 were bio-naïve. A progressive reduction in PsO severity measured by PASI scores over 6 years of treatment was revealed: the PASI score decreased from a baseline value of 18.1 (±9.1) to 0.7 (±1.6) after 6 years of follow-up. Adverse events, including mucocutaneous fungal infections and cardiovascular disturbances, were reported in 19.9% of patients. The persistence rate was 86.8% at 24 months, decreasing to 66.4% at 72 months. Psoriatic arthritis onset during treatment was observed in 15 (9.0%) of patients. Conclusions : This study highlights the sustained effectiveness and favorable safety profile of secukinumab over 6 years, providing valuable real-world evidence. Understanding the long-term persistence rate and predictors of discontinuation could help clinicians optimize treatment decisions and improve patient outcomes in PsO management. We found that the absence of scalp PsO, no involvement of the genital area and normal weight were the best factors of persistence in secukinumab treatment in the long term.

Introduction: The introduction of biological therapies has revolutionized the treatment of moderate-to-severe plaque psoriasis. In particular, ixekizumab, an inhibitor of interleukin-17A, has shown great results in terms of efficacy and safety in both clinical trials and real-world experiences. However, there is a lack of long-term real-world data available for ixekizumab., Methods: We conducted a multicenter real-life study to evaluate the effectiveness and safety of ixekizumab in patients with moderate-to-severe plaque psoriasis. Psoriasis Area and Severity Index score (PASI) was collected at baseline and after 1, 2, 3, 4, and 5 years. The occurrence of any adverse events was recorded at each time point., Results: We enrolled 1096 patients treated with ixekizumab for at least 1 year. At week 52, the percentages of PASI 90 and PASI 100 were 85.04% and 69.07%, respectively. After 5 years of treatment with ixekizumab, out of 145 patients, a PASI 90 response was achieved by 86.90% of patients, while complete skin clearance was reached by 68.28% of patients. We did not observe any new significant safety findings throughout the study period., Conclusion: This study supports the long-term effectiveness and safety of ixekizumab in a real-world setting., (© 2024. The Author(s).)

Introduction: There are several treatment options for plaque psoriasis (PsO), but uncertainty remains around the optimal sequencing of treatments. The aims of this study were to investigate how adopting a best-treatment-first treatment sequence impacts patient outcomes and healthcare systems and to quantify the cost of treatment failure to the healthcare system., Methods: A 3-year state-transition treatment-sequencing model which identifies all possible treatment sequences in PsO was adapted to the Italian healthcare setting. Treatments considered in the model are those with European Medicines Agency marketing authorization and reimbursement in Italy as of December 2022. Italian market share data (2019-2021) and list prices (2022) informed the current prescribed sequences; these sequences were compared against all possible sequences to determine opportunities for improvement. Both the national perspective in Italy as well as the local perspective from seven regions were considered. The cost of treatment failure was informed through a questionnaire circulated to Italian dermatologists., Results: Overall, 1284 possible treatment sequences are possible when four lines of treatment are considered for patients with moderate-to-severe PsO in Italy. Within the estimated range of treatment failures across those sequences (0.97-2.56 per patient over 3 years), current prescribing behavior from the national perspective suggests patients will face 1.44 failures on average; this highlights the potential for improvement. For every treatment failure, the cost borne by the Italian National Healthcare Service (NHS) is €676.80. Overall, prescribing more optimized treatment sequences results in a 22.95% reduction in failures with a 2.27% increase in costs. The regional analyses found similar trends., Conclusions: Results suggest that selecting the most effective treatment sequences for incident patients provides the greatest opportunity to reduce treatment failures and maximize patient outcomes with a modest impact on costs. While regional variations exist, there is room for improvement across the board, which could translate to more efficient local healthcare systems., (© 2024. The Author(s).)

Introduction: Genital involvement is observed in approximately 60% of patients with psoriasis, presenting clinicians with formidable challenges in treatment. While new biologic drugs have emerged as safe and effective options for managing psoriasis, their efficacy in challenging-to-treat areas remains inadequately explored. Intriguingly, studies have shown that interleukin (IL)-17 inhibitors exhibit effectiveness in addressing genital psoriasis., Objectives: We aimed to determine the effectiveness profile of bimekizumab in patients affected by moderate-to-severe plaque psoriasis with involvement of genitalia., Methods: Bimekizumab, a dual inhibitor of both IL-17A and IL-17F, was the focus of our 16-week study, demonstrating highly favorable outcomes for patients with genital psoriasis. The effectiveness of bimekizumab was evaluated in terms of improvement in Static Physician Global Assessment of Genitalia (sPGA-G) and Psoriasis Area and Severity Index., Results: Sixty-five adult patients were enrolled. Remarkably, 98.4% of our participants achieved a clear sPGA-G score (s-PGA-g = 0) within 16 weeks. Moreover, consistent improvements were observed in Psoriasis Area and Severity Index scores, accompanied by a significant reduction in the mean Dermatology Life Quality Index, signifying enhanced quality of life. Notably, none of the patients reported a severe impairment in their quality of life after 16 weeks of treatment. In our cohort of 65 patients, subgroup analyses unveiled that the effectiveness of bimekizumab remained unaffected by prior exposure to other biologics or by obesity., Conclusions: Our initial findings suggest that bimekizumab may serve as a valuable treatment option for genital psoriasis. Nevertheless, further research with larger sample sizes and longer-term follow-up is imperative to conclusively validate these results.

Introduction: The introduction of biologics for the treatment of plaque psoriasis is one of the major therapeutic advances of the last decades in dermatology. The efficacy of this class of drugs can be influenced by multiple factors including obesity, being overweight, prior treatment failures, and disease severity., Areas Covered: Most of the currently available approved biologics are limited by their lack of dosing flexibility for adapting the therapy to the complexity of real-world patients with psoriasis. Among the class of anti-interleukin-23, tildrakizumab allows a greater dosing flexibility, increasing clinical benefits of patients with high burden of the disease or body weight >90 kg., Expert Opinion: This meta-opinion discusses the clinical data that were foundational for tildrakizumab dosage flexibility, elaborates on the definition of high burden of disease specifically linked to tildrakizumab dosage, and profiles the ideal patient that could benefit from treatment with the higher approved tildrakizumab dosage of 200 mg.

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.)

Background: Risankizumab is a humanized monoclonal antibody that selectively inhibits interleukin-23. It has been approved for moderate-to-severe plaque psoriasis and has shown efficacy and safety in clinical trials and real-world experiences. This study aimed to evaluate the long-term effectiveness, safety, and drug survival of risankizumab in a real-life setting., Materials and Methods: We included patients treated with risankizumab from January 2019 to February 2023. A Psoriasis Area and Severity Index score (PASI) was collected at weeks 0, 16, 28, 52, 104, and 156, when available. The occurrence of any adverse events was recorded at each visit., Results: We enrolled 1047 patients. At week 52, a ≥90% improvement in PASI was observed in 81.44% of patients, with a continuous improvement throughout the study (88.99% and 99.07% at weeks 104 and 156, respectively). After three years of treatment, all patients involving the scalp, palms/soles, and genitalia and 95% of patients with nail psoriasis achieved a complete or almost complete skin clearance. No significant safety findings were observed, and 90.73% of the patients were still on treatment after 36 months., Conclusions: This study supports the long-term effectiveness and safety of risankizumab in a real-world setting, even in patients involving difficult-to-treat areas.

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.)

Psoriasis is a chronic disease, involving skin and joints, characterized by inflamed lesions. Psoriasis negatively impacts the patients' quality of life due to the physical, emotional, and social burden that accompanies this condition. Also, psoriasis is associated with a number of psychiatric comorbidities, including sexual dysfunctions. The present study investigates the variables associated with sexual functioning in psoriasis patients. One-hundred-three psoriasis patients and 101 matched control subjects took part in the present study. Each participant completed five self-report measures investigating the presence of depression, anxiety and stress symptoms, body image, quality of life, and sexual experience. Our results show that differences in sexual activity, but not in sexual functioning, emerged between groups. In men with psoriasis, more sexual difficulties were associated with more negative automatic thoughts about sexuality. In women, more sexual difficulties were associated with more negative automatic thoughts; anxiety, depression, and stress; severity of symptoms; comorbid disease; age; quality of life. Our findings expand the current knowledge about sexual functioning in psoriasis and shed light on specific cognitive, psychological, and demographic variables associated with sexual impairment in men and women with psoriasis.

A nationwide cross-sectional online survey was administered to dermatologists managing patients with moderate-to-severe plaque psoriasis across Italy to obtain real-world dermatologists' perspectives on the impact of psoriasis and its treatment on patients' daily lives and quality of life (QoL). A total of 91 dermatologists (aged 39.1 ± 11.2 years) completed a 31-question survey and workshop sessions were undertaken in order to identify the best management approach to achieve patient wellbeing. Social (4.2 ± 0.1), physical (4.26 ± 0.2) and mental components (4.1 ± 0.3) were rated by dermatologists as contributing to patient wellbeing to similar extents. While a high proportion (85.4%; rating of 4.3 out of 5) of dermatologists felt that they considered the QoL of patients, a lower proportion (69.6%; rating of 3.7 out of 5) felt that patients were satisfied in this regard. The psoriasis area and severity index and body surface area were the instruments most frequently used to assess the physical domain, while interviews/questions and the dermatology life quality index were used to assess social and mental domains, with only 60% of dermatologists following up on these aspects. The importance of investigating the presence of comorbidities was recognized but not always carried out by many dermatologists, (>70%), particularly for obesity and anxiety/depression. This survey identified key components contributing to barriers impacting on the QoL of patients with moderate-to-severe psoriasis from the perspective of the dermatologist.

Atopic dermatitis and psoriasis are traditionally considered diseases that cannot coexist, since they are described as the result of the activation of opposing inflammatory pathways. However, this belief has been debunked, and numerous cases of psoriasis induced by dupilumab, a biologic treatment for atopic dermatitis, have been reported. We report three cases of dupilumab-induced psoriasis and we present a literature review including cases of "de novo" psoriasis and of the relapse of psoriasis that occurred during treatment with dupilumab. In total, 39 publications met the inclusion criteria, including 112 AD patients, 101 of whom developed "de novo" psoriasis, and 11 with a flare of pre-existent psoriasis. In the first group, patients more frequently developed plaque psoriasis on the scalp and extremities, after an average latency period from the initiation of dupilumab of 5 months. In the second group, the incidence of dupilumab-induced relapses of psoriasis was 43%, after an average of 4 months since the first administration. The most common psoriasis type was plaque psoriasis, with the involvement of the scalp and upper extremities. Dupilumab was interrupted in 38% of patients with "de novo" psoriasis and in 50% of relapsed patients, leading, in most cases, to an improvement of psoriasis. In conclusion, atopic dermatitis and psoriasis can definitely co-exist, and biologic drugs used to treat the former can promote the latter. It is thus crucial to perform a careful personal and familiar anamnesis before prescribing any biologic treatment. Moreover, a study of cytokine expression and blood proteomic markers could be considered in these patients.

Introduction: Bimekizumab is a monoclonal antibody that targets Interleukin-17 A and F, approved for the treatment of moderate-to-severe plaque psoriasis. While bimekizumab has been evaluated in several phase-III clinical trials, real-world evidence is still very limited., Method: This multicenter retrospective study included patients affected by plaque psoriasis treated with bimekizumab from May 1, 2022 to April 30, 2023, at 19 Italian referral hospitals. Patients affected by moderate-to-severe plaque psoriasis eligible for systemic treatments were included. The effectiveness of bimekizumab was evaluated in terms of reduction in psoriasis area and severity index (PASI) compared with baseline at weeks 4 and 16. The main outcomes were the percentages of patients achieving an improvement of at least 75% (PASI75), 90% (PASI90) and 100% (PASI100) in PASI score., Results: The study included 237 patients who received at least one injection of bimekizumab. One hundred and seventy-one patients and 114 reached four and 16 weeks of follow-up, respectively. Complete skin clearance was achieved by 43.3% and 75.4% of patients at weeks 4 and 16, respectively. At week 16, 86.8% of patients reported no impact on their quality of life. At week 16, there were no significant differences between bio-naïve and bio-experienced patients in terms of PASI75, PASI90 and PASI100. The most commonly reported adverse events (AEs) were oral candidiasis (10.1%). No severe AEs or AEs leading to discontinuation were observed throughout the study., Conclusion: Our experience supports the effectiveness and tolerability of bimekizumab in a real-world setting with similar results compared with phase-III clinical trials., Competing Interests: LG 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. LB has received honoraria as a speaker or consultant for AbbVie, Janssen, Almirall Eli-Lilly, Leopharma, Novartis, Sanofi, Pfizer, and UCB Pharma. GC reports consulting fees or honorarium and payment for lectures from Lilly and Novartis. CD reports consulting fees or honorarium from Abbvie, Amgen, Novartis, Celgene, Sanofi, UCB Pharma, Janssen, and Lilly and payment for lectures from Abbvie, Lilly, Novartis, UCB Pharma, and Celgene. PG has been a consultant and/or speaker for Abbvie, Almirall, Amgen, Janssen, Leo-Pharma, Eli-Lilly, Novartis, Pierre Febre, Sandoz, Sanofi, and UCB. 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. 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. AG received grants or is an investigator for Biogen and Lilly; and is a consultant/advisory board/speaker for AbbVie, Almirall, Celgene, Janssen, Leo Pharma, Eli Lilly, Merck Sharpe Dohme, Novartis, Pfizer, Sandoz, and UCB. FL served on advisory boards and/or received honoraria for lectures from Abbvie, Janssen-Cilag, Novartis, Lilly, Sanofi. AM reports consultancy/advisory boards disease-relevant honoraria from AbbVie, Boehringer-Ingelheim, Novartis, Pfizer, Sanofi, and UCB. MMe acted as a speaker or consultant for Abbvie, Eli Lilly, Janssen, Leo-Pharma, UCB, and Novartis. AO acted as a speaker and consultant for Abbvie, Eli Lilly, Novartis, Celgene, Sanofi, Galderma, Leo Pharma, and Pierre Fabre. MV served as a speaker or advisory board member for Abbvie, Almirall, Amgen, Eli-Lilly, Galderma, Leo Pharma, Novartis, Pierre Fabre, and UCB Pharma. ACo 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 © 2023 Gargiulo, Narcisi, Ibba, Balato, Bianchi, Brianti, Buononato, Burlando, Caldarola, Campanati, Campione, Carrera, Carugno, Cristaudo, Cusano, Dapavo, Dattola, De Simone, Gaiani, Gisondi, Giunta, Loconsole, Maione, Mortato, Marzano, Maurelli, Megna, Mercuri, Offidani, Orsini, Parodi, Pellacani, Potestio, Quaglino, Richetta, Romano, Sena, Venturini, Malagoli and Costanzo.)

Introduction: Brodalumab is a monoclonal antibody that targets the subunit A of the interleukin-17A receptor (IL17RA), inhibiting the signaling of various isoforms of the IL-17 family. It has been approved for the treatment of moderate-to-severe plaque psoriasis after being evaluated in three Phase-3 trials. However, long-term data on brodalumab in a real-life setting are still limited., Methods: The aim of this study was to evaluate the long-term effectiveness and safety of brodalumab in psoriasis. We also assessed the drug survival of brodalumab in a 3 years timespan. We conducted a retrospective multicenter study on 606 patients followed up at 14 Italian dermatology units, all treated with brodalumab according to Italian guidelines. Patients' demographics and disease characteristics were retrieved from electronic databases. At baseline and weeks 12, 24, 52, 104 and 156, we evaluated the psoriasis area and severity index (PASI) score and investigated for adverse events. The proportions of patients reaching 75, 90 and 100% (PASI 75, PASI 90 and PASI 100, respectively) improvement in PASI, compared with baseline, were also recorded., Results: At week 12, 63.53% of the patients reached PASI 90 and 49.17% PASI 100. After 3 years of treatment, 65.22% of patients maintained a complete skin clearance, and 91.30% had an absolute PASI of 2 or less. Patients naïve to biological therapies had better clinical responses at weeks 12, 24 and 52. However, after 2 years of treatment, no significant differences were observed. Body mass index did not interfere with the effectiveness of brodalumab throughout the study. No new safety findings were recorded. After 36 months, 85.64% of our patients were still on treatment with brodalumab., Conclusion: Our data confirm the effectiveness and the safety of brodalumab in the largest real-life cohort to date, up to 156 weeks., Competing Interests: The 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 © 2023 Gargiulo, Ibba, Malagoli, Amoruso, Argenziano, Balato, Bardazzi, Burlando, Carrera, Damiani, Dapavo, Dini, Fabbrocini, Franchi, Gaiani, Girolomoni, Guarneri, Lasagni, Loconsole, Marzano, Megna, Sampogna, Travaglini, Costanzo and Narcisi.)

Patients with a stoma are at risk of developing peristomal skin complications (PSCs) that can negatively impact their quality of life. This study aims to identify potential risk factors for dermatitis, pruritis/xerosis, infections, and ulcerations among patients with a stoma and evaluate preventive measures. This cross-sectional study involved data regarding 232 Italian patients with a stoma. A questionnaire was used to collect patient characteristics, comorbidities, and stoma management data. The most frequent PSCs observed were dermatitis and pruritis/xerosis in approximately 60% of patients. Psoriasis was strongly correlated with dermatitis, while being overweight or obese increased the risk of pruritis/xerosis. Class 2 obesity and atopic dermatitis were associated with an increased risk of infections. Being underweight, completely nonautonomous, and having inflammatory bowel disease were associated with a higher risk of ulcerations, while radiotherapy was a strong risk factor for ulceration. Preventive measures such as using hydrocolloid barriers, TNT gauze cleansing, and low pH detergent were effective in preventing dermatitis. Appropriate stoma care and maintenance, including the use of protective film and careful monitoring of weight and comorbidities, are crucial in minimizing the risk of complications associated with a stoma.

Brodalumab is a recombinant, fully human immunoglobulin IgG2 monoclonal antibody specifically targeted against interleukin-17RA that has been approved for the treatment of moderate-to-severe psoriasis in Europe. We developed a Delphi consensus document focused on brodalumab for the treatment of moderate-to-severe psoriasis. Based on published literature and their clinical experience a steering committee drafted 17 statements covering 7 domains specific to the treatment of moderate-to-severe psoriasis with brodalumab. A panel of 32 Italian dermatologists indicated their level of agreement using a 5-point Likert scale (from 1 = "strongly disagree" to 5 = "strongly agree") using an online modified Delphi method. After the first round of voting (32 participants), positive consensus was reached for 15/17 (88.2%) of the proposed statements. Following a face-to-face virtual meeting, the steering committee decided that 5 statements would form "main principles" and 10 statements formed the final list. After a second round of voting, consensus was reached in 4/5 (80%) of the main principles and 8/10 (80%) for consensus statements. The final list of 5 main principles and 10 consensus statements identify key indications specific to the use of brodalumab in the treatment of moderate-to-severe psoriasis in Italy. These statements aid dermatologists in the management of patients with moderate-to-severe psoriasis.

Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Background: Guselkumab is a fully human monoclonal antibody that binds selectively to the p19 subunit of interleukin-23, which has shown efficacy in patients with previous incomplete response to ustekinumab in the NAVIGATE clinical trial. [Correction added on [28-02-2023], after first online publication: 'humanized monoclonal antibody' has been changed to 'fully human monoclonal antibody' in the preceding sentence.] OBJECTIVES: We conducted a 104-week multicenter retrospective study to assess the effectiveness and safety of guselkumab in patients affected by plaque psoriasis with an inadequate response to ustekinumab in a real-life setting., Methods: Our retrospective study included 233 adults affected by moderate-to-severe plaque psoriasis, enrolled in 14 different Italian centres, and treated with guselkumab after failing therapy with ustekinumab. Patient characteristics and PASI (Psoriasis Area and Severity Index) score at each visit (baseline, weeks 16, 52 and 104) were recorded. The percentages of patients achieving 75%, 90% and 100% (PASI 75, PASI 90 and PASI 100) improvement in PASI, compared with baseline, were registered., Results: At week 52, PASI 75 was reached by 89.88% of patients, PASI 90 by 71.43%, PASI 100 by 58.83% and absolute PASI ≤2 by 90.48%. At week 104, similar effectiveness results were observed. Compared to the NAVIGATE trial, we observed higher rates of PASI 75/90/100. Patients with the involvement of difficult-to-treat areas were significantly less likely to achieve PASI90 and PASI100 at week 16. Obese patients had significantly lower rates of PASI75 and PASI ≤2 at week 52. At week 104, comparable responses were observed among all patients' subgroups, regardless of BMI status, involvement of difficult-to-treat areas, presence of cardiometabolic comorbidities and concomitant psoriatic arthritis. No significant safety findings were reported throughout the study., Conclusion: Our data suggest that the efficacy of guselkumab in patients with inadequate response to ustekinumab for plaque psoriasis in 'real-life' clinical practice is comparable with NAVIGATE study with higher percentages of patients achieving PASI90 and PASI100 at weeks 16, 52 and 104., (© 2023 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: Generalized pustular psoriasis (GPP) is a rare, severe inflammatory skin disease characterized by recurrent episodes of flares. Characteristics of patients experiencing a flare are hardly described in a real-life setting. The aim of the study is to investigate the clinical characteristics of patients experiencing a flare of GPP., Methods: Multicenter retrospective observational study on consecutive patients experiencing a flare of GPP between 2018 and 2022. Disease severity and quality of life were assessed by Generalized Pustular Psoriasis Area, Body Surface Area (BSA), and Severity Index (GPPASI), and Dermatology life quality index (DLQI) questionnaire, respectively. Visual analogue scale (VAS) of itch and pain, triggers, complications, comorbidities, pharmacological therapies, and outcome were collected., Results: A total of 66 patients, 45 (68.2%) females, mean age 58.1 ± 14.9 years, were included. The GPPASI, BSA, and DLQI were 22.9 ± 13.5 (mean ± standard deviation), 47.9 ± 29.1, and 21.0 ± 5.0, respectively. The VAS of itch and pain were 6.2 ± 3.3 and 6.2 ± 3.0, respectively. Fever (>38 °C) and leukocytosis (WBC > 12 × 10 9 /L) were found in 26 (39.4%) and 39 (59.1%) patients, respectively. Precipitating triggers were identified in 24 (36.3%) and included infections (15.9%), drugs (10.6%), stressful life events (7.6%), and corticosteroids withdrawal (3.0%). Fourteen (21.2%) patients were hospitalized because of complications including infections in 9 (13.6%) leading to death in one case and hepatitis in 3 (4.5%)., Conclusions: GPP flares can be severe and cause severe pain and itch with significant impact on the quality of life. In about one-third of patients the flare may have a persistent course and, with complications, lead to hospitalization.

Background: Xerosis is an extremely common condition, especially in the elderly population. It is the most common cause of pruritus in the older adult. Since xerosis is generally caused by a lack of epidermal lipids, the use of leave-on skin care products is the mainstay treatment. The aim of this open prospective analytical observational study was to investigate the clinical and self-reported hydrating efficacy of a moisturizer formulation containing a synergy between amino-inositol and urea (INOSIT-U 20) in patients with psoriasis and xerosis., Methods: Twenty-two patients with psoriasis successfully treated with biologic therapy, and who presented xerosis, were recruited. Each patient was instructed to apply the topical with a frequency of two applications per die on the identified skin area. Corneometry values and a VAS itch questionnaire were measured at baseline (T0) and after 28 days (T4). To evaluate the cosmetic efficacy, the volunteers also completed a self-assessment questionnaire., Results: Comparing Corneometry values at T0 and T4, a statistically significant increase value was observed in the area subjected to topical treatment (P<0.0001). A significant decrease in itch (P=0.001) was also observed. Moreover, the patients' ratings of the cosmetic properties of the moisturizer showed significant confirmation rates., Conclusions: This study provides preliminary evidence that INOSIT-U20 provides a good hydrating effect on xerosis, further reducing self-reported itch.

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., Competing Interests: L. Stingeni has acted as a speaker and board member for AbbVie, Eli Lilly, Novartis, Almirall, Celgene, Sanofi, and Janssen; G. Malara has acted as a speaker and consultant for AbbVie, Janssen, Amgen, Sanofi, Novartis, Eli Lilly, and UCB Pharma; A. Conti has acted as a consultant for AbbVie, Abbott, Amgen, Celgene, Eli Lilly, Janssen Cilag, Leo Pharma, MSD, Novartis, Sandoz, Schering Plough, UCB Pharma, and Wyeth; C.G. Carrera has reported collaboration with Novartis, AbbVie, Janssen, Lilly, and Leo Pharma; M. Burlando has served as a speaker and consultant for AbbVie, Janssen, Amgen, Novartis, Eli Lilly, and UCB Pharma; P. Malagoli has acted as a consultant or had advisory board agreements for Janssen, Amgen, AbbVie, UCB, Novartis, Lilly, Almirall, and Leo Pharma; M.L. Musumeci has served as a consultant/investigator for AbbVie, Eli Lilly, Janssen Cilag, Novartis, and Biogen; F. Bardazzi has acted as a speaker and/or consultant for Almirall, AbbVie, Celgene, Janssen, Eli Lilly, UCB Pharma, and Leo Pharma; V. Brazzelli has acted as a consultant and congress guest for Janssen Cilag SpA, Novartis, and Sanofi Genzyme; P. Amerio has received honoraria and is on the advisory board of Sanofi, Jansen, Novartis, Pfizer, Celgene, and Eli Lilly; C. De Simone has acted as a speaker and consultant for Almirall, AbbVie, Janssen, Celgene, Leo Pharma, Novartis, Eli Lilly, and UCB Pharma; S. Trevisini has served as a speaker for AbbVie, Novartis, and Janssen; A. Balato has served as speaker and/or consultant for AbbVie, Lilly, and Sanofi; M. Megna has served as a speaker or consultant for AbbVie, Eli Lilly, Novartis, Janssen, and Leo Pharma; M. Bartezaghi employees of Novartis; A. Rausa was an employee of Novartis during study conduct and manuscript submission. She approved the final version to be submitted while she was working for Novartis; E. Aloisi and R. Orsenigo are employees of Novartis; A. Costanzo has served as a speaker and consultant for AbbVie, Eli Lilly, Novartis, Almirall, Celgene, Sanofi, Janssen, and Pfizer. The authors report no other conflicts of interest in this work., (© 2023 Stingeni et al.)

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.)

This study aimed to evaluate if patients under biologics have a lower risk of psoriasis flares after coronavirus disease 2019 (COVID-19) vaccination than other psoriatic patients. Of 322 recently vaccinated patients admitted for psoriasis at the Dermatological Psoriasis Unit during January and February 2022, 316 (98%) had no psoriasis flares after COVID-19 vaccination (79% under biologic treatment, 21% not biologically treated) and 6 (2%) presented psoriasis flares after COVID-19 vaccination (33.3% under biologic treatment, 66.6% not biologically treated). Overall, psoriasis patients under biologic treatment, developed fewer psoriasis flares after COVID-19 vaccination (33.3%), than patients not under biologic treatment (66.6%) (p=0.0207; Fisher's exact test)., Competing Interests: No potential conflict of interest relevant to this article was reported., (© Korean Vaccine Society.)

Dimethyl fumarate (DMF) was recently approved by the European Medicines Agency for systemic treatment of moderateto- severe chronic plaque psoriasis. Appropriate management of DMF treatment is required to achieve optimal clinical benefits. 7 dermatology experts gathered online for 3 meetings to identify consensus on the use of DMF in patient selection, drug dosage/titration, side effects management, and follow-up, with the aim to provide guidance on the use of DMF for psoriasis in clinical dermatological practice based on literature data and expert opinion. 20 statements were discussed and voted on using a facilitator- mediated modified Delphi methodology. Strong consensus was reached for all statements (agreement level of 100%). DMF treatment is characterized by dosage flexibility, sustained efficacy, high rates of drug survival, and low potential for drug-drug interactions. It can be used in a broad range of patients, including the elderly or those with comorbidities. Side effects (mainly gastrointestinal disorders, flushing, and lymphopenia) are frequently reported but are generally mild and transient and can be minimized by dosage adjustments and a slow titration schedule. Hematologic monitoring throughout the treatment course is required to reduce the risk of lymphopenia. This consensus document provides clinical dermatologists with answers on the optimal use of DMF to treat psoriasis., Competing Interests: Conflict of interest: MB, served as a consultant and received fees and speaker's honoraria from AbbVie, Almirall, Amgen, Eli Lilly, Janssen, Leo Pharma, Novartis, and UCB. EC, served as a consultant for Almirall, BMS, Amgen, and UCB; GM, reports no conflict of interest. AC, has been an advisor board member and/or consultant and/or received speakers’ honoraria and/or received grants and/or received research support and/or participated in clinical trials with the following pharmaceutical companies: Almirall, Amgen, Eli Lilly, Janssen- Cilag, Novartis; LN, has received honoraria as a scientific consultant for AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, IBSA, Janssen, Leo, Lilly, Novartis, Pfizer, and Sanofi; FP, served as advisory board member and consultant and received fees and speaker's honoraria or has participated in clinical trials for AbbVie, Almirall, Biogen, Boehringer-Ingelheim, Leo Pharma, Lilly, Janssen, Novartis, and Sanofi Genzyme; LZ, received honoraria as a scientific consultant for AbbVie, Almirall, Leo, Lilly, and Novartis. Informed consent: the manuscript does not contain any individual person’s data in any form., (©Copyright: the Author(s).)

Background: Psoriasis is associated with multiple comorbidities, including cardiovascular disease. Identifying biomarkers such as N-terminal fragment of the BNP precursor (NT-pro-BNP) with preventive, diagnostic, and prognostic implications in the cardiovascular diseases of psoriatic patients may be helpful in these patient's management. However, their predictive ability for future cardiovascular events in psoriatic patients is still unknown. Therefore, the study aimed to determine whether NT-pro-BNP levels were increased in psoriatic patients., Methods: One hundred forty psoriatic patients without cardiovascular disease and 140 healthy control patients were enrolled., Results: The NT-pro-BNP level was significantly correlated with lipid profile but not with disease duration; or the ongoing biologic therapy., Conclusions: Our work demonstrates that pro-BNP values are higher in patients with psoriasis than in controls and emphasizes the correlation between psoriasis and cardiovascular disease and the importance of biomarkers that can identify those patients most at risk of developing cardiovascular disease.

Competing Interests: None disclosed.

Introduction: There is limited evidence to guide clinicians on the treatment of psoriasis with biologics in patients with a history of malignancy who are often excluded from clinical trials investigating biologics. The aim of this work is to report a multicenter real-life experience of secukinumab treatment in patients with psoriasis and a personal history of cancer., Methods: This retrospective observational study included adult patients with moderate-to-severe plaque psoriasis treated with secukinumab for at least 24 weeks and a previous diagnosis of cancer at 15 Italian referral centers. The primary endpoint of the study was tumor recurrence or progression and new cancer diagnosis during treatment. Secondary outcome assessment of secukinumab effectiveness (reduction of Psoriasis Area and Severity Index [PASI] score, improvement of Dermatology Life Quality Index [DLQI], itch and pain)., Results: Forty-two patients (27 male) were included. Malignancy was diagnosed in the previous 5 years in 21 (56.8%) and in the previous 10 years in 37 (88.1%). The mean interval between cancer diagnosis and the start of secukinumab treatment was 3.5 ± 3.3 years. No tumor recurrence nor progression occurred over a mean of 56 ± 31.7 weeks of treatment. Three patients developed a new malignancy not related to the previous cancer. At week 48, PASI 90 was reached by 64.7% of patients and PASI 100 by 38.2%. Mean DLQI, itch, and pain VAS scores significantly improved during treatment., Conclusions: Our multicenter real-life experience is the largest reported to date focusing on a specific biologic and adds evidence to the safety of secukinumab in psoriatic patients with a personal history of cancer., (© 2022. The Author(s).)

This study aimed to compare adalimumab originator vs. biosimilar in HS patients, and to evaluate the effect of a switch to a biosimilar, or a switch back to the originator, in terms of treatment ineffectiveness. Patients with a diagnosis of HS were enrolled from 14 Italian sites. Treatment ineffectiveness was measured using Hurley score. The major analyses were 1) comparison between the two treatment groups (non-switcher analysis), and 2) the cross-over trend of Hurley score between treatment switchers (switcher analysis). Cox and Poisson regression models were used to compare the treatment ineffectiveness between groups. A total of 326 patients were divided into four groups: 171 (52.5%) taking originator; 61 (18.7%) patients taking biosimilar; 66 (20.2%) switchers; 28 (8.6%) switchers from originator to biosimilar and switched. A greater loss of efficacy was observed in the group allocated to the biosimilar than the originator group. The switcher analysis showed an effectiveness loss in the biosimilar compared to the originator. These results seem to indicate that a switch from one drug to the other may lead to a greater risk of inefficacy. A return to the previous treatment also does not ensure efficaciousness.

Background: Psoriasis has a significant impact on quality of life and affects the sexual sphere in 25-70% of patients. The aim of this study is to determine the prevalence of sexual dysfunction in female patients with psoriasis and to assess the possible correlation of sexual dysfunction with disease severity, genital involvement, age and some comorbidities., Methods: In this prospective case-control study, all female patients with psoriasis followed at three Psoriasis Outpatient Services were divided into two groups depending on psoriasis severity assessed by the Psoriasis Area Severity Index. Both psoriatic patients and female controls without psoriasis were given the Female Sexual Function Index (FSFI) questionnaire., Results: One hundred forty female patients with psoriasis were evaluated, 70 with mild disease and 70 with moderate-severe disease, and compared with 70 female controls without psoriasis. According to FSFI Score, prevalence of sexual dysfunctions was significantly higher in moderate-severe psoriatic patients compared to controls. Psoriatic women under the age of 46 presented lower FSFI scores than women over 46. No correlation between genital localization of psoriasis and worsening of sexual health was found. Diabetes mellitus and hypertension were significantly associated with sexual dysfunction, whereas the smoking habit did not significantly affect the sexual sphere of these patients., Conclusions: Sexual dysfunction should be routinely investigated in female patients with psoriasis in the case of moderate-severe disease due to its negative impact on quality of life, especially in younger women and in presence of diabetes mellitus and hypertension.

This open-label multicentre trial evaluated the efficacy and safety of oral dimethyl fumarate (DMF) in patients with moderate-to-severe plaque psoriasis in real-life clinical practice over 52 weeks. Disease severity and improvement were assessed using the psoriasis area severity index (PASI), body surface area (BSA) affected, and Physician Global Assessment (PGA). Quality of life (QoL) was assessed using the Dermatology Life Quality Index (DLQI) questionnaire. The visual analogue scale (VAS) was used to quantify pruritus and measure treatment satisfaction. A total of 141 patients were included, being 66.7% male, aged 49.1 ± 14.7 years and with disease duration of 16 ± 12.1 years. After 52 weeks, mean PASI decreased from 15.9 ± 6.8 to 1.5 ± 2 and 87.7%, 56.9% and 24.6% of patients achieved PASI 75/90/100 response, respectively. BSA decreased from 26.5 ± 14.8% to 2.7 ± 3.5% at 52 weeks, and 81.5% of patients had a PGA 0-1. DLQI scores decreased from 9.4 ± 6.4 to 2.1 ± 3.3, and VAS of pruritus decreased from 53 ± 28.4 to 19.1 ± 26.2 at Week 52. VAS for treatment satisfaction was 79.4 ± 29.4 at Week 52. A total of 34.2% of patients had an AE leading to permanent discontinuation. These findings show that DMF can significantly improve indices of disease severity, pruritus and QoL, with high levels of patient satisfaction and similar safety profile to other fumarates., Competing Interests: The authors declare no conflict of interest.