BACKGROUND/OBJECTIVES:The concept of super responders (SRs) has gained increasing attention in psoriasis. However, evidence focusing exclusively on risankizumab remains limited. This multicenter, international, real-world study aimed to assess the prevalence, predictors, and long-term maintenance of SR status among patients with moderate-to-severe plaque psoriasis treated with risankizumab. METHODS:A retrospective observational study was conducted across 10 Italian and Portuguese referral centers. SRs were defined as patients achieving complete skin clearance (PASI 0) at week 20. Predictors of SR achievement and maintenance were assessed using multivariate logistic regression models at weeks 52, 104, and 130 (2.5 years). RESULTS:A total of 1372 patients were included (mean PASI 14.9 ± 8.2). At week 20, 610 (44.5%) achieved PASI 0 and were classified as SRs; 84.4% maintained this status at week 52 and 64.9% at 2.5 years. Biologic-naïve status (OR 1.65; p < 0.001) predicted SR achievement, whereas palmoplantar psoriasis (OR 0.58; p = 0.005) and higher BMI (OR 0.96; p = 0.011) negatively influenced it. Biologic-naïve status remained the strongest predictor of long-term maintenance (OR 2.87; p = 0.003). CONCLUSIONS:Risankizumab demonstrated high and sustained long-term effectiveness, inducing rapid and sustained complete clearance in a substantial proportion of patients.

Background: Guselkumab, a monoclonal antibody selectively targeting the p19 subunit of interleukin-23, is typically administered with an induction phase at weeks 0 and 4 followed by maintenance dosing every 8 weeks for the treatment of psoriatic arthritis (PsA). In Europe, a four-week regimen (Q4W) has recently been approved for patients at high risk of joint damage progression; however, real-world evidence on this intensified schedule remains limited. This study aimed to evaluate the effectiveness and safety of guselkumab Q4W in routine clinical practice. Methods: This retrospective observational study included 18 PsA patients at high risk of structural damage treated with guselkumab Q4W at two psoriasis referral centers in the Lazio region of Italy. Baseline and 24-week clinical data were collected from medical records. Outcome measures included Disease Activity Index for Psoriatic Arthritis (DAPSA), Minimal Disease Activity (MDA), pain Visual Analog Scale (VAS), Dermatology Life Quality Index (DLQI), and Psoriasis Area and Severity Index (PASI). Results: After 24 weeks, mean DAPSA decreased from 34.3 ± 7.6 to 3.7 ± 3.0; 55.6% of patients achieved DAPSA remission and 77.8% achieved MDA. Significant improvements were observed in pain VAS, DLQI, and PASI scores. All patients achieved PASI 75, while 83.3% achieved PASI 90 and PASI 100. Treatment was generally well tolerated, with no adverse events or new safety signals documented during follow-up. Conclusions: In our study, guselkumab Q4W showed marked multidomain effectiveness and a favorable safety profile, supporting its use in PsA patients at high risk of joint damage progression.

Objectives: To evaluate the impact of non-invasive imaging techniques such as dermoscopy, reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) to monitor the efficacy of risankizumab on plaque psoriasis of the legs by analyzing morpho-histological changes. Materials and Methods: Multicentre, real-world retrospective study involving 37 adults with moderate-to-severe plaque psoriasis. Assessments performed during routine visits at baseline, Week 4 and Week 12 included clinical response, dermoscopy, RCM and OCT. Results: Thirty-seven patients were included (mean age 52.1 years; 54% male; mean BMI 27.0 kg/m2). Dermoscopy showed progressive vascular normalization: at Week 12, 94.29% of lesions had minimal or no vascular pattern. White and yellow scales decreased significantly. On RCM, dilated vessels, inflammatory infiltrate, and papillomatosis progressively normalized. OCT showed reduction in epidermal and stratum corneum thickness and a decline in vascular intensity at multiple depths. Baseline haemorrhagic dots predicted early complete response: 44.8% of lesions with dots achieved complete clearance at Week 4 versus 0% without. Conclusions: Risankizumab induced rapid, significant regression of psoriatic changes, normalizing vascular patterns and skin architecture and reducing epidermal thickness. Findings support its efficacy and rapid onset of action in difficult-to-treat areas and highlight the value of non-invasive imaging for monitoring.

Introduction: Emotional dysregulation (ED), common among patients with psoriasis, lead to psychopathology and impair treatment adherence. Objective: This study examines the changes in prevalence of ED in patients and its effects on illness perception, mental health, and quality of life (QoL) during one year of treatment with risankizumab. Method: ED, illness perception, general health and QoL were measured at baseline, and at 4, 16, and 52 weeks post-treatment in 58 patients with psoriasis. Results: Higher ED was associated with greater psychological distress and poorer QoL. Patients with higher levels of ED reported greater psychological distress, worse QoL, and higher symptom-related distress throughout treatment as compared to those with lower ones. Although both groups improved in illness perception and clinical severity outcomes, patients with high ED consistently experienced worse subjective outcomes. Conclusion: ED is frequent in psoriasis patients and negatively affects mental health and QoL, despite clinical improvements in skin symptoms. Targeted psychological interventions may be necessary for patients who exhibit higher levels of emotional dysregulation to ensure comprehensive care and better long-term outcomes.

Introduction: Psoriasis has a profound impact on patients’ quality of life, affecting their emotional well-being, social interactions, and career choices. However, current assessment tools fail to capture the long-term burden of psoriasis. Objective: The aim of this study was to develop the CORONATE questionnaire, designed to assess the lifelong impact of moderate-to-severe psoriasis on patients' lives. Methods: A multicenter cross-sectional study was conducted in 15 Italian dermatology centers. This study included 300 patients (age ≥30 years) diagnosed with moderate-to-severe psoriasis (PASI ≥10 or PASI <10 with involvement of sensitive areas). The CORONATE questionnaire, initially consisting of 25 items, was refined through factor analysis. Exploratory and confirmatory factor analyses were performed. Results: The final questionnaire included 18 items grouped into two dimensions: "Work Issues" (5 items) and "Psychosocial Life" (13 items). Factor analysis confirmed strong internal consistency (Cronbach’s alpha: Work Issues = 0.81; Psychosocial Life = 0.91). The model showed excellent fit indices (χ² (153) = 6956.471, P<0.001; Comparative Fit Index = 0.998; Tucker-Lewis Index = 0.998; Standardized Root Mean Square Residual = 0.053). Conclusion: The CORONATE questionnaire is a reliable tool for assessing the cumulative burden of psoriasis. Its implementation in clinical practice may improve personalized patient care.

Psoriasis affects both physical and psychological health. This study explored how demoralization and the satisfaction or frustration of basic psychological needs (autonomy, competence, and relatedness), and demoralization are related to euthymia and fatigue in psoriasis patients, and how these psychological factors are linked to disease severity. This cross-sectional study of 215 psoriasis patients assessed psychological variables using the Euthymia Scale, Basic Psychological Need Satisfaction and Frustration Scale, Demoralization Scale-II, FACIT-F, Patient Health Questionnaire-4, and Physician Global Assessment. Lower anxiety and higher satisfaction with autonomy, relatedness, and competence were associated with greater euthymia. Fatigue was associated with autonomy frustration and depression. Lower relatedness satisfaction and higher Meaning and Purpose dimension of demoralization were linked to higher risk of disease severity. Considering basic psychological needs could complement existing treatments for psoriasis.

Background: Psoriasis is a chronic inflammatory condition that may develop into psoriatic arthritis (PsA) in a significant number of patients. Clinical signs such as enthesitis and nail involvement have been suggested as early indicators of this progression. IL-23 inhibitors have demonstrated effectiveness in psoriasis and, more recently, in PsA. This article aims to evaluate the effect of IL-23 inhibitors on clinical outcomes and progression of PsA in patients with moderate-to-severe psoriasis and early musculoskeletal involvement. Methods: This was a retrospective, multicentre observational study conducted in Italy. Data were collected from 207 adult patients who had already started treatment with guselkumab, risankizumab or tildrakizumab prior to inclusion. All clinical data, including baseline characteristics and follow-up outcomes, were retrieved retrospectively from medical records across eight dermatology centres. Results: Enthesitis was observed in 44.8% of patients with joint involvement. Guselkumab was the most commonly used treatment (57%) and demonstrated sustained improvements in Psoriasis Area and Severity Index, Visual Analogue Scale pain and Dermatology Life Quality Index scores. Importantly, no patients with enthesitis treated with guselkumab progressed to overt PsA. At 52 weeks, the average Psoriasis Area and Severity Index score was 0.61, Visual Analogue Scale pain score was 0.59 and Dermatology Life Quality Index score was 0.91. Conclusion: IL-23 inhibitors have proven effective in managing both skin and joint symptoms in patients with psoriasis at risk for PsA. Whilst the findings suggest that IL-23 inhibitors may help control early musculoskeletal symptoms in patients with psoriasis at risk of PsA, the absence of systematic rheumatological evaluation and the retrospective design preclude definitive conclusions about their disease-modifying potential. These results suggest a potential disease-modifying role that warrants further prospective validation.

Introduction: Psychological symptoms associated with psoriasis include depression, anxiety, and social phobia, often exacerbated by high rates of alexithymia. Treatment decisions should consider not only clinical severity but also patient characteristics and quality of life. However, the psychosocial burden of psoriasis may not always align with clinical severity. Objectives: This study aimed to assess emotional regulation difficulties in outpatients with psoriasis, comparing these difficulties to those of the general population and examining associations with sociodemographic factors, comorbidities, and treatment options. Methods: A cross-sectional, multicenter study enrolled 107 consecutive patients with psoriasis from dermatological centers in Lazio, Italy. For every patient the Psoriasis Area Severity Index (PASI), Investigator's Global Assessment (IGA), and Difficulties in Emotional Regulation scale (DERS) were recorded. Results: Analysis revealed that patients with psoriasis reported significantly higher emotional regulation difficulties compared to the general Italian population, even those with mild disease. A significant association was found between psoriasis severity and emotional regulation difficulties, particularly in patients with higher PASI scores. Biological treatments were associated with lower levels of emotional regulation difficulties. Conclusions: This study corroborates the existing literature on the association between psoriasis severity and emotional regulation difficulties. However, it diverges from prior findings regarding the association between body mass index (BMI) and emotional dysregulation. Assessing emotional regulation difficulties may aid clinicians in identifying vulnerable patients and optimizing treatment decisions to improve overall quality of life and treatment adherence. Further research is needed to validate these findings and to explore longitudinal associations between emotional regulation and psoriasis outcomes.

INTRODUCTION:Psoriasis is a chronic systemic inflammatory disease that requires long-term treatment strategies to maintain sustained disease control. Treatment persistence is an important real-world indicator of therapeutic effectiveness and tolerability. Guselkumab, an IL-23 inhibitor, has shown favorable persistence in several studies, but extended long-term data remain limited. OBJECTIVES:To assess 3- and 5-year drug survival rates of guselkumab in patients with moderate-to-severe plaque psoriasis and to examine the relationship between persistence and clinical variables such as PASI, BMI, prior biologic exposure, and involvement of difficult-to-treat areas. METHODS:This was a multicenter retrospective observational study conducted across 14 dermatology centers in Italy. Adult patients with moderate-to-severe plaque psoriasis who started guselkumab were included. Data collected included demographics, clinical history, disease severity, comorbidities, and treatment details. Drug survival was analyzed using Kaplan-Meier curves and Cox proportional hazards models. RESULTS:A total of 247 patients were included. At three years, 80.2% of patients remained on guselkumab, and at five years, 72.8% continued treatment. Persistence was not significantly influenced by BMI, PASI, or age. However, prior biologics exposure was associated with a higher risk of discontinuation (hazard ratio (HR): 1.84; P=0.0208), especially in those previously treated with IL-17 inhibitors (HR:2.14; P=0.0150). The involvement of difficult-to-treat areas did not significantly affect persistence, although a trend toward reduced discontinuation was observed in patients with genital involvement (P=0.0539). CONCLUSIONS:Guselkumab demonstrated high long-term persistence in real-world clinical practice. Drug survival remained consistently high across various subgroups, with prior IL-17 inhibitor exposure being the main predictor of decreased persistence.

Background/Objectives: Brodalumab is a monoclonal antibody against the anti-IL-17 receptor A, approved for patients with moderate-to-severe psoriasis. This retrospective study investigated patients in clinical practice to assess the impact of body weight and previous treatments with biologics on the effectiveness of brodalumab. Methods: Patients were treated according to clinical practice, and assessed at baseline, 16, 36 and 52 weeks by means of the Psoriasis Area Severity Index (PASI) and DLQI score. Overall, 299 patients were included (147 naïve to biologics). Results: Mean PASI was significantly reduced compared with the baseline in the overall population by week 4 and continued to decrease at each study time point (15.9 ± 7.9 at baseline, 5.4 ± 5.3 at week 4, 1.9 ± 3.6 at week 6, 1.0 ± 2.1 at week 36, and 0.8 ± 2.1 at week 52; p < 0.001 at each control). PASI improved significantly both in bio-naïve and bio-experienced patients (p < 0.001). The proportions of patients achieving PASI 75, PASI 90, and PASI 100 were comparable between the bio-naïve and bio-experienced groups at all time points. The percentages of patients who achieved PASI 75 were similar in obese and non-obese subjects at all determinations except the visit performed after 36 weeks of treatment (94.3% non-obese vs. 83.1% obese, p = 0.005). PASI 90 was achieved more frequently among non-obese patients than obese patients after 36 weeks (80.7% vs. 64.4%, p = 0.008) and 52 weeks of treatment (84.1% vs. 71.7%, 0.027). The probability of achieving PASI 75 and PASI 100 was independent of nutritional status at any time during the study. Conclusions: In conclusion, our results confirm that brodalumab has both rapid and sustained effectiveness in patients with moderate-to-severe psoriasis; our results could be extended to patients with multiple risk factors impairing treatment response, such as multiple biological failure and obesity.

Introduction: The use of brodalumab in patients with psoriasis who have failed other biologic drugs is an under-explored topic; A variable percentage of patients still experience primary therapeutic failure, incomplete response, or progressive loss of treatment efficacy (secondary therapeutic failure). In this context, switching treatments among different mechanisms of action has been explored in previous studies conducted on psoriatic patients. However, criteria providing a clear clinical rationale for such transitions are lacking, and no clear guidance is provided by international guidelines to date. Objectives: To evaluate the safety and the efficacy of brodalumab in a subgroup of psoriasis patients who already failed anti-IL23 or anti-IL12/23 treatment. Methods: We retrospectively evaluated, using the PASI and DLQI index, a cohort of 23 patients with psoriasis who underwent a change of therapy with brodalumab exclusively following primary or secondary therapeutic failure of anti-IL-23 or anti-12/23 drugs. Results: The mean PASI decreased significantly following the introduction of brodalumab after 4 weeks of treatment, and continued to decrease at 16 and 36 weeks, reaching the nadir at 52 weeks (baseline PASI baseline= 14.6 ± 9.2 vs. 52 weeks PASI= 1.1 ± 1.8; p <0.001). The 63.6% of patients reached PASI 100 just after 16 weeks. The same trend of improvement was also observed for the DLQI. The adverse effects observed in our study population were generally mild. Conclusions: Our results are in line with the current literature and suggest that patients who have failed therapy with IL-23 or IL-12/23 inhibitors may benefit from switching to brodalumab, which could be considered a good choice for patients who need a rapid resolution of the inflammatory skin condition.

The aim of this study is to assess the efficacy of brodalumab in a multicentre Italian cohort of patients with psoriasis who had not achieved Psoriasis Area Severity Index 75 or had lost response to any of the other interleukin-17 blockers (bimekizumab, ixekizumab and secukinumab).

Treatment of psoriasis associated with human immunodeficiency virus (HIV) infection is challenging due to the high incidence of comorbidities and polypharmacy and the lack of evidence on the efficacy and safety of available drugs in these patients. Therefore, clinical or anecdotal reports provide useful indications for therapy decision-making. A 64-year male with plaque psoriasis (Psoriasis Area and Severity Index=14.3) infected with HIV for 4 years, with hypercholesterolemia, hypertension, and impaired quality of life (Dermatology Life Quality Index=14) was resistant to topical therapy and acitretin. Tildrakizumab 200 mg was started, obtaining Psoriasis Area and Severity Index=0 at week 16 which was maintained after 13 months of follow-up. No adverse event was reported, and immune cell levels were unchanged. This is the first report on the treatment of psoriasis with tildrakizumab in an HIV+ patient. A literature search showed that prior to this patient, 38 HIV+ subjects had been treated with anti-cytokine agents for psoriasis.

BackgroundThe recent introduction of biological drugs specifically targeting the interleukins involved in psoriasis pathogenesis revolutionized the therapeutic scenario of moderate to severe forms of psoriasis. Among these, risankizumab, an anti-IL-23, was shown to be effective both in clinical trials and real-life experiences. However, data on its use on very severe forms of psoriasis, defined by a Psoriasis Area Severity Index (PASI) of at least 30, are scant. In this context, our study aimed to investigate the outcomes of patients with very severe psoriasis, and the involvement of difficult-to-treat areas treated with risankizumab for up to 2 years.MethodsA retrospective, observational study enrolled patients with very severe plaque psoriasis and the involvement of difficult-to-treat areas undergoing treatment with risankizumab. Clinical and demographic data were collected at baseline. Moreover, at baseline and each dermatological examination (16, 28, 40 and 104 weeks), clinical improvement was measured using the percentage of patients achieving PASI 75/90/100 response, site-specific Psoriasis Global Assessment and Dermatology Life Quality Index.ResultsAt baseline, the mean PASI was 35.1 +/- 5.1. A significant reduction was observed since week 16 and maintained up to week 104. Moreover, the Psoriasis Global Assessment and Dermatology Life Quality Index improved as well.ConclusionsRisankizumab showed to be effective and safe in patients affected by very severe forms of psoriasis with the involvement of difficult-to-treat areas.

The data that support these findings are available from the corresponding author (Dario Graceffa) upon reasonable request.

The pandemic of SARS-CoV-2 during the first years of the 2020s led to a great commitment to develop effective vaccines. Despite of the good safety and tolerability profile, vaccines may trigger a broad spectrum of cutaneous side effects. Granulomatous dermatitis has been rarely reported after SARS-CoV-2 mRNA vaccines, but no cases of annular elastolytic giant cell granuloma have been already described. Moreover, in our case, it was also associated with a central area of mid-dermal elastolysis, confirming the strong association between these two diseases already reported in literature. The observation of occasional eosinophils within the infiltrate and the presentation of the cutaneous eruption few days after the administration of the second dose of Pfizer/BioNTech (BNT162b2) vaccine are highly suggestive of a drug-related eruption. To our knowledge, this is the first report in literature of an annular elastolytic giant cell granuloma as an adverse effect of SARS-CoV-2 vaccination.

BACKGROUND:IL-23 inhibitors were recently approved for the treatment of skin psoriasis and psoriatic arthritis (PsA). Risankizumab, a humanized monoclonal antibody that specifically binds the p19 subunit of IL-23, has proven effective on PsA in two randomized controlled trials. To date, only a few real-world data are available on this topic. METHODS:Our study aimed to prospectively evaluate the effectiveness of risankizumab in patients with PsA in a real-world setting. For this purpose, both rheumatologic and dermatologic assessments were performed at baseline and after 28-40 weeks of continuous risankizumab administration. Moreover, joint and entheses ultrasound assessment was performed at the mentioned time points. The rheumatologic assessment was carried out by means of the following scores: (i) clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA); (ii) Leeds Enthesitis Index (LEI); (iii) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and (iii) Bath Ankylosing Spondylitis Functional Index (BASFI). The degree of skin involvement was measured by both the Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA). Quality of life was assessed by the Health Assessment Questionnaire (HAQ) and Dermatology Life Quality Index (DLQI). Ultrasound assessment of joints and entheses was performed on the basis of the EULAR-OMERACT score. RESULTS:After treatment, cDAPSA decreased from a mean value of 12.9 ± 7.6 to 7.0 ± 6.1 (P < 0.001), and the median PD score significantly decreased from baseline (3; range 1-8) to TP1 (1; range 0-7) (P < 0.001). PASI score also decreased from 8.4 ± 4.9 to 0.3 ± 0.5 (P < 0.001), and PGA from 3.1 ± 1.0 to 0.4 ± 0.5 (P < 0.001). CONCLUSION:We can conclude that risankizumab led to substantial improvement in both skin and joint involvement.