Comparative effectiveness of tildrakizumab 200 mg versus tildrakizumab 100 mg in psoriatic patients with high disease burden or above 90 kg of body weight: a 16-week multicenter retrospective study - IL PSO (Italian landscape psoriasis).

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.

Long-Term Effectiveness and Safety of Ixekizumab for the Treatment of Moderate-to-Severe Plaque Psoriasis: A Five-Year Multicenter Retrospective Study-IL PSO (Italian Landscape Psoriasis).

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.

Psoriasis dermatitis: a new entity or a different phenotypic expression of psoriasis and atopic dermatitis?

BACKGROUND: Psoriasis (P) and atopic dermatitis (AD) share some common characteristics. The resulting clinical picture with shared manifestations is a new entity called psoriasis dermatitis (PD), atopic psoriasis or psorema. The purpose of this study was to identify the clinical manifestations of this new dermatological condition, focusing on the adult population. METHODS: We recruited adult patients from two outpatient clinics, the "severe psoriasis" and the "adult atopic dermatitis," between January 1st, 2021, and December 31st, 2021. The 26 patients meeting the inclusion criteria were followed for 12 months, and two control groups of patients were enrolled in the same period. RESULTS: The frequencies of the variables examined within the patients affected by PD were compared with those of P or AD group. The age at disease onset was significantly higher in PD patients and the duration of symptoms was also significantly lower in PD patients, compared to both P and AD groups. Affected areas were similar between PD and P, instead the scalp, feet and genitals were more frequently involved in the PD group than in the AD group. CONCLUSIONS: P and AD seem part of a spectrum rather than a dichotomy, where PD is an entity in the middle of this spectrum.

A case of guttate psoriasis after primary herpetic gingivostomatitis.

Herpetic gingivostomatitis and anogenital herpes are widely known manifestations of sexually transmitted herpesvirus infections. What is less recognized is the potential causative role of such infections in triggering immune-mediated skin disorders such as guttate psoriasis. We describe the case of a 23-year-old man with an acute episode of guttate psoriasis related to primary herpetic gingivostomatitis. The diagnosis of guttate psoriasis was pathologically confirmed and the condition fully regressed after proper antiviral therapy. This case adds herpes simplex virus to the growing list of pathogens capable of acting as triggers for guttate psoriasis and highlights the need for better insight of the relationship between psoriasis and viral infections.

Effectiveness, Tolerability, and Drug Survival of Risankizumab in a Real-World Setting: A Three-Year Retrospective Multicenter Study-IL PSO (ITALIAN LANDSCAPE PSORIASIS).

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.

Topical applications of heterologous platelet rich plasma (PRP) for refractory gingival lesions in autoimmune blistering diseases.

BACKGROUND: Recalcitrant gingival erosions, blisters and desquamative gingivitis are common features in oral autoimmune blistering diseases (AIBD). First line treatments include high-dosage corticosteroids and other immunosuppressive drugs, with several side effects and elevated number of recurrences. Autologous platelet-rich plasma (PRP) has been recently introduced as an alternative treatment and its use seems to be promising and safe. METHODS: In this study we describe the use of topical application of heterologous PRP in nine patients affected by mucous membrane pemphigoid, with gingival lesions refractory to previous treatments. Topical applications of PRP were performed once a week for 2 months and the endpoint for clinical evaluation was set 3 months after the last session. Oral disease severity score (ODSS) and VAS scores for pain measurement were recorded before and after treatment. RESULTS: The procedure was painless, well accepted, and free from adverse reactions. All patients (100%) reported a reduction in VAS whereas reduction in ODSS was observed in 89% of patients. CONCLUSIONS: Within the limits of the study, topical heterologous PRP is a safe and promising procedure to be studied in future controlled randomized trials as adjuvant treatment for refractory gingival lesions in patients with AIBDs.

Long-Term Drug Survival and Effectiveness of Secukinumab in Patients with Moderate to Severe Chronic Plaque Psoriasis: 42-Month Results from the SUPREME 2.0 Study.

Purpose: SUPREME, a phase IIIb study conducted in Italy, demonstrated safety and high efficacy of secukinumab for up to 72 weeks in patients with moderate-to-severe plaque-type psoriasis. SUPREME 2.0 study aimed to provide real-world data on the long-term drug survival and effectiveness of secukinumab beyond 72 weeks. Patients and Methods: SUPREME 2.0 is a retrospective observational chart review study conducted in patients previously enrolled in SUPREME study. After the end of the SUPREME study, eligible patients continued treatment as per clinical practice, and their effectiveness and drug survival data were retrieved from medical charts. Results: Of the 415 patients enrolled in the SUPREME study, 297 were included in SUPREME 2.0; of which, 210 (70.7%) continued secukinumab treatment throughout the 42-month observation period. Patients in the biologic-naïve cohort had higher drug survival than those in the biologic-experienced cohort (74.9% vs 61.7%), while HLA-Cw6-positive and HLA-Cw6-negative patients showed similar drug survival (69.3% and 71.9%). After 42 months, Psoriasis Area and Severity Index (PASI) 90 was achieved by 79.6% of patients overall; with a similar proportion of biologic-naïve and biologic-experienced patients achieving PASI90 (79.8% and 79.1%). The mean absolute PASI score reduced from 21.94 to 1.38 in the overall population, 21.90 to 1.24 in biologic-naïve and 22.03 to 1.77 in biologic-experienced patients after 42 months. The decrease in the absolute PASI score was comparable between HLA-Cw6-positive and HLA-Cw6-negative patients. The baseline Dermatology Life Quality Index scores also decreased in the overall patients (10.5 to 2.32) and across all study sub-groups after 42 months. Safety was consistent with the known profile of secukinumab, with no new findings. Conclusion: In this real-world cohort study, secukinumab showed consistently high long-term drug survival and effectiveness with a favourable safety profile.

An easy to use, ceramide-containing skincare routine: effectiveness and improvement of quality of life in elderly patients with xerosis.

BACKGROUND: Xerosis negatively impacts the quality of life (QoL) for older adults by producing pruritus (itching), burning or stinging, and an uncomfortable sensation of tightness in the skin. Furthermore, chronic illness and pharmacological therapies could worsen skin health. Severe xerosis can also result in redness or cracking of the skin. The aim of this prospective open-label trial is to evaluate the effectiveness of a ceramide-based moisturizing cream and cleanser routine on elderly xerosis. METHODS: During the 4-week treatment study, patients followed the routine according to the established protocol. At different timepoints (baseline, visit 1; after 28±5 days, visit 2) evaluations on the skin health and QoL of the patients were conducted by a healthcare professional (HCP), along with a patients' self-evaluation. RESULTS: The study demonstrates that the treatment with the investigated products determines an overall significant improvement in all skin dryness criteria. In particular, after the observational period: 93% of the subjects had no or minimal skin roughness; 96% of patients had no or minimal discomfort due to skin dryness; 97% of patients did not present any fissures; patient self-assessments on skin dryness were consistent with HCP evaluation. QoL has globally improved in all patients, with a significant reduction of embarrassment, and a positive impact on social and daily activities. Patients' overall satisfaction was high in 87% of patients and 93% of them stated that they would continue the treatment also after the study had been completed. CONCLUSIONS: After 4 weeks, the daily use of a ceramide-based routine significantly improved signs and symptoms of senile xerosis and chronic discomfort associated with xerosis in elderly adults. Furthermore, the impact of senile xerosis on subjects' QoL was also reduced after 4 weeks. The subjects also reported high satisfaction with the skincare regimen and its results.

Brodalumab for the treatment of plaque psoriasis in a real-life setting: a 3 years multicenter retrospective study-IL PSO (Italian landscape psoriasis).

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.

Brodalumab for the Treatment of Moderate-to-Severe Psoriasis: An Expert Delphi Consensus Statement.

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.

The potential role of serum polyclonal free light chains as markers of immune activation in psoriatic patients.

BACKGROUND: Polyclonal free light chains (FLCs) of immunoglobulins include κ and λ chains and represent a sensitive marker of activation and/or dysfunction of the immune system. OBJECTIVES: The aim of this study was to investigate the role of FLCs as markers of immune activation in the management of psoriatic patients treated with biologics. MATERIALS & METHODS: The overall study population included 45 patients affected by mild-to-severe psoriasis with either ongoing biological treatment or without any current systemic therapy. Peripheral blood samples were taken from all patients and 10 healthy subjects in order to determine immunoglobulins, light chains and FLCs by quantitative nephelometric assay. Moreover, antinuclear antibodies (ANA) were detected by immunofluorescence. RESULTS: Psoriatic patients showed significant increased levels of κ and λ FLCs compared to healthy controls. Interestingly, κ and λ FLCs values were significantly increased only in psoriatic patients with ongoing biological treatment and, in particular, in responder subjects. Furthermore, both κ and λ FLCs significantly correlated with duration of therapy. For patients with FLC levels above normal range and under biological treatment for more than 12 months, the odds of being ANA+ was greater relative to patients with FLC levels above normal range but under biological treatment for less than 12 months. CONCLUSIONS: Increased FLC levels may represent a marker of immune reactivation in psoriatic patients treated with biologic agents. We suggest that determining FLC levels has clinical relevance, with a cost/benefit ratio justifying such evaluation in the clinical management of psoriasis.