Effectiveness of risankizumab for the treatment of psoriatic arthritis: a multicenter, real-world study.

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.

Efficacy and safety of tildrakizumab in elderly patients: real-world multicenter study (ESTER - study).

Purpose of the article: Interleukin-23 inhibitors, such as tildrakizumab, have emerged as safe and effective options for the management of psoriasis. Yet their efficacy in elderly patients (aged 65 years or more), particularly in those with difficult-to-treat areas involvement, remains insufficiently explored. We conducted this real-life retrospective multicentric observational study to assess the effectiveness of tildrakizumab in elderly patients with moderate-to-severe psoriasis, with involvement of difficult-to-treat areas.Materials and methods: We enrolled forty-nine patients aged 65 years old or more (mean age 73.1 ± 6.0), all treated with tildrakizumab for at least 28 weeks. The effectiveness of tildrakizumab was assessed by Static Physician's Global Assessment of Genitalia (sPGA-G), fingernail-PGA (f-PGA), palmoplantar PGA (pp-PGA), scalp-specific PGA (sc-PGA), and Psoriasis Area and Severity Index (PASI) scores.Results: Significant improvements in PASI scores were observed within 28 weeks of treatment, with 77.5%, 60%, and 45.2% of patients achieving PASI75, PASI90, and PASI100, respectively. The mean PASI decreased significantly from baseline (13.6 ± 9.9) to 1.3 ± 1.7 at week 28. More than 90% of patients had clear sPGA-G and pp-PGA scores and over 70% had clear f-PGA and sc-PGA scores after 28 weeks.Conclusions: Our findings suggest that tildrakizumab could be a valuable option for the treatment of elderly patients, including those with difficult-to-treat areas involvement.

Bimekizumab for the Treatment of Plaque Psoriasis With Involvement of Genitalia: A 16-Week Multicenter Real-World Experience - IL PSO (Italian Landscape Psoriasis).

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's 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 PASI scores, accompanied by a significant reduction in the mean Dermatology Life Quality Index (DLQI), 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.

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.

Effectiveness of ixekizumab for the treatment of moderate-to-severe plaque psoriasis with involvement of difficult-to-treat areas: A 52-week multicenter retrospective study.

Biological drugs have dramatically changed the approach to treating moderate-to-severe plaque psoriasis, achieving excellent skin clearance and safety outcomes. However, the management of difficult-to-treat areas (e.g., scalp, palms/soles, nails, and genitalia) still represents a challenge in psoriasis treatment. Data in the literature on difficult-to-treat sites are limited and, frequently, no specific analysis is performed during clinical trials. We conducted a 52-week, retrospective study to evaluate the effectiveness of ixekizumab in 120 patients with moderate-to-severe plaque psoriasis of at least one difficult-to-treat area (scalp, palmoplantar surfaces, nails, and genitalia). Ninety-nine patients had scalp psoriasis, 35 had involvement of the palms or soles, 27 were affected by genital psoriasis, and 22 patients reported involvement of the nails. After 1 year of treatment, 96% of patients with scalp involvement, 95.6% of patients with palmoplantar psoriasis, 95.2% of patients with genital psoriasis, and 85% of patients with nail involvement achieved a site-specific Physician's Global Assessment of 0 or 1 (clear or almost clear). No serious adverse events were observed during the study. Our study supports the effectiveness of ixekizumab in plaque psoriasis involving difficult-to-treat sites.

Effectiveness and safety of risankizumab in HIV patients with psoriasis: A case series.

Biological therapies represent the gold-standard treatment of severe forms of plaque psoriasis. However, people living with HIV are often under-treated for psoriasis because very limited data are available on the use of biologics in this population. We report four cases of patients affected by HIV and moderate-to-severe plaque psoriasis, all treated with risankizumab, a monoclonal antibody that selectively targets interleukin-23. After 16 weeks, all patients experienced complete or almost complete skin clearance without any adverse events. Data on the effectiveness and safety of biological therapies in people living with HIV are limited to case reports or small case series, especially for the most recently approved inhibitors of interleukin-23. Our experienced, although limited, supports the role of risankizumab as a safe and effective therapy for psoriasis amongst patients living with HIV.

Stroke pathway performance assessment: a retrospective observational study.

BACKGROUND AND AIM: Performance assessment of the Stroke Pathway is a key element in healthcare quality. The aim of this study has been to carry out a retrospective assessment of the Stroke Pathway in a first level Stroke Unit in Italy, analyzing the temporal trend of the Stroke Pathway performance and the impact of the COVID-19 pandemic. METHODS: A retrospective observational study was carried out analyzing data from 1/01/2010 to 31/12/2020. The following parameters were considered: volume and characteristics of patients with ischemic stroke undergoing intravenous thrombolysis, baseline modified Rankin Scale (mRS) and National Institutes of Health Stroke Scale (NIHSS) scores, Onset-to-Door (OTD), Door-To-Imaging (DTI) and Door-To-Needle (DTN) Times, mRS score 3 months after the ischemic event onset (3 m-mRS) and NIHSS score 24 h after the ischemic event onset (24 h-NIHSS). The study also compared the pre-COVID-19 pandemic period (March-December 2019) with the one immediately following it (March-December 2020). RESULTS: 418 patients were included. Over time, treatment was extended to older patients (mean age from 66.3 to 75.51 years; p = 0.006) and with a higher level of baseline disability (baseline mRS score from 0.22 to 1.22; p = 0.000). A statistically significant reduction over the years was found for DTN, going from 90 min to 61 min (p = 0.000) with also an increase in the number of thrombolysis performed within the "golden hour" - more than 50% in 2019 and more of 60% in 2020. Comparing pre- and during COVID-19 pandemic periods, the number of patients remained almost unchanged, but with a significantly higher baseline disability (mRS = 1.18 vs. 0.72, p = 0.048). The pre-hospital process indicator OTD increased from 88.13 to 118.48 min, although without a statistically significant difference (p = 0.197). Despite the difficulties for hospitals due to pandemic, the hospital process indicators DTI and DTN remained substantially unchanged, as well as the clinical outcome indicators 3 m-mRS, NHISS and 24 h-NHISS. CONCLUSIONS: The results of the retrospective assessment of the Stroke Pathway highlighted its positive impact both on hospital processes and patients' outcomes, even during the COVID-19 pandemic, so that the current performance is aligning itself with international goals. Moreover, the analysis showed the need of improvement actions for both hospital and pre-hospital phases. The Stroke Pathway should be improved with the thrombolysis starting in the diagnostic imaging department in order to further reduce the DTN score. Moreover, health education initiatives involving all the stakeholders should be promoted, also by using social media, to increase population awareness on timely recognition of stroke signs and symptoms and emergence medical services usage.

Rapidly and successful improvement of nail psoriasis with risankizumab.

This clinical case demonstrates quick resolution of nail psoriasis in a patient treated with risankizumab, highlighting the role of IL-23 in the pathogenesis of nail psoriasis.

Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study-IL PSO (Italian landscape psoriasis).

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.

Effectiveness of risankizumab in plaque psoriasis with involvement of difficult-to-treat areas: a real-world experience from two referral centers.

The management of plaque psoriasis that affects difficult-to-treat areas can be challenging. Biologics have become the treatment of choice for moderate-to-severe plaque psoriasis. However, there are limited data on their efficacy in difficult-to-treat sites (including scalp, palms/soles, nails and genitalia). We conducted a 52-week retrospective study to evaluate the effectiveness of risankizumab in 202 patients with moderate-to-severe involvement of at least one difficult-to-treat area. One hundred and sixty-five patients had scalp psoriasis, 21 had involvement of palms or soles, 72 were affected by genital psoriasis, and 50 patients reported the involvement of the fingernails. After one year of treatment, 97.58% of patients with scalp involvement, 95.28% of patients with palmoplantar psoriasis, 100% of patients with genital psoriasis and 82% of patients with nail involvement achieved a site-specific Physician's Global Assessment of 0 or 1 (clear or almost clear). No serious adverse events were observed during the study. Our study supports the effectiveness of risankizumab in plaque psoriasis involving difficult-to-treat sites.

Analysing the COVID-19 epidemic in Italy through the Reed-Frost model: A methodology to delimit epidemic waves over time.

OBJECTIVES: to set out a method based on the Reed Frost model to delimit over time COVID-19 epidemic waves in Italy. DESIGN: the available national epidemic reports published by the Protezione Civile (Italian civil defence) from 24.02.2020 to 16.022022 were used to collect data on COVID-19 epidemic in Italy. Then, the Reed-Frost model was applied to develop a methodology based on the calculation of the effective contact probability, i.e., the probability of contact. SETTING AND PARTICIPANTS: in Italy, a daily report related to the epidemic was immediately available, including main epidemiological data (point and periodic infection prevalence, mortality, etc), which made it possible for researchers from different institutions to perform analyses about the epidemic. RESULTS: an iterative methodology was developed resulting in the identification of the start-of-wave, end-of-wave, and inter-wave periods and of the starting and ending days of the COVID-19 epidemic waves in Italy (first wave: from 26±2 February 2020 to 28±2 June 2020). CONCLUSIONS: this study led to the development of an accessible and reproducible method to determine the start-of-wave and end-of-wave dates of an epidemic, starting only from the number of cases and susceptible people. The main implications of the method mainly consist in allowing benchmarking and forecasting analyses of the epidemic trend to be carried out to support policy and decision-making processes.

Long-term management of pediatric psoriasis with ixekizumab: a case report.

Psoriasis in pediatric patients is uncommon and the management of moderate-to-severe cases can be challenging. We report the case of a 17-year-old girl who presented with severe plaque psoriasis unresponsive to UVB phototherapy. The Psoriasis Area Severity Index (PASI) was 18 and the Dermatology Life Quality Index was 24. We decided to prescribe ixekizumab, observing complete skin clearance after only 8 weeks. The patient is still on treatment with no reported adverse events after two years.

Instrumental evaluation of skin barrier function and clinical outcomes during dupilumab treatment for atopic dermatitis: An observational study.

BACKGROUND: Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by pruritus, xerosis, and skin barrier dysfunction. Skin barrier alteration is associated with an increase in trans-epidermal water loss (TEWL) and reduction in skin hydration. Dupilumab is a monoclonal antibody targeting interleukin-13 modulating pro-inflammatory signal transduction, which has been approved for moderate to severe AD. The aim of this study is to evaluate the effects of Dupilumab on skin barrier functions, using non-invasive instruments and clinical evaluation. MATERIALS AND METHODS: Thirty patients affected by moderate-severe AD, who had been administered dupilumab, were evaluated by clinical examination and through the instrumental measurements of TEWL and corneometry at the baseline (T0) and 8 weeks (T1) on lesional skin. The clinical evaluation was performed using the Eczema Area and Severity Index (EASI) score. Moreover, a Dermatology Life Quality Index (DLQI) and 7-day numeric rating scale (NRS) questionnaires were administered to each patient. RESULTS: The instrumental parameters of skin barrier recovery confirmed the clinical improvement outcomes with a statistically significant reduction of TEWL at T1. CONCLUSION: Our data confirm the clinical outcomes already reported in the literature and show that there was an inverse proportional correlation between TEWL levels and clinical severity after 8 weeks of treatment with dupilumab.

Long-term safety and efficacy of adalimumab in psoriasis: a multicentric study focused on infections (connecting study).

INTRODUCTION: This Italian multicenter retrospective study evaluated safety and efficacy of the anti-TNF drug, adalimumab, in a cohort of patients affected by tuberculosis (TB), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV). Psoriasis is an autoimmune disease affecting around 3% of the Italian population and associated with several comorbidities, including arthritis, cardio-metabolic diseases and depression. In its moderate-to-severe form, psoriasis profoundly impairs quality of life of patients. AIM: Therefore, these patients deserve systemic treatments including conventional DMARDS (disease modifying anti-rheumatic drugs) and biologics. Management of moderate and severe psoriasis patients affected by relevant infections such as TB, HBV, HCV and HIV may be difficult because of the toxicity of the conventional systemic treatment. MATERIAL AND METHODS: The CONNECTING study analysed 28 moderate to severe psoriasis patients infected by TB, HBV, HCV and HIV who were treated with adalimumab for up to 96 weeks together with respective prophylactic treatment. RESULTS: We observed a rapid decrease in PASI (psoriasis area severity index) reaching a 75% improvement in 91% of patients. Some of these patients (n = 9) were also affected by arthritic comorbidity. The patients experienced a rapid decrease in pain, measured by pain VAS (visual analogic scale) that reached 0 in all of them. Monitoring of the respective infection did not show any worsening or reactivation of infection or any severe adverse events during the entire observation period. CONCLUSIONS: Adalimumab is effective and safe in patients affected by these important infections.

Recreational drugs and STI diagnoses among patients attending an STI/HIV reference clinic in Rome, Italy.

BACKGROUND: An observational study was conducted to assess recreational drug use in association with recent STIs among clients of an STI/HIV reference centre in Rome, Italy. METHODS: Attendees self-compiled a questionnaire concerning sexual behaviours and drug use, including the nine drugs used for sex (amphetamines, poppers, cocaine, ketamine, erectile dysfunction agent (EDA), steroids and the three chemsex drugs, ie, chems: γ-hydroxybutyric acid/γ-butyrolactone, crystal and Mcat). RESULTS: Overall, 703 patients participated, with men who have sex with men (MSM) accounting for 50.4% of the total and 73.2% of HIV-positive patients. Apart from condylomatosis, whose prevalence was higher among females (38.8%) and non-MSM (45.8%) than MSM (14.4%), STIs were more frequent among MSM, particularly syphilis (14.1%), gonorrhoea (4.8%), urethritis (3.4%) and hepatitis A (6.5%). Recreational drug use was significantly more frequent among MSM (39.8% vs 17.6% in females and 22.7% in non-MSM). A total of 26.3% of MSM used at least one of the nine drugs and 5.1% at least one of the three chems. Cocaine (13.3%) and poppers (13.0%) were the most used sex drugs in MSM.The use of any of the nine drugs was associated with being MSM (adjusted OR (AOR): 1.94, 95% CI 1.05 to 3.58), sex with partner contacted online (1.99, 95% CI 1.14 to 3.45), group sex (4.08, 95% CI 2.40 to 6.93) and STI in the last year (1.65, 95% CI 1.05 to 2.61). Use of any of the nine chems among MSM was associated with condomless sex (2.24, 95% CI 1.21 to 4.14), group sex (2.08, 95% CI 1.01 to 4.31) and STI diagnosis in the last year (4.08, 95% CI 2.32 to 7.19). CONCLUSIONS: Our data suggest that recreational drug use is quite common among MSM in Italy. No evidence of association with STI was found among non-MSM and females, where only cannabis and cocaine use was reported. The use of chems is still limited, but cocaine, poppers and EDA are widely used among MSM. Recreational drug use appears associated with high-risk sexual behaviours and a higher risk of STI.