Real-world Safety and Efficacy of Risankizumab in Psoriatic Patients: A Multicenter, Retrospective, and Not-interventional Study.

BACKGROUND AND OBJECTIVE: Risankizumab - a humanized monoclonal antibody that targets the p19 subunit of IL-23 - has been recently approved to treat moderate-to-severe plaque psoriasis. Real-world data based on a representative pool of patients are currently lacking. OBJECTIVE: To assess the mid- and long-term safety and efficacy profile of risankizumab in patients with moderate-to-severe psoriasis in the routine clinical practice. METHODS: This was a retrospective and multicenter study of consecutive psoriatic patients on risankizumab from April 2020 through November 2022. The primary endpoint was the number of patients who achieved a 100% improvement in their Psoriasis Area and Severity Index (PASI) (PASI100) on week 52. RESULTS: A total of 510 patients, 198 (38.8%) women and 312 (61.2%) men were included in the study. The mean age was 51.7±14.4 years. A total of 227 (44.5%) study participants were obese (body mass index [BMI] >30kg/m2). The mean baseline PASI score was 11.4±7.2, and the rate of patients who achieved PASI100 on week 52, 67.0%. Throughout the study follow-up, 21%, 50.0%, 59.0%, and 66% of the patients achieved PASI100 on weeks 4, 16, 24, and 40, respectively. The number of patients who achieved a PASI ≤2 was greater in the group with a BMI ≤30kg/m2 on weeks 4 (P=.04), 16 (P=.001), and 52 (P=.002). A statistically significantly greater number of patients achieved PASI100 in the treatment-naïve group on weeks 16 and 52 (P=.001 each, respectively). On week 16 a significantly lower number of participants achieved PASI100 in the group with psoriatic arthropathy (P=.04). Among the overall study sample, 22 (4.3%) patients reported some type of adverse event and 20 (3.9%) discontinued treatment. CONCLUSIONS: Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.

Psoriasis, metabolic syndrome and cardiovascular risk factors. A population-based study.

BACKGROUND: Psoriasis is a very prevalent systemic chronic inflammatory disease. Major cardiovascular events are the main cause of mortality in these patients which suggests an association between psoriasis and traditional cardiovascular risk factors. OBJECTIVE: To identify classic cardiovascular risk factors and metabolic syndrome (MS) in patients with psoriasis, their possible association with its severity and compare it with the non-psoriatic population. METHODS: This is an observational and cross-sectional population study in Lleida (Spain) from a joint hospital/primary care database. RESULTS: The database comprised 398 701 individuals. There were 6868 cases registered as psoriasis (1.7%), and 499 of them (7.3%) were classified as moderate-severe psoriasis. Patients with psoriasis had a higher prevalence of traditional cardiovascular risk factors than non-psoriatic population: diabetes mellitus 2 (13.9% vs 7.4%, OR 2.01), dyslipidaemia (28.8% vs 17.4%, OR 1.92), arterial hypertension (31.2% vs 19.0%, OR 1.93), obesity (33.7% vs 28.1%, OR 1.30), altered fasting basal glycaemia (21.4% vs 15.1%, OR 1.54), low cholesterol HDL (38.1% vs 32.3%, OR 1.29), hypertriglyceridaemia (45.7% vs 35.2%, OR 1.55) and high waist circumference (75.7% vs 72.3%, OR 1.19). MS was more prevalent in psoriatic patients (28.3% vs 15.1%, OR 2.21), and cardiovascular risk factors were similar between psoriasis severity groups. Psoriatic patients had a higher prevalence of ischaemic heart disease (3.3% vs 1.8%, OR 1.87) and vascular cerebral accidents (1.8% vs 1.2%, OR 1.55). A model for MS showed a significant nonlinear relationship with age and sex and significant differences between patients with and without psoriasis. CONCLUSION: We found statistically significant differences in relation to the prevalence of cardiovascular risk factors, MS and major cardiovascular events in psoriatic patients. However, differences were not seen between psoriasis severity groups. Our work reinforces the need for a multidisciplinary approach and close monitoring of cardiovascular risk factors in these patients to prevent a cardiovascular event.

Epidemiology of Psoriasis. A Population-Based Study. / Características epidemiológicas de la psoriasis. Un estudio poblacional.

BACKGROUND AND OBJECTIVES: Psoriasis is a chronic immunoinflammatory skin disease very frequent in the western world. Several authors have tried to calculate its prevalence in different regions, although most of them obtained the data from surveys and there are few publications from Mediterranean areas. The objective of our study was to analyze the prevalence and severity of psoriasis in Lleida (a northeastern region in Spain), identify age and sex specific differences and compare our results with other European series. MATERIALS AND METHODS: A joint database of primary care medicine and the dermatology department was obtained from the entire province of Lleida with epidemiological data and psoriasis diagnosis and treatment codification. RESULTS: A corrected database was obtained with 398,701 individuals and 6,868 of them (1.72%) were coded with the diagnosis of psoriasis. The prevalence was significantly higher in men than in women (1.88% vs 1.56%, OR=1.21, 95% CI: 1.15-1.27). The highest prevalence of psoriasis was found in the 61-70 years group (2.90%) and psoriasis in population under 18 years of age was 0.30%. In our sample, 7.27% of the patients were classified as moderate-severe psoriasis (499/6,868). CONCLUSION: This study reports the prevalence and severity of psoriasis in a large Mediterranean region sample, obtaining the information through a electronic database. This study reveals a lower prevalence of psoriasis compared to other European countries, and the proportion of severe psoriasis (based on treatment criteria) is lower than in other studies. We emphasize that these differences could probably due to genetic background, life style and diet.