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Psoriasis is a chronic inflammatory skin disease associated with significant physical and psychological burden. Tildrakizumab, an interleukin-23 p19 inhibitor, has demonstrated efficacy in treating moderate-to-severe plaque psoriasis both in clinical trials and real-world setting. However, limited data are available on the impact of the effective treatment of psoriasis on the psychological health of patients. The aim of this study was to assess changes in psychological well-being, as well as clinical and quality-of-life outcomes, in patients with moderate-to-severe plaque psoriasis treated with tildrakizumab in routine clinical practice in Italy.Methods
This was an interim analysis (IA) of a 52-week multicenter, prospective, observational study. Adults with moderate-to-severe plaque psoriasis initiating tildrakizumab were enrolled. Endpoints focused on well-being and psychological health and included changes, from baseline to week 28, in Depression, Anxiety, and Stress Scale-21 (DASS-21) scores, Dermatology Life Quality Index (DLQI), European Social Survey (ESS) items, and World Health Organization-Five Well-Being Index (WHO-5). Effectiveness was also monitored via Psoriasis Area and Severity Index (PASI), and safety via treatment-emergent adverse event reporting.Results
A total of 115 patients were included (mean age 52.5 years, 60.8% male), 102 receiving ≥ 1 dose of tildrakizumab and completing DASS-21 evaluations at baseline and week 28. At week 28, improvements were observed in DASS-21 subscales [depression (- 2.6, 95% CI - 2.0 to - 1.0), anxiety (- 2.3, 95% CI - 2.0 to - 1.0), and stress (- 3.4, 95% CI - 4.0 to - 2.0)], accompanied by marked PASI reduction (- 13.7, 95% CI - 12.8 to - 10.1). DLQI, ESS, and WHO-5 scores also improved. Adverse events were generally mild or moderate, with no unexpected safety signals.Conclusion
In this real-world IA, tildrakizumab was observed to improve the psychological well-being of patients, reflected by a reduction in all items of the DASS-21 scale and, in parallel, confirmed its effectiveness in managing physical symptoms of psoriasis, establishing its role in the holistic management of psoriasis.Weiterlesen
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Interleukin-17 inhibitors (IL-17i) and interleukin-23 inhibitors (IL-23i) are advanced therapeutic options for moderate-to-severe psoriasis. In real-world settings, biologic persistence is commonly used as a proxy for effectiveness and safety, and a treatment-free status following biologic discontinuation may provide insights into disease remission. This study aimed to assess persistence and treatment-free status for IL-17i versus IL-23i among biologic-naïve patients with psoriasis in Japan.Patients and methods
This retrospective cohort study analyzed data from the Japanese Medical Data Vision database from 01 January 2015 to 31 December 2022. Patients diagnosed with psoriasis who initiated IL-17i or IL-23i during this study period were included. Persistence of the index biologic and post-discontinuation treatment-free status were assessed using Kaplan-Meier methodology. Propensity score methods with inverse probability of treatment weighting and matching were employed to control potential confounding between treatment cohorts.Results
There were 1,751 and 1,721 patients included in the IL-17i cohort and IL-23i cohort, respectively. Persistence rates for IL-17i were 55.7% [95% CI 53.2-58.1%] at the first year and 21.5% [95% CI 18.9-24.2%] at the fourth year, versus 77.7% [95% CI 75.4-79.8%] and 47.8% [95% CI 42.2-53.2%], respectively, for IL-23i. The risk of discontinuation of IL-23i was half that of IL-17i (adjusted hazard ratio [aHR]=0.49 [95% CI 0.44-0.54]). After discontinuation, 19.2% [95% CI 16.1-22.4%] and 31.5% [95% CI 27.8-41.2%] of patients in the IL-17i and IL-23i cohorts, respectively, remained treatment-free for at least 1 year. Patients treated with IL-23i had a lower risk for resuming systemic therapy after biologic discontinuation (aHR=0.57 [95% CI 0.49-0.67]).Conclusion
IL-23i was associated with longer persistence and a longer post-discontinuation treatment-free period than IL-17i in patients with psoriasis. These findings may provide actionable insights for healthcare providers and patients as they develop treatment strategies. Future research integrating comprehensive clinical data is warranted to evaluate different treatment strategies, thereby informing clinical decision-making.Weiterlesen
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Psoriasis beyond the skin: systemic inflammation as a bridge to metabolic and hepatic comorbidities.
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Risankizumab is a high-cost biologic treatment for chronic plaque psoriasis, an immune-mediated inflammatory disease presenting with painful red scaly skin lesions. Inter-individual heterogeneity in treatment response may be better addressed with personalised rather than fixed dosing. We sought to develop a pharmacokinetic/pharmacodynamic (PK/PD) model to characterise the relationship between risankizumab exposure and treatment response.Methods
A sequential population PK/PD model was developed using real-world data (UK Biomarkers of Systemic Treatment Outcomes in Psoriasis study) comprising serial PK and Psoriasis Area and Severity Index (PASI) measures. Models were built using R (V4.3.1) and nlmixr2 (V2.1.1.9). One and two-compartment PK models were tested. A maximal effect turnover model was used to describe PASI, with drug effect on lesion development rate (Kin).Results
The dataset (82 serum risankizumab concentrations; 101 PASI observations) comprised 50 patients with psoriasis (median weight 79.3 kg; age 47 years). PK data were described by a one-compartment model with first-order absorption/elimination. Absorption rate (Ka) was fixed from the literature (0.229). Estimated clearance was 0.34 L/day, and volume of distribution 12.9 L. Baseline PASI at model initiation, drug potency (EC50) and lesion recovery rate (Kout) were estimated at 23.4, 0.11 mg/L and 0.05 day-1, respectively.Conclusions
Pharmacokinetic parameters were similar to risankizumab clinical trials. Kout estimates aligned with other psoriasis turnover models, highlighting the capture of disease dynamics that may be applied across drugs. This model may inform personalised dosing based on individual patient characteristics, drug exposure and response, to optimise treatment outcomes.Weiterlesen
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Narrowband ultraviolet B (NB-UVB) phototherapy is a well-established, safe, and effective treatment for pediatric psoriasis; however, relapse after therapy remains a major challenge. Data regarding prognostic factors influencing remission durability in children are limited.Objectives
To evaluate treatment response, relapse patterns, and predictors of relapse-free duration in pediatric psoriasis patients treated with NB-UVB phototherapy, with a particular focus on concomitant topical corticosteroid and calcipotriol use, and clinical features such as nail involvement.Methods
This multicenter retrospective study included 114 pediatric psoriasis patients treated with NB-UVB across six tertiary dermatology centers in Türkiye. Treatment response was defined as ≥ 75% improvement in the Psoriasis Area and Severity Index (PASI75). Relapse was defined as clinically significant recurrence requiring renewed NB-UVB or systemic therapy within 6 months after treatment completion. Multivariable linear regression identified independent predictors of relapse-free duration.Results
Of 114 patients (mean age 12.2 ± 3.6 years; 52.6% male), 65.8% achieved PASI75 and 42.1% PASI90. Responders received significantly higher cumulative doses and more sessions than nonresponders (p < 0.001). Relapse occurred in 24.0% of responders within 6 months. In multivariate analysis, concomitant topical corticosteroid use independently predicted longer relapse-free duration (β = 0.578, p = 0.001), whereas nail involvement predicted shorter remission (β = -0.520, p = 0.002). Topical calcipotriol and disease subtype were not significant predictors. NB-UVB was well tolerated, with mild erythema and pruritus as the most frequent adverse events (16.7%).Conclusion
NB-UVB phototherapy provides high efficacy and an acceptable safety profile in pediatric psoriasis. Concomitant topical corticosteroid use may prolong remission, while nail involvement identifies patients at higher relapse risk, supporting closer monitoring and individualized follow-up and maintenance strategies.Weiterlesen
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Patient-reported outcome (PRO) assessments alongside clinical parameters help to holistically determine treatment benefits.Objective
To assess PROs among bimekizumab-treated patients with moderate to severe plaque psoriasis.Design, setting, and participants
The BE RADIANT multicenter, phase 3b randomized clinical trial and open-label extension (OLE) had a 48-week double-blinded period and 96-week OLE (3 years' total treatment). Patients initially received bimekizumab or secukinumab. At year 1 (week 48/OLE entry), bimekizumab-randomized patients continued bimekizumab treatment (continuous bimekizumab-treated patients) and secukinumab-randomized patients switched to bimekizumab (secukinumab/bimekizumab-treated patients).Interventions
Continuous bimekizumab-treated patients received bimekizumab, 320 mg, every 4 weeks to week 16, then every 4 weeks or every 8 weeks to 1 year and into the OLE. Secukinumab/bimekizumab-treated patients received secukinumab, 300 mg, every 4 weeks to 1 year, then switched to bimekizumab, 320 mg, every 4 weeks or every 8 weeks. All received bimekizumab every 8 weeks by week 64.Main outcomes and measures
Patient-reported itching/skin pain/scaling (Psoriasis Symptoms and Impacts Measure [P-SIM]) and concurrent achievement of Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores are reported (nonresponder imputation to 1 year; modified nonresponder imputation to 1-3 years).Results
A total of 373 bimekizumab-treated and 370 secukinumab-treated patients were randomized at baseline; 336 and 318, respectively, entered the OLE. Among bimekizumab-randomized and secukinumab-randomized patients, 127 (34.0%) and 93 (25.1%) reported no itching; 278 (74.5%) and 222 (60.0%) no skin pain; and 172 (46.1%) and 80 (21.6%) no scaling at week 4, respectively; at year 1, rates remained higher in bimekizumab-randomized vs secukinumab-randomized patients (itching: 227 [60.9%] vs 178 [48.1%]; nominal P < .001; skin pain: 293 [78.6%] vs 262 [70.8%]; nominal P = .01; scaling: 263 [70.5%] vs 184 [49.7%]; nominal P < .001). Bimekizumab-randomized patients had greater concurrent achievement rates of PASI = 0 and DLQI 0/1 vs secukinumab-randomized patients (week 4: 43 [11.5%] vs 17 [4.6%]; nominal P < .001; year 1: 230 [61.7%] vs 158 [42.7%]; nominal P < .001). In patients entering the OLE, high P-SIM = 0 rates were maintained to year 3. At OLE entry, concurrent achievement of PASI = 0 and DLQI 0/1 was reported in 69.2% continuous bimekizumab-treated and 48.5% secukinumab/bimekizumab-treated patients. After switching, secukinumab/bimekizumab responses increased, and high rates were maintained to year 3 for both continuous bimekizumab and secukinumab/bimekizumab (62.2% and 63.8%, respectively).Conclusions and relevance
In this randomized clinical trial and OLE, bimekizumab rapidly and durably improved symptoms/health-related quality of life to 3 years, demonstrating that clinical efficacy translates to quality of life improvements. Secukinumab-randomized patients reported improvements on switching to bimekizumab.Trial registration
ClinicalTrials.gov Identifier: NCT03536884.Weiterlesen
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To describe the comorbidity profile in patients with moderate-to-severe psoriasis treated with biologics and their association with clinical phenotype and therapeutic choice.Material and methods
This was an observational, cross-sectional, single-center study conducted at the Lozano Blesa University Clinical Hospital (Zaragoza, Spain). Consecutive patients with moderate-to-severe psoriasis receiving biologic treatment were included. Data were collected during the Dermatology consultation and reviewed from medical records. The variables analyzed included demographic data, clinical phenotype, previous and current treatments, cardiometabolic comorbidities, neoplasia, infections, and lifestyle habits. Statistical analysis employed means and proportions comparison tests, and logistic regression to explore associations between phenotype, comorbidities, and biologic type.Results
350 patients were included (median age 54.1years; 57% men; 84% plaque psoriasis). The most prevalent comorbidities were dyslipidemia (55%), hypertension (42%), and obesity (36%). Among patients with liver elastography, 58% met MASLD criteria. Significant associations were observed between clinical phenotype and comorbidities: plaque psoriasis with hypertension and vitaminD deficiency, erythrodermic psoriasis with alcoholism and neoplasia, pustular psoriasis with dyslipidemia and kidney disease, and guttate psoriasis with a lower prevalence of cardiovascular factors. Guselkumab was the most commonly used biologic (15%).Conclusions
Patients with moderate-to-severe psoriasis have a high burden of comorbidities, with differential profiles according to phenotype. These results reinforce the need for a multidisciplinary approach and the role of primary care in screening and managing comorbidities to improve disease control and overall prognosis.Weiterlesen
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Nail involvement is common in psoriasis, yet objective and non-invasive biomarkers of nail disease activity are limited. The biochemical composition of the nail plate may reflect local pathophysiological changes and could provide measurable indicators of disease severity.Objective
To compare the nail biochemical composition between psoriatic patients with and without nail involvement, and to examine its associations with nail severity.Methods
In this case-control study, nail clippings from adults with psoriasis were analyzed for trace elements (Cr, Cu, Fe, Mn, Mg, Se, Zn) by ICP-OES and for amino acids by LC-MS/MS. Group comparisons and correlation analyses with the Nail Psoriasis Severity Index (NAPSI) were conducted, and multivariable logistic regression identified independent predictors of nail involvement.Results
Fifty-seven patients were included (30 with nail involvement; 27 without). Compared with patients without nail involvement, those with nail psoriasis showed significantly lower nail levels of several trace elements and amino acids, whereas histidine was higher (all p < 0.05). NAPSI correlated negatively with selenium, zinc, glycine, and proline, and positively with histidine. In multivariable analysis, lower nail selenium and asparagine and higher histidine independently predicted nail involvement.Conclusion
Psoriatic nail dystrophy is associated with a distinct biochemical profile in the nail plate. Selected trace elements and amino acids correlate with clinical severity and may represent potential biochemical indicators of nail disease activity. Prospective studies are warranted to validate these findings.Weiterlesen
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Human beta-defensin 2 (hBD-2) is an antimicrobial peptide upregulated by IL-17A and TNF-α, important in skin immunity and inflammation. While hBD-2 is elevated in psoriatic skin, its systemic expression and clinical significance remain unclear, particularly in psoriatic arthritis (PsA).Objectives
To compare serum hBD-2 levels among patients with psoriasis vulgaris, PsA, and healthy controls, and to evaluate its correlation with disease severity and inflammatory markers.Methods
This case-control study included 66 patients with psoriasis, 30 with PsA, and 67 healthy controls. Serum hBD-2, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) were measured. Psoriasis severity was assessed using the Psoriasis Area and Severity Index (PASI). A p value < 0.05 was considered statistically significant.Results
Median serum hBD-2 levels were significantly higher in psoriasis and PsA groups compared to controls (p < 0.001), but no significant difference was found between the two patient groups (p: 0.223). In the psoriasis group, hBD-2 showed no significant correlation with PASI (r: 0.218, p: 0.095), CRP (r: 0.158, p: 0.277), or ESR (r: 0.129, p: 0.369). CRP and ESR were significantly higher in the PsA group than in other groups (p < 0.001 and p: 0.002, respectively).Conclusions
Although serum hBD-2 is elevated in psoriasis and PsA, it does not correlate with clinical or laboratory disease activity in psoriasis. These findings suggest that hBD-2 may reflect local cutaneous immune activation rather than systemic inflammation.Weiterlesen
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Asthma (AS) and chronic obstructive pulmonary disease (COPD) are prevalent chronic airway disorders with shared inflammatory pathways. Considering the systemic inflammatory nature of psoriasis, this study utilized the National Health Interview Survey (NHIS) to investigate its potential association with COPD and AS.Methods
Data from the 2023 NHIS were analyzed, with participants selected based on specific inclusion criteria. A baseline table was constructed, and multivariate logistic regression models, along with risk stratification analysis, were employed to examine the correlations between psoriasis and COPD and AS. Receiver operating characteristic (ROC) analysis was conducted to assess the predictive value for both conditions.Results
A total of 27,106 participants were included in the study. Significant differences were observed in the baseline characteristics of psoriasis, age, race, region, gender, education, marital status, employment, income, smoking habits, health status, mental health, disability, heart attack history, BMI, prediabetes, cancer, hypertension, hypercholesterolemia, arthritis, coronary heart disease, stroke, health insurance, anxiety, and depression (P < 0.001). Multivariate logistic regression revealed a strong association between psoriasis and COPD (model 1: OR 2.63, 95% CI: 2.13-3.23, P < 0.001; model 2: OR 2.43, 95% CI: 1.95-2.99, P < 0.001; model 3: OR 1.54, 95% CI: 1.21-1.96, P < 0.001). A similar association was found between psoriasis and AS (model 1: OR 1.68, 95% CI: 1.42-1.97, P < 0.001; model 2: OR 1.74, 95% CI: 1.47-2.05, P < 0.001; model 3: OR 1.32, 95% CI: 1.11-1.56, P < 0.01). The ROC analysis based on model 3 demonstrated substantial predictive power of psoriasis for COPD, with an AUC of 0.881.Conclusion
Psoriasis was identified to have a strong association with COPD and AS, which provided valuable insights into understanding the pathogenesis of these diseases.Weiterlesen
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