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Neue Studien
Perceptions over biologics for psoriasis after 5 years of access in Brazil: a cross-sectional study.
Biologic therapies have transformed psoriasis management, and their incorporation into Brazil's public healthcare system (SUS) in 2019 expanded access nationwide. However, real-world utilization and perceptions remain incompletely understood.Objectives
To evaluate perceptions, barriers, and prescription patterns regarding biologic therapy among Brazilian dermatologists and patients five years after universal incorporation, while quantifying the prevalence of undertreatment.Methods
We conducted two independent cross-sectional online surveys throughout 2024 among dermatologists (n = 225) and patients with psoriasis or psoriatic arthritis (n = 1,001). Data on demographics, clinical characteristics, and perceived barriers were analyzed.Results
Overall, 64.9% of dermatologists prescribed biologics, with higher prescribing rates among younger physicians (p = 0.022), those with fewer years of practice (p = 0.013), higher patient volumes (p < 0.001), and practice in tertiary centers (p = 0.001). Only 25.5% of patients were receiving biologics, strongly associated with psoriatic arthritis (p < 0.001), with no difference between public and private care. Key barriers included perceptions that conventional therapies are sufficient (59.5%), insufficient training (38.0%), and administrative burden (45.5%), while patients mainly reported safety (45.7%) and cost (30.9%) concerns. Undertreatment was prevalent, affecting over 50% of patients with moderate-to-severe disease. While 71.3% of non-users were willing to start biologics, only 28.0% had received a medical recommendation.Conclusions
Persistent educational and structural barriers continue to limit optimal biologic use despite formal availability, highlighting the need for targeted education, streamlined care pathways, and improved physician-patient communication to achieve equitable outcomes.Weiterlesen
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The clinical definition of moderate psoriasis is debated, affecting treatment eligibility and patient outcomes.Objective
A panel of Italian dermatologists aimed to propose practical criteria to define moderate psoriasis, based on a comprehensive literature review and clinical experience.Methods
The panel reviewed publications between 2016 and 2024 focusing on key severity scores, including the Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), and Physician's Global Assessment (PGA), along with special area involvement and patient-reported outcomes.Results
Despite variability among studies, and the lack of universally accepted thresholds, the panel defined moderate psoriasis as a BSA of 5%-10%, DLQI of 5-10, a PGA score of 3, and involvement of at least two special areas (e.g. scalp, face, genitals, nails, hands, or feet). Distressing itch and psychosocial impact were also recognized as critical elements influencing perceived disease burden. A composite PGA-based approach, integrating objective measures with patient-centered criteria, is proposed for identifying patients with moderate psoriasis who may benefit from systemic therapy.Conclusion
This pragmatic approach may help bridge the gap between guidelines and real-world clinical practice, ensuring more accurate treatment allocation and reducing undertreatment of psoriasis.Weiterlesen
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Activation of NF-κB signaling in tissue-resident memory T cells promotes recurrent psoriasis in mice
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To compare on-label persistence among adults with psoriasis who switched from other advanced therapies to guselkumab versus subcutaneous tumor necrosis factor inhibitors (SC TNFi), subcutaneous interleukin-17 inhibitors (SC IL-17i), or apremilast.Materials and methods
This retrospective cohort study used U.S. claims data from the IQVIA PharMetrics® Plus database (2016- 2023). Overlap propensity score weights were used to balance cohorts on baseline characteristics. On-label persistence was defined as the absence of drug discontinuation (event) and any dose change relative to the U.S. label (censoring). Survival analyses were used to assess on-label persistence from the start of the maintenance phase.Results
At 12, 18, and 24 months after the start of the maintenance phase, respectively, on-label persistence was 190%, 180%, and 179% more likely on guselkumab versus SC TNFi; 78%, 87%, and 91% more likely on guselkumab versus SC IL-17i; and 187%, 199%, and 193% more likely on guselkumab versus apremilast (all p < 0.001).Conclusions
Patients experiencing suboptimal outcomes with other psoriasis-indicated advanced therapies achieved higher on-label persistence after switching to guselkumab, raising the potential for improved disease control relative to other treatment options.Weiterlesen
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The Psoriatic Disease Assessment Index (PSODAI) Score to Evaluate Systemic Involvement of Psoriasis.
To the best of our knowledge, no validated scoring instrument currently exists that comprehensively evaluates both cutaneous manifestations and systemic comorbidities of psoriasis. This multicenter study aimed to develop and validate a novel multidimensional scoring system addressing this clinical gap.Methods
Under the guidance of the Shenzhen Psoriasis Academy, we conducted seven expert meetings to analyze existing evidence from PubMed, Wanfang, and CNKI databases. Through iterative Delphi consensus processes involving 26 specialists across 10 disciplines, we established the Psoriasis Disease Assessment Index (PSODAI). This 60-point composite instrument evaluates cutaneous involvement and nine key organ/system comorbidities. An accompanying online calculator (http://www.psodai.com.cn/) was developed for clinical implementation. Validation involved 254 psoriasis patients from six tertiary centers, with comparative analyses against PASI and DLQI metrics.Results
The PSODAI framework stratifies disease severity as mild (0-20), moderate (21-40), and severe (41-60). Comparative analysis revealed comparable proportions of moderate-to-severe cases between PSODAI and conventional tools (PASI/DLQI) (p>0.05). Notably, 11 patients (4.3%) classified as severe by PASI were re-categorized as mild through PSODAI's systemic evaluation, primarily due to limited extracutaneous manifestations.Conclusion
As the first comorbidity-integrated assessment tool, PSODAI enables cross-specialty collaboration for holistic patient management. Its clinical adoption may facilitate timely comorbidity detection and preventive interventions. Further multicenter validation is warranted to confirm these preliminary findings.Weiterlesen
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Psoriasis is frequently accompanied by depression. However, the role of specific symptom domains, including cognitive-affective and somatic symptoms, as well as potential metabolic mediators between psoriasis and depression, remains unclear.Methods
We analyzed data from the National Health and Nutrition Examination Survey (NHANES, n = 14,964) and the Health and Retirement Study (HRS, n = 4364). Depressive symptoms were classified into cognitive-affective and somatic domains. Cross-sectional associations were evaluated in NHANES, and longitudinal symptom trajectories were identified in HRS using group-based trajectory modeling. Based on genome-wide association study summary statistics, bidirectional and two-step Mendelian randomization (MR) were performed to assess causality and identify plasma metabolite mediators.Results
In NHANES, total depressive symptoms (OR = 1.03, 95% CI: 1.01-1.06, P = 0.018) and somatic symptoms (OR = 1.08, 95% CI: 1.03-1.12, P = 0.003) showed positive associations with psoriasis, but not cognitive-affective symptoms. In HRS, persistently high trajectories of total (OR = 1.58, 95% CI: 1.08-2.32, P = 0.018) was associated with psoriasis, with no significant association for the cognitive-affective and somatic domains after full adjustment. MR supported a causal relationship of psoriasis on depression and identified sphingomyelin (d17:2/16:0, d18:2/15:0) and urate as mediators, accounting for 10.2% and 6.8% of the total effect, respectively.Conclusion
Depressive symptoms were linked to psoriasis in both cross-sectional and longitudinal analyses. Lipid and antioxidant-related pathways involving sphingomyelin and urate may mediate the relationship between psoriasis and depression, offering potential targets for intervention.Weiterlesen
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Psoriasis, a chronic autoimmune condition, can severely impact patients' well-being. It is characterized by erythema, thickening, and scaling of the skin. Plaque psoriasis, the most prevalent type, affects 80%-90% of psoriasis patients, ranging from localized to severe cases. Although corticosteroids are commonly used to treat psoriasis, prolonged use poses risks. Therefore, alternative therapies are needed. Roflumilast, a potent phosphodiesterase 4 inhibitor, is currently being considered as a treatment for plaque psoriasis.Methods
We searched four electronic databases (Cochrane Central Register of Controlled Trials, PubMed, Scopus, and Web of Science) up to March 2024 for relevant articles evaluating the efficacy and tolerability of roflumilast in the management of psoriasis. The quality of evidence from trials was assessed using the Cochrane Risk of Bias tool (RoB1). Data from the included studies were extracted into a standardized online sheet and analyzed using RevMan 5.4.Results
Roflumilast significantly increased the proportion of patients achieving an Investigator's Global Assessment score of 0 or 1 and a 2-point improvement score at both weeks 4 and 8 compared to placebo (RR = 3.48, 95% CI [2.04 to 5.92], P < 0.00001, and RR = 4.02, 95% CI [3.17 to 5.11], P < 0.00001, respectively). The pooled studies demonstrated homogeneity at both weeks 4 (P = 0.17, I² = 38%) and 8 (P = 0.38, I² = 5%). Regarding the results of the Psoriasis Area and Severity Index, 75% favored roflumilast over placebo (RR = 2.72, 95% CI [1.18 to 6.28], P < 0.00001, and RR = 3.41, 95% CI [2.19 to 5.32], P < 0.00001, at weeks 4 and 8, respectively). Subgroup analysis addressed the observed heterogeneity in the results.Conclusion
This meta-analysis represents the first investigation into the efficacy and safety of roflumilast for treating psoriasis. Results suggest that roflumilast is both effective and well-tolerated in managing psoriasis. However, additional robust clinical trials are needed to validate these observations..Weiterlesen
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Weiterlesen
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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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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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