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1.
J Psoriasis Psoriatic Arthritis ; 9(2): 69-81, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-39156223

RESUMEN

Background: Adherence to a Mediterranean Diet (MeD) has been associated with lower disease severity in patients with psoriasis. However, the mechanism behind how this diet may lead to disease modification remain understudied. Recent studies have revealed dysbiosis of the gut microbiome in patients with psoriasis suggestive of inflammation and altered immune regulation. Diet affects the gut microbiome and this review aims to evaluate whether correcting this dysbiosis may be one theoretical mechanism by which the MeD may be associated with lower psoriasis severity. Methods: A literature search of the PubMed database was conducted for the terms 1) 'psoriasis' and 'microbiome' or 'microbiota,' and 2) 'Mediterranean diet' and 'microbiome' or 'microbiota' with manual screening for relevant articles. In total, we identified 9 relevant primary research studies investigating the gut microbiome in patients with psoriasis and 16 relevant primary research studies investigating changes in the microbiota for those consuming a MeD. Results: Though varying in exact levels of certain bacteria, studies analyzing the microbiome in psoriasis revealed dysbiosis. Those analyzing the effect of the Mediterranean diet on the microbiome revealed beneficial changes, including alleviating some of the same alterations seen in the microbiome of those with psoriasis. Conclusion: Microbiota change is a possible mechanism why the MeD has previously been associated with lower psoriasis severity.

2.
Dermatol Ther (Heidelb) ; 14(8): 2077-2092, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38937404

RESUMEN

INTRODUCTION: Certolizumab pegol (CZP) is an anti-tumor necrosis factor alpha (TNFα) approved for the treatment of moderate to severe plaque psoriasis (PSO). However, data on its real-world use is currently limited. The objective of this study was to describe the 1-year real-world effectiveness of CZP, its impact on health-related quality of life (HRQoL), and safety outcomes in patients with moderate to severe PSO in multi-country settings. METHODS: CIMREAL, a prospective, noninterventional study, was conducted across Europe and Canada from August 2019 to December 2022. Patients were followed for 1-year, receiving CZP 400 mg initial doses at weeks 0, 2, and 4, followed by CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg Q2W maintenance dosing. Effectiveness was assessed using the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety was also evaluated. RESULTS: Overall, 399 patients with moderate to severe PSO were included. Of these, 93.7% (374/399) and 77.9% (311/399) completed months 3 and 12, respectively. Mean age (± standard deviation) was 42.9 ± 13.5 years and body mass index was 28.5 ± 6.8 kg/m2, with the majority of patients being female (68.2%). At 12 months, CZP showed substantial effectiveness, achieving PASI 75 and PASI 90 response rates (≥ 75% and ≥ 90% improvement from baseline, respectively) of 77% and 56.5%, respectively. Patients with PASI score of ≤ 3 and ≤ 2 experienced improvement from 3 months (49.8% and 41.1%, respectively) to 12 months (82.0% and 75.3%, respectively). HRQoL considerably improved, with mean DLQI scores decreasing from 12.4 to 2.3 after 12 months of treatment, and the proportion of patients with DLQI 0/1 increased from 28.6% at 3 months to 59.4% at 12 months. The 1-year probability of persistence was approximately 85%. Overall, 30.6% of the patients experienced any adverse events and 9.3% had serious adverse events. CONCLUSION: In routine clinical practice, CZP exhibited consistent effectiveness, positively impacting both skin psoriasis activity and HRQoL. The 1-year persistence of CZP was high, and no new safety signals were identified. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04053881 https://www. CLINICALTRIALS: gov/study/NCT04053881 .

3.
Arch Dermatol Res ; 316(7): 362, 2024 Jun 08.
Artículo en Inglés | MEDLINE | ID: mdl-38850346

RESUMEN

Secukinumab is a fully human IgG1 antibody that selectively binds to and neutralizes the proinflammatory cytokine interleukin-17A. Secukinumab is an effective and well-tolerated treatment for plaque psoriasis. There is a limited real-word evidence for dose optimisation of secukinumab based on clinical response. PURE is a multi-national, prospective, observational study in patients with moderate to severe chronic plaque psoriasis in Canada and Latin America, assessing the real-world safety and effectiveness of secukinumab and other indicated therapies. The aim of the current snapshot analysis was to evaluate the effectiveness and safety of on-label dose and updosed secukinumab in patients with plaque psoriasis enrolled in the PURE study. At the time of analysis, 676 patients received secukinumab, of which 84.6% (n = 572) remained on the on-label dose, while 15.4% (n = 104) were updosed. With on-label secukinumab, the absolute Psoriasis Area and Severity Index (PASI) score was reduced from 13.6 at baseline to 1.2 over 36 months, with treatment persistence of 73% at 40 months. At Month 36, 73.2% of the patients receiving on-label secukinumab achieved Investigator's Global Assessment (IGA) 0/1. With updosed secukinumab (300 mg every 2 weeks, 300 mg every 3 weeks, 450 mg every 4 weeks, or 450 mg every 3 weeks), 57.9% of the patients showed improvement in the absolute PASI score at the first visit after updosing, with treatment persistence of 50% at 12 months after updosing. At Month 15, 40% of patients receiving updosed secukinumab achieved IGA 0/1. Patients with previous biologic exposure (odds ratio [OR]: 3.25; 95% confidence interval [CI]: 2.03, 5.18, p < 0.0001) were more likely to be updosed while those with a body weight < 90 kg (OR: 0.49; 95% CI [0.31, 0.77], p = 0.0019) were less likely to be updosed. Previous biologic exposure (HR [hazard ratio]: 1.47; 95% CI [1.24, 1.75], p < 0.0001) and current biologic exposure (secukinumab vs. other indicated therapies: HR 0.57; 95% CI [0.43, 0.75], p = 0.0001) were significantly associated with time to secukinumab updosing. No new or unexpected safety signals were observed with updosed secukinumab. Secukinumab updosing was efficacious and well-tolerated in patients with psoriasis who failed to respond to the approved on-label regimen, suggesting that updosing may be a useful therapeutic option for approved dose non-responders.


Asunto(s)
Anticuerpos Monoclonales Humanizados , Psoriasis , Sistema de Registros , Índice de Severidad de la Enfermedad , Humanos , Psoriasis/tratamiento farmacológico , Anticuerpos Monoclonales Humanizados/efectos adversos , Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales Humanizados/uso terapéutico , Masculino , Femenino , Estudios Prospectivos , Persona de Mediana Edad , Resultado del Tratamiento , Sistema de Registros/estadística & datos numéricos , Adulto , Canadá , Fármacos Dermatológicos/efectos adversos , Fármacos Dermatológicos/administración & dosificación , Fármacos Dermatológicos/uso terapéutico , América Latina , Interleucina-17/antagonistas & inhibidores , Interleucina-17/inmunología
4.
JMIR Form Res ; 8: e55855, 2024 Jun 27.
Artículo en Inglés | MEDLINE | ID: mdl-38738977

RESUMEN

BACKGROUND: Psoriasis vulgaris (PsV) and psoriatic arthritis (PsA) are complex, multifactorial diseases significantly impacting health and quality of life. Predicting treatment response and disease progression is crucial for optimizing therapeutic interventions, yet challenging. Automated machine learning (AutoML) technology shows promise for rapidly creating accurate predictive models based on patient features and treatment data. OBJECTIVE: This study aims to develop highly accurate machine learning (ML) models using AutoML to address key clinical questions for PsV and PsA patients, including predicting therapy changes, identifying reasons for therapy changes, and factors influencing skin lesion progression or an abnormal Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score. METHODS: Clinical study data from 309 PsV and PsA patients were extensively prepared and analyzed using AutoML to build and select the most accurate predictive models for each variable of interest. RESULTS: Therapy change at 24 weeks follow-up was modeled using the extreme gradient boosted trees classifier with early stopping (area under the receiver operating characteristic curve [AUC] of 0.9078 and logarithmic loss [LogLoss] of 0.3955 for the holdout partition). Key influencing factors included the initial systemic therapeutic agent, the Classification Criteria for Psoriatic Arthritis score at baseline, and changes in quality of life. An average blender incorporating three models (gradient boosted trees classifier, ExtraTrees classifier, and Eureqa generalized additive model classifier) with an AUC of 0.8750 and LogLoss of 0.4603 was used to predict therapy changes for 2 hypothetical patients, highlighting the significance of these factors. Treatments such as methotrexate or specific biologicals showed a lower propensity for change. An average blender of a random forest classifier, an extreme gradient boosted trees classifier, and a Eureqa classifier (AUC of 0.9241 and LogLoss of 0.4498) was used to estimate PASI (Psoriasis Area and Severity Index) change after 24 weeks. Primary predictors included the initial PASI score, change in pruritus levels, and change in therapy. A lower initial PASI score and consistently low pruritus were associated with better outcomes. BASDAI classification at onset was analyzed using an average blender of a Eureqa generalized additive model classifier, an extreme gradient boosted trees classifier with early stopping, and a dropout additive regression trees classifier with an AUC of 0.8274 and LogLoss of 0.5037. Influential factors included initial pain, disease activity, and Hospital Anxiety and Depression Scale scores for depression and anxiety. Increased pain, disease activity, and psychological distress generally led to higher BASDAI scores. CONCLUSIONS: The practical implications of these models for clinical decision-making in PsV and PsA can guide early investigation and treatment, contributing to improved patient outcomes.

5.
Exp Dermatol ; 33(4): e15082, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38664884

RESUMEN

As a chronic relapsing disease, psoriasis is characterized by widespread skin lesions. The Psoriasis Area and Severity Index (PASI) is the most frequently utilized tool for evaluating the severity of psoriasis in clinical practice. Nevertheless, long-term monitoring and precise evaluation pose difficulties for dermatologists and patients, which is time-consuming, subjective and prone to evaluation bias. To develop a deep learning system with high accuracy and speed to assist PASI evaluation, we collected 2657 high-quality images from 1486 psoriasis patients, and images were segmented and annotated. Then, we utilized the YOLO-v4 algorithm to establish the model via four modules, we also conducted a human-computer comparison through quadratic weighted Kappa (QWK) coefficients and intra-class correlation coefficients (ICC). The YOLO-v4 algorithm was selected for model training and optimization compared with the YOLOv3, RetinaNet, EfficientDet and Faster_rcnn. The model evaluation results of mean average precision (mAP) for various lesion features were as follows: erythema, mAP = 0.903; scale, mAP = 0.908; and induration, mAP = 0.882. In addition, the results of human-computer comparison also showed a median consistency for the skin lesion severity and an excellent consistency for the area and PASI score. Finally, an intelligent PASI app was established for remote disease assessment and course management, with a pleasurable agreement with dermatologists. Taken together, we proposed an intelligent PASI app based on the image YOLO-v4 algorithm that can assist dermatologists in long-term and objective PASI scoring, shedding light on similar clinical assessments that can be assisted by computers in a time-saving and objective manner.


Asunto(s)
Algoritmos , Aprendizaje Profundo , Psoriasis , Índice de Severidad de la Enfermedad , Psoriasis/patología , Humanos , Procesamiento de Imagen Asistido por Computador/métodos
6.
Actas Dermosifiliogr ; 2024 Mar 06.
Artículo en Inglés, Español | MEDLINE | ID: mdl-38452889

RESUMEN

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.

7.
Actas Dermosifiliogr ; 2024 Mar 29.
Artículo en Inglés, Español | MEDLINE | ID: mdl-38556202

RESUMEN

BACKGROUND AND OBJECTIVE: The Simplified Psoriasis Index (SPI) is a recently validated tool in Spanish that measures psoriasis severity by integrating 3 different spheres: clinical severity (SPI-s), psychosocial impact (SPI-p), and natural history (SPI-i). Our objective was to study the validity and equivalence of this new scale compared to routinely used scales such as the Psoriasis Area and Severity Index, PASI, and the Dermatology Life Quality Index (DLQI). MATERIALS AND METHODS: This was a cross-sectional and observational study that included 45 patients aged 18 to 74 years. Demographic data and information associated with psoriasis severity and the patients' quality of life were collected, using PASI, DLQI, and SPI simultaneously. The correlation of reference scales (PASI and DLQI) with SPI was examined. The degree of agreement between the 2 versions of SPI completed by the physician (proSPI-s) and self-administered by the patient (saSPI-s), was also studied. RESULTS: The mean age of the study population was 51 years, with a mean psoriasis history of 14.05 years. A strong correlation was found between PASI and proSPI-s (r=0.89), as well as between DLQI and SPI-p (r=0.89), with a moderate correlation being reported between PASI and saSPI-s (r=0.52). The degree of agreement between proSPI-s and saSPI-s was moderate. CONCLUSIONS: These findings represent the initial results of real clinical practice using the validated Spanish version of SPI, making its use truly promising in the routine clinical practice.

8.
Int J Nanomedicine ; 19: 1163-1187, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38344440

RESUMEN

Purpose: Improving the treatment of psoriasis is a serious challenge today. Psoriasis is an immune-mediated skin condition affecting 125 million people worldwide. It is commonly treated with cyclosporine-A (CsA) and dithranol (DTH). CsA suppresses the activation of T-cells, immune cells involved in forming psoriatic lesions. Meanwhile, DTH is a potent anti-inflammatory and anti-proliferative drug that effectively reduces the severity of psoriasis symptoms such as redness, scaling, and skin thickness. CsA and DTH belong to BCS class II with limited oral bioavailability. We aim to develop a drug delivery system for topical co-delivery of CsA and DTH, exploring its therapeutic potential. Methods: Firstly, we developed a niosomal drug delivery system based on ceramide IIIB to form Cerosomes. Cerosomes were prepared from a mixture of Ceramide, hyaluronic acid, and edge activator using a thin-film hydration technique. To co-deliver CsA and DTH topically for the treatment of psoriasis. These two hydrophobic drugs encapsulated into our synthesized positively charged particle cerosomes. Results:  Cerosomes had an average particle size of (222.36 nm± 0.36), polydispersity index of (0.415±0.04), Entrapment Efficiency of (96.91%± 0.56), and zeta potential of (29.36±0.38mV) for selected formula. In vitro, In silico, in vivo, permeation, and histopathology experiments have shown that cerosomes enhanced the skin penetration of both hydrophobic drugs by 66.7% compared to the CsA/DTH solution. Imiquimod (IMQ) induced psoriatic mice model was topically treated with our CsA/DTH cerosomes. We found that our formulation enhances the skin penetration of both drugs and reduces psoriasis area and severity index (PASI score) by 2.73 times and 42.85%, respectively, compared to the CsA/DTH solution. Moreover, it reduces the levels of proinflammatory cytokines, TNF-α, IL-10, and IL-6 compared to CsA/DTH solution administration. Conclusion: The Cerosomes nano-vesicle-containing CsA/DTH represents a more promising topical treatment for psoriasis, giving new hope to individuals with psoriasis, compared to commercial and other conventional alternatives.


Asunto(s)
Antralina , Psoriasis , Humanos , Animales , Ratones , Antralina/farmacología , Antralina/uso terapéutico , Ciclosporina/farmacología , Fosfolípidos , Ceramidas/farmacología , Administración Cutánea , Psoriasis/tratamiento farmacológico , Psoriasis/patología , Piel , Modelos Animales de Enfermedad
9.
Rheumatol Ther ; 11(2): 457-474, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38416392

RESUMEN

INTRODUCTION: Two biologic therapies for psoriatic arthritis (PsA), guselkumab and ustekinumab, have demonstrated superior efficacy versus placebo in clinical trials. However, no head-to-head studies have been conducted comparing these two treatments for PsA. The objective was to indirectly compare guselkumab and ustekinumab on joint and skin efficacy up to week 52, using pooled individual patient-level data (IPD) from PsA trials. METHODS: IPD, including baseline characteristics, American College of Rheumatology (ACR) scores and Psoriasis Area Severity Index (PASI) response from guselkumab (DISCOVER-1 and -2) and ustekinumab (PSUMMIT 1 and 2) trials were pooled. Differences in patient characteristics across trials were adjusted using multivariate logistic regression. Odds ratios (OR) were used to derive absolute response probabilities in the guselkumab trial population and were presented with 95% confidence intervals. RESULTS: Most baseline characteristics for guselkumab-treated patients (100 mg every 8 weeks [Q8W]; 100 mg every 4 weeks [Q4W]) were comparable to ustekinumab-treated patients (45/90 mg). In biologic-naïve patients, both guselkumab doses showed significantly higher ACR 20 (Q8W: 1.97; 1.37, 2.84; Q4W: 2.04; 1.40, 2.96) and PASI 90 (Q8W: 2.33; 1.52, 3.56; Q4W: 2.57; 1.67, 3.97) versus ustekinumab from week 16 onwards. In biologic-experienced patients, both guselkumab doses showed significantly higher ACR 20 (Q8W: 2.57; 1.11, 5.93; Q4W: 2.63; 1.12, 6.17) versus ustekinumab from week 24 onwards; for PASI 90, both guselkumab doses were superior to ustekinumab at week 16 and 52 (Q8W: 3.96; 1.39, 11.27; Q4W: 13.10; 4.18, 41.04). Guselkumab efficacy was similar and robust across primary, scenario, and sensitivity analyses. CONCLUSIONS: IPD analysis demonstrated that both guselkumab doses were superior to ustekinumab for ACR 20 from weeks 16 (biologic-naïve) and 24 (biologic-experienced) onwards, and for PASI 90 at weeks 16 and 52 for both subgroups.

11.
J Transl Med ; 22(1): 121, 2024 01 31.
Artículo en Inglés | MEDLINE | ID: mdl-38297242

RESUMEN

BACKGROUND: Treatment responses to biologic agents vary between patients with moderate to severe psoriasis; while some patients achieve total skin clearance (TSC), a proportion of patients may only experience partial improvement. OBJECTIVE: This study was designed to identify potential predictors for achieving TSC in psoriasis patients treated with IL-17 inhibitors. It also aimed to develop an easy-to-use calculator incorporating these factors by the nomogram to predict TSC response. METHODS: A total of 381 patients with psoriasis receiving ixekizumab were included in the development cohort and 229 psoriasis patients who initiated secukinumab treatment were included in the validation cohort. The study endpoint was achieving TSC after 12 weeks of IL-17 inhibitors treatment, defined as the 100% improvement in Psoriasis Area and Severity Index (PASI 100). Multivariate Cox regression analyses and LASSO analysis were performed to identify clinical predictors and blood predictors respectively. RESULTS: The following parameters were identified as predictive factors associated with TSC: previous biologic treatment, joint involvement, genital area affected, early response (PASI 60 at week 4), neutrophil counts and uric acid levels. The nomogram model incorporating these factors achieved good discrimination in the development cohort (AUC, 0.721; 95% CI 0.670-0.773) and validation cohort (AUC, 0.715; 95% CI 0.665-0.760). The calibration curves exhibited a satisfactory fit, indicating the accuracy of the model. Furthermore, the decision curve analysis confirmed the clinical utility of the nomogram, highlighting its favorable value for practical application. Web-based online calculator has been developed to enhance the efficiency of clinical applications. CONCLUSIONS: This study developed a practical and clinically applicable nomogram model for the prediction of TSC in patients with moderate to severe psoriasis. The nomogram model demonstrated robust predictive performance and exhibited significant clinical utility. Trial registration A multi-center clinical study of systemic treatment strategies for psoriasis in Chinese population;ChiCTR2000036186; Registered 31 August 2020; https://www.chictr.org.cn/showproj.html?proj=58256 .


Asunto(s)
Productos Biológicos , Psoriasis , Humanos , Interleucina-17 , Resultado del Tratamiento , Índice de Severidad de la Enfermedad , Psoriasis/tratamiento farmacológico , Productos Biológicos/uso terapéutico
12.
Exp Dermatol ; 33(1): e14973, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37926911

RESUMEN

Psoriasis vulgaris is a chronic, autoimmune skin disease involving a complex interplay of epidermal keratinocytes, dermal fibroblast and infiltrating immune cells. Differential expressions of miRNAs are observed in psoriasis and the deregulated miRNAs are sometimes associated with disease severity. This study aims to identify miRNAs altered in the serum of psoriasis patients that are associated with the Psoriasis Area and Severity Index (PASI). In order to assess miRNA levels in the serum of psoriasis patients, we selected 24 differentially expressed miRNAs in the psoriatic skin are possibly derived from the skin and immune cells, as well as five miRNAs that are enriched in other tissues. We identified 16 miRNAs that exhibited significantly (p < 0.05) altered levels in the serum of psoriasis patients compared to healthy individuals. Among these, 13 miRNAs showed similar expression pattern in the serum of psoriasis patients as also observed in the psoriatic skin tissues. Ten miRNAs showed an accuracy of greater than 75% in classifying the psoriasis patients from healthy individuals. Further analysis of differential miRNA levels between the low PASI group and the high PASI group identified three miRNAs (miR-147b, miR-3614-5p, and miR-125a-5p) with significantly altered levels between the low severity and the high severity psoriasis patients. Our systematic investigation of skin and immune cell-derived miRNAs in the serum of psoriasis patients revealed alteration in miRNA levels to be associated with disease severity, which may help in monitoring the disease progression and therapeutic response.


Asunto(s)
MicroARNs , Psoriasis , Humanos , MicroARNs/metabolismo , Psoriasis/metabolismo , Piel/metabolismo , Queratinocitos/metabolismo , Gravedad del Paciente , Enfermedad Crónica
13.
Expert Rev Clin Pharmacol ; 16(10): 999-1008, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37710355

RESUMEN

BACKGROUND: Further dose optimization is required for patients with moderate-to-severe plaque psoriasis who do not benefit from the approved secukinumab dose regimen. This study aimed to develop an exposure-response model for secukinumab to recommend dose regimens for patients of different body weights. METHODS: We searched the PubMed and Cochrane Library databases for randomized controlled trials using PASI 75 and PASI 90 response rates as primary outcomes. A model-based meta-analysis was developed to quantitatively analyze the distribution of six secukinumab dose regimens in patients weighing 50-120 kg. RESULTS: Sixteen trials involving 6,197 subjects were included in the analysis. The established model accurately described the time-course characteristics of PASI 75 and PASI 90 response rates over 52 weeks. Simulations indicated that maintenance doses could be reduced to 150 mg every 4 weeks and to 150 mg every 3 weeks for patients weighing 50 and 60 kg, respectively. In contrast, maintenance doses of 300 mg every 3 weeks should be selected for patients weighing 120 kg. Patients weighing 70-110 kg remained on approved maintenance doses of 300 mg every 4 weeks. CONCLUSIONS: Based on patient body weights, the exposure-response model recommends efficacious and economical dose regimens for patients with moderate-to-severe plaque psoriasis.

14.
Infect Drug Resist ; 16: 5165-5172, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37581169

RESUMEN

Background: Palmoplantar pustulosis (PPP) is a common chronic and recurrent skin disease of the palms and soles with significant pain, mental distress, and functional disability. PPP is challenging to treat and usually requires prolonged management. Therapy resistance and frequent relapse discourages patients from follow-up. No unified standard and no published therapeutic guidelines have yet been defined on PPP treatment. In general, all therapeutic options known for autoimmune diseases, psoriasis in particular, have been tested in PPP. Tofacitinib, an oral JAK inhibitor, has been approved for the treatment of rheumatoid arthritis and shows promise in the treatment of moderate-to-severe plaque psoriasis. However, no clinical trials or case reports have been conducted to confirm the efficacy of tofacitinib in palmoplantar pustulosis. Methods: Six in total with 6 PPP patient, aged 42-58 years were recruited according to the inclusion and exclusion criteria. Patient characteristics, including triggering factors, concomitant diseases, and previous therapeutic drugs, were investigated. All patients experienced a lack of response to topical drugs and at least one systemic agent. During treatment, visits were scheduled at the start of treatment and at 2, 4, and 12 weeks, and efficacy was assessed using the PPP ASI and PPP PGA. Results: Our six patients showed an excellent response to tofacitinib as all patients did achieve at least 50% reduction and half of our patients with more than 80% reduction in PPPASI after 4 weeks treatment; at week 12, 5 (83.3%) patients had 80% reduction in PPPASI with no serious adverse events were reported. Conclusion: The JAK inhibitor tofacitinib is a promising treatment for refractory palmoplantar pustulosis that requires further clinical observation and research.

15.
Ann Med ; 55(1): 2231847, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37417705

RESUMEN

BACKGROUND: Psoriasis critically influences the psychosocial well-being of patients and reduces their quality of life and work efficiency beyond skin symptoms. However, evidence on the association between life quality based on the Dermatology Life Quality Index (DLQI) and psoriasis severity is limited, particularly in China. This study aimed to explore the association between life quality based on the DLQI evaluation and disease severity among psoriasis patients in China. METHODS: Four thousand two hundred and thirty psoriasis patients were recruited from the Chinese National Clinical Research Center for Skin and Immune Diseases from 2020 to 2021. Information was collected by applying a structured questionnaire and onsite physical examination. Data analysis was performed by using SAS software (version 9.4; SAS Inc., Cary, NC), and statistical significance was set at p < .05. RESULTS: Four thousand two hundred and thirty psoriasis patients were predominantly male (64.6%), with a median age of 38.6 years (interquartile range (IQR): 30.0-50.9). The Psoriasis Area and Severity Index (PASI) score for patients with psoriasis was 7.2 (IQR: 3.0-13.5), and 50% of patients with PASI scored over 7. A total of 84.1% of psoriasis patients reported that psoriasis affected their quality of life from mild to severe. The DLQI scores among psoriasis patients were positively correlated with PASI scores (r = 0.43, p < .01), both in patients of different sex and different age. Logistic regression analysis with the adjustment of potential confounders indicated that patients with higher PASI score also had higher DLQI score, the odds ratio (OR) were 1.69 (95% confidence interval (CI): 1.38-2.08) for patients with PASI score 3-7, 2.61 (95% CI: 2.10-3.25) for patients with PASI score 8-11 and 3.36 (95% CI: 2.78-4.07) for patients with PASI score ≥12, compared with patients with PASI score <3, respectively. CONCLUSIONS: Life quality based on DLQI evaluation positively correlated with disease severity among patients with psoriasis, especially among male patients and those with higher body mass index. Therefore, we recommend that clinicians treat the DLQI as an important indicator during patient treatment.


Asunto(s)
Dermatología , Psoriasis , Humanos , Masculino , Adulto , Femenino , Calidad de Vida , Estudios Transversales , Índice de Severidad de la Enfermedad , Psoriasis/diagnóstico , China/epidemiología
16.
Artículo en Inglés | MEDLINE | ID: mdl-37317722

RESUMEN

Background Palmoplantar psoriasis (PPP), a troublesome variant, does not have any validated scoring system to assess disease severity. Objective To validate modified Palmoplantar Psoriasis Area and Severity Index (m-PPPASI) in patients affected with PPP and to categorise it based on Dermatology Life Quality Index (DLQI). Methods In this prospective study, patients with PPP aged > 18 years visiting the psoriasis clinic at a tertiary care centre were included and requested to complete DLQI during each visit at baseline, 2nd week, 6th and 12th week. m-PPPASI was used by the raters to determine the disease severity. Results Overall, 73 patients were included. m-PPPASI demonstrated high internal consistency (α = 0.99), test-retest reliability of all three raters, that is, Adithya Nagendran (AN) (r = 0.99, p < 0.0001), Tarun Narang (TN) (r = 1.0, p < 0.0001) and Sunil Dogra (SD) (r = 1.0, p < 0.0001) and inter-rater agreement (intra-class correlation coefficient = 0.83). Face and content validity index for items I-CVI = 0.845 were robust, and the instrument was uniformly rated as easy to use (Likert scale 2) by all three raters. It was found to be responsive to change (r = 0.92, p < 0.0001). Minimal clinically important differences (MCID)-1 and MCID-2 calculated by receiver operating characteristic curve using DLQI as anchor were 2 and 35%, respectively. DLQI equivalent cutoff points for m-PPPASI were 0-5 for mild, 6-9 for moderate, 10-19 for severe, and 20-72 for very severe disease. Limitation Small sample size and single-center validation were the major limitations. m-PPPASI doesn't objectively measure all characteristics of PPP such as "fissuring" and "scaling" which could also be taken into consideration. Conclusion m-PPPASI is validated in PPP and can be readily utilized by physicians. However, further large-scale studies are needed.

17.
Dermatology ; 239(5): 802-810, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37311426

RESUMEN

BACKGROUND: Newer biologics, such as interleukin (IL)-17 inhibitors, make it possible to achieve complete skin clearance (CSC) in patients with moderate-to-severe psoriasis. However, the clinical meaningfulness and predictive factors of CSC in daily practice have not yet been fully investigated. OBJECTIVE: The study was conducted to, first, assess the impact of CSC on quality of life (QoL) improvements compared with treatment responses without clearance and, second, identify clinical parameters as predictors of CSC response in psoriasis patients treated with ixekizumab. METHODS: Patients attending 26 dermatology centers across China were recruited into this real-world setting between August 2020 and May 2022. Prospective cohort study in which response to ixekizumab was assessed using the Psoriasis Area and Severity Index (PASI) and Dermatology Quality of Life Index (DLQI). The absolute DLQI score and DLQI (0) response at week 12 were compared between groups achieving various levels of skin clearance. A stepwise logistic regression analysis was applied to identify which baseline clinical characteristics were predictive factors for CSC. RESULTS: After 12 weeks of treatment, 226 of 511 (44.2%) patients achieved CSC, defined as 100% improvement in PASI score (PASI-100). A significantly higher proportion of patients with CSC versus almost clear skin (PASI 90-99) achieved DLQI score of 0, corresponding to the experience of no impairment on QoL (54.4% vs. 37.7%, p = 0.001). Females patients were more likely than males to achieve CSC response (odds ratio [OR] = 1.83; 95% confidence interval [CI]: 1.24-2.70), while previous biologic treatment (OR = 0.43; 95% CI: 0.24-0.81) and joint affected (OR = 0.61; 95% CI: 0.42-0.89) were significantly associated with less CSC response. CONCLUSIONS: This study highlights the fact that clinical parameters are important in determining CSC response in psoriasis. In daily practice, achieving CSC represents a clinically meaningful treatment goal, especially from the patient perspective.


Asunto(s)
Psoriasis , Calidad de Vida , Masculino , Femenino , Humanos , Estudios Prospectivos , Resultado del Tratamiento , Piel , Psoriasis/tratamiento farmacológico , Psoriasis/complicaciones , Inhibidores de Interleucina , Índice de Severidad de la Enfermedad
18.
J Dermatolog Treat ; 34(1): 2200868, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37026590

RESUMEN

BACKGROUND: Long-term real-life data on secukinumab use in psoriasis are limited. OBJECTIVES: Determine the long-term effectiveness of secukinumab in moderate-to-severe psoriasis in real-life. METHODS: Multicenter retrospective study analyzing data from adult patients treated with secukinumab for at least 192 weeks and up to 240 weeks in Southern Italy, between 2016 and 2021. Clinical data, including concurrent comorbidities and prior treatments were collected. Effectiveness was assessed by Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI) scores at the initiation of secukinumab and at weeks 4, 12, 24, 48, 96, 144, 192, and 240. RESULTS: Two hundred and seventy-five patients (174 males), mean age 50.80 ± 14.78 years, were included; 29.8% had an uncommon localization, 24.4% psoriatic arthritis, 71.6% comorbidities. PASI, BSA, and DLQI improved significantly from week 4 and continued to improve over time. Between weeks 24 and 240, PASI score was mild (≤10) in 97-100% of patients, 83-93% had mild affected BSA (BSA ≤ 3), and 62-90% reported no effect of psoriasis on their quality of life (DLQI 0-1). Only 2.6% of patients reported adverse events and no patient discontinued the treatment during the study period. CONCLUSIONS: Secukinumab effectiveness in the long-term treatment of psoriasis is confirmed in real-world.


Asunto(s)
Anticuerpos Monoclonales , Psoriasis , Adulto , Masculino , Humanos , Persona de Mediana Edad , Anciano , Anticuerpos Monoclonales/efectos adversos , Estudios Retrospectivos , Calidad de Vida , Resultado del Tratamiento , Índice de Severidad de la Enfermedad , Psoriasis/tratamiento farmacológico , Psoriasis/inducido químicamente , Italia
19.
J Med Internet Res ; 25: e44932, 2023 03 16.
Artículo en Inglés | MEDLINE | ID: mdl-36927843

RESUMEN

BACKGROUND: Psoriasis is one of the most frequent inflammatory skin conditions and could be treated via tele-dermatology, provided that the current lack of reliable tools for objective severity assessments is overcome. Psoriasis Area and Severity Index (PASI) has a prominent level of subjectivity and is rarely used in real practice, although it is the most widely accepted metric for measuring psoriasis severity currently. OBJECTIVE: This study aimed to develop an image-artificial intelligence (AI)-based validated system for severity assessment with the explicit intention of facilitating long-term management of patients with psoriasis. METHODS: A deep learning system was trained to estimate the PASI score by using 14,096 images from 2367 patients with psoriasis. We used 1962 patients from January 2015 to April 2021 to train the model and the other 405 patients from May 2021 to July 2021 to validate it. A multiview feature enhancement block was designed to combine vision features from different perspectives to better simulate the visual diagnostic method in clinical practice. A classification header along with a regression header was simultaneously applied to generate PASI scores, and an extra cross-teacher header after these 2 headers was designed to revise their output. The mean average error (MAE) was used as the metric to evaluate the accuracy of the predicted PASI score. By making the model minimize the MAE value, the model becomes closer to the target value. Then, the proposed model was compared with 43 experienced dermatologists. Finally, the proposed model was deployed into an app named SkinTeller on the WeChat platform. RESULTS: The proposed image-AI-based PASI-estimating model outperformed the average performance of 43 experienced dermatologists with a 33.2% performance gain in the overall PASI score. The model achieved the smallest MAE of 2.05 at 3 input images by the ablation experiment. In other words, for the task of psoriasis severity assessment, the severity score predicted by our model was close to the PASI score diagnosed by experienced dermatologists. The SkinTeller app has been used 3369 times for PASI scoring in 1497 patients from 18 hospitals, and its excellent performance was confirmed by a feedback survey of 43 dermatologist users. CONCLUSIONS: An image-AI-based psoriasis severity assessment model has been proposed to automatically calculate PASI scores in an efficient, objective, and accurate manner. The SkinTeller app may be a promising alternative for dermatologists' accurate assessment in the real world and chronic disease self-management in patients with psoriasis.


Asunto(s)
Inteligencia Artificial , Psoriasis , Humanos , Índice de Severidad de la Enfermedad , Psoriasis/diagnóstico , Enfermedad Crónica , Encuestas y Cuestionarios
20.
Clin Cosmet Investig Dermatol ; 16: 443-451, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36815200

RESUMEN

Background: The Psoriasis Area and Severity Index (PASI) and the Dermatology Life Quality Index (DLQI) are important evaluation tools for assessing psoriasis severity and guiding treatment options. However, the scores of PASI and DLQI are often inconsistent. Objective: This study aimed to identify the factors affecting the consistency between PASI and DLQI. Methods: The retrospective study was based on 4125 patients. We collected the PASI, DLQI, demographic and clinical characteristics data. Results: DLQI has a weak correlation with PASI (r=0.37; P<0.001). For the DLQI >10 groups, DLQI has almost no correlation with PASI (r=0.16; P<0.001). There are 43.60% of mild-to-moderate patients (PASI<10) in the DLQI>10 groups. Our adjusted model showed that foot (OR=2.109; 95% CI:1.581-2.815) involvement led to the greatest impairment of QoL except for PASI≥10 (OR=5.547; 95% CI:3.477-8.845). Furthermore, DLQI impairment was associated with female (OR=1.336; 95% CI:1.071-1.667); the age of 20-39 subgroup (OR=1.795; 95% CI:1.100-2.930); psoriatic arthritis (OR=1.718; 95% CI:1.208-2.443); higher income (OR = 1.408; 95% CI: 1.067-1.858); family history of psoriasis (OR=1.460; 95% CI:1.131-1.885). Moreover, the influence of exposed lesions (such as scalp; face; neck; nails; and hands) were positively associated with severely impaired QoL. Conclusion: Dermatologists should recognize the underestimated disease burden of psoriasis patients and actively identify and treat mild-to-moderate patients with high burden. In particular, the foot was a significant contributor to the burden.

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