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Menschen mit Psoriasis haben oft auch andere Krankheiten wie Herzprobleme oder Übergewicht. Neue Forschung zeigt: Wer zusätzlich mit GLP-1-Rezeptor-Agonisten (zum Beispiel Semaglutid) behandelt wird, hat ein deutlich geringeres Risiko, an Herz-Kreislauf-Erkrankungen oder psychiatrischen Problemen zu erkranken und sogar ein geringeres Sterberisiko. Das Medikament gilt als sicher, besonders für Menschen mit Psoriasis und gleichzeitigem Übergewicht oder Diabetes. Ärztinnen und Ärzte könnten diese Medikamente deswegen bei passender Vorgeschichte in Erwägung ziehen[1][2][5]. Originaltitel: GLP-1RA and reduced mortality, cardiovascular and psychiatric risks in psoriasis: a large-scale cohort study. Link zur Quelle

Eine neue Methode mit Fluoreszenz-Bildgebung (FOI) kann helfen, zu unterscheiden, ob jemand Psoriasis-Arthritis oder eine erosive Handarthrose hat[2]. Bei FOI bekommt man nach einer Farbstoff-Injektion Bilder, die zeigen, wie stark die Gelenke entzündet sind. In der Studie hatten Menschen mit Handarthrose vor allem an den Mittel- und Endgelenken (PIP und DIP) eine stärkere Entzündung als Menschen mit Psoriasis-Arthritis. Umgekehrt kam ein spezielles Muster, der sogenannte „Werner sign“, deutlich häufiger bei Psoriasis-Arthritis vor. Das macht die Diagnose genauer und hilft dabei, die passende Behandlung zu finden[2]. Originaltitel: Differential diagnosis between psoriatic arthritis and hand osteoarthritis using indocyanine green-based fluorescence optical imaging. Link zur Quelle

Menschen mit generalisierter pustulöser Psoriasis (GPP) bekommen nach der Diagnose meist **kortisonhaltige Cremes** verschrieben, danach oft auch **Kortison-Tabletten**[3]. Bei Patienten mit GPP und normaler Psoriasis gab es häufiger **Biologika** als bei denen mit nur GPP[3]. Das liegt daran, dass es damals keine zugelassenen speziellen Therapien für GPP gab[3]. Problematisch ist, dass ein **Absetzen von Kortison** oft zu einem neuen Krankheitsschub führt[3]. Die Behandlung wurde oft gewechselt, weil viele Medikamente nicht langfristig helfen und immer noch ein großer **Bedarf an besseren Therapien** besteht[1]. Originaltitel: Real-world treatment patterns in patients with generalized pustular psoriasis (GPP). Link zur Quelle

Bei der GRAPPA-Tagung 2024 haben Dermatologen und Rheumatologen lebhaft darüber gestritten, wer bei Muskelschmerzen und Gelenkbeschwerden bei Menschen mit Schuppenflechte das Sagen haben soll. Rheumatologen wie Dr. Proft meinen, sie sollten die Behandlung steuern, weil sie Entzündungen mit speziellen Untersuchungen erkennen können. Dermatologen wie Dr. Savage sehen sich aber oft als die ersten Ansprechpartner und wissen, wie wichtig es ist, Frühzeichen zu erkennen und früh zu behandeln. Beide Seiten sind sich einig: Am besten arbeiten beide Fachrichtungen zusammen, damit Haut und Gelenke optimal behandelt werden[2][4]. Originaltitel: Managing Musculoskeletal Symptoms in Patients With Psoriasis: Who Should Be in the Driver's Seat? Link zur Quelle

Mit Fluoreszenz-Optischer Bildgebung (FOI) kann man verschiedene rheumatische Erkrankungen an den Händen schnell und genau voneinander unterscheiden. Forschende haben typische Muster gefunden, zum Beispiel für entzündete Gelenke, Haut oder Nägel. Ein Atlas dieser FOI-Merkmale hilft, Krankheiten wie Rheumatoide Arthritis, Psoriasis-Arthritis, Kollagenosen oder Arthrose zu erkennen. Besonders Arthrose lässt sich sehr sicher von den anderen Krankheiten abgrenzen, bei Autoimmun-Erkrankungen gibt es verschiedene Merkmale. FOI kann so die Diagnose beschleunigen und als Ergänzung zu anderen Bildgebungsverfahren genutzt werden[1][2][3]. Originaltitel: To optimise the diagnostic process of rheumatic diseases affecting the hands using fluorescence optical imaging (FOI). Link zur Quelle

Bei Menschen mit schwerer, pustulöser Psoriasis steigt während eines Schubs der Spiegel des Botenstoffs **microRNA-223** an[3]. Die Behandlung mit dem Medikament **Spesolimab** kann diesen Anstieg gezielt steuern[1]. Das hilft, die Entzündungen im Körper besser zu kontrollieren. Spesolimab ist extra für solche Schübe entwickelt und kann das Risiko für neue Schübe um 84 Prozent senken[2]. Damit gibt es für Betroffene eine wichtige neue Behandlungsmöglichkeit. Originaltitel: MicroRNA-223 expression during flares in patients with generalized pustular psoriasis is regulated by spesolimab treatment. Link zur Quelle

Hidradenitis suppurativa (HS) ist eine chronische Hautkrankheit, die oft mit entzündeten Knoten und Abszessen an Stellen wie Achseln oder Leisten beginnt[1][5]. Der genaue Grund für die Entstehung ist noch nicht vollständig bekannt, aber Forscher vermuten, dass eine gestörte Immunabwehr, die Zusammensetzung der Hautbakterien und die Gene eine Rolle spielen[5][3]. Faktoren wie Übergewicht, Rauchen und Diabetes können das Risiko erhöhen[1][5]. HS kann den Alltag stark belasten und führt oft zu psychischen Problemen[1]. Die Behandlung ist kompliziert, da viele Methoden kombiniert werden müssen, zum Beispiel Medikamente, Operationen und Änderungen des Lebensstils[1][5]. Neue Medikamente geben Hoffnung auf besseres Ansprechen in Zukunft[5]. Originaltitel: Hidradenitis suppurativa: complexity in pathogenesis and management - Authors' reply. Link zur Quelle

Bimekizumab hilft vielen Menschen mit *Psoriasis*, nicht nur die Haut, sondern auch die Nägel komplett von Schuppenflechte zu befreien. Die Auswertung von mehreren Studien zeigt, dass mit Bimekizumab deutlich mehr Patientinnen und Patienten eine vollständige Heilung von Haut und Nägeln erreichen als mit den Vergleichsmedikamenten Adalimumab, Ustekinumab oder Secukinumab. Je nach Studie schafften bis zu 63% mit Bimekizumab den Maximalwert, während die anderen Mittel oft unter 40% lagen. Das Ergebnis blieb sogar langfristig stabil, egal ob Betroffene dauerhaft Bimekizumab bekamen oder erst später darauf umstiegen[1][3][4]. Originaltitel: Bimekizumab Complete Clearance of Both Skin and Nail Psoriasis: Comparative Efficacy in Phase III/IIIb Studies. Link zur Quelle

Upadacitinib ist ein Mittel gegen Rheuma, Psoriasis-Arthritis und ähnliche Krankheiten. Forschende haben die Sicherheit bei über 8.600 Patientinnen und Patienten über fast 30.000 Behandlungsjahre untersucht. Häufige Nebenwirkungen sind Erkältungen, COVID-19, Gürtelrose, Harnwegsinfekte und Akne[2]. Schwerwiegende Nebenwirkungen wie Infektionen, Herzprobleme oder Blutgerinnsel kommen selten vor und sind meist stabil geblieben. Im Vergleich zu anderen Medikamenten treten einige Nebenwirkungen wie Gürtelrose und Hautkrebs etwas öfter auf[2]. Insgesamt bestätigen die Studien, dass Upadacitinib auch über längere Zeit genutzt werden kann[2]. Originaltitel: Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Link zur Quelle

Secukinumab hilft Kindern und Jugendlichen mit mittelschwerer bis schwerer Plaque-Psoriasis langfristig gut. Fast 80 Prozent der Teilnehmenden hielten vier Jahre durch und erzielten dauerhaft deutliche Verbesserungen der Haut. Bei beiden Dosierungen blieb die Haut meist zu mindestens 75 Prozent klar, oft sogar noch besser. Die Lebensqualität stieg und auch die Sicherheit war über vier Jahre hinweg unauffällig. Schwerwiegende Nebenwirkungen traten selten und ähnlich häufig auf, unabhängig von der Dosis. Wachstum und Entwicklung wurden durch die Behandlung nicht beeinflusst[1]. Originaltitel: Long-Term Efficacy and Safety of Secukinumab in Children and Adolescents with Moderate-to-Severe Chronic Plaque Psoriasis: Four-Year Results of a Randomized, Phase III, Open-Label Trial. Link zur Quelle

Bei Psoriasis läuft der Fettstoffwechsel in der Haut oft aus dem Ruder: Ein Enzym namens FADS2 spielt dabei eine Schlüsselrolle. Bei Betroffenen ist FADS2 in der Haut weniger aktiv, das fördert Entzündungen durch mehr NF-κB-Signale und lockt Entzündungszellen an[2]. Das Problem: FADS2 macht aus bestimmten Fetten entzündungshemmende Stoffe wie DHA. Fehlendes FADS2 heißt weniger DHA, also mehr Entzündung. Ein Schalter für FADS2 ist PPARα. Wird PPARα aktiviert, wird FADS2 hochgefahren und die Entzündung gebremst. Neue Therapien könnten sich diesen Mechanismus zunutze machen[2][5]. Originaltitel: Reprogramming of Fatty Acid Metabolism via PPARα-Orchestrated FADS2 in Keratinocytes Modulates Skin Inflammation in Psoriasis. Link zur Quelle

Psoriasis is one of the most common chronic inflammatory skin diseases and is characterised by the uncontrolled proliferation of keratinocytes and their abnormal differentiation. Sirtuins are a group of enzymes that play an important role in post-translational modifications of proteins, such as deacetylation, poly-ADP-ribosylation, demalonylation and lipoamidation. They are found in various cell types and are involved in ribosomal DNA recombination, gene silencing and DNA repair. This study aimed to examine the plasma levels of sirtuin 3, 4 and 5 in patients with psoriasis and correlate these levels with clinical parameters. The study included 43 patients with plaque-type psoriasis and 28 healthy controls. The plasma concentrations of sirtuin 3 were statistically significantly increased in patients with psoriasis compared to the control subjects. The plasma concentrations of sirtuin 4 and 5 were statistically significantly lower in patients with psoriasis than in the control group. No statistically significant correlations were found between the plasma levels of sirtuin 3 and 4 and the psoriasis activity tools of PASI, DLQI and the BSA index or the selected clinical parameters in patients with psoriasis. Plasma concentrations of sirtuin 5 correlated statistically significantly with the BSA index, haemoglobin and leukocytes. The results of this study suggest the involvement of sirtuin 3, 4 and 5 in the pathogenesis of psoriasis. However, an explanation of the role of sirtuins in psoriasis requires further research.Weiterlesen

It is challenging to distinguish nail psoriasis (NP) from nonspecific nail changes, contributing to heterogeneity in clinical trials. Existing scoring tools for NP are currently used to assess severity after diagnosis is established. The aim of this study is to evaluate the diagnostic performance of two of these severity scoring tools. A cohort study was conducted with psoriasis patients and matched controls. Fingernails were scored using the Nail Psoriasis Severity Index (NAPSI) and the Nijmegen-Nail Psoriasis Activity Index Tool (N-NAIL). To determine their diagnostic properties, cutoff values were established. Receiver operating characteristic (ROC) curves were constructed, and sensitivity and specificity were calculated for various cutoff points. The best cutoff value was chosen based on the Youden Index and clinical reasoning. In total, 104 psoriasis patients were included, of which 68 were clinically diagnosed with NP. For the N-NAIL, a cutoff value of 2 showed the best accuracy in the psoriasis population (sensitivity = 83.8% and specificity = 83.3%) and the general population (sensitivity = 83.8% and specificity = 67.3%). For the NAPSI, a cutoff value of 7 showed the best accuracy in the psoriasis population (sensitivity = 80.9% and specificity = 69.4%), while a cutoff value of 10 was optimal in the general population (sensitivity = 72.1% and specificity = 70.2%). Both N-NAIL and NAPSI provide accurate cutoff values in a psoriasis population. Therefore, these scoring tools may not only be used to assess severity but also in clinical trials for the inclusion of NP patients in a psoriasis population to create homogeneity between studies. We prefer using the N-NAIL, with a cutoff value of 2, because it showed better accuracy compared to the NAPSI.Weiterlesen

Psoriasis is an immune-mediated chronic inflammatory skin disease affecting over 60 million adults and children worldwide and can occur at any age, from childhood to adulthood. If the patient has a diffuse form of psoriasis, affecting more than ten percent of the body surface, or involving sensitive areas such as the face, scalp, nails, and/or palmoplantar region, he or she is a candidate for systemic therapy. Currently, several drugs are approved for the treatment of moderate to severe chronic plaque psoriasis in Europe and US. These are classified into conventional systemics, biologics, and small molecules. These immunomodulatory agents are available in different forms of administration, such as oral, subcutaneous, and intravenous. Novel treatments, including biologics and small molecules, can provide reliable disease control with a good safety profile even in the long term and have greatly improved the quality of life for many patients. Nevertheless, biologics can be expensive, placing a significant burden on national healthcare systems and creating a barrier to access for patients in need of these life-changing therapies. A biosimilar drug is a biologic medical product that is highly similar to an already approved reference biologic drug (also known as the originator). Biosimilars have no clinically meaningful differences in terms of safety, purity, and efficacy compared to the reference product. Biosimilar drugs have been on the market-and therefore in clinical practice-for several years now, helping to overcome these challenges. Biosimilars have the potential to improve access to biologic therapies for psoriasis while reducing healthcare costs. The aim of this narrative review is to describe biosimilars and the potential cost-saving benefits their use can offer. In this review, we will discuss adalimumab, infliximab, etanercept, and ustekinumab, as well as their corresponding biosimilars.Weiterlesen

Erythrodermic psoriasis is a rare subtype of psoriasis with widespread skin lesions, with some patients experiencing severe systemic symptoms. We aimed to develop and validate an artificial intelligence-driven model for accurate classification of erythrodermic psoriasis severity by integrating clinical and laboratory indicators. A retrospective cohort study was conducted at Peking Union Medical College Hospital (2005-22). Patients were divided into mild and moderate-to-severe groups using k-means clustering. After imputing missing values, we trained seven candidate algorithms-K-Nearest Neighbors, Artificial Neural Network, Random Forest, Extreme Gradient Boosting, Support Vector Machine, Bayesian classifier, and logistic regression-using repeated, stratified ten-fold cross-validation with three repeats (10 × 3 CV); performance was summarized by the mean area under the receiver operating characteristic curve across folds. Feature importance was assessed using SHAP (Shapley Additive exPlanations), a game-theoretic approach that quantifies each features contribution to individual model predictions, ten indicators were incorporated into a diagnostic scoring system. The optimal cut-off for mild/moderate-to-severe cases classification was selected with the Youden index on the cross-validated receiver operating characteristic curve. Of 260 screened records, 242 erythrodermic patients met the study criteria. Histology confirmed psoriasis in 108 cases, while the remaining patients were diagnosed based on clinical presentation and medical history. K-means clustering assigned 94 patients to the moderate-to-severe group and 148 to the mild group. Moderate-to-severe erythrodermic psoriasis was characterized by a higher inflammatory burden (median neutrophil-to-lymphocyte ratio 4.11 vs 2.70, p < 0.001), more frequent fever (88% vs 41%, p < 0.001), greater edema severity (16% vs 1.4%, p < 0.001), lower albumin and higher calcium levels (both p < 0.001), and longer hospitalization (median 26 vs 20 days, p = 0.005). After adjustment for age and sex, moderate-to-severe cases required systemic therapy roughly twice as often as mild cases (odds ratio 2.21, p < 0.05). Of seven machine-learning algorithms, the Artificial Neural Network yielded the highest mean validation area under the curve. The SHAP analysis highlighted the ten most influential predictors adopted from the Artificial Neural Network-edema, edematous erythema (defined as the combination of both redness and swelling of the skin), fever, albumin, neutrophil-to-lymphocyte ratio, serum calcium, white blood cell count, acute-phase reactants (C-reactive protein or erythrocyte sedimentation rate), pruritus, and superficial lymphadenopathy-and these were converted to integer points to form the bedside score. The receiver operating characteristic analysis identified 33.5 points as the optimal threshold for distinguishing between mild and moderate-to-severe cases. The model, named 'EPICS' (Erythrodermic Psoriasis Integrated Classification System), effectively stratified patients, as evidenced by internal validation. This model is currently available online ( https://pumch-dermatology.shinyapps.io/classification/ ). The EPICS model is a robust tool for assessing erythrodermic psoriasis severity, offering precise classification based on easily accessible clinical and laboratory indicators. However, its effectiveness in clinical practice requires further validation through additional research.Weiterlesen

Psoriasis is an immune-mediated dermatosis characterized by systemic inflammation and multifactorial pathogenesis. Among its many triggers, psychological stress has emerged as a pivotal yet underappreciated contributor to disease onset and exacerbation. Although the pathomechanisms by which psychological stress is involved in the pathogenesis of psoriasis are not clear, evidence suggests a regulatory role of psychologic stress in immune functions, including increasing expression levels of proinflammatory cytokines and intracellular adhesion molecule-1 (ICAM-1), and decreasing anti-inflammatory cytokines and the function of glucocorticoid receptors, possibly in part via activation of corticotropin-releasing hormone (CRH)-proopiomelanocortin (POMC)-adrenocorticotropic hormone (ACTH)-corticosteroids axis. In addition, the onset and/or worsening of psoriasis can also be attributed to psychological stress-induced defective epidermal permeability barrier function. Moreover, the bidirectional nature of this relationship often leads to a vicious cycle of flare-ups and psychological distress, further complicating patient management and quality of life. This review aims to synthesize current evidence on the relationship between stress and psoriasis, examining mechanistic pathways through which psychosocial stress contributes to immune dysregulation in psoriatic pathology. It also underscores the significance of psychological interventions in the management of psoriasis.Weiterlesen

Abstract In the context of psoriasis lesion segmentation, traditional methods in image segmentation, including region-based approaches like Mask R-CNN, have shown notable success. However, the problem of segmenting irregular and intricate biological structures such as psoriasis lesions presents significant challenges that cannot be effectively captured by standard bounding box approximations. This paper explores the potential of transforming psoriasis lesion segmentation into pixel labeling tasks, which promise greater efficiency and integration with modern image-to-image networks widely used across various domains. We investigate the limitations of convolutional-based architectures in generating dense pixel embeddings capable of distinguishing individual lesions. Through both theoretical analysis and empirical evidence, we propose a novel approach that leverages semi-convolutional operations. These modifications, which introduce spatially guided pixel embeddings, offer substantial improvements over traditional methods and demonstrate their applicability to the segmentation of complex biological forms. By drawing connections to advanced techniques such as Hough voting and bilateral kernels steered by convolutional networks, we show that these methods significantly enhance the segmentation accuracy of psoriasis lesions, outperforming conventional region-based models like Mask R-CNN in terms of precision and adaptability to irregular shapes. Weiterlesen

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The nature of the relationship between psoriasis and alcohol consumption has been the topic of discussion for many years. Some studies have found that a higher intake of alcohol may be associated with a more severe manifestation of the disease. At the same time, patients with psoriasis often demonstrate elevated levels of alcohol consumption. It has not yet been fully established whether alcohol abuse serves as a trigger for psoriasis or if patients with psoriasis are simultaneously more prone to alcohol abuse. The objective of this study was to employ Google Trends as a tool for crowdsourcing data on a national level to explore the relationship between psoriasis and the consumption of alcohol in Sweden. This study examines crowdsourced web search data related to psoriasis and other skin disease-related search terms (such as utslag [rash]) as well as search interest in different types of alcohol. The analysis covers a 5-year period from 2018 to 2023 in Sweden, focusing on search behavior and correlations across this period. The search behavior regarding psoriasis and alcohol-related search terms showed seasonal variations throughout the year. The relative search volume for psoriasis peaked in February, while alcohol-related searches, particularly Systembolaget and vodka, peaked in December and June. Our statistical analysis revealed relationships between the search interest regarding psoriasis and terms related to alcohol consumption, with disparities between different types of alcohol. The term "psoriasis" was negatively correlated with "Systembolaget" (r=-0.210), "vitt vin" (r=-0.224), and "vodka" (r=-0.220) (all P<.001), while the term "utslag" showed positive correlations with these same alcohol-related terms (r=0.278-0.347; P<.001). Crowdsourced data can offer valuable insights into population-level behavior. The observed negative correlations between psoriasis and alcohol-related searches suggest complex interactions, possibly reflecting reduced disease awareness or care during periods of higher alcohol consumption. The direction and strength of the correlations with psoriasis were not consistent across the different types of alcohol investigated in this study, which poses the question whether the relationship might be influenced by the type of beverage consumed. Further research is warranted to explore underlying mechanisms and validate these findings in clinical populations.Weiterlesen

To assess the efficacy of long-term treatment with risankizumab across the updated Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) domains and key related conditions of psoriatic arthritis (PsA). This post hoc analysis primarily used data from the phase 3 KEEPsAKE 1 trial of adult patients with PsA, with data from KEEPsAKE 2 pooled for prespecified outcomes. Outcomes measuring risankizumab efficacy across key GRAPPA-recognised domains of PsA (peripheral arthritis, enthesitis, dactylitis, skin and nail psoriasis, axial disease) and PsA-related conditions such as inflammatory bowel disease (IBD) and uveitis were assessed over 100 weeks of treatment (~2 years). Statistical approaches included non-responder imputation (as-observed with imputation) for categorical variables and mixed-effect model for repeated measures for continuous variables including as-observed measurements at all visits. PsA-related conditions were evaluated via adverse events through 100 weeks. Overall, in KEEPsAKE 1 and KEEPsAKE 2, 412/483 (85.3%) and 181/224 (80.8%) of patients randomised to risankizumab completed treatment to week 100. Risankizumab demonstrated efficacy across all GRAPPA-defined domains through 100 weeks, including swollen and tender joint counts, enthesitis, dactylitis, skin and nail outcomes, and axial disease. In KEEPsAKE 1, 42.4% of patients had achieved a Disease Activity in Psoriatic Arthritis measurement of low disease activity and 62.9% had reached a minimal clinically important difference in pain at week 100. Rates of new onset or flare of IBD and uveitis were low. Treatment with risankizumab provides durable improvement in the signs and symptoms of PsA across all GRAPPA disease domains and related conditions.Weiterlesen

Keratinocyte hyperproliferation and excessive inflammatory responses are associated with psoriasis pathogenesis. Trifolirhizin has anti-inflammatory and anti-proliferation effects. The purpose of the study was to investigate the role of trifolirhizin in psoriasis-like skin lesions and its molecular mechanism. Imiquimod-induced psoriasis-like mouse models were treated with trifolirhizin. Skin lesions and inflammatory factors were assessed. In vitro, human HaCaT keratinocytes were stimulated by a mixture of interleukin (IL)-1α, IL-17, IL-22, tumor necrosis factor (TNF)-α, and oncostatin M (M5) to establish a psoriatic keratinocyte model. Cell viability and cycle were assessed via CCK-8 assay and flow cytometry. Inflammatory factors, autophagy levels, and AMPK-mTOR pathway activation were detected by western blot. Trifolirhizin dose-dependently inhibited epidermal layer erythema, scaling, and thickening and reduced epidermal thickness and IL-12 level in an imiquimod-induced psoriasis-like mouse model. Trifolirhizin also inhibited cell viability, PCNA expression, and excessive synthesis and secretion of IL-8 and IL-12 in HaCaT keratinocytes induced by M5. Furthermore, the inhibition of autophagy and AMPK-mTOR pathway could be reversed by trifolirhizin in M5-induced HaCaT keratinocytes and skin lesions from imiquimod-mediated psoriasis-like mouse model. The improvement effects of trifolirhizin could be inhibited by the autophagy inhibitor chloroquine. Trifolirhizin up-regulated autophagy through the AMPK-mTOR pathway, improved the hyperproliferation and excessive inflammatory responses of keratinocytes, thus alleviating psoriatic skin lesions. Trifolirhizin may have therapeutic potential in improving the progression of psoriasis.Weiterlesen

Numerous indicators have been proposed to evaluate the efficacy for randomized clinical trials (RCTs) of psoriasis (Pso) and psoriatic arthritis (PsA), but their comparability and correlation remain unknown. We aim to evaluate the preference and relative sensitivity of the most widely used indicators that report response rate, and to offer guidance for the primary endpoint selection for Pso and PsA trials. We conducted a systematic search, including five databases and four registries, to identify all pharmacological intervention-controlled RCTs. A Bayesian hierarchical linear mixed model was employed to assess relative discriminations and provide a ranking of these indicators. This model, considered the gold standard for sparse and heterogeneous data, was applied to estimate differences between control and intervention groups and assess the preference and relative sensitivity of outcome indicators in Pso and PsA. Altogether, 386 RCTs met our inclusion criteria. We included 9 and 8 commonly used response rate indicators for Pso and PsA trials, respectively, all of which were treated as primary endpoints. We found evidence of significant differences among indicators. PASI 50, PASI 75 and IGA 0,1 proved to be robust indicators for assessing pharmacological efficacy in the majority of RCTs of Pso. Conversely, PASI 125, DIQI 0,1 and NRS-4 were not preferred under different circumstances. Furthermore, PASI 50, PASI 75 and PASI 90 appeared to be highly effective in almost all categories of pharmacological RCTs of PsA. However, due to their extreme sensitivity, it was advisable to use ACR 20 to prevent an overestimation of the therapeutic benefits of interventions. ACR 50, ACR 70 and MDA were less sensitive, but they were supposed to be more cautious in evaluating disease changing. The choice of indicators was slightly influenced by disease severity, intervention type and administration method. The notable efficacy discrimination ability of indicators underscores the importance of flexibility and comprehensiveness in selecting primary outcome(s). Our findings provide practical implications for optimizing indicator selection in future trial design, ensuring better alignment with trial objectives and disease characteristics. PROSPERO number: CRD42022337725.Weiterlesen

Abstract Background This systematic review evaluates the efficacy, safety, and tolerability of ixekizumab (IXE), an anti-IL 17A monoclonal antibody, in treating moderate to severe psoriasis. Methods A comprehensive search of PubMed and Scopus using the terms ‘ixekizumab’ and ‘psoriasis’ was conducted. This study was registered in PROSPERO (CRD42024539975) and followed the PRISMA guidelines for reporting systematic reviews. Inclusion criteria encompassed randomised clinical trials assessing the efficacy and safety/tolerability of ixekizumab for moderate-to-severe psoriasis, published from inception until April 2024. Case reports, conference papers, and observational studies were excluded. A total of 5 studies (6 randomised controlled trials) with 4705 participants met the selection criteria out of 1172 search results. The risk of bias was assessed among the selected studies using the RoBViS tool. Results The standardised dosing regimen of ixekizumab demonstrated superior efficacy compared to placebo in improving Psoriasis Area and Severity Index (PASI) from baseline and Static Physician Global Assessment (sPGA) across most of the included studies. No significant difference in efficacy was observed when comparing ixekizumab with ustekinumab in a survey conducted by Reich et al. Most adverse events were mild, although some serious ones were reported. Conclusion Ixekizumab, a monoclonal antibody approved for treating moderate to severe psoriasis, exhibits a superior safety profile comparable to other biologics used in psoriasis. However, its widespread usage in psoriasis is still relatively less than conventional non-selective immunomodulatory agents. Weiterlesen