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Background: Brodalumab, a fully human monoclonal immunoglobulin IgG2 antibody that binds the human interleukin 17 receptor subunit A, is available for the treatment of moderate‐to‐severe plaque psoriasis in Europe since September 2017, but so far there are only a few studies on its use in real‐world conditions. Objectives: To assess the management of moderate‐to‐severe psoriasis with brodalumab 210 mg in daily practice after 12 and 52 weeks (W). In addition, patient profiles and treatment pathways are described. Methods: LIBERO is a prospective, multicenter, non‐interventional study including adult patients with plaque psoriasis treated with brodalumab 210 mg. Results: In total, 638 patients (65% male, mean age: 49.3 ± 14.4 years) from 148 sites in Germany were enrolled. The majority suffered from severe (51.1%) or very severe (13.1%) psoriasis according to physician global assessment (PGA0‐5). When starting with brodalumab, 58.5% were biologic naïve and 41.5% were previously treated with another biologic, mainly adalimumab (18.5%) and secukinumab (17.9%). About 74.0% of patients met the primary endpoint of an absolute PASI ≤3 at ~W12 (n = 618, LOCF). The mean PASI was reduced significantly as of ~W2 from 17.2 (±11.7) to 9.7 (±8.8) and improved further to 3.3 (±6.3) at ~W12 (p < 0.001). At ~W52 85.5% of patients reached a PGA0/1‐response (primary endpoint) and 54.1% patients were assessed as completely clear (PGA0) (both n = 399, as observed). Effectiveness of brodalumab was confirmed in relevant subgroup analysis by previous treatment regimen. Most frequently reported adverse events were nasopharyngitis (4.6%), psoriasis (4.6%) and arthralgia (4.1%), new safety signals were not detected. Conclusions: This representative, non‐interventional study confirms the short‐ and long‐term effectiveness and safety profile of brodalumab in the management of psoriasis in daily practice as well as in relevant treatment pathways. [ABSTRACT FROM AUTHOR]

Targeted biologic drugs and small molecules have transformed the psoriasis treatment landscape in recent years. The Belgian healthcare system, in common with many others across Europe, must balance the burgeoning use of these transformative, yet expensive, drugs with the sustainable use of limited resources. Drawing on recent updates to the EuroGuiDerm and the German S2 psoriasis guidelines, eight Belgian dermatologists experienced in treating patients with psoriasis undertook a quasi‐Delphi initiative to provide perspectives on the current opportunities and challenges in psoriasis. This update focuses on responsible ways to rationalize the use of innovative treatments (e.g. biologics and small molecules). Inherently, this required viewpoints on the International Psoriasis Council's new definition of severe psoriasis, defining psoriasis severity and the concept of treating to target. It discusses the appropriateness of using older biologics classes, biosimilars and personalized dosing and lastly, how teledermatology may play a role in providing sustainable, patient‐centric psoriasis care. In addition, this manuscript includes the updated Belgian evidence‐based treatment advice in psoriasis (BETA‐PSO) to reflect recent data and drug approvals. The recommendations reflect the best practices for clinicians when using systemic and biologic therapies to treat patients with psoriasis and offer guidance on how they may prescribe these drugs sustainably and efficiently. [ABSTRACT FROM AUTHOR]

Generalized pustular psoriasis (GPP) is a rare, chronic skin disease, characterized by widespread pustules and erythema, often accompanied with systemic signs and symptoms. GPP flares occur episodically but may be protracted. Left untreated, GPP can be life‐threatening. Despite being first reported over 100 years ago, definitions and diagnostic criteria for GPP have been inconsistent and varied due, in part, to its rarity and a limited understanding of its pathogenesis. As such, many patients with GPP face delays in diagnosis and subsequent treatment. This manuscript aims to increase the recognition of GPP and provide foundational considerations to aid in the definition and diagnosis of this disease. [ABSTRACT FROM AUTHOR]

Background: Response to biologics in psoriasis varies in real‐world settings. Serum biomarkers could aid biologic selection and dose modifications to improve patient outcomes while encouraging cost‐effective care. Objectives: To explore the exposure–response relationship for guselkumab (GUS), to define a GUS concentration target for optimal response and to evaluate the potential of serum protein levels as predictive biomarker candidates. Methods: This is a prospective, multicentric, cohort study in psoriasis patients treated with GUS. Serum GUS trough concentrations (TCs) collected at multiple timepoints were measured using an in‐house immunoassay. Next, proximity extension assay technology (Target 96 Inflammation Panel Olink®) was used to measure serum protein levels in a subcohort including 38 GUS patients (week 0 and week 4), six psoriasis patients naive for systemic treatment and four healthy controls. Results: Seventy‐five patients participated and 400 samples were collected. Guselkumab TCs and clinical response were correlated at week 4, week 12 and in steady‐state (≥20 weeks). Optimal responders (Psoriasis Area and Severity Index [PASI] ≤ 2) had significantly higher TCs than suboptimal responders from week 4 onwards in treatment. An optimal steady‐state TC of 1.6 μg/mL was defined. Although TC and absolute PASI were lower and worse, respectively, in patients weighing ≥90 kg, clinical outcomes referred to desirable to excellent PASI ranges. Therefore, we do not recommend systematically higher GUS doses in obese patients. We could not reveal early differentially expressed proteins to distinguish future optimal from suboptimal responders. Conclusions: We demonstrated an exposure–response relationship for GUS and an optimal steady‐state TC of 1.6 μg/mL in real‐world psoriasis patients. Hereby, we deliver more evidence that therapeutic drug monitoring poses a promising strategy in optimizing GUS treatment. No biomarker candidates were identified through serum proteomics. We propose protein screening should be repeated in larger cohorts to continue the quest for predictive biomarkers. [ABSTRACT FROM AUTHOR]

Background: Two phase 3 trials, POETYK PSO‐1 and PSO‐2, previously established the efficacy and overall safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, in plaque psoriasis. Objectives: To further assess the safety of deucravacitinib over 52 weeks in the pooled population from these two trials. Methods: Pooled safety data were evaluated from PSO‐1 and PSO‐2 in which patients with moderate‐to‐severe plaque psoriasis were randomized 1:2:1 to receive oral placebo, deucravacitinib or apremilast. Results: A total of 1683 patients were included in the pooled analysis. Adverse event (AE) incidence rates were similar in each treatment group, serious AEs were low and balanced across groups, and discontinuation rates were lower with deucravacitinib versus placebo or apremilast. No new safety signals emerged with longer deucravacitinib treatment. Exposure‐adjusted incidence rates of AEs of interest with placebo, deucravacitinib and apremilast, respectively, were as follows: serious infections (0.8/100 person‐years [PY], 1.7/100 PY, and 1.8/100 PY), major adverse cardiovascular events (1.2/100 PY, 0.3/100 PY, and 0.9/100 PY), venous thromboembolic events (0, 0.2/100 PY, and 0), malignancies (0, 1.0/100 PY and 0.9/100 PY), herpes zoster (0.4/100 PY, 0.8/100 PY, and 0), acne (0.4/100 PY, 2.9/100 PY, and 0) and folliculitis (0, 2.8/100 PY, and 0.9/100 PY). No clinically meaningful changes from baseline in mean levels, or shifts from baseline to CTCAE grade ≥3 abnormalities, were reported in laboratory parameters with deucravacitinib. Conclusions: Deucravacitinib was well‐tolerated with acceptable safety over 52 weeks in patients with psoriasis. [ABSTRACT FROM AUTHOR]

The study "Psoriasis may increase the risk of lung cancer: A two-sample Mendelian randomization study" examines the potential connection between psoriasis and lung cancer. Using the Mendelian randomization method, the authors establish a possible causal relationship between the two conditions, suggesting that psoriasis could aid in early detection of lung cancer. However, another group of researchers attempted to replicate the study and found discrepancies in sample sizes and dataset differences, raising concerns about the reliability of the conclusions. Their independent analysis failed to confirm a genetic link between psoriasis and lung cancer. The document provides a table of data related to lung cancer and psoriasis, which may be helpful for researchers studying this relationship. A meta-analysis of 365 studies found a correlation between psoriasis and lung cancer, with individuals with psoriasis being more susceptible to lung cancer. However, a separate investigation found no significant difference in lung cancer development among patients with psoriasis. This study, using Mendelian Randomization, found no genetic link between psoriasis and lung cancer. The authors suggest that further large-scale epidemiological investigations are necessary to fully comprehend the relationship between psoriasis and the risk of lung cancer. [Extracted from the article]

Background: Generalized pustular psoriasis (GPP) is a rare, inflammatory skin disease characterized by widespread eruption of sterile pustules with or without systemic symptoms. Objectives: This study aimed to describe the demographics of patients with GPP in Central and Eastern Europe (CEE), present the clinical characteristics of individual GPP flares and explore the current treatment landscape. Methods: Patient demographics were collected at the times of last observation and previous treatment. Characteristics of a patient's last (most recent) and most severe (from all documented episodes) flare were provided at clinician's discretion. Results: Fifty‐eight patients were recruited from 12 centres in nine CEE countries; median (range) age was 61 (16–92) years and 60.3% (35 out of 58) were female. The most common comorbidities were hypertension (43.1% [25 out of 58]) and hyperlipidaemia (32.8% [19 out of 58]). Thirty‐four patients (58.6%) presented with concomitant plaque psoriasis before or during the course of GPP. Data from two separate flares were recorded in 26 individuals; in 32 patients, the most recent flare was reported as the most severe. Over 90% of patients with a flare episode classified as most severe by clinicians were hospitalized, with >75% of these individuals having a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total score of 3 or 4. Systemic symptoms were more common in patients with a GPPGA score of 3 or 4 but were also manifest in individuals with a GPPGA score ≤2. A significant correlation was observed between a combined systemic disease score of clinical and laboratory features and both GPPGA total score (r = 0.385, p < 0.001) and GPPGA pustulation subscore (r = 0.305, p < 0.05). Conclusions: Considerable heterogeneity in the presentation of GPP flares was observed, both between patients and within‐patient. All GPP flares were associated with a significant clinical burden, highlighting the unmet need for accurate and early diagnosis. [ABSTRACT FROM AUTHOR]

Background: Psoriasis is one of the most common dermatoses associated with a variety of comorbidities. There have been some reports on its possible association with ocular disorders however dry eye syndrome (DES) in such patients has been poorly investigated. Objectives: To investigate the frequency of DES symptoms in psoriatic patients, also regarding psoriasis severity in PASI, manifestation and therapy. Methods: 40 patients with psoriasis and 40 volunteers without dermatoses were enrolled in the study. They completed Ocular Surface Disease Index (OSDI) questionnaire and were objectively examined by IDRA® device to perform automatic interferometry, automatic meibography of lower eyelid glands, non‐invasive break‐up time (NIBUT), blink quality and tear meniscus height. Results: Patients with psoriasis had statistically significantly thicker lipid layer (p = 0.0042 left eye, p = 0.0313 right eye) and greater loss of Meibomian glands compared to controls (p = 0.0128 left eye, p = 0.048 right eye). The patients had lower, although insignificantly, eye blink quality and tear meniscus height than the control group, as well as shorter NIBUT and higher score in OSDI. After the division of patients into two groups–with or without nails involvement/psoriatic arthritis/systemic treatment– we did not observe any significant differences between the groups. PASI did not correlate with any DES parameter. Conclusions: This is the first study of DES symptoms with an objective IDRA® analyzer. We managed to observe that patients with psoriasis have thicker lipid layer and higher Meibomian glands' loss in lower eyelids. Based on all assessed objective and subjective parameters psoriatics do not seem to have an increased risk of DES. The presence of psoriatic arthritis or nail involvement does not seem to be a predisposing factor for DES development. PASI probably cannot be a prognostic factor for any of the DES‐associated parameters. Nevertheless, DES in psoriasis requires further research on bigger samples to establish reliable recommendations. [ABSTRACT FROM AUTHOR]

Background: Generalized pustular psoriasis (GPP) is a rare, chronic, inflammatory skin disease associated with considerable patient burden. The Psoriasis Symptom Scale (PSS), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT‐Fatigue) and pain‐Visual Analogue Scale (pain‐VAS) are patient‐reported outcomes (PROs) that have not yet been validated in patients with GPP. Objectives: To evaluate the psychometric properties of the PSS, FACIT‐Fatigue and pain‐VAS using data from Effisayil 1, a randomised trial of spesolimab in patients with moderate‐to‐severe GPP. Methods: Inter‐item correlations and confirmatory factor analysis (CFA) were performed using Week 1 data. Internal consistency was assessed with Cronbach's α coefficient using baseline and Week 1 data. Test–retest reliability was assessed using intraclass correlation coefficients (ICCs); change data for the GPP Physician Global Assessment total score and pustulation subscore were used to define a stable population. Convergent validity was assessed at baseline and Week 1 using Spearman's rank‐order correlations. Known‐groups validity was measured by analysis of variance using Week 1 data. Ability to detect change from baseline to Week 1 was evaluated by analysis of covariance. Results: Inter‐item and item‐to‐total correlations were moderate or strong for most PSS and FACIT‐Fatigue items. CFA demonstrated the unidimensionality of the PSS and FACIT‐Fatigue, with high factor loadings for most items (PSS range, 0.75–0.94; FACIT‐Fatigue range, 0.11–0.93) and acceptable fit statistics. Both scores demonstrated internal consistency (Cronbach's α, 0.71 and 0.95, respectively). The PSS, FACIT‐Fatigue and pain‐VAS demonstrated test–retest reliability (ICCs ≥0.70) and good evidence of convergent validity. Furthermore, the PROs could differentiate between known groups of varying symptom severity (range, p < 0.0001–0.0225) and detect changes in symptom severity from baseline to Week 1 (range, p < 0.0001–0.0002). Conclusions: Overall, these results support the reliability, validity and ability to detect change of the PSS, FACIT‐Fatigue and pain‐VAS as PROs in patients with GPP. [ABSTRACT FROM AUTHOR]

Background Objectives Materials and Methods Results Conclusions Facial (FP) and genital psoriasis (GP) significantly affect patients' quality of life. Despite the advances in treatments, limited data on efficacy and safety are available on these difficult‐to‐treat areas. Guselkumab is an interleukin (IL)‐23 inhibitor which has been proven effective in treating patients with moderate‐to‐severe plaque psoriasis.The aim of this interim analysis was to report the efficacy and safety of guselkumab in the treatment of patients with FP and/or GP.GULLIVER is a 52‐week Italian observational study to evaluate the effectiveness and safety of guselkumab in a real‐life setting in patients with FP and/or GP. Adult patients with facial and/or genital moderate‐to‐severe psoriasis (sPGA score ≥ 3) were included. The primary endpoint of this analysis was the percentage of patients achieving a facial or genital sPGA score of 0 (clear) or 1 (almost clear), at Week 12. The change in the score of the facial or genital sPGA components in patients with a score ≥3 for each sPGA component was assessed. PASI score in patients with a baseline PASI above or below 10 was evaluated.Overall, 351 patients were included in the study; 83.3% of FP and 76.5% of GP patients achieved the primary endpoint. Similar response rates were observed for the facial or genital sPGA components in patients with a baseline facial or genital sPGA score ≥3 in each component. Among patients with a baseline PASI score >10, mean PASI score improved from 19.0 (SD 8.3) to 2.2 (SD 4.8). Forty‐four AEs were observed in 32 patients; two mild and transient AEs (fatigue and nausea) were considered treatment related. No SAEs were observed.Guselkumab, showing to be effective and safe in treating FP and GP, may be a valid therapeutic option for patients with psoriasis localized in these difficult‐to‐treat areas. [ABSTRACT FROM AUTHOR]

Background: GPP is a rare, chronic, neutrophilic skin disease, with limited real‐world data characterizing patients with flares and the impact of flares on disease progression and morbidity. Objective: Describe the clinical characteristics of patients with GPP, comorbidities, disease epidemiology and frequency and severity of flares, and compare patients with GPP with a matched severe psoriasis population. Methods: In this population‐based real‐world cohort study an algorithm was developed to identify patients with GPP flares. Three cohorts were identified using the Système National des Données de Santé (SNDS) database covering almost the entire French population; a prevalent cohort (2010–2018), an incident cohort (2012–2015). A severe psoriasis cohort was compared with the GPP incident cohort using propensity score matching. Results: The prevalent and incident cohorts comprised 4195 and 1842 patients, respectively. In both cohorts, mean age was 58 years; 53% were male. Comorbidities were significantly more common in the incident cohort versus matched psoriasis cohort, respectively, including hypertension (44% vs. 26%), ischaemic heart disease (26% vs. 18%) and hyperlipidaemia (25% vs. 15%). In the incident cohort, the flare rate was 0.1 flares/person‐year and 0.4 flares/person‐year among the 569 out of 1842 patients hospitalized with flares. These patients had a mean (±SD) stay of 11.6 ± 10.4 days; 25% were admitted to the intensive care unit. In 2017, the cumulative incidence and cumulative GPP age–sex standardized prevalence were 7.1 and 45.2 per million, respectively. Conclusions: Patients with GPP had a distinct comorbidity profile compared to patients with severe psoriasis, and GPP flares were associated with long hospitalizations. [ABSTRACT FROM AUTHOR]

Background: Despite that brodalumab's efficacy and safety have been assessed in randomized clinical trials, real‐life data remain scarce. BrIDGE was an observational, prospective, single‐cohort, multicentre study that recruited patients with moderate‐to severe plaque psoriasis in Greece. Objectives: The primary objective was to assess the proportion of patients who achieved Psoriasis Area and Severity Index (PASI)100 after 24 weeks. Other endpoints included: the maintenance of PASI90/100 through to 104 weeks, the short‐term response [PASI75/90/100 and static Physician's Global Assessment (sPGA) 0/1] to brodalumab at 12–16 weeks and time to complete clearance. Moreover, we explored the change in quality of life [Dermatology Life Quality Index (DLQI) 0/1] and adherence to brodalumab. Methods: Two hundred patients who were initiating treatment with or switching to brodalumab, were recruited. Analyses were conducted using the as observed data and three imputation approaches were also applied for the missing data (last observation carried forward, 'worst case' and 'best case' scenario). Continuous variables were reported using summary statistics, whereas categorical variables were reported in frequency tables. Results: Based on the 'as observed data', 42.0% of patients achieved PASI100 at Week 24 after 25.9 ± 3.5 weeks and 65% of patients attained PASI100 at Week 104. In total, 70.2%, 47.5% and 32.0% achieved PASI75/90/100, respectively, whereas 72.6% of patients achieved sPGA 0/1, at Weeks 12–16. With respect to sPGA status 82.8%, 89.2% and 92.5% of patients achieved sPGA 0/1 at Weeks 24, 52 and 104, respectively. The time to achieve PASI100 at Weeks 12–16 was 13.7 ± 1.3, 52.1 ± 3.4 weeks at Week 52 and 105.5 ± 4.8 weeks at Week 104. Mean DLQI and Psoriasis Symptom Inventory (PSI) scores decreased by 11.4 ± 7.0 and 15.4 ± 6.5 points from baseline to Week 104, respectively. Adherence to treatment was equal to 98.9%. Conclusions: Brodalumab confers rapid and durable responses, as well as improvements in the quality of life of moderate‐to‐severe psoriasis patients. [ABSTRACT FROM AUTHOR]

Objective: A3 adenosine receptor (A3AR) is overexpressed in the skin and peripheral blood mononuclear cells of psoriasis patients. We investigated the efficacy/safety of piclidenoson (CF101), an orally bioavailable A3AR agonist that inhibits IL‐17 and IL‐23 production in keratinocytes, in moderate‐to‐severe plaque psoriasis. Methods: The randomized, placebo‐ and active‐controlled, double‐blind phase 3 COMFORT‐1 trial randomized patients (3:3:3:2) to piclidenoson 2 mg BID, piclidenoson 3 mg BID, apremilast 30 mg BID or placebo. At Week 16, patients in the placebo arm were re‐randomized (1:1:1) to piclidenoson 2 mg BID, piclidenoson 3 mg BID or apremilast 30 mg BID. The primary end point was the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI‐75) at Week 16 versus placebo. Results: A total of 529 patients were randomized and received ≥1 dose of study medication (safety population). The efficacy analysis population for the primary end point included 426 patients (piclidenoson 2 mg BID, 127; piclidenoson 3 mg BID, 103; apremilast, 118; placebo, 78). Piclidenoson at 2 and 3 mg BID exhibited similar efficacy. The primary end point was met with the 3 mg BID dose: PASI 75 rate of 9.7% versus 2.6% for piclidenoson versus placebo, p = 0.037. The PASI responses with piclidenoson continued to increase throughout the study period in a linear manner. At week 32, analysis in the per‐protocol population showed that a greater proportion of patients in the piclidenoson 3 mg BID arm (51/88, 58.0%) achieved improvement from baseline in Psoriasis Disability Index (PDI) compared to apremilast (59/108, 55.1%), and the test for noninferiority trended towards significance (p = 0.072). The safety/tolerability profile of piclidenoson was excellent and superior to apremilast. Conclusions: Piclidenoson demonstrated efficacy responses that increased over time alongside a favourable safety profile. These findings support its continued clinical development as a psoriasis treatment (ClinicalTrials.gov identifier: NCT03168256). [ABSTRACT FROM AUTHOR]

Background: Psoriasis is an inflammatory skin disease that impacts a heterogeneous group of patients and can have multiple clinical manifestations. Risankizumab is approved for the treatment of moderate-to-severe plaque psoriasis. Objectives: To evaluate the long-term efficacy of risankizumab according to baseline patient characteristics, and for the treatment of high-impact disease manifestations (nail, scalp and palmoplantar psoriasis), through 256 weeks of continuous treatment in the phase 3 LIMMitless study. Methods: This subgroup analysis evaluated pooled data from patients with moderateto- severe plaque psoriasis who were randomized to risankizumab 150 mg during two double-blind, phase 3, 52-week base studies (UltIMMa-1/2; NCT02684370/ NCT02684357) and were enrolled in the phase 3 LIMMitless open-label extension study (NCT03047395). Subgroup assessments included the proportion of patients who achieved ≥90%/100% improvement in Psoriasis Area and Severity Index (PASI 90/100). Among patients with nail, scalp and/or palmoplantar psoriasis in addition to skin psoriasis, assessments included changes from baseline in and resolution of these three psoriatic manifestations. Results: Overall, a numerically similar proportion of patients (N = 525) achieved PASI 90/100 through Week 256, regardless of their baseline age, sex, body mass index, weight, PASI or psoriatic arthritis status. Patients with nail, scalp and/or palmoplantar psoriasis experienced substantial improvements in manifestation-specific indices (mean improvement from baseline to Week 256 of >81%, >94% and >97%, respectively); in patients with all three manifestations (N = 121), 44.6% achieved complete clearance of these manifestations at Week 256. Conclusions: Risankizumab demonstrated generally consistent efficacy through 256 weeks across patient subgroups and showed durable long-term efficacy for psoriatic disease manifestations. [ABSTRACT FROM AUTHOR]

Background: Little is known about the therapeutic benefits of a value-based healthcare model compared to a traditional activity-based incentive model in psoriasis (PsO). Objectives: This prospective non-interventional study evaluated an outcome-based, patient-centred management model for patients with PsO. Methods: In total, 49 patients with a Psoriasis Area and Severity Index (PASI) ≥3 who were starting or switching between treatments were included. Patients were assessed at baseline, 3 and 9 months. The patient benefit index (PBI) was calculated using predefined questionnaires. An expected PBI was calculated and adjusted for risk factors known to complicate treatment, that is overweight and smoking. The model remunerated the department on whether the observed PBI exceeded the expected PBI to incentivize over-performance. Results: In total, 40 patients (80%) completed all three visits; 32.7% were smokers and 73.5% were overweight. Mean PASI at baseline was 11.5 (SD 9.1); PASI improved significantly from baseline through 3 months: mean reduction, 8.0 (SD 9.2), p < 0.001 and was maintained until 9 months: mean further reduction, 0.1 (SD 3.3), p = 0.893. The mean PBI was 2.5 (SD 1.3) and 2.8 (SD 1.1) at 3 and 9 months, respectively. A PBI ≥1 was achieved by 87.8% at 3 and 95.1% at 9 months. Overall, the department was remunerated a mean 2721.1 DKK (SD 4472.8) per patient. In subgroup analysis, the department was remunerated a mean of, respectively, 2428.6 (SD 5089.5), 2636.6 (SD 4471.3) and 3196.5 (SD 4497.1) DKK for patients with none, 1 or 2 risk factors, that is smoking or/and overweight. Conclusions: The model evaluated herein is the first value-based model to calculate remuneration from patient reported outcomes and showed to successfully predict the expected PBI and remunerate treatment based on whether the expected treatment goal was met or exceeded. This can be utilized in the patient-centred management of PsO. [ABSTRACT FROM AUTHOR]

Background: Psoriasis is an inflammatory skin disease. The pathogenesis of psoriasis has not been fully elucidated. T-lymphokine-activated killer cell-originated protein kinase (TOPK) activity increases in a proinflammatory environment, and inhibiting TOPK blocks inflammation. However, whether TOPK is involved in the pathogenesis of psoriasis remains to be identified. Objectives: We aimed to study the role of TOPK in psoriasis and attempted to find a drug targeting TOPK for the prevention and treatment of psoriasis. Method: Firstly, the expressions of TOPK in psoriatic patients, psoriatic cell and animal model were analysed by Gene Expression Omnibus database, immunohistochemistry (IHC) staining and western blot (WB). After inhibiting TOPK by chemical or gene knockout, the effect of TOPK on the development of psoriasis was verified in cell and animal model by WB, qRT-PCR, ELISA, haematoxylin--eosin (H&E) and IHC staining. Moreover, phosphoproteomic analysis was performed to explore the signalling pathways regulated by TOPK in the occurrence and development of psoriasis. Then, an in vitro kinase assay was performed to prove TOPK kinase activity was inhibited by worenine. Ultimately, WB, qRT-PCR, ELISA, H&E and IHC staining were used to verify the anti-psoriasis effect of worenine by inhibiting TOPK was in cell and animal model. Results: In this study, we found that TOPK was highly expressed in psoriasis patients, psoriatic cell and animal model, which suggests that TOPK might be associated with psoriasis pathogenesis. Interestingly, chemical or genetic inhibition of TOPK alleviated M5-and imiquimod (IMQ)-induced psoriasis-like dermatitis, which further confirmed the role of TOPK in promoting the development of psoriasis. Moreover, we determined that worenine inhibited TOPK kinase activity. In addition, worenine relieved M5-and IMQ-induced psoriasiform dermatitis by inhibiting TOPK activity. Conclusions: T-lymphokine-activated killer cell-originated protein kinase promotes the development of psoriasis. Therefore, TOPK might be a promising drug target for the prevention and treatment of psoriasis. Worenine alleviates psoriasiform dermatitis by inhibiting TOPK activity, providing new strategies for clinical intervention. [ABSTRACT FROM AUTHOR]

This article is a letter to the editor of a medical journal discussing the development of a definition for disease modification in plaque psoriasis. The study involved a literature review and a consensus process with experts in psoriasis care. The panel developed a definition of disease modification as a sustained improvement in the disease course of plaque psoriasis resulting from a change in pathophysiology that reduces the need for treatment. The letter also mentions the concept of remission in chronic plaque psoriasis and the assessment tools used to measure psoriasis severity. The study was funded by Janssen Immunology, and the authors disclosed their conflicts of interest. [Extracted from the article]

Introduction: Ixekizumab proved to be effective and safe for psoriasis treatment in several randomized clinical trials and real‐life studies. Nevertheless, long‐term real‐world experiences are still lacking, with little data up to 4 years of treatment. Objectives: To analyse survival, effectiveness and safety of ixekizumab in a real‐life cohort of patients affected by moderate‐to‐severe psoriasis or psoriatic arthritis up to 260 weeks (5 years). Methods: We included all patients treated with ixekizumab from December 2017 to March 2021. Drug survival (DS) was analysed in patients at risk for up to 5 years. Cox analysis was adopted to evaluate possible predictive factors of discontinuation. Psoriasis Area Severity Index (meanPASI and PASI100, 90, and ≤3) was used as outcomes of effectiveness on observed patients at 16, 52, 104, 156, 208 and 260 weeks. Logistic regression was performed to identify possible predictive factors of response. Results: DS was 65.5% at 260 weeks, with being a super‐responder patient (achievement of PASI100 at 16 weeks and maintained at 28 weeks) correlated with less risk of discontinuation. PASI100, 90 and ≤3 was achieved by 54.1%, 60.5% and 73% of observed patients, respectively, at 16 weeks, and by 59.1%, 81.8% and 95.5%, respectively, at 260 weeks. High mean BMI was the only factor strongly associated with less achievement of the outcomes at the earlier time points: PASI100 at 16 weeks (OR 0.93, CI 0.87–0.98, p = 0.014) and at 104 weeks (OR 0.91, CI 0.84–0.98, p = 0.019), PASI90 achievement at 16 weeks (OR 0.94, CI 0.88–0.99, p = 0.028) and 104 weeks (OR 0.91, CI 0.83–0.99, p = 0.027), and PASI ≤3 (OR 0.86, CI 0.76–0.97, p = 0.018) at 104 weeks. No severe adverse events were observed. Conclusions: Ixekizumab showed high effectiveness and safety for up to 5 years, with survival of 2/3 of treated patients. Rapid response to treatment is predictive of long‐term response. [ABSTRACT FROM AUTHOR]

This article discusses the rates of depression screening for patients with psoriasis in the United States. The study found that depression screening was performed at a low rate of 1.2% of psoriasis visits, with primary care providers more likely to screen for depression compared to dermatologists. The study also found that Asian and Hispanic patients were less likely to undergo depression screening compared to non-Hispanic White patients, potentially due to cultural stigma and language barriers. The authors emphasize the importance of identifying and monitoring depression in psoriasis patients, and suggest that education and implementation efforts may help increase screening rates. [Extracted from the article]

This article discusses the development and validation of a prognostic model for predicting flares in generalized pustular psoriasis (GPP). GPP is a rare auto-inflammatory skin disease characterized by recurrent flares of neutrophil-filled sterile pustules. These flares can have a significant impact on the daily activities and overall well-being of patients and can lead to life-threatening complications if left untreated. The study aimed to identify risk factors for GPP flare and construct a predictive model based on clinical characteristics to forecast the occurrence of flares. The model incorporates four features: history of psoriasis vulgaris, risky alcohol use, temperature at fever, and albumin levels. The model achieved promising results in internal and external validation processes and may provide critical insights into GPP flare patterns and help prevent such episodes. [Extracted from the article]

This article examines the impact of the COVID-19 pandemic on the number of first diagnosis and follow-up visits for patients with pemphigus, bullous pemphigoid, scleroderma, psoriasis, and vitiligo. The study found that there was a reduction in both first diagnosis and follow-up visits for these diseases during the pandemic compared to the pre-pandemic years. This suggests that many patients may have avoided or delayed medical care during the pandemic, potentially increasing the risk of complications. The authors recommend adopting telehealth for first diagnosis and making specific treatments available at home to mitigate the impact of future pandemics. [Extracted from the article]

This article examines the connection between lifestyle choices and the likelihood of developing psoriasis in young adults with inflammatory bowel disease (IBD) in South Korea. The study analyzed data from health exams conducted by the Korean National Health Insurance Corporation, including 5,356 IBD patients and 6,648,818 non-IBD controls. The research discovered that smoking and heavy alcohol consumption were linked to a significantly higher risk of psoriasis in young adults with IBD, with smoking having a particularly strong impact on patients in their 20s. The article emphasizes the importance of lifestyle modifications, such as quitting smoking and moderating alcohol intake, in reducing the risk of psoriasis in individuals with IBD, and highlights the need for healthcare professionals to educate their patients, especially young adults with IBD, about the potential benefits of these changes. [Extracted from the article]

Background: Line‐field confocal optical coherence tomography (LC‐OCT) is a new, valid means for a rapid and non‐invasive in vivo examination of the epidermis and upper dermis, allowing digital interpretation and measurement of high‐resolution images on a cellular level. Given these properties, it may represent a valid tool for monitoring psoriasis during treatment, allowing a new method to set a precise objective severity of the disease. Objectives: We aimed to investigate the potentialities of LC‐OCT in the non‐invasive monitoring of microscopical changes associated with moderate–severe plaque psoriasis (PP) during the treatment with the most common biological drugs. Materials and Methods: We performed LC‐OCT imaging of PP lesions from 17 patients before and after 8 weeks of treatment. The clinical severity of the single lesions was evaluated using a lesion score (LS), designed considering three parameters: erythema, desquamation and infiltration. LC‐OCT images were segmented by artificial intelligence and evaluated based on three microscopic criteria: the thickness of the stratum corneum, the thickness of the living epidermis and the undulation of the dermo‐epidermal junction. Results: Line‐field confocal optical coherence tomography digital analysis allowed recognition and quantification of the three microscopic criteria, showing a reduction of all these during the follow‐up. Furthermore, a high correlation between change in LS and the thickness of the stratum corneum and the thickness of the living epidermis was found. Conclusion: Line‐field confocal optical coherence tomography can non‐invasively monitor the response of PP to different treatments. Morphometric changes occurring in the psoriatic lesion during the 8‐week treatment period were identified by in vivo LC‐OCT and measured by using artificial intelligence. Although future studies are required, based on these preliminary results, LC‐OCT may represent a valid potential tool for precise monitoring of therapeutic response. [ABSTRACT FROM AUTHOR]

Psoriasis causes detriment in a person's physical, mental and social health which impairs their quality of life (QoL). However, the current psoriasis management may not adequately address all relevant health domains. Since the goal of healthcare is to restore or maintain health, health outcomes should include all areas of the patient's overall health. Life satisfaction, QoL and patient well‐being are essential to a comprehensive approach to the disease. With the inclusion of more people‐centred policies, care of patients with psoriasis should evolve towards a holistic and integrated assessment of the disease impact, including subjective measures of well‐being in order to encompass all aspects of health. The main objective of this expert review is to give the concept of well‐being a place as an entity within the holistic therapeutic approach for patients with psoriasis. Identifying and defining common goals beyond the skin with the patient and testing them throughout the course of treatment will benefit and enhance treatment success. We propose a series of recommendations for application in clinical practice, providing tangible clinical guidance for implementing well‐being in the management of psoriasis. Among the recommendations are the need to initially listen to the patient, to know their level of empowerment or what they want to achieve, their preferences in decision making, the evaluation of not only the physical but also the emotional impact of the disease (well‐being), the definition of the aspects that can generate a cumulative deterioration of the disease throughout life, and a continuous assessment of the patient's preferences with the opinion of the expert clinician and the integration of the knowledge of external clinical evidence. [ABSTRACT FROM AUTHOR]

Generalized pustular psoriasis (GPP) is a rare, chronic, neutrophilic inflammatory skin disease characterized by episodes of widespread eruption of sterile, macroscopic pustules that can be accompanied by systemic inflammation and symptoms. A systematic literature review and narrative synthesis were conducted to determine the impact of GPP on patients' health‐related quality of life (HRQoL) and patient‐reported severity of symptoms and to compare its impact to patients with plaque psoriasis (plaque PsO). Searches were undertaken in Embase, MEDLINE and the Cochrane Library from 1 January 2002 to 15 September 2022. Screening was carried out by two reviewers independently. Outcome measures included generic (e.g. EQ‐5D, SF‐36) and dermatology‐specific (e.g. DLQI) clinical outcome assessments, and other relevant patient‐reported outcome measures (PROMs) (e.g. severity of pain measured by a numerical rating scale). Overall, 20 studies were found to be eligible for inclusion, of which seven also had data for plaque PsO. The DLQI was the most frequently reported outcome measure (16 out of 20 studies). When reported, mean DLQI (SD) scores varied from 5.7 (1.2) to 15.8 (9.6) across the studies, indicating a moderate to very large effect on HRQoL; the wide range of scores and large SDs were explained by the small population sizes (n ≤ 12 for all studies except two). Similar ranges and large SDs were also observed for other measures within individual studies. However, in general, people with GPP reported a greater impact of their skin condition on HRQoL, when compared to people with plaque PsO (i.e. higher DLQI scores) and higher severity for itch, pain and fatigue. This systematic review highlighted the need for studies with a larger population size, a better understanding of the impact of cutaneous and extracutaneous symptoms and comorbidities on HRQoL during and between GPP flares, and outcome measures specifically tailored to the unique symptoms and the natural course/history of GPP. [ABSTRACT FROM AUTHOR]

Background: The risks of serious infections that lead to hospitalization and mortality in patients with psoriasis in Asia have not been comprehensively studied. Objectives: We examined the incidence of serious infection and infection mortality in patients with psoriasis. Methods: This population‐based retrospective cohort study used the Taiwan National Health Insurance claims database from 2000 to 2017. Adult patients with psoriasis were identified by a relevant International Classification of Diseases (ICD) code and matched to six comparators without psoriasis on age and sex. Psoriasis patients were categorized as having moderate‐to‐severe disease once exposed to systemic therapies, phototherapy or biologic therapies. The incidence of serious infection and infection mortality were identified by ICD codes from inpatient hospitalization and death registration. Cox proportional hazard models were used to compare the risk, and the results were adjusted for covariates and presented as adjusted hazard ratios (aHR) and 95% confidence interval (95% CI). Results: Overall, 185,434 psoriasis patients and 1,112,581 comparators were included. A higher rate of serious infection (aHR: 1.21, 95% CI: 1.19–1.22) was found in patients with psoriasis compared to matched comparators without psoriasis, and the risk was enhanced when patients had moderate‐to‐severe psoriasis (aHR: 1.30, 95% CI: 1.27–1.34). Specifically, there was an increased risk of serious infection due to respiratory infections (aHR: 1.11, 95% CI: 1.09–1.13), skin/soft‐tissue infections (aHR: 1.57, 95% CI: 1.52–1.62), sepsis (aHR: 1.23, 95% CI: 1.19–1.27), urinary tract infections (aHR: 1.11, 95% CI: 1.08–1.14), hepatitis B (aHR: 1.18, 95% CI: 1.06–1.30) and hepatitis C (aHR: 1.49, 95% CI: 1.32–1.69). Furthermore, psoriasis patients were associated with a higher risk of infection‐related mortality (aHR: 1.15, 95% CI: 1.11–1.18) compared to matched comparators. Conclusion: Patients with psoriasis had a higher risk of serious infection and infection mortality, which was enhanced by moderate‐to‐severe psoriasis. Practitioners should be aware of the increased risk in patients with psoriasis, but it should not be a barrier to offering effective treatment. [ABSTRACT FROM AUTHOR]

This article examines the effectiveness of risankizumab, a medication used to treat moderate-to-severe plaque psoriasis. The study found that risankizumab was effective in improving psoriasis symptoms, with a high percentage of patients experiencing significant improvement and complete skin clearance. The study also found that patients who had not previously been treated with biologic drugs and those with a shorter disease history had better responses to the treatment. However, the study has some limitations, and further research is needed to fully understand the long-term effects of risankizumab on psoriasis. [Extracted from the article]

This article discusses the importance of considering patients' perspectives in the treatment of psoriasis, a chronic skin disease that can significantly impact quality of life. The study conducted a Delphi consensus involving psoriasis patients, physicians, and nurses to determine the definition of freedom from disease in psoriasis. The results showed that while there was a high level of consensus among all groups, there were some differences in the perceived importance of various aspects of freedom from disease. For example, physicians placed greater importance on the management of clinical symptoms, while patients were more concerned about the cost of treatments. The study also found that patients with milder psoriasis placed greater importance on psychosocial elements and healthcare team support, while patients with more severe psoriasis were less concerned with the cost of treatment. Additionally, females placed greater importance on psychosocial elements, such as worrying about other people's reactions to their skin. The findings suggest the need for personalized treatment plans and shared decision-making between patients and healthcare professionals. However, it is important to note that the study has limitations, such as the potential lack of representativeness in certain groups. [Extracted from the article]

Background: Tildrakizumab is a humanized, IgG1/κ antibody that interacts with the p19 subunit of interleukin 23. It is approved for the treatment of moderate‐to‐severe plaque psoriasis. Real‐world evidence on the effectiveness and safety of tildrakizumab is limited. Objectives: To assess the effectiveness and safety of tildrakizumab at 24 weeks in patients with moderate‐to‐severe plaque psoriasis in routine clinical practice. Methods: Retrospective, observational, multicentre study including adult patients with moderate‐to‐severe plaque psoriasis treated with tildrakizumab under real‐life conditions. Patient data were extracted from anonymized electronic medical records. Statistical analysis was performed using SPSS22. Results: A total of 190 patients were included. About 53.9% were men with a mean age of 51.45 (SD 3.9) and a mean BMI of 29.13 (SD 6.21). About 79.8% (132 out of 190) of patients had previously received biological therapy (BT) and 17.3% (33 out of 191) had psoriatic arthritis. Baseline PASI was 10.7 (SD 6.53). Up to 109 patients reached Week 24 and at this point mean baseline PASI decreased to 1.7 (SD 4.8), representing an 88.79% mean PASI reduction. At 6 months, 87.1% and 40.3% of the treated patients achieved PASI ≤3 and ≤1, respectively. At Week 24 mean BSA decreased from 13.2 (SD 10.07) to 1.6 (SD 4.40) and mean DLQI went from 12.5 (SD 7.12) to 1.2 (SD 3.27). Multivariate analysis showed no differences when effectiveness was correlated with gender, obesity, psoriatic arthritis or prior exposure to BT. The rate of adverse events (AE) was 5.9% (11 out of 190), where infections were the most frequent AE (4 out of 11). One patient suffered a haemorrhagic ictus and one patient died due to causes unrelated to the study. Conclusion: Tildrakizumab was effective and safe in a large cohort of patients with moderate‐to‐severe plaque psoriasis treated in a routine clinical setting. [ABSTRACT FROM AUTHOR]

Background: Atopic‐like dermatitis (ALD) is a common side effect of interleukin‐17A (IL‐17A) inhibitors. Objective: To determine the prevalence, risk factors, outcomes and treatment of ALD in a cohort of psoriasis patients treated with IL‐17A inhibitors. Methods: This retrospective study included 226 psoriasis patients treated with an IL‐17A inhibitor in our dermatology department between July 2020 and July 2022. The patients were reviewed over 2 years. A logistic regression model in rare events data (relogit) was used to predict the risk factors for ALD. Results: Of the 226 patients, 14 had ALD. Data including age, body mass index, IL‐17A inhibitor use, personal and family history of atopic disease, pet ownership history, and immunoglobulin E (IgE) levels were analysed using the relogit regression model. It indicated a personal history of atopic disease (odd ratio [OR] 27.830, 95% confidence interval [CI] 3.801–203.770; p = 0.001) and elevated IgE levels (OR 5.867, 95% CI 1.131–30.434; p = 0.035) as independent predictors of incident ALD. In one patient, anti‐IL‐17A therapy was discontinued, and treatment was switched to tofacitinib. Thirteen patients who continued with IL‐17A inhibitor were treated with topical therapy and/or antihistamines, and their ALD was partially or completely resolved. Conclusion: In this study, the incidence rate of ALD was 6.19%. Elevated IgE levels and a personal history of atopic disease were found to be the risk factors for ALD. Our study findings suggest that treatment should be provided based on the severity of psoriasis and incident ALD. Prior to treatment, psoriasis patients who have the risk factors for ALD should be informed of the possible development of ALD, and alternative psoriatic therapeutic options should be considered if severe ALD develops. [ABSTRACT FROM AUTHOR]

This study explores the impact of exclusion criteria on the applicability of research findings to older adults with psoriasis. It reveals that age, cardiovascular comorbidity, and malignancies are key factors that affect the generalizability of evidence from trials to real-world situations in this population. The study also examines the comorbidity burden in older adults with psoriasis, finding a higher prevalence of conditions such as depression, skin cancer, obesity, and hyperlipidemia. The findings emphasize the need for more inclusive research to inform treatment decisions for older adults with psoriasis. The study was funded by Almirall, but the funding did not influence the study design or results. [Extracted from the article]

This document summarizes a study on the use of guselkumab as a treatment for moderate-to-severe psoriasis. The study analyzed data from two Phase 3 trials and found that guselkumab was effective and safe in treating psoriasis. The presence of anti-drug antibodies to guselkumab did not significantly impact the clinical response, and most patients had low antibody levels. The study also found that guselkumab concentrations were similar between patients with and without antibodies. The document cautions against comparing antibody development across different studies or treatments. [Extracted from the article]

This article discusses the use of a new antibody called spesolimab in treating patients with flare-ups of generalized pustular psoriasis (GPP), a rare and potentially life-threatening inflammatory disease. The study focuses on a group of 11 patients with GPP flare-ups who were treated with intravenous spesolimab. The results showed that spesolimab was effective in reducing the severity of GPP symptoms and improving the patients' quality of life. The study suggests that spesolimab could be a viable treatment option for GPP flare-ups that do not respond to other conventional and biological systemic treatments. The article also provides information about the authors and their affiliations, references to related studies and publications, and discloses potential conflicts of interest. The data from the study are available upon request, and the patients involved have given consent for the publication of their case details. [Extracted from the article]

A study published in the Journal of the European Academy of Dermatology & Venereology examined the awareness of obesity among patients with psoriasis. The study found that while most participants were aware of the negative effects of obesity on their general health, fewer were aware of its impact on psoriasis severity and response to treatment. However, the majority of patients expressed a desire to lose weight, with obese patients being more motivated than overweight patients. The findings suggest that there is a strong motivation among individuals with psoriasis to address their weight and improve their overall health. [Extracted from the article]

Psoriasis (PsO) and atopic dermatitis (AD) are chronic skin disorders that may be associated with erectile dysfunction (ED). However, a Mendelian randomization study found that there was no significant genetic association between PsO and ED. On the other hand, the study showed that genetically predicted increase in AD was associated with a lower risk of ED. The study also identified specific genes and the JAK-STAT signaling pathway as potential factors linking AD and ED. Further research is needed to validate and expand upon these findings. [Extracted from the article]

This article discusses a study that aimed to evaluate the effectiveness of the inactivated SARS-CoV-2 vaccine (CoronaVac) in patients with psoriasis and atopic dermatitis (AD). The study included 197 participants, including healthy controls, psoriasis patients, and AD patients. The results showed that all groups had enhanced antibody responses to the vaccine after the third dose. However, psoriasis patients who were not receiving treatment had lower antibody levels compared to those receiving anti-IL-17A treatment and healthy controls. The study suggests that correcting the Th1/Th17 imbalance in psoriasis patients may enhance the effectiveness of the COVID-19 vaccine. [Extracted from the article]

This article discusses a study on the use of risankizumab for the treatment of genital psoriasis. Genital involvement in psoriasis can have a significant impact on quality of life and sexual activity. The study found that risankizumab, a monoclonal antibody that blocks interleukin-23, was effective in reducing psoriasis symptoms in the genital area. The treatment showed a fast onset of action and sustained effectiveness for up to 52 weeks. The study also reported a favorable safety profile, with no relevant adverse events or treatment discontinuation due to side effects. However, further research is needed to evaluate long-term management of genital psoriasis. [Extracted from the article]

Background: The fixed dose combination of calcipotriene (CAL) and betamethasone dipropionate (BDP) is a well‐established topical treatment option for psoriasis based on strong scientific rationale for the single agents having complementary efficacy and safety. CAL/BDP PAD‐cream is an easily spreadable cream based on PAD Technology™, an innovative formulation and drug delivery system. Objectives and Methods: A Phase 3, multicentre, randomized, investigator‐blind, active and vehicle‐controlled trial enrolling 490 patients with mild to moderate psoriasis according to the Physician Global Assessment (PGA) scale was conducted in three European countries. Products were applied once daily for 8 weeks. The aim of the trial was to evaluate the efficacy and safety of CAL/BDP PAD‐cream as well as treatment acceptability compared to CAL/BDP gel and PAD‐cream vehicle. Primary endpoint was percentage change in modified Psoriasis Area and Severity Index (mPASI) from baseline to Week 8. Results: The percentage mean change from baseline to Week 8 in mPASI for CAL/BDP PAD‐cream (67.5%) was superior compared to PAD‐cream vehicle (11.7%; p < 0.0001) and non‐inferior to CAL/BDP gel (63.5%). The proportion of patients achieving PGA treatment success (at least two‐step improvement to clear or almost clear) after 8 weeks was superior for CAL/BDP PAD‐cream (50.7%) compared to PAD‐cream vehicle (6.1%, p < 0.0001) and statistically significantly greater than CAL/BDP gel (42.7%, p = 0.0442). Patient‐reported psoriasis treatment convenience score (PTCS) for CAL/BDP PAD‐cream was rated superior to CAL/BDP gel at Week 8 (p < 0.0001) and the mean change in DLQI from baseline to Week 8 improved statistically significantly more in the CAL/BDP PAD‐cream group compared to both PAD‐cream vehicle (p < 0.0001) and CAL/BDP gel (p = 0.0110). Safety assessments during the trial demonstrated that CAL/BDP PAD‐cream was well‐tolerated. Conclusion: CAL/BDP PAD‐cream is a novel topical treatment of psoriasis that has a high efficacy and a favourable safety profile combined with a superior patient‐reported treatment convenience. [ABSTRACT FROM AUTHOR]

A trend (factors used for multivariate analysis, I p i < 0.20) was observed for females ( I p i = 0.09), younger age ( I p i = 0.11), history of psoriatic arthritis ( I p i = 0.12) and use of systemic treatments ( I p i = 0.07), including use of biologic therapies ( I p i = 0.17) (Table 1). Flares were defined as exacerbation of psoriasis within 1 month after the onset of SARS-CoV-2 infection. Psoriasis worsened within 1 month of infection in 25 (17.7%) children and 26 (17.5%) SARS-CoV-2-infections (Table 1). 1 TABLE Risk factors for psoriasis flares after SARS-CoV-2 infection. [Extracted from the article]

Background: Skin is a target organ and source of the corticotropin‐releasing hormone–proopiomelanocortin (CRH‐POMC) system, operating as a coordinator and executor of responses to stress. Environmental stress exacerbates and triggers inflammatory skin diseases through modifying the cellular components of the immune system supporting the importance of CRH‐POMC system in the pathogenesis of psoriasis. The aim of this study was to analyse the association of CRH‐POMC polymorphisms with psoriasis and evaluate transcript expression of lesional psoriatic and normal skin in RNA‐seq data. Methods: Samples of 104 patients with psoriasis and 174 healthy controls were genotyped for 42 single nucleotide polymorphisms (SNPs) of CRH‐POMC using Applied Biosystems SNPlex™ method. The transcript quantification was performed using Salmon software v1.3.0. Results: This study demonstrated the associations between melanocortin 1 receptor (MC1R) polymorphisms rs2228479, rs3212369, dopachrome tautomerase (DCT) polymorphisms rs7987802, rs2031526, rs9524501 and psoriasis in the Tatar population. Very strong association was evident for the SNP rs7987802 in the DCT gene (pc = 5.95е‐006) in psoriasis patients. Additionally, the haplotype analysis provided AT DCT (rs7992630 and rs7987802) and AGA MC1R (rs3212358, 2228479 and 885479) haplotypes significantly associated (pc ˂ 0.05) with psoriasis in the Tatar population, supporting the involvement of DCT and MC1R to the psoriasis susceptibility. Moreover, MC1R‐203 and DCT‐201 expression levels were decreased in psoriasis lesional skin compared with healthy control skin. Conclusions: This study is the first to identify genetic variants of the MC1R and DCT genes significantly associated with psoriasis in Tatar population. Our results support potential roles of CRH‐POMC system genes and DCT in the pathogenesis of psoriasis. [ABSTRACT FROM AUTHOR]

Background: Guselkumab is an interleukin (IL)‐23 inhibitor with demonstrated efficacy in patients with psoriasis. Objectives: Evaluate the impact of early disease intervention on clinical responses following 28 weeks of guselkumab treatment in patients with moderate‐to‐severe plaque psoriasis. Correlate clinical response and disease duration data with serum biomarker data. Methods: GUIDE is a phase IIIb randomized, double‐blind, parallel‐group, multicentre study of adults with moderate‐to‐severe plaque psoriasis. In study part 1, patients with a short disease duration (SDD [≤2 years]) or a long disease duration (LDD [>2 years]) received guselkumab 100 mg at Week (W) 0, 4, 12, and 20. Those achieving complete skin clearance at W20 and W28 were defined as a super responder (SRe). A multivariable logistic regression analysed the association between baseline factors and the likelihood of becoming an SRe. The relationship between clinical response, disease duration and serum biomarker data was assessed at W0 and 4. Results: In total, 880 patients were enrolled (SDD/LDD = 40.6%/59.4% of patients). More SDD than LDD patients achieved absolute Psoriasis Area and Severity Index (PASI) = 0 at W28 (51.8% vs. 39.4%) and were SRes (43.7% vs. 28.1% [overall 34.4%]). SDD patients also achieved PASI = 0 quicker than LDD patients (median 141 vs. 200 days). Disease duration and prior biologic use had the greatest impact on becoming an SRe, with no strong association among these independent variables. At baseline, there were no significant differences in the serum biomarker levels of IL‐17A, IL‐17F, IL‐22 and β‐defensin 2 between SDD and LDD patients, or between SRe and non‐SRe patients. Guselkumab rapidly decreased these markers of systemic inflammation across all patient groups analysed at W4. Guselkumab was well tolerated. Conclusions: Guselkumab efficacy was consistent across subpopulations, on the skin and systemically. The proportion of SRes was higher in SDD than LDD patients, indicating early treatment intervention may improve clinical outcomes. [ABSTRACT FROM AUTHOR]

Biologicals have transformed the management of severe disease phenotypes in psoriasis and are often prescribed in women of childbearing age. However, information on safety of biologicals in pregnancy are lacking. We conducted a systematic review and meta‐analysis aimed to describe the characteristics and pregnancy outcomes in women with psoriasis exposed to biologics within 3 months before or during pregnancy, and to estimate the pooled prevalence of spontaneous, elective and total abortions, and congenital malformations in their newborns. Bibliographic searches were performed in the PubMed, Embase, Scopus and Web of Science databases up to 14 April 2022. No restrictions on sample size or publication date were applied. Review performance complied with PRISMA guidelines, and two reviewers assessed randomized controlled trials and nonrandomized studies reporting pregnancy outcomes in women exposed to biologics indicated for psoriasis during the pre‐gestational and/or gestational period. Studies focusing on rheumatologic or gastroenterological immune‐mediated inflammatory diseases were excluded. Regardless of data heterogeneity, a random‐effects model was used to pool prevalence estimates. We included 51 observational studies, involving 739 pregnancies exposed to approved biologics for psoriasis. Administration was mostly (70.4%) limited to the first trimester, and the most common drug was ustekinumab (36.0%). The estimated prevalence of miscarriage was 15.3% (95% confidence interval [CI] 12.7–18.0) and elective abortions, 10.8% (95% CI 7.7–14.3). Congenital malformations occurred in about 3.0% (95% CI 1.6–4.8) of live births exposed to biologics during pregnancy. Altogether, exposure to biologics for psoriasis during pregnancy and/or conception does not seem to be associated with an increased risk of miscarriage/abortion or congenital malformations, showing similar rates to the general population. These results suggest that biologic drugs are safe and pose an acceptable risk to the foetuses/neonates. [ABSTRACT FROM AUTHOR]

Background: Tildrakizumab (TIL) is an interleukin (IL)‐23p19 inhibitor for the treatment of moderate‐to‐severe plaque psoriasis with long‐term efficacy and safety demonstrated in Phase III trials. Studies conducted in conditions closer to clinical practice are needed. Objectives: The TRIBUTE study (open‐label, Phase IV) assessed the efficacy and impact on health‐related quality of life (HRQoL) of TIL 100 mg in adult moderate‐to‐severe psoriasis patients (naïve to IL‐23/Th17 pathway inhibitors) in conditions similar to clinical practice. Methods: Key efficacy measure was Psoriasis Area Severity Index (PASI). HRQoL was evaluated using the Dermatology Life Quality Index (DLQI) and Skindex‐16. Additional patient‐reported outcomes included Pain‐, Pruritus‐ and Scaling‐Numerical Rating Scale (NRS), Medical Outcome Study (MOS)‐Sleep, Work Productivity and Activity Impairment (WPAI), Patient Benefit Index (PBI) and Treatment Satisfaction Questionnaire for Medication (TSQM). Results: One hundred and seventy‐seven patients were enrolled (six patients did not complete the study). After 24 weeks, the proportion of patients achieving PASI scores ≤ 3, PASI 75, PASI 90 and DLQI 0/1 was 88.4%, 92.5%, 74.0% and 70.4%, respectively. Skindex‐16 overall score improved (mean absolute change from baseline, MACB [95%CI]: −53.3 [−58.1, −48.5]). Significant benefits (MACB [95%CI]) were found on pruritus‐, pain‐ and scaling‐NRS scores (−5.7 [−6.1, −5.2], −3.5 [−4.1, −3.0] and −5.7 [−6.2, −5.2], respectively), MOS‐Sleep (−10.4 [−13.3, −7.4] Sleep problems Index II) and WPAI (−36.4 [−42.6, −30.2] activity impairment, −28.2 [−34.7, −21.7] productivity loss, −27.0 [−32.9, −21.1] presenteeism and −6.8 [−12.1, −1.5] absenteeism). 82.7% of patients reported PBI ≥ 3 and the mean (SD) global TSQM score was high (80.5 [18.5]). Only one serious treatment‐emergent adverse event was reported (not‐related to TIL). Conclusions: TIL 100 mg treatment after 24 weeks in conditions close to real clinical practice showed a quick and high improvement in psoriasis signs and HRQoL. Patient reported improvements in sleep outcomes and work productivity, relevant benefits and high treatment satisfaction. The safety profile was favourable and consistent with Phase III trials. [ABSTRACT FROM AUTHOR]

Background: Patients treated with systemics for moderate‐to‐severe psoriasis have increased risk of cardiovascular disease (CVD). However, to the best of our knowledge, there are no data on the association between clinical disease activity and future cardiovascular events in this population. Such data could help identify patients at increased CVD risk and inform the potential for CVD prevention with effective psoriasis treatment. Objective: To estimate the association between the Psoriasis Area and Severity Index (PASI) and cardiovascular events defined as hospitalization for CVD and cardiovascular death. Methods: We linked prospectively collected data on PASI and CVD risk factors to population‐based administrative data on hospitalizations and causes of death. We estimated the association between PASI and cardiovascular events using Cox proportional hazard models with PASI and Framingham 10‐year cardiovascular risk as time‐varying covariates. Results: A total of 767 patients with 6264 PASI scores were included. After adjusting for 10‐year cardiovascular risk and prior CVD, a one‐point increase in PASI was associated with a hazard ratio of 1.04 (95% CI: 1.01–1.07) for cardiovascular events. The findings were robust in sensitivity analyses. Conclusion: PASI is an independent marker for future cardiovascular events in patients with moderate‐to‐severe psoriasis. [ABSTRACT FROM AUTHOR]

Background: Psoriasis is associated with an increased mortality risk, with cardiovascular disease being the leading excess cause (in a dose–response manner with psoriasis severity). Statins have demonstrated a reduction in all‐cause mortality with no excess of adverse events among the general population. The underuse of interventions in cardiovascular prevention, such as statins, for patients with psoriasis may be the result of an insufficient evaluation. Objectives: To provide the dermatologist with a tool for systematizing the treatment of dyslipidemia in psoriasis, which generally escapes the scope of dermatological practice, and to facilitate decision‐making about the referral and treatment of patients. Methods: The Psoriasis Task Force of the European Academy of Dermatology and Venereology performed this two‐phase study to achieve a consensus and create recommendations on the use of statin therapy in patients with psoriasis. The first phase included a systematic review to identify a list of outline concepts and recommendations according to guidelines. The second phase consisted in a two‐round Delphi study to evaluate those recommendations not literally taken from guidelines. Results: A list of 47 concepts and recommendations to be followed by dermatologists involved in the treatment of patients with moderate–severe psoriasis was created. It included six main concepts about cardiovascular risk and psoriasis, six items related with the role of low‐density lipoprotein cholesterol (LDL‐c) and the benefits of statin treatment in psoriasis patients, eight recommendations about how cardiovascular risk should be assessed, three on the role of non‐invasive cardiovascular imaging, three on LDL‐c thresholds, eight key points related to statin prescription, 10 on statin treatment follow‐up and three on patient referral to another specialist. Conclusions: The application of this position statement (close final list of concepts and recommendations) will help dermatologists to manage dyslipidemia and help psoriasis patients to reduce their cardiovascular risk. [ABSTRACT FROM AUTHOR]

Background: Rapid skin improvement is a key treatment goal of patients with moderate‐to‐severe psoriasis (PsO). Objectives: To compare the speed of clinical improvement of approved biologics on the symptoms and signs of psoriasis assessed by patients using the validated Psoriasis Symptoms and Signs Diary (PSSD) through 12 weeks. Methods: Psoriasis Study of Health Outcomes (PSoHO) is an international, prospective, non‐interventional study that compares the effectiveness of anti‐interleukin (IL)‐17A biologics versus other biologics, together with pairwise comparisons of ixekizumab versus five individual biologics in patients with PsO. Using the PSSD 7‐day recall period, patients assessed the symptoms (itch, skin tightness, burning, stinging and pain) and signs (dryness, cracking, scaling, shedding/flaking, redness and bleeding) of their psoriasis (0–10). Symptom and sign summary scores (0–100) are derived from the average of individual scores. Percentage change in summary scores and proportion of patients with clinically meaningful improvements (CMI) in PSSD summary and individual scores are evaluated weekly. Longitudinal PSSD data are reported as observed with treatment comparisons analysed using mixed model for repeated measures (MMRM) and generalized linear mixed models (GLMM). Results: Across cohorts and treatments, eligible patients (n = 1654) had comparable baseline PSSD scores. From Week 1, the anti‐IL‐17A cohort achieved significantly larger score improvements in PSSD summary scores and a higher proportion of patients showed CMIs compared to the other biologics cohort through 12 weeks. Lower PSSD scores were associated with a greater proportion of patients reporting their psoriasis as no longer impacting their quality‐of‐life (DLQI 0,1) and a high level of clinical response (PASI100). Results also indicate a relationship between an early CMI in PSSD score at Week 2 and PASI100 score at Week 12. Conclusions: Treatment with anti‐IL‐17A biologics, particularly ixekizumab, resulted in rapid and sustained patient‐reported improvements in psoriasis symptoms and signs compared with other biologics in a real‐world setting. [ABSTRACT FROM AUTHOR]

Background: Anti‐drug antibodies (ADA) are formed in patients treated with adalimumab (ADL). This might increase clearance of ADL, potentially causing a (secondary) non‐response. Combination therapy of ADL and methotrexate (MTX) reduces ADA levels and has a clinical benefit in rheumatologic diseases. In psoriasis however, the long‐term effectiveness and safety have not been studied. Objectives: To investigate the three‐year follow‐up data of ADL combined with MTX compared to ADL monotherapy in ADL‐naive patients with moderate to severe plaque type psoriasis. Methods: We conducted a multicentre RCT in the Netherlands and Belgium. Randomization was performed by a centralized online randomization service. Patients were seen every 12 weeks until week 145. Outcome assessors were blinded. We collected data on drug survival, effectiveness, safety, pharmacokinetics and immunogenicity of patients that started ADL combined with MTX compared to ADL monotherapy. We present descriptive analysis and patients were analysed according to the group initially randomized to. Patients becoming non‐adherent to the biologic were excluded from analyses. Results: Sixty‐one patients were included and 37 patients (ADL group n = 17, ADL + MTX group n = 20) continued in the follow‐up study after 1 year. After 109 weeks and 145 weeks, there was a trend towards longer drug survival in the ADL + MTX group compared to the ADL group (week 109: 54.8% vs. 41.4%; p = 0.326, week 145: 51.6% vs. 41.4%; p = 0.464). At week 145, 7/13 patients were treated with MTX. In the ADL group, 4/12 patients that completed the study developed ADA, and 3/13 in the ADL + MTX group. Conclusions: In this small study, there was no significant difference in ADL overall drug survival when it was initially combined with MTX, compared to ADL alone. Discontinuation due to adverse events was common in the combination group. To secure accessible healthcare, combination treatment of ADL and MTX can be considered in individual patients. [ABSTRACT FROM AUTHOR]

This article explores the role of AU-binding factor 1 (AUF-1) in chronic inflammatory skin conditions such as atopic dermatitis (AD) and psoriasis. The study examines the expression of AUF-1 in skin biopsies of AD and psoriasis patients and investigates the modulation of AUF-1 in vitro using human keratinocyte cell cultures. The results show a different pattern of AUF-1 expression in AD compared to psoriasis, suggesting a potential role of AUF-1 in chronic immune-driven skin inflammation. The findings highlight the importance of understanding endogenous mechanisms involved in resolving AD and identifying new therapeutic targets. [Extracted from the article]