Background: The gold standard for diagnosing skin cancer is the skin biopsy. However, as an invasive method, the skin biopsy might be an uncomfortable process for individuals. Optical coherence tomography (OCT) is a non-invasive method capable of providing cross-sectional images of skin tissue. The intensity information in OCT images may encode information related to skin tissues. Thus, the purpose of this study is to explore the diagnostic ability of intensity-and gradient-based parameters with OCT in the diagnosis of skin cancers. Methods: This study involved 5 patients with amelanotic melanomas (AM), 8 patients with basal cell carcinoma (BCC), 4 subjects with pigment nevi, and 3 normal subjects. The cross-sectional images were collected using the customized spectral domain OCT (SD-OCT). For each subject, 5 OCT images were used. From the OCT images, 10 intensity-and gradient-based features, and 5 texture features were calculated. Analyses of variance and receiver operating characteristics were utilized to analyze the diagnostic performances of features between study groups. Results: The mean of gradients showed the highest accuracy in differentiating BCC from normal skin tissue [area under receiver operating characteristic (AUROC) =0.932, sensitivity =1.000, specificity =0.775]. The variance of gradient showed high diagnostic performance (AUROC =0.719, sensitivity =0.700, specificity =0.875) to differentiate BCC from nevi. The highest accuracy was achieved by using the skewness of gradient for distinguishing AM from nevi (AUROC =0.828, sensitivity =0.750, specificity =1.000). Moreover, in differentiating AM from BCC, the skewness and kurtosis of intensity and gradient demonstrated high diagnostic performances. The highest accuracy was achieved by using the skewness and kurtosis of intensity (AUROC =0.900, sensitivity =0.875, specificity =1.000). Conclusions: Our findings have suggested that intensity-and gradient-based features could capture subtle interface irregularities and optical homogeneity for classifying skin cancers.
BackgroundSSGJ-608 is an anti-interleukin-17A monoclonal antibody with high specificity and high affinity and has shown promising efficacy in treatment of moderate-to-severe psoriasis in preliminary trials.ObjectiveThis multicenter, randomized, open-label, phase 3 trial aimed to further evaluate SSGJ-608 at different dosing intervals (80mg every two weeks and 160mg every four weeks) in patients with moderate-to-severe plaque psoriasis.MethodsA total of 770 patients with moderate to severe plaque psoriasis were randomly assigned (1:1) to receive subcutaneous injections of 80mg of SSGJ-608 every two weeks (Q2W) after a starting dose of 160mg at week 0(608A group), or 160mg of SSGJ-608 every four weeks (Q4W) (608 B group) for 12 weeks. Efficacy was assessed by PASI75 and sPGA 0 or 1 response rates at week 12 as co-primary endpoints, and proportion of patients who achieved PASI90, PASI100 or sPGA score of 0 at week 12 as secondary endpoints. The safety profile was also evaluated.ResultsAt week12, the proportions of patients achieving PASI75 (92.7% vs. 95.1%) and sPGA 0/1 (80.3% vs. 79.0%) were comparable between the two SSGJ-608 dose regimens. The PASI90, PASI100 and sPGA 0 response rates were 81.0% vs.82.3%, 49.4% vs. 47.5%, and 49.4% vs.47.3% in the 608A group and the 608B group, respectively. In the subgroup of patients previously treated with anti-IL-17 therapy, SSGJ-608 also achieved high clinical response rates at week12. The most common TEAEs were hypertriglyceridemia, upper respiratory tract infection, hyperuricemia, increased alanine aminotransferase and hypercholesterolemia. Both treatment groups demonstrated a favorable safety profile and no new safety signals were identified.ConclusionsSSGJ-608 was highly effective for treating patients with moderate-to-severe plaque psoriasis at 80mg Q2W and 160mg Q4W in a larger population, especially in patients previously treated with anti-IL-17 therapy, and exhibited a favorable tolerability profile in Chinese patients with moderate-to-severe plaque psoriasis.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT06299982.
BackgroundAtopic dermatitis (AD) is a common inflammatory skin disease influenced by multiple factors such as genetic, environmental and lifestyle factors. This study explored the association between smoking and AD.MethodsThe China Atopic Dermatitis Registry (ChinaSTAD) is a nationwide observational registry of patients with moderate to severe AD in China. We conducted a cross-sectional analysis of adult patients enrolled from July 2021 to April 2023 across 26 provinces. Patients were categorized as ever-smokers or non-smokers based on smoking history. Propensity scores were estimated using demographic and socioeconomic covariates, with 1:1 nearest neighbor matching applied. Associations between smoking status and clinical/patient-reported outcomes were evaluated using linear regression models with robust standard errors. Sensitivity analyses were performed by comparing results from unmatched, matched and doubly robust approaches.ResultsAfter propensity scores matching, baseline characteristics were well-balanced. In the doubly robust analyses, smoking was associated with greater body surface area (BSA) values (adjusted mean difference 2.29, 95% CI 0.22–4.36), and showed a weak association with Patient Oriented Eczema Measure (POEM) scores (adjusted mean difference 0.59, 95% CI −0.00 to 1.19). In contrast, no clear association was found between smoking and other patient-reported outcomes and quality of life indicators. Sensitivity analysis showed that effect estimates varied across strategies and were generally attenuated after doubly robust adjustment.ConclusionIn this study, smoking was associated with BSA, but with weak or no association with disease severity, clinical phenotype or quality of life scores. Further prospective studies are required to clarify the relationship between smoking and AD.
BACKGROUND:We conducted a phase IIb clinical trial of pumecitinib 3% gel (PG-011), a novel selective Janus kinase (JAK)1/2 inhibitor, applied topically to treat mild-to-moderate atopic dermatitis (AD). OBJECTIVES:To assess pumecitinib 3% gel for its efficacy and safety in treating adult patients with mild-to-moderate AD, and to determine the optimal treatment regimen. METHODS:In this study, 139 participants with mild-to-moderate AD were randomized 1 : 1 : 1 to pumecitinib 3% gel twice daily (n = 47), pumecitinib 3% gel once daily (n = 46) and placebo (n = 46) for 8 weeks of treatment. Percentage change in Eczema Area and Severity Index (EASI) score from baseline to week 8 was the primary efficacy endpoint. The percentage of participants with an Investigator's Global Assessment score of 0 or 1 (≥ 2-point improvement from baseline) at week 8, the proportion of participants attaining ≥ 50% improvement in EASI (EASI 50), ≥ 75% improvement in EASI (EASI 75) and ≥ 90% improvement in EASI (EASI 90) at week 8, and improvement in quality of life were also evaluated. Safety, local tolerability and some pharmacokinetics were monitored. RESULTS:At week 8, the percentage change from baseline in EASI score in the pumecitinib 3% gel twice daily, pumecitinib 3% gel once daily and placebo groups was -83.6%, -44.0% and -22.0%, respectively. Both pumecitinib treatment regimens showed a significantly greater effect compared with placebo (P < 0.006) and the pumecitinib 3% gel twice-daily regimen had a greater effect than once-daily treatment (P < 0.001). Other efficacy endpoints were also improved in participants in the pumecitinib groups vs. those in the placebo group, and pumecitinib 3% gel twice daily consistently exhibited better efficacy than the once-daily treatment. With regard to safety, the rate of adverse events in the pumecitinib and placebo groups was 48% and 48%, respectively. Safety profiles were generally similar between the pumecitinib and placebo groups, and treatment was well tolerated. Mean plasma drug concentrations were low (range 38-104 pg mL-1) over the 8-week treatment period. CONCLUSIONS:Pumecitinib 3% gel showed good efficacy and safety profiles in the treatment of adults with mild-to-moderate AD. The pumecitinib 3% twice-daily treatment regimen showed greater efficacy than the once-daily regimen in treating mild-to-moderate AD. Pumecitinib 3% gel was well tolerated and generated low systemic drug exposure when used topically. It may be a new choice of topical JAK inhibitor to treat mild-to-moderate AD.
Necroptosis is a novel programmed cell death that affects the tumor heterogeneity, microenvironment, and prognosis, which is not well elucidated in skin cutaneous melanoma (SKCM). The SKCM-TCGA, GSE65904, and GSE215120 datasets were downloaded from the TCGA and GEO databases, respectively. The necroptosis-related genes were identified by weighted co-expression network analysis (WGCNA) and single-cell sequencing analysis. COX and LASSO regression was used to construct the prognostic model. Survival analysis, immune infiltration analysis, and tumor mutation analysis between the high-necroptosis score (NCPTS) and low-NCPTS groups were performed. Finally, real-time PCR experiment was carried out to verify the results. A prognostic model based on 9 necroptosis-related genes (TUFM, CD53, CLEC2D, KLRC1, STAT4, IFI35, XCL1, TAPBP, and SOD2) was constructed to predict the prognosis of SKCM patients. The patients in high-NCPTS group had a poor prognosis. The expression of immune checkpoint-related gene and drug sensitivity were higher than those in the low-NCPTS groups, indicating susceptible for immunotherapy. Real-time PCR showed that TUFM expression was significantly higher in A375 cells than control (P < 0.05). Besides, TUFM expression was also validated by TISCH and HPA database. The prognostic model might provide guidance for the prognosis and immunotherapy for SKCM patients, contributing to a better understanding of necroptosis in SKCM.
Background:Surgical removal is the primary method for the clinical treatment of ear keloids. However, there are numerous surgical options available, and no standardized approach in the literature. Objectives:This study aimed to evaluate the impact of five-blade core excision on the removal of ear keloids. Methods:A preliminary study involving 11 patients (21 lesions) with ear keloids was conducted between January 2023 and December 2023. Five-blade core excision was performed; superficial electron beam radiotherapy was administered at a dose of 4 Gy for 5 post-operative consecutive days, and pressure clips were applied for 6 months. The Vancouver Scar Scale (VSS) and the Patient and Observer Scar Assessments Scale (POSAS) were used to assess the results. Results:The mean age of the patients was 24.36 years (18-44 years). Postoperative follow-up ranged from 20 months. The patients underwent 5 days of postoperative radiotherapy and pressure clips for 6 months. Nine patients had no recurrence, whereas two patients had a mild recurrence (one patient rejected radiotherapy). The VSS and POSAS scores significantly decreased (p < 0.01). Conclusion:Five-blade core excision combined with pressure and superficial electron beam radiotherapy demonstrates effective therapeutic outcomes for ear keloid.
In China, real-world evidence on the burden and management of moderate-to-severe atopic dermatitis (AD) is needed. The ChinaSTAD study aimed to characterise the treatment and disease and health economic burden of patients with moderate-to-severe AD uncontrolled on topical therapy in China. The ChinaSTAD national prospective registry study enrolled individuals aged ≥ 12 years with AD, with a SCORing Atopic Dermatitis (SCORAD) score of ≥ 25, at participating hospitals. At baseline (enrolment visit), clinical status (SCORAD, Patient-Oriented Eczema Measure [POEM], Peak Pruritus Numerical Rating Scale [PP-NRS], Atopic Dermatitis Control Tool [ADCT]), health-related quality of life (Dermatology Life Quality Index [DLQI] and Children’s DLQI [CDLQI]), AD treatment, and healthcare resource use in the previous year, were evaluated. Costs were estimated from the patient’s perspective. Baseline visit data are reported here for the subgroup of patients who had not received prior systemic AD therapy continuously up to the point of study enrolment. Data are expressed as mean ± standard deviation unless stated otherwise. Of 2962 patients enrolled at data cut-off (31 October 2022), 2550 were included in this analysis (aged 40.2 ± 21.0 years). The baseline SCORAD was 54.4 ± 15.7; 85.6
Introduction:Nail psoriasis is a common, treatment-refractory manifestation of psoriasis. Smoking is a key environmental factor implicated in nail and articular psoriasis. While smoking's association with cutaneous psoriasis is well-studied, its relationship with nail psoriasis remains less explored. Objective:The primary objective of this study was to investigate the impact of smoking on the severity of nail psoriasis and arthritic psoriasis in patients with nail psoriasis. Methods:Data from 1044 nail psoriasis patients within a population-based registry in China were analyzed. We assessed associations of smoking status and intensity with sociodemographics, disease severity and dermatology quality of life measures (including PASI, BSA, DLQI, and PEST scores), and PsA diagnosis. Analyses used SPSS 29.0; p < 0.05 defined significance. Results:The current smoking rate among patients with nail psoriasis is 34.6%, which is much higher than the current smoking rate among patients without nail psoriasis (20.2%). The proportions of the three different smoking intensities are also much higher than those among patients without nail psoriasis. Current smoking affects the total nail involvement count in patients with nail psoriasis, and severe smoking affects both the total nail involvement count and the nails with > 90% area involvement count in these patients. However, we found that smoking intensity was negatively correlated with DLQI scores in nail psoriasis, which is contrary to previous studies on plaque psoriasis. Spearman's correlation analysis revealed that smoking intensity and smoking index were positively associated with total nail involvement count and individual nails > 90% with area involvement count. In the regression analysis for PSA, the OR for current smokers was 0.57 (95% CI: 0.35-0.92) compared to non-smokers, and the OR for severe smokers was 0.37 (95% CI: 0.15-0.90) compared to mild smokers. Conclusion:Patients with nail psoriasis have higher smoking rates and smoking intensity compared to those without nail psoriasis. The total nail involvement count was higher in current smokers than in non-smokers. Smoking intensity was positively associated with total nail involvement count and individual nails with > 90% area involvement count. Current smoking was a negative associated factor for PEST risk level. Both current smoking and severe smoking were negative associations with the presence of psoriatic arthritis.
Alopecia areata (AA) is a common non-scarring hair loss condition whose specific pathogenesis is not yet fully understood. In children, AA often co-occurs with atopic dermatitis (AD), complicating treatment. Here, we report the case of a child with myasthenia gravis who had severe AA and moderate AD. The child had previously been treated with local injections of corticosteroids and developed total hair loss and AD after discontinuing corticosteroid use. After approximately one year of treatment with baricitinib, 4 mg once daily, combined with twice-daily application of a corticosteroid ointment, a significant improvement in the child's condition was observed, with the Severity of Alopecia Tool score dropping from 100 to 24.4 and Eczema Area Severity Index score to 0. New vellus hairs were clearly observable under trichoscopy, which contrasted significantly with the pre-treatment state. Throughout the treatment process, the patient's clinical symptoms, blood cell counts, liver and kidney function, and coagulation functions were essentially normal, with no significant adverse reactions observed except for folliculitis on the scalp. We discuss common targets in the pathogenesis of AA and AD as well as the safety and prospects of Janus kinase inhibitors for the treatment of pediatric patients with these conditions.
There are several comorbidities associated with psoriasis, including genetic disorders such as hereditary hemochromatosis, which can lead to organ damage secondary to iron overload. Herein, we report the case of a 38-year-old Chinese man with hereditary hemochromatosis who received secukinumab for the treatment of severe psoriasis. Follow-up after 3 months showed that the patient’s lesions had almost resolved and remained well-controlled for 2 years without any reported side effects. Patients with psoriasis and hereditary hemochromatosis have limited treatment options due to the effects of iron overload on the liver, particularly because it may increase the risk of hepatocellular carcinoma. Interleukin-17A (IL-17A) inhibitors, such as the secukinumab used in this case, may benefit these patients.
Having psoriasis in hard-to-treat areas, such as the scalp, face, palms, soles, nails, and genitals, can suffer from a reduced quality of life. This study was designed to investigate the prevalence and risk factors of hard-to-treat body locations of psoriasis, and to describe patients’ clinical and demographic characteristics, and quality of life impacts. We conducted a multicenter observational epidemiological study involving over 1000 hospitals in China, enrolling a total of 7032 psoriasis patients. Groups were compared to patients without involvement of hard-to-treat areas. The most frequently affected hard-to-treat area was the scalp (60.01
Purpose:The purpose of this study was to investigate the comprehensive impact of family history of psoriasis, lesion size, disease severity, and the possibility of joint involvement on patients' quality of life(QoL).Patients and Methods:Data from 5961 patients with psoriasis recruited from 440 hospitals throughout China were analyzed. The effects of family history of psoriasis, Body Surface Area(BSA), Psoriasis Area and Severity Index(PASI), and Psoriasis Epidemiology Screening Tool(PEST) on their Dermatology Life Quality Index(DLQI) were studied using a moderated chained mediated effects test.Results:A total of 912 patients (15.30%) had a family history of psoriasis, and 5071 patients (85.10%) had plaque psoriasis. In patients with plaque psoriasis, the variables of family history, PASI, PEST, and DLQI were positively correlated with each other. Additionally, in patients with other types of psoriasis, PASI was positively correlated with PEST and DLQI. Age was positively correlated with PASI and PEST and negatively correlated with DLQI in patients with plaque psoriasis; their Body Mass Index(BMI) and disease duration were in positive correlation with PASI and PEST. The mediation effect of PASI and PEST between family history and DLQI was remarkable in patients with plaque psoriasis and not in those with other types of psoriasis. BSA moderated the association between family history and PASI in patients with plaque psoriasis.Conclusion:PASI and PEST play a chain mediating role in the relationship between family history and DLQI in patients with plaque psoriasis, and high levels of BSA increase the ability of family history to positively predict PASI in plaque psoriasis, thereby affecting the patient's QoL.
BACKGROUND:Psoriasis is a persistent inflammatory skin condition driven by an immune response and influenced by both genetic and environmental factors. The high likelihood of disease recurrence has been a major concern for many patients, while the concurrent presence of other conditions has significantly impacted their quality of life. OBJECTIVE:To improve early detection of and treatment for patients by studying the epidemiological characteristics of patients with psoriasis in China. METHODS:The Psoriasis Real-World Big Data Collection Platform was initiated by the National Skin and Immune Diseases Clinical Medical Research Center (Beijing First Hospital of Peking University) in August 2020. During the period from August 2020 to June 2022, a total of 1012 hospitals across the nation participated in data entry. This article presents an epidemiological feature analysis based on the real case questionnaire survey form collected over the past 2 years. RESULTS:The prevalence of psoriasis is highest among young and middle-aged men, affecting largely the skin area. Factors such as smoking, obesity, and family history are likely to influence disease onset. In this study's data, the limbs and trunk were the most common sites for psoriasis onset, with cardiovascular disease being the most prevalent comorbidity. Topical corticosteroid creams are frequently used in treatment by Chinese patients, along with a notable proportion opting for oral Chinese medicine for systemic treatment. Secukinumab is the primary choice when utilizing biological agents. CONCLUSION:The actual data of patients with psoriasis from 2020 to 2022 offer crucial insights into the disease progression among the Chinese psoriasis population in recent years. Through an analysis of patient characteristics and treatment modalities, it furnishes valuable guidance for the prevention, early detection, and management of psoriasis.
Ixekizumab, a monoclonal antibody against interleukin-17A, demonstrated effectiveness in the treatment of psoriasis in a Chinese real-world study that was consistent with previous randomized controlled trials. Here, we report further analyses from this study to explore the effectiveness of ixekizumab for treating patients with psoriasis and the involvement of special body areas (scalp, nail, joint, palmoplantar, or genital areas). A multicenter, prospective, observational, single-arm, post-marketing surveillance study was conducted in patients aged ≥ 18 years with moderate-to-severe plaque psoriasis and prescribed with ixekizumab in 26 Chinese hospitals. Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores were compared between patients with versus without psoriasis in special body areas in the overall study population and across subgroups by body area. In total, 612 patients were included. At baseline, most patients (93.6
Anoikis is considered strongly associated with a biological procession of tumors. Herein, we utilized anoikis-related genes (ARGs) to predict the prognosis and immunotherapeutic efficacy for skin cutaneous melanoma (SKCM). RNA-seq data were obtained from The Cancer Genome Atlas and Gene Expression Omnibus databases. After dividing patients into novel subtypes based on the expression of prognostic ARGs, K-M survival was conducted to compare the survival status. Subsequently, differentially expressed ARGs were identified and the predictive model was established. The predictive effects were validated using the areas under the curve about the receiver operating characteristic. Moreover, tumor mutation burden, the enriched functional pathway, immune cells and functions, and the immunotherapeutic response were also analyzed and compared. The distribution of model genes at cell level was visualized by the single-cell seq with tumor immune single-cell hub database. Patients of The Cancer Genome Atlas-SKCM cohort were divided into 2 clusters, the cluster 1 performed a better prognosis. Cluster 2 was more enriched in metabolism-related pathways whereas cluster 1 was more associated with immune pathways. A predictive risk model was established with 6 ARGs, showing the areas under the curves of 1-year, 3-year, and 5-year ROC were 0.715, 0,720, and 0.731, respectively. Moreover, risk score was negatively associated with tumor mutation burden and immune-related pathways enrichment. In addition, patients with high-risk scores performed immunosuppressive status but the decreasing scores enhanced immune cell infiltration, immune function activation, and immunotherapeutic response. In this study, we established a novel signature in predicting prognosis and immunotherapy. It can be considered reliable to formulate the complex treatment for SKCM patients.
IntroductionPsoriasis, a chronic inflammatory skin disease, is believed to be influenced by both genetic and environmental factors. Despite this understanding, the clinical epidemiological status of psoriasis patients with a family history of the disease remains uncertain.MethodsIn this study, we participated in a multicenter observational epidemiological study involved over 1,000 hospitals and enrolled a total of 5,927 psoriasis patients. These patients were categorized into two groups based on the presence or absence of a family history of psoriasis: family history cases (896) and sporadic cases (5,031). The clinical manifestations of these two groups were analyzed through clinical classification, comorbidities, treatment response, and other relevant factors.ResultsThe findings of our study indicate that individuals with a family history of psoriasis predisposition exhibit a notably elevated prevalence of psoriatic arthritis compared to those with sporadic occurrences. Moreover, patients with a family history of psoriasis display a more rapid and efficacious response to secukinumab. Additionally, individuals with moderate to severe psoriasis are at a heightened risk of developing cardiovascular and liver diseases in comparison to those with mild psoriasis, with no discernible impact of familial history on the likelihood of comorbidities.DiscussionOur study identified the clinical characteristics of individuals with a familial predisposition to psoriasis, offering novel insights into the management and therapeutic approaches for patients with this condition.
BACKGROUND:Coronavirus disease 2019 (COVID-19) affects different organ systems, including the skin. A retrospective analysis of skin manifestations in Chinese outpatient and inpatient settings is lacking. The study aims to analyze cutaneous manifestations in COVID-19 patients and the recurrence or aggravation of previous skin diseases. MATERIALS AND METHODS:A retrospective cross-sectional study was conducted from November 2022 to July 2023 in a university hospital in eastern China. It involved reverse transcriptase polymerase chain reaction (RT-PCR)-positive COVID-19 patients, documenting various skin manifestations and the recurrence or aggravation of pre-existing skin conditions. The pattern of skin lesions and other variables were assessed. RESULTS:The study included 303 patients, with 127 males and 176 females. Maculopapular rash was the predominant new cutaneous manifestation (54.92%), mainly in middle-aged individuals. Other findings included urticaria (16.39%), herpes zoster (11.89%), and herpes simplex (4.10%), vesicular rashes (2.46%), purpura (2.05%), erythema multiforme (1.64%), livedo reticularis (0.41%) and so on. Severe disease was associated with herpes zoster and livedo reticularis. Critical COVID-19 cases were linked to vesicular rashes, purpura, and erythema multiforme. The mean time for skin lesion emergence post-infection varied from 3 days for seborrheic dermatitis to 17.48 days for herpes zoster. Vasculitic manifestations correlated with elevated D-dimer levels. A total of 59 cases (19.47%) of recurrent or aggravated skin diseases were reported following infection with COVID-19, with dermatitis being the most common, followed by acne and folliculitis, psoriasis, urticaria, bullous pemphigoid, pemphigus, tinea corporis and androgenetic alopecia. CONCLUSION:The cutaneous phenotypes delineated in this study expand the dermatologic spectrum associated with COVID-19. Cutaneous manifestations may result from overactive immune responses, complement activation, and microvascular damage. Herpes zoster typically occurs in elderly COVID-19 patients with weaker immune systems or more severe diseases. Purpura and livedo reticularis, although rare, may indicate disease severity. It is possible to predict the course of COVID-19 with different severity through cutaneous manifestations. Recognizing these skin manifestations could aid in predicting COVID-19 severity and guide dermatologists in managing the pandemic response.
Objective: Erythroderma is an uncommon and severe skin disorder with many underlying causes and identifying its etiology can facilitate further treatments. This study was performed to evaluate the clinical profile and etiology of erythroderma. Methods: We collected the data on 136 patients diagnosed with erythroderma with respect to the epidemiological, clinical, biological, and histological data, treatments, and outcomes in The First Affiliated Hospital of Ningbo University from 2011 to 2021. The analyses of qualitative data were performed with the chi-square test or Fisher’s exact test. The groups of quantitative data were compared using a t-test or analysis of variance. Results: The patients’ mean age in this study was 65.00 ± 16.51 years, with a male:female ratio of 5.8:1.0. Acute onset occurred in 27 patients (19.9%) and was associated with drug reactions (P = 0.002). The mean length of stay was 19.18 ± 9.75 days. Clinical characteristics were dominated by pruritus (135, 99.3%), fever (44, 32.4%), edema (82, 60.3%), nail changes (14, 10.3%), arrhythmia (16, 11.8%), and superficial lymphadenopathy (57, 41.9%). Combined with biopsy, history inquiry and laboratory testing, this study found that most common causative factor was pre-existing dermatoses (107, 78.7%), followed by drug reactions (15, 11.0%), malignancies (8, 5.9%), and undetermined etiology (6, 4.4%). Among the pre-existing dermatoses, eczema was the most common etiology (33.9%). We also found that psoriasis, solar dermatitis, hypereosinophilic syndrome, atopic dermatitis, scabies, pemphigus foliaceus, and pityriasis rubra pilaris were causes of erythroderma. In the drug-induced group, anticonvulsants were the most frequently implicated drug. Compared to other cause diseases, patients with psoriasis had a significant higher rate of fever (P = 0.022), nail changes (P < 0.001), arthralgia (P < 0.001), and infection (P = 0.007). Eosinophilia and an increased immunoglobulin E concentration were associated with hypereosinophilic syndrome (P = 0.005) and eczema (P = 0.032), respectively compared to other cause diseases. The infection rate was significantly higher in patients with abnormal liver function compared to the patients with normal liver function (P < 0.001). Conclusion: Most of the clinical features of erythroderma are unspecific with the exception of fever, nail changes, and arthralgia, which were mostly found in patients with psoriasis. Clinicohistopathological examination helps to establish the etiology of erythroderma and reminder doctors to focus on high-risk populations.
Ixekizumab, a monoclonal antibody against interleukin-17A, is efficacious and well tolerated for the treatment of moderate-to-severe plaque psoriasis. However, there are limited data on the real-world safety of ixekizumab in Chinese patient populations. We performed an observational study of ixekizumab for the treatment of moderate-to-severe plaque psoriasis in routine clinical practice in China. Here we present a further safety analysis of this study. In this prospective, observational, single-arm, multicenter, post-marketing safety study, adults (≥18 years) with moderate-to-severe plaque psoriasis receiving ixekizumab were enroled at dermatology departments in hospitals across China and prospectively followed for 12 weeks or until their last dose of ixekizumab. In this analysis, we evaluated adverse events (AEs) of special interest (AESIs) identified using MedDRA® search strategies. We also analyzed AEs and AESIs occurring in greater than ten patients in subgroups by age (< 65/≥ 65 years), sex, body weight (< 60/60 kg to < 80/≥ 80 kg), renal impairment, hepatic impairment, history of tuberculosis, history of HBV infection, recent or active infection, history of allergic reaction/hypersensitivity, and number (0–1/2–4/5–7) of ixekizumab 80 mg injections after baseline until day 105. This analysis included 663/666 patients enrolled in the primary study. At least one AESI was reported in 224 (33.8