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BACKGROUND: Kerion is a severe type of tinea capitis that is difficult to treat and remains a public health problem. OBJECTIVES: To evaluate the epidemiologic features and efficacy of different treatment schemes from real-world experience. METHODS: From 2019 to 2021, 316 patients diagnosed with kerion at 32 tertiary Chinese hospitals were enrolled. We analysed the data of each patient, including clinical characteristics, causative pathogens, treatments and outcomes. RESULTS: Preschool children were predominantly affected and were more likely to have zoophilic infection. The most common pathogen in China was Microsporum canis. Atopic dermatitis (AD), animal contact, endothrix infection and geophilic pathogens were linked with kerion occurrence. In terms of treatment, itraconazole was the most applied antifungal agent and reduced the time to mycological cure. A total of 22.5% of patients received systemic glucocorticoids simultaneously, which reduced the time to complete symptom relief. Furthermore, glucocorticoids combined with itraconazole had better treatment efficacy, with a higher rate and shorter time to achieving mycological cure. CONCLUSIONS: Kerion often affects preschoolers and leads to serious sequelae, with AD, animal contact, and endothrix infection as potential risk factors. Glucocorticoids, especially those combined with itraconazole, had better treatment efficacy.
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Antifúngicos , Itraconazol , Microsporum , Tiña del Cuero Cabelludo , Humanos , Preescolar , Antifúngicos/uso terapéutico , Masculino , Femenino , Tiña del Cuero Cabelludo/tratamiento farmacológico , Tiña del Cuero Cabelludo/epidemiología , Tiña del Cuero Cabelludo/microbiología , Itraconazol/uso terapéutico , China/epidemiología , Microsporum/aislamiento & purificación , Niño , Lactante , Glucocorticoides/uso terapéutico , Resultado del Tratamiento , Dermatitis Atópica/tratamiento farmacológico , Dermatitis Atópica/epidemiología , Dermatitis Atópica/microbiología , Factores de Riesgo , Adolescente , Adulto , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
BACKGROUND: Data on nail psoriasis (PsO) in China are scarce. OBJECTIVES: To provide nail PsO-related data regarding epidemiologic characteristics, manifestations, fungal infections, arthritic complaints and treatments that may facilitate improved patient management globally. METHODS: From August 2021 to August 2022, patients with nail PsO were enrolled in a prospective multicentre observational study at 25 hospitals in China. We collected and analysed data concerning nail PsO demography, clinical signs, fungal detection, arthritic symptoms and treatment. RESULTS: A total of 817 patients with nail PsO were involved, with a mean body mass index of 24.13 ± 2.93. In addition, 71.41% of the patients were male. The Nail PsO Severity Index score was weakly positively correlated with body surface area. The percentage of nail involvement was 95.29% for fingernails and 57.18% for toenails, with pitting (67.11%) and subungual hyperkeratosis (60.40%) being the most prevalent manifestations, respectively. Toenails showed a significantly higher frequency of nailfold scales, subungual hyperkeratosis and nail plate crumbling and a lower frequency of splinter haemorrhages, pitting and erythema of the lunula. A total of 13.26% of the PsO patients had onychomycosis, and 77.08% were observed in the toenails. Articular symptoms were reported by 12.17% of the patients, with the peripheral type being predominant. Significant associations between articular symptoms and nailfold swelling, subungual hyperkeratosis, nailfold scales, onycholysis and longitudinal ridges were found. Only 2.30% (20 out of 871) of patients with nail PsO received treatment. The most frequently employed therapy for cutaneous PsO with nail involvement was biologic therapy (n = 366). CONCLUSIONS: PsO showed distinct manifestations in the toenails and fingernails. Additionally, toenail PsO combined with onychomycosis requires special attention. Articular symptoms in psoriatic patients are associated with specific nail changes. It is important to research and advocate for more potent treatments for nail PsO.
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Enfermedades de la Uña , Onicomicosis , Psoriasis , Humanos , Masculino , Femenino , Onicomicosis/diagnóstico , Estudios Prospectivos , Enfermedades de la Uña/diagnóstico , Psoriasis/epidemiología , Psoriasis/terapia , Psoriasis/complicaciones , China/epidemiologíaRESUMEN
OBJECTIVES: To investigate the current etiological, diagnostic, and therapeutic characteristics of tinea capitis in children in Jilin Province. METHODS: Sixty pediatric patients with tinea capitis were enrolled between August 2020 and December 2021. Data on calcofluor white (CFW) fluorescence microscopy, fungal culture, Wood's lamp examination, dermoscopy, treatment, and follow-up were collected and analyzed. RESULTS: 1. Of all the enrolled patients, 48 had a history of animal contact, mostly with cats and dogs. Fifty-one strains were isolated, of which 46 were Microsporum canis (M. canis). 2. All enrolled patients were examined using fluorescence microscopy, and 59 were positive. Forty-one cases of tinea alba were examined using Wood's lamp, and 38 were positive. Forty-two cases of tinea alba were examined using dermoscopy, and 39 demonstrated specific signs. Effective treatment manifested as a fading bright green fluorescence, decreased mycelial/spore load, reduced specific dermoscopic signs, and hair regrowth. 3. Treatment was terminated in 23 and 37 cases based on mycological and clinical cures, respectively. No recurrence occurred during follow-up. CONCLUSION: 1. M. canis is the predominant pathogen causing tinea capitis in children in Jilin Province. Animal contact is considered the main risk factor. 2. CFW fluorescence microscopy, Wood's lamp, and dermoscopy can be used to diagnose ringworms and follow-up patients. 3. Both mycological and clinical cures can be the endpoint of adequate treatment for tinea capitis.
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Tiña del Cuero Cabelludo , Tiña , Humanos , Niño , Animales , Gatos , Perros , Tiña del Cuero Cabelludo/diagnóstico , Tiña del Cuero Cabelludo/epidemiología , Tiña del Cuero Cabelludo/tratamiento farmacológico , Microsporum , Cabello/microbiologíaRESUMEN
INTRODUCTION: Pulsed dye laser (PDL) is the main treatment for port wine stain (PWS), but a considerable number of patients show low clearances. The reason for the poor efficacy is related to PDL-induced angiogenesis. Vascular endothelial growth factor (VEGF) plays an important role in PDL-induced angiogenesis and can activate the tyrosine kinase activity of VEGF receptor (VEGFR) in endothelial cells. It triggers a full range of responses, and then participates in the regulation of angiogenesis. Tivozanib is an inhibitor of VEGFR tyrosine kinase activity, which can block the pro-angiogenic effect of VEGF and reduce vascular permeability. METHOD: Different energy densities of PDL were used to irradiate the abdominal skin of rats. According to the general and pathological changes of the irradiated area, the energy density of 8 J/cm2 with smaller scab and stronger vascular effect was selected for follow-up experiments. Divided the rat abdomen skin into four areas, irradiated three of them uniformly with an energy density of 8 J/cm2 , and applied different concentrations of Tivozanib coating agent to the laser irradiation area, and grouped them as follows: (1) vacant group, (2) control group, (3) 0.5% Tivozanib group, (4) 1% Tivozanib group. Camera and dermoscopy were used to observe skin changes. Hematoxylin-eosin staining, immunohistochemical staining, and blood vessels were counted to detect dermal vascular regeneration. Transcriptome sequencing and real-time polymerase chain reaction (PCR) were conducted to elucidate the mechanism and validate the reliability. RESULTS: The number of blood vessels in the 0.5% Tivozanib group and 1% Tivozanib group was significantly reduced on the 7, 10, and 14 days compared with the control group. The number of blood vessels in the 1% Tivozanib group was significantly reduced compared with the 0.5% Tivozanib group, indicating that Tivozanib successfully inhibited PDL-induced angiogenesis, and the inhibitory effect of 1% Tivozanib was more significant than that of 0.5% Tivozanib. Transcriptome sequencing results showed a total of 588 significantly differentially expressed genes, including 90 upregulated genes and 498 downregulated genes. Gene ontology (GO) and kyoto encyclopedia of genes and genomes (KEGG) enrichment analysis showed that the significantly differentially expressed genes were mainly enriched in the metabolic pathways which were closely related to angiogenesis. Finally, real-time PCR was used to verify the genes with higher expression differences, the top ranking and closely related to angiogenesis, namely, Cxcl1, Cxcl2, Cxcl3, Cxcl6, Ccl3, Csf3, IL1ß, iNOS, Mmp9, Mmp13, Plau, Ets1, Spp1, Nr4a1. The results were consistent with the trend of transcriptome sequencing results, which proved the reliability of this study. CONCLUSION: This study explored the inhibitory effect of Tivozanib on PDL-induced angiogenesis, and provided a new idea for the treatment of clinical PWS. Transcriptome sequencing explored the mechanism and provided reliable clues for later in-depth research.
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Láseres de Colorantes , Neovascularización Patológica , Compuestos de Fenilurea , Mancha Vino de Oporto , Quinolinas , Animales , Células Endoteliales , Láseres de Colorantes/efectos adversos , Neovascularización Patológica/tratamiento farmacológico , Compuestos de Fenilurea/uso terapéutico , Mancha Vino de Oporto/patología , Proteínas Tirosina Quinasas , Quinolinas/uso terapéutico , Ratas , Reproducibilidad de los Resultados , Resultado del Tratamiento , Factor A de Crecimiento Endotelial VascularRESUMEN
Noninvasive pulsed dye laser is the current gold standard for the treatment of port wine stains. However, most port wine stains are not completely cleared after pulsed dye laser therapy, owing to insufficient photocoagulation and laser-induced vascular regeneration and reperfusion. Several studies have explored approaches designed to improve treatment efficacy. This integrative literature review summarizes the results of clinical and animal studies published between 2004 and 2021. Pulsed dye laser has been administered in combination with photoelectric devices (the neodymium: yttrium-aluminum-garnet lasers, dual-wavelength 1064-/595-nm laser irradiation, fiberoptic Nd-YAG laser, photodynamic therapy, and radio frequency), and drugs (rapamycin, imiquimod, timolol, axitinib, endothelin receptor antagonist, artificial red blood cells and oxymetazoline). The initial results suggest that combination therapy is a direction worth exploring in the future. Further large prospective, blinded and controlled multicenter clinical trials with longer follow-up period are required to obtain more robust evidence.
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Terapia por Láser , Láseres de Colorantes , Láseres de Estado Sólido , Mancha Vino de Oporto , Animales , Láseres de Colorantes/uso terapéutico , Láseres de Estado Sólido/uso terapéutico , Estudios Multicéntricos como Asunto , Fototerapia , Mancha Vino de Oporto/radioterapia , Mancha Vino de Oporto/cirugía , Estudios Prospectivos , Resultado del TratamientoRESUMEN
Sporothrix globosa is an important clinical pathogen in the Sporothrix complex, which is causing sporotrichosis. S. globosa is distributed worldwide, especially in Asia. The transmission medium of S. globosa is mainly contaminated soil or decaying vegetation, and the infection usually caused by transcutaneous trauma, through which the fungal conidia or yeast cells enter the host. Although the clinical manifestations of sporotrichosis caused by S. globosa is always benign, there have been several outbreaks worldwide. In this study, we established a novel real-time polymerase chain reaction (PCR) method based on the internal transcribed spacer (ITS) sequence for the identification of S. globosa. The assay was further evaluated by clinical specimens obtained from patients of sporotrichosis. The sensitivity and specificity of the real-time PCR method was both 100%. The detection limit was 10 fg. The positive detection rate for 30 clinical specimens, which were confirmed infected by S. globosa, was 100%. The real-time PCR method established in this paper is a rapid, sensitive and specific method for the identification of S. globosa. It can detect S. globosa in clinical specimen from patients with sporotrichosis, which is helpful for fast clinical diagnosis.
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Reacción en Cadena en Tiempo Real de la Polimerasa/métodos , Sporothrix/genética , Esporotricosis/diagnóstico , Cartilla de ADN/genética , ADN de Hongos/genética , ADN Intergénico/genética , Humanos , Límite de Detección , Filogenia , Sensibilidad y Especificidad , Esporotricosis/microbiologíaRESUMEN
BACKGROUND: More and more azole-resistant strains emerged through the development of acquired resistance and an epidemiological shift towards inherently less susceptible species. The mechanisms of azoles resistance of Candida albicans is very complicated. In this study, we aim to investigate the mechanism of azole-resistant C. albicans isolated from the oral cavity of a patient with chronic mucocutaneous candidiasis (CMC). CASE PRESENTATION: CMC diagnosis was given based on clinical manifestations, laboratory test findings and gene sequencing technique. Minimum inhibitory concentration (MIC) of the fungal isolate, obtained from oral cavity termed as CA-R, was obtained by in vitro anti-fungal drugs susceptibility test. To further investigate the resistant mechanisms, we verified the mutations of drug target genes (i.e. ERG11 and ERG3) by Sanger sequencing, and verified the over-expression of ERG11 and drug efflux genes (i.e. CDR1 and CDR2) by RT-PCR. A heterozygous mutation of c.1162A > G resulting in p.K388E was detected in STAT1 of the patient. The expression of CDR1 and CDR2 in CA-R was 4.28-fold and 5.25-fold higher than that of type strain SC5314, respectively. CONCLUSIONS: Up-regulation of CDR1 and CDR2 was mainly responsible for the resistance of CA-R. For CMC or other immunodeficiency patients, drug resistance monitoring is necessary.
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Antifúngicos/farmacología , Azoles/farmacología , Candida albicans/efectos de los fármacos , Candidiasis Mucocutánea Crónica/tratamiento farmacológico , Candidiasis Mucocutánea Crónica/microbiología , Farmacorresistencia Fúngica/genética , Mutación , Adolescente , Candida albicans/genética , Candida albicans/aislamiento & purificación , Candidiasis Mucocutánea Crónica/etiología , Farmacorresistencia Fúngica/efectos de los fármacos , Proteínas Fúngicas/genética , Regulación Fúngica de la Expresión Génica/efectos de los fármacos , Humanos , Masculino , Proteínas de Transporte de Membrana/genética , Pruebas de Sensibilidad Microbiana , Boca/microbiologíaRESUMEN
BACKGROUND: In China, the prevalence of superficial fungal infections of the foot is high and recurrence is common. However, a prospective, large-scale and multicentre study on the aetiology of superficial fungal infections of the foot is still lacking. OBJECTIVES: To study the epidemiology of aetiological agents of superficial fungal infections of the foot in urban outpatients in mainland China, as well as to understand the aetiology features of the pathogenic agent. METHODS: The study was designed as a multicentre, prospective epidemiological survey. A total of 1704 subjects were enrolled from seven geographical areas in mainland China. For each subject, one mycological sample and one bacterial sample were collected. KOH wet mount examination and culture were performed at local laboratories. The bacterial results were only reported in those with positive mycology. Further morphological identification and, if necessary, molecular biological identification were conducted in a central laboratory. RESULTS: Of 1704 enrolled subjects, 1327 (77.9%) subjects had positive fungal culture results. The incidence of dermatophytes, yeasts and moulds was 90.1%, 8.1% and 1.1%, respectively. The most frequently isolated aetiological agent (fungus) was Trichophyton rubrum. Moccasin form was the most commonly reported clinical diagnosis of superficial fungal infections. The most frequently isolated bacterial genus in patients was Staphylococcus. CONCLUSION: This study prospectively investigated the clinical and mycological features of human dermatophytosis in mainland China. T rubrum was the most frequently isolated fungus, and moccasin form was the most commonly reported clinical diagnosis of superficial fungal infections.
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Dermatomicosis , Pie/microbiología , Adulto , Arthrodermataceae/aislamiento & purificación , Arthrodermataceae/patogenicidad , China/epidemiología , Dermatomicosis/epidemiología , Dermatomicosis/etiología , Dermatomicosis/patología , Femenino , Pie/patología , Hongos/aislamiento & purificación , Hongos/patogenicidad , Humanos , Incidencia , Masculino , Micosis/epidemiología , Micosis/etiología , Micosis/patología , Pacientes Ambulatorios , Prevalencia , Estudios Prospectivos , Levaduras/aislamiento & purificación , Levaduras/patogenicidadRESUMEN
BACKGROUND: Dermatophytosis is a fungal infectious disease caused by dermatophytes, which produce protease and keratinase to digest keratin, leading to the colonization, invasion, and infection of the stratum corneum of the skin, hair shafts, and nails. Trichophyton interdigitale belongs to Trichophyton mentagrophytes complex, which is the common pathogen causing dermatophytosis. Fungal keratitis, also called keratomycosis, is an infectious disease of cornea. CASE PRESENTATION: Here, we report a case of simultaneous dermatophytosis and keratomycosis caused by Trichophyton interdigitale. A 67-year-old man presented with extensive erythema all over the body since 4 years ago, fungal infection of left eye for 2 years, and loss of vision in the eye. These symptoms had become aggravated in the last month. Dermatological examinations showed extensive erythematous plaques with clear borders and scales, scattered red papules with ulceration, and scabs throughout the body. Onychomycosis was observed on the nails of left hand, conjunctival infection with secretion and loss of vision were noted in left eye. Hyaline septate hyphae were observed under direct microscopic examination, fungal culture and internal transcribed spacer sequencing revealed T. interdigitale. Histopathological examination suggested infectious granuloma. A diagnosis of dermatophytosis and keratomycosis caused by T. interdigitale with loss of vision in left eye was made. The patient was treated with luliconazole cream (two applications per day) and itraconazole (100 mg, BID, PO). Complete clinical remission was achieved after 1 month. Subsequently, the patient underwent left eye enucleation in the ophthalmology department. CONCLUSIONS: In the present study, we reported a case of simultaneous dermatophytosis and keratomycosis caused by T. interdigitale, and reviewed the literature on corneal infection caused by Trichophyton. A total of 10 articles with 45 patients were published between 1973 and 2018. The pathogen of 27 patient were identified to species level. There were T. schoenleinii (17), T. mentagrophytes (4), T. verrucosum (3), T. rubrum (1), T. erinacei (1), and T. interdigitale (1). Five patients had corneal trauma, one had contact lens use history. Direct microscopic examination, fungal culture, and analysis of physiological characteristics were the main methods of identification. Early diagnosis and prompt treatment may help improve the management and outcomes.
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Queratitis/microbiología , Tiña/microbiología , Trichophyton/aislamiento & purificación , Anciano , Antifúngicos/administración & dosificación , Humanos , Itraconazol/administración & dosificación , Queratitis/diagnóstico , Queratitis/tratamiento farmacológico , Masculino , Uñas/microbiología , Piel/microbiología , Tiña/diagnóstico , Tiña/tratamiento farmacológico , Trichophyton/genética , Trichophyton/crecimiento & desarrollo , Trichophyton/fisiologíaAsunto(s)
Síndrome de Klippel-Trenaunay-Weber/complicaciones , Melanosis/complicaciones , Síndromes Neurocutáneos/complicaciones , Anciano , Femenino , Humanos , Síndromes Neurocutáneos/diagnóstico , Nevo Pigmentado/diagnóstico , Nevo Pigmentado/etiología , Enfermedades de la Esclerótica/diagnóstico , Enfermedades de la Esclerótica/etiologíaRESUMEN
Synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome is a rare chronic inflammatory disease mainly manifested as skin and osteoarticular lesions. Herein, we describe a female patient with SAPHO syndrome exhibited paradoxical psoriasis and primary palmoplantar pustulosis (PPP) worsened during treatment with adalimumab. We then switched to secukinumab and obtained significant improvement in both skin lesions and osteoarticular pain. These findings suggest that secukinumab might be an appropriate option for patients with SAPHO syndrome who present with TNF-α-inhibitor-induced paradoxical psoriasis.
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This study aimed to investigate the molecular mechanism of sporotrichosis and identify possible novel therapeutic targets. Total RNA was extracted from skin lesion samples from sporotrichosis patients and used to construct a long-chain RNA transcriptome library and miRNA transcriptome library for whole transcriptome sequencing. The differentially expressed genes (DEGs) between the groups were identified, and then Gene Ontology, Kyoto Encyclopedia of Genes and Genomes, and Gene Set Enrichment Analysis enrichment analyses were performed based on the DEGs. An lncRNA-miRNA-mRNA ceRNA network was constructed. The expressions of JAK/STAT pathway-related proteins were detected in the patient and control tissues using RT-qPCR and Western blot analysis. Enrichment analysis showed that the DEGs were mainly enriched in various infectious diseases and immune response-related signaling pathways. Competing endogenous RNA network analysis was performed and identified the hub lncRNAs, miRNAs, and mRNAs. Compared with the control group, the mRNA expressions of SOCS3, IL-6, and JAK3 were significantly upregulated, while the expression of STAT3 did not change significantly. Also, the protein expressions of SOCS3, IL-6, JAK3, and STAT3, as well as phosphorylated JAK3 and STAT3, were significantly upregulated. We identified 671 lncRNA DEGs, 3281 mRNA DEGs, and 214 miRNA DEGs to be involved in Sporothrix globosa infection. The study findings suggest that the JAK/STAT pathway may be a therapeutic target for sporotrichosis.
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MicroARNs , ARN Largo no Codificante , Esporotricosis , Humanos , ARN Largo no Codificante/genética , Esporotricosis/genética , Secuenciación del Exoma , Interleucina-6/genética , Quinasas Janus/genética , Redes Reguladoras de Genes , Transducción de Señal/genética , Factores de Transcripción STAT/genética , MicroARNs/genética , Transcriptoma , ARN Mensajero/genéticaRESUMEN
BACKGROUND: Limited information exists regarding the impact of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection on psoriasis patients. The objective of this study was to identify clinical factors associated with the prognosis of psoriasis following SARS-CoV-2 infection. METHODS: A retrospective, multicenter study was conducted between March and May 2023. Univariable and multivariable logistic regression analyses were employed to identify factors associated with coronavirus disease 2019 (COVID-19)-related psoriasis outcomes. The study included 2371 psoriasis patients from 12 clinical centers, with 2049 of them having been infected with SARS-CoV-2. RESULTS: Among the infected groups, lower exacerbation rates were observed in individuals treated with biologics compared to those receiving traditional systemic or nonsystemic treatments (22.3% [236/1058] vs . 39.8% [92/231] vs . 37.5% [140/373], P <0.001). Psoriasis progression with lesions (adjusted odds ratio [OR] = 8.197, 95% confidence interval [95% CI] = 5.685-11.820, compared to no lesions), hypertension (adjusted OR = 1.582, 95% CI = 1.068-2.343), traditional systemic (adjusted OR = 1.887, 95% CI = 1.263-2.818), and nonsystemic treatment (adjusted OR = 1.602, 95% CI = 1.117-2.297) were found to be associated with exacerbation of psoriasis after SARS-CoV-2 infection, but not biologics (adjusted OR = 0.931, 95% CI = 0.680-1.274, compared to no treatment), according to multivariable logistic regression analysis. CONCLUSIONS: A reduced risk of psoriasis exacerbation after SARS-CoV-2 infection was observed with biologics compared to traditional systemic and nonsystemic treatments. Significant risk factors for exacerbation after infection were identified as existing psoriatic lesions and hypertension. TRIAL REGISTRATION: ClinicalTrials.gov (No. NCT05961605).
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COVID-19 , Psoriasis , SARS-CoV-2 , Humanos , Psoriasis/complicaciones , Psoriasis/tratamiento farmacológico , COVID-19/complicaciones , Estudios Retrospectivos , Masculino , Femenino , Persona de Mediana Edad , Adulto , China/epidemiología , Anciano , Modelos LogísticosRESUMEN
BACKGROUND: Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD. METHODS: This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied. RESULTS: At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs . placebo, 95% CI 31%-69%) and 45% (low vs . placebo, 95% CI 26%-64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator's Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310. CONCLUSION: CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.
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Dermatitis Atópica , Adulto , Humanos , Dermatitis Atópica/tratamiento farmacológico , Resultado del Tratamiento , Índice de Severidad de la Enfermedad , Anticuerpos Monoclonales Humanizados/uso terapéutico , Inyecciones Subcutáneas , Método Doble CiegoRESUMEN
BACKGROUND: There is a need for effective and safe therapies for psoriasis that provide sustained benefits. The aim of this study was to assess the efficacy and safety of tildrakizumab, an anti-interleukin-23p19 monoclonal antibody, for treating moderate-to-severe plaque psoriasis in Chinese patients. METHODS: In this multi-center, double-blind, phase III trial, patients with moderate-to-severe plaque psoriasis were enrolled and randomly assigned (1:1) to receive subcutaneous tildrakizumab 100 mg or placebo at weeks 0 and 4. Patients initially assigned to placebo were switched to receive tildrakizumab at weeks 12, 16, and every 12 weeks thereafter. Patients in the tildrakizumab group continued with tildrakizumab at week 16, and every 12 weeks until week 52. The primary endpoint was the Psoriasis Area and Severity Index (PASI 75) response rate at week 12. RESULTS: At week 12, tildrakizumab demonstrated significantly higher PASI 75 response rates (66.4% [73/110] vs. 12.7% [14/110]; difference, 51.4% [95% confidence interval (CI), 40.72, 62.13]; P <0.001) and Physician's Global Assessment (60.9% [67/110] vs. 10.0% [11/110]; difference, 49.1% [95% CI, 38.64, 59.62]; P <0.001) compared to placebo. PASI 75 response continued to improve over time in both tildrakizumab and placebo-switching to tildrakizumab groups, reaching maximal efficacy after 28 weeks (86.8% [92/106] vs . 82.4% [89/108]) and maintained up to 52 weeks (91.3% [95/104] vs . 87.4% [90/103]). Most treatment-emergent adverse events were mild and not related to tildrakizumab. CONCLUSION: Tildrakizumab demonstrated durable efficacy through week 52 and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis. TRIAL REGISTRATION: ClinicalTrials.gov , NCT05108766.