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Keywords = Urticaria Activity Score

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16 pages, 613 KB  
Article
Clinical and Immunological Associations of Plasma Platelet-Activating Factor in Chronic Spontaneous Urticaria
by Lāsma Lapiņa, Klinta Suhecka, Guna Ziedone and Nataļja Kurjāne
Biomedicines 2026, 14(8), 1745; https://doi.org/10.3390/biomedicines14081745 - 2 Aug 2026
Viewed by 378
Abstract
Background/Objectives: Chronic spontaneous urticaria (CSU) is a heterogeneous immune-mediated condition involving multiple inflammatory pathways. The clinical utility of platelet-activating factor (PAF) as a biomarker in CSU remains insufficiently defined. This study aimed to evaluate plasma PAF levels in patients with CSU and [...] Read more.
Background/Objectives: Chronic spontaneous urticaria (CSU) is a heterogeneous immune-mediated condition involving multiple inflammatory pathways. The clinical utility of platelet-activating factor (PAF) as a biomarker in CSU remains insufficiently defined. This study aimed to evaluate plasma PAF levels in patients with CSU and to investigate their associations with clinical characteristics, disease activity, and laboratory and immunological parameters. Methods: This cross-sectional study included 205 adult patients diagnosed with CSU between January 2016 and May 2023. Clinical data, patient-reported outcome measures (PROMs), and extensive laboratory parameters were collected. Plasma PAF levels were measured using ELISA in 171 patients. Associations were analyzed using appropriate statistical methods. Results: The cohort was predominantly female (77.6%), with a mean age of 42.6 ± 15.3 years. Most patients had uncontrolled disease (76.9%). The median Urticaria Activity Score over 7 days (UAS7) score was 14, corresponding to mild disease activity. PAF levels differed significantly across clinical subgroups. Higher PAF levels were observed in patients with angioedema (alone or in combination with urticaria) compared to those with urticaria alone (p = 0.002), and in patients with predominantly nocturnal and early morning symptoms (p = 0.018). No associations were found between PAF levels and disease activity scores or treatment response. PAF levels showed positive correlations with age, age at symptom onset, IgM, IgG anti-IgE, HSP70, and the CD4/CD8 ratio (all p < 0.05). Conclusions: Plasma PAF levels are associated with specific clinical phenotypes, circadian symptom patterns, and selected immunological markers in CSU, suggesting that PAF may serve as a marker of underlying biological heterogeneity and immune activation. However, the present cross-sectional findings do not establish clinical utility, prognostic significance, or predictive relevance for treatment response, and these aspects require further longitudinal investigation. Full article
(This article belongs to the Section Immunology and Immunotherapy)
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11 pages, 2256 KB  
Article
Time to Meaningful Clinical Response Across Approved and Emerging Therapies for Antihistamine-Refractory Chronic Spontaneous Urticaria: A Network Meta-Analysis
by Sarayu Balachandar, Dylan R. Clapp and Alan B. Fleischer
J. Clin. Med. 2026, 15(12), 4622; https://doi.org/10.3390/jcm15124622 - 14 Jun 2026
Viewed by 627
Abstract
Background/Objectives: Several novel biologics and small-molecule therapies have emerged for the treatment of antihistamine-refractory chronic spontaneous urticaria (CSU), yet no study has directly compared their speed of response. This study aims to provide indirect evidence on the relative time to meaningful clinical [...] Read more.
Background/Objectives: Several novel biologics and small-molecule therapies have emerged for the treatment of antihistamine-refractory chronic spontaneous urticaria (CSU), yet no study has directly compared their speed of response. This study aims to provide indirect evidence on the relative time to meaningful clinical response across approved and investigational therapies using a Bayesian network meta-analysis. Methods: Phase 2 and phase 3 randomized controlled trials reporting UAS7 scores in a graphical format for antihistamine-refractory CSU were included. The primary outcome was the mean time in weeks to minimal clinically important difference (MCID), defined as a UAS7 reduction of 10 points. Data were extracted using WebPlotDigitizer (v4.7) and analyzed via Bayesian random-effects network meta-analysis in MetaInsight (v6.4.0), with placebo as the reference node. Results: All drugs except rilzabrutinib 400 mg daily demonstrated faster mean time to MCID than placebo. Fenebrutinib had the fastest mean time to MCID (0.67–0.76 weeks), and tezepelumab the slowest (5.41–5.65 weeks). Only omalizumab 300 mg every 4 weeks, dupilumab 300 mg every 2 weeks, and ligelizumab 72 mg and 120 mg every 4 weeks achieved statistically significant reductions compared with placebo. All treatments had wide credible intervals reflecting limited direct comparisons. Conclusions: This is the first network meta-analysis comparing time to meaningful symptom control across therapies for antihistamine-refractory CSU. Omalizumab, dupilumab, and ligelizumab demonstrated statistically significant reductions in time to MCID compared with placebo. Head-to-head trials with standardized outcome reporting would enable more definitive comparative conclusions. Full article
(This article belongs to the Section Dermatology)
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11 pages, 1148 KB  
Article
Serum Immunometabolic Biomarkers Reveal Distinct Phenotypes in Chronic Urticaria
by Nilay Duman, Can Muftuoglu, Begüm Tahhan, Tolga Coşkun, Deniz Ece, Ufuk Mert, Sıla Özkal and Ayse Caner
Diagnostics 2026, 16(8), 1148; https://doi.org/10.3390/diagnostics16081148 - 13 Apr 2026
Viewed by 998
Abstract
Background/Objectives: Chronic urticaria (CU) is a heterogeneous inflammatory disorder generally attributed to mast cell activation. However, emerging evidence suggests that metabolic reprogramming and systemic immune dysregulation also contribute to the disease pathophysiology. This study aimed to investigate the interplay between epithelial barrier [...] Read more.
Background/Objectives: Chronic urticaria (CU) is a heterogeneous inflammatory disorder generally attributed to mast cell activation. However, emerging evidence suggests that metabolic reprogramming and systemic immune dysregulation also contribute to the disease pathophysiology. This study aimed to investigate the interplay between epithelial barrier integrity, innate immune regulation, metabolic activity, and mast cell effector mechanisms in CU. Methods: Forty CU patients and 40 healthy controls were evaluated. Clinical parameters included disease severity, disease subtype, antihistamine response, IgE levels, anti-TPO status, gastrointestinal symptoms, and angioedema. Serum levels of histamine, intestinal fatty acid-binding protein (IFABP), soluble CD14 (sCD14), diamine oxidase (DAO), D-lactic acid, endotoxin, zonulin, calprotectin, and related ratios were measured. Disease activity and control were assessed using the UAS7 and UCT scores. Results: CU patients exhibited significantly higher DAO (p = 0.003) and lactic acid (p = 0.004) levels compared to controls, whereas other markers showed no significant differences. In anti-TPO-positive patients, sCD14 levels were reduced (p = 0.024), while histamine/sCD14 (p = 0.005), lactic acid/sCD14 (p = 0.014), IFABP/sCD14 (p = 0.008), and zonulin/sCD14 (p = 0.027) were significantly elevated, suggesting relative amplification of metabolic and barrier-related signals under impaired innate immune regulation. Severe anti-TPO-positive patients exhibited lower sCD14 (p = 0.022) and NLR (p = 0.013) but higher UAS7 (p = 0.032), histamine (p = 0.011), calprotectin (p = 0.041), and CD14-normalized ratios, including histamine (p = 0.003), IFABP (p = 0.028), lactic acid (p = 0.019), zonulin (p = 0.029), and calprotectin (p = 0.011) compared with severe anti-TPO-negative patients, indicating a mast cell-dominant and metabolically active inflammatory phenotype. The lactic acid/DAO ratio was significantly lower in controlled versus uncontrolled CU (p = 0.013) and showed discriminatory potential for disease control. Patients with angioedema had higher CRP (p = 0.038) and UAS7 scores (p < 0.001). Conclusions: CU exhibits marked immunometabolic heterogeneity. Elevated DAO and lactic acid indicate increased histamine turnover and metabolic activation, whereas altered sCD14-normalized biomarker profiles reveal immune dysregulation in anti-TPO-positive patients. Severe CU with features suggestive of thyroid autoimmunity manifests as a mast cell-dominant, metabolically active phenotype with relative suppression of innate immune modulators, contrasting with alternative pathways in other CU phenotypes. The lactic acid/DAO ratio may serve as a candidate biomarker of disease control. These results underscore the importance of phenotype-tailored therapeutic strategies in CU. Full article
(This article belongs to the Special Issue Novel Advances in the Diagnosis of Dermatology)
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12 pages, 990 KB  
Article
Vitamin D and Disease Perception Outcomes in a Cluster of Patients with High-Disease-Activity Chronic Spontaneous Urticaria
by Eralda Lekli, Mehmet Hoxha, Maria Bova, Dorian Shkëmbi, Ester Ndreu, Xheini Hajrulla, Elizana Petrela and Etleva Qirko
J. Clin. Med. 2026, 15(7), 2717; https://doi.org/10.3390/jcm15072717 - 3 Apr 2026
Viewed by 623
Abstract
Background/Objectives: Chronic Spontaneous Urticaria (CSU) is a skin disorder marked by recurrent wheals and itching, with or without angioedema, which can greatly affect the quality of life. Vitamin D has been implicated in the pathophysiology of various immune-mediated conditions, including CSU. The [...] Read more.
Background/Objectives: Chronic Spontaneous Urticaria (CSU) is a skin disorder marked by recurrent wheals and itching, with or without angioedema, which can greatly affect the quality of life. Vitamin D has been implicated in the pathophysiology of various immune-mediated conditions, including CSU. The connection between vitamin D levels, patients’ perceived symptoms, and life impact remains unexplored. This study aims to elucidate vitamin D levels and their correlation with perceived disease-related burden in individuals with CSU. Methods: PROM-based questionnaires, serum 25(OH)D levels, and BMI were statistically analyzed in high-disease-activity CSU, among hospitalized and outpatients who attended the main tertiary hospital center during a 1-year period. These data were compared with a control group, after obtaining their consent. Results: The study included 104 patients, 74 (71.15%) females, mean age 43.17 ± 18.26 years, and 23 controls, 12 (52.17%) females, mean age 44.61 ± 12.77 years. Levels of 25(OH)D were significantly lower in patients compared to controls and in the hospitalized versus the outpatient group (p < 0.05). Suboptimal 25(OH)D was found in 94.23% of patients (mean level 18.29 ± 6.74 ng/mL) and 82.61% of controls (mean 24.01 ± 7.44 ng/mL). A BMI > 25 kg/m2 was found in 71 (68.3%) patients and 11 (47.83%) controls. Age was not significantly correlated with vitamin D levels. A significant positive correlation was found between vitamin D levels and the perceived bothersomeness score of urticarial elements and pruritus. Age was negatively correlated with perceived bothersomeness of pruritus. Irrespective of 25(OH)D levels, perceived bothersomeness of urticarial elements positively correlated with scores for angioedema, pruritus, and the impact of CSU on life and daily activities. Life and daily activities impact scores were also positively correlated with angioedema and pruritus. Conclusions: Suboptimal levels of 25(OH)D were common in CSU patients, especially among hospitalized patients, and were significantly lower compared with controls, suggesting a potential link between low vitamin D status and high disease activity. PROMs did not show a significant association between lower vitamin D levels and worse scores for perceived bothersomeness of urticarial elements, angioedema, pruritus, or impact on life and daily activities. Full article
(This article belongs to the Special Issue Fresh Insights in Skin Disease)
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11 pages, 377 KB  
Article
Disease Control, Activity and Quality of Life in Chronic Spontaneous Urticaria: A Cross-Sectional Study from Kazakhstan
by Aray Batyrbayeva, Zhanat Ispayeva, Marat Pashimov, Rustem Tuleutayev, Jamilya Kaibullayeva, Madina Baidildayeva, Balnur Sultanova, Arailym Maldybayeva and Kamila Turebekova
Diagnostics 2026, 16(5), 672; https://doi.org/10.3390/diagnostics16050672 - 26 Feb 2026
Cited by 1 | Viewed by 729
Abstract
Background and Objectives: Chronic spontaneous urticaria (CSU) significantly affects patients’ quality of life (QoL) and remains challenging to manage, particularly in under-researched regions. This study aimed to assess the clinical burden, disease control, and quality of life among patients with CSU in [...] Read more.
Background and Objectives: Chronic spontaneous urticaria (CSU) significantly affects patients’ quality of life (QoL) and remains challenging to manage, particularly in under-researched regions. This study aimed to assess the clinical burden, disease control, and quality of life among patients with CSU in Kazakhstan and to identify predictors of severe disease activity. Materials and Methods: We conducted a cross-sectional study of 350 patients with CSU attending the Republican Allergy Center in Almaty between December 2024 and June 2025. Patients were classified based on the presence of co-existing chronic inducible urticaria (CIndU), angioedema, or both. Disease activity, control, and QoL were assessed using the Urticaria Activity Score over 7 days (UAS7), Urticaria Control Test (UCT), and Dermatology Life Quality Index (DLQI), respectively. Multivariable logistic regression and correlation analyses were used to identify predictors of severe disease and interrelationships among clinical measures. Results: Among 350 patients (mean age 43.5 ± 14.7 years; 78% female), 46.3% had CSU alone, while 53.7% had associated phenotypes. Severe urticaria (UAS7 ≥ 28) affected 30% of patients. Suboptimal disease control (UCT ≤ 11) was reported in 30%, and 30% experienced strong or very strong QoL impairment (DLQI > 10). Older disease onset (≥60 years; OR = 1.98; 95% CI: 1.02–3.81) and nighttime symptoms (OR = 1.67; 95% CI: 1.02–2.73) were independently associated with severe disease. A strong inverse correlation was observed between UAS7 and UCT (ρ = −0.71), and a positive correlation between UAS7 and DLQI (ρ = 0.66), highlighting the impact of disease activity on control and QoL. Conclusions: CSU imposes a substantial clinical and psychosocial burden in Kazakhstan. One-third of patients experience severe symptoms and impaired QoL despite ongoing treatment. Older age at disease onset and nighttime symptoms may serve as practical indicators of disease severity. These findings highlight the need for improved access to advanced therapies, systematic monitoring using validated tools, and multidisciplinary care strategies in resource-constrained settings. Full article
(This article belongs to the Section Clinical Diagnosis and Prognosis)
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13 pages, 498 KB  
Article
An Assessment of Melatonin Levels in the Saliva of Patients with Chronic Urticaria in Comparison with Their Sleep Quality and Dermatologic Quality of Life
by Iva Bešlić, Alen Vrtarić, Ivana Škrinjar, Ema Barac, Ana-Karla Vodanović and Liborija Lugović-Mihić
Clin. Pract. 2026, 16(2), 36; https://doi.org/10.3390/clinpract16020036 - 6 Feb 2026
Viewed by 1172
Abstract
Background: For the majority of chronic spontaneous urticaria (CSU) sufferers, nocturnal itch has a profound effect on quality of life (QoL), as it leads to sleep disturbances. To ensure good sleep quality (SQ), the body must produce an adequate amount of melatonin, which [...] Read more.
Background: For the majority of chronic spontaneous urticaria (CSU) sufferers, nocturnal itch has a profound effect on quality of life (QoL), as it leads to sleep disturbances. To ensure good sleep quality (SQ), the body must produce an adequate amount of melatonin, which regulates the sleep cycle. Methods: This study examines the levels of salivary melatonin in 38 CSU patients and 38 healthy controls, as well as the relationship between CSU severity, QoL and SQ. The Enzyme-Linked Immunosorbent Assay (ELISA), Dermatology Quality of Life Index (DLQI), and Pittsburgh Sleep Quality Index (PSQI) were used to determine salivary melatonin levels, QoL, and SQ. In addition, the CSU participants were given the Urticaria Activity Score (UAS) and the Urticaria Control Test. Results: The median value of salivary melatonin in CSU patients was lower than that in healthy individuals (0.2 vs. 15.985 pg/mL; p < 0.001). A decreased melatonin level was seen in 90% of CSU patients and 18% of healthy individuals. Individuals with lower melatonin levels were significantly more likely to have CSU compared with those with higher melatonin levels (OR = 37.6; 95% CI 10.0–141.1). Melatonin was linearly related to QoL and sleep quality in the whole sample (r = −0.606 and −0.536; p < 0.001) but not in CSU patients. Impaired QoL in patients correlated with itch intensity and the number of hives (r = 0.740 and 0.646). The severity and activity of CSU are linearly related to impaired QoL and sleep quality (r = −0.606 and −0.536; p < 0.001). Sleep quality acts as the mediator of the association between QoL and salivary melatonin, when controlling for the effect of age and gender (B = −0.347; 95% CI = −0.679 to −0.080). Conclusions: The data suggest that melatonin may be more a non-specific marker of sleep disturbance than the severity of CSU. Sleep quality may act as a mediator linking dermatology-related QoL, circadian dysregulation and reduced melatonin secretion. Full article
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7 pages, 221 KB  
Article
Impact of Seasonal, Environmental, and Inflammatory Factors on Chronic Urticaria Activity and Serum Biomarkers: A Prospective Cohort Study
by Gulistan Alpagat, Ayşe Fusun Kalpaklioglu and Ayse Baccioglu
J. Clin. Med. 2026, 15(2), 645; https://doi.org/10.3390/jcm15020645 - 13 Jan 2026
Cited by 2 | Viewed by 973
Abstract
Background: Chronic urticaria (CU) is characterized by recurrent wheals and/or angioedema persisting for more than six weeks. While disease triggers are often unidentified, seasonal and environmental factors may modulate disease activity; however, evidence regarding their clinical impact remains limited. Objective: This study aimed [...] Read more.
Background: Chronic urticaria (CU) is characterized by recurrent wheals and/or angioedema persisting for more than six weeks. While disease triggers are often unidentified, seasonal and environmental factors may modulate disease activity; however, evidence regarding their clinical impact remains limited. Objective: This study aimed to evaluate the effects of seasonal, meteorological, and pollutant-specific environmental factors on urticaria control using the Urticaria Control Test (UCT), and to compare these effects between chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIU) in relation to inflammatory serum biomarkers. Materials and Methods: This prospective observational study was conducted at the Allergy and Clinical Immunology outpatient clinic of Kirikkale University Faculty of Medicine between 1 June 2023 and 1 April 2024. Patients with CU were classified as CSU or CIU according to international guidelines. Each participant was evaluated during summer and winter seasons. Area-level air pollution data and meteorological parameters were obtained from national monitoring systems. Disease control was assessed using the UCT, and inflammatory biomarkers were analyzed. Results: Urticaria control showed significant seasonal variation, with lower UCT scores during summer and higher scores during winter in both CSU and CIU patients. Among environmental factors, ozone (O3) was the only pollutant consistently associated with poorer urticaria control, whereas particulate matter and traffic-related pollutants, despite being higher in winter, showed no clinically relevant association. Summer months were characterized by increased inflammatory activity, including elevated leukocyte counts, neutrophil-to-lymphocyte ratio (NLR), C-reactive protein (CRP), and D-dimer levels, particularly in CSU patients. D-dimer emerged as an independent marker associated with poor disease control during summer. Conclusions: CU demonstrates marked seasonal variation, with disease worsening during summer months. Pollutant-specific effects, particularly O3 exposure, rather than overall air pollution burden, appear to be clinically relevant in urticaria control. Inflammatory and coagulation-related biomarkers may provide additional insight into disease activity. These findings support a season-aware and individualized management approach and highlight the need for future studies incorporating individual-level exposure assessment and biomarker-guided strategies. Full article
(This article belongs to the Section Immunology & Rheumatology)
13 pages, 748 KB  
Article
Association Between Proinflammatory Cytokines IL-6 and TNF-Alpha, Psychological Stress and Chronic Spontaneous Urticaria Severity
by Liborija Lugović-Mihić, Maja Štrajtenberger, Matea Kuna, Blaženka Ladika-Davidović, Ema Barac and Maja Vilibić
Int. J. Mol. Sci. 2025, 26(21), 10384; https://doi.org/10.3390/ijms262110384 - 25 Oct 2025
Cited by 4 | Viewed by 3501
Abstract
Chronic urticaria (CU), defined as the appearance of wheals/angioedema lasting ≥6 weeks, is often associated with psychological factors like stress. Stress-induced reactions involve the psychological–neuroendocrine–immunological network, which influences disease course/outcome and patient quality of life (QoL). With 46 participants (23 with CU and [...] Read more.
Chronic urticaria (CU), defined as the appearance of wheals/angioedema lasting ≥6 weeks, is often associated with psychological factors like stress. Stress-induced reactions involve the psychological–neuroendocrine–immunological network, which influences disease course/outcome and patient quality of life (QoL). With 46 participants (23 with CU and 23 healthy controls/HCs), this research examined the relationship between values of serum proinflammatory cytokines (IL-6 and TNF-α), stress indicators (cortisol levels, perceived stress level), and clinical chronic spontaneous urticaria (CSU) features (CSU severity/UAS, patient QoL). For CSU patients, significantly higher levels of IL-6 (p = 0.002) and TNF-α (p = 0.001) were recorded, as well as higher cortisol levels (p = 0.015) and a lower perception of stress/PSS (p < 0.001) than for HCs. CSU severity linearly and positively correlated with serum cortisol level (r = 0.463; p = 0.463) and impaired QoL (r = 0.715; p < 0.001). Additionally, impaired QoL correlated positively with perceived stress (r = 0.523; p = 0.010) and negatively with age (r = −0.529; p = 0.009). Also, IL-6 levels negatively correlated with perceived stress (r = −0.402; p = 0.006) linearly and moderately. The significant negative correlation between psychological stress and CU indicates that a comprehensive approach to treatment is necessary. Full article
(This article belongs to the Special Issue Dialogue Between Inflammation and Immunity: From Mechanism to Therapy)
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11 pages, 723 KB  
Article
Real-World Long-Term Management of Chronic Urticaria Patients with Omalizumab: Safety, Effectiveness, and Predictive Factors for Successful Outcome
by Ciro Romano, Domenico Cozzolino, Giuseppina Rosaria Umano and Ernesto Aitella
Biologics 2025, 5(4), 33; https://doi.org/10.3390/biologics5040033 - 22 Oct 2025
Cited by 1 | Viewed by 5558
Abstract
Background/Objectives: Omalizumab is a monoclonal anti-IgE antibody approved for the treatment of chronic urticaria. There are no established or validated prognostic markers currently available to identify likely responders. The aim of this study was to retrospectively analyze a cohort of chronic urticaria patients [...] Read more.
Background/Objectives: Omalizumab is a monoclonal anti-IgE antibody approved for the treatment of chronic urticaria. There are no established or validated prognostic markers currently available to identify likely responders. The aim of this study was to retrospectively analyze a cohort of chronic urticaria patients treated with omalizumab, in order to determine the clinical and laboratory characteristics associated with complete response to therapy. Methods: Medical records of chronic urticaria patients receiving omalizumab were reviewed. The following parameters were collected: age, sex, disease duration, Urticaria Activity Score over 7 days (UAS7), time to response, total serum IgE levels, presence or absence of atopy, neutrophil-to-lymphocyte ratio, eosinophil and basophil counts, presence or absence of autoimmune conditions, and treatment duration. Complete response was classified as dependent on continued drug administration or drug-free (sustained remission after discontinuation). Adverse events were also recorded. Results: Omalizumab was well tolerated by all patients, with no serious adverse events reported. Complete response was achieved in 81.3% of patients; partial and no responses were observed in 8.3% and 10.1%, respectively. The majority of responders (~79.5%) maintained complete control of hives with low-dose omalizumab; subsequently, most of these patients eventually achieved sustained, drug-free remission. Total serum IgE levels appeared to predict complete response, with 164.7 IU/mL identified as the cut-off value potentially distinguishing responders from nonresponders. Conclusions: Omalizumab is a safe and effective treatment for chronic urticaria. Total serum IgE levels may help identify complete responders. Long-term low-dose regimens could be considered to reduce the economic burden on healthcare systems, although this is currently an off-label approach. Full article
(This article belongs to the Section Monoclonal Antibodies)
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13 pages, 1639 KB  
Article
Prevalence and Burden of Chronic Spontaneous Urticaria in Japan: A Cross-Sectional Study
by Michihiro Hide, Akihito Uda, Fuyuko Maki, Noriko Miyakawa, Ravneet Kaur Kohli, Shaloo Gupta, Kathryn Krupsky, Bridget Balkaran and Maria-Magdalena Balp
J. Clin. Med. 2025, 14(4), 1162; https://doi.org/10.3390/jcm14041162 - 11 Feb 2025
Cited by 6 | Viewed by 4638
Abstract
Background: Real-world data on the prevalence and burden of patients with chronic spontaneous urticaria (CSU) are limited in Japan. This study aimed to estimate CSU prevalence and assess its humanistic and economic burden. Methods: This analysis utilized data from Japanese adult [...] Read more.
Background: Real-world data on the prevalence and burden of patients with chronic spontaneous urticaria (CSU) are limited in Japan. This study aimed to estimate CSU prevalence and assess its humanistic and economic burden. Methods: This analysis utilized data from Japanese adult respondents self-reporting physician-diagnosed CSU collected through the 2019 National Health and Wellness Survey. The weighted 12-month prevalence was estimated using 2018 international census projections. Outcomes included the SF-12v2 (physical and mental component summary [PCS and MCS] scores), health utility index (SF-6D and EQ-5D), Dermatology Life Quality Index (DLQI), Generalized Anxiety Disorder-7, Patient Health Questionnaire-9, Work Productivity and Activity Impairment scores at data collection, and healthcare resource utilization over the past 6 months. Results: Among 30,006 respondents, 334 reported having CSU, of whom 62.3% were female. The mean (SD) age at data collection and CSU diagnosis was 50.8 (15.3) and 39.2 (14.9) years, respectively. The weighted prevalence of CSU was 1.1%. The mean (SD) PCS and MCS scores were 50.3 (7.0) and 45.1 (10.0), respectively. The mean (SD) health utility measures (SF-6D and EQ-5D) were 0.71 (0.13) and 0.79 (0.18), respectively. The mean (SD) DLQI score was 3.8 (6.0). More than 40% of patients reported mild/moderate/severe anxiety and depression. The mean % (SD) scores for absenteeism, presenteeism, overall work impairment, and activity impairment were 7.6 (17.6), 27.2 (27.2), 30.3 (29.6), and 28.5 (27.8), respectively. Approximately 90.0% of patients visited healthcare providers, including emergency room visits (6.9%) and hospitalizations (9.9%). Conclusions: This study provides insights into the diagnosed prevalence and burden of CSU in Japan, highlighting its impact on patients’ lives. Full article
(This article belongs to the Section Dermatology)
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10 pages, 333 KB  
Article
Efficacy and Safety of Omalizumab and Dupilumab in Pediatric Patients with Skin Diseases: An Observational Study
by Francesca Galletta, Ludovica Rizzuti, Stefano Passanisi, Emanuela Rosa, Lucia Caminiti and Sara Manti
J. Pers. Med. 2025, 15(2), 64; https://doi.org/10.3390/jpm15020064 - 7 Feb 2025
Cited by 3 | Viewed by 4424
Abstract
Background: Chronic spontaneous urticaria (CSU) and moderate-to-severe atopic dermatitis (AD) are significant challenges in pediatric populations, negatively impacting quality of life (QoL). Biologic therapies, including omalizumab and dupilumab, showed considerable promise for patients unresponsive to conventional treatments. This study evaluated the real-life efficacy [...] Read more.
Background: Chronic spontaneous urticaria (CSU) and moderate-to-severe atopic dermatitis (AD) are significant challenges in pediatric populations, negatively impacting quality of life (QoL). Biologic therapies, including omalizumab and dupilumab, showed considerable promise for patients unresponsive to conventional treatments. This study evaluated the real-life efficacy and safety of these biologics in pediatric CSU and AD patients. Methods: A retrospective, monocentric study was conducted enrolling pediatric patients (aged 6–18 years) followed at the “G. Martino” Hospital, University of Messina. This study included patients with CSU unresponsive to antihistamines and those with moderate-to-severe AD refractory to topical therapies. Disease severity and treatment efficacy were evaluated using the Urticaria Activity Score 7 (UAS7) for CSU, the Eczema Area and Severity Index (EASI) for AD, and QoL metrics, including the Dermatology Life Quality Index (DLQI) and numerical rating scales, for pruritus (p-NRS) and sleep (s-NRS), at baseline, 16 weeks, and 52 weeks. Safety was assessed through the monitoring of reported adverse events (AEs). Results: Omalizumab significantly reduced UAS7 scores by 71.9% at 16 weeks and 75.3% at 52 weeks (p < 0.001), with concurrent improvements in c-DLQI. Dupilumab reduced the EASI score by 75.3%, p-NRS by 40%, and s-NRS by 52.9% over 52 weeks, with c-DLQI improving by 72.6%. No severe AEs were observed; mild reactions included injection-site erythema and respiratory symptoms. Conclusions: Omalizumab and dupilumab demonstrated significant efficacy in reducing disease severity and improving QoL in pediatric patients with CSU and AD. Moreover, their safety profile underscores their potential as essential treatments for these conditions. Full article
(This article belongs to the Section Personalized Therapy in Clinical Medicine)
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8 pages, 407 KB  
Article
Chronic Spontaneous Urticaria—New Predictor on the Horizon?
by Bartosz Bartosik, Katarzyna Kapeluszna, Dagmara Bartosik, Agata Chobot, Paulina Ciszewska-Hołda, Ewa Gawrylak-Dryja, Anna Klus, Rafał Bułdak and Zenon Brzoza
J. Clin. Med. 2024, 13(22), 6812; https://doi.org/10.3390/jcm13226812 - 13 Nov 2024
Cited by 2 | Viewed by 1891
Abstract
Chronic urticaria is one of the most common diseases in allergology and dermatology practice with unclear causes of occurrence. Background: Some studies emphasize the correlation between inflammation in chronic urticaria and disturbed intestinal microbiota. It raises the question about the role of some [...] Read more.
Chronic urticaria is one of the most common diseases in allergology and dermatology practice with unclear causes of occurrence. Background: Some studies emphasize the correlation between inflammation in chronic urticaria and disturbed intestinal microbiota. It raises the question about the role of some intestine-related substances in the pathogenesis of urticaria as well as their potential role as disease predictors. Calprotectin is an acute-phase protein with a well-established diagnostic position in the field of gastroenterology. There are some data on the relationship between this parameter and gut microbiota. The major aim of this preliminary study is to investigate whether calprotectin can be potentially taken into account as a disease course predictor in urticaria. Methods: We included in our study 54 chronic spontaneous urticaria (CSU) patients (of whom 26 manifested the symptoms of recurrent angioedema) and 29 patients allergic to Hymenoptera venom for the reference group (in these patients, before venom immunotherapy induction, full diagnostics is performed including intestinal problems). Disease activity in the CSU patients was assessed using the Urticaria Activity Score (UAS) and the disease control in this group was assessed with the Urticaria Control Test (UCT). Moreover, we analyzed fecal and serum calprotectin concentrations. Results: Positive correlation was found only between the values of serum calprotectin concentration and the control level of CSU symptoms with the lack of other relations. Conclusions: Our results do not supply unequivocal evidence for calprotectin as a potential marker of CSU course, though this concept, in the light of growing evidence for microbiota’s role in urticaria, requires further research. Full article
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10 pages, 1954 KB  
Communication
Serum Concentration of IL-5 Receptor (IL-5R) and Associations with Disease Severity in Patients with Chronic Spontaneous Urticaria (CSU) and Atopic Dermatitis (AD)
by Krzysztof Gomułka, Maciej Tota, Julia Laska, Karina Gojny and Łukasz Sędek
Int. J. Mol. Sci. 2024, 25(14), 7598; https://doi.org/10.3390/ijms25147598 - 11 Jul 2024
Cited by 8 | Viewed by 2879
Abstract
The immunological pathogenesis of atopic dermatitis (AD) and chronic spontaneous urticaria (CSU) has not been fully elucidated yet. The aim of our research was to assess the serum concentration of interleukin-5 receptor (IL-5R) in relation to the disease activity and pruritus intensity in [...] Read more.
The immunological pathogenesis of atopic dermatitis (AD) and chronic spontaneous urticaria (CSU) has not been fully elucidated yet. The aim of our research was to assess the serum concentration of interleukin-5 receptor (IL-5R) in relation to the disease activity and pruritus intensity in adult patients with AD and CSU. This pilot study included 45 participants (15 patients with AD, 15 patients with CSU, and 15 healthy controls). Blood samples were taken to examine the serum levels of IL-5R using the enzyme-linked immunosorbent assay (ELISA) test. The Scoring Atopic Dermatitis (SCORAD) index, the Urticaria Activity Score (UAS7), and the Visual Analogue Scale (VAS) were used to assess the disease activity and the pruritus intensity, respectively. Obtained results revealed that the IL-5R concentration was significantly higher in patients with CSU than in patients with AD and in the controls (p = 0.038). There was a positive correlation between the IL-5R level and the SCORAD index in patients with AD (r = −0.9, p = 0.047), which was not found for the CSU activity by UAS7 and with the pruritus severity by VAS in both examined groups of patients. Our findings underscore higher serum levels of IL-5R among CSU and AD patients, which may highlight its functional role in the pathogenesis of these diseases. In contrast, IL-5R might not be fully useful in reflecting the severity of symptoms. Although our results are promising, this study should be conducted on a larger cohort of patients. Full article
(This article belongs to the Special Issue Molecular Regulation in Inflammatory and Autoimmune Diseases)
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9 pages, 2578 KB  
Article
Blood Adhesion Molecules as Biomarkers in Children with Chronic Urticaria
by Ioanna Angeli, Emilia Vassilopoulou, Dimitrios Cassimos, Ioannis Fotopoulos, Anastasios Serbis, Makis Alexandros and Sophia Tsabouri
Children 2024, 11(4), 449; https://doi.org/10.3390/children11040449 - 8 Apr 2024
Cited by 1 | Viewed by 2188
Abstract
Background: The prevailing etiological model of both acute and chronic urticaria implicates specific allergen exposure that triggers the local release of vasoactive factors and inflammatory adhesion molecules, including vascular cell adhesion molecule 1 (VCAM-1), intercellular adhesion molecule 1 (ICAM-1), endothelial leukocyte adhesion molecule [...] Read more.
Background: The prevailing etiological model of both acute and chronic urticaria implicates specific allergen exposure that triggers the local release of vasoactive factors and inflammatory adhesion molecules, including vascular cell adhesion molecule 1 (VCAM-1), intercellular adhesion molecule 1 (ICAM-1), endothelial leukocyte adhesion molecule 1 (ELAM-1), P-selectin and E-selectin in the superficial dermis. This study focused on the possible role of VCAM-1 and ICAM-1 as biomarkers in children with acute and chronic urticaria. Methods: This study involved 184 children, 40 with acute urticaria, 71 with chronic urticaria, and 73 matched comparison subjects. The serum levels of ICAM-1 and VCAM-1 were determined in venous blood in all the participants on enrollment. Antihistamine treatment was administered to all the patients. In the children with chronic urticaria, the Urticaria Activity Score Questionnaire (UAS7) was completed daily by the parents. In 16 of the patients with acute urticaria and 43 with chronic urticaria, the serum levels of ICAM-1 and VCAM-1 were determined at follow-up after 6–8 weeks of treatment. Results: The mean serum levels of both VCAM-1 and ICAM-1 were higher in both groups of children with urticaria than in the comparison subjects at the start of the study. In the chronic urticaria group, the levels decreased significantly (p = 0.03 and p = 0.01, respectively) following treatment. Similarly, the acute urticaria group exhibited significant reduction in the mean levels of VCAM and ICAM (p < 0.001). In both groups, the mean level of ICAM after treatment was comparable with that of the comparison group. Conclusions: VCAM-1 and ICAM-1 are suggested as promising biomarkers for monitoring both acute and chronic urticaria in children. Future research should explore their utility in larger cohorts and investigate their role in personalized treatment strategies. Full article
(This article belongs to the Section Pediatric Allergy and Immunology)
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17 pages, 3928 KB  
Article
The Alarmin Triad—IL-25, IL-33, and TSLP—Serum Levels and Their Clinical Implications in Chronic Spontaneous Urticaria
by Carmen-Teodora Dobrican-Băruța, Diana Mihaela Deleanu, Ioana Adriana Muntean, Irena Nedelea, Radu-Gheorghe Bălan, Gabriela Adriana Filip and Lucia Maria Procopciuc
Int. J. Mol. Sci. 2024, 25(4), 2026; https://doi.org/10.3390/ijms25042026 - 7 Feb 2024
Cited by 18 | Viewed by 5400
Abstract
This study delves into the critical role of alarmins in chronic spontaneous urticaria (CSU), focusing on their impact on disease severity and the quality of life (QoL) of patients. We investigated the alterations in alarmin levels in CSU patients and their correlations with [...] Read more.
This study delves into the critical role of alarmins in chronic spontaneous urticaria (CSU), focusing on their impact on disease severity and the quality of life (QoL) of patients. We investigated the alterations in alarmin levels in CSU patients and their correlations with the Urticaria Activity Score (UAS7) and the Dermatology Life Quality Index (DLQI). We analyzed serum levels of interleukin-25 (IL-25), interleukin-33 (IL-33), and thymic stromal lymphopoietin (TSLP) in 50 CSU patients, comparing these to 38 healthy controls. The study examined the relationship between alarmin levels and clinical outcomes, including disease severity and QoL. Elevated levels of IL-33 and TSLP in CSU patients (p < 0.0001) highlight their potential role in CSU pathogenesis. Although IL-25 showed higher levels in CSU patients, this did not reach statistical significance (p = 0.0823). Crucially, IL-33’s correlation with both UAS7 and DLQI scores underscores its potential as a biomarker for CSU diagnosis and severity assessment. Of the alarmins analyzed, IL-33 emerges as particularly significant for further exploration as a diagnostic and prognostic biomarker in CSU. Its substantial correlation with disease severity and impact on QoL makes it a compelling candidate for future research, potentially serving as a target for therapeutic interventions. Given these findings, IL-33 deserves additional investigation to confirm its role and effectiveness as a biomarker and therapeutic target in CSU. Full article
(This article belongs to the Special Issue Advanced Research of Skin Inflammation and Related Diseases)
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