Urticaria Research Articles

Management of severe chronic spontaneous urticaria with omalizumab

Management of severe chronic spontaneous urticaria with omalizumab

The Efficacy and Safety of High Dose (10 mg) of Desloratadine (Dazit® 10) in the Treatment of Chronic Spontaneous Urticaria in India: A Phase III, Multicentric, Open-Label, Single-Arm Study.

Chronic spontaneous urticaria (CSU) is a debilitating affliction that affects diverse quality of life (QoL) parameters such as sleep, self-esteem, and daily activities. Second-generation antihistamines, such as desloratadine, are more effective and safer in managing CSU. Desloratadine is a nonsedating, potent, and highly selective H1 receptor antagonist. At its daily dose of 5 mg, almost half of CSU patients do not show symptomatic improvement. European Academy of Allergy and Clinical Immunology (EAACI)/Global Allergy and Asthma European Network (GA2LEN)/European Dermatology Forum (EDF) (EuroGuiDerm)/Asia Pacific Association of Allergy, Asthma and Clinical Immunology (APAAACI) guidelines recommend increasing the dosage to up to four times in such nonresponsive patients. However, there is insufficient clinical evidence in Indian settings. We evaluated the efficacy and safety of 10 mg desloratadine (OD) in 256 nonresponsive patients with moderate to severe CSU. The primary outcome was the change in Urticaria Activity Score (UAS7) from baseline to four weeks. Additionally, change in Chronic Urticaria Quality of Life (CU-Q2oL) scores during the course of treatment was also evaluated. The mean UAS7 scores showed a significant reduction from 31.9 ± 4.8 at baseline to 18.2 ± 8.1 at the end of the study (p < 0.0001). The use of a higher dose of desloratadine also decreased the CU-Q2oL scores significantly from 59.8 ± 14.7 at baseline to 35.4 ± 10 at four weeks (p < 0.0001). The incidence of adverse events (AEs) possibly linked to the drug was low (1.6%), and no serious adverse events were reported. Results indicated improvements in the disease severity as well as its positive impact on participants' QoL. This study confirms the efficacy and safety of daily use of a twofold dose of desloratadine in nonresponsive moderate to severe CSU patients.

The comparative burden of chronic spontaneous urticaria, atopic dermatitis and psoriasis in five European countries

AbstractBackgroundSkin diseases can have a significant impact on the physical, psychological and social well‐being of patients. Quantification of the burden of chronic spontaneous urticaria (CSU) compared to other dermatological conditions is limited.ObjectivesTo evaluate the comparative humanistic and economic burden of CSU, atopic dermatitis (AD), and psoriasis (PSO) in five European countries (EU5).MethodsThis cross‐sectional analysis compared data from adult respondents with a physician diagnosis of CSU, AD and PSO from the 2020 National Health and Wellness Survey in EU5 (France, Germany, Italy, Spain and the United Kingdom). Outcomes included Short Form (SF)‐12v2 [mental (MCS) and physical component (PCS) summary scores], SF‐6D, EQ‐5D, EQ‐Visual Analogue Scale (VAS), Dermatology Life Quality Index (DLQI), General Anxiety Disorder‐7 (GAD‐7), Patient Health Questionnaire‐9 (PHQ‐9), Work Productivity and Activity Impairment (WPAI) and healthcare resource utilization (HRU). Multivariable analyses comparing CSU to AD and PSO, respectively, were conducted for each outcome.ResultsThis analysis included 379 CSU, 788 AD and 2,636 PSO patients. Adjusted MCS and PCS scores were lower among CSU patients than AD (MCS, p = 0.006; PCS, p &lt; 0.001) and PSO (p &lt; 0.001 for all). SF‐6D and EQ‐5D scores were consistently lower among CSU patients versus AD and PSO (p &lt; 0.001 for all), whereas the EQ VAS was lower in CSU cohort versus PSO cohort (p = 0.003). Higher DLQI scores were reported in the CSU cohort versus AD and PSO (p &lt; 0.001 for both) and the proportion of patients with anxiety and depression, respectively, (GAD‐7 and PHQ‐9 scores ≥5) was greater among the CSU cohort versus AD and PSO (p &lt; 0.001 for all). Finally, higher HRUs and worse WPAI scores (p &lt; 0.005) were observed in the CSU cohort relative to AD and PSO cohort.ConclusionsCSU is associated with significantly worse health‐related quality of life, more mental comorbidities, negative impact on patients' daily lives and the ability to work, ultimately leading to higher HRU compared with AD and PSO.

Circulating basophils in patients with type IIb autoimmune chronic spontaneous urticaria have a lower histamine content

AbstractBackgroundPatients suffering from chronic spontaneous urticaria (CSU) are typically classified as type I or type IIb autoimmune CSU, but further patient stratification is hindered by the lack of biomarkers.ObjectivesWe investigated whether the histamine content of individual basophils differ between patient subtypes in CSU to evaluate its potential as a biomarker.MethodsA total of 101 patients diagnosed with CSU were included in the study. The histamine content per circulating basophil was derived from the basophil count in peripheral blood and levels of total cellular blood histamine. These measures, together with results from the serum‐induced basophil histamine release assay (s‐BHRA), were correlated to information on demographics, clinical characteristics, patient reported outcomes and laboratory analyses.ResultsThe histamine content per basophil was significantly different between s‐BHRA positive and ‐negative patients (0.175 vs. 1.40 pg/cell, p &lt; 0.001) and showed a significant negative correlation to the degree of basophil activation in s‐BHRA (ρ = −0.209, p = 0.036). Furthermore, the amount of histamine in individual basophils was found to be significantly correlated with levels of total cellular blood histamine (ρ = 0.376, p &lt; 0.001), eosinophil counts (ρ = 0.205, p = 0.040), levels of thyroid stimulating hormone (ρ = −0.246, p = 0.014) and titre of antibodies against thyroid peroxidase (ρ = −0.216, p = 0.031) and thyroglobulin (ρ = −0.203, p = 0.044).ConclusionsLow content of intracellular histamine in circulating basophils is associated with known markers of type IIb autoimmune CSU. Further studies are required to assess whether the amount of histamine in basophils can be used to monitor or predict response to treatment in patients.

Beyond skincare routines: Follow your gut to healthy skin – A review of the interplay between gut microbiome and skin

The gut microbiome, comprising trillions of microorganisms with diverse genetic material, plays a pivotal role in human health. Its impact on immunity, metabolism, and even psychological well-being has garnered significant attention. This review delves into the evolution of microbiome research, highlighting historic breakthroughs and modern revelations. The gut microbiota’s influence extends beyond digestion, impacting immune system development, hormone regulation, and maintenance of protective barriers. Disturbances in this balance, known as dysbiosis, can disrupt immune responses, fostering harmful bacteria over beneficial ones. Dysbiosis has been linked to various diseases, motivating exploration of the gut-skin axis. Research suggests that the gut microbiome significantly influences dermatological conditions. Imbalances can contribute to skin diseases like atopic dermatitis and psoriasis. Short-chain fatty acids produced by gut bacteria have anti-inflammatory effects and maintain skin health. Gut dysbiosis can lead to systemic inflammation, affecting skin physiology. Ultraviolet (UV) damage and skin aging are also affected by the gut microbiome. Studies reveal that certain Lactobacillus strains, ingested orally, possess anti-inflammatory properties, mitigating UV-induced skin aging. Moreover, supplementation with specific bacteria enhances skin elasticity and hydration. Conditions such as rosacea, hidradenitis suppurativa, and chronic spontaneous urticaria have been linked to gut dysbiosis. Research indicates a potential for treatments that target the gut microbiome, such as fecal microbiota transplantation and probiotics, to alleviate dermatological disorders. In conclusion, the gut microbiome exerts a profound influence on skin health and diseases. Its intricate interactions with the immune system, systemic inflammation, and barrier maintenance underscore its significance. Harnessing these insights could lead to innovative therapies for various skin conditions, paving the way for enhanced well-being.

Management of Atopy with Dupilumab and Omalizumab in CADINS Disease.

The caspase activation and recruitment domain 11 (CARD11) gene encodes a scaffold protein required for lymphocyte antigen receptor signaling. Dominant-negative, loss-of-function (LOF) pathogenic variants in CARD11 result in CARD11-associated atopy with dominant interference of NF-κB signaling (CADINS) disease. Patients with CADINS suffer with severe atopic manifestations including atopic dermatitis, food allergy, and chronic spontaneous urticaria in addition to recurrent infections and autoimmunity. We assessed the response of dupilumab in five patients and omalizumab in one patient with CADINS for the treatment of severe atopic symptoms. CARD11 mutations were validated for pathogenicity using a T cell transfection assay to assess the impact on activation-induced signaling to NF-κB. Three children and three adults with dominant-negative CARD11 LOF mutations were included. All developed atopic disease in infancy or early childhood. In five patients, atopic dermatitis was severe and recalcitrant to standard topical and systemic medications; one adult suffered from chronic spontaneous urticaria. Subcutaneous dupilumab was initiated to treat atopic dermatitis and omalizumab to treat chronic spontaneous urticaria. All six patients had rapid and sustained improvement in atopic symptoms with no complications during the follow-up period. Previous medications used to treat atopy were able to be decreased or discontinued. In conclusion, treatment with dupilumab and omalizumab for severe, refractory atopic disease in patients with CADINS appears to be effective and well tolerated in patients with CADINS with severe atopy.

Comparison of Study Designs for Primary Phase III Trials for Omalizumab Versus Dupilumab for Patients With Chronic Spontaneous Urticaria

Introduction&#x0D; Omalizumab is currently the only biologic approved and recommended as second-line treatment for patients with chronic spontaneous urticaria (CSU). However, clinical trial programs are underway for other biologic treatments such as dupilumab. Given head-to-head trials will not be conducted, consideration of study design may be important.&#x0D; Methods&#x0D; Comparison of participants, interventions, outcomes, and results for phase III primary efficacy clinical trials for omalizumab versus dupilumab for patients with CSU. The omalizumab trials were ASTERIA I/II (NCT01287117 and NCT01292473) and the dupilumab trial was LIBERTY-CSU CUPID (NCT04180488) that consisted of Study A, B, and C.&#x0D; Results&#x0D; Participants in ASTERIA I/II were 12 to 75 years with a diagnosis of CSU refractory to H1 antihistamines. Participants in LIBERTY-CSU CUPID were 6 to 80 years (Study A and C) or 12 to 80 years (Study B) with a diagnosis of CSU refractory to H1 antihistamines, and Urticaria Activity Score (UAS)7≥16 and Itch Severity Score (ISS)7≥8 during the 7 days before randomization; Study A and C included participants who were omalizumab naïve and Study B included intolerant or incomplete responders to omalizumab. For ASTERIA I and II, the interventions were placebo or omalizumab (75mg, 150mg, 300mg) every 4 weeks for 24 and 12 weeks, respectively. For LIBERY-CSU CUPID, the interventions were placebo or dupilumab (200mg or 300mg, weight based) every 2 weeks for 24 weeks. The primary efficacy outcome for ASTERIA I/II was change from baseline in ISS7 at Week 12. The primary efficacy outcome for LIBERTY-CSU CUPID was change from baseline in ISS7 at Week 24. For the ASTERIA I primary outcome, the change from baseline in ISS7 at Week 12 was -3.6 for placebo and -6.5, -6.7, and ‑9.4 for omalizumab 75mg, 150mg, and 300mg, respectively. For the ASTERIA II primary outcome, the change from baseline in ISS7 at Week 12 was -5.1 for placebo and ‑5.9, ‑8.1, and ‑9.8 for omalizumab 75mg, 150mg, and 300mg, respectively. For the LIBERTY-CSU CUPID Study A primary outcome, the change from baseline in ISS7 at Week 24 was ‑6.0 for placebo and -10.2 for dupilumab. The LIBERTY-CSU CUPID Study B was stopped due to futility based on a pre-specified interim analysis.&#x0D; Conclusion&#x0D; Comparing study designs for primary clinical trials for omalizumab and dupilumab for patients with CSU will aid in the comparative analysis and clinical evaluation of final trial results.&#x0D; Funding: ASTERIA I/II were funded by Genentech Inc. and Novartis Pharma AG.

Oral tofacitinib in refractory chronic spontaneous urticaria

Chronic spontaneous urticaria (CSU) is a skin condition marked by the emergence of wheals on their own that persist for six weeks or more. CSU is quite common, affecting up to 1% of the population, and has a serious detrimental effect on a patient's health and quality of life. Antihistamines (AH) are currently the backbone of treatment for chronic urticaria (CU), however up to 40% of patients do not respond to even large (four-fold) daily dosages of AH. Tofacitinib is a small-molecule that inhibits intracellular signalling of several important cytokines involved in the inflammatory cascade and blocks JAK1/3. While there are reports of tofacitinib's positive effects in patients with mast cell activation disorder, there are none in those with urticaria. The aim of our study is to assess the efficacy of oral tofacitinib in refractory chronic spontaneous urticaria. 5 cases of refractory CSU between the age group of 20 to 40 years were included in our study and they were followed up for 6 months. The patients were started on oral tofacitinib 5mg twice a day. On every weekly follow-up, we used clinical assessment, urticaria activity score and urticaria control test to evaluate the treatment response The usage of oral tofacitinib significantly improves the clinical picture in refractory CSU. Although more research is required to determine Tofacitinib's effectiveness in CSU, our study raises the possibility that it could represent a novel therapeutic option for individuals with refractory CSU.

A prospective observational study correlating possible novel biomarkers with disease severity and antihistamine response in chronic spontaneous urticaria.

Role of complement fraction 5a (C5a), interleukin (IL)-9, and apolipoprotein (apo) A-IV as biomarkers of disease severity and antihistamine response in chronic spontaneous urticaria (CSU) remains elusive. To identify the role of C5a, IL-9, and apo A-IV as potential biomarkers in predicting disease severity and antihistamine response in CSU patients. This was a prospective observational study of 95 patients and 42 controls. Serum analysis of C5a, IL-9, and apo A-IV was done using enyzme linked immunosorbent assay kits. Also, serum IgE and anti-thyroid peroxidase (TPO) levels were assessed in all patients. All patients were started on oral levocetirizine 5 mg at baseline and dose was titrated upwards to maximum of 20 mg based on response. Patients were categorized into antihistamine responders or nonresponders as per their disease response. Serological markers, serum IgE, and anti-TPO were correlated with baseline disease severity and antihistamine response. C5a levels were significantly higher in cases as compared to controls (P = 0.004). Significantly higher IL-9 levels were observed in antihistamine responders than nonresponders (P = 0.008). Baseline urticaria severity demonstrated a statistically significant positive and negative correlations with IL-9 (ρ = 0.277, P = 0.007) and apo A-IV (ρ = -0.271, P = 0.008) levels, respectively. Levels of serum IgE (P = 0.031) and anti-TPO (P = 0.039) were significantly higher in antihistamine nonresponders compared to responders. IL-9 and apo A-IV might be potential novel biomarkers to predict urticaria severity. Higher IL-9 might be a predictor of antihistamine response. Elevated anti-TPO and serum IgE might predict poor antihistamine response.

Evaluation of Pediatric Chronic Urticaria with Emphasis on Clinical and Laboratory Characteristics and Treatment Response to Omalizumab: A Real-Life Experience from a Tertiary Allergy Center.

Pediatric data on the clinical and etiologic features, treatment response, and use of omalizumab for chronic urticaria (CU) are quite limited. The aim of this study was to evaluate the clinical and demographic characteristics, laboratory findings, and response to treatment of CU in children. Children with a diagnosis of CU between 2019 and 2023 were included in the study. Information on demographic characteristics, clinical features, laboratory tests, provocation tests for inducible urticaria, urticaria activity scores (UAS7), and treatment responses were obtained from patients' medical records. A total of 150 children (50.7% male) with CU were enrolled in the study. A total of 14 (9.3%) patients had autoimmune diseases of which 11 (7.3%) had autoimmune thyroiditis. Overall, 97 (64.7%) patients had chronic spontaneous urticaria (CSU) and 53 (35.3%) had chronic inducible urticaria. A total of 16 patients who remained symptomatic despite high-dose antihistamines were treated with omalizumab, with a good response in 13 (81.3%) and a partial response in 3 (18.7%) patients. CSU accounts for the majority of pediatric CU, with the etiology being in part related to an autoimmune background. This study provides an overview of CU in children and demonstrates the safety and efficacy of treatment with omalizumab.

Features of the clinical course and treatment of anaphylaxis in children in the Ryazan region according to survey data

Anaphylaxis is a life-threatening systemic hypersensitivity reaction with the rapid development of critical changes in hemodynamics and /or disorders of the respiratory system, which can lead to death. Despite the trend towards the spread of anaphylaxis among children, there are difficulties in monitoring statistical data, since there is no generally accepted cipher “Anaphylaxis” in the ICD-10, and designations from allergic urticaria to anaphylactic shock appear as a diagnosis. Epidemiological studies on anaphylaxis in the Russian Federation are isolated, so the assessment of data from each region is relevant.Objective: to study the clinical features and medical care for anaphylaxis in children of the Ryazan region in real clinical practice.Materials and methods: A retrospective analysis of medical documentation was carried out in 300 children who had suffered an “acute allergic reaction” over the past 5 years, followed by a telephone survey of patients’ parents about the disease, and based on the clinical criteria for the diagnosis of anaphylaxis presented by the World Organization of Allergists (WAO) in 2020 and in the Federal Clinical Guidelines for the Diagnosis and Treatment of anaphylaxis, 57 patients were selected for anaphylactic shock of the Russian Federation in 2022, whose data were compared in a spreadsheet and analyzed using SPSS V24.0, including descriptive statistics.Results: It was revealed that the average age of first—time anaphylaxis is 3.5 years. Clinical manifestations from the skin and mucous membranes were present in 67.2 % of patients, symptoms from the respiratory system in 11.8 % of cases. The leading trigger for the occurrence of anaphylaxis in children is the nutritional factor (n = 27 (40 %), (χ2 = 4.56; p = 0.033)). In 29 % of cases, the causally significant allergen remained unknown. The most common drugs in the treatment of anaphylaxis in real clinical practice were glucocorticosteroids (n = 48 (84.2 %)) and antihistamines of the first and second generation (n = 47 (82.5 %)). The frequency of epinephrine use was only 3 cases (5 %).Conclusion: The epidemiological study of anaphylaxis in the Ryazan region was a pilot project for our region. It showed difficulties both in the organization and in the interpretation of the data obtained. According to preliminary results, food allergy is a frequent trigger of anaphylaxis in children of the Ryazan region. Regional studies of anaphylaxis in children in real clinical practice make it possible to identify not only the features of this urgent pathology, but also to note the problems of providing primary medical care in order to improve it. Further study of population models of anaphylaxis, apparently, should be based on the creation of a unified questionnaire of the pediatric community, following the example of the ISAAC questionnaires or the creation of registers, which will more accurately help determine the true prevalence of anaphylaxis, determine the need to identify anaphylactogenic relevant molecules in the pediatric population, and improve the provision of assistance to children with these conditions.

Solar urticaria involves rapid mast cell STAT3 activation and neutrophil recruitment, with FcεRI as an upstream regulator

Solar urticaria is a rare photodermatosis characterized by rapid-onset sunlight-induced urticaria, but its pathophysiology is not well understood. We sought to define cutaneous cellular and molecular events in the evolution of solar urticaria following its initiation by solar-simulated UV radiation (SSR) and compare with healthy controls (HC). Cutaneous biopsy specimens were taken from unexposed skin and skin exposed to a single low (physiologic) dose of SSR at 30 minutes, 3 hours, and 24 hours after exposure in 6 patients with solar urticaria and 6 HC. Biopsy specimens were assessed by immunohistochemistry and bulk RNA-sequencing analysis. In solar urticaria specimens, there was enrichment of several innate immune pathways, with striking early involvement of neutrophils, which was not observed in HC. Multiple proinflammatory cytokine and chemokine genes were upregulated (including IL20, IL6, and CXCL8) or identified as upstream regulators (including TNF, IL-1β, and IFN-γ). IgE and FcεRI were identified as upstream regulators, and phosphorylated signal transducer and activator of transcription 3 expression in mast cells was increased in solar urticaria at 30 minutes and 3 hours after SSR exposure, suggesting a mechanism of mast cell activation. Clinical resolution of solar urticaria by 24 hours mirrored resolution of inflammatory gene signature profiles. Comparison with available datasets of chronic spontaneous urticaria showed transcriptomic similarities relating to immune activation, but several transcripts were identified solely in solar urticaria, including CXCL8 and CSF2/3. Solar urticaria is characterized by rapid signal transducer and activator of transcription 3 activation in mast cells and involvement of multiple chemotactic and innate inflammatory pathways, with FcεRI engagement indicated as an early event.

P04 A Complex Case of Urticaria

Abstract An 11 year old female, with Type 1 diabetes and no previous atopy or allergy , presented with a 6 week history of facial swelling and a generalised urticaria on the trunk and limbs. She had been seen privately by “Allergy” clinic and diagnosed with chronic spontaneous urticaria with angioedema. Blood tests for common allergens were negative, with a total IgE &amp;lt;20 kU/L. Treatment with Loratadine, Cetirizine 10mg, Fexofenadine 120mg QDS, Acrivastine 8mg BD, Montelukast 10mg OD and prednisolone 20mg OD had only a limited effect. Skin biopsy confirmed urticaria with no evidence of vasculitis. Immunology bloods were negative. Despite reporting compliance, she continued to experience debilitating symptoms with raised UAS scores. Desloratadine 2.5mg BD and multiple intermittent short courses of prednisolone were needed. Omalizumab was started at 300mg monthly for 6 months with partial improvement. However symptoms flared on cessation and following tertiary advice, a 2nd course of Omalizumab was commenced at 300 mg s/c monthly for 3 months &amp; 300mg s/c fortnightly for 3 months with the addition of 100mg BD Ciclosporin and Famotidine 10mg BD. Ciclosporin was discontinued after 1 month due to side effects and substituted with Methotrexate 15mg OW. If control is not obtained, management plans include Mycophenolate Mofetil, or trialing omalizumab 450mg S/C monthly. This is a case of extremely difficult to control urticaria in a child highlighting available systemic treatment options1.

Gut microbiota facilitate chronic spontaneous urticaria

Chronic spontaneous urticaria (CSU) comes with gut dysbiosis, but its relevance remains elusive. Here we use metagenomics sequencing and short-chain fatty acids metabolomics and assess the effects of human CSU fecal microbial transplantation, Klebsiella pneumoniae, Roseburia hominis, and metabolites in vivo. CSU gut microbiota displays low diversity and short-chain fatty acids production, but high gut Klebsiella pneumoniae levels, negatively correlates with blood short-chain fatty acids levels and links to high disease activity. Blood lipopolysaccharide levels are elevated, link to rapid disease relapse, and high gut levels of conditional pathogenic bacteria. CSU microbiome transfer and Klebsiella pneumoniae transplantation facilitate IgE-mediated mast cell(MC)-driven skin inflammatory responses and increase intestinal permeability and blood lipopolysaccharide accumulation in recipient mice. Transplantation of Roseburia hominis and caproate administration protect recipient mice from MC-driven skin inflammation. Here, we show gut microbiome alterations, in CSU, may reduce short-chain fatty acids and increase lipopolysaccharide levels, respectively, and facilitate MC-driven skin inflammation.

Assessment of Serum Zonulin Levels in Individuals Diagnosed With Chronic Spontaneous Urticaria.

There have been reports indicating a correlation between heightened intestinal permeability and many autoimmune and chronic inflammatory disorders. The involvement of autoimmunity is now recognized as a significant factor in the development of chronic spontaneous urticaria (CSU). Zonulin is an important biomarker that regulates tight junction permeability within cells in the gastrointestinal tract, hence facilitating intestinal permeability. To evaluate the correlation of CSU with intestinal permeability by measuring the serum levels of zonulin in patients diagnosed with CSU. The study included 60 patients diagnosed with CSU and 64 age- and sex-matched healthy individuals as controls. Levels of serum zonulin were determined using the ELISA method. Although the serum zonulin value of the patients was higher compared to the controls, the difference did not reach a significant level (24.65±8.49 ng/ml vs. 21.03±7.36 ng/ml, p=0.077). The serum zonulin level had a significant correlation with the urticaria activity score in the CSU group (p=0.013). The results of the current study revealed that serum zonulin values significantly differed between patients with CSU and healthy controls. This study is important in terms of being the first to investigate the serum zonulin levels in CSU. However, there is a need for further studies with larger patient groups.

Serum ferritin levels in chronic spontaneous urticaria in association with autologous serum skin test: A cross-sectional study

Abstract BACKGROUND: Chronic spontaneous urticaria (CSU) is a common clinical condition presenting with wheals or along with angioedema. It has a complex pathogenesis having a considerable impact on quality of life. In patients with chronic spontaneous urticaria (CSU) exhibiting poor response to conventional treatments, the presence of hyposiderinemia suggests that oral iron therapy could potentially lead to resolution of the urticaria symptoms. OBJECTIVES: (1). To estimate serum ferritin levels in patients with CSU. (2) To assess the correlation between urticarial activity score, autologous serum skin test (ASST), and serum ferritin levels in CSU. MATERIALS AND METHODS: This prospective study enrolled 37 cases of clinically diagnosed CSU attending the dermatology outpatient department from December 2019 to November 2020 after Institutional Ethics Committee approval. ASST and serum ferritin level estimation were done on all patients. The severity of urticaria was calculated using the Urticaria Activity Score. Statistical analysis was done by frequency, standard deviation, and Chi-square test. RESULTS: Among ASST-positive patients, only 4 (19%) had low ferritin levels. No association was found between ASST and serum ferritin levels (P = 0.342). Mean serum ferritin levels in ASST-positive patients were high 91.34 ± 87.24 μg/L which was statistically significant compared to mean serum ferritin levels in ASST-negative patients 49.64 ± 46.91 μg/L. There was significant involvement of palms and soles in ASST-positive patients (P = 0.038). CONCLUSION: Although there was no significant correlation of serum ferritin levels with CSU, oral iron supplementation may be considered an add-on treatment in case of refractory urticaria.

The effectiveness of omalizumab therapy in patients with chronic spontaneous urticaria: the experience of a single-centre study in Poland.

Omalizumab, which is a recombinant, humanised anti-immunoglobulin-E antibody, is the only approved drug for antihistamine refractory chronic spontaneous urticaria (CSU). It has been reported that it is an effective and safe drug, but the data about long-term effectiveness are still lacking. To perform a retrospective analysis of the patients with CSU treated with omalizumab at the dermatology department to assess effectiveness of omalizumab therapy in the single centre in Poland. A two-and-a-half-year retrospective analysis of patients with CSU undergoing the therapy with omalizumab was conducted. Patients' data were analysed for many factors such as age, gender, severity indexes (UAS7, DLQI), duration and effects of the treatment used. Sixty-one patients with CSU have been treated with omalizumab in the drug program. The number of female patients - 42 (68.9%) significantly dominated over the number of male patients - 19 (31.1%). The mean UAS7 during the first course of treatment declined from 33.2 to 2.8, during the second from 30.9 to 1.7 and during the third 32.7 to 2.5. In case of DLQI the mean scores decrease from 18 to 2.1 in the first cycle, from 16.9 to 1.9 in the second and from 18.6 to 1.1 in the third. Our study confirmed that omalizumab is an effective medicine in a long-term treatment which improves a physical as well as psychological condition of the patients with antihistamine-resistant CSU. To our knowledge, it is the first study in Poland that presents omalizumab effectiveness during three courses of treatment.

Evaluating the impact of Gayatri Mantra chanting and meditation on treatment outcomes in patients with chronic spontaneous urticaria: A prospective study

ABSTRACT Background: Chronic spontaneous urticaria (CSU) is a long-lasting skin condition marked by the appearance of hives and angioedema, which significantly impacts quality of life. Despite standard pharmacotherapies, many patients remain symptomatic, necessitating the exploration of complementary treatments. This study examines the effects of integrating Gayatri Mantra (GM) chanting and meditation with conventional pharmacotherapy on CSU management. Materials and Methods: This study was conducted at the Diabetes and Allergy Asthma Therapeutics Specialty Clinic in Kolkata, India, this prospective observational study included 119 patients with CSU who had been on antihistamines for at least 6 months. Participants were randomized into two groups: Group A received standard pharmacotherapy, and Group B received the same pharmacotherapy along with daily GM chanting and meditation. Primary outcomes measured were the Urticaria Activity Score 7 (UAS7), Beck Anxiety Inventory (BAI), Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), and Dermatology Life Quality Index (DLQI) assessed at baseline and after 6 months. Results: Both groups showed significant improvements in UAS7, CU-Q2oL, and DLQI scores posttreatment. However, Group B, which participated in GM chanting and meditation, exhibited more pronounced improvements: UAS7 scores were reduced by 49.4% compared to 41.9% in Group A; CU-Q2oL scores by 52.9% compared to 42.5%; and DLQI scores by 73.7% compared to 60.5%. The reductions in BAI scores were also significantly greater in Group B (42.3% reduction) compared to Group A (4.96%). Conclusion: The addition of GM chanting and meditation to standard pharmacotherapy for CSU significantly enhances the effectiveness of treatment, suggesting that this integrative approach could provide substantial benefits in the management of CSU. These findings advocate for the incorporation of spiritual and meditative practices alongside conventional medical treatments to achieve better patient outcomes.

Chronic spontaneous urticaria: Evidence of systemic microcirculatory changes.

Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease where activation of endothelial cells (ECs) at sites of skin lesions leads to increased blood flow, leakage of fluid into the skin, cellular infiltration, and vascular remodeling. To understand the disease duration and the sometimes vague systemic symptoms accompanying flares, the objective of this study was to examine if CSU comes with systemic vascular changes at the microcirculatory level. We investigated CSU patients (n=49) and healthy controls (HCs, n=44) for microcirculatory differences by nailfold videocapillaroscopy (NVC) and for blood levels of the soluble EC biomarkers serum vascular endothelial growth factor (VEGF), soluble E-selectin, and stem cell factor (SCF). Patients were also assessed for clinical characteristics, disease activity, and markers of autoimmune CSU (aiCSU). CSU patients had significantly lower capillary density, more capillary malformations, and more irregular capillary dilations than HCs on NVC. Serum levels of VEGF, soluble E selectin and SCF were similar in CSU patients and HCs. CSU patients with higher VEGF levels had significantly more abnormal capillaries. Patients with markers of aiCSU, that is, low IgE levels or increased anti-TPO levels, had significantly more capillaries and less capillary dilations than those without. Our results suggest that CSU comes with systemic microcirculatory changes, which may be driven, in part, by VEGF.

The Correlation between Serum Vitamin D and Total IgE Levels and Chronic Spontaneous Urticaria among Chinese Population: A Retrospective Study.

This study aims to investigate the relationship between serum vitamin D, total IgE levels and chronic spontaneous urticaria (CSU). We collected data from 101 patients with chronic spontaneous urticaria (experimental group) and 115 healthy normal subjects (control group) in the same period of physical examination. The results showed that the number of deficient and absolute deficient 25-hydroxyvitamin D in the experimental group was significantly lower than in the control group (P < 0.05). Pearson correlation analysis showed that the activity score of CSU patients was negatively correlated with serum vitamin D (r = -0.2278, P = 0.0220) and positively correlated with IgE (r = 0.2078, P = 0.0380). It was observed that serum vitamin D in CSU patients was negatively correlated with their activity (r = -0.2278, P = 0.0220) and positively correlated with age (r = 0.2675, P = 0.0069). The Point-biserial correlation analysis revealed that gender was positively correlated with serum vitamin D (Pearson correlation coefficient = 0.286, P = 0.004) and UAS score (Pearson correlation coefficient = 0.273, P = 0.006). Ordinal logistic regression analysis showed that only serum vitamin D was correlated to activity scores (P = 0.008). In addition to activity scores, age (P = 0.005) and gender (P = 0.04) were correlated to serum vitamin D. The activity score of CSU patients was negatively correlated with serum vitamin D and positively correlated with IgE. Serum vitamin D in CSU patients was negatively correlated with activity score and disease duration and positively correlated with age and gender.