Treatment Of Chronic Spontaneous Urticaria Research Articles

Comparative analysis of clinical efficacy and safety of omalizumab biosimilar in the treatment of patients with chronic spontaneous urticaria

BACKGROUND: Importance of optimizing strategy for treatment of chronic spontaneous urticaria is highly becoming relevance for the clinicians. Nowadays monoclonal antibodies are preferred option of treatment the refractory chronic spontaneous urticaria, main of that is omalizumab.
 AIM: to establish comparative analysis of the efficacy and safety of Genolair (JSC Generium, Russia) and Xolair (Novartis Pharma AG, Switzerland) in the treatment of patients with chronic spontaneous urticaria.
 MATERIALS AND METHODS: A 36-week, open parallel-group study was conducted. Were included 43 adult patients with chronic spontaneous urticaria who were resistant to ongoing therapy with standard and escalated doses of second-generation H1-antihistamines. All patients were divided into 2 groups: the main group (MG; n=18) ― patients who administrated Genolair; the comparison group (CG; n=25) ― patients who firstly administrated Xolair and then switching therapy to Genolair. Throughout the study period, patients completed questionnaires on the assessment of disease activity (UAS 7), urticaria control (UCT), quality of life index (DLQI). Additionally, the level of total IgE in blood serum was assessed. For statistical data processing, EXCEL 2010 and STATISTICA 7.0 software packages were used.
 RESULTS: After 4 weeks from the start of monoclonal antibody therapy, patients in both groups were responders to omalizumab. At the same time, there were no significant differences when comparing scores on the UAS 7, UCT scale between patients of the MG and the CG during the entire observation period (p 0.05). The change in treatment paradigm in CG also did not have a statistically significant effect on the indicators of urticaria activity and disease control (p 0.05). At the same time, the quality of everyday life changed more positively in the MG, which was reflected in a more pronounced change in the DLQI index at the time of the control assessment since 20 weeks of therapy (p=0.032). An increase in the level of total IgE in the blood serum of all patients with chronic spontaneous urticaria after the initiation of a course of immunobiological therapy was demonstrated, while there were no statistically significant intergroup differences in relation to changes in this laboratory parameter (p 0.05).
 CONCLUSION: During the treatment of patients with severe chronic spontaneous urticaria, resistant to ongoing therapy with standard and escalated doses of second-generation H1-antihistamines, comparable clinical efficacy and safety of the study drug Genolair and the reference drug Xolair were shown.

Prevalence and treatment of Chronic Spontaneous Urticaria in Children

This literature review investigates the prevalence of Chronic Spontaneous Urticaria (CSU) in children, drawing from 15 articles found in PubMed and EMBASE databases, all published in English. Despite CSU being commonly associated with adults, the selected studies consistently demonstrate its presence in pediatric populations. Prevalence rates vary by region, with Western countries reporting figures between 0.1% to 0.3% among children, while some Asian populations exhibit higher rates. These discrepancies may stem from genetic, environmental, and ethnic factors. Additionally, the review emphasizes the substantial impact of CSU on children's lives, disrupting sleep, daily activities, and emotional well-being. Comorbidities, including other allergic diseases, are also prevalent among pediatric CSU cases, necessitating comprehensive clinical assessments and integrated management. The review addresses diagnostic challenges, stressing the importance of accurate differentiation from other urticarial conditions and systemic disorders. It explores evolving insights into CSU's pathophysiology in children, with emerging research implicating autoimmunity and chronic inflammation. In this review reaffirms that CSU affects children, with varying prevalence rates worldwide. It underscores the substantial burden on affected children and the need for accurate diagnosis, multidisciplinary care, and further research to understand CSU's mechanisms and risk factors in children better, ultimately improving their quality of life and outcomes.

Involvement of CCL2 and CH25H Genes and TNF signaling pathways in mast cell activation and pathogenesis of chronic spontaneous urticaria.

Chronic spontaneous urticaria (CSU), a mast cell-driven disease, substantially affects the quality of life. While genetics affect CSU susceptibility and severity, the specific genetic factors associated with mast cell activation in CSU remain elusive. We aimed to identify key genetic factors and investigate their roles in CSU pathogenesis. Two gene expression datasets from the Gene Expression Omnibus were merged and validated using principal component analysis and boxplots. The merged dataset was subjected to limma and weighted gene co-expression network analyses. Genes whose expression correlated highly with CSU were identified and analyzed using Gene Set Enrichment Analysis (GSEA), Gene Ontology (GO), and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses. As GSEA, GO, and KEGG analyses highlighted the importance of chemokine (C-C motif) ligand 2 (CCL2) and cholesterol 25-hydroxylase (CH25H) gene and tumor necrosis factor (TNF) signaling pathways in CSU; the three corresponding genes were knocked down in human mast cell line-1 (HMC-1), followed by incubation with thrombin to mimic CSU pathogenesis. CCL2, CH25H, and TNF knockdown reduced excitability and cytokine production in HMC-1. Our findings suggest that genes involved in the CCL2, CH25H, and TNF pathways play crucial roles in CSU pathogenesis, providing insights into potential therapeutic targets for CSU treatment.

Effects of the immunoglobulin/histamine complex on panic disorder concurrent with chronic spontaneous urticaria: a case report

BackgroundPanic disorder and panic attacks are two of the most common problems in psychiatry. A psychoimmunological correlation between allergic diseases and panic disorder has been strongly suggested. Histamine H1 receptor antagonists have been suggested as alternative drugs for the treatment of panic disorder. Chronic spontaneous urticaria (CSU) and panic disorder improved simultaneously with selective serotonin reuptake inhibitor antidepressants. Panic disorder has also been treated with the antihistamine chlorpheniramine. The immunoglobulin/histamine complex is a histamine-fixed immunoglobulin preparation that was reported to be effective in treating CSU. This case report describes the successful treatment of a patient with concomitant panic disorder and CSU for 23 years using immunoglobulin/histamine complex therapy.Case presentationThis report describes a 52-year-old female Korean patient who suffered from CSU with panic disorder for 23 years. Basic allergy tests (blood tests and skin prick tests) were conducted before and after treatment for the evaluation of allergic conditions. A multiple allergosorbent test (MAST) for the detection of allergen-specific IgE levels was also performed. The clinical severity of CSU was evaluated using the urticaria severity score system. Diagnostic interviews systematically assessed the diagnostic criteria outlined by the DSM-V, and the patient was evaluated before, during and after treatment using the Beck Depression Inventory (BDI-2) for depression, the State-Trait Anxiety Inventory (STAI) for anxiety and the Beck Hopelessness Score (BHS) for hopelessness. The patient received 2 ml of Histobulin™ (12 mg human immunoglobulin/0.15 µg histamine complex) once a week by subcutaneous injection for the treatment of CSU. Initial improvement of CSU was achieved after the third injection. After the twenty-seventh injection of Histobulin™, she showed no symptoms or signs and ceased allergic medication use. With the remission of CSU, allergic rhinitis was also completely resolved. The frequency of the common cold was significantly decreased during and after treatment. The medication frequency and development of clinical manifestations of panic disorder changed in parallel with the clinical severity of CSU. Moreover, the patient exhibited no clinical manifestations and ceased medication for panic disorder and sleeping pills for insomnia simultaneously with the remission of CSU. In the psychological evaluation, the BDI, STAI and BHS scores improved accordingly.ConclusionsThe immunoglobulin/histamine complex was effective in treating CSU and concomitant panic disorder in this patient and could be effective in treating some types of panic disorder. Considering the mechanisms of action of histamine and the immunoglobulin/histamine complex together with the patient’s clinical progress, histamine seemed to be related to panic disorder in this case. The concept of histamine-mediated syndromes, including allergies and psychiatric disorders, shows that a wider disease identity may be needed. Further studies on the immunopathogenesis of panic disorder and the mechanisms of action of the immunoglobulin/histamine complex are necessary.

Basophil Characteristics as a Marker of the Pathogenesis of Chronic Spontaneous Urticaria in Relation to the Coagulation and Complement Systems.

Chronic spontaneous urticaria (CSU) is a common skin disorder characterized by daily or almost daily recurring skin edema and flare with itch and pruritus anywhere on the body for more than 6 weeks. Although basophil- and mast cell-released inflammatory mediators, such as histamine, play important roles in the pathogenesis of CSU, the detailed underlying mechanism is not clear. Since several auto-antibodies, IgGs which recognize IgE or the high-affinity IgE receptor (FcεRI) and IgEs against other self-antigens, are detected in CSU patients, they are considered to activate both mast cells in the skin and basophils circulating in the blood. In addition, we and other groups demonstrated that the coagulation and complement system also contribute to the development of urticaria. Here, we summarized the behaviors, markers and targets of basophils in relation to the coagulation-complement system, and for the treatment of CSU.

Association of Gut Lachnospiraceae and Chronic Spontaneous Urticaria.

(1) Background: Chronic spontaneous urticaria (CSU) has been linked to the dysbiosis of the gut microbiota. Furthermore, various studies have highlighted the anti-inflammatory properties of short-chain fatty acids (SCFAs), whose production is primarily regulated by the gut microbiota. However, only a few studies have investigated the role of major SCFA producers, such as Lachnospiraceae, in skin inflammatory diseases. (2) Goal: This study aimed to compare the abundance of Lachnospiraceae between CSU patients and healthy controls (HCs). (3) Material and methods: In this case-control study, 16S rRNA sequencing was performed to compare the composition of the gut microbiome between 22 CSU patients and 23 HCs. (4) Results: Beta-diversity revealed significant clustering (p < 0.05) between the CSU patients and HCs. Alpha diversity in the CSU group was significantly decreased according to the Evenness index (p < 0.05). The linear discriminant analysis effect size (LEfSe) identified the significant depletion of the Lachnospiraceae family in CSU patients. (5) Conclusion: Our study revealed the dysbiosis of the gut microbiota in CSU patients, including decreased levels of Lachnospiraceae members, responsible for SCFA production, suggesting that SCFAs may contribute to immune dysfunction in the pathogenesis of CSU. We speculate that the modulation of SCFAs could serve as a prospective additional option in CSU treatment.

Management of Autoimmune urticaria in a patient with Myasthenia Gravis, a challenging case.

The pathophysiology of chronic spontaneous urticaria (CSU) is not yet fully understood; however, increasing evidence supports the association between CSU and autoimmunity. Myasthenia gravis (MG) is an autoimmune neuromuscular disorder. MG management relies on using immunosuppressants and avoiding certain medications that can precipitate an MG crisis. The coexistence of CSU and MG was described in the literature on elderly patients. Herein we present a challenging case regarding the management of CSU in a young female with MG. A 22-year-old lady known to have Myasthenia gravis post thymectomy, with a history of multiple MG crises, presented to the Allergy Clinic with recurrent itchy hives typical for urticaria without associated angioedema. Despite being on Azathioprine and low-dose steroids for MG treatment, she had an active CSU disease, UAS7:32, UCT: 5. The neurologist advised against the use of regular oral antihistamines because they might exacerbate MG. Although we do not have serum autologous skin testing, basophil activation test, or IgG autoantibodies for a definitive definition of autoimmune CSU (aiCSU), the patient has some features supporting the diagnosis of aiCSU (see Table 1). In addition, she has a normal total IgE level, normal C3, C4, negative RF, ANA, ANCA, anti-TPO, and anti-thyroglobulin antibodies. After the discussion with the neurologist, we started her on Omalizumab 300 mg every four weeks, which was increased to 450 mg every two weeks with partial control of CSU. She was started on rituximab to treat MG with improvement in CSU. To the best of our knowledge, limited data describing the association between MG and CSU in young patients. Moreover, there is insufficient data on the safety of antihistamines in patients with MG, which are the first line of treatment for CSU. There are clinical and laboratory biomarkers that help in identifying CSU endotypes. Recognition of aiCSU endotype is essential as it helps predict disease course and response to treatment. Moreover, careful therapeutic interventions in patients with CSU and coexistent autoimmune diseases are warranted to achieve efficacy and reduce drug interactions and adverse effects.

The efficacy and safety of high-dose nonsedating antihistamines in chronic spontaneous urticaria: a systematic review and meta-analysis of randomized clinical trials

BackgroundStandard doses of second-generation H1-antihistamines (sgAHs) as first-line treatment are not always effective in treating chronic spontaneous urticaria (CSU), and hence an increase in the dose of sgAHs is recommended. However, literature evaluating the efficacy and safety of this treatment remains inconclusive, highlighting the need for a systematic review and meta-analysis. The aim of this systematic review and meta-analysis was to evaluate the efficacy and safety of high-dose sgAHs compared with standard-dose sgAHs in treating CSU.MethodsA systematic literature search of double-blind, randomized controlled trials (RCT) utilizing multiple doses of sgAHs was performed by searching the electronic databases Medline, Embase, PsycInfo, Cochrane databases, and Web of Science. Bibliographies were also manually searched. The Cochrane Risk of Bias Tool for assessing risk of bias was used to assess the quality of randomized controlled trials (RCTs). Two reviewers screened studies, extracted data, and evaluated the risk of bias independently. The response rate, the number of adverse events, somnolence, and withdrawal due to adverse events were extracted from each article. The data were combined and analyzed to quantify the safety and efficacy of the treatment. RevMan (V5.3) software was used for data synthesis.ResultsA total of 13 studies were identified, seven of which met the eligibility criteria for the meta-analysis. Our pooled meta-analyses showed that high-dose sgAHs was associated with a significantly higher response rate than standard-dose (RR 1.13, 95% CI 1.02 to 1.26; P = 0.02). Conversely, high doses of sgAHs were associated with significantly higher somnolence rates than standard dose (RD 0.05, 95% CI 0.01 to 0.09; P = 0.02). There was no significant difference in adverse events or withdrawal due to adverse events between standard- and high-dose treatments.ConclusionsOur analyses showed that a high dose of sgAHs (up to two times the standard dose) might be more effective than a standard dose in CSU treatment. High-dose and standard-dose sgAHs showed similar adverse events, except for somnolence, where incidence was found to be dose-dependent in some studies. However, given the limited number of studies, our meta-analysis results should be interpreted with caution.

Analysis of the Efficacy and Recurrence of Omalizumab Use in the Treatment of Chronic Spontaneous Urticaria and Chronic Inducible Urticaria

Introduction: Chronic urticaria (CU) is a common skin condition that can be divided into chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). Omalizumab is one treatment option for CU, but currently there are limited clinical studies of omalizumab’s efficacy for treating CU in Chinese patients. This study sought to investigate the efficacy and safety of omalizumab treatment for CU patients in a Chinese patient population. Specifically, we aimed to compare the differential efficacy of omalizumab for CSU and CIndU patients and predict risk factors for recurrence. Methods: We completed a retrospective clinical data review of 130 CU patients who received omalizumab treatment from August 2020 to May 2022, with a maximum follow-up period of 18 months. Results: A total of 108 CSU patients and 22 CIndU patients were included in the study. After treatment with omalizumab, the response rate in the CSU group was higher than that in the CIndU group (93.5% vs. 68.2%), and CSU patients accounted for a higher proportion of responders and early responders (responders: 87.1% vs. 12.9%, p < 0.001; early responders: 95.7% vs. 4.3%, p = 0.001). Nonresponders had lower total immunoglobulin E (IgE) levels (75.0 vs. 167.5 IU/mL, p = 0.046) and a relatively shorter duration of treatment (1.0 vs. 3.0 months, p = 0.009) compared to responders. Early responders had shorter disease duration (1.0 vs. 3.0 years, p = 0.028), higher baseline UCT (4.0 vs. 2.0, p = 0.034), lower baseline DLQI (18.0 vs. 18.5, p = 0.026), and shorter total treatment time (2.0 vs. 4.0 months, p < 0.001) compared to late responders. All adverse events reported during treatment were mild. Seventy-four patients with CU discontinued the drug after achieving complete disease control, of which 26 (35.1%) relapsed for 2.0 months (interquartile range: 1.0–3.0 months). Compared with nonrelapsed patients, relapsed patients often had other allergic diseases (42.3% vs. 18.8%, p = 0.029), higher basal levels of total IgE (263.0 vs. 140.0 IU/mL, p = 0.033), and longer disease duration (4.2 vs. 1.0 years, p = 0.002). Relapsed patients could still achieve good disease control after restarting omalizumab therapy. Conclusion: Omalizumab was effective and safe for CSU and CIndU patients. Patients with CSU responded more quickly to omalizumab and showed a relatively better treatment effect. However, there was a possibility of relapse after discontinuation of omalizumab after complete control of CU, and in these cases, restarting omalizumab treatment after relapse was effective.

Stepping Down Treatment in Chronic Spontaneous Urticaria: What We Know and What We Don't Know.

In chronic spontaneous urticaria (CSU), wheals, angioedema, or both appear spontaneously for >6 weeks. Current recommended treatment options for urticaria target mast cell mediators such as histamine, or activators, such as autoantibodies. The goal of CSU treatment is to treat the disease until it is gone as effectively and safely as possible. As no cure is available for CSU as of now, the treatment is aimed at continuously suppressing disease activity, with complete control of the disease and a normalization of quality of life. To achieve this, pharmacological treatment should be continued until no longer needed. Treatment of CSU should follow the basic principles of treating as much as needed and as little as possible taking into consideration that the activity of the disease may vary. Since CSU is a disease with spontaneous remission, it is hard to tell, in patients with complete control and no signs or symptoms, when medication is no longer needed. The current international guideline for urticaria suggests that the treatment can be stepped down once a patient is free of signs and symptoms. Other reasons for stepping down the treatment of CSU patients include safety concerns or issues, pregnancy or wanting to become pregnant, and economic factors. As of now, it is unclear over which period, with what intervals and with which dosages CSU treatment should be stepped down. Guidance on this is needed for all recommended therapies: (i) standard-dosed second-generation H1-antihistamine (sgAH), (ii) higher than standard-dosed sgAH, (iii) standard-dosed omalizumab, (iv) higher than standard-dosed omalizumab, and (v) cyclosporine. However, there is a lack of controlled trials on the step down and discontinuation of these treatments. Here, we aim to provide a summary of what is known and what needs to be investigated in further studies, based on our own experience and real-world evidence.

Autologous Whole Blood Therapy in Chronic Spontaneous Urticaria: A Comparative Study Between Autologous Serum Skin Test Positive and Negative Patients

Introduction: Chronic Spontaneous Urticaria (CSU) is frequently encountered in our day to day practice. Patients are often reluctant to take medicines for prolonged durations and seek interventions for rapid and prolonged remission. Autologous Whole Blood Therapy (AWBT) has been used with varied results in CSU and Autologous Serum Skin Test (ASST) reactivity has shown to influence the therapeutic response in some studies. Aim: To compare the efficacy of AWBT in ASST positive versus negative CSU. Materials and Methods: The present prospective, interventional, parallel group study was conducted in the Department of Dermatology, Command Hospital Air Force (tertiary care centre), Bangalore, India, from January 2014 to December 2015. Eight weekly injections of AWB (5 mL) were administered to 30 ASST positive and 30 age and sex matched ASST negative patients of CSU and followed-up for four weeks. Modified Urticaria Severity Score (MUSS) was recorded at baseline, 4th, 8th and 12th weeks to assess objective response to AWBT. Subjective response was documented as poor, satisfactory, good and excellent based on patient’s feedback at the end of 12 weeks. Independent two-sample t-test, Chi-square (χ2 ) test and cross tabulations were used to analyse the data through Statistical Package for the Social Sciences (SPSS) software version 21.0. A p-value of &lt;0.05 was considered statistically significant. Results: A total of 102 consenting patients were subjected to ASST, out of which 38 patients were ASST positive. After excluding those who were lost to follow-up, data from 30 ASST positive patients and corresponding age and sex matched ASST negative controls were analysed. Baseline MUSS of ASST positive group was significantly higher, indicating more severe nature of CSU. With AWBT, improvement in MUSS of ASST positive group (68.49±10.32%) was significantly higher than the ASST negative group (p-value &lt;0.001) and ASST positive group required significantly lesser doses of rescue antihistamines (p-value &lt;0.001) at the end of 12 weeks. Subjective response to AWBT was either good or excellent in both groups. Conclusion: Although AWBT resulted in significant reduction of MUSS in ASST positive patients, it benefited patients in both groups irrespective of their ASST reactivity status. AWBT can be used as an effective adjuvant in the treatment of CSU.

Effects of BCG‐PSN on the Levels of Inflammatory Factors and Th1/Th2 Differentiation in Chronic Spontaneous Urticaria: Meta‐Analysis and Systematic Review

Background. Bacillus Calmette–Guerin polysaccharide nucleic acid (BCG‐PSN), as an immune modulator, can effectively regulate the immune function of the body, control the release of histamine inflammatory substances, and achieve allergic effects against chronic spontaneous urticaria (CSU). This study aimed to evaluate the effectiveness of BCG‐PSN on the levels of inflammatory factors and Th1/Th2 differentiation in CSU. Methods. A systemic literature search of BCG‐PSN treatment of CSU was performed using the PubMed, Cochrane Library, Web of Science, CBM, and other databases. A quantitative meta‐analysis was conducted according to the guidelines of the Cochrane Handbook. Review manager software 5.4 was used for meta‐analysis. Results. Twenty‐seven studies pertaining to 2840 patients were included. The duration of treatment was 4 to 12 weeks. BCG‐PSN can increase CD3+T levels (MD = 6.06; 95% CI: 5.30 to 6.82; p &lt; 0.00001; I2 = 31%), CD4+T levels (MD = 5.41; 95% CI: 4.82 to 6.01; p &lt; 0.00001; I2 = 40%), and CD4+/CD8+(MD = 0.33; 95% CI: 0.28 to 0.38; p &lt; 0.00001; I2 = 15%); at the same time, BCG‐PSN can downregulate CD8+T levels (MD = −3.28; 95% CI: −3.82 to −2.74; p &lt; 0.00001; I2 = 32%). Furthermore, BCG‐PSN could downregulate IL‐4 levels (MD = −4.06, 95% CI: −5.15 to −2.97, p &lt; 0.00001; I2 = 0%), TNF‐α levels (MD = −2.34; 95% CI: −3.01 to −1.66; p &lt; 0.00001; I2 = 26%) and upregulate IL‐10 levels (MD = 25.59, 95% CI: 23.50 to 27.69, p &lt; 0.00001; I2 = 0%) and INF‐γ levels (MD = 4.62, 95% CI: 3.79 to 5.45, p &lt; 0.00001; I2 = 5%). Conclusions. BCG‐PSN can regulate the levels of inflammatory factors and Th1/Th2 differentiation in CSU. However, the long‐term effectiveness and more objective experimental indicators of BCG‐PSN remain to be further studied. Trial Registration. This trial is registered with PROSPERO ID: CRD42022332475.

SALIVARY MELATONIN VALUES SIGNIFICANTLY CORRELATE WITH REDUCED QUALITY OF LIFE IN CHRONIC SPONTANEOUS URTICARIA PATIENTS: A PILOT STUDY.

Chronic spontaneous urticaria (CSU) is a dermatological disorder accompanied by itching that greatly affects the quality of life and quality of sleep. Therefore, it is assumed that CSU patients consequently experience reduced melatonin secretion and lower values of serum or salivary melatonin. This pilot study included 20 patients with CSU (chronic urticaria of unknown etiology that lasts for more than 6 weeks) and 10 healthy controls. All subjects were examined by a dermatovenereologist-allergist, as well as an oral pathologist, to exclude oral pathological conditions. Salivary melatonin levels were determined by ELISA and all subjects completed a standardized Dermatology Life Quality Index questionnaire and Pittsburgh Sleep Quality Index on the same day they gave a saliva sample for analysis. According to our results, 86% of CSU patients had decreased values of salivary melatonin, and lower salivary melatonin values significantly correlated with a reduced quality of life in CSU patients. This study was the first to analyze melatonin in CSU patients, also suggesting a possible new therapeutic option for the treatment of CSU.

Omalizumab in Chronic Spontaneous Urticaria: Assessment of Response in Twenty-Five Patients

Background Omalizumab is a recombinant humanized monoclonal antibody against immunoglobulin E (IgE). It is approved for the treatment of chronic spontaneous urticaria (CSU) in patients ≥12-years of age. Objective We carried out a retrospective cross-sectional study in 25 patients with CSU to evaluate the characteristics of response of CSU to omalizumab treatment. Method A retrospective cross-sectional study of a convenient sample of all patients diagnosed as CSU who have been using omalizumab treatment during the study period from January 2018 to January 2020 in the Dermatology Department in King Abdulaziz Hospital, Makkah, Saudi Arabia. Results A total of 25 patients have participated in this study. The average age of patients was 40-years. Majority of the patients were female (52.0%, n=15). The average duration of illness was 1.32-years. Majority of the patients (72.0%, n=18) received two courses of omalizumab treatment. Minority of patients (28.0%, n=7) received one course of omalizumab treatment which was statistically significant (p value&lt;0.01). Number of patients who have been using oral 2nd generation antihistamine during the first course and 2nd course was (72%, n=18 out of 25) and (50%, n=9 out of 18) respectively. Number of flare-ups during 2nd course (1.72 flares up per patient, n=31 flare-ups among 18 patients) was less than the number of flares-up during 1st course (2.96 flares-up per patient, n=74 flare-ups among 25 patients) which was statistically significant (p value&lt;0.01). Number of patients who showed no flare-ups during the 1st and 2nd course of omalizumab treatment was (16%, n=4 out of 25 patients) and (27.77%, n=5 out of 18 patients) respectively. The average intensity of flares-up during 2nd course of omalizumab treatment was less than the average intensity of flares-up during first course of omalizumab treatment as the following; during 2nd course ( 33.33%, n=6 out of 18 patients), (27.77% n=5 out of 18 patients), (11.11%, n=2 out of 18 patients) mild, moderate and severe flares-up respectively and the severity during 1st course was (40.0%, n=10 out of 25 patients), (28.0%, n=7 out of 25 patients), (16.0%, n=4 out of 25 patients) mild, moderate and severe flares-up respectively. Conclusion According to expert’s guidelines, CSU of ≥3-years would be treated with omalizumab for a minimum of one-year. In our study, in spite of the short duration of CSU (average duration was 1.32-years), the majority of patients (72.0%, n=18) received omalizumab for 1-year (two courses of omalizumab treatment) suggesting that the majority of patients with CSU in general requires omalizumab ≥1-year. Our study also showed 5 patients who were free of any flare-up and they were not using 2nd generation antihistamines suggesting that omalizumab alone as monotherapy can be effective

The Benefit of Complete Response to Treatment in Patients With Chronic Spontaneous Urticaria—CURE Results

Chronic spontaneous urticaria (CSU) is a distressing disease. We report real-world data from the global Chronic Urticaria Registry (CURE) about associations between various CSU states and sleep impairment, plus important health-related quality-of-life (HRQoL) outcomes and compared different methods to assess CSU states. CURE data were collected at baseline and 6-monthly follow-ups (FU). Assessments included CSU states using the Urticaria Control Test (UCT), weekly Urticaria Activity Score (UAS7), and Physician Global Assessment (PhyGA) of treatment response. Complete response to treatment (CR, UAS7= 0), complete control of disease (CC, UCT= 16), and PhyGA= CR were assessed, plus the Dermatology Life Quality Index and the Chronic Urticaria Quality-of-Life Questionnaire (CU-Q2oL) sleep domain. Overall, 2078 patients were included. At baseline, 9.8%, 17.9%, and 42.3% of patients had UCT= 16, UAS7= 0, or PhyGA= CR, respectively, which increased at FU1 and FU2. Patients with higher UCT scores had better sleep and HRQoL. The presence of angioedema without wheals, episodic disease, omalizumab treatment, and male sex were associated with CC (P < .05). Among 469 patients who achieved CC or CR, 16.4% (n= 77) showed CC or CR with all 3 instruments. Agreement between UCT= 16 and UAS7= 0 measurements was moderate (κ= 0.581), but poor between UCT= 16 and PhyGA= CR (κ= 0.208). Few patients had CR/CC of their CSU at baseline entry. Disease control strongly related to good sleep and better HRQoL; therefore, it is important to aim for CR in CSU treatment. Patient-reported UCT and UAS7 assessments demonstrated a more accurate measurement of CSU state versus physician assessments.

Biologics for chronic spontaneous urticaria: toward a personalized treatment

ABSTRACT Introduction Chronic spontaneous urticaria (CSU) is characterized by the recurrent occurrence of short-lived wheals with or without angioedema for more than 6 weeks. Although its pathogenesis is not completely defined, several mechanisms seem involved, including autoimmunity and autoallergy with complement and coagulation activation. Various biologics are currently available or under investigation to counteract different CSU pathomechanisms. Areas covered The recent literature dealing with biologics in the treatment of CSU was screened and analyzed; the different treatments were divided into anti-IgE and other than anti-IgE biologics. The latter were subdivided according to their target mechanisms. Expert opinion Biologic drugs exert their effects in a very precise and specific manner. A majority of patients (arguably those with type I disease) respond to anti-IgE treatment. Others, possibly with type IIa disease, show a slow response to anti-IgE drugs. Things are much more complicated in anti-IgE-refractory patients. Some respond well to nonspecific immune suppressors, such as corticosteroids and cyclosporin suggesting that an immune-mediated pathogenic mechanism, not involving the high-affinity IgE receptor, is probably active. Several ongoing studies are evaluating biologics and small molecules counteracting other pathomechanisms, including anti-receptor biologics, Bruton tyrosine kinase (BTK) inhibitors, mast cell targets, and specific cytokines.

RWD83 Real-World Treatment Patterns in Chronic Spontaneous Urticaria in the United States

Treatment of chronic spontaneous urticaria (CSU) in the US is a stepwise approach recommended by local guidelines. First line: non-sedating H1-antihistamines (ns-H1AH); 2nd line & 3rd line: increased licensed dose ns-H1AH or change of H1AH or add H2-antihistamines (H2AH) or leukotriene inhibitor (LTRA) or sedating H1AH or doxepin; 4th line: add omalizumab or cyclosporine. Rescue medication with short-course oral corticosteroids (OCS), in case of exacerbations. The objective of the study was to assess real-world treatment patterns in adult patients with CSU.

422 Biologic therapy: the last resort in the treatment of chronic spontaneous urticaria

Chronic spontaneous urticaria (CSU) is defined by the presence of recurrent hives, associated in over 60% of cases with angioedema, lasting for more than 6 weeks, due to unknown trigger. It affects around 1% of the adult population and has a negative impact on patients’ quality of life, interfering with their daily activities and work productivity. Omalizumab is an anti-IgE monoclonal antibody, the first biologic agent approved for the treatment of CSU in patients not responding to traditional H1 antihistamines.

Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from China

BackgroundOmalizumab is an effective treatment for chronic spontaneous urticaria (CSU) patients aged ≥12 years, but its efficacy in patients aged <12 years has not been fully documented. We evaluated the therapeutic efficacy and safety of omalizumab in Chinese CSU population across all age groups. ObjectivesTo assess the efficacy and safety of omalizumab treatment against CSU in China. MethodsThis study was a retrospective and observational study, and the clinical data of CSU patients treated with omalizumab from October 2018 to August 2021 were collected and analyzed. ResultsWe enrolled 235 patients in this study, and 54.0% (n = 127/235) of patients were female. All patients received at least three injections of omalizumab treatment, and the mean treatment duration was 3.4 ± 1.0 months. At the end of week-12, 98.7% (n = 232/235) of patients responded to omalizumab, among which 91.1% (n = 214/235) achieved a complete response (CR). An excellent response to omalizumab treatment was observed across all ages. All patients aged <12 years (n = 26) achieved a CR at the end of week-12, and clinical improvement was maintained until treatment cessation. Eighty-seven patients received 3–9-month follow-up after the end of treatment, with a mean duration of 5.7 ± 2.0 months, and 17.2% (n = 15/87) patients experienced recurrence after discontinuing treatment. No factors associated with therapeutic response and recurrence to omalizumab treatment were found in this study. ConclusionOmalizumab is a safe and efficacious therapy for CSU patients, including those aged <12 years. We recommend addition of omalizumab to the treatment regimen in CSU patients under 12 years of age. Trial registration numberThis study was registered in Chinese Clinical Trial Registry (www.chictr.org.cn, Registration number: ChiCTR2200056599).

CHRONIC SPONTANEOUS URTICARIA, LOW HISTAMINE DIET AS A TREATMENT

<h3>Introduction</h3> Chronic Spontaneous Urticaria (CSU) is defined as urticaria that persists longer than six weeks. It was previously known as Chronic Idiopathic Urticaria. The current mainstay treatments for CSU include antihistamines and immunomodulators. The exact pathogenesis of CSU remains unclear. Here, we discuss two patients treated for CSU who demonstrated persistently elevated histamine levels with normal tryptase suggesting a non-mast-cell-mediated histamine elevation. Both were responsive to low-Histamine diet (LHD) as a primary treatment. <h3>Case Description</h3> A 50-year-old male presented for CSU. The patient was placed on intramuscular and oral corticosteroids for his symptoms with minimal relief. Laboratory studies revealed an elevated histamine level of 5.1 ng/mL and a normal tryptase level of 7.1 mcg/L. The patient was placed on LHD and subsequently reported complete resolution of CSU. 38-year-old male presented for a pruritic skin rash diagnosed as CSU. The patient was previously placed on antihistamines and steroid cream. Laboratory studies revealed multiple elevated histamine levels greater than 6.0 ng/mL and normal tryptase levels of 6.5 and 7.7 mcg/L. The patient was placed on LHD with satisfactory resolution of symptoms. <h3>Discussion</h3> Persistently elevated histamine levels may contribute to CSU in a subgroup of patients who may be experiencing symptoms due to a non-mast-cell-mediated histamine elevation. Further research is needed to evaluate LHD as a primary treatment for CSU articulately in the presence of persistently elevated histamine.