Treatment Of Chronic Spontaneous Urticaria Research Articles

Minimal clinically important difference for acupuncture for patients with chronic spontaneous urticaria: secondary analysis from a multicentre randomised controlled trial in China.

To evaluate the minimal clinically important difference (MCID) value for acupuncture treatment in chronic spontaneous urticaria (CSU), providing guidance for its application in CSU management. Secondary analysis of data from a multicentre randomised controlled trial. Three tertiary hospitals across three cities in China. 103 CSU patients (78.7% female) with an average age of 39.97 years. Participants received acupuncture treatment for 4 weeks in the original study. MCID and minimal detectable change (MDC) for the Urticaria Activity Score over 7 days (UAS7) in acupuncture treatment of CSU. Convergent validity assessed by intraclass correlation coefficient (ICC). Responsiveness evaluated through Spearman correlation between UAS7 improvements and anchor tools (physician's and patient's assessments). MDC calculated using SE of measurement of changes in UAS7 scores. MCID estimated using distribution-based and anchor-based methods. The ICC for UAS7 was 0.86. Improvements in UAS7 scores were significantly correlated with patient (r=0.44, p<0.01) and physician (r=0.85, p<0.01) assessments of CSU activity shifts. The MDC for UAS7 was 5.08. The MCID for acupuncture treatment in CSU was 8.3. This study provides the first MCID value for acupuncture treatment in CSU. These findings contribute to the understanding of acupuncture's effects in treating CSU and may inform future research and clinical practice in the management of this condition. ChiCTR1900022994.

Omalizumab for the Treatment of Chronic Spontaneous Urticaria in Adults and Adolescents: An Eight-Year Real-Life Experience.

Background: Omalizumab, an anti-IgE monoclonal antibody, is an effective treatment for patients with chronic spontaneous urticaria (CSU) resistant to antihistamines, but about 10% are unresponsive. Our aim was to assess the effectiveness, safety, and drug survival (DS) of omalizumab by considering clinical and laboratory characteristics. Methods: We conducted a retrospective study on 296 patients with severe CSU treated with omalizumab. Disease activity, comorbidities, and serum levels of total IgE and anti-thyroid autoantibodies were evaluated over a period of up to 8 years. DS was analyzed using unadjusted Kaplan-Meier survival curves. When applicable, the risk of discontinuation was assessed using Cox regression analysis. Results: Out of 296 patients, 118 (40.4%) were early responders, 72 (25.0%) were late responders, 76 (26.0%) were partial responders, and 25 (8.6%) were non-responders. Early responders were more likely to be patients without associated inducible urticaria (p = 0.021, χ2 = 9.692), without autoimmune thyroiditis (p = 0.007, χ2 = 12.037), and those with higher IgE levels (p = 0.039, χ2 = 8.385). Overall, DS was 53.5% at 8 years, primarily due to clinical remission. DS due to inefficacy and clinical remission were 83.9% and 62.1%, respectively, at 8 years. No patients discontinued omalizumab due to adverse events. Patients with normal IgE levels (p = 0.012, HR = 4.639, CI: 1.393-15.445) and those with autoimmune thyroiditis (p = 0.028, HR = 3.316, CI: 1.128-8.718) had a higher risk of discontinuing omalizumab due to inefficacy. Conclusions: This study confirms the long-term effectiveness and safety of omalizumab in the treatment of CSU over a period of up to 8 years. Most patients discontinued omalizumab due to clinical remission, while only 5.1% discontinued it due to ineffectiveness.

Jujube Oxymel for the Treatment of Chronic Spontaneous Urticaria: Efficacy and Safety.

Chronic spontaneous urticaria (CSU) is a challenging disorder that severely impacts the quality of life. The current study objective was to evaluate the efficacy and safety of jujube oxymel (JO) for treating CSU. In this randomized double-blind controlled trial, 92 patients (aged 12-65) with CSU were randomly allocated to JO or placebo groups. They received 30cc of each syrup three times daily with 10 mg cetirizine for 28 days, subsequently taking 10 mg cetirizine alone for the next 4 weeks. Outcomes were evaluated using the weekly urticaria activity score (UAS-7) and Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL). After four weeks, the UAS-7 score mean and standard deviation in the JO group significantly decreased to 10.89 ± 4.87 compared to the placebo group at 15.06 ± 7.55 (P: 0.002). In the follow-up period, JO group participants achieved a score of 10.28 (4.67), while a significant increase occurred in the control group (18.33 ± 6.29) (P = 0.001). On day 28, there was a notable improvement in the quality of life within the JO group (P < 0.05). By the eighth week, both groups experienced an increase in CU-Q2oL score, but the changes in the control group were statistically significant (18.09 (5.96) vs 41.31 (10.34) (P: 0.001). JO, as part of integrated therapy, exhibited potentially longer-lasting efficacy than cetirizine alone, contributing to enhanced quality of life and increased patient satisfaction due to minimal side effects.

Combining dipyridamole and cilostazol with up-dosing antihistamines improves outcomes in chronic spontaneous urticaria with high D-dimer levels: A randomized controlled trial.

In a double-blind, randomized controlled trial, we investigated the effectiveness of adding antiplatelet drugs to up-dosing antihistamines for the treatment of chronic spontaneous urticaria (CSU) in patients with elevated D-dimer levels who had an inadequate response to conventional antihistamine doses. Twenty patients with Urticaria Activity Score over 7 days (UAS7) ≥16 and D-dimer >500 ng/mL were randomized to receive either antiplatelet therapy (cilostazol 150 mg/day + dipyridamole 50 mg/day) with antihistamine (desloratadine 20 mg/day) or antihistamine alone for 4 weeks. The antiplatelet group demonstrated a greater decrease in UAS7 compared to the control group (28.10 to 8.90 vs. 22.90 to 16.40, p < 0.001 vs. p = 0.054). Both groups experienced improved quality of life (DLQI), but the improvement was greater in the antiplatelet group (p = 0.046). D-dimer levels decreased only in the antiplatelet group (1133.67 ng/mL to 581.89 ng/mL, p = 0.013) with no significant change observed in the control group. This suggests that combining dipyridamole and cilostazol with up-dosing antihistamines may be more effective for CSU patients with high D-dimer levels compared to up-dosing antihistamines alone. This could be due to a reduction in platelet activation, as evidenced by the decrease in D-dimer levels observed in the antiplatelet group.

Efficacy and Mechanism of Acupoint Catgut Embedding in the Treatment of Chronic Spontaneous Urticaria: Protocol for a Randomized Double-Blind Placebo-Controlled Trial.

Chronic spontaneous urticaria (CSU) is a common chronic inflammatory skin disease that manifests as itching and wheals, seriously affecting quality of life. Clinical observations and previous research trials have shown that acupuncture is safe and effective for the treatment of CSU. However, there are problems, such as a short duration of action and frequent treatment. Compared with traditional acupuncture, acupoint catgut embedding (ACE) has the advantages of a longer effect and higher compliance. Clinical trials are needed to prove its efficacy and mechanism of action. This trial aims to provide definitive evidence for the treatment of CSU with ACE and explore the mechanism of ACE. This is a randomized, double-blind, placebo-controlled trial. In this trial, 108 participants aged 18-60 years with a diagnosis of CSU and no history of ACE will be randomly assigned to 2 groups (1:1 ratio) using the Statistical Analysis System: treatment (ACE) and control (sham ACE). The participants and efficacy evaluators will be blinded to the grouping. Both the ACE and sham ACE groups will undergo acupuncture, but the sham ACE group will not receive catgut sutures. Treatment will be performed twice weekly for 8 weeks, with a 1-week run-in period and a 16-week follow-up period. Twenty patients will be randomly selected to undergo functional magnetic resonance imaging before and after the treatment period. The primary outcome will be the urticaria activity score over 7 days (UAS7). We will use R (version 4.0.1; R Project for Statistical Computing) to perform ANOVA and independent samples t tests to compare the differences within and between groups before and after treatment by judging the rejection range based on a significance level of .05. The study protocol has been approved by the Ethics Committee of Guang'anmen Hospital on September 7, 2022, and has been registered on November 30, 2022. Recruitment began on March 1, 2023. A total of 4-6 participants are expected to be recruited each month. The recruitment is planned to be completed on March 1, 2025, and we expect to publish our results by the winter of 2025. As of November 1, 2023, we have enrolled 25 participants with CSU. This randomized, double-blind, placebo-controlled trial aims to provide definitive evidence for the treatment of CSU with ACE and explore the mechanism of ACE. We hypothesize that wheals and itching will show greater improvement in participants receiving active therapy than in those receiving sham treatment. The limitations of this study include its single-center trial design, small sample size, and short treatment duration, which may have certain impacts on the research results. Chinese Clinical Trial Registry ChiCTR2200066274; https://www.chictr.org.cn/showprojEN.html?proj=179056. DERR1-10.2196/54376.

Assessment of ELR, PLR, NLR and BLR Ratios during Omalizumab Treatment of Chronic Spontaneous Urticaria.

Background: There is a need for searching for biomarkers indicating patients who will benefit the most from treatment with omalizumab for chronic spontaneous urticaria (CSU). The aim of this study was to assess whether the eosinophil/neutrophil/platelet/basophil-to-lymphocyte ratio (ELR, NLR, PLR, BLR) may predict the response to omalizumab treatment of chronic spontaneous urticaria. Methods: A retrospective data analysis of CSU patients treated s-c with 300 mg of omalizumab every four weeks under the drug program was carried out. NLR, ELR, PLR and BLR, DLQI, UAS-7, CRP, anti-TPO and tIgE were assessed before (V0) and after three (V3) and six months (V6) of treatment. Results: Among 52 patients with CSU, 21 were responders, 24 were partially responders and 6 were non-responders to treatment with 300 mg omalizumab every four weeks. An amount of 18 patients had features of type I autoallergic CSU (CSUaiTI) and 34 patients had autoimmunity type IIb CSU with mast cell-directed activating autoantibodies (CSUaiTIIb). NLR, ELR, PLR and BLR indices did not change during a six-month-course of biological treatment. Initial values of ELR and BLR were significantly correlated with the initial tIgE level and anti-TPO/IgE ratio. Initial values of NLR, ELR and BLR were significantly correlated with initial CRP. Comparisons between type I autoallergic CSU (CSUaiTI) and autoimmunity type IIb CSU (CSUaiTIIb) revealed that the absolute number and percentage of eosinophils, basophils, BLR and tIgE were significantly higher in type CSUaiTI and anti-TPO and anti-TPO/IgE were significantly lower in type CSUaiTI. Conclusions: NLR, ELR, PLR and BLR do not change significantly during six months of omalizumab treatment and do not appear to be useful in predicting its efficacy.

Chronic spontaneous urticaria: diagnosis, treatment, and management

Chronic spontaneous urticaria (CSU) is a disabling condition in which recurrent wheals, with or without angioedema, occur for over 6 weeks. CSU occurs in up to 1% of the general population at any time and, on average, lasts 2–5 years in duration. Standard therapy for CSU includes second-generation antihistamines and omalizumab. However, 25%–50% of patients are refractory to these treatments. CSU profoundly impairs patients’ quality of life and has a substantial societal impact, including significant health care costs and decreased work productivity. These factors underscore the importance of health care providers to be familiar with the diagnosis and management of this condition. This article reviews the epidemiology, pathogenesis, aggravating factors, clinical manifestations, diagnostic assessment, and treatment of CSU.

What can be learned from real-world data about chronic spontaneous urticaria?

Background: Chronic spontaneous urticaria (CSU) is a common disease with complex pathogenesis. Patients' clinical characteristics and responses to treatment vary. Objective: We aimed to investigate the role of data obtained from routinely recommended tests in predicting the response to omalizumab, the only biologic agent approved for treatment, and in defining the clinical characteristics of the patients. Methods: A retrospective study of patients who started omalizumab treatment for CSU between 2015 and 2022 at the Department of Dermatology, Pamukkale University, was conducted. Response criteria were based on the urticaria control test, and patients with a urticaria control test score <12 at 6 months were considered treatment non-responders. Eosinophil and basophil counts, neutrophil-lymphocyte ratio (NLR), systemic immune inflammation index (SII), systemic inflammation response index (SIRI), and total immunoglobulin E (IgE) levels of the patients were evaluated before treatment and at the sixth month of treatment. Results: A total of 23.1% of the patients were unresponsive to omalizumab. The response rate to the omalizumab treatment of the patients with a total IgE level ≤ 30 IU/L (n = 4 [5.7%]) was significantly lower than patients with total IgE level > 30 IU/L (n = 66 [94.3%]) (p = 0.015). The mean ± standard deviation SIRI levels were significantly higher in non-responders versus responders (1.53 ± 1.03 versus 1.15 ± 7.76; p = 0.026). Eosinophil counts positively correlated with basophil counts (r = 587; p < 0.001) and IgE levels (r = 0.290; p = 0.005) but a negative correlation was found with levels of NLR (r = -0.475; p < 0.001), SIRI (r = -0.259; p = 0.013), and SII (r = -0.285; p = 0.006). NLR levels were lower in CSU patients with atopy, than in those without atopy (1.9 ± 0.9 vs 2.9 ± 2.1, p = 0.022). Conclusion: We suggest that eosinopenia and high NLR levels are linked to autoimmune CSU. Predicting a poor response to omalizumab seems possible with total IgE levels < 30 IU/L and high SIRI levels.

Inflammatory cytokine levels and changes during omalizumab treatment in chronic spontaneous urticaria

While several studies have examined the role of T cells and related cytokines in the development of chronic spontaneous urticaria (CSU), there is a limited amount of research focusing on the changes in cytokine levels during omalizumab treatment. The primary objective of this study was to investigate the inflammatory cytokine profile (including IL-4, IL-5, IL-10, IL-13, IL-17, IL-31, IL-33, and TNFα) among CSU patients undergoing to omalizumab treatment. Plasma levels of cytokines were measured using ELISA. Measurements were taken before CSU treatment, at the 3rd and 6th months of omalizumab treatment, and once in the control group. The severity of the patients’ disease was assessed using the weekly Urticaria Activity Score(UAS7), and disease control was evaluated using the Urticaria Control Test(UCT). Thirty-one CSU patients and 56 age- and gender-matched healthy controls were included. Plasma levels of IL-4 and IL-33 were significantly lower in patients with CSU compared to healthy controls (p = 0.001; p = 0.038, respectively). During omalizumab treatment, IL-4 levels showed a significant increase in the 3rd month compared to baseline (p = 0.01), and IL-5 levels significantly decreased in the 6th month compared to both the 3rd month and baseline (6th month vs. baseline; p = 0.006, 6th month vs. 3rd month; p = 0.001). One potential mechanism of action for omalizumab may involve its regulatory effects on type 2 inflammatory cytokines in CSU patients. This finding partially explains the efficacy of anti-IL-4/13 treatments in chronic spontaneous urticaria. Further investigations on drugs targeting type 2 inflammatory cytokines in CSU are warranted.

A Prospective Randomized Non-Blinded Study of Safety and Efficacy of Bilastine Up-Dosing (40 mg) Versus Combination of Bilastine 20 mg With Levocetirizine 5 mg in the Treatment of Chronic Spontaneous Urticaria.

Chronic spontaneous urticaria (CSU) is the most commonly diagnosed skin condition in dermatology outpatient departments. Second-generation antihistamines are shown to be effective in the control of CSU. As per the guidelines, a combination of antihistamines is less recommended due to the lack of synergistic effect, though used widely. Exploring effective treatment options are crucial, given the challenges posed by CSU. To assess the safety and efficacy of Bilastine up-dosing versus combination of 20 mg Bilastine with 5 mg Levocetirizine in the treatment of CSU. This prospective randomized non-blinded comparative trial involved 62 patients, with 32 in group A and 30 in group B. Group A received Tablet Bilastine 20 mg bd, while Group B received a combination of Tablet Bilastine 20 mg and Tablet Levocetirizine 5 mg. Urticarial Activity Score 7 was performed at baseline and follow-up visits (every 2 weeks for 6 weeks). Both groups had a higher number of male patients in the 20-30 years age group. Angioedema was present in 15.6% of group A and 23.3% in group B. After 6 weeks, both the groups showed a significant improvement in UAS 7 scores (P value <0.05). Group A demonstrated a remarkable reduction in UAS 7 from 19.4% to 0.03% with minimal side effects. Bilastine up-dosing proved to be efficient, secure, and well tolerated when compared to the combined dose of Levocetirizine 5 mg and Bilastine 20 mg, suggesting that up-dosing of Bilastine could be a valuable addition to the current medication arsenal with the minimal side effects.

Approved therapies and their effects on the main symptoms of urticaria : When symptom control of itchy wheals is not adequate-does updosing help?

International guidelines for the treatment of chronic spontaneous urticaria support the updosing of second-generation antihistamines to four times of the approved dose when adequate symptom control cannot be achieved with the standard dosage. However, this recommendation is primarily based on expert opinions, and there is alack of large, well-designed, double-blind clinical trials. Most the existing trials provide insufficient data, and due to the heterogeneity of the conducted trials on antihistamine effects (definition of control, design, quality, lack of an active comparator, no placebo arm, small sample size, outcomes) and their short duration, comparative analysis is challenging. However, it can be concluded that the use of modern second-generation antihistamines is both effective and safe based on the available data and our own long-term experiences in the specialized outpatient clinic of auniversity dermatology department, even though increased dosages (up to fourfold as per the current international guidelines) may be necessary for symptom control. Another therapeutic option for refractory symptoms in chronic spontaneous urticaria is subcutaneous administration of omalizumab at adosage of 300 mg at 4‑week intervals as avery safe and effective treatment.

Total IgE as a biomarker of omalizumab response in chronic spontaneous urticaria: A meta-analysis.

Background: Omalizumab is approved for the treatment of chronic spontaneous urticaria (CSU) that is refractory to antihistamines. Total immunoglobulin E (IgE) levels have emerged as a possible biomarker to predict response to omalizumab. However, the existing literature is heterogenous, with conflicting conclusions with regard to the role of total IgE levels. Objective: We sought to clarify the role of evaluating total IgE levels in patients with CSU by performing a meta-analysis on the existing literature to determine if meaningful changes exist between responders and nonresponders to omalizumab. Methods: A total of 68 unique citations were returned and screened by two independent reviewers. Editorials, reviews, and case reports were excluded, and a total of 33 original articles were identified and underwent secondary evaluation. Studies that present mean ± standard deviation total IgE levels and/or 95% confidence intervals (CI) were included, whereas studies with < 25 subjects were excluded. Three studies ultimately met these criteria. Results: We found a mean difference in total IgE levels between those who responded to omalizumab versus those without a response of 49.76 (95% CI, 7.13-92.38; p = 0.02), which demonstrated higher mean IgE values in responders compared with nonresponders. Conclusion: This study presents additional evidence that supports evaluation of total IgE levels as it pertains to response to omalizumab therapy in CSU. When considering the current evidence, it seems reasonable to consider the baseline total IgE level as a biomarker to predict the treatment response to omalizumab. Based on the existing literature, we cannot conclude at what threshold nonresponse is more likely to occur.

Effectiveness of Symbiotic in Treatment of Chronic Spontaneous Urticaria: RCT

Background: A challenging health issue nowadays is chronic spontaneous urticaria, which affects almost 2% of the normal population, with half of its sufferers failing to respond to standard treatment therapy. Aim: To determine the efficacy and safety of a symbiotic in the treatment of chronic spontaneous urticaria. Method: This was a randomized trial. This experiment at the Lahore General Hospital involved 204 participants with chronic spontaneous urticaria. Participants were randomized into two groups: oral antihistamines plus an oral probiotic sachet (1.5g) twice daily or oral antihistamines alone for eight weeks. The Urticaria Activity Score was used to evaluate efficacy and safety, while the validated Dermatology Life Quality Index assessed quality of life. An independent sample t-test and a Mann-Whitney test were used to compare the age, UAS7, and DLQI score between the two groups. A p-value ≤0.05 was considered significant. Results: Both treatments significantly improved the UAS7 and DLQI scores from baseline; however, the experimental group produced a significantly greater reduction in the UAS7 and DLQI scores compared to the control group. There was no significant difference in the mean baseline score between both groups. A Wilcoxon signed rank test was used to compare the mean DLQI score before and after treatment in both groups. The results revealed that there was a significant reduction in score from the baseline in both groups. Practical Implication: Due to a lack of clinical data regarding the effective treatment of this health issue, we planned the current project. The results of this study helped us assess the efficacy of probiotics as adjuvant therapy in our local population and added to our local literature. Conclusion: It was concluded that the combination of probiotics and antihistamines showed better efficacy than the antihistamine alone, based on the UAS7 and DLQI scores; hence, they can be used as treatment options among patients. Although further research must be done to validate these findings. Keywords: Efficacy, Safety, Probiotics, DLQI scores, Chronic Urticaria.

A global perspective on stepping down chronic spontaneous urticaria treatment: Results of the Urticaria Centers of Reference and Excellence SDown-CSU study.

Although there have been significant advances in the treatment of chronic spontaneous urticaria (CSU) in recent years, there remains a lack of clear guidance on when and how to step down treatment in responders. This study aims to investigate stepping down approaches of different steps of CSU treatment from a global perspective. "Stepping down chronic spontaneous urticaria treatment" (SDown-CSU) is an international, multicenter, observational, cross-sectional, survey-based study of the Urticaria Centers of Reference and Excellence (UCARE) network. The questionnaire included 48 questions completed by physicians in the UCARE network. Surveys completed by 103 physicians from 81 UCAREs and 34 countries were analyzed. Seventy-eight percent of the participants responded that they had a national urticaria management guideline written by their professional societies and 28% responded that they had to operate under a regulatory guideline proposed by central health funding organizations. Seventy-two and 58.7% of these national recommendations do not contain any detailed information on when and/or how CSU treatment should be discontinued. There was a lack of detailed information on antihistamines and cyclosporine in particular. A predefined maximum duration was generally not applicable to omalizumab and cyclosporine (81% and 82%, respectively). Nearly all UCAREs step down omalizumab within 6months from the first controlled status and 42% discontinue cyclosporine after 6months regardless of the control status. The findings from the SDown-CSU study clearly highlight a global need for guidance on the process of stepping down treatment in CSU. Additionally, the study offers a step-down algorithm applicable to all stages of CSU treatment.

Mapping the intellectual structure of the research of omalizumab in chronic spontaneous urticaria: A bibliometric analysis

BackgroundGuidelines for treating Chronic Spontaneous Urticaria (CSU) recommend using the IgE-targeted biologic Omalizumab in patients with antihistamine-refractory disease. ObjectiveTo present a bibliometric review of publications related to Omalizumab and CSU over the past two decades. MethodsPublications that are relevant from 2003 to 2022 were extracted from the Science Citation Index-Expanded (SCI-EXPANDED) in the Web of Science Core Collection (WoSCC) database as of January 8, 2023. We utilized CiteSpace (version 6.1.R3), VOSviewer (version 1.6.18), and the R package (version 4.2.1) to analyze and visualize the data. The R package bibliometrix (version 4.2.1) was also used. ResultsBetween 2003 and 2022, a total of 566 articles were published. Since 2014, there has been a rapid increase in publication outputs. According to the collaboration network, the most influential country/institute/scholar was the USA, Charité Universitätsmedizin Berlin, and Maurer Marcus, respectively. The study identified the Journal of Allergy and Clinical Immunology: In Practice as the most productive journal and the Journal of Allergy and Clinical Immunology as the most co-cited journal. The analysis of keywords revealed that high-frequency terms such as angioedema, IgE, treatment, anti-IgE, asthma, and atopic dermatitis were present. Moreover, recent studies in this area have mainly concentrated on biomarkers, Dupilumab, and COVID-19. ConclusionThere has been a growing interest in the use of Omalizumab in CSU in recent years. The current trending topics in this research are the identification of biomarkers and the development of new monoclonal antibodies for the treatment of CSU.

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.

Efficacy evaluation of acupuncture combined with pricking blood therapy in the treatment of chronic spontaneous urticaria: a randomized controlled trial.

To assess the efficacy of combining acupuncture with pricking blood therapy to treat chronic spontaneous urticaria (CSU) and compare its outcomes with those of second-generation H1-antihistamines. Seventy CSU patients were enrolled and randomly assigned to receive treatment with either oral loratadine tablets or a combination of acupuncture and pricking blood therapy (n=35 each). Evaluations were conducted at baseline, at the conclusion of the 4-week treatment period, and at the 4th and 8th weeks post-treatment time points. We used six scales to gauge the severity of the skin lesions, itchiness, quality of life, and emotional and sleep states of the CSU patients. Upon completion of the treatment, both groups demonstrated a significant reduction in the scores of six scales from the baseline (P < 0.05). Notably, the scores of the itch visual analog scale (VAS), Hamilton Anxiety Scale, and Hamilton Depression Scale in the acupuncture and pricking blood therapy group were lower than those in the loratadine group (all P < 0.05). At the 8-week follow-up, the scores for all six scales were reduced from baseline in both groups (all P < 0.05), though the acupuncture and pricking blood therapy group showed significantly lower scores on the 7-day urticaria activity scale, with the Dermatology Life Quality Index, and the itchiness VAS compared with the loratadine group (all P < 0.05). Acupuncture combined with pricking blood therapy significantly ameliorated skin lesions, itchiness, and the associated psychological distress in CSU patients. This integrative approach not only matched the short-term efficacy of oral loratadine but surpassed its long-term benefits.

Disease burden and predictors associated with non-response to antihistamine-based therapy in chronic spontaneous urticaria

BackgroundH1-antihistamines (H1AH) are the first-line treatment for chronic spontaneous urticaria (CSU), but 50% of patients have inadequate disease control at standard doses. ObjectiveTo assess the comorbidity burden and healthcare resource utilization (HRU) associated with non-response to H1AH-based treatments; to identify predictors of non-response. MethodsOptum® de-identified Electronic Health Record dataset (2007–2020) was used to identify adult patients with CSU who initiated a H1AH, alone or in combination with other oral non-biologics (index treatment). Based on twelve-month treatment patterns observed after index treatment initiation, patients were categorized as responders (continued index treatment or had only 1 next H1AH treatment without corticosteroids) or non-responders (continued corticosteroids or had 2 or more treatment switches). Patient characteristics and HRU were assessed in the 12 months before (baseline) and ≥12 months after (follow-up) index treatment initiation. Baseline predictors associated with non-response were identified using machine learning. ResultsThere were 17 062 patients who met inclusion criteria, and 14824 (86.9%) were classified as non-responders. A higher proportion of non-responders had records of CSU-related symptoms, comorbidities, polypharmacy, and certain laboratory tests than responders at baseline. A higher proportion of non-responders than responders visited an allergist or dermatologist during follow-up (59.5% vs 53.0%). Non-responders had a larger increase in hospitalizations (15.7% vs −2.4%) than responders during follow-up vs baseline. Predictors of non-response included index and baseline treatment classes, types of specialists seen, chronic pulmonary disease, depression, and female sex. ConclusionA large proportion of CSU patients treated with H1AH-based therapies had uncontrolled disease, contributing to increased HRU and patient burden. Non-responders had more comorbidities and HRU at baseline and follow-up, with steep increases in follow-up hospitalizations relative to baseline, highlighting an urgent need for early disease control.

Safety of omalizumab in chronic urticaria during pregnancy: a real-life study.

Managing a pregnant patient with chronic spontaneous urticaria (CSU) is often challenging. Recent data have shown that most CSU treatments in pregnant patients are second-generation H1 antihistamines (sgAHs), while data on the safety of omalizumab are scant. To evaluate, in a routine clinical practice setting, the efficacy and safety of omalizumab in patients with severe CSU refractory to sgAHs who either became pregnant during treatment or who started the drug during pregnancy. We conducted a retrospective study of women aged ≥ 18 years who were pregnant, who received one or more doses of omalizumab at any time during their pregnancy or who were taking omalizumab at the time of, or in the 8 weeks before, conception. Twenty-nine pregnant patients were evaluated: 23 (79%) conceived a child while taking omalizumab (group A), while 6 (21%) started omalizumab treatment during pregnancy (group B). Among patients in group A, we observed 23 births (21 liveborn singletons and 1 liveborn twin pair) and 1 miscarriage. Fifteen (65%) patients discontinued omalizumab after confirming their pregnancy, while eight (35%) were exposed to omalizumab during their entire pregnancy. In group B, omalizumab was introduced at a mean (SD) 10.83 (3.60) weeks' gestation and all patients were exposed to it until the end of pregnancy. In this group, there were seven liveborn infants (five singletons and one twin pair). No adverse events, pregnancy complications or congenital anomalies in newborns were recorded in either group. Omalizumab for CSU treatment before and during pregnancy does not appear to have negative effects on maternal or fetal outcomes.

Reappraisal of the role of Helicobacter pylori in chronic spontaneous urticaria

Aims: Chronic spontaneous urticaria (CSU) is one of the most prevalent skin disorders. Helicobacter pylori (HP) infection has been linked to CSU, and HP eradication therapy has been questioned as a viable treatment option. However, studies have produced contradictory results. In addition, recent studies suggest that gastritis, rather than HP bacteria, may be responsible for CSU symptoms. Herein, we aimed to ascertain the prevalence of HP infection in CSU, explore associations between HP infection, gastritis, and CSU severity or treatment response in CSU, and investigate the impact of HP eradication therapy on the CSU course.&#x0D; Methods: We retrospectively analyzed CSU patients who were investigated for HP infection. Patient characteristics, in-clinic urticaria activity scores (ic-UAS) and urticaria control test (UCT) scores, and CSU treatment responses were compared across different patient groups. &#x0D; Results: The study included 325 CSU patients, of whom 57.2% were HP-positive and 60.9% had gastritis. The mean baseline ic-UAS showed no difference between HP-positive and HP-negative patients (2.55±2 vs 2.45±1.98, p&gt;0.05) or between patients with and without gastritis (2.33±2 vs 2.51±2, p&gt;0.05). HP-positive patients had higher rates of elevated CRP levels (45% vs 29.9%, p=0.023) and ASST positivity (54.8% vs 29.8%, p0.05).&#x0D; Conclusion: Over half of CSU patients have been found to be infected with HP. However, the HP bacterium itself, the eradication of HP, or gastritis have no significant effect on CSU severity or treatment response.