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Introdução: A urticária crônica espontânea é caracterizada por lesões máculo-papulares eritematosas, associadas a prurido e angioedema, que não possui estímulo externo reconhecido e de difícil controle. A primeira e a segunda linha terapêutica, disponibilizadas pelo Sistema Único de Saúde, não apresentam resultados significativos, os quais se tornam refratários. O omalizumabe, considerado terceira linha terapêutica e que não é amplamente disponibilizado pelo Sistema Único de Saúde, pode apresentar resultado significativo na interrupção dos sintomas da doença. Objetivo: O presente estudo tem como objetivo avaliar pacientes com urticária crônica espontânea que usaram ou estão em uso de omalizumabe. Métodos: Trata-se de um estudo observacional transversal do tipo série de casos, cuja análise foi feita através dos prontuários, com população de 34 pacientes com urticária crônica espontânea submetidos ao tratamento com omalizumabe no Instituto de Olhos de Santa Catarina (IOSC). Resultados: Constatou-se no estudo que a maioria dos pacientes com urticária crônica espontânea em uso de omalizumabe é constituída do sexo feminino (76,5%) e idade média de 41 anos. A doença mais associada à urticária crônica espontânea foi depressão (38,2%). O sucesso do tratamento com omalizumabe é medido pelo questionário UAS7 (Urticaria Activity Score), o qual, segundo os dados dos prontuários, todos os pacientes apresentavam resultado maior que 35 pontos antes do uso da medicação, e 32 conseguiram alcançar um índice de 0 após o uso do omalizumabe, variando apenas no tempo de tratamento. Conclusão: A urticária crônica espontânea é uma doença que não tem cura e possui alta refratariedade, mas pode ter seus sintomas reduzidos, principalmente com o uso do omalizumabe, que se mostrou eficiente nos casos analisados.
Introduction: Chronic spontaneous urticaria is a disease characterized by erythematous maculopapular eruption, associated with itching and angioedema, that has no recognized external stimulus and is difficult to control. First- and second-line treatments, available through the Brazilian Unified Health System, do not yield meaningful results, and patients become refractory. Omalizumab, considered a third-line treatment and not widely available through the Brazilian Unified Health System, may yield meaningful results in halting disease symptoms. Objective: To evaluate patients with chronic spontaneous urticaria who have used or are using omalizumab. Methods: We conducted a cross-sectional case series observational study with a review of the medical records of 34 patients with chronic spontaneous urticaria treated with omalizumab at the Eye Institute of Santa Catarina, south of Brazil. Results: Most patients with chronic spontaneous urticaria receiving omalizumab were female (76.5%) with a mean age of 41 years. The disease most commonly associated with chronic spontaneous urticaria was depression (38.2%). Omalizumab treatment success was measured with the Urticaria Activity Score (UAS7). Based on data extracted from the medical records, all 34 patients had a score greater than 35 before treatment. After receiving omalizumab, 32 patients managed to reach a score of 0, differing only in the duration of treatment. Conclusion: Chronic spontaneous urticaria is an incurable, highly refractory disease, but its symptoms can be reduced mainly with the use of omalizumab, which proved to be effective in the cases analyzed here.
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Humans , Male , Female , Adult , Middle Aged , AgedABSTRACT
The autoimmune pathogenesis of chronic spontaneous urticaria was first proposed in 2013 by Konstantinou et al. In recent years, genetic, epigenetic, and immunological studies have provided supporting evidence for the autoimmune pathogenesis of chronic spontaneous urticaria, and this review summarizes relevant research progress.
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Mast cells, autoantibodies, inflammatory cells, coagulation cascade, complement system and nervous system are all involved in the complex pathogenesis of chronic spontaneous urticaria (CSU) , while mast cells play a pivotal role in it. With deeper understanding of the pathogenesis of CSU, cutting-edge therapeutic methods are gradually being used in clinical practice. Nowadays, pharmacotherapyeutic studies are more focused on accurately modulating the pathological state of mast cells. This review summarizes recent advances in the pathogenesis of and medicines for CSU.
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Objective:To investigate clinical features of patients with chronic spontaneous urticaria (CSU) in China.Methods:A questionnaire survey was carried out in CSU patients at the first visit and 4 follow-up visits in Departments of Dermatology of 12 third-grade hospitals in northern and southern China from January to December 2019. The survey content included demographic characteristics, pruritus intensity, the number of wheals, concomitant symptoms (such as pain in skin lesions, arthralgia, fever) during the last week prior to the admission, classification and subtypes of urticaria, and previous and current treatment regimens, etc., and the 7-day urticaria activity score (UAS7) was used to evaluate the therapeutic effect. Patients from 9 hospitals in Sichuan, Hubei and Fujian provinces were enrolled into the southern China group, and patients from 3 hospitals in Beijing municipality and Liaoning province were enrolled into the northern China group. Differences between groups were analyzed by two-independent-sample t-test, Mann-Whitney U test or chi-square test. Results:Overall, 1 396 CSU outpatients were enrolled, including 592 males and 804 females; their age was 38.32 ± 16.13 years, 1 109 (79.5%) were aged between 20 and 60 years, and 660 (47.3%) were aged between 20 and 40 years. Their age at onset was 35.85 ± 16.03 years, and the disease duration was 0.50 (0.25, 2.00) years. Allergic diseases were the most common concomitant diseases, 269 (19.3%) patients were diagnosed with accompanied allergic rhinitis or conjunctivitis, 169 (14%) with accompanied eczema/dermatitis, 39 (2.8%) with accompanied asthma; only 19 (1.4%) CSU patients had a history of thyroid diseases, but 133 (9.5%) were positive for anti-thyroid peroxidase (TPO) or anti-thyroglobulin (Tg) antibodies at the visit; elevated serum total IgE levels were observed in 437 (31.3%) patients, and 104 (7.4%) were positive for autoantibodies. There were 1 078 (77.2%) patients in the southern China group and 318 (22.8%) in the northern China group, and the southern China group showed significantly longer disease duration (2.16 ± 4.76 years vs. 1.53 ± 2.80 years, P < 0.001) , and significantly higher proportions of patients with family history (10.7% vs. 3.5%) , with painful lesions (5.8% vs. 0.9%) , and those with arthralgia (10.7% vs. 0) compared with the northern China group (all P < 0.05) . The three most prevalent urticaria subtypes were CSU (835 cases, 49.9%) , symptomatic dermographism (437 cases, 31.3%) , and angioedema (138 cases, 9.9%) , and the proportion of patients with the single diagnosis of CSU was significantly higher in the southern China group (53%) than in the northern China group (38.9%, P < 0.001) . In terms of treatment, 1 365 (97.8%) patients received conventional-dose second-generation H1 antihistamines alone or in combination, and only 31 (2.2%) were treated with antihistamines at high doses; other medicines were mostly administered in combination, and compound glycyrrhizin was most frequently prescribed (36.6%) , while omalizumab was only administered in 7 patients (0.5%) . Conclusions:Significant differences in the clinical features of CSU were observed between northern and southern China. Nowadays traditional modalities are inadequate for the treatment of CSU, and new therapeutic drugs are somewhat promising.
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Objective:To evaluate the clinical efficacy of omalizumab in the treatment of patients with chronic spontaneous urticaria accompanied by other allergic diseases.Methods:Clinical data were retrospectively collected from 74 patients, who were clinically diagnosed with chronic spontaneous urticaria and other allergic diseases, and received subcutaneous injections of omalizumab in the Department of Allergy, Tianjin Medical University General Hospital from June 2020 to September 2022. Types of allergic diseases, serum total IgE (tIgE) and allergen-specific IgE (sIgE) levels before treatment, treatment outcomes and adverse drug reactions were analyzed. Differences before and after treatment were assessed using paired t-test and Wilcoxon signed-rank sum test. Results:A total of 74 patients with chronic spontaneous urticaria were involved, including 29 with complicated allergic asthma (39.2%) , 61 with complicated allergic rhinitis (82.4%) , 6 with complicated atopic dermatitis (8.1%) , and 4 with food allergy (5.4%) . Before treatment, elevated serum tIgE or sIgE levels were observed in 44 (59.5%) patients. After the first omalizumab treatment, the urticaria control test (UCT) score significantly increased compared with that before treatment (16.00 [13.0.0, 16.00] vs. 6.00 [5.75, 9.00], Z = 7.39, P < 0.001) ; after 4 sessions of the omalizumab treatment, 82.5% (33/40) of the patients achieved complete control of urticaria symptoms or showed complete response. After omalizumab treatment, asthmatic attacks were decreased in 29 patients with allergic asthma, and asthma control test (ACT) scores significantly increased compared with those before treatment (21.07 ± 2.88 points [after the first treatment] vs. 18.48 ± 3.20 points [before treatment], t = 8.87, P < 0.001) ; among 61 patients with allergic rhinitis, global rhinitis symptom-based visual analog scale (VAS) scores (before treatment: 5.89 ± 1.29 points; after the first treatment: 3.28 ±1.46 points) and rhinoconjunctivitis quality of life questionnaire (RQLQ) scores (before treatment: 60.10 ± 20.53 points; after the first treatment: 37.26 ± 18.83 points) both significantly decreased after the first treatment ( t = 15.04, 10.01, respectively, both P < 0.001) , and rhinitis symptoms were relieved at the same time; skin itching was relieved in 4 patients with atopic dermatitis, and allergic symptoms after contact with food allergens were also relieved in the 2 patients with food allergy after omalizumab treatment. During the treatment, only 1 patient experienced erythematous swelling, induration, and pain at the injection site. Conclusions:In the treatment of chronic spontaneous urticaria accompanied by allergic diseases, the use of omalizumab not only effectively improved urticaria symptoms, but also well controlled allergic diseases, with a good safety profile. Multiple benefits may be achieved by the use of omalizumabin in patients with chronic spontaneous urticaria accompanied by other allergic diseases.
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Objective:To investigate the efficacy and safety of omalizumab in the treatment of chronic urticaria (CU) patients with poor response to H1 antihistamines.Methods:CU patients, who showed poor response to H1 antihistamines and received omalizumab treatment, were collected from the Department of Dermatology, Xiangya Hospital, Central South University from June 2020 to June 2021. The efficacy of omalizumab was evaluated by using the 7-day urticaria activity score (UAS7) and urticaria control test (UCT) score at weeks 4, 12 and 24 after the start of treatment. The t-test, chi-square test, and Pearson correlation analysis were used to analyze the relationship between the clinical characteristics and efficacy. Results:A total of 121 CU patients who met the inclusion criteria and had relatively complete medical records were included in this study, including 54 males (44.63%) and 67 females (55.37%) , and their ages ranged from 13 to 70 years (39.88 ± 14.36 years) ; 88 patients were diagnosed with chronic spontaneous urticaria (72.73%) , 10 with chronic inducible urticaria (8.26%) , and 23 with chronic spontaneous urticaria accompanied by chronic inducible urticaria (19.01%) . At week 4 after the start of omalizumab treatment, the response rate was 50.86% (59/116) , and the complete response rate was 25.86% (30/116) ; at week 12, the response rate was 78.26% (54/69) , and the complete response rate was 34.78% (24/69) ; at week 24, the response rate was 64.71% (22/34) , and the complete response rate was 23.53% (8/34) . At week 4, CU patients with baseline serum total IgE levels of < 40 IU/ml had a lower response rate (26 cases, 30.77%) than those with baseline serum total IgE levels of ≥ 40 IU/ml (61 cases, 65.57%; χ2 = 8.93, P = 0.004) . Correlation analysis showed that the age at treatment, age at onset, allergic diseases, concomitant symptoms, baseline erythrocyte sedimentation rates, and baseline C-reactive protein levels were significantly correlated with the UCT scores (all P < 0.05) , while the course of disease, clinical types, serum total IgE levels, peripheral blood counts, dermatology life quality index scores, and UAS7 scores were not significantly correlated with the UCT scores. Among the 121 CU patients, 8 (6.61%) reported mild to moderate adverse reactions. Conclusion:Omalizumab could effectively improve clinical symptoms and signs of CU patients with poor response to H1 antihistamines, and was well tolerated;omalizumab treatment may be more beneficial to patients without allergic comorbidities such as allergic rhinitis, without concomitant symptoms such as angioedema, and with lower erythrocyte sedimentation rates and C-reactive protein levels.
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Chronic spontaneous urticaria (CSU) is a recurrent systemic inflammatory disease. At present, there are few biological indicators that can effectively reflect CSU activity in clinical practice, and some indicators have not been widely used. To identify sensitive and easy-to-check indicators may be helpful for the diagnosis and treatment of as well as prediction of therapeutic efficacy in CSU. This review comprehensively summarizes current clinical application of indicators related to CSU activity, in order to provide a reference for clinical practice and related scientific research.
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Objective:To investigate the correlation between food-specific IgG (sIgG) antibodies and phenotypes of chronic spontaneous urticaria (CSU) .Methods:Serum samples were collected from outpatients with active CSU, symptomatic dermographism (SD) , or acute urticaria (AU) , and healthy controls from 5 third-grade class-A hospitals such as the First Hospital of China Medical University between April 2014 and March 2015. Enzyme-linked immunosorbent assay was conducted to detect serum levels of 90 food-sIgG antibodies and total IgE, Western blot analysis to detect levels of 20 allergen-specific IgE antibodies, and chemiluminescent microparticle immunoassay to detect levels of anti-thyroid peroxidase IgG antibodies and anti-thyroglobulin IgG antibodies. Comparisons of normally distributed quantitative data between two groups and among several groups were performed by t test and one-way analysis of variance, respectively; comparisons of non-normally distributed quantitative data between two groups were performed by Mann-Whitney U test; for comparisons of proportions, chi-square test and Fisher′s exact test were used. Results:A total of 248 patients with CSU, 22 with SD, 15 with AU and 13 healthy controls were recruited. The cut-off level for sIgG positivity was 100 U/ml (at least 2+) , and the positive rate of food-sIgG antibodies was slightly higher in the patients with CSU (176/248, 70.97%) , SD (15/22, 68.18%) and AU (11/15) than in the healthy controls (7/13; χ2 = 1.80, P = 0.615) . Among the 248 CSU patients, the proportion of patients with family history of allergic diseases was significantly higher in the sIgG-positive group (71/176, 40.34%) than in the sIgG-negative group (19/72, 26.39%; χ2 = 4.30, P = 0.042) , while no significant difference was observed in the 1-day urticaria activity score (UASday) between the two groups ( Z = 0.18, P = 0.859) . Totally, 177 CSU patients completed 12- to 40-week treatment; their condition could be completely controlled by second-generation H1-antihistamines, and there was no significant difference in the required dosage of second-generation H1-antihistamines between the sIgG-positive group (128 cases) and sIgG-negative group (49 cases; Z = -1.06, P = 0.298) . Conclusions:The prevalence of family history of allergic diseases was relatively high in food-sIgG-positive patients with CSU. However, food-sIgG could not be used as an indicator to reflect the disease activity of CSU and treatment response.
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Autologous serum skin test (ASST) is commonly used as a screening test to assess immune subtypes of chronic spontaneous urticaria (CSU) in clinical practice, but its immunological mechanisms and associations with clinical features and prognosis of CSU are not yet clear. Studies have shown that positive ASST is associated with increased immunoglobulin G autoantibodies, decreased eosinophil and basophil counts, increased CD63 expression on basophils, and changes in circulating inflammatory cytokine levels in CSU patients, but not associated with age, disease duration, and personal or family history of CSU patients, and may be a predictor of severity of chronic urticaria. ASST-positive patients may respond poorly to second-generation H1 antihistamines, slowly to omalizumab, but respond well to cyclosporine and autologous whole blood/serum injections. This review summarizes the immunological and clinical characteristics of ASST-positive patients, and discusses the predictive value of positive ASST for the efficacy of different treatment regimens.
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Objective:To explore predictive factors for the efficacy of omalizumab in the treatment of refractory chronic spontaneous urticaria (CSU) .Methods:Totally, 40 patients with refractory CSU treated with omalizumab were enrolled from Department of Dermatology, the Second Affiliated Hospital of Soochow University from 2019 to 2021. Before treatment, clinical data including the urticaria activity score over 7 days (UAS7) and dermatology life quality index (DLQI) were collected; venous blood samples were collected for the detection of total immunoglobulin E (IgE) antibodies, eosinophil counts and basophil counts, anti-thyroid peroxidase (TPO) IgG antibody levels, mean platelet volume, as well as C-reactive protein (CRP) , D-dimer, complements C3 and C4, interleukin (IL) -2, IL-4, IL-6, IL-10, IL-17A, tumor necrosis factor (TNF) -α and interferon (IFN) -γ levels, and percentages of CD4 + T cells and CD8 + T cells; meanwhile, the autologous serum skin test (ASST) was performed. After 12-week treatment with omalizumab, 40 CSU patients were divided into well-responding group and poorly-responding group according to the UAS7 score, and the above laboratory indicators were compared between the two groups. For continuous variable indicators with significant differences, the accuracy of prediction and optimal cut-off values were determined by using the receiver operating characteristic (ROC) curve; for categorical variable indicators with significant differences, the sensitivity and specificity for the prediction of poor clinical response to omalizumab were calculated; correlations among the above indicators were analyzed by Pearson correlation analysis. Results:After 12-week treatment with omalizumab, 28 CSU patients responded well to omalizumab, and 12 responded poorly. Before treatment, the poorly-responding group showed significantly increased proportions of patients with eosinopenia (6/12) , basopenia (7/12) , decreased C3 (6/12) , decreased C4 (6/12) , positive anti-TPO IgG antibodies (5/12) and low total IgE levels (8/12) , increased proportion of CD4 + T cells (71.13% ± 3.26%) , and increased IL-17A levels (27.16 ± 9.75 pg/ml) compared with the well-responding group (14.3%, 10.7%, 14.3%, 7.1%, 10.7%, 14.3%, 60.33% ± 5.12%, 19.24 ± 10.84 pg/ml, respectively; all P < 0.05) , but decreased IL-6 levels compared with the well-responding group ( t = 5.75, P < 0.05) . According to the ROC analysis and calculation of sensitivity, specificity and accuracy, the above indicators showed high accuracy in predicting therapeutic effect of omalizumab, and the optimal cut-off values of IL-6, IL-17A, and CD4 + T cell proportion were 8.672 pg/ml, 23.415 pg/ml, and 67.95%, respectively. In addition, the IL-6 level was significantly positively correlated with the total IgE level in CSU patients at baseline ( r = 0.43, P = 0.006) . Conclusion:Before the selection of omalizumab for the treatment of refractory CSU, there is a need to detect the eosinophil and basophil counts, levels of complements C3, C4, anti-TPO IgG antibodies, total IgE, IL-17A and IL-6, and CD4 + T cell proportions to predict therapeutic effect of omalizumab, so as to determine whether omalizumab is suitable for the patients.
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Background: Second generation antihistamines are first line therapy for chronic spontaneous urticaria (CSU). Sedation has been always a concern as a side effect of antihistamine for both patients and treating dermatologist. It is always better to prefer non-sedative antihistamine for CSU. Bepotastine is such promising non-sedative agent. Aim and Objectives: The objective of the study was to compare the efficacy and safety of bepotastine and levocetirizine in patients of CSU. Materials and Methods: This is a double arm, open label, randomized, and controlled study. Out of 99 patients, 50 patients belonged to Group A while 49 belonged to Group B. Subjects in Group A received bepotastine 10 mg twice daily while subjects in Group B received levocetirizine 5 mg once daily for 8 weeks. Patients were evaluated at baseline, day 14, day 28, and day 56 using Urticaria Activity Score (UAS) and Urticaria Control Test (UCT) for efficacy; and visual analog scale (VAS) for safety, that is, sedation. Results: The fall in mean UAS scores was statistically significant at day 14, day 28, and day 56 for both Groups A and B (P < 0.05) on intragroup comparison. While comparing the overall improvement between the two groups, there was no significant difference in UAS and UCT score at day 14, day 28, and day 56 between Group A and Group B, respectively (P > 0.05). At day 56, there was significant difference in mean VAS of Group A and B. Only one patient in Group B developed headache. Conclusion: Thus, both levocetirizine and bepotastine are equally effective for the treatment of CSU. Bepotastine has less sedative potential than levocetirizine.
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Background: The subtypes of chronic urticaria share a common clinical expression, but may show differences phenotypically. Meanwhile, two or more different subtypes of chronic urticaria can coexist in any given patient which may involve different phenotypes. Aims: The study aims to compare the two phenotypes in terms of demographics, clinical profile and treatment response. Methods: In this retrospective study, 2678 chronic urticaria patients were divided into the single subtype chronic urticaria group and mixed subtype chronic urticaria group as was appropriate.The differences in the clinical features, possible causes, urticaria activity score of seven days, dermatology life quality index score, laboratory investigations and response to treatments were evaluated among the two groups. Results: An obvious female predominance was detected in chronic urticaria, especially in mixed subtype chronic urticaria patients. Of the 2678 chronic urticaria patients, there were 837(31.25%) mixed subtype chronic urticaria. Chronic spontaneous urticaria combined with symptomatic dermographism was the most common group in the mixed subtype chronic urticaria. Patients with mixed subtype chronic urticaria were more likely to have associated chest tightness/shortness of breath and showed greater urticaria activity. In patients with single subtype chronic urticaria, the positive rate of family history with allergic rhinitis, asthma or urticaria was lower. Based on evaluation of the treatment, control with second-generation antihistamines at licensed doses was achieved in only 38.83% of mixed subtype chronic urticaria patients, compared with 56.32% of patients with single subtype. Limitations: First, this study was a single-center design retrospective study. Second, omalizumab treatment was not included. Third, the differences between different subtypes of mixed subtype chronic urticaria were not discussed in detail. Conclusion: This study showed that mixed subtype chronic urticaria had some distinct features. Comprehensive knowledge about it may help us define effective therapeutic strategies and improve symptom control and the quality of life for chronic urticaria patients
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OBJECTIVE@#To compare the clinical therapeutic effect and the impacts on recurrence rate on chronic spontaneous urticaria (CSU) between the combined treatment of bloodletting therapy and auricular point sticking on the base of xuanfu theory and the oral solution of levocetirizine hydrochloride.@*METHODS@#A total of 86 patients with CSU were randomized into an observation group (43 cases, 1 case dropped off) and a control group (43 cases, 3 cases dropped off). In the observation group, bloodletting therapy at Dazhui (GV 14), Feishu (BL 13), Geshu (BL 17) and Pishu (BL 20) was combined with auricular point sticking at lung (CO14), kidney (CO10), shenmen (TF4) and heart (CO15), etc. This combined treatment was given once every two days. In the control group, the oral solution of levocetirizine hydrochloride was prescribed, 10 mL each time, once daily. The treatment lasted for 4 weeks in the two groups. Before and after treatment, urticaria activity score 7 (UAS7), the score of dermatology life quality index (DLQI) and the levels of serum immune globulin E (IgE), interleukin 4 (IL-4) and interferon γ (IFN-γ) were compared in the patients between the two groups. The clinical therapeutic effect was evaluated in patients of the two groups and the recurrence rate was followed up 4, 8 and 12 weeks after treatment separately.@*RESULTS@#After treatment, the scores of UAS7 and DLQI, as well as the levels of serum IgE and IL-4 were all reduced as compared with those before treatment in the two groups (P<0.05), and the level of serum IFN-γ was increased (P<0.05). The total effective rate was 83.3% (35/42) in the observation group and was 85.0% (34/40) in the control group. There was no statistical significance for the difference in the clinical therapeutic effect between the two groups (P>0.05). Eight and 12 weeks after treatment, the recurrence rates were 21.1% (4/19) and 26.3% (5/19) in the observation group, lower than 55.0% (11/20) and 65.0% (13/20) in the control group, respectively (P<0.05).@*CONCLUSION@#The combined therapy of bloodletting and auricular point sticking on the base of xuanfu theory relieves the clinical symptoms, regulates the levels of serum IgE, IL-4 and IFN-γ and improves the quality of life in the patients with CSU. The clinical therapeutic effect of this combined treatment is similar to the oral solution of levocetirizine hydrochloride. But, the recurrence rate of the combined treatment of bloodletting and auricular point sticking is lower and its long-term curative effect is better.
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Humans , Acupuncture Points , Acupuncture Therapy , Acupuncture, Ear , Bloodletting , Chronic Urticaria , Quality of Life , Treatment OutcomeABSTRACT
Objective:To evaluate the clinical efficacy and safety of omalizumab in the treatment of chronic spontaneous urticaria (CSU) .Methods:Clinical data were collected from 60 patients, who were diagnosed with CSU and received subcutaneous injections of omalizumab at a dose of 300 mg once every 4 weeks for 3 sessions in Hospital of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College from March 2020 to September 2020, and retrospectively analyzed. At weeks 0, 2, 4, 6, 8, 10 and 12, urticaria activity score over 7 days (UAS7) and chronic urticaria quality of life (CU-Q2oL) score were used to evaluate clinical symptoms and quality of life of patients. Changes in the use of other drugs were evaluated before and after the treatment with omalizumab. Paired t test was used to compare UAS7 or CU-Q2oL score before and after treatment. Results:All the 60 CSU patients received 12 weeks of omalizumab treatment. The baseline UAS7 score was 22.37 ± 8.88 points; after one session of the treatment, the UAS7 score dropped to 2.01 ± 5.13 points, reaching the treatment plateau; at week 12, it dropped to 0.6 ± 2.63 points, and 0 point (complete control) in 93.3% of the patients, 1-6 points (favorable control) in 3.3%; the time required for UAS7 score to decrease to 0 point was 22.4 ± 3.2 days. The baseline CU-Q2oL score was 34.10 ± 15.01 points; after one session of the treatment, the CU-Q2oL score dropped to 2.41 ± 7.18 points, reaching the treatment plateau; at week 12, it was 0.56 ± 2.90 points; the time required for CU-Q2oL score to drop to 0 point was 21.15 ± 16.02 days. After the combination treatment with omalizumab, a gradual decrease in dosage or withdrawal of previous therapeutic drugs was realized. At week 12, 39 patients (65%) achieved complete control, and withdrew all therapeutic drugs except omalizumab. During the treatment and follow-up, omalizumab showed good safety, and no adverse reactions were observed.Conclusion:Omalizumab at a dose of 300 mg once every 4 weeks is markedly effective and safe for the treatment of CSU, providing a new treatment option for CSU patients with poor response to traditional therapy.
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Objective:To investigate differences in gut microbiota between patients with chronic spontaneous urticaria (CSU) and healthy controls.Methods:A total of 18 patients with CSU (CSU group) and 18 age- and gender-matched healthy controls (HC group) were enrolled from Department of Dermatology, Tianjin First Central Hospital between January 2019 and December 2019. Fecal samples were collected from these subjects, and total DNA was extracted. The 16S rRNA sequencing technology was used to identify microbial species in gut microbiota, and bioinformatics methods were applied to analyze differences in gut microbiota composition between the 2 groups. The SPSS 23.0 software was used for statistical analysis of the experimental data.Results:In terms of α diversity, there was no significant difference in the Observed OTU index, Chao1 index, Shannon index or Simpson index between the CSU group (161.28 ± 35.47, 161.31 ± 35.51, 5.15 ± 0.47, 0.94 ± 0.03, respectively) and HC group (154.89 ± 54.46, 154.92 ± 54.43, 4.92 ± 0.88, 0.91 ± 0.08, respectively; t = 0.417, 0.417, 0.952, 1.116, respectively, all P > 0.05) . In terms of β diversity, principal component analysis showed that the first and second principal components explained 6.66% and 4.93% respectively, and there was no significant difference in the microbiota structure between the 2 groups ( P = 0.672) . The relative abundance of the genus Holdemania in the gut microbiota significantly differed between the CSU group and HC group (0.04% vs. 0.01%, P = 0.025) . Conclusion:The gut microbiota differs between the patients with CSU and healthy controls.
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Objective:To retrospectively evaluate efficacy and safety of omalizumab in the treatment of chronic spontaneous urticaria (CSU) , as well as recurrence after its withdrawal.Methods:Clinical data on patients with CSU, who received omalizumab treatment in Peking University First Hospital from February 2018 to January 2021, were collected and analyzed retrospectively. Through outpatient follow-up, urticaria control test (UCT) and dermatology life quality index (DLQI) were recorded to assess disease severity, and adverse events and recurrence after omalizumab withdrawal were monitored. Comparisons of normally distributed measurement data between groups were carried out using t test or analysis of variance, comparisons of non-normally distributed measurement data between groups using Mann-Whitney U test, Wilcoxon signed-rank test or Kruskal-Wallis H test, and comparisons of enumeration data between groups using chi-square test or Fisher′s exact test. Results:A total of 59 patients with CSU were included and treated with omalizumab for at least 3 months, of whom, 45 were treated for more than 6 months, and 15 for more than 12 months. After the start of omalizumab treatment, UCT scores increased from 3.0 (1.0, 6.0) points at baseline to 11.0 (3.0, 14.0) points at 1 month and 15.0 (12.0, 16.0) points at 3 months (both P < 0.05) ; DLQI scores decreased from 16.0 (12.0, 20.0) points at baseline to 7.0 (1.0, 13.0) points at 1 month and 1.0 (0.0, 4.0) points at 3 months (both P < 0.05) . The proportion of patients achieving partial or complete disease control increased from 0 at baseline to 44.1% at 1 month, 78.0% at 3 months, and 88.9% at 6 months. The proportion of patients whose quality of life was severely or extremely severely affected by CSU decreased from 84.7% at baseline to 30.5% at 1 month, 15.3% at 3 months, and 4.4% at 6 months. The disease duration was significantly shorter in the complete response group and partial response group than in the non-response group ( t = -2.894, -2.511, P = 0.011, 0.036, respectively) ; the treatment duration was significantly longer in the complete response group than in the partial response group and non-response group ( t = 2.479, 2.677, P = 0.039, 0.022, respectively) . Compared with the rapid response group, the slow response group showed higher DLQI scores ( Z = -2.622, P = 0.009) and lower UCT scores ( Z = -2.746, P = 0.006) at baseline. Nineteen patients withdrew omalizumab after complete control of CSU, of whom 13 (68.4%) experienced relapse 7.0 (5.0, 8.0) weeks after the withdrawal, and showed significantly higher UCT scores at relapse than at baseline ( Z = 3.172, P = 0.001) . The disease duration was significantly longer in the recurrence group than in the non-recurrence group ( Z = -2.635, P = 0.007) . After recurrence, 5 patients restarted omalizumab treatment, and all of them regained partial or complete disease control. The adverse events reported during the treatment were all mild to moderate. Conclusions:Omalizumab can effectively and safely control symptoms of CSU and improve the quality of life of patients with CSU. However, recurrence frequently occurs after omalizumab withdrawal, and reinitiating omalizumab treatment after recurrence is still effective.
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A urticária crônica é uma doença com grande impacto socioeconômico e na qualidade de vida do indivíduo. O adequado conhecimento de formas de tratamento eficazes e com perfil de segurança satisfatório, assim como dos mecanismos preditores de resposta ao tratamento, são essenciais para que se alcance um controle adequado da doença. O omalizumabe é um anticorpo monoclonal anti-IgE com eficácia reconhecida e bom perfil de segurança no tratamento da urticária crônica. Objetivamos elucidar questões envolvidas no manejo desta medicação, através da revisão em literatura de estudos atuais e com relevância clínica. Foi realizado levantamento de questões importantes e pouco elucidadas, buscando respostas baseadas nestes estudos. Com isso, foram abordados aspectos práticos do tratamento com o omalizumabe, esclarecendo desde os fenótipos dos pacientes e conduta adequada para estas diferentes situações, trazendo possíveis fatores preditores de resposta ao tratamento e contemplando também um novo anticorpo monoclonal anti-IgE no manejo destes pacientes.
Chronic urticaria is a disease with great socioeconomic impact on people's quality of life. Adequate knowledge of effective treatments with a satisfactory safety profile as well as of the predictive mechanisms of response to treatment are essential for achieving adequate disease control. Omalizumab is an anti-IgE monoclonal antibody with recognized efficacy and a good safety profile in the treatment of chronic urticaria. We aim to elucidate issues involving the management of this medication through a literature review of current studies with clinical relevance. A survey of important and unclear questions was conducted, and the answers were sought in the studies. Thus, practical aspects of omalizumab treatment were addressed, including the phenotypes of patients and appropriate approaches for different situations. Possible predictive factors of response to treatment and a new anti-IgE monoclonal antibody for the management of these patients were also reported.
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Humans , Male , Female , Omalizumab , Chronic Urticaria , Antibodies, Monoclonal , Patients , Phenotype , Quality of Life , Safety , Therapeutics , Immunoglobulin EABSTRACT
Background: Etiopathogenesis in Chronic Spontaneous Urticaria (CSU) is not completely clear. Some vitamins, inflammatory markers and even some microorganisms have been held responsible for this process. There are limited number of publications in this field in the literature. The aim of this study is to shed light on the etiology of chronic urticaria.Methods: This study included a total of 90 patients that 45 with CSU patients and 45 healthy subjects who admitted to Allergy and Clinical Immunology and Internal Medicine outpatient clinics of University of Health Sciences, Bursa Postgraduate Research and Training Hospital between October 2018 and June 2019. They were between the ages of 18-55. Both groups were examined for CRP, Procalcitonin (PCT), Erythrocyte Sedimentation Rate (ESR), Vitamin B12, vitamin D, folic acid and Helicobacter pylori (H. pylori) antibody.Results: ESR, CRP, PCT, Vitamin B12 and Vitamin D levels were not statistically different according to the groups (p>0.05). Folic acid levels were significantly different between groups (p=0.026; p<0.05); the low folic acid ratio in the healthy group is higher than in the urticaria group. There was no statistically significant difference between the groups according to H. pylori antibody positivity (p>0.05). In urticaria group, sufficient vitamin D ratio was higher in who were H. pylori antibody negative. In healthy group; insufficient and sufficient vitamin D ratio was higher in who were H. pylori antibody positive.Conclusions: There is no direct correlation between urticaria and Vitamin B12, Vitamin D, folic acid deficiencies and inflammatory biomarkers. CRP, ESR and PCT levels may be generally normal as in patients with urticaria. However, CRP may also increase slightly in patients with severe urticaria. It may be wrong to see H. pylori as a direct cause of urticaria.
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@#Autoimmune chronic spontaneous urticaria (aiCSU) is characterized by the presence of anti-FceR1 and anti-IgE autoantibodies. In this study we aimed to compare the efficacy and safety of bilastine versus cetirizine in aiCSU.
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Introdução: A urticária crônica espontânea (UCE) é considerada atualmente uma condição autoimune, onde o mastócito é a célula central e sua ativação envolve a participação de autoanticorpos IgG e/ou IgE. Entretanto, várias outras condições podem estar associadas ao não controle da UCE, como a infecção pelo Helicobacter pylori (Hp), embora os dados na literatura sejam controversos. O objetivo deste estudo foi avaliar a influência do tratamento do Hp no controle clínico da UCE. Métodos: Estudo retrospectivo de prontuários eletrônicos de pacientes com UCE que foram submetidos à pesquisa de Hp devido a sintomas gastroesofágicos. Foram avaliados os dados demográficos e a refratariedade aos anti-histamínicos destes pacientes. Posteriormente, a positividade ao Hp e a influência do tratamento do Hp sobre o controle clínico da UCE também foram avaliados. A UCE foi considerada controlada quando o UAS7 < 6, juntamente com a redução do uso de medicamentos para UCE. Resultados: Foram incluídos 50 pacientes, a maioria do sexo feminino (84%), e com idade média de 56,0 anos. A positividade para o Hp foi observada em 18 pacientes (36%), porém, o tratamento para erradicação do Hp foi realizado em apenas 13 pacientes, e, destes, 9 (69,2%) apresentaram melhora dos sintomas da UCE, avaliados em média 5,6 meses após este tratamento. Não houve associação da infecção pelo Hp com a gravidade da UCE e nem com o tempo de doença. Conclusões: Embora a UCE tenha a autoimunidade como a principal hipótese para ativação do mastócito, outras situações estão associadas ao não controle da UCE, como a infecção pelo Hp. Este estudo encontrou que a frequência de positividade do Hp nos pacientes com UCE foi mais baixa do que a encontrada na literatura, porém, cerca de 70% dos pacientes tratados para erradicação do Hp apresentaram melhora clínica da UCE.
Introduction: Chronic spontaneous urticaria (CSU) is currently considered an autoimmune disorder, where mast cells are the key cells and their activation is associated with IgG and/ or IgE autoantibodies. However, many other conditions may be associated with uncontrolled CSU, such as Helicobacter pylori (Hp) infection, although the literature is controversial in this regard. The aim of this study was to evaluate the influence of Hp treatment on CSU control. Methods: We retrospectively reviewed the medical records of patients with CSU who underwent Hp screening because of gastroesophageal symptoms. Data on demographics and antihistamine resistance were assessed in these patients. Hp positivity and the influence of Hp treatment on CSU control were also evaluated. CSU was considered controlled if UAS7 <6 and the medication for CSU control was reduced. Results: Fifty patients were included in the study; most were women (84%) and the mean age was 56.0 years. Hp infection was observed in 18 patients (36%), although only 13 were treated for Hp eradication; of these, 9 (69.2%) showed improvement in CSU symptoms, reassessed at a mean of 5.6 months after treatment. There was no association of Hp infection with CSU severity or disease duration. Conclusions: Although the main hypothesis for mast cell activation in CSU is autoimmunity, other conditions are associated with uncontrolled CSU, such as Hp infection. This study found a lower rate of Hp positivity than that reported in the literature, but about 70% of patients with CSU treated for Hp eradication showed clinical improvement.