Urticaria Activity Score Research Articles

Combination therapy of omalizumab with house dust mite immunotherapy in chronic spontaneous urticaria associated with sensitization to dust mites-case series

Chronic spontaneous urticaria (CSU) is a heterogeneous disorder with recurrent pruritic wheals and/or angioedema. The anti-immunoglobulin E (omalizumab) is used in CSU patients resistant to four-fold second-generation anti-histamines. Most clinical trials have experienced relapse after stopping omalizumab treatment. Here, we present a case series of five cases of chronic atopic urticarial concomitant allergic rhinitis and asthma which have shown immunologically significant positivity to Dermatophagoides pteronyssinus and Dermatophagoides farinae. Disease control was achieved (Urticaria Activity Score 7 <6) in four cases by combination therapy of omalizumab with house dust mite (HDM) Allergen Immunotherapy (AIT) and remained sustained for three years on follow-up even after discontinuation of AIT for one year. We hypothesize that this combined therapy may contribute to enhanced clinical efficacy, safety, and faster achievement of disease control in CSU.

Analysis of clinical factors as possible predictors of response to omalizumab and relapse after treatment discontinuation in chronic spontaneous urticaria.

Omalizumab is a monoclonal anti-IgE antibody which is effective in chronic spontaneous urticaria (CSU), although clinical response appears to be variable in the real-life setting. The aim of this study was to evaluate whether the response of CSU to omalizumab and disease relapse are associated with individual and/or clinical characteristics of patients. We retrospectively evaluated the clinical records of 124 patients treated with omalizumab for moderate to severe CSU refractory to antihistamines. Disease activity was assessed using the urticaria activity score over the last 7 days (UAS7). After 24 weeks of treatment, 91% of patients showed complete remission (UAS7=0) or good control (UAS7 < 7) of CSU. Omalizumab was re-administered in 45 patients because of recurrence of moderate to severe symptoms at week 8 after treatment discontinuation or later, and clinical results achieved with retreatment were similar to those observed in the first course. Among the parameters included in our analysis (age and sex of patients, documented history of atopy or autoimmune thyroid disease, CSU duration and baseline severity, concurrent angioedema, and association with chronic inducible urticaria), none was associated with response to omalizumab in our study population. Similarly, these parameters did not significantly differ between patients who experienced CSU relapse and those without relapse. Predictors of response to omalizumab treatment in CSU patients are still unclear, and further studies are needed to evaluate the presence of baseline factors that can influence treatment outcome.

Safety and clinical efficacy of bilastine in reduction of pruritus in patients with chronic spontaneous urticaria

Objective — to evaluate the efficacy/safety of bilastine in relieving pruritus in patients with chronic spontaneous urticaria.&#x0D; Materials and methods. This prospective randomized study included 50 adult patients aged 18 to 59 years with chronic spontaneous urticaria and pruritus with an intensity of more than 4 points by the visual analog scale of pruritus assessment in the last 3 days and more than 16 points by the Urticaria activity score 7 (UAS7) which assessed chronic urticaria intensity for the last week.Patients received bilastine orally at a dose of 20 mg once a day for 8 weeks. Patients who did not respond to therapy within the first 2 weeks subsequently received bilastine at a dose of 40 mg per day (two 20 mg tablets) till the end of the study (for 6 weeks).&#x0D; Results and discussion. The mean age of patients was 39.61 years with standard deviation (SD) of 12.33 years. In the group of patients who responded positively to the initial therapy, within 8 weeks, the pruritus intensity scoring level decreased significantly to 0.46 (95 % CI: 0.14—0.78) points (p &lt; 0.05). The patients who received a double dose of bilastine also revealed a decrease in the intensity of pruritus and on average on the 8th week of treatment had 0.48 (95 % CI: 0.26—0.70) points (p &lt; 0.05).The study reported 14 adverse events (AE) that occurred during bilastine treatment in 10 (23.8 %) patients. All of them were classified as mild and the most common was headache, registered in 12 (85.7 %) cases. No moderate or severe AEs were reported during the study.&#x0D; Conclusions. 8 week treatment with bilastine has demonstrated proven clinical efficacy both in reducing the urticaria activity index according to UAS7 and in reducing the intensity of pruritus in the absence of moderate and severe AEs. Patients who did not respond to starting therapy after doubling the bilastine dose also significantly decreased the urticaria activity index according to UAS7 and reduced the intensity of pruritus. At the same time, increasing the dose of the drug did not lead to an increase in the frequency of AEs.

Exploring Machine Learning Techniques to Predict the Response to Omalizumab in Chronic Spontaneous Urticaria.

Background: Omalizumab is the best treatment for patients with chronic spontaneous urticaria (CSU). Machine learning (ML) approaches can be used to predict response to therapy and the effectiveness of a treatment. No studies are available on the use of ML techniques to predict the response to Omalizumab in CSU. Methods: Data from 132 CSU outpatients were analyzed. Urticaria Activity Score over 7 days (UAS7) and treatment efficacy were assessed. Clinical and demographic characteristics were used for training and validating ML models to predict the response to treatment. Two methodologies were used to label the data based on the response to treatment (UAS7 ≥ 6): (A) at 1, 3 and 5 months; (B) classifying the patients as early responders (ER), late responders (LR) or non-responders (NR) (ER: UAS 7 ≥ 6 at first month, LR: UAS 7 ≥ 6 at third month, NR: if none of the previous conditions occurred). Results: ER were predominantly characterized by hypertension, while LR mainly suffered from asthma and hypothyroidism. A slight positive correlation (R2 = 0.21) was found between total IgE levels and UAS7 at 1 month. Variable Importance Analysis (VIA) reported D-dimer and C-reactive proteins as the key blood tests for the performance of learning techniques. Using methodology (A), SVM (specificity of 0.81) and k-NN (sensitivity of 0.8) are the best models to predict LR at the third month. Conclusion: k-NN plus the SVM model could be used to identify the response to treatment. D-dimer and C-reactive proteins have greater predictive power in training ML models.

Glucocorticoid-induced Changes in the Transcriptional Activity of Genes of the Innate and Adaptive Immune System in the Blood of Patients with Acute Urticaria

Background: A number of the main effects of glucocorticoids (GCs) are their direct action on T cells, mainly through the transcriptional regulation: elevated expression of immune-regulatory proteins, inhibitory receptors, and reduced expression of pro-inflammatory cytokines, co-stimulatory molecules, and cell cycle mediators. But controversies arise due to the clinical effectiveness of GCs in the treatment of acute urticaria. Methods: In our research, we applied a pathway-specific PCR array (Human Innate &amp; Adaptive Immune Responses RT2 Profiler PCR Array, QIAGEN, Germany) to detect and verify innate &amp; adaptive immune responses pathway-focused genes expression in the blood of patients with acute urticaria who received treatment with glucocorticoids in addition to standard therapy. Results: Adding glucocorticoids to standard therapy did not notably affect the nature of the clinical presentation of acute urticaria, which was assessed according to the UAS scale (urticaria activity score). Analysis of the transcriptional profile of peripheral blood mononuclear cells in patients with acute urticaria against the background of glucocorticoid therapy showed the induction expression of the FOXP3 and IL10 genes against the background of repression of the transcriptional activity of the genes for chemokines and cytokines CCL5, CXCL8, IFNG, IL2, IL5, IL17A, IL1B, and TNF. Glucocorticoid-induced changes in the transcriptome also manifested by pronounced repression in genes of CD40 and CD80 (B7-1) co-stimulatory molecules, transcriptional regulators of Th1-cells differentiation - TBX21 and STAT1, Th17 cells - RORC, NLRP3-inflammasome genes, and the transcription factor NFKB1 compared with the control group. Conclusions: Adding glucocorticoids to the standard therapy of acute urticaria has a pronounced immunosuppressive potential at the transcriptome level of immune response genes in the blood; however, it does not have any noticeable clinical effect.

Fenebrutinib in H1 antihistamine-refractory chronic spontaneous urticaria: a randomized phase 2 trial

Bruton’s tyrosine kinase (BTK) is crucial for FcεRI-mediated mast cell activation and essential for autoantibody production by B cells in chronic spontaneous urticaria (CSU). Fenebrutinib, an orally administered, potent, highly selective, reversible BTK inhibitor, may be effective in CSU. This double-blind, placebo-controlled, phase 2 trial (EudraCT ID 2016-004624-35) randomized 93 adults with antihistamine-refractory CSU to 50 mg daily, 150 mg daily and 200 mg twice daily of fenebrutinib or placebo for 8 weeks. The primary end point was change from baseline in urticaria activity score over 7 d (UAS7) at week 8. Secondary end points were the change from baseline in UAS7 at week 4 and the proportion of patients well-controlled (UAS7 ≤ 6) at week 8. Fenebrutinib efficacy in patients with type IIb autoimmunity and effects on IgG-anti-FcεRI were exploratory end points. Safety was also evaluated. The primary end point was met, with dose-dependent improvements in UAS7 at week 8 occurring at 200 mg twice daily and 150 mg daily, but not at 50 mg daily of fenebrutinib versus placebo. Asymptomatic, reversible grade 2 and 3 liver transaminase elevations occurred in the fenebrutinib 150 mg daily and 200 mg twice daily groups (2 patients each). Fenebrutinib diminished disease activity in patients with antihistamine-refractory CSU, including more patients with refractory type IIb autoimmunity. These results support the potential use of BTK inhibition in antihistamine-refractory CSU.

The Role of Bradykinin Receptors in the Etiopathogenesis of Chronic Spontaneous Urticaria.

Background and Objectives: Chronic spontaneous urticaria (CSU) is a distressing skin condition, which manifests as red, swollen, itchy, and sometimes painful hives or wheals appearing on skin. Recently, CSU has been associated with bradykinin release, which was previously discovered to be the main trigger of hereditary angioedema attacks. To study the role of bradykinin receptors 1 (BR1) and 2 (BR2) in the etiopathogenesis of CSU. Materials and Methods: A total of 60 individuals, 30 patients with CSU and 30 healthy subjects, were recruited to the study. CSU was diagnosed in accordance with the standardized protocol of dermatological assessment of skin symptoms. The level of bradykinin receptors was determined in populations of CD3+, CD4+, and CD8+ lymphocytes as well as in CD14++CD16−, CD14++CD16+ and CD14+CD16+ monocytes. In addition, urticaria activity score summed over 7 days (UAS-7) was assessed and correlated with BR1 and BR2 expression. Results: A statistically significant higher concentration of BR1 expression in lymphocytes was found in patients with CSU, compared to the control group (p < 0.001). Moreover, a statistically significant positive correlation was observed between UAS-7 and BR1/BR2 expression in CD14++CD16− cells (p = 0.03, R = 0.4). Conclusions: Bradykinin receptors are elevated in selected populations of lymphocytes in symptomatic CSU patients compared to healthy controls, indicating their role in the etiopathogenesis of the disease.

Relation between Chronic Urticaria and Quality of Life: An Observational Study of 112 Portuguese Patients

Introduction: Chronic urticaria is a complex multifactorial dermatological disease. It is highly prevalent throughout the world and contributes to lower patients’ quality of life. The purpose of this study is to evaluate the impact of chronic urticaria on the quality of life (QoL) and mental status in Portuguese patients.&#x0D; Methods: This observational study included the evaluation of Portuguese patients from the consultation of chronic urticaria in the Coimbra University Hospital Centre, using several questionnaires including: weekly urticaria activity score (UAS7), Urticaria Control Test (UCT), Dermatology Life Quality Index (DLQI), Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) and the Hospital Anxiety and Depression Scale (HADS). The results of the questionnaires were posteriorly analysed, and the quality of life and mental status assessed in these patients were correlated with sociodemographic parameters and clinical aspects of chronic urticaria.&#x0D; Results: We studied 112 patients, mainly female (80%), with an average age of 46 years, mostly classified with mild urticaria activity, according to UAS7, and the majority (85%) were poorly controlled, regarding the UCT classification. Using both CU-Q2oL and DLQI we obtained mean values of 48.98 (±19.53) and 7.23 (±7.67), respectively, that show a high impact on the QoL. CU also interferes with mental status values in HADS concordant with anxiety (in a total of 45 patients) and depression (in 22 patients). A strong and positive correlation was found between both instruments used to measure quality of life, with pruritus, number of papules, quality of sleep and the embarrassment caused by cutaneous lesions as the mostly affected parameters in our sample. QoL varies significantly with gender, degree of instruction, clinical severity of symptoms and level of disease control. Although not always directly related, clinical activity of the disease remains the most significant factor of patients' QoL. Anxiety and depression show a significantly relationship with quality of life, however it was not found a significant correlation with the urticaria clinical activity.&#x0D; Discussion: Patient-Reported Outcomes (PRO) proved to be a practical and effective tool in daily clinic assessment of Portuguese patients suffering from chronic urticaria. The variation of quality of life according to sociodemographic characteristics is in conformity with literature. Moreover, new results were achieved regarding the level of instruction. The mostly impaired domains in our sample’s QoL are not totally identical to previous studies, which suggests a meaningful effect of the geographic location. This investigation supported the significant influence of clinical activity of the urticaria and psychological well-being in QoL as previously published.&#x0D; Conclusion: In Portuguese patients with chronic urticaria, it is essential to establish an integrated approach that encompasses the clinical control of urticaria, but also the control of the associated psychological symptomatology.

Plasma matrix metalloproteinase-9 level change with omalizumab treatment in chronic spontaneous urticaria.

Matrix metalloproteinase-9 (MMP-9) is an enzyme that contributes to inflammation and tissue remodelling. In chronic urticaria, increased plasma levels of MMP-9 and its correlation with disease severity have been shown in several studies, suggesting that MMP-9 could be used to evaluate the effects of new treatments. We aimed to compare MMP-9 levels in chronic urticaria patients with those of healthy patients. Then we planned to investigate the changes in plasma MMP-9 levels with chronic urticaria treatment, the role of this enzyme in demonstrating the efficacy of treatment, and its correlation with C-reactive protein (CRP). Forty-one patients with chronic urticaria who were scheduled for omalizumab treatment and 41 sex- and age-matched healthy volunteers were included in the study. In the patient group, before treatment and at the end of the 12th week, the urticaria activity score used for 7 consecutive days (UAS7) was calculated, and the MMP-9 and CRP levels were measured. Plasma MMP-9 levels were measured from venous blood in the control group. The plasma MMP-9 levels of the patients before treatment were significantly higher than those of the control group (P<.01). In the patient group, there was no significant relationship between the UAS7 score and the MMP-9 and CRP levels before treatment. The UAS7 values were 28±7 before omalizumab treatment and 5±6 at the end of the 12th week (P<.0001). The post-treatment MMP-9 levels (1818±297pg/mL) were higher compared with the pre-treatment values (1617±380) (P<.05). The post-treatment CRP levels of the patients (2.41±2.17mg/L) were lower than their pre-treatment CRP levels (8.20±19.70) (P<.05). MMP-9 levels were not associated with the severity of disease, and MMP-9 levels were not decreased with treatment response. Therefore, MMP-9 cannot be used as a parameter of disease activity in chronic urticaria or to evaluate the efficacy of new treatments.

Serum Leptin in correlation to clinical severity in patients with chronic urticaria

Abstract Background Chronic urticaria (CU) is a complex disease associated with a systemic inflammatory response. This inflammation could be related to the release of adipokines with proinflammatory properties such as leptin. In recent years, leptin has been associated with different diseases, wound healing and immune cell activation. Objective to evaluate leptin levels in patients with chronic spontaneous urticaria, to investigate the possible role of leptin in chronic spontaneous urticaria pathogenesis and to outline relationships between serum leptin and urticaria severity. Methods A case-control study was conducted at the allergy and immunology outpatient clinic at Ain Shams University hospital, and included 60 patients with chronic spontaneous urticaria and 30 healthy individuals who were group matched with cases for age and sex serving as the control group. All the patients were subjected to the following: Full history, clinical examination, calculation of body mass index (BMI), CBC, ESR, CRP, Thyroid profile, AST, ALT, Skin prick test or Specific IgE for common allergens, and measurement of serum leptin level after overnight fasting by ELISA. Results The present study showed that patients with chronic spontaneous urticaria had higher level of serum leptin in comparison to control subjects and there was a positive correlation between leptin level and urticaria severity which was assessed by urticaria activity score. Conclusion serum leptin is increased in chronic spontaneous urticaria and it is positively correlated to urticaria severity.

Oral mini-pulse steroid therapy in severe chronic urticaria

Background: Treatment of chronic urticaria can be difficult at times. The present study aimed to evaluate the efficacy of oral mini-pulse (OMP) therapy with methylprednisolone in management of severe chronic urticaria (CU). Methods and material: 100 patients with severe chronic urticaria, not controlled with maximum dose of a second generation antihistamine, were enrolled in the study after an informed written consent. All patients were treated with methylprednisolone 16 mg tablet on two consecutive days of a week for 2 months along with levocetirizine 5 mg tablet once daily. All patients were reviewed at 0, 2, 4, and 8 weeks with urticaria activity score (UAS). Results: The study comprised of 100 patients (33 males and 67 females) with severe chronic urticaria. 29 patients (29%) had raised TSH levels while Autologous Serum Skin Test was positive in 37 patients. Mean UAS in patients treated with OMP was 5.76 at baseline which reduced to 0.6 at the end of treatment period. Conclusion: Mean UAS showed a significant decline following OMP therapy with methylprednisolone. Most of the patients maintained the benefits of therapy at the end of follow up period of 4 months.

Association between the severity of chronic spontaneous urticaria and sleep-disordered breathing

BackgroundChronic spontaneous urticaria (CSU) is a common mast cell-driven disease, presenting with wheals, angioedema, or both. Sleep-disordered breathing (SDB) is also a common condition and contributes to various diseases by causing chronic inflammation. Recent studies have suggested an association between CSU and SDB. MethodsTo determine the association between the severity of SDB and that of CSU, we studied consecutive patients with CSU who visited the Sagamihara National Hospital allergy department or dermatology department between April 1 and October 31, 2018. The severity of CSU and SDB was evaluated based on the urticaria activity score 7 (UAS7) and peripheral arterial tone apnea-hypopnea index (pAHI) derived from out-of-center sleep testing (OCST) findings, respectively; their correlation was examined. ResultsOf the 37 patients studied, 19 had symptom-free-to-mild CSU (UAS7 ≤15) and 18 had moderate-to-severe CSU (UAS7 ≥16). The pAHI in the latter group was significantly higher than that in the former group (18 vs. 4.2, p = 0.001). In multivariate logistic analysis, moderate-to-severe SDB (pAHI ≥15) was significantly associated with moderate-to-severe CSU even after adjusting for the BMI (adjusted odds ratio 22 [95% confidence interval, 1.7–285]). ConclusionsThe severity of SDB is correlated with that of CSU independently of the BMI. Physicians should consider comorbid SDB when treating patients with CSU.

COVID-19 Disease Leading to Chronic Spontaneous Urticaria Exacerbation: A Romanian Retrospective Study.

(1) Background: The COVID-19 pandemic has resulted in the exacerbation of various chronic diseases. Due to the potential impact of SARS-CoV-2 on mast cells, we aimed to analyze the relevance of COVID-19 disease on chronic spontaneous urticaria (CSU) clinical presentation and biological profile. (2) Methods: This study is a retrospective case series of patients with CSU diagnosed and treated in the Allergy Department of the Professor Doctor Octavian Fodor RIGH, (Cluj-Napoca, Romania). Patients were assessed for disease activity and level of control with the weekly urticaria activity score and the visual analogue scale. Results were correlated with COVID-19 severity and with nonspecific markers of inflammation during and after the SARS-CoV-2 infection. (3) Results: SARS-CoV-2 impacted a significant proportion (33%) of the CSU patients, of which 71% developed a moderate-severe form of COVID-19. Most of the patients (68%) had moderate-severe forms of CSU and 65% took AH1 treatment (one dose, two-fold dose or four-fold dose). The rest of them (35%) received the second-line treatment (40.3% Omalizumab, 53% Prednisolone and 4.8% Cyclosporine). In Omalizumab treated group of UCS patients we observed that COVID-19 disease was not severe. We established a positive correlation between the severity of the infection and that of the CSU clinical presentation, with most bothersome symptoms of urticaria being experienced by moderate to severe COVID-19 CSU patients (47%). Inflammatory markers were positively correlated (p = 0.01) with a more severe clinical profile of CSU, in accordance with our hypothesis that the level of inflammation triggered by COVID-19 disease has a role in CSU exacerbation. The non-specific inflammatory markers, such as CRP, were positively associated with the UAS7 score (R2 = 0.363; p = 0.001). An increased rate of exacerbation of CSU was observed in moderate-severe COVID-19 infection. (4) Conclusions: COVID-19 disease can result in the exacerbation of chronic spontaneous urticaria, more likely in moderate to severe forms of infection.

Clinical difference between single subtype and mixed subtype chronic urticaria: A retrospective study

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. The study aims to compare the two phenotypes in terms of demographics, clinical profile and treatment response. 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. 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. 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. 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.

Factors Affecting the Duration of Disease in Chronic Urticarial; Single-Center Experience

Chronic urticaria (CU) is characterized by recurrent itchy blisters, angioedema, or both for more than six weeks. We evaluated patients' clinical and demographic characteristics, laboratory results, and factors affecting the disease's duration followed up with the diagnosis of chronic urticaria in our clinic. In our study 101 patients who applied to our outpatient clinic between March and December 2020 were included in the study. Demographic features, comorbid illness of patients, skin prick test results, phadiatop, Total IgE, anti-TPO, vitamin B12, vitamin D, ferritin, complete blood count, autologous serum skin test, urticaria activity score over seven days (UAS7) were examined from hospital records retrospectively. Correlations between variables and their effects on the duration of the disease were statistically investigated. It was observed that the duration of the disease was longer in chronic urticaria patients with anti-TPO positivity (p=0.019). As a result of the multiple regression analysis, it had been determined that the UAS7 value had 2,989 folding effects on the duration of the disease. A positive correlation between the duration of the disease and the UAS7 (r=0,277; p=0,005) was determined. The patients in the study defined as a longer disease duration in the patients with angioedema (p=0,005), dermatographism (p=0,012) and gender of female (p=0,031) Anti-TPO positivity, concomitant angioedema, dermatographism, and higher UAS7 scores predicts that their chronic urticaria will last longer.

Evaluation of the Reliability and Validity of the Persian Version of Urticaria Control Test (UCT)

The urticaria control test (UCT) is a patient-reported outcome measure (PROM) for chronic urticaria (CU) patients. As a Persian version of the UCT was not available, the present research aimed to develop such a version, to test its reliability and validity as well as to evaluate urticaria control among Persian-speaking patients. This research was conducted at the Urticaria Centre of Reference and Excellence (UCARE) of Ghaem Hospital, Mashhad, Iran. In a first step, a linguistically validated Persian version of the UCT was developed through a structured forward and backward translation process and subsequent cognitive debriefing interviews. In a second step, the Persian version of the UCT was completed by 100 well-characterized CU patients together with two anchor instruments, the Chronic Urticaria Quality of life Questionnaire (CU-Q2oL) and the urticaria activity score (UAS), to obtain information on its internal consistency reliability and convergent validity. The Persian version of the UCT was found to have acceptable internal consistency reliability with a Cronbach's alpha coefficient of 0.68. In addition, the results obtained with the Persian UCT correlated with the CU-Q2oL total score (-0.48, p<0.001) and the UAS (-0.404, p˂0.001), suggesting convergent validity. Virtually all patients had poorly controlled CU (UCT<12). A Persian version of the UCT is now available and may help to improve the assessment and monitoring of disease control in Persian-speaking CU patients and to optimize treatment decisions.

Safety of Methotrexate in Chronic Urticaria Unresponsive to Omalizumab

Omalizumab (humanized anti-immunoglobulin IgE) is currently the first choice of treatment for chronic urticaria refractory to high-dose second-generation antihistamines (sgAH). Despite its high safety profile, response to omalizumab is insufficient in one-third of patients. Some studies have suggested that methotrexate is effective in antihistamine-refractory chronic urticaria, but there are no studies on its efficacy and safety in patients unresponsive to omalizumab. This retrospective study aimed to investigate the clinical effectiveness and adverse effects of methotrexate in patients with chronic urticaria unresponsive to omalizumab + high-dose sgAH. The patients were evaluated in terms of age at disease onset, duration of the urticaria episode before methotrexate therapy, treatment before methotrexate therapy, final treatment, treatment responses, 7-day urticaria activity score (UAS7) before and after treatment, and total IgE levels. Methotrexate was administered subcutaneously at a dose of 15 mg once weekly as monotherapy or in combination with other drugs to 10 chronic urticaria patients with a history of nonresponse to omalizumab + high-dose sgAH. The mean age of the patients was 44.6±11.5 (31-65) years, and 9 (90%) of the patients were female. The mean duration of methotrexate therapy was 5.1±2.4 months (1.5-9 months). Complete response or well-controlled response was observed in 70% of the patients and partial response was observed in 1 patient (10%). Methotrexate was well tolerated by 80% of the patients. Methotrexate seems to be a useful treatment option both as monotherapy or combined therapy in patients resistant to omalizumab + sgAH.

27362 High rate of complete response achieved with ligelizumab in patients with moderate to severe chronic spontaneous urticaria throughout the phase 2b core study

Introduction: This analysis explores the shift of Weekly Urticaria Activity Score (UAS7) severity bands with ligelizumab treatment compared with omalizumab in patients with moderate or severe chronic spontaneous urticaria (CSU) at baseline.

“Chronic urticaria and obstructive sleep apnea: Is there a significant association?”

BackgroundFew studies have explored the association between obstructive sleep apnea (OSA) and chronic urticaria (CU). Our study aims to fill this gap by determining the frequency of the risk categories for OSA and how they might correlate with the specific CU patient reported outcome measures urticaria activity score (UAS7), urticaria control test (UCT) and CU quality of life questionnaire (CU-Q2oL). MethodsWe conducted a cross-sectional study involving a cohort of 171 Latin American CU patients. Descriptive statistics were used to determine frequency and proportions for demographic and clinical variables, while a chi-squared test for association between STOP-Bang OSA questionnaire categories and both UAS7 and UCT categories was performed to analyze how such variables interact. To further assess the strength of the correlation a Cramer's V coefficient was reported. Finally, a Kendall-Tau b correlation coefficient was performed to measure the correlation between the STOP-Bang score and other independent continuous variables. ResultsThe average STOP-Bang score was 2.5, with 24% and 21% of patients falling into the intermediate and high-risk category for moderate-to-severe OSA, respectively. There was a strong statistically significant association (Cramer's V = 0.263; p = .000) between UAS-7 categories and STOP-Bang risk categories. A similar pattern of strong significant association (Cramer's V = .269; p = .002) was observed between UCT categories and STOP-Bang risk categories. A weak positive correlation between the STOP-Bang score and the CU-Q2oL average score (τb = 0.188, p = .001) was identified. Overall, 72.5% patients reported limitations with respect to sleep in a varied degree according to the CU-Q2oL. ConclusionsOur results suggest that a considerable proportion of patients with CU are at intermediate to high risk for OSA. Higher disease activity, poor CU control, and worse quality of life were all found to be associated with an increased risk. Additional studies are needed to determine the exact link between these conditions, and to determine whether screening and treatment for OSA might benefit patients with CU.

Artículo traducido] Práctica clínica diaria en el manejo de la urticaria crónica en España: resultados del estudio UCREX

BackgroundChronic Urticaria (CU) is a debilitating disease whose treatment is mainly symptomatic. UCREX study aimed to identify CU patients’ profile, disease management and quality-of-life (QoL) in daily clinical practice in Spain. MethodsObservational, 12-months prospective, multicenter study, included de novo or established CU patients attending to dermatology/allergy consultations in 39 Spanish hospitals. Main variables: Urticaria Activity Score (UAS), UAS over 7 days (UAS7). Secondary variables: CU-QoL Questionnaire (CU-Q2oL), EuroQol-5 dimensions (EQ-5D), Medical Outcomes Study Sleep (MOS-Sleep) scale, Hospital Anxiety and Depression Scale (HADS). Results361 patients included. Of them, 176 (48.8%) considered for the main objective analysis. Mean age (SD) of 46.6 (14.2) years and 71.8% women. The year prior to inclusion, most patients (57.1%) were treated with non-sedating H1-antihistamines (NS-H1AH). At baseline, mean (SD) 3.6 (6.8) visits were registered to primary care. Mean (SD) UAS7 at baseline was 14.3 (11.0) and CU-Q2oL 24.1 (17.0) which tended to improve by 8.6 (9.7) and 13.9 (15.0), respectively, at 12-months. MOS-Sleep and EQ-5D remained steady during the study, except pain/discomfort and anxiety/depression which went from 58.7% and 49.6% to 29.6% and 26.9%, respectively. At baseline, HADS showed a mean (SD) anxiety of 8.7 (4.5) and depression 5.1 (4.4), decreasing to 7.0 (4.3) and 4.7 (4.3), respectively, at 12-months. ConclusionsAlthough most CU patients are treated with NS-H1AH, disease activity is still important, negatively affecting patients’ QoL, work activity and healthcare resources use. An appropriate disease management could be the basis for symptoms control, QoL improvement and resources optimization.