Chronic inducible urticaria (CIndU) is characterized by wheals and/or angioedema for longer than 6 weeks induced by specific triggers. The data regarding epidemiology of CIndU is scarce with limited available literature on urticaria severity, investigations, and treatment responses in CIndU compared to CSU. We performed a retrospective chart review of all CIndU patients(cases) enrolled in our Urticaria clinic, past seven years between January 2017 to December 2023. Equal number of CSU patients enrolled during study period were taken as controls. Patients with absence of weals and both CSU and CIndU were excluded from the study. Urticaria severity was assessed by Urticaria activity score over 7 days (UAS7). Statistical analyses were performed using SPSS V29 with P < 0.05 as significant. Out of all records screened, 222 CIndU (cases) and 226 CSU (controls) were eligible based on complete availability of data. Both groups were comparable in terms of age and gender with slight female preponderance. Mean UAS7 at baseline was comparable(p = 0.619) between two groups [(11.49 ± 10.37 in CIndU vs. 10.9 ± 12.2 in CSU)]. The mean CRP (mg/dl) levels for CIndU vs. CSU patients was 2.8 ± 4.2 vs. 6.9 ± 11.2 (p < 0.001). Serum D-dimer levels (mg/dl) were also significant between cases(167 ± 220) and controls(265 ± 452) (p = 0.020). The quality of life assessed by CU-QOL score was 9.39 ± 9.5 in CIndU vs. 16 ± 14.8 in CSU (p < 0.001). 80% of CIndU patients and 52% of CSU patients required updosing of antihistamines upto 4 times and the difference was statistically significant between two groups(p = < 0.001). The mean time taken to achieve remission i.e. UAS7 = 0 (T0) was 60 ± 42 days amongst CIndU while it was shorter in CSU (27.77 ± 27 days) (p < 0.001).Amongst all CIndU cases, commonest subtypes were symptomatic dermographism (SD) (39.5%) followed by cholinergic urticaria(4.2%) and cold urticaria(1.8%). Our study underscores the distinct clinical and laboratory profiles between CIndU and CSU patients. CIndU patients exhibit poorer response to standard antihistamine doses, requiring more frequent updosing and longer treatment duration. The time to attain remission as assessed by UAS7 score was also longer in CIndU patients than CSU patients (mean difference of 33 days). Further research is warranted to elucidate the underlying mechanisms and explore targeted treatment approaches for CIndU.

Many drugs have been found to be effective in treating chronic urticaria, and many others are under investigation. Second-generation antihistamines are the first-line treatment for this condition, as they block peripheral histamine receptors with minimal drowsiness and anticholinergic effects. Therefore, the aim of the current study was to investigate the short-term efficacy and safety of bilastine in Iraqi patients with chronic idiopathic urticaria. This prospective study was conducted at Dermatology Unit/ AL-Diwaniyah Teaching Hospital/ Iraq during the period from January to June 2023. A total of 100 patients, 50 males and 50 females, were enrolled in this study. All these patients were switched over to Bilastine 20 mg/day for one month. The patients were evaluated using the UAS7 scoring system before and one month after bilastine therapy. Statistical analysis was performed using the Statistical Package for Social Sciences, and a paired t-test was used to compare between means. The level of statistical significance was considered at a P value < 0.05. The mean UAS7 score before Bilastine treatment was 18.91 ±7.18, which was significantly reduced (P < 0.001) to 2.38 ±0.72 after one month of treatment with bilastine. Also, before Bilastine treatments, 19 patients (19%) had mild symptoms, 24 patients (24%) had moderate symptoms, and 57 patients (57%) had severe symptoms. However, after treatment, 51 patients (51%) became symptom-free and 49 patients (49%) had well-controlled urticaria. Switching over to bilastine 20mg/day resulted in significant improvement in patients with chronic idiopathic urticaria who had no/ or poor response to conventional antihistamines.

Chronic spontaneous urticaria (CSU) is a distressing skin condition characterized by the recurrent appearance of itchy hives. A subset of CSU patients remains resistant to conventional treatment with high-dose antihistamines. Tofacitinib, a Janus kinase inhibitor, has shown promise in various inflammatory skin diseases. We aimed to evaluate the efficacy of oral tofacitinib in patients with CSU resistant to antihistamines. This study examined data retrospectively from seven patients who were diagnosed with CSU and were treated with tofacitinib for at least six months. These patients initially exhibited resistance to treatment with four-fold up-dosed antihistamines. One of the patients was already on omalizumab, and another was tried on cyclosporine. The patients were administered oral tofacitinib at a dosage of 5 mg twice daily for six months. Patients were followed up monthly for disease control and side effects. The response to treatment was evaluated using the urticaria activity score over 7 days (UAS7) and urticaria control test (UCT). Paired t-tests were conducted to determine the statistical significance of the results using SPSS version 25 software. Six out of the seven patients demonstrated a significant improvement in both UAS7 and UCT scores after six months of treatment with oral tofacitinib. The mean UAS7 score decreased from 24.86 at baseline to 3.83 at the study endpoint (P < 0.0001). Similarly, the mean UCT score increased from 0.57 at baseline to 14 at the study endpoint (P < 0.0001). The standard deviations for both measures were 4.85 and 0.98 at baseline and 3.1 and 3.1 at the study endpoint for UAS7 and UCT, respectively. In this six-month follow-up study, oral tofacitinib demonstrated significant efficacy in treating CSU patients' resistant to high-dose antihistamines. Most patients experienced a remarkable reduction in urticaria activity and an improvement in disease control. These findings suggest that tofacitinib holds promise as a potential therapeutic option for this challenging subset of CSU patients. However, larger, randomized controlled trials are warranted to further investigate the long-term safety and effectiveness of tofacitinib in this population.

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.

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

Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials

To determine the feasibility of conducting a full-scale randomized controlled trial (RCT) and investigate the basic information and safety of acupuncture for patients with chronic spontaneous urticaria (CSU). A total of 80 participants with CSU from July 2018 to July 2019 were randomly assigned to receive active acupuncture (n=41) on a fixed prescription of acupoints or sham acupuncture (n=39) with superficial acupuncture on non-acupuncture points through the completely randomized design. Patients in both groups received 5 sessions per week for 2 weeks, and participants were followed for a further 2 weeks. Feasibility was assessed by recruitment and randomization rates, retention of participants, treatment protocol adherence, and the incidence of adverse events (AEs). The clinical primary outcome was the changes from baseline weekly urticaria activity scores (UAS7) after treatment at 2 weeks. Secondary outcomes included the Visual Analogue Scale (VAS) score of itching intensity, Dermatology Life Quality Index (DLQI), Hamilton Depression Scale (HAMD), and Hamilton Anxiety Scale (HAMA). A total of 80 participants were enrolled. The recruitment rate of 24.02%, randomization rate of 100%, a loss rate of 6.25%, and no obvious AEs were observed in either group. The decrease from baseline in the mean UAS7 total score at week 2 in the active acupuncture group was -8.63 (95%CI, -11.78 to -5.49) and -6.21 (95%CI, -9.43 to -2.98) in the sham acupuncture group for a between-group difference of -2.42 (95% CI, -6.93 to 2.07). The change in the DLQI, VAS of itching intensity, HAMA, and HAMD were a slightly better improvement trend in the active acupuncture group than the sham acupuncture group, but the between-group difference was not significant. Active acupuncture had a better improvement trend in alleviating symptoms, improving quality of life and regulating the mood of anxiety and depression in patients with CSU than sham acupuncture. (Registration Nos. AMCTR-ICR-18000190 and ChiCTR2100054776).

Chronic spontaneous urticaria (CSU) in children is mostly spontaneous in onset (57%). Treatment comprises long-term antihistaminic therapy without need for elaborate investigations. A subset of such patients don't respond to conventional treatment and novel therapies to help reduce pill burden is the need of the hour. To determine the efficacy and safety of autologous serum therapy (AST) in pediatric patients with chronic spontaneous urticaria. All pediatric patients, aged between 6-16 years, attended to our OPD from March 2019 to March 2020 were recruited. Clinico-demographic data and baseline investigations of all patients were performed. Two-weekly AST therapy was given for 8 visits with levocetrizine tablet 5mg on an on-demand basis. Urticaria activity score (UAS) sheet was provided to record and return every 2 weeks. Statistical analysis was done using the IBM SPSS 26 software package. Autologous serum skin test (ASST) was positive in 63% patients. Both the ASST positive and ASST negative group showed significant reduction in UAS7 score at week 14 compared to baseline. The reduction in mean UAS7 score was associated with a decreased pill burden and positive response in the patient and physician global assessment scale. No statistically significant difference between the two groups in terms of mean UAS7 reduction was found. This study has explored the efficacy and safety of autologous serum therapy in the pediatric CSU patients. Both ASST positive and ASST negative group respond to AST therapy.

REMIBRUTINIB IMPROVES CHRONIC SPONTANEOUS URTICARIA IN PATIENTS IRRESPECTIVE OF CU-INDEX: RESULTS FROM PHASE 2B STUDY

Abstract BackgroundAtopic dermatitis (AD) and chronic spontaneous urticaria (CSU) are two prevalent, visible and itching skin diseases associated with decreased quality of life (QoL), sleep disturbance, depression and anxiety. However, little is known about stigmatisation among patients suffering from these diseases.ObjectivesTo examine whether patients with AD or CSU experience stigmatisation and if disease severity or psychosocial variables associate with experienced stigmatisation.MethodsA cross‐sectional survey was performed among adult AD and CSU patients from two highly specialised university hospitals and two private dermatology clinics. External stigmatisation was examined using the 6‐item Stigmatisation Scale (6SS). AD severity was assessed by dermatologists using the Eczema Area and Severity Index (EASI) score. Patient‐reported outcome measures (PROMs) included: Patient‐Oriented Eczema Measure, Urticaria Activity Score over 7 days (UAS7), Urticaria Control Test, Dermatology Life Quality Index, 9‐item Patient Health Questionnaire, 7‐item Generalised Anxiety Disorder, Insomnia Severity Index and Work Productivity and Activity Impairment Questionnaire: General Health. Nonparametric statistics were used due to nonnormal distribution of data. Data were managed in REDCap and analysed with Stata for macOS.ResultsMean EASI score was 7.6 (±10.7) and the mean UAS7 score was 15.6 (±12.0), for patients with AD and CSU, respectively. External stigmatisation was reported by 78.6% of AD patients and 57.3% of CSU patients. Mean 6SS score was 2.9 (±2.8) among AD patients and 1.9 (±2.8) among CSU patients, and stigmatisation levels differed significantly (p &lt; 0.001). In both AD and CSU patients, stigmatisation correlated weakly to moderately with sleep disturbance (rs = 0.48 and rs = 0.30) and symptoms of depression (rs = 0.50 and rs = 0.38) and anxiety (rs = 0.46 and rs = 0.36), but not with disease severity as measured by EASI and UAS7.ConclusionBoth AD and CSU patients report external stigmatisation, which correlated with psychological parameters but not with disease severity. Further studies on stigmatisation are needed and should include a standardised scale embracing both external and internal facets of stigmatisation.

Chronic urticaria (CU) is a debilitating mast cell-driven disease, often refractory to standard therapy (ie, antihistamines). Lirentelimab, an anti-sialic acid-binding immunoglobulin-like lectin 8 mAb, selectively inhibits mast cells and depletes eosinophils. We sought to determine safety and efficacy of lirentelimab in patients with CU. This phase 2a study enrolled patients with CU refractory to up to 4-fold H1-antihistamine doses. Patients received 6 monthly intravenous doses of lirentelimab (0.3, 1, and up to 3 mg/kg). Primary efficacy end point was change in Urticaria Control Test score at week 22. Urticaria Activity Score weekly average (UAS7) was assessed in patients with chronic spontaneous urticaria (CSU), and Cholinergic UAS7 was used for patients with cholinergic urticaria (CholU). A total of 45 patients were enrolled in 4 cohorts (n= 13 omalizumab-naive CSU, n= 11 omalizumab-refractory CSU, n= 11 CholU, n= 10 symptomatic dermographism). Urticaria Control Test scores increased with lirentelimab across cohorts, with mean changes at week 22 of 11.1± 4.1, 4.8± 7.0, 6.5± 6.2, and 3.4± 4.1 and complete response rates (Urticaria Control Test score≥ 12) of 92%, 36%, 82%, and 40%, respectively. In omalizumab-naive and omalizumab-refractory patients with CSU, disease activity decreased at week 22 (mean UAS7 change, -73% and -47%, respectively), with UAS7 response rates (≥50% reduction) of 77% and 45%, respectively. In patients with symptomatic dermographism, 50% (5 of 10) and 40% (4 of 10) had complete itch and hive resolution by FricTest, respectively, and 100% (7 of 7) evaluable patients with CholU had negative responses to Pulse-Controlled Ergometry exercise test. Most common adverse events included infusion-related reactions (43%; all mild/moderate and transient), nasopharyngitis (21%), and headache (19%). No treatment-related serious adverse events occurred. Lirentelimab demonstrated activity across 3 forms of antihistamine-refractory CU.

Background: Chronic urticaria (CU) is one of the most common case found in dermatology and venereology and it decreases the quality of life. Autohemotherapy (AHT) is an innovative therapy that works by desensitization and activation of the local immune system, and it is effective for recurrent or refractory urticaria. AHT technique is simple, inexpensive, and does not require special expertise that can be done at all levels of health services in Indonesia. Purpose: to determine the effectiveness of AHT in the CU treatment. Methods: This was a clinical trial research with involving patients with CU in the Allergo-Immunology Clinic of Department of Dermatology and Venereology Dr. Mohammad Hoesin General Hospital (DV RSMH) and Pertamina Hospital Palembang. The Urticaria Activity Score (UAS7) and Dermatology Life Quality Index (DLQI) assessments were carried out on week 1 and week 10. Result: The research was conducted from 1 July - 30 September 2019 involving 72 eligible patients with 2 dropouts (2.8%). The mean age was 47 years (15-72 years), with 46 (63.9%) are women. Chronic spontaneous urticaria (CSU) was the most frequent diagnosis observed in 64 people (88.9%). Adverse events included bruises at the injection site (n=1; 1.4%) and at the blood draw location (n=1; 1.4%). On week 1, mean UAS7 was 30.77 ± 2.46, mean DLQI 21.66 ± 3.60. By week 10, UAS7 and DLQI significantly decrease to 4.12 ± 2.89 and 2.51 ± 1.53 (p &lt;0.005). Conclusion: There was a significant decrease in UAS7 and DLQI in chronic urticaria patients after receiving AHT therapy for 10 weeks. This research concluded AHT can serve as an option in chronic urticaria treatment.

Purpose Chronic spontaneous urticaria (CSU) is defined as urticaria and/or angioedema that appears spontaneously due to known or unknown causes and lasts for at least 6 weeks. Omalizumab, an anti-IgE antibody that binds circulating free IgE, has recently emerged as a promising treatment for CSU, a condition which impairs patients’ quality of life. We aimed to contribute real life data by reporting our experience with omalizumab in the treatment of intractable CSU. Methods Of 140 patients treated with omalizumab in our clinic between September 2013 and January 2018, 86 CSU patients with available current data were retrospectively evaluated in terms of sex, age, urticaria duration, urticaria activity score over 7 days (UAS7) before and after omalizumab, relapses and time to relapse, length of remission after omalizumab cessation, adverse events, and comorbidities. Results The mean age of the patients was 45.5 ± 14.3 years and 73.3% were women. Mean duration of urticaria before initiation of omalizumab therapy was 54.5 ± 67 months. All patients had used antihistamines before starting omalizumab treatment. The mean number of omalizumab doses was 11.9 ± 9.3. The mean duration of omalizumab treatment was 13.3 ± 10.4 months. Mean UAS7 score was 38.9 ± 4.1 before the start of omalizumab treatment, and 7.9 ± 10.5 after treatment. Treatment was discontinued in 10 patients (11.6%) due to nonresponse or loss of effect. Four patients (4.65%) experienced adverse events. Treatment was discontinued in 1 patient (1.16%) due to side effects. Of the 55 patients whose treatment was discontinued after their symptoms resolved, 31 (56.3%) relapsed after omalizumab cessation. Twenty-four patients (43.6%) did not relapse after omalizumab cessation. Conclusions Our results show that omalizumab was an effective treatment for intractable CSU and did not cause any serious adverse effects other than asthenia, vertigo, and injection site reaction in four patients. These findings are relevant because they reflect real-life data.

Omalizumab reduces food allergy symptoms in patients with alpha-gal syndrome

Omalizumab is a third-line treatment for chronic spontaneous urticaria (CSU). Studies investigating the use of higher doses of omalizumab in patients unresponsive to regular doses are limited. This study aims to investigate the effectiveness and safety of omalizumab 450 mg in CSU. A retrospective cohort study was conducted. The response to therapy was evaluated using the Urticaria Activity Score over 7 days (UAS7) and the Urticaria Control Test (UCT). Patients showing complete response (CR) (UAS7: 0-1) to omalizumab 300 mg (Group 1) and patients receiving at least 3 doses of omalizumab 450 mg (Group 2) between 2016 and 2018 were included. A total of 72 patients (Group 1: 59; Group 2: 13) were included. In Group 2, the mean UAS7 score decreased from 18.6 to 5.1 and the mean UCT score increased from 8.6 to 12 after a mean 4.3 courses of 450 mg omalizumab treatment. Of the 13 patients in Group 2, 6 had CR and 3 had good disease control (UAS7: 2-6). The rate of patients with low baseline IgE levels (< 43 IU/mL) was significantly higher in Group 2. Higher doses of omalizumab are effective and safe in patients with CSU that is unresponsive to omalizumab 300 mg. Lower baseline total IgE levels might be used as a predictor of nonresponse to omalizumab and the need for higher doses.

Abstract Introduction: Urticaria is one of the most common allergic skin disorders having significant psychological impact. It occurs either acutely or evolves in chronic course, this study estimates significance of serum IgE levels, AEC in chronic urticaria and also the association between activity of chronic urticaria and serum Ig E levels. Objective: To measure the serum Ig E levels and Absolute eosinophil count (AEC) in cases and control group and to correlate Serum Ig E with disease activity in chronic urticaria Materials and Methods: It is a prospective case control study conducted in 103 chronic urticaria cases, Serum Ig E levels and AEC were measured in cases and controls, serum Ig E level was correlated with UAS7 in cases. Results: Out of 103 age and sex matched cases and controls the mean age was 29.23±1.27 years in patient group, mean AEC in patients was 541±36.01, significantly higher compared to the controls 126.74±12.82, and mean Ig E levels in patients was 759.19±73.79 IU/ml, significantly higher compared to the controls 153.24±11.51IU/ml. Mean UAS7 score was 19.95±1.02 in cases, five had well controlled urticaria (4.85%), 31 mild (30.09%), 48 moderate (46.60%) and 19 had severe urticaria (18.44%). We observed a statistically significant correlation between serum Ig E and UAS7. Conclusion: The present study suggests that serum Ig E levels needs to be considered as a valuable serological marker of disease severity in cases of chronic urticaria or management. Further similar studies are also required to assess based on the regional and ecological changes as the immunology differs from region to region and lifestyle changes. Keywords: Chronic urticaria, Serum Ig E levels, AEC, UAS7. Introduction Urticaria is a common allergic skin disease affecting 15% to 25% of the population atleast once in lifetime, which occurs either acutely or evolve in chronic course. Acute urticaria can present as acute onset of transient w

Comparing azathioprine with cyclosporine in the treatment of antihistamine refractory chronic spontaneous urticaria: A randomized prospective active-controlled non-inferiority study

Omalizumab chronic spontaneous urticaria: Efficacy, safety, predictors of treatment outcome, and time to response

IntroductionOmalizumab is indicated for the treatment of patients affected by chronic spontaneous urticaria (CSU) refractory to antihistamines. The aim of this study was to assess the efficacy, safety, and recurrence of symptoms in a real-life experience of omalizumab as an add-on therapy for H1-antihistamine-refractory CSU patients (refractory CSU).MethodsA retrospective review of the clinical records of all refractory CSU treated with omalizumab at our dermatology center from June 2014 to April 2017 was performed. Patients previously treated with second-generation antihistamines at a fourfold increased dose without clinical responses at 4 weeks of treatment were selected. Omalizumab was administered at a single dosage of 300 mg every 4 weeks for 6 months. Disease severity was assessed using the 7-day Urticaria Activity Score (UAS7).ResultsEighteen patients (14 women; mean age 51 years, range 25–74) were enrolled. Mean UAS7 at baseline was 27.3 (range 15–38). Symptoms improved in all patients at 4 weeks (UAS7 = 16.1, range 0–36). Treatment was completed in 17 patients (94.4%), and among these, a complete response (UAS7 = 0) was registered in 10 patients (58.8%). Adverse events included thrombocytopenia in 1 patient (5.6%) at 16 weeks; therapy was suspended after 20 weeks and the complication was resolved, resulting in a freedom from major adverse events of 94.4%. Symptom recurrence occurred in 3 patients (17.6%) at 4, 5, and 7 months from the end of the primary therapy. Retreatment with omalizumab was successful without any adverse effects. Mean follow-up was 9.5 months (range 1–28).ConclusionAdd-on omalizumab therapy for refractory CSU in a real-life setting seems to be effective and safe with a relatively low incidence of symptom recurrence. Further research should investigate personalized omalizumab treatment dosages and administration intervals, and the identification of biomarkers for future treatment algorithms.

Efficacy of omalizumab treatment for patients with chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) in Taiwan