Treatment Of Chronic Idiopathic Urticaria Research Articles

Comparative efficacy and safety of the treatment by Omalizumab for chronic idiopathic urticaria in the general population: A systematic review and network meta-analysis.

Omalizumab is the only licensed drug that serves as a third-line treatment for chronic idiopathic urticaria (CIU). The optimum doses of omalizumab remain controversial. Therefore, this study aims to estimate the efficacy and safety of different doses of omalizumab in the treatment of CIU patients. Four databases were searched from the database's creation to April 8, 2023. Several keywords such as omalizumab and urticarias were used to retrieve related studies. The meta-analytical outcomes were analyzed in R 4.2.1 software and Stata 15.1 software. Cochrane risk-of-bias tool Ver. 2 was used to evaluate the risk of bias in randomized controlled trials (RCTs). In total, 2331 patients were included. Five indexes were employed to assess, including weekly Itch Severity Score (ISS7), weekly Hive Severity Score (HSS7), weekly Urticaria Activity Score (UAS7), Dermatology Life Quality Index (DLQI), and adverse events (AE). A 300mg dose of omalizumab was the optimum dose to treat CIU, followed by the 150mg dose. Furthermore, 600mg of omalizumab only showed a significant difference from the placebo in HSS7. No significant statistical difference was observed in AE. Meta-regression analysis revealed that time, as a covariate, was statistically significant in the comparison of omalizumab 150mg with placebo. 300mg of omalizumab was the optimum dosage to treat CIU patients, with a 150mg dose also exhibiting good efficacy. Further studies are required to explore the efficacy and safety of different doses of omalizumab in the treatment of CIU patients.

Efficacy and safety of bilastine vs. levocetirizine for the treatment of chronic idiopathic urticaria: A multicenter, double-blind, double-dummy, phase III, non-inferiority, randomized clinical trial.

Efficacy and safety of bilastine vs. levocetirizine for the treatment of chronic idiopathic urticaria: A multicenter, double-blind, double-dummy, phase III, non-inferiority, randomized clinical trial.

A Study of 105 Patients Treated with Omalizumab for Chronic Idiopathic Urticaria

Omalizumab (Xolair®) was approved for the treatment of chronic idiopathic urticaria in 2017. Furthermore, consistent with international guidelines published in 2018, the Urticaria Clinical Practice Guidelines by the Japanese Dermatological Association provide detailed instructions for the use of omalizumab. However, there are no reports summarizing the efficacy of omalizumab in chronic idiopathic urticaria in Japan. The subjects of our study were 105 patients treated with omalizumab 300 mg/month for chronic idiopathic urticaria at Tokyo Medical University Hospital from June 2017 to March 2021, inclusive of 23 male and 82 female patients, with a mean age of 45.4 ± 16.0 and disease duration of 46.9 ± 99.4 months. Three months after treatment, omalizumab was discontinued in 63 patients with a Urticaria Control Test score of 16. The mean number of dose completions was 6.4 ± 4.1. There were nine cases of relapse in which seven of the nine cases discontinued omalizumab within six doses. Most of the relapsed cases improved with re-administration of omalizumab, but it was again discontinued in five cases. Omalizumab has lesser side effects than steroids and cyclosporine, and the criteria for its use were revised in 2018, requiring an allergist or dermatologist to be available to treat adverse events such as asthma and anaphylaxis at the facility or in collaboration with neighboring medical institutions. Omalizumab can also be used in dermatology clinics. The drug is an effective treatment for severe chronic idiopathic urticaria and is anticipated to be used by more dermatologists.

MiR-18a-5p Reduces Inflammatory Response and Human Dermal Microvascular Endothelial Cells Permeability by Targeting Thrombospondin 1 in Chronic Idiopathic Urticaria

Chronic idiopathic urticaria (CIU) is a skin disease that has an acute attack when patient encounters an allergen. Previous research demonstrated that microRNA (miRNA) has a crucial role in CIU occurrence and development. This study aimed to investigate the role and mechanism of miR-18a-5p in CIU. StarBase and dual luciferase reporter gene assay confirmed that thrombospondin 1 (THBS1) was a direct target of miR-18a-5p. miR-18a-5p negatively regulated THBS1 expression in human mast cell line HMC-1 and human dermal microvascular endothelial cells (HDMECs). Further analysis indicated that miR-18a-5p mimic significantly reduced inflammatory factors including interleukin (IL)-6, IL-8, IL-1β and tumor necrosis factor (TNF)-α release, decreased the degranulation rate and histamine release rate of HMC-1 cells. Besides, we found that miR-18a-5p reduced the permeability of HDMECs by suppressing THBS1 expression. Finally, the data indicated that miR-18a-5p inhibited the transforming growth factor beta (TGF-β)/SMAD family member 3 (Smad3) signaling pathway in HDMECs by inhibiting the expression of THBS1. Taken together, the results suggested that miR-18a-5p reduced inflammation and human skin microvascular endothelial cell permeability in CIU by targeting THBS1. miR-18a-5p might be a new target for CIU treatment.

Efficacy of Rupatadine in Treatment of Chronic Idiopathic Urticaria

Introduction: Urticaria is a vascular lesion of the skin characterized by the appearance of well demarcated wheels along with angioedema. In more than 75% of cases, a causative agent can’t be established and thus is termed as chronic Idiopathic Urticaria. Treatment of this condition focuses on measures which provide symptomatic relief; 2nd and 3rd generation anti-histaminic drugs are the mainstays now for the treatment of chronic idiopathic urticaria. Objectives: To determine the efficacy of rupatadine in the treatment of chronic idiopathic urticaria. Materials and Methods: A clinical trial was conducted on 60 patients who were suffering from chronic idiopathic urticaria from March to August 2015 at Department of Dermatology and Venereology, Combined Military Hospital (CMH), Dhaka. Tab. Rupatadine 5 mg 1 tab daily was given for 6 weeks. Clinical response of treatment and adverse effect was assessed at every two weeks’ interval by taking history and clinical examination. Ethical issue was addressed Results: The patients reported a considerable improvement in overall chronic idiopathic urticaria due to the use of Rupatadine. The mean total symptom score (TSS) value reduced by 83% compared to the base line evaluation at the end of the therapy duration. Total disappearance of symptom was recorded in 25% patients. There were 79% decrease in the score for number of wheals, 81% reduction in the score for size of the wheals, 88% reduction in the pruritus severity score, and 83% reduction in the duration of pruritus score in relation to baseline evaluation. Conclusion: 5mg of Rupatadine once daily is effective in patients with chronic idiopathic urticaria. JAFMC Bangladesh. Vol 17, No 2 (December) 2021: 39-42

Association between Chronic Idiopathic Urticaria (CIU) and H. Pylori Infection: A Single Center Case-Control Study in Bangladesh

Introduction: Some studies have shown the possible involvement of Helicobacter pylori (H. pylori) infection in chronic idiopathic urticaria, but the relationship remains controversial. The aim of this study was to quantitatively assess the association between H. pylori infection and chronic idiopathic urticaria.
 Material & Methods: A case-control type of analytical study was conducted in the department of Dermatology and Venereology, Naval Base Hospital (BNS Patenga), Chattogram, Bangladesh for duration of 06 months. Total 50 patients were enrolled in this study. 25 Patients of CIU with no identifiable cause were taken as case and patients without urticaria were taken as control, attending in the outpatient department. H. pylori infection was confirmed by Serum IgG for H. pylori test.
 Results: The result shows that Helicobacter pylori significantly affect a high percentage of patients with chronic idiopathic urticaria and response to eradication therapy was evident in more patients in whom H. pylori were eradicated.
 Conclusion: The study shows that Helicobacter pylori significantly affects a high percentage of patients with CIU. Response to eradication therapy was evident in more patients in whom H. pylori was eradicated while few patients showed no response despite eradication of H. pylori. The result of this study suggests that H. pylori infection should be included in diagnostic work up of patients with no response to usual treatment for CIU.
 CBMJ 2021 January: vol. 10 no. 02 P: 75-79

Trends in pharmacologic treatment of chronic idiopathic urticaria from 2016 to 2020

Chronic idiopathic urticaria (CIU; also called chronic spontaneous urticaria) is characterized by urticaria lasting for at least 6 weeks, with or without angioedema, and with no identifiable trigger.1 This condition affects patients of all ages and is common with an estimated global point prevalence of 1.4%.2 The average duration of CIU ranges between 1 and 5 years, and symptoms can markedly impact patient physical and mental well-being and quality of life.3 Most patients remain symptomatic despite first-line therapy with high doses of daily nonsedating H1 antihistamines.

Comparison of Rupatadine Monotherapy and Combined Levocetirizine with Ranitidine Dual Therapy for the Treatment of Chronic Idiopathic Urticaria

Background: Effective treatment for chronic idiopathic urticaria (CIU) with conventional combined therapy comprising H1 and H2 antihistamine is effective but associated with high relapse rate. Newer H1 blocker rupatadine alone is similarly effective with less relapse rate. Also it is convenient for the patient as similar efficacy is obtained with single dosage compared to 3 times dosing in combined therapy. This study was done to compare the traditional treatment with levocetirizine and ranitidine to a newly introduced antihistamine rupatadine for CIU. Materials and Methods: The study was a hospital based prospective randomized control trial among 40 patients with CIU in Dermatology and Venereology department of Bangabandhu Sheikh Mujib Medical University(BSMMU), Dhaka from April 2020 to September 2020.Forty patients of CIU were randomly enrolled into two equal groups (group A and B). Patients of group-A were treated with 5 mg of levocetirizine once daily plus 150 mg of ranitidine twice orally daily and group-B were treated with rupatadine 10 mg once daily for one month. The efficacy was assessed 1st and 4th week during treatment and 4 weeks after completion of treatment by observing reduction of itching, regression of the size and shape of lesions and appearance of new lesions. Adverse effects and patient satisfaction were also noted. Results: 75% patients in group A and 80% patients in group B responded to treatment (p>0.05).80% in group A and 85% in group B showed improvement in itching in the first week (p>0.05). . At the end of 4 weeks 95% showed improvement in each group. Appearance of new lesions in first week was 10% and 5% (p>0.05) and at 4th week, 5% and 0% respectively (p>0.05). 75% in group A and 80% in group B had regression in their lesions at the end of first week (p>0.05). At the end of 4th week, it was 85% and 90% (p>0.05). 40% in group A and 25% in group B had relapse of itching at follow up (p<0.05). Relapse of lesions were 35% and 20% (p<0.05). Overall occurrence of side effects (3 compared to 1) was more in group A. Conclusion: The result of the present study show that both conventional treatment with levocetirizine and ranitidine combination and newer agent rupatadine alone has similar efficacy in reducing clinical sign and symptoms of CIU. But rupatadine has significantly reduced the relapse rate and so it is a more efficacious and also safer option with less adverse effects for the treatment of CIU in comparison to conventional treatment. Rupatadine is also more convenient option for patients in term of dosage schedule.

The Addition of Montelukast for the Treatment of Chronic Idiopathic Urticaria.

IntroductionChronic urticaria (CU) is a common disorder that can significantly affect the quality of life. The goal of treatment is complete symptomatic relief. Conventional therapy, with antihistamines, is not always effective in all patients. Leukotrienes are believed to be involved in the pathogenesis of urticaria. Leukotriene receptor antagonists (LTRAs), such as montelukast, have been suggested as useful agents in patients with chronic idiopathic urticaria. Our objective is to document the efficacy of montelukast in our patients.Materials and methodsPatients who received montelukast were identified from clinic letters. Data including clinical features were collected and analyzed. The main endpoint was adequate disease control.ResultsA total of nine patients who met the inclusion criteria were included in this study. Four patients reported having a good response to montelukast and three patients reported full control of the disease.ConclusionThese findings suggest that leukotriene antagonists, such as montelukast, are effective as an add-on therapy to anti-histamines and their use in histamine resistant patients is justifiable.

Readability, quality, and timeliness of patient online health resources for urticaria

Readability, quality, and timeliness of patient online health resources for urticaria

Rituximab as Treatment of Chronic Idiopathic Urticaria

Conventional treatment of chronic idiopathic urticaria involves high doses of antihistamines followed by omalizumab in refractory cases, however, there are patients who do not achieve resolution of symptoms despite both of these therapies. The following case series describes two cases of chronic idiopathic urticaria successfully treated with rituximab. The first patient is a 43 year-old woman with psoriatic arthritis and autoimmune thyroiditis who presented to us with chronic idiopathic urticaria. She was found to have elevated levels of anti-IgE receptor antibodies with levels greater than maximum level of detection. She was unresponsive to high doses of antihistamines, cyclosporine, prednisone, dapsone, mycophenolate mofetil, hydroxychloroquine, and omalizumab and ultimately trialed on rituximab with complete resolution of urticaria. Our second patient is a 49 year-old woman with multiple sclerosis, allergic rhinitis, and atopic dermatitis who was referred with humoral immunodeficiency. She was diagnosed with common variable immune deficiency and started on SQ immune globulin therapy. She also had long-standing generalized urticaria refractory to antihistamines which responded to rituximab started by her neurologist for a flare of her multiple sclerosis. Use of rituximab in treatment of chronic idiopathic urticaria is not well documented in literature today and should be entertained as possible therapy for cases of treatment-resistant chronic urticaria, especially in the setting of other autoimmune conditions.

Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients With Chronic Idiopathic (Spontaneous) Urticaria

Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) (also known as chronic spontaneous urticaria) in adolescents and adults with persistent hives not controlled with antihistamines. The effectiveness of omalizumab in the real-world management of CIU is largely unknown. To quantitatively synthesize what is known about the benefits and harms of omalizumab in the real-world clinical management of CIU regarding urticaria activity, treatment response, and adverse events. Published observational studies (January 1, 2006, to January 1, 2018) and scientific abstracts on the effectiveness of omalizumab in CIU were identified using PubMed, Embase, Web of Science, and Cochrane search engines; references were searched to identify additional studies. Included studies were observational in design and included at least 1 outcome in common with other studies and at a concurrent time point of exposure to omalizumab. A total of 67 articles (35.2% of those screened) were included in the analysis. PRISMA and MOOSE guidelines were followed; independent selection and data extraction were completed by 2 observers. Random-effects meta-analyses were performed. Main outcomes were change in weekly Urticaria Activity Score (UAS7; range, 0-42), change in Urticaria Activity Score (UAS; range 0-6) (higher score indicating worse outcome in both scales), complete and partial response rates (percentages), and adverse event rate (percentage). Omalizumab therapy was associated with an improvement in UAS7 scores (-25.6 points, 95% CI, -28.2 to -23.0; P < .001; 15 studies, 294 patients), an improvement in UAS scores (-4.7 points, 95% CI, -5.0 to -4.4, P < .001; 10 studies, 1158 patients), an average complete response rate of 72.2% (95% CI, 66.1%-78.3%; P < .001; 45 studies, 1158 patients) with an additional average partial response rate of 17.8% (95% CI, 11.7%-23.9%; P < .001; 37 studies, 908 patients), and an average adverse event rate of 4.0% (95% CI, 1.0%-7.0%; P < .001; any level of severity, 47 studies, 1314 patients). Benefits and safety of omalizumab in the real-world treatment of CIU meet or exceed results gleaned from clinical trials. These real-world data on omalizumab in CIU may help inform both clinical treatment expectations and policy decision making.

Real-world use of omalizumab in patients with chronic idiopathic/spontaneous urticaria in the United States.

Omalizumab was approved for the treatment of chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) in the United States in March 2014. This study sought to describe real-world omalizumab use, in the United States, in a large cohort of patients with CIU/CSU. Patients with CIU/CSU (ages ≥12 years) initiated on omalizumab (index date) with ≥12 months of pre- and postindex data were identified in the an insurance claims data base (January 1, 2013, to July 31, 2016). Treatment patterns, including the dosing regimen and continuous use of omalizumab (no gaps for ≥60 days), were described during the 12-month postindex follow-up period. A total of 1546 patients (mean ± standard deviation [SD] ages, 44 ± 14.5 years; 73.1% women) were identified. Most of the patients (84.5%) were initiated on omalizumab 300-mg dose; 90% maintained the initial dose, 7.5% had a dose increase, and 4.6% had a dose decrease. The mean ± SD omalizumab treatment duration was 9.1 ± 3.8 months, the mean ± SD number of omalizumab administrations was 8.3 ± 4.8, and the mean ± SD administration frequency was 44 ± 29 days. A proportion of the patients continuously treated with omalizumab for 6, 9, and 12 months was 67.3, 54.8, and 47.4%, respectively. Among the patients who discontinued omalizumab for ≥3 months (39.8%), 21% restarted the treatment after a mean ± SD of 4.4 ± 1.3 months. The proportion of patients who used other CIU/CSU-related medications decreased pre- to postindex (94.8 to 81.1%), with the highest decrease observed in oral corticosteroids (75.7 to 49.9%). In this large real-world study, the majority of the patients with CIU/CSU were initiated on a 300-mg omalizumab dose and treated without titration up or down for 9 months on average. Most of the patients were continuously treated with omalizumab for ≥6 months, and one-fourth of the patients who discontinued treatment resumed it. Moreover, compared with baseline levels, the use of other CIU/CSU-related medications was lower after omalizumab initiation, with the most prominent decrease observed in oral corticosteroids.

Role of Helicobacter pylori eradication in the treatment of chronic idiopathic urticaria

Background Chronic urticaria is a common immunological disorder, with a prevalence of 15–25%. Several exogenous and endogenous causes have been proposed as causative agents; one of them is infection of the gastrointestinal tract. Despite thorough investigation, the etiology remains unresolved in more than 80% of the cases. Objective The aim of the present study was to assess the prevalence of chronic idiopathic urticarial (CIU) patients presented with Helicobacter pylori infection and to study the effect of H. pylori eradication on the skin lesion in patients with CIU. Methodology This prospective study was carried out at the outpatient clinic of Dermatology Department of Al Azhar Assuit University Hospital on 30 patients with chronic urticaria (20 women and 10 men); their ages ranged from 16 to 65 years. The duration of the disease ranged from 6 weeks to 18 years. A primary diagnosis of CIU was made when an etiological factor accounting for the majority of the lesions could not be elucidated during the history-taking and physical examination. All the patients were subjected to careful history-taking at initial visit; physical examination to assess the number of urticaria wheals, size, and distribution, and associated angioedema; gastroscopy to obtain gastric mucosal biopsy from the antrum; and histopathological assessment of the gastric mucosal biopsy using hematoxylin and eosin, and Giemsa stains. The patients were scored according to the severity of disease (number of wheals, area of distribution, and the duration of the disease; itching and style of life; history of angioedema). The patients were treated for 2 weeks with amoxicillin (1 g/twice daily), metronidazole (500 mg/three doses daily), and omeprazole (20 mg/twice daily). All patients were followed up during the study duration of 3 months. To assess eradication efficacy, a repeated H. pylori stool antigen test was carried out for each patient 6 weeks after the end of anti-H. pylori therapy. Statistical analysis of the data was performed by using the SPSS_16 software. Results Fourteen patients (46.7%), aged less than 30 years, and 16 patients (53.3%), aged equal to or more than 30 years, were included in the present study. The mean of the ages of all patients was 34.9 years, and their age ranged from 16 to 65 years. There were 10 men (33.3%) and 20 women (66.7%). The mean of the duration of disease in all cases was 4 years, and ranged from 2 to 15 years. Nineteen patients presented with gastric symptoms. Seven patients (23.3%) had mild urticaria, 15 (50.0%) had moderate urticaria, and the remaining 8 (26.7%) had severe urticaria. Treatment results showed that 13 patients (43.3%) had complete remission, 12 patients (40.0%) had partial remission, and five patients (16.7%) showed no response. There was no statistically significant difference between age, sex, duration of illness, and gastric symptoms on the prognosis of urticaria after treatment. In addition, the results showed a highly statistically significant (P Conclusion H. pylori infection is considered as a main cause of CIU, specifically in patients with gastric symptoms, and the eradication of H. pylori may help in the treatment of CIU.

UV SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE DETERMINATION OF BILASTINE USING EXPERIMENTAL DESIGN FOR ROBUSTNESS

Bilastine is a novel nonsedative H1-receptor antagonist, which may be used for the symptomatic treatment of chronic idiopathic urticaria (CU). This study describes the validation of an UV spectrophotometric method for quantitative determination of bilastine in tablets using 0.1 mol L-1 HCl as solvent. The method was specific, linear, precise, exact and robust at 210 nm, confirming that the method is fast and useful to the routine quality control of bilastine in tablets. The validate method was compared to liquid chromatography (HPLC), which was previously developed and validated to the same drug, and no significative difference between the methods using Student´s t test was found to bilastine quantitation.

Real-World Characteristics and Treatment Patterns in Patients with Urticaria Initiating Omalizumab in the United States.

Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) in patients aged 12 years or older with persistent hives that are not adequately controlled by H1 antihistamines. While its safety and efficacy in CIU patients have been evaluated in multiple clinical trials, real-world use of omalizaumab in CIU has not been well characterized. To assess demographics, clinical characteristics, and treatment patterns of CIU patients who initiated omalizumab to better understand the usage of this agent in CIU management in the real world. This retrospective cohort study used medical and pharmacy claims data in the United States from the HealthCore Integrated Database to identify patients with CIU newly treated with omalizumab (≥ 4 omalizumab claims within 6 months of the initial claim) between March 21, 2014, and October 31, 2015 (study intake period). The index date was defined as the date of the first claim for omalizumab during the study intake period. Demographic and clinical characteristics were described for patients treated with omalizumab, as were treatment patterns associated with omalizumab and concomitant medications associated with CIU treatment. Descriptive and inferential statistics were reported. The Kaplan-Meier method was used to examine omalizumab treatment patterns. This study included 298 omalizumab-treated patients (mean [SD] age of 43.5 [13.64] years; 70.8% female); approximately 84% were seen by an allergist/immunologist. All patients had ≥ 12 months of continuous enrolment and a subset of 138 patients had ≥ 18 months of follow-up. For patients with ≥ 12 months of post-index follow-up, 12.1% (n = 36), 28.5% (n = 85), and 32.9% (n = 98) discontinued omalizumab within the 6-month, 12-month, and the entire post-index periods (mean 530 days), respectively; the mean number of days patients were continuously treated with omalizumab was 443.1 (95% CI = 425.0-461.3); the probabilities of continuous treatment (95% CI) were 0.879 (0.836-0.911), 0.711 (0.656-0.759), and 0.647 (0.585-0.703) for the 6-, 12-, and 18-month post-index periods, respectively. For the 98 patients who discontinued omalizumab during the entire post-index period, 28.6% restarted omalizumab after the first discontinuation within the post-index period (mean time from first discontinuation to first restart=329 days). Use of medications such as oral corticosteroids, montelukast, cyclosporine, and prescription H1 and H2 antihistamines decreased during the 1- to 6-month and 7- to 12-month post-index periods compared with those within the 6-month pre-index period. In this cohort of CIU patients who were newly prescribed omalizumab, the majority were treated by allergists/immunologists as expected, and approximately 60% of patients continued on therapy beyond 18 months. Concomitant medication use decreased after omalizumab initiation. These data on the real-world use of omalizumab for CIU may help to better inform decision-making processes for health care payers by quantifying omalizumab and concomitant medication treatment patterns over a longer time frame relative to previous studies. This study was sponsored by Novartis Pharmaceuticals, which provided funding support for the conduct of the study. Kavati, Ortiz, and Paknis are employees of Novartis Pharmaceuticals. Ke, Wertz, Huang, Wang, Willey, and Stephenson are employees of HealthCore, an independent research organization that received funding from Novartis Pharmaceuticals for the conduct of this study. Beck is an employee of the University of Rochester Medical Center, who was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports grants from Genentech, outside the currently submitted work. Bernstein is affiliated with Bernstein Clinical Research Center, which was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports receiving grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Genentech outside of the submitted work, and is an author on the Joint Task Force for Practice Parameters for Urticaria and the GALEN international guidelines for urticaria under preparation. Selected study data were presented in a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual International Meeting on May 20-24, 2017, in Boston, MA. A poster based on this dataset was presented at the 2017 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26-30, 2017, in Boston, MA.

Real-World Characteristics and Treatment Patterns in Patients with Urticaria Initiating Omalizumab in the United States.

Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) in patients aged 12 years or older with persistent hives that are not adequately controlled by H1 antihistamines. While its safety and efficacy in CIU patients have been evaluated in multiple clinical trials, real-world use of omalizaumab in CIU has not been well characterized. To assess demographics, clinical characteristics, and treatment patterns of CIU patients who initiated omalizumab to better understand the usage of this agent in CIU management in the real world. This retrospective cohort study used medical and pharmacy claims data in the United States from the HealthCore Integrated Database to identify patients with CIU newly treated with omalizumab (≥ 4 omalizumab claims within 6 months of the initial claim) between March 21, 2014, and October 31, 2015 (study intake period). The index date was defined as the date of the first claim for omalizumab during the study intake period. Demographic and clinical characteristics were described for patients treated with omalizumab, as were treatment patterns associated with omalizumab and concomitant medications associated with CIU treatment. Descriptive and inferential statistics were reported. The Kaplan-Meier method was used to examine omalizumab treatment patterns. This study included 298 omalizumab-treated patients (mean [SD] age of 43.5 [13.64] years; 70.8% female); approximately 84% were seen by an allergist/immunologist. All patients had ≥ 12 months of continuous enrolment and a subset of 138 patients had ≥ 18 months of follow-up. For patients with ≥ 12 months of post-index follow-up, 12.1% (n = 36), 28.5% (n = 85), and 32.9% (n = 98) discontinued omalizumab within the 6-month, 12-month, and the entire post-index periods (mean 530 days), respectively; the mean number of days patients were continuously treated with omalizumab was 443.1 (95% CI = 425.0-461.3); the probabilities of continuous treatment (95% CI) were 0.879 (0.836-0.911), 0.711 (0.656-0.759), and 0.647 (0.585-0.703) for the 6-, 12-, and 18-month post-index periods, respectively. For the 98 patients who discontinued omalizumab during the entire post-index period, 28.6% restarted omalizumab after the first discontinuation within the post-index period (mean time from first discontinuation to first restart=329 days). Use of medications such as oral corticosteroids, montelukast, cyclosporine, and prescription H1 and H2 antihistamines decreased during the 1- to 6-month and 7- to 12-month post-index periods compared with those within the 6-month pre-index period. In this cohort of CIU patients who were newly prescribed omalizumab, the majority were treated by allergists/immunologists as expected, and approximately 60% of patients continued on therapy beyond 18 months. Concomitant medication use decreased after omalizumab initiation. These data on the real-world use of omalizumab for CIU may help to better inform decision-making processes for health care payers by quantifying omalizumab and concomitant medication treatment patterns over a longer time frame relative to previous studies. DISCLOSURES This study was sponsored by Novartis Pharmaceuticals, which provided funding support for the conduct of the study. Kavati, Ortiz, and Paknis are employees of Novartis Pharmaceuticals. Ke, Wertz, Huang, Wang, Willey, and Stephenson are employees of HealthCore, an independent research organization that received funding from Novartis Pharmaceuticals for the conduct of this study. Beck is an employee of the University of Rochester Medical Center, who was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports grants from Genentech, outside the currently submitted work. Bernstein is affiliated with Bernstein Clinical Research Center, which was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports receiving grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Genentech outside of the submitted work, and is an author on the Joint Task Force for Practice Parameters for Urticaria and the GALEN international guidelines for urticaria under preparation. Study concept and design were primarily contributed by Kavati, Ortiz, and Paknis, with assistance from the other authors. Huang, Wang, and Ke took the lead in data collection, with assistance from Wertz, Willey, and Stephenson. Data interpretation was performed by Ke, Wertz, and Willey, assisted by the other authors. The manuscript was written by Stephenson, Ke, and Wang, along with Willey, Wertz, and Huang, and revised by Bernstein and Beck, with assistance from the other authors. Selected study data were presented in a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual International Meeting on May 20-24, 2017, in Boston, Massachusetts. A poster based on this dataset was presented at the 2017 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26-30, 2017, in Boston, Massachusetts.

P152 Omalizumab and levothyroxine in the treatment of chronic idiopathic urticaria with positive thyroid antibodies

P152 Omalizumab and levothyroxine in the treatment of chronic idiopathic urticaria with positive thyroid antibodies

Omalizumab for the Treatment of Chronic Idiopathic Urticaria: Systematic Review of the Literature.

Omalizumab is recombinant humanized monoclonal antibody to immunoglobulin E. Guidelines for the treatment of chronic idiopathic urticaria (also known as chronic spontaneous urticaria) recommend the use of omalizumab as third-line therapy in addition to high doses of histamine receptor type 1 (H1 ) antihistamines when they are unsuccessful as first- and second-line therapy. We performed a systematic review of the literature to identify studies that evaluated the efficacy of omalizumab for the treatment of chronic idiopathic urticaria, in both controlled and real-world settings, to assess its potential role as a preferred therapy. The PubMed, ScienceDirect, LILACS (Latin American and Caribbean Health Sciences Literature), and Google Scholar databases were searched between January 1, 2000, and November 21, 2016. The search was limited to articles published in peer-reviewed journals in the English language, and 29 studies were included in this review. Omalizumab 300 mg administered every 4 weeks appears to be the most effective and safe dosage, with a rapid response time, for the treatment of chronic idiopathic urticaria, with few minor adverse effects, and appears to be safe in the offspring of pregnant patients who received the drug. However, as published studies of omalizumab are sparse, future studies are warranted. When findings are confirmed in larger studies, due to its efficacy, safety, and increased benefit/cost ratio, omalizumab could become the preferred method of treatment for chronic idiopathic urticaria in patients unresponsive to H1 antihistamines.

Effectiveness and safety of fexofenadine in chronic idiopathic urticaria − open-label noncomparative study in daily practice

Objective This study aimed to evaluate effectiveness and safety of fexofenadine in the treatment of chronic idiopathic urticaria (CIU) in routine practice in Egypt. Patients and methods This study is a local, multicenter, noninterventional, prospective, open-label, noncomparative, observational product registry conducted across Egypt. Three mandatory visits were made by the investigator for each eligible patient, and patients were assessed by urticaria symptoms score. Result The results of this study showed a statistically significant reduction (P Conclusion Fexofenadine demonstrated statistically significant reduction in symptoms and signs of CIU. Pruritis status was decreased in 74.95% of patients. Hives status were relieved in 81.1% of patients, after a mean treatment duration of 14.93±5.49 days at visit 2 and 27.94±4.56 days at visit 3 (end of study). In addition, treatment with fexofenadine was well tolerated.