Chronic Idiopathic Urticaria Patients 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.

Association between Chronic Idiopathic Urticaria and Helicobacter Pylori Infection

Chronic idiopathic urticaria (CIU) is a recalcitrant skin disease characterized by pruritic wheals lasting more than six weeks in the absence of a physical cause. A case-control type of analytical study was conducted from January 2012 to August 2012 on patients of chronic idiopathic urticaria attending the outpatient department of Dermatology and Venereology, Bangabandhu Sheikh Mujib Medical University, Dhaka. The objective of the study was to see the association between chronic idiopathic urticaria and Helicobacter pylori infection. In serum, IgG positive individuals, female covers about two-thirds (14 respondents with 73.3%) than male counterparts (5 respondents with 26.3%). Among the IgG negative individuals, females were again more in percentage (63.6%) and males were 36.4%. Serum IgG for H. Pylori positive respondents were highest among the students (42.1%) followed by housewives (31.6%) and in IgG negative individuals, the same trend exists. When we considered education level for IgG positivity, it was found that graduate and above educated respondents showed higher results (42.1%) and SSC level showed next incidences (26.3%). In IgG negative group, the same trend exists. We found the same positivity for IgG of H. pylori among the different food intake, heat, and sunlight exposed history respectively whereas food intake history covers more in IgG negative individuals. Most of the IgG positive respondents were ill-looking (94.7%), though IgG negative individuals were also ill-looking. Chronic idiopathic urticaria is a disorder that often baffles dermatologists and allergists alike. Without a known cause, it is nearly impossible to prescribe an effective treatment.
 Bangabandhu Sheikh Mujib Med. Coll. J. 2022;1(1):20-23

TO CHALLENGE OR AVOID? POSSIBLE ASPIRIN ALLERGY IN PATIENTS WITH CHRONIC IDIOPATHIC URTICARIA AND ANGIOEDEMA

<h3>Introduction</h3> Aspirin remains an important component of dual antiplatelet therapy following percutaneous coronary intervention (PCI). Despite studies showing safety in discontinuing aspirin post PCI through use of P2Y12 inhibitor therapy plus anticoagulation, no large, randomized trials evaluate an initial aspirin-free regimen post PCI without systemic anticoagulation. Aspirin intolerances occur in 20% of patients, with only 2% being true allergies. Most aspirin intolerances are linked to asthma, rhinitis, and chronic idiopathic urticaria (CIU). Differentiating this population is important for optimizing care. <h3>Case Description</h3> C.P. is a 54-year-old male with CIU referred for evaluation of aspirin allergy prior to coronary angiography with possible PCI. In 2001, C.P. developed right periorbital edema an hour after his third dose of daily aspirin therapy. Antihistamines reduced the swelling within hours, however due to reaction, his physician recommended discontinuing aspirin. He noted taking aspirin as a child and ibuprofen as an adult without incident. An in-clinic open oral drug challenge to aspirin was conducted. The patient was given 1/10^th of the full dose, followed by the remaining dose then monitored for 1 hour. The patient was diagnosed with NSAID exacerbated CIU and discharged with aspirin and antihistamines for control. <h3>Discussion</h3> Without clear guidelines for managing NSAID induced CIU, many physicians recommend avoidance, resulting in suboptimal care. 20-40% of CIU patients have flares triggered by NSAIDs, and many are misdiagnosed with an aspirin allergy. Our case demonstrates that through careful history and oral challenge, aspirin exacerbated CIU can be effectively managed without forgoing quality care.

Comparison of chronic idiopathic urticaria patients with positive and negative autologous serum skin test

&lt;p&gt;&lt;strong&gt;Background&lt;/strong&gt;: Chronic urticaria, with or without angioedema, has been defined as daily or almost daily symptoms and signs recurring for more than six weeks. Chronic urticaria has an idiopathic etiology in majority. This is called as chronic idiopathic urticaria (CIU) or chronic spontaneous urticaria (CSU). Aim and objectives were to compare the clinical features in CIU patients with a positive autologous serum skin test (ASST) and negative ASST.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods&lt;/strong&gt;: Fifty clinically diagnosed patients of CIU attending the department of DVL OPD at tertiary care teaching hospital, were enrolled based on the inclusion and exclusion criteria.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results:&lt;/strong&gt; ASST was positive in 48% (24/50) of patients with CSU. In study of 50 patients, 66% were females and 34% were males. The mean age of patients was 36.8 years. The disease's median duration was 10 months and 11 months in ASST positive and ASST negative groups respectively. Of the 50 patients, 20 patients showed a positive response to the test for simple dermographism, of which 13 were ASST positive. Of the 50 patients, 8 patients gave a history of atopy, of which 5 were in the ASST positive group, 3 were in ASST negative group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions&lt;/strong&gt;: In the present study ASST was positive in 48% of patients with CIU. Majority of ASST positive patients had almost daily attacks. ASST positive patients had a longer duration of persistence of wheals. ASST is a fairly good indicator of autoimmune etiology for chronic urticaria.&lt;/p&gt;

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.&#x0D; Material &amp; 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.&#x0D; 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.&#x0D; 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.&#x0D; CBMJ 2021 January: vol. 10 no. 02 P: 75-79

Open-label Non-blinded Cohort study on Anti-Histaminic Resistant Chronic Idiopathic Urticaria in Western India.

Chronic idiopathic urticaria (CIU) is a chronic relapsing disease with hives for a period of six weeks or more. It has a significant impact on the physical and mental well-being of patients. Open-label non-blinded study of over 600 patients diagnosed with CIU was done. The aim of the study was to observe the following: 1. Characteristics of patients of anti-histaminic resistant CIU, 2. Efficacy of cyclosporin and any adverse events in the study population and 3. Prognosis and relapse rates of these patients at the end of one year. Detailed history taking and guided clinical evaluation were done to include chronic resistant urticarias in the study and their clinical characteristics and prognosis were studied. A total of 610 patients were diagnosed with CIU over a period of four years. Of these, 47 patients (7.7%) were diagnosed with anti-histaminic resistant urticaria. Of these, 30 patients (4.9%) who took treatment with cyclosporin at the above dosages were included in group 1. Rest 17 patients were in group 2 that were continued on anti-histaminics. Patients in cyclosporin group 1 showed a significant reduction in symptom scores as compared with group 2 at the end of six months. A lower need for corticosteroid therapy was noted in the cyclosporin group. Cyclosporin in low doses is very useful in anti-histaminic resistant urticaria with the duration of therapy being six months. It is cost-effective in low and medium-income countries and easily available.

Correlation of serum IgG antibodies to helicobacter pylori in chronic skin disorders: A case-control study

It is known that chronic idiopathic urticaria occasionally develops in association with Helicobacter pylori infection, but this relationship remains unproven. Also, many studies show. We investigated the role of H. pylori infection in patients of chronic idiopathic urticaria, other chronic skin disorders as well as healthy controls using urease breath test and immunoturbidimetry for anti H. pylori IgG antibodies. Three groups of eighty-nine patients each were taken as cases, controls and placebo controls respectively. All patients having IgG titer of 10U/ml or above and Urease Breath Test Positivity were considered positive. : The positive rate of anti H. Pylori IgG antibodies was 78.65% (70/89) in case group, 84.71% (22/89) in controls with other skin disorders and 32.58% (29/89) in placebo control group. While positive rate for Urease Breath Test were found to be 79.8% (71/89) in cases, 35.95% (32/89) in controls with other skin diseases and 32.58% (29/89) in placebo controls. In chronic idiopathic urticaria a high titer of anti H. pylori IgG and Urease Breath Test positivity suggests that inclusion of anti H. pylori therapy in it’s the management would be beneficial and would lead to lower rates of recurrence. Also, low positivity rates of Urease Breath Test and Anti H. pylori IgG in controls with other chronic skin diseases and placebo controls points towards no clear evidence to prove a causal relationship between these diseases and H. pylori infection.

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&gt;0.05).80% in group A and 85% in group B showed improvement in itching in the first week (p&gt;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&gt;0.05) and at 4th week, 5% and 0% respectively (p&gt;0.05). 75% in group A and 80% in group B had regression in their lesions at the end of first week (p&gt;0.05). At the end of 4th week, it was 85% and 90% (p&gt;0.05). 40% in group A and 25% in group B had relapse of itching at follow up (p&lt;0.05). Relapse of lesions were 35% and 20% (p&lt;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.

Stressful Major Life Events and Chronic Urticaria

Background: The skin and central nervous system are derivatives of embryonic ectoderm. There is an etiological factor of stressful life events in various skin diseases such as chronic urticaria through psychosomatic mechanisms. Many observations and case series are reported in favor of this opinion. Objectives: To evaluate the stressful life events within one year, six months and a month preceding onset or exacerbation of lesions in chronic idiopathic urticaria cases enrolled in this study. Material and Methods: It is an Observational descriptive questionnaire-based study, which included minimum of 50 patients of chronic idiopathic urticaria and important stressful events were noted in these subjects using Gurmeet Singh's presumptive stressful life events (PSLE) scale. Results: Out of 50 cases, stressful life events preceded the exacerbation of the chronic urticaria in 16 (32%) patients. Amongst them 12 (24%) showed slight degree and four (8%) showed moderate degree of stress and none of the cases reported great degree of stress. Among 16 cases, eight (50%) cases noticed exacerbation within six months of experiencing stressful life event with higher degree of severity in older age group (p = 0.004). Financial loss or problem was the most common stressful life event seen in four out of 16 cases (25%) (p = 0.000). Few desirable events were also found as stressors in four cases accounting for 25%. Conclusion: These results support association between psychological factors and exacerbation of the disease. The need for stress management programs in high stress scores to cope up with the stressful events, will further help in reducing the morbidity.

Chronic urticaria: a clinico-etiological study and autologous serum skin test role in chronic idiopathic urticaria

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Appearance of wheals daily for more than six weeks is chronic urticarial (CU). No cause is identified in about 50-70% of chronic urticaria patients and are labelled as chronic idiopathic urticaria (CIU). The aim of the present study is to study the clinical and etiological pattern of chronic urticaria and to find out the incidence of autoimmune urticaria by performing autologous serum skin test (ASST) in patients with CIU.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; This was a cross sectional study enrolling 100 chronic urticaria patients satisfying including and excluding criteria. The study was done for a period of 1 year. ASST was done in all the CIU patients after recording detailed history, complete physical and systemic examination.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; Most of the patients (33%) were in 21-30 years age group with female preponderance (66%). Students (38%) followed by house wives (27%) were majorly involved. 21% patients had history of atopy and 8% had abnormal thyroid function tests. Causative factors noticed in 46% patients and remaining were idiopathic (54%). Infections (32.6%) constituted the major etiological factor followed by physical urticaria (30.4%), food (23.9%), medication (11%) and inhalants (2.1%). In infective agents, 46.6% were bacterial followed by helminthic (33.3%). In 29.6% of CIU patients, the ASST was positive indicating auto-immune urticaria.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; The etiology cannot be identified in most number of patients and hence they were labelled as CIU and the common causative agents observed were infections followed by physical urticaria, food and medication. ASST is considered as the relevant screening test to detect autoimmune urticaria.&lt;/p&gt;

SELE Downregulation Suppresses Mast Cell Accumulation to Protect against Inflammatory Response in Chronic Idiopathic Urticaria

Background:Chronic idiopathic urticaria (CIU) represents a common skin disorder often characterized by mast cell activation and secretion of histamine and other proinflammatory factors. E-selectin (SELE) has been implicated in the pathogenesis of common inflammatory cutaneous disorders, while the role of SELE in CIU is yet to be fully understood. Thus, we aimed to investigate the mechanism by which SELE influences CIU in connection with the involvement of mast cells. Methods: SELE expression was measured in blood samples obtained from CIU patients and normal individuals. A CIU mouse model was subsequently established by intradermally injecting a normal saline solution with ovalbumin IgE antiserum into the mice. Loss- and gain-of-function investigations were conducted on the mouse models. The number of degranulated mast cells and the amount of histamine release in vitro were determined. The levels of SELE, tumor necrosis factor (TNF)-α, homologous restriction factor (HRF), and interleukin (IL)-6 levels were determined. Results: The CIU clinical samples exhibited upregulated SELE, while the CIU mice showed increased mast cell degranulation and an increased rate of histamine directional release, as well as an elevated expression of SELE, TNF-α, HRF, and IL-6. SELE silencing was found to decrease the number of degranulated mast cells and reduce the rate of histamine directional release, along with suppressed TNF-α, HRF, and IL-6 expression, in the serum of CIU mice. Ketotifen was observed to rescue the increased expression of TNF-α, HRF, and IL-6 caused by SELE overexpression. Conclusions:This study highlights the potential of SELE downregulation to repress inflammatory factor secretion caused by the accumulation of mast cells, which ultimately inhibits the development of CIU.

Inactivated P. aeruginosa restores immune imbalance of chronic idiopathic urticaria.

The main pathology involved in chronic idiopathic urticaria (CIU) is immunological dysfunction which mainly adapts to the immune system of body. Pseudomonas aeruginosa-mannose-sensitive hemagglutinin (PA) is an inactivated Pseudomonas aeruginosa biological product which displays a broad immune regulatory effect. The current study was designed to explore the protective nature of PA as an immune regulator in CIU. The participants were randomly divided into CIU + PA, CIU, control + PA and control group. lg E, anti FcεRI, anti IgE antibody, IL-4, IL-17, TGF-β1 and interferon-γ in the sera were assayed by ELISA. Then CD4+ T cells and CD19+ B cells were isolated from peripheral blood of patients with CIU (n = 10) and healthy control (n = 10). CD4+ T cells and CD19+ B proliferation and apoptosis were analyzed through CCK-8 and flow cytometry respectively. T helper cells differentiations were assessed by real-time PCR. The results revealed that compared with the control group, the curative effect of CIU + PA group was more effective than that of the CIU control group. There was a hyper proliferation of CD19+ B cells in the CIU patients. Moreover, it was also discovered that presence of Th1 decreased while Th2 cells increased in CIU patients. PA significantly inhibited the proliferation of CD19+ B and Th2 cells but at the same time promoted the proliferation of Th1 compared to healthy control. The conclusion arrived at from this study is that the PA displayed a remarkable regulatory effect in CD4+ T cells and CD19+ B cells function by promoting Th1 but inhibited Th2 and the hyperfunction of B cells of CIU patients.

Posttraumatic Stress Disorder and Chronic Idiopathic URTICARIA: the Role of Coping and Personality.

This study compared the severity of chronic idiopathic urticaria (CIU) and psychiatric symptoms between patients with different levels of posttraumatic stress disorder (PTSD) and investigated a model depicting the interrelationship between PTSD from past trauma, personality traits, coping strategies, CIU severity and psychiatric symptom severity. One hundred CIU and 60 allergy patients participated in the study, completing measures on PTSD, psychiatric symptoms, personality traits and coping strategies. The results showed that for CIU patients, 7%, 40 and 34% met the diagnostic criteria for no-PTSD, partial-PTSD and full-PTSD respectively whereas for allergy patients, 15%, 45 and 18% met the same criteria. Apart from CIU, psychiatric symptom severity differed significantly between diagnostic groups. PTSD was associated with coping strategies which were in turn associated with CIU severity and psychiatric symptom severity. PTSD was not significantly associated with personality. Emotion-focused coping mediated PTSD and CIU severity, PTSD and psychiatric symptom severity and neuroticism and CIU severity. To conclude, psychiatric symptom severity varies depending on the level of PTSD among CIU patients. Neurotic patients with a high level of PTSD from past trauma show raised CIU and psychiatric symptom severity when using emotion-focused coping strategies.

Eradication of Helicobacter pylori, as add-on therapy, has a significant, but temporary influence on recovery in chronic idiopathic urticaria: a placebo-controlled, double blind trial in the Polish population.

IntroductionThe infectious factor like Helicobacter pylori (HP) has been thought to trigger the vicious circle of chronic idiopathic urticaria (CIU), therefore its eradication could modify the course of the disease.AimTo reveal the influence of HP eradication on CIU clinical course.Material and methodsSixty-four CIU patients, receiving fexofenadine, as the basic treatment, took part in the research, divided into 3 groups: HP patients treated by eradication, HP patients receiving placebo, and patients without bacteria. Gastroscopy, urease test and histopathology were done to detect HP. Patients with HP were randomized and received eradication treatment or placebo. The efficacy of eradication was checked after 6 weeks by means of another gastroscopy, urease test and histopathology. In the 6th week and in the 4th and 6th month after eradication, the symptoms were evaluated basing on the score symptom scale.ResultsHelicobacter pylori did not occur more frequently in CIU patients than in the healthy population. A statistically significant clinical improvement of CIU symptoms was observed in the 6th week after eradication as compared to the group receiving placebo (p = 0.02) and patients who were not infected (p = 0.02). Further observation in the eradicated patients group revealed the rebound phenomenon – worsening of the clinical state (p = 0.001), which in the 4th month did not differ from the patients not infected or patients receiving placebo.ConclusionsAlthough HP occurs as frequently in CIU patients as in the healthy population, eradication, added to basic antihistaminic treatment, has a significant influence on CIU patients’ recovery parallel to the reduction of stomach inflammation features.

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.

Real-world treatment patterns and outcomes of omalizumab use in patients with chronic idiopathic urticaria

Objective: To examine treatment patterns, treatment response, and demographic and clinical characteristics of patients with chronic idiopathic urticaria (CIU) newly initiated on omalizumab therapy in real-world practice in the US.Methods: This retrospective observational cohort study used US claims data from the HealthCore Integrated Research Database (HIRD®) augmented with medical record data to identify CIU patients newly-treated with omalizumab (≥4 omalizumab claims within 6 months of initial claim; index date = first omalizumab claim date) between March 21, 2014 and October 31, 2015 and with ≥6 months pre- and ≥12 months post-index health plan eligibility. Study outcomes were captured from medical records for up to 12 months pre-index and up to 24 months post-index. Descriptive statistics were reported.Results: This study consisted of 88 patients with a mean (SD) age of 43.4 (± 13.46) years, 68.2% were female, and 36 patients had ≥18 months post-index eligibility. Among 69 patients with documented index dose, 75.4% received omalizumab 300 mg and 69.6% remained on index dose throughout follow-up. For 52 patients with documented index dosing frequency, 96.2% had every 4-week dosing frequency. Among 86 patients with omalizumab documentation, 83.7% reported CIU improvement after omalizumab initiation and 24.4% discontinued omalizumab. For all patients, the proportion using oral corticosteroids (OCS) decreased pre- to post-index (52.3% vs 39.8%). Similar results were observed for patients with ≥18 months post-index eligibility.Conclusions: In this real-world analysis, the majority of patients remained on omalizumab for ≥12 months, and had a positive response. OCS use decreased following omalizumab initiation.

Study on Association between Chronic Idiopathic Urticaria and Helicobacter Pylori Infection in Armed Forces Personnel

Introduction: Chronic Idiopathic Urticaria (CIU) has an estimated prevalence of 35-65% and impacts 15 to 25% of the population at some point in their lives. Studies have shown the possible involvement of Helicobacter pylori (H. pylori) infection in chronic idiopathic urticaria (CIU), but the relationship remains controversial.&#x0D; Objective: To quantitatively assess the association between H. pylori infection and chronic idiopathic urticaria.&#x0D; Materials and Methods: This was a case-control type of analytical study and 100 patients were enrolled fifty patients of CIU fulfilling inclusion criteria with no identifiable cause were taken as case and patients without urticaria were taken as control, attending in the department of Dermatology &amp; Venereology, CMH Dhaka for treatment from May 2015 to Aug 2016. Helicobacter pylori infection was confirmed by serum IgG for H. pylori test.&#x0D; Results: The result showed that H. pylori infection significantly affected a high percentage of patients 30 (60%) with chronic idiopathic urticaria. Male respondents were more positive 16(53.3%) than female 14(46.7%), in the middle aged 31-50 year about 18(60%) and triple drug therapy was successful in 16(53.33%) patients in whom H. pylori was detected.&#x0D; Conclusion: Urticaria is a common clinical disorder with complex triggering factors. Chronic urticaria has provided evidence that enteric infection with H. pylori may induce the disease. In this case control study, it was evident that chronic idiopathic urticaria was associated with positive serum IgG for H. Pylori. A trial of H. pylori eradication therapy may be offered to patients with CIU and evidence of H. pylori infection.&#x0D; Journal of Armed Forces Medical College Bangladesh Vol.12(2) 2016: 122-126

Anti-Thyroid Antibodies in Chronic Idiopathic Urticaria Patients

Background: Chronic Idiopathic Urticaria (CIU) is defined as recurrent hives occurring for at least 6 weeks. In the majority of cases, there is no identifiable underlying etiology despite extensive evaluation. It was reported an association between autoimmune thyroiditis and CIU. Objectives: This study was carried out to evaluate the relation between anti-thyroid antibodies and patients and chronic idiopathic urticaria. Methodology: This study was conducted in Allergy and Immunology unit in Zagazig University. In this study, 40 patients suffered from chronic idiopathic urticaria as a case group were selected and compared to a control group of 40 healthy individuals. The anti- thyroid antibodies, total IgE and ASST were studied in the both groups. Results: We reported significant difference regarding anti-thyroid antibodies, total IgE and ASST between the control group and the patient group (P=0.000). Concolusion: The prevalence of anti-thyroid antibodies was high in the patients suffering from chronic idiopathic urticaria.

평위산가미방으로 치료한 만성 특발성 두드러기 환자의 추적조사

평위산가미방으로 치료한 만성 특발성 두드러기 환자의 추적조사