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1. Omalizumab (Xolair) PBS listed for use in children with asthma

Omalizumab (Xolair) PBS listed for use in children with asthma Omalizumab (Xolair) PBS listed for use in children with asthma - NPS MedicineWise Log In Menu Featured topics Professional development Publications An independent peer-reviewed journal providing critical commentary on drugs and therapeutics. Timely, independent, evidence-based information on new drugs and medical tests, and changes to the PBS and MBS. Featured topics Talk to a professional Information for consumers on prescription (...) and consumers. Featured resources 4 February 2019 4 February 2019 18 October 2018 Featured topic 20 years of helping Australians make better decisions about medicines, medical tests and other health technologies Partner with us Latest projects Search Search Search Search POPULAR Log in Log in All fields are required Email address* Password* Log in Breadcrumb And Text Resize Omalizumab (Xolair) PBS listed for use in children with asthma Omalizumab (Xolair) PBS listed for use in children with asthma 3 min

2018 National Prescribing Service Limited (Australia)

2. Omalizumab (Drug Plan Submission) ( Xolair )

Omalizumab (Drug Plan Submission) ( Xolair ) Omalizumab (Drug Plan Submission) | CADTH.ca Find the information you need Omalizumab (Drug Plan Submission) Omalizumab (Drug Plan Submission) Last Updated: October 6, 2015 Result type: Reports Project Number: SR0457-000 Product Line: Generic Name: Omalizumab (Drug Plan Submission) Brand Name: Xolair Manufacturer: Novartis Pharmaceuticals Canada Inc. Indications: Asthma, severe persistent Submission Type: Resubmission 2 Project Status: Complete Date

2016 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

3. 4-month omalizumab efficacy outcomes for severe allergic asthma: the Dutch National Omalizumab in Asthma Registry (Full text)

4-month omalizumab efficacy outcomes for severe allergic asthma: the Dutch National Omalizumab in Asthma Registry Omalizumab is licensed as add-on therapy for patients with severe allergic asthma. Response is in most studies scored by the physician's global evaluation of treatment effectiveness (GETE). A good clinical and validated parameter for treatment response is currently missing. Also, there are no established criteria for identifying patients who will respond to omalizumab based on pre (...) -treatment characteristics. The Dutch National Omalizumab in Asthma Registry was developed in 2011 to better evaluate inclusion criteria and measure treatment response after 4 months.This is a "real world" prospectively designed, observational data registry in which the outcomes of patients who received omalizumab between 2012 and 2015 were evaluated. Data were collected from all centers in the Netherlands comprising demographic features, criteria for starting treatment, GETE, FEV1, oral corticosteroid

2017 Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology PubMed

4. Omalizumab for asthma in adults and children. (PubMed)

Omalizumab for asthma in adults and children. Asthma is a respiratory (airway) condition that affects an estimated 300 million people worldwide and is associated with significant morbidity and mortality. Omalizumab is a monoclonal antibody that binds and inhibits free serum immunoglobulin E (IgE). It is called an 'anti-IgE' drug. IgE is an immune mediator involved in clinical manifestations of asthma. A recent update of National Institute for Health and Care Excellence (NICE) guidance in 2013 (...) recommends omalizumab for use as add-on therapy in adults and children over six years of age with inadequately controlled severe persistent allergic IgE-mediated asthma who require continuous or frequent treatment with oral corticosteroids.To assess the effects of omalizumab versus placebo or conventional therapy for asthma in adults and children.We searched the Cochrane Airways Group Specialised Register of trials for potentially relevant studies. The most recent search was performed in June 2013. We

2014 Cochrane

5. Efficacy of omalizumab therapy in allergic bronchopulmonary aspergillosis: a meta analysis

Efficacy of omalizumab therapy in allergic bronchopulmonary aspergillosis: a meta analysis Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites

2019 PROSPERO

6. Omalizumab Treatment for Adults and Children with Allergic Asthma

Omalizumab Treatment for Adults and Children with Allergic Asthma Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. Rapid responses should be considered (...) study only. It may not be copied, posted on a web site, redistributed by email or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions. TITLE: Omalizumab Treatment for Adults and Children

2015 Canadian Agency for Drugs and Technologies in Health - Rapid Review

7. Is the treatment with omalizumab efficacious and safe for patients with eosinophilic asthma?

Is the treatment with omalizumab efficacious and safe for patients with eosinophilic asthma? Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability for the content of this registration record, any associated files or external

2019 PROSPERO

8. Structural basis of omalizumab therapy and omalizumab-mediated IgE exchange (Full text)

Structural basis of omalizumab therapy and omalizumab-mediated IgE exchange Omalizumab is a widely used therapeutic anti-IgE antibody. Here we report the crystal structure of the omalizumab-Fab in complex with an IgE-Fc fragment. This structure reveals the mechanism of omalizumab-mediated inhibition of IgE interactions with both high- and low-affinity IgE receptors, and explains why omalizumab selectively binds free IgE. The structure of the complex also provides mechanistic insight (...) into a class of disruptive IgE inhibitors that accelerate the dissociation of the high-affinity IgE receptor from IgE. We use this structural data to generate a mutant IgE-Fc fragment that is resistant to omalizumab binding. Treatment with this omalizumab-resistant IgE-Fc fragment, in combination with omalizumab, promotes the exchange of cell-bound full-length IgE with omalizumab-resistant IgE-Fc fragments on human basophils. This combination treatment also blocks basophil activation more efficiently than

2016 Nature communications PubMed

9. Effects of Omalizumab Compared to Non-Omalizumab Treatment in Asthma Patients

Effects of Omalizumab Compared to Non-Omalizumab Treatment in Asthma Patients Effects of Omalizumab Compared to Non-Omalizumab Treatment in Asthma Patients - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more (...) . Effects of Omalizumab Compared to Non-Omalizumab Treatment in Asthma Patients The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02921178 Recruitment Status : Unknown Verified September 2016 by Hae-Sim Park, Ajou University School of Medicine. Recruitment status was: Active, not recruiting First Posted

2016 Clinical Trials

10. Anaphylaxis after Elosulfase A infusion: Omalizumab as coadyuvant for enzyme replacement therapy desensitization. (PubMed)

Anaphylaxis after Elosulfase A infusion: Omalizumab as coadyuvant for enzyme replacement therapy desensitization. Type IV A Mucopolysaccharidosis (MPS IV A) is a lysosomal storage disease caused by an autosomal recessive mutation in the gene encoding the enzyme galactosamine-6-sulfatase, which catalyses the degradation of glycosaminoglycans (GAGs). It leads to the accumulation of GAGs keratan sulfate. Symptoms include skeletal dysplasia, atlantoaxial instability, pectus carinatum, short stature

2019 Pediatric Allergy and Immunology

11. Asthma with multiple allergic comorbidities is associated with complete response to omalizumab. (PubMed)

Asthma with multiple allergic comorbidities is associated with complete response to omalizumab. Patients with severe asthma constitute a heterogeneous population, and different phenotypes have been identified both in adults and children. Severe asthma affects 4.5% of children with current asthma. Several studies have shown that omalizumab, a humanized anti-IgE monoclonal antibody, is effective in exacerbations and asthma control, and well tolerated in children with severe allergic asthma

2019 Clinical and Experimental Allergy

12. Efficacy and safety of reslizumab in severe asthma patients with inadequate response to omalizumab: a multicentre, open-label, pilot study. (Full text)

Efficacy and safety of reslizumab in severe asthma patients with inadequate response to omalizumab: a multicentre, open-label, pilot study. Patients with severe allergic and eosinophilic asthma could qualify for different biologic therapies.To evaluate the efficacy and safety of weight-based intravenous reslizumab dosing in patients who have previously failed therapy with omalizumab.We carried out a 24-week prospective, multicenter, open-label, single-group, self-controlled study in patients (...) with severe eosinophilic asthma who had previously failed to respond to omalizumab. The main objective was to determine whether treatment with reslizumab significantly improved asthma symptoms assessed by the Asthma Control Test (ACT) at week 24. Secondary objectives were to evaluate symptoms at weeks 4 and 12, change in FEV1 at week 24, and the incidence of severe exacerbations over the study period.Twenty-nine patients (62.1% women, median age, 50.8 years) were included in the study. The median ACT

2019 The journal of allergy and clinical immunology. In practice PubMed

13. Efficacy and Safety of Omalizumab (Xolair) for Cholinergic Urticaria in Patients Unresponsive to a Double Dose of Antihistamines: A Randomized Mixed Double-Blind and Open-Label Placebo-Controlled Clinical Trial. (PubMed)

Efficacy and Safety of Omalizumab (Xolair) for Cholinergic Urticaria in Patients Unresponsive to a Double Dose of Antihistamines: A Randomized Mixed Double-Blind and Open-Label Placebo-Controlled Clinical Trial. Cholinergic urticaria (UCOL) is a highly disabling inducible urticaria triggered by an increase in core body temperature.To explore the safety and efficacy of omalizumab in controlling UCOL.We conducted a multicenter randomized mixed double-blind and open-label (first 4 months blinded (...) and potential efficacy of omalizumab in patients with UCOL.Copyright © 2019 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

2019 The journal of allergy and clinical immunology. In practice

14. Real-life data on the effectiveness and safety of omalizumab in monotherapy or combined for chronic spontaneous urticaria: A retrospective cohort study. (PubMed)

Real-life data on the effectiveness and safety of omalizumab in monotherapy or combined for chronic spontaneous urticaria: A retrospective cohort study. The real-life data on the effectiveness and safety of omalizumab in chronic spontaneous urticaria (CSU) with validated methods are scarce. There is also a lack of information on the use of combination treatments.A retrospective cohort study was done to evaluate the effectiveness and safety of omalizumab in real-life conditions. The patients (...) with CSU treated with omalizumab between 2015 and 2018 were included. The response to therapy was evaluated using urticaria activity score over 7 days (UAS7) and urticaria control test (UCT).A total of 106 patients were included. A complete response (CR) (UAS7:0) and a well-controlled activity (WCA) (UAS7:1 to <6) were observed in 50 (47.2%) and 35 (33%) patients, respectively. The number of patients with an UCT score ≥12 was also significantly increased. Higher rates of CR/WCA were observed

2019 Journal of Dermatological Treatment

15. Systemic reaction rates with omalizumab, subcutaneous immunotherapy, and combination therapy in children with allergic asthma. (PubMed)

Systemic reaction rates with omalizumab, subcutaneous immunotherapy, and combination therapy in children with allergic asthma. Background: For children with moderate-to-severe persistent allergic asthma, omalizumab is effective. However, it is expensive, and there are no current guidelines for discontinuation. Subcutaneous immunotherapy (SCIT) is the only approach that can provide persistent beneficial effects after treatment is discontinued. However, SCIT is contraindicated in poorly (...) controlled asthma. Therefore, we performed, to our knowledge, the first U.S. study that exclusively compared the safety of omalizumab, SCIT, and combination (omalizumab and SCIT) therapy in children with allergic asthma. Objective: We hypothesize that the systemic reaction (SR) rates in children who receive combination therapy are comparable with omalizumab alone. Methods: We performed a retrospective study of children ages 6-18 years old with allergic asthma who, from July 2010 to June 2017, received

2019 Allergy and Asthma Proceedings

16. Omalizumab may decrease the thickness of the reticular basement membrane and fibronectin deposit in the bronchial mucosa of severe allergic asthmatics. (PubMed)

Omalizumab may decrease the thickness of the reticular basement membrane and fibronectin deposit in the bronchial mucosa of severe allergic asthmatics. Immunoglobulin E is an important modulator of the inflammatory reaction in allergic asthma. It also contributes to airway remodeling in the course of the disease. The authors evaluated airway structural changes in severe allergic asthma during the omalizumab therapy.The study included 13 patients with severe allergic asthma treated (...) with omalizumab for at least one year. In each patient clinical, laboratory, and spirometry parameters were evaluated before and after the treatment. In addition, bronchoscopy with bronchial mucosa biopsy and bronchoalveolar lavage was performed. The basal lamina thickness, inflammatory cell infiltration, fibronectin, as well as type I and III collagen accumulation were assessed in bronchial mucosa specimens, together with the assessment of bronchoalveolar lavage cellularity.The omalizumab therapy led

2019 Journal of Asthma

17. The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma. (PubMed)

The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma. Mepolizumab and omalizumab are treatments for distinct but overlapping severe asthma phenotypes.To assess if patients eligible for both biologics but not optimally controlled with omalizumab experience improved asthma control when switched directly to mepolizumab.OSMO was a multicenter, open-label, single-arm, 32-week trial in patients with ≥2 asthma exacerbations in the year prior to enrollment (...) , despite receiving high-dose inhaled corticosteroids and other controller(s), plus omalizumab (≥4 months). At baseline, patients with blood eosinophil counts ≥150 cells/μL (or ≥300 cells/μL in the prior year) and an Asthma Control Questionnaire (ACQ)-5 score ≥1.5 discontinued omalizumab and immediately commenced mepolizumab 100 mg subcutaneously every 4 weeks. Endpoints included change from baseline in ACQ-5 score (primary), St George's Respiratory Questionnaire (SGRQ) score and the proportions of ACQ

2019 Allergy

18. Omalizumab as alternative to chronic use of oral corticosteroids in severe asthma. (PubMed)

Omalizumab as alternative to chronic use of oral corticosteroids in severe asthma. Systemic/oral corticosteroids (OCS) have been used for decades in the management of acute asthma exacerbations and chronically in patients with uncontrolled severe asthma. However, while OCS are effective at treating acute exacerbations, there is only empirical evidence regarding the efficacy of OCS at reducing the rate of exacerbations. Evidence, although scarce, is suggestive of high exacerbation rates (...) the use of biologics, instead of maintenance OCS, in patients with severe asthma (GINA Step 5). These include one biologic targeting immunoglobulin E (IgE) (omalizumab), and different biologics targeting interleukin-5 (IL-5), the IL-5 receptor (IL-5R) or IL-4 receptor α-unit (IL-4R α), including mepolizumab (subcutaneous), reslizumab (intravenous), benralizumab (subcutaneous) and dupilumab (subcutaneous). Omalizumab for the treatment of severe allergic asthma reduces exacerbations, irrespective

2019 Respiratory medicine

19. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. (PubMed)

Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. The Observational Study of the Use and Safety of Xolair (omalizumab) during Pregnancy (EXPECT) pregnancy registry was a prospective observational study established in 2006 to evaluate perinatal outcomes in pregnant women exposed to omalizumab and their infants.This analysis compares EXPECT outcomes with those from a disease-matched population of pregnant women not treated with omalizumab. Data from (...) a substudy of platelet counts among newborns are also presented.The EXPECT study enrolled 250 women with asthma exposed to omalizumab during pregnancy. The disease-matched external comparator cohort of women with moderate-to-severe asthma (n = 1153), termed the Quebec External Comparator Cohort (QECC), was created by using data from health care databases in Quebec, Canada. Outcome estimates were age adjusted based on the maternal age distribution of the EXPECT study.Among singleton infants in the EXPECT

2019 Journal of Allergy and Clinical Immunology

20. Factors related to omalizumab resistance in chronic spontaneous urticaria. (PubMed)

Factors related to omalizumab resistance in chronic spontaneous urticaria. Background: Omalizumab resistance (OmR) in chronic spontaneous urticaria (CSU) remains poorly understood. Objective: To identify clinical and laboratory attributes of patients that may be predictive of OmR in CSU. Methods: We conducted a retrospective observational study by using an electronic patient record data base of patients with severe CSU refractory to a fourfold H1-antihistamine dose, treated with omalizumab 300 (...) mg every 4 weeks for at least 24 weeks. Complete response (CR) was defined as the reduction of baseline urticaria activity score by ≥ 90%, partial response (PR) by ≥ 30% to <90%, and OmR by <30% at 24 weeks. The patient characteristics of the CR, PR, and OmR groups were compared. Results: Sixty-three patients (58.9%) had a complete remission at 24 weeks of omalizumab therapy, and 16 patients (14.9%) had OmR. The patients who were OmR were characterized by a higher rate of arterial hypertension 7

2019 Allergy and Asthma Proceedings

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