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1. Omalizumab for antihistamine-resistant chronic spontaneous urticaria

Omalizumab for antihistamine-resistant chronic spontaneous urticaria '); } else { document.write(' '); } ACE | Omalizumab for antihistamine-resistant chronic spontaneous urticarial Search > > Omalizumab for treating antihistamine-resistant chronic spontaneous urticarial - Omalizumab for treating antihistamine-resistant chronic spontaneous urticaria Published on 2 January 2019 Guidance Recommendations The Ministry of Health's Drug Advisory Committee has recommended: Omalizumab 150 mg powder (...) and solvent for solution for injection as an add-on therapy to H 1 -antihistamines for treating severe chronic spontaneous urticaria (CSU) in patients aged 12 years and older, with a mean weekly Urticaria Activity Score (UAS7) of 28 and above, despite the use of, or who are intolerant to, four-times registered dose of second-generation non-sedating H 1 -antihistamines. A maximum of six 300 mg doses of omalizumab should be administered for each treatment course. Re-treatment with omalizumab can

2019 Appropriate Care Guides, Agency for Care Effectiveness (Singapore)

2. 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)

3. Long-term evaluation of response to omalizumab therapy in real life by a novel multimodular approach: The Real-life Effectiveness of Omalizumab Therapy (REALITY) study. (Abstract)

Long-term evaluation of response to omalizumab therapy in real life by a novel multimodular approach: The Real-life Effectiveness of Omalizumab Therapy (REALITY) study. The evidence on long-term real-life response measures to omalizumab therapy in moderate to severe asthma is limited. A universal assessment tool is needed to adequately evaluate response to omalizumab in these patients.To design a multimodular response assessment tool and use it to measure and define response to omalizumab (...) therapy in real-world settings.The Real-life Effectiveness of Omalizumab Therapy (REALITY) study is a retrospective, long-term, real-life clinical study that evaluates response in individuals with allergic asthma who received omalizumab between 2004 and 2011. The Standardized Measure to Assess Response to Therapy (SMART) tool was designed to define response (1 year before to after treatment) by 3 modules: (1) physician's subjective assessment of asthma symptoms and control; (2) objective assessment

2019 Asthma & Immunology

4. Treatment Effect of Omalizumab on Severe Pediatric Atopic Dermatitis: The ADAPT Randomized Clinical Trial (Abstract)

Treatment Effect of Omalizumab on Severe Pediatric Atopic Dermatitis: The ADAPT Randomized Clinical Trial Systemic treatments for severe childhood atopic dermatitis have limited evidence and/or are unlicensed. Despite the efficacy of anti-IgE medication (omalizumab) in the treatment of atopy, no large randomized studies in childhood atopic dermatitis have been published.To determine the effectiveness of omalizumab in treating severe atopic dermatitis in children.The Atopic Dermatitis Anti-IgE (...) ) that was unresponsive to optimum therapy. Statistical analysis was conducted using the intention-to-treat principle.Subcutaneous omalizumab or placebo for 24 weeks. The drug manufacturer's dosing tables were used to determine the dosage based on total IgE (30-1500 IU/mL) and body weight (in kilograms) at randomization.Objective SCORAD index after 24 weeks of treatment.In total, 62 children (mean [SD] age, 10.3 [4.2] years; 32 (52%) were male) were randomized to either omalizumab (n = 30) or placebo (n = 32). Five

2020 EvidenceUpdates

5. Omalizumab for previously treated chronic spontaneous urticaria

Omalizumab for previously treated chronic spontaneous urticaria Omalizumab for pre Omalizumab for previously treated viously treated chronic spontaneous urticaria chronic spontaneous urticaria T echnology appraisal guidance Published: 8 June 2015 nice.org.uk/guidance/ta339 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance represent the view (...) inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Omalizumab for previously treated chronic spontaneous urticaria (TA339) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 53Contents Contents 1 Guidance 4 2 The technology 5 3

2015 National Institute for Health and Clinical Excellence - Technology Appraisals

6. 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

7. 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

8. 4-month omalizumab efficacy outcomes for severe allergic asthma: the Dutch National Omalizumab in Asthma Registry Full Text available with Trip Pro

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

9. Omalizumab for treating severe persistent allergic asthma (review of technology appraisal guidance 133 and 201) (TA278)

Omalizumab for treating severe persistent allergic asthma (review of technology appraisal guidance 133 and 201) (TA278) Overview | Omalizumab for treating severe persistent allergic asthma | Guidance | NICE Omalizumab for treating severe persistent allergic asthma Technology appraisal guidance [TA278] Published date: 24 April 2013 Share Guidance on omalizumab (Xolair) for treating severe persistent allergic asthma in people aged 6 and over. This guidance replaces NICE technology appraisal (...) guidance on omalizumab for the treatment of severe persistent allergic asthma in children aged 6–11 (TA201) and omalizumab for severe persistent asthma (TA133). Guidance development process Is this guidance up to date? . We found nothing new that affects the recommendations in this guidance. Next review : This guidance will be reviewed if there is new evidence that is likely to affect the recommendations. Your responsibility The recommendations in this guidance represent the view of NICE, arrived

2013 National Institute for Health and Clinical Excellence - Technology Appraisals

10. [Omalizumab for the management of asthma]

[Omalizumab for the management of asthma] Omalizumab para el tratamiento del asma [Omalizumab for the management of asthma] Omalizumab para el tratamiento del asma [Omalizumab for the management of asthma] Ruano Gándara R, Rey-Ares L, Pichon-Riviere A, Augustovski F, García Martí S, Alcaraz A, Bardach A, Ciapponi A, López A Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been (...) made for the HTA database. Citation Ruano Gándara R, Rey-Ares L, Pichon-Riviere A, Augustovski F, García Martí S, Alcaraz A, Bardach A, Ciapponi A, López A. Omalizumab para el tratamiento del asma. [Omalizumab for the management of asthma] Buenos Aires: Institute for Clinical Effectiveness and Health Policy (IECS). Informe de Respuesta Rapida No. 440. 2015 Authors' objectives To assess the available evidence on the efficacy, safety and coverage related aspects regarding omalizumab in the management

2015 Health Technology Assessment (HTA) Database.

11. Omalizumab for asthma in adults and children. (Abstract)

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

12. Is omalizumab effective for eosinophils in asthmatic patients?

Is omalizumab effective for eosinophils in asthmatic patients? 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. Email salutation (e.g. "Dr

2019 PROSPERO

13. 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

14. 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

15. Omalizumab in the treatment of allergic rhinitis: a systematic review and meta-analysis of randomized controlled trials

Omalizumab in the treatment of allergic rhinitis: a systematic review and meta-analysis of randomized controlled trials 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. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Email salutation (e.g. "Dr Smith" or "Joanne") for correspondence

2019 PROSPERO

16. Omalizumab in patients with severe asthma and persistent sputum eosinophilia. Full Text available with Trip Pro

Omalizumab in patients with severe asthma and persistent sputum eosinophilia. Omalizumab, a recombinant humanized monoclonal antibody targeting the IgE molecule, is the first biologic approved for moderate-to-severe allergic asthmatics, who remain uncontrolled despite high dose inhaled corticosteroid and bronchodilators. Steroid-sparing effect of omalizumab has not been demonstrated in asthmatics with persistent airway eosinophilia in a randomised controlled trial till date. From this double (...) -blind, placebo-controlled, multi-centred, randomized parallel group design, we report that omalizumab is possibly inadequate to control sputum eosinophilia, and therefore may not have a steroid-sparing effect, especially in those maintained on oral corticosteroids daily. This needs to be confirmed or refuted in a larger trial, which may be a challenge with respect to recruitment, since there are currently three additional biologics available to prescribe. Trial registration Clinicaltrials.gov

2019 Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology Controlled trial quality: predicted high

17. Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU). Full Text available with Trip Pro

Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU). 31034999 2019 09 09 2213-2201 7 7 2019 Sep - Oct The journal of allergy and clinical immunology. In practice J Allergy Clin Immunol Pract Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU). 2487-2490.e1 S2213-2198(19)30393-9 10.1016/j.jaip.2019.04.020 Casale Thomas B TB University of South

2019 The journal of allergy and clinical immunology. In practice Controlled trial quality: uncertain

18. Predicting Chronic Spontaneous Urticaria Symptom Return After Omalizumab Treatment Discontinuation: Exploratory Analysis. Full Text available with Trip Pro

Predicting Chronic Spontaneous Urticaria Symptom Return After Omalizumab Treatment Discontinuation: Exploratory Analysis. Omalizumab is highly effective in controlling chronic spontaneous urticaria (CSU) symptoms; however, patients can experience symptom return on treatment discontinuation. Pivotal clinical trials have identified 2 categories of patients who experience symptom return: rapid and slow.The objective of this study was to identify potential predictors of the speed of symptom return (...) after stopping omalizumab treatment.Phase III randomized controlled trial (RCT) data from ASTERIA I (n = 319; 6 × 4 weekly injections of omalizumab 75, 150, 300 mg or placebo; NCT01287117) and ASTERIA II (n = 323; 3 × 4 weekly injections of omalizumab 75, 150, 300 mg, or placebo; NCT01292473) were pooled to identify predictors of symptom return after stopping omalizumab treatment (16-week follow-up). The least absolute shrinkage and selection operator regularization regression model was used

2019 The journal of allergy and clinical immunology. In practice Controlled trial quality: uncertain

19. A Phase 2 Randomized Controlled Multisite Study Using Omalizumab-facilitated Rapid Desensitization to Test Continued Full Text available with Trip Pro

A Phase 2 Randomized Controlled Multisite Study Using Omalizumab-facilitated Rapid Desensitization to Test Continued As there is limited data on the sustainability of desensitization of multifood-oral immunotherapy (multifood-OIT), we conducted a multisite multifood-OIT study to compare the efficacy of successful desensitization with sustained dosing vs discontinued dosing after multifood-OIT.We enrolled 70 participants, aged 5-22 years with multiple food allergies confirmed by double-blind (...) placebo-controlled food challenges (DBPCFCs). In the open-label phase of the study, all participants received omalizumab (weeks 1-16) and multi-OIT (2-5 allergens; weeks 8-30) and eligible participants (on maintenance dose of each allergen by weeks 28-29) were randomized 1:1:1 to 1 g, 300 mg, or 0 mg arms (blinded, weeks 30-36) and then tested by food challenge at week 36. Success was defined as passing 2 g food challenge to at least 2 foods in week 36.Most participants were able to reach a dose

2019 Eclinicalmedicine Controlled trial quality: predicted high

20. Cost-effectiveness of omalizumab for the treatment of moderate-to-severe uncontrolled allergic asthma in the United States. Full Text available with Trip Pro

Cost-effectiveness of omalizumab for the treatment of moderate-to-severe uncontrolled allergic asthma in the United States. Objective: Uncontrolled asthma is associated with considerable clinical burden and costs to payers and patients. US economic models evaluating biologics using data from clinical trials demonstrate high incremental cost-effectiveness ratios (ICERs), but the cost-effectiveness based on real-world treatment patterns is unknown. This analysis used real-world evidence to assess (...) the cost-effectiveness of adding omalizumab to standard of care (SOC). Methods: A Markov model was applied to track patients' health states in 2-week cycles, comparing costs and treatment effects of SOC alone versus SOC + omalizumab over a lifetime (US payer perspective). Outcomes included exacerbation events, life years, quality-adjusted life years (QALYs), total costs, and an ICER. Patient characteristics, exacerbations, patient-reported outcomes, and work productivity were derived from the real

2019 Current medical research and opinion

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