xolair

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In 2021, Medicare spending on biologics was $926 million in Part B (FFS) and $1.3 billion in Part D (FFS/MA). Between 2017 and 2021, annual Medicare spending on biologics increased by approximately 200%. Between 2023 and 2025, Medicare Part D OOP costs for biologics will decrease by an estimated 50%-60%.

Biosimilars are highly complex and similar biological drugs are developed with different manufacturing processes which are not similar to originator manufacturing process. Due to this, biosimilar products inherently have quality differences in comparison to innovator molecule which may be related to size, charge and glycosylation. Despite these differences they are supposed to demonstrate similar behaviour in safety and efficacy profile to the reference product and these differences should not be clinically meaningful...

Analytical and functional comparison is key for substantiating the level of convergence (essential sameness) or divergence between versions or variants of a given biological medicine. Accordingly, an overlapping biological activity between products meant to be equal probably reflects a highly similar structure and anticipates a comparable pharmacodynamic behavior. We developed an orthogonal approach to compare the human IgE binding features of different lots and versions of Xolair® (omalizumab), an anti-human IgE monoclonal antibody...

Omalizumab (Xolair) is a humanized monoclonal antibody derived by recombinant DNA technology. It binds specifically to immunoglobulin E (IgE) which plays a major role in allergic reaction by releasing histamine and other inflammatory factors from mast cells. Omalizumab binds circulatory IgE with high affinity and prevents from its binding to mast cell receptor. Charge variants are one of the critical quality attributes (CQAs) in biological drug development and sources of heterogeneity which needs to be considered in biosimilarity assessment...

BACKGROUND: Asthma remission has emerged as a potential treatment goal. This study evaluated the effectiveness of two biologics (mepolizumab/omalizumab) in achieving asthma remission. METHODS: This observational study included 453 severe asthma patients (41% male; mean age ± SD 55.7 ± 14.7 years) from two real-world drug registries: the Australian Mepolizumab Registry and the Australian Xolair Registry. The composite outcome clinical remission was defined as zero exacerbations and zero oral corticosteroids during the previous 6 months assessed at 12 months and 5-item Asthma Control Questionnaire (ACQ-5) ≤1 at 12 months...

BACKGROUND: Bronchial asthma (asthma) is a chronic inflammatory disease of the airways, involving a variety of cells and cellular components, that manifests clinically as recurrent episodes of wheezing, shortness of breath, with or without chest tightness or cough, airway hyperresponsiveness, and variable airflow limitation. The number of people with asthma has reached 358 million worldwide and asthma causes huge economic loss. However, there is a subset of patients who are not sensitive to existing drugs and the existing drugs have many adverse effects...

BACKGROUND: Current practice in health technology assessment (HTA) of pharmaceuticals conducts cost-effectiveness analyses (CEAs) based on a static price or the estimated price at market launch. Recent publications suggest incorporating dynamic pricing. To test the feasibility and importance of including dynamic pricing, we compared the standard static approach to four dynamic scenarios by replicating US-based HTA evaluations with dynamic pricing inputs. METHODS: The four case examples included omalizumab (Xolair® ) for the treatment of allergic asthma, elagolix (Orilissa® ) for the treatment of endometriosis, ocrelizumab (Ocrevus® ) for the treatment of primary progressive multiple sclerosis (PPMS), and dupilumab (Dupixent® ) for the treatment of atopic dermatitis (AD)...

Omalizumab, the anti-immunoglobulin IgE antibody is the only approved and available monoclonal antibody as an auxiliary medicament for the severe respiratory allergic reactions. It forms small size immune complexes by binding to free IgE, thereby inhibiting the interaction of IgE with its receptors. Additionally, the anti-IgE can also differently shape the airflow by impeding the stimulation of IgE receptors present on structural cells in the respiratory tract. The present study aimed to use plants as an expression system for anti-human IgE antibody production, using Nicotiana benthamiana as hosts...

BACKGROUND: Asthma can manifest in a variety of clinical phenotypes like cough variant asthma, chest tightness variant asthma (CTVA), and masked asthma. Patients with CTVA usually have a singular or primary complaint of chest tightness, which is often overlooked or misdiagnosed due to the lack of characteristic asthma symptoms. We hereby report a case of CTVA managed by omalizumab. CASE REPORT: A 15-year-old female patient reported to us with repeated coughing persisting for 3 weeks...

Omalizumab (XOLAIR®) is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that binds to IgE and was first introduced in Qatar in 2009. Omalizumab is used to treat moderate-to-severe allergic asthma (SAA), chronic idiopathic urticaria (CIU), and chronic rhinosinusitis with nasal polyposis (CRSwNP). In this study, we have described a proposal to investigate the outcomes and impact of the clinical use of omalizumab for the labeled indications (SAA, CIU, and CRSwNP) and other off-label indications (food allergy, dermatitis, and others) in clinical practice in Qatar...

Objective: To evaluate the efficacy and safety of omalizumab in patients with refractory allergic asthma using meta-analysis. Methods: We searched databases including PubMed, Web of Science, Embase and the website of ClinicalTrials. gov registry for randomized controlled trials (RCTs), using the search terms: ("anti-IgE" OR "anti-immunoglobulin E" OR "anti-IgE antibody" OR "omalizumab" OR "rhuMAb-E25" OR "Xolair") AND ("allergic asthma"). The time was up to September 19th 2020. Review Manager 5.4 software and Stata16 software were used to calculate pooled RR or WMD , perform heterogeneity test, and assess publication bias...

BACKGROUND: Oxaliplatin hypersensitivity reactions (HSRs) are immunoglobulin E (IgE)-mediated and prevent maximum benefit from this drug. This study was designed to determine whether oxaliplatin HSRs could be prevented or reduced with omalizumab (Xolair), an anti-IgE antibody. PATIENTS/METHODS: This was a single-arm prospective pilot study. Patients receiving oxaliplatin-based chemotherapy for gastrointestinal cancers who were experiencing grade 1/2 HSRs were eligible...

Background: Combining a fraction of exhaled nitric oxide (FeNO) and blood eosinophil count (B-EOS) may be a useful strategy for administration of biologics such as anti-IgE or anti-IL-5 to patients with type 2 inflammatory-predominant severe asthma and is important to be elucidated considering the increasing use of biologics. Methods: This cross-sectional study analyzed the clinical data from 114 adult patients with severe asthma, who were treated at Saitama Medical University Hospital. The eligible patients were stratified into four subgroups defined by thresholds of FeNO and blood eosinophil (B-EOS) counts to detect sputum eosinophilia, using the receiver operating characteristic curve analysis...

The role of IgE autoantibodies has been demonstrated in the pathogenesis of bullous pemphigoid for many years. Recently, omalizumab (OMZ), a humanized monoclonal anti-IgE antibody that depletes total serum IgE, has been used off-label in a few case series of bullous pemphigoids demonstrating a rapid efficacy and allowing significant improvements or complete remission as add-on therapy in first-line treatment-resistant patients. Herein, we report the largest retrospective study to evaluate OMZ effectiveness in patients with subepidermal autoimmune blistering diseases...

Bullous pemphigoid (BP) is an autoimmune blistering skin disease. Current treatment strategies are limited by their efficacy and/or side effect profile and the need for safer and effective alternatives is undeniable. We aimed to conduct a systematic review focusing on the efficacy and safety of omalizumab in BP patients. Embase, PubMed, Cochrane, and clinicaltrials.gov were searched for English and French articles published from inception to July 1, 2021, using search terms "omalizumab" OR "Xolair" OR "IGE025" OR "olizumab" AND "bullous pemphigoid...

Background: Real-world studies on the allergen specific immunotherapy (AIT), omalizumab, and dupilumab associated anaphylactic events are limited. We aimed to analyze the characteristics of drug associated anaphylaxis, and to compare the differences among different drugs. Methods: A disproportionality analysis and Bayesian analysis were used in data mining to identify suspected anaphylaxis associated with AIT, omalizumab, and dupilumab based on the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from January 2004 to March 2021...

The anti-immunoglobulin E (IgE) antibody, omalizumab (Xolair), is approved in the United States for the treatment of allergic asthma and chronic spontaneous urticaria, and has recently been studied for the treatment of nasal polyposis following completion of the two replicate phase 3 studies (POLYP 1 and POLYP 2). The dosing of omalizumab used in the phase 3 studies is based on a combination of patients' pre-treatment IgE level and body weight, similar to the approach used in allergic asthma. The objectives of the current analyses were to evaluate whether the pharmacokinetics (PK) of omalizumab and its pharmacodynamic (PD) effect on free and total IgE level in chronic rhinosinusitis with nasal polyps (CRSwNP) are consistent with those in allergic asthma via population PK/PD modeling and simulation, and to graphically explore exposure-response relationships and free IgE-response relationships in CRSwNP...

Urticaria is a common group of dermatologic disorders characterized by hives. Solar urticaria and heat urticaria are two rare types of chronic inducible urticarias. Solar urticaria is triggered by exposure to sunlight or ultraviolet radiation. Heat urticaria is triggered by exposure or contact with a heat stimulus. A 63-year-old woman is described who has both solar urticaria and heat urticaria and the features of these chronic inducible urticarias are reviewed. The woman presented with urticarial lesions that appeared both after exposure to the sun and after cooking at a stove...

BACKGROUND: Omalizumab is currently approved for the treatment of moderate-to-severe allergic asthma in patients 6 years and older. OBJECTIVE: To assess the effectiveness and safety of subcutaneous omalizumab as an add-on therapy option for moderate-severe allergic asthma in patients aged 6-20 years old. METHODS: The studies published from July, 1970 to May, 2021 were searched from the electronic databases which followed keywords: ("anti-IgE" OR "anti-immunoglobulin E" OR "anti-IgE antibody" OR "omalizumab" OR "rhuMAb-E25" OR "Xolair") AND "asthma" AND ("child" OR "children" OR "adolescents" OR "youth" OR "teenager" OR "kids" OR "pediatric")...