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Omalizumab

Omalizumab is a monoclonal antibody used to treat moderate to severe asthma.
It works by binding to and inactivating immunoglobulin E (IgE), a key mediator in the inflammatory response underlying asthma.
Omalizumab has been shown to reduce asthma exacerbations, improve lung function, and decrease the need for corticosteroid medications.
It is typically administered subcutaneouslly every 2 to 4 weeks.
Omalizumab is an importannt therapeutic option for patients with difficult-to-control asthma who remain symptomatic despite inhaled corticosteroid and long-acting bronchodilator treatment.

Most cited protocols related to «Omalizumab»

In this genome-wide association study, we used a two-stage design to identify novel and significant genome-wide associations that confer susceptibility to moderate-to-severe asthma. We used a two-stage case-control design, with variants that showed suggestive association (p<1 × 10−6) in stage 1 tested in stage 2 and then meta-analysed across the two stages to maximise power.
For stage 1, we selected individuals of European ancestry with moderate-to-severe asthma who had been recruited from primary and secondary care settings across the UK as part of the Genetics of Asthma Severity and Phenotypes (GASP) initiative, with additional cases included from the U-BIOPRED asthma cohort26 (link) and the UK Biobank May, 2015,27 , 28 (link) genetic data release (appendix). Genotyped data were assessed for quality control (details are in the appendix). From GASP and U-BIOPRED, we identified patients with moderate-to-severe asthma by assessing clinical records that indicated that a patient was taking medication required for patients defined as having moderate-to-severe asthma according to the British Thoracic Society (BTS) 2014 guidelines.29 From the UK Biobank, cases of moderate-to-severe asthma were defined as having asthma diagnosed by a doctor, taking medication for asthma, no diagnosis of emphysema or chronic bronchitis by a doctor, and meeting the definition of moderate-to-severe asthma by BTS criteria. Therefore, cases were selected from individuals for whom medication information was available and who met BTS stage 3–5 criteria—ie, for stage 3, taking a long-acting β2 agonist plus inhaled corticosteroid; stage 4, taking higher dose inhaled corticosteroids than stage 3 patients, and addition of a fourth drug (eg, leukotriene receptor antagonist, theophylline); and stage 5, taking oral corticosteroid or omalizumab, or both. A complete list of medications used to identify patients with moderate-to-severe asthma is in the appendix. Controls for stage 1 were identified from the UK Biobank by taking the remaining subjects for whom genotyped data were available that passed quality control and excluding individuals with asthma, rhinitis, eczema, allergy, emphysema, or chronic bronchitis as diagnosed by a doctor, or if medication data were not available to assign to either the mild-moderate or moderate-severe asthma group. Additional controls for stage 1 were included from U-BIOPRED to ensure we had controls from each cohort. Patients in the U-BIOPRED cohort had not been screened for rhinitis or eczema, and so this information was not available for these controls at time of selection. For stage 2, both cases and controls were selected from the UK Biobank May, 2017, release using the same criteria to define cases and controls as in stage 1. There was no overlap in the patients included in stage 1 and stage 2. A case-control ratio of 1:5 was chosen for both stages to balance power and computational time. Cases and controls were matched across age and sex strata, and in stage 1 across genotyping arrays. All cohorts included individuals with self-reported European ancestry; individuals of non-European ancestry were excluded to reduce confounding of the study by ancestry.
UK Biobank has ethical approval from the UK National Health Service (NHS) National Research Ethics Service (Ref 11/NW/0382). All other studies were approved by an appropriate ethics committee. Informed consent was obtained from all participants.
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Publication 2019
Adrenal Cortex Hormones Asthma Bronchitis, Chronic Eczema Emphysema Ethics Committees Europeans Genome Genome-Wide Association Study Hypersensitivity Leukotriene Antagonists Omalizumab Patients Pharmaceutical Preparations Phenotype Physicians Reproduction Rhinitis Secondary Care Susceptibility, Disease Theophylline
The Inner-City Anti-IgE Therapy for Asthma (ICATA) Study was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial of omalizumab in 419 inner-city children, adolescents, and young adults (6 to 20 years of age) with persistent allergic asthma. A physician’s diagnosis of asthma or documentation of symptoms of asthma for more than 1 year before study entry was required. Patients receiving long-term therapy for disease control were also required to have symptoms of persistent asthma or evidence of uncontrolled disease as indicated by hospitalization or unscheduled urgent care in the 6 to 12 months preceding study entry. Those not receiving long-term control therapy were eligible for enrollment only if they had both persistent symptoms and uncontrolled asthma. In addition, all patients were required to have at least one positive skin test for a perennial allergen, to weigh between 20 and 150 kg, and have total serum levels of IgE between 30 and 1300 IU per milliliter.
The protocol, which includes the statistical analysis plan, was approved by the institutional review boards of all participating institutions and is available with the full text of this article at NEJM.org. Written informed consent was obtained from each participant or the participant’s parent or legal guardian. Participants who were younger than 18 years of age provided assent.
Publication 2011
Adolescent Allergens anti-IgE Asthma Child Diagnosis Ethics Committees, Research Hospitalization Legal Guardians Omalizumab Parent Patients Physicians Placebos Serum Test, Skin Therapeutics Young Adult Youth

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Publication 2014
Antibiotics Azathioprine Biological Factors Cetirizine Clemastine Cyclosporins Dermatitis, Atopic Dermatitis, Atopic, 2 Diagnosis Eczema Etanercept fexofenadine Histamine Antagonists Immunomodulation immunomycin Immunosuppressive Agents Infliximab Interferon Type II Intravenous Immunoglobulins Leukotrienes Loratadine Methotrexate Microbicides montelukast Mycophenolate Mofetil Olopatadine Omalizumab Papaverine Patients Photochemotherapy Phototherapy Physicians, Family physiology pimecrolimus Prednisolone Prednisone Primary Health Care Prognosis Tacrolimus Terfenadine Theophylline Tumor Necrosis Factor Inhibitors zafirlukast
We fed mice autoclaved water +/− ampicillin (0.5 mg ml−1), gentamicin (0.5 mg ml−1), metronidazole (0.5 mg ml−1), neomycin (0.5 mg ml−1), and vancomycin (0.25 mg ml−1) continuously via water bottle for four weeks. In the event of poor animal hydration, we supplemented control and antibiotic water with artificial sweetener. We conventionalized germ–free mice by housing with conventionally–reared mice for 4–8 weeks. We inoculated mice intranasally on D–17, D–14, D–7 with 50 μl of PBS +/− 100 μg of D. pteronyssinus extract (Greer)25 (link). We injected mice subcutaneously in contralateral footpads with 50 μl of PBS +/− 50 μg of papain (Calbiochem)28 (link) and sacrificed on D3 or D4 post injection for basophil or TH2 cell analyses. We treated mice by intraperitoneal injection (i.p.) with 10 μg of MAR1 or isotype antibody (eBioscience) on D–3, –2, –1. We treated littermate control or BaS–TRECK mice i.p with 750 ng DT on D–2 and D0. We treated Rag1−/− mice i.p. with 50 μg of IgG or IgE antibody (BD Bioscience) daily for seven days. We treated mice i.p. with 200 μg of control IgG or Omalizumab (IgE–specific) antibody (Genentech) daily for 7–9 days. We treated mice i.p. weekly with 100 μl of PBS containing 100 μg of GpC–Phos (5’-ZOOFZEFEOZZOOZEFEZOZT-3’) or CpG–Phos (5’-ZOOFZEFOEZZOOZEFOEZZT-3’).
Publication 2012
Ampicillin Animals Antibiotics Artificial Sweeteners Basophils Dermatophagoides pteronyssinus Gentamicin Immunoglobulin Isotypes Immunoglobulins Injections, Intraperitoneal Metronidazole Mice, House Neomycin Omalizumab Papain RAG-1 Gene Type-2 Helper T Cell Vancomycin
The primary outcome was response to omalizumab treatment at T4–6 compared with T−12 using three criteria.
1) The physician's overall evaluation according to the Global Evaluation of Treatment Effectiveness (GETE) scale. GETE is a five-point scale, where 1=excellent (complete control of asthma), 2=good (marked improvement), 3=moderate (discernible, but limited improvement), 4=poor (no appreciable change) and 5=worsening. The rating of symptoms control as “excellent”/“good” or “moderate”/“poor”/“worsening” allowed the patient to be defined as a “responder” or “nonresponder”, respectively.
2) A decrease in the annual exacerbation rate, with a “responder” defined as having a reduction in the annual exacerbation rate of ≥40%. An asthma exacerbation was defined as a significant worsening of asthma requiring a short burst of oral corticosteroids (OCSs) or, for patients treated with an OCS, an increase in the OCS dose regimen. The annual exacerbation rate was calculated by adjusting the number of exacerbations according to the duration of exposure to omalizumab treatment; treatment duration was 4–6 months for all patients and 12 months for 706 patients (81%).
3) A combination of the GETE evaluation and a ≥40% reduction in the annual exacerbation rate (“combined response”).
Response was analysed according to blood eosinophil count (cells·µL−1) measured in the year prior to omalizumab initiation (last measurement available prior to initiation).
Publication 2018
Adrenal Cortex Hormones Asthma Cells Eosinophil Omalizumab Patients Treatment Protocols

Most recents protocols related to «Omalizumab»

To understand the role of framework mutations on Ab structure and dynamics, we investigated the behavior of the fragment antigen-binding (Fab) region of five mature Abs (Atezolizumab, Daratumumab, Omalizumab, Pertuzumab, and Trastuzumab) both with and without GL-reverting mutations (herein, referred to as control Abs). This allowed us to parse out the effects of key single- and double-point mutations along the evolutionary trajectories of the clinically-relevant Abs of interest. Mutations are annotated throughout the text using the IMGT numbering scheme (e.g., X100Y, where X mutates to Y). The mutations were chosen based upon our previously-published (12 (link)) position specific scoring matrix (PSSM) for human Ab repertoires (Table S1), and were selected to include both high and low probabilities in the PSSM as well as a range of amino acid types.
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Publication 2023
Amino Acids atezolizumab Biological Evolution daratumumab Homo sapiens Immunoglobulins, Fab Mutation Omalizumab pertuzumab Point Mutation Trastuzumab
A total of 136 patients with asthma were prospectively enrolled at Ajou University Hospital (Suwon, South Korea). Asthma was diagnosed according to the Global Initiative for Asthma guideline (GINA) 2022 by the allergy specialists.1 Asthmatics were classified into three groups according to their symptom control status: UA, partly‐controlled asthma (PA), and well‐controlled asthma (CA). Exclusion criteria for enrollment were as follows: (1) asthmatics who had been treated with biologics, including omalizumab, mepolizumab, reslizumab, and dupilumab within 130 days of enrollment; (2) current smokers or ex‐smokers who quit smoking within 30 days of enrollment; and (3) asthmatics whose controller medications were changed within 7 days of enrollment.
AERD was defined by a typical clinical history (recurrent exacerbation of upper or lower respiratory reactions after ingestion of NSAIDs/aspirin) and/or a positive response to the lysine‐aspirin bronchial provocation test (Lys‐ASA BPT). The Lys‐ASA BPT was performed with increasing doses of Lys‐ASA solution up to 300 mg/ml using the method previously reported.18 The Lys‐ASA BPT result was considered positive if forced expiratory volume in one second (FEV1)% was decreased by more than 20% after the challenge. ATA was defined when subjects showed negative results to the Lys‐ASA BPT or denied any upper or lower respiratory tract symptom changes after ingestion of NSAIDs/aspirin. Asthma control status was evaluated according to the GINA guideline,1 asthma control test (ACT), and asthma control questionnaire (ACQ‐6: ACQ mean of six individual item scores).19 UA was defined when ACT ≤ 19 or ACQ ≥ 1.5.1 SA was diagnosed according to the definition of international European respiratory society/American thoracic society guidelines.20 Eosinophilic asthma was defined as the PEC ≥ 300/μl.
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Publication 2023
acetylsalicylic acid lysinate Anti-Inflammatory Agents, Non-Steroidal Aspirin Asthma Biological Factors Bronchial Provocation Tests dupilumab Eosinophil Europeans Ex-Smokers Hypersensitivity mepolizumab Omalizumab Patients Pharmaceutical Preparations reslizumab Respiratory Rate Signs and Symptoms, Respiratory Specialists Volumes, Forced Expiratory
Adult patients suffering from CU at the Urticaria Clinic of the Department of Dermatology of Hospital del Mar (Barcelona, Spain) were included in the study. Specifically, we included patients with CSU with disease duration of more than 3 months and with an urticaria activity score (UAS7) defined at least as moderate (UAS7 ≥ 16; itch ≥ 8). In the case of pure CIndU, a positive result for each standardized provocation test was required. For CSU, the UAS7 and the urticaria control test (UCT) were used to validate patient reported outcomes and to assess efficacy of the treatment. For CIndU, besides the UCT, specific thresholds, as defined in the guidelines,13 were assessed at baseline and after 6 months of treatment. Treatment included second generation H1‐antihistamines combined with anti‐IgE (omalizumab) therapy to establish the control of the disease. In total, 44 patients were included (22 with CSU and 22 with CIndU).
Peripheral blood samples from patients with CU were analyzed before the initiation of omalizumab therapy to assess both total IgE serum levels and the FcεR1a expression on blood basophils. According to their clinical response to omalizumab, IgE and FcεR1a receptor expression on blood basophils, patients were classified as responders or non‐responders to anti‐IgE therapy using thresholds previously established.9, 11 CSU patients who were clinically non‐responders to omalizumab despite increasing the dose of the drug up to 600 mg, did not obtain a UAS7 <16, UCT > 12, and did not reduce their baseline UAS7 after 6 months of treatment. The dose of omalizumab was increased after the third administration due to not achieving a goal of reducing UAS7 to <16, UCT > 12, or a reduction in UAS7 after the third administration. CIndU patients non‐responders to omalizumab did not obtained UCT > 12 despite increasing the dose of the drug up to 600 mg. The dose of omalizumab was increased after the third administration if the goal of UCT>12 was not obtained.
In addition, peripheral blood samples from a control group of 22 sex‐equivalent healthy adult controls (HCs) with no family or personal history of allergic asthma, allergic rhinitis, CU, or atopic dermatitis were included as reference.
Exclusion criteria for study participation were: <18 years old, concomitant treatment with immunosuppressive agents and/or corticosteroids, and chronic pruritic diseases.
The present study has been carried out in accordance with The Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans. The local Clinical Research Ethics Committee granted ethical approval for the study (approval no. 2018/7915/I). Signed informed consent was obtained from all participants.
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Publication 2023
Adrenal Cortex Hormones Adult anti-IgE Asthma Basophils BLOOD Chronic Inducible Urticaria Dermatitis, Atopic Disease, Chronic Grouping, Blood Histamine H1 Antagonists, Non-Sedating Homo sapiens Immunosuppressive Agents Omalizumab Patients Pharmaceutical Preparations Pruritus Regional Ethics Committees Rhinitis, Allergic Serum Urticaria
We performed a retrospective analysis of data from a prospective observational cohort study (MUPPITS1)17 (link) and validated our findings with data from a randomised, double-blind, placebo-controlled trial in an independent cohort (ICATA).18 (link)The MUPPITS1 study was a longitudinal observational study of 208 children with exacerbation-prone asthma in low-income urban centres, who were followed up between 2015 and 2017 for respiratory illnesses. This study has previously been described elsewhere.17 (link) Briefly, participants were recruited between Oct 7, 2015, and Oct 18, 2016, across hospital clinics in major urban areas in nine US cities. An individual was eligible for enrolment if they were aged 6–17 years; were diagnosed with asthma by a clinician more than 1 year before recruitment; had at least two asthma exacerbations (ie, required systemic corti costeroids or hospital admission, or both) in the year before recruitment; were treated with at least one puff of fluticasone 250 μg twice daily, or its equivalent for children aged 6–11 years, or treated with at least one puff of fluticasone 250 μg plus salmeterol 50 μg twice daily, or its equivalent for children aged 12 years and older; had more than or equal to 150 peripheral blood eosinophils per mm3; did not smoke; and lived in a census tract with a density of more than or equal to 1000 families per square mile and with at least 10% of families with income below the poverty level (based on American Community Survey data19 ). Participants were identified for recruitment through the Registry for Asthma Characterization and Recruitment 2 and site-approved recruitment sources (NCT02513264). Participants were followed up prospectively for up to two respiratory illnesses or approximately 6 months, whichever occurred first. Participants who reported a respiratory illness were asked to return to the clinic twice in the 6-day period after the start of symptoms for collection of nasal samples and pulmonary function testing. Each illness was defined as a viral (V+) or non-viral (V–) event on the basis of virological assessment of the first nasal blow sample by use of the Luminex Respiratory Viral Panel (Luminex, Austin, TX, USA), with (Ex+) or without an asthma exacerbation (Ex–) on the basis of whether the participant was treated with systemic corticosteroids within 10 days following the onset of the respiratory event or not (appendix p 11). The last study visit occurred on Jan 6, 2017.
The ICATA study was a randomised, double-blind, placebo-controlled trial of omalizumab conducted from 2006 to 2009 in 419 inner-city children, adolescents, and young adults (ie, aged 6–20 years) with persistent allergic asthma, as previously described.18 (link) Briefly, participants were enrolled between Oct 23, 2006, and March 25, 2008, across hospital clinics in major urban areas in eight US cities. An individual was eligible for enrolment if they were aged 6–20 years; were diagnosed with asthma by a clinician more than a year before recruitment or diagnosed with asthma and had symptoms for longer than 1 year; had bodyweight and total serum IgE suitable for omalizumab dosing and a positive skin-prick test to at least one perennial allergen; did not smoke; and lived in a census tract with a density of more than or equal to 1000 families per square mile with and at least 10% of families with income below the poverty level. In an exploratory substudy of 189 of 419 participants in four of eight US cities (ie, New York, NY, Chicago, IL, Dallas, TX, and Cleveland, OH), 100 nasal samples were collected within 7 days of the onset of an asthma exacerbation (ie, required systemic corticosteroids; Ex+) and 165 nasal samples were collected at study week 48 in the absence of an exacerbation. The last study visit occurred on Dec 30, 2009. The nasal samples were used for virological assessment by use of the Eragen Multi-Code Respiratory Virus Panel (Eragen Biosciences, Madison, WI, USA) and defined as V+ or V–(appendix pp 12–13).
In this analysis, we included participants from the MUPPITS1 cohort who reported a respiratory event at some point during the follow-up and participants from the ICATA cohort who had nasal samples collected due to a respiratory event or at a scheduled visit. Sex was self-reported by participants, with the options of male or female.
The MUPPITS1 and ICATA protocols were approved by the Inner-City Asthma Consortium steering committee, protocol review committee, and data safety monitoring board. The MUPPITS1 protocol20 was reviewed by a single institutional review board, and the ICATA protocol21 was reviewed by the institutional review boards of all participating institutions. Written informed consent for the MUPPITS1 and ICATA studies was obtained from the parents or legal guardians of all participants and applies to this analysis.
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Publication 2023
Adolescent Adrenal Cortex Hormones Allergens Asthma austin Body Weight Child Clinical Trials Data Monitoring Committees Cocaine Eosinophil Ethics Committees, Research Fluticasone Fluticasone Salmeterol Legal Guardians Males Nose Omalizumab Parent Placebos POU3F2 protein, human Respiratory Rate Serum Smoke Specimen Collection Test, Skin Virus Woman Young Adult
This study included 113 patients aged over 18 years and of Caucasian origin diagnosed with SUA according to GEMA 5.1 criteria, recruited in the Respiratory Medicine Department of the Hospital Universitario Virgen de las Nieves de Granada (Spain) between March 2007 and April 2022. Out of the 113 patients recruited, the response was evaluated in 110 patients treated with omalizumab, prior to beginning treatment and when 12 months had elapsed from the start of the biological therapy. The administration route of the drug was subcutaneous, with doses of 75 mg to 600 mg, depending on the initial IgE concentration and the patient’s weight, every 2 or 4 weeks [37 ]. The remaining patients did not meet the study’s evaluation criteria.
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Publication 2023
Caucasoid Races Omalizumab Patients Therapies, Biological

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More about "Omalizumab"

Omalizumab, a monoclonal antibody medication, is an effective treatment option for patients with moderate to severe asthma who continue to experience symptoms despite using inhaled corticosteroids and long-acting bronchodilators.
By binding to and inactivating immunoglobulin E (IgE), a key mediator in the inflammatory response underlying asthma, Omalizumab (also known as Xolair) helps reduce asthma exacerbations, improve lung function, and decrease the need for corticosteroid medications.
This subcutaneously administered medication is typically given every 2 to 4 weeks and is an important therapeutic choice for individuals with difficult-to-control asthma.
Researchers can optimize Omalizumab studies by utilizing resources like PubCompare.ai, which can enhance reproducibility and accuracy by locating relevant protocols from literature, pre-prints, and patents, and leveraging AI-driven comparisons to identify the best Omalizumab protocols and products.
Tools like the Guava easyCyte flow cytometer and SAS version 9.4 software can also support Omalizumab research and analysis.
By incorporating these insights and resources, researchers can improve the quality and impact of their Omalizumab-related studies.