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https://www.readbyqxmd.com/read/27826098/a-randomized-multicenter-study-evaluating-xolair%C3%A2-persistency-of-response-after-long-term-therapy-xport
#1
Dennis Ledford, William Busse, Benjamin Trzaskoma, Theodore A Omachi, Karin Rosén, Bradley E Chipps, Allan T Luskin, Paul G Solari
BACKGROUND: Few data are available to assist clinicians with decisions regarding long-term use of asthma therapies, including omalizumab. OBJECTIVE: To evaluate the benefit and persistency of response in subjects continuing or withdrawing from long-term omalizumab treatment. METHODS: Evaluating the Xolair® Persistency Of Response After Long-Term Therapy (XPORT) was a randomized, double-blind, placebo-controlled withdrawal study that included subjects with moderate-to-severe persistent asthma receiving long-term omalizumab...
November 5, 2016: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/27742181/omalizumab-treatment-response-in-a-severe-allergic-asthma-population-with-overlapping-copd
#2
Steven Maltby, Peter G Gibson, Heather Powell, Vanessa M McDonald
BACKGROUND: Asthma and chronic obstructive pulmonary disease (COPD) are common airway diseases. Individuals with overlapping asthma and COPD experience increased health impairment and severe disease exacerbations. Efficacious treatment options are required for this population. Omalizumab (anti-IgE) therapy is effective in patients with severe, persistent asthma, but limited data are available on efficacy in populations with overlapping asthma and COPD. METHODS: Data from the Australian Xolair Registry (AXR) was used to compare treatment responses in individuals with asthma-COPD overlap to severe asthma alone...
October 11, 2016: Chest
https://www.readbyqxmd.com/read/27609658/omalizumab-facilitates-rapid-oral-desensitization-for-peanut-allergy
#3
Andrew J MacGinnitie, Rima Rachid, Hana Gragg, Sara V Little, Paul Lakin, Antonella Cianferoni, Jennifer Heimall, Melanie Makhija, Rachel Robison, R Sharon Chinthrajah, John Lee, Jennifer Lebovidge, Tina Dominguez, Courtney Rooney, Megan Ott Lewis, Jennifer Koss, Elizabeth Burke-Roberts, Kimberly Chin, Tanya Logvinenko, Jacqueline A Pongracic, Dale T Umetsu, Jonathan Spergel, Kari C Nadeau, Lynda C Schneider
BACKGROUND: Peanut oral immunotherapy is a promising approach to peanut allergy, but reactions are frequent, and some patients cannot be desensitized. The anti-IgE medication omalizumab (Xolair; Genentech, South San Francisco, Calif) might allow more rapid peanut updosing and decrease reactions. OBJECTIVE: We sought to evaluate whether omalizumab facilitated rapid peanut desensitization in highly allergic patients. METHODS: Thirty-seven subjects were randomized to omalizumab (n = 29) or placebo (n = 8)...
September 5, 2016: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/27377155/real-life-effectiveness-of-omalizumab-in-severe-allergic-asthma-above-the-recommended-dosing-range-criteria
#4
Mark Hew, Andrew Gillman, Michael Sutherland, Peter Wark, Jeff Bowden, Michael Guo, Helen K Reddel, Christine Jenkins, Guy B Marks, Frank Thien, Janet Rimmer, Gregory P Katsoulotos, Matthew Cook, Ian Yang, Constance Katelaris, Simon Bowler, David Langton, Craig Wright, Michael Bint, Veronica Yozghatlian, Scott Burgess, Pathmanathan Sivakumaran, Kwok Y Yan, Vicky Kritikos, Matthew Peters, Melissa Baraket, Ali Aminazad, Paul Robinson, Adam Jaffe, Heather Powell, John W Upham, Vanessa M McDonald, Peter G Gibson
BACKGROUND: Omalizumab (Xolair) dosing in severe allergic asthma is based on serum IgE and bodyweight. In Australia, patients eligible for omalizumab but exceeding recommended ranges for IgE (30-1500 IU/mL) and bodyweight (30-150 kg) may still receive a ceiling dose of 750 mg/4 weeks. 62% of patients receiving government-subsidised omalizumab are enrolled in the Australian Xolair Registry (AXR). OBJECTIVES: To determine if AXR participants above the recommended dosing ranges benefit from omalizumab, and to compare their response to within-range participants...
July 5, 2016: Clinical and Experimental Allergy: Journal of the British Society for Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/27358151/efficacy-and-safety-of-omalizumab-in-paediatric-age-an-update-of-literature-data
#5
N Matin, O Tabatabaie, R Falsaperla, P Pavone, A Serra, S Cocuzza, P Di Mauro, L Licciardello, R Lubrano, G Vitaliti
Immunoglobulin E (IgE) was discovered in 1966 and was found responsible for immune defense against helminths, type I hypersensitivity and allergic diseases. IgE mediates allergic responses by binding to Fc receptors (the high affinity Fc-epsilon receptor I and the low affinity Fc-epsilon receptor II or CD23) expressed on tissue mast cells and blood basophils. This binding leads to degranulation and release of pro-inflammatory mediators. Considering the pivotal role of IgE in allergic diseases, antibodies against IgE potentiate an array of new therapeutic strategies and in this regard omalizumab (rhuMAb-E25, Xolair) has been developed as a monoclonal biologic drug to block serum IgEs...
April 2016: Journal of Biological Regulators and Homeostatic Agents
https://www.readbyqxmd.com/read/27350385/effectiveness-and-response-predictors-of-omalizumab-in-a-severe-allergic-asthma-population-with-a-high-prevalence-of-comorbidities-the-australian-xolair-registry
#6
P G Gibson, H Reddel, V M McDonald, G Marks, C Jenkins, A Gillman, J Upham, M Sutherland, J Rimmer, F Thien, G P Katsoulotos, M Cook, I Yang, C Katelaris, S Bowler, D Langton, P Robinson, C Wright, V Yozghatlian, S Burgess, P Sivakumaran, A Jaffe, J Bowden, P A B Wark, K Y Yan, V Kritikos, M Peters, M Hew, A Aminazad, M Bint, M Guo
BACKGROUND: Severe asthma is a high impact disease. Omalizumab targets the allergic inflammatory pathway; however, effectiveness data in a population with significant comorbidities are limited. AIMS: To describe severe allergic asthma, omalizumab treatment outcomes and predictors of response among the Australian Xolair Registry participants. METHODS: A web-based post-marketing surveillance registry was established to characterise the use, effectiveness and adverse effects of omalizumab (Xolair) for severe allergic asthma...
September 2016: Internal Medicine Journal
https://www.readbyqxmd.com/read/27238573/ethnic-sensitivity-assessment-of-pharmacokinetics-and-pharmacodynamics-of-omalizumab-with-dosing-table-expansion
#7
Wataru Honma, Aurélie Gautier, Ines Paule, Masayuki Yamaguchi, Philip J Lowe
A three-part license expansion for omalizumab (Xolair(®)), humanized anti-IgE antibody, was recently made in Japan for paediatric use, additional higher doses and revised dosing frequency in allergic asthma. The dosing level and frequency of omalizumab are guided by a dosing table based on the total serum IgE and bodyweight. Nonlinear mixed-effect pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation techniques described the binding between omalizumab and its target IgE. The population PKPD analysis was conducted using data from the nine studies included originally in the European application of dosing table expansion together with three Japanese clinical studies to assess the influence of the ethnicity...
June 2016: Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/26747278/efficacy-of-omalizumab-xolair%C3%A2-in-patients-with-moderate-to-severe-predominately-chronic-oral-steroid-dependent-asthma-in-taiwan-a-retrospective-population-based-database-cohort-study
#8
Hao-Cheng Chen, Chien-Da Huang, Erin Chang, Han-Pin Kuo
BACKGROUND: Omalizumab (Xolair®), a recombinant monoclonal anti-IgE antibody, has demonstrated efficacy in clinical trials conducted in patients with moderate to severe persistent allergic asthma. We aimed to investigate the efficacy, discontinuation and medical resource utilization of omalizumab in the real-life setting in Taiwan. METHODS: This study was a retrospective, population-based database cohort study using the Taiwan NHIRD from 2007 to 2011 assessing the efficacy of omalizumab therapy over 4 months on changes in asthma medication, asthma control, frequency of exacerbations and hospitalization rates at baseline and after omalizumab discontinuation...
January 8, 2016: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/26436166/omalizumab-xolair-and-chronic-spontaneous-urticaria-too-many-adverse-effects-and-uncertainties
#9
(no author information available yet)
Omalizumab has only modest and transient symptomatic efficacy when an antihistamine is ineffective. Its adverse effects can be severe, and its safety during long-term use is uncertain. Omalizumab is not better than a corticosteroid.
June 2015: Prescrire International
https://www.readbyqxmd.com/read/26361716/serological-evidence-that-activation-of-ubiquitous-human-herpesvirus-6-hhv-6-plays-a-role-in-chronic-idiopathic-spontaneous-urticaria-ciu
#10
REVIEW
D H Dreyfus
Acute infection with viral pathogens in the herpesviridae family can trigger acute urticaria, and reactivation of herpesviridae is associated with cutaneous urticarial-like syndromes such as drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (DRESS). Reactivation of latent herpesviridae has not been studied systematically in chronic idiopathic/spontaneous urticaria (CIU). This review proposes that CIU is an inflammatory disorder with autoimmune features (termed 'CVU' for chronic viral urticaria), based on serology consistent with the hypothesis that reactivation of a latent herpesvirus or -viruses may play a role in CIU...
February 2016: Clinical and Experimental Immunology
https://www.readbyqxmd.com/read/26340860/evaluation-of-ige-antibodies-to-omalizumab-xolair%C3%A2-and-their-potential-correlation-to-anaphylaxis
#11
Dana L Baker, Gerald R Nakamura, Henry B Lowman, Saloumeh Kadkhodayan Fischer
Omalizumab (Xolair®) is a recombinant humanized monoclonal antibody that selectively binds to human immunoglobulin E (IgE). Omalizumab is used to treat IgE-mediated diseases such as chronic idiopathic urticaria (CIU) and moderate to severe allergic asthma. In pre-marketing clinical trials in patients with asthma, anaphylaxis was reported in 3 of 3,507 (0.1%) patients. In post-marketing spontaneous reports, the frequency of anaphylaxis attributed to omalizumab use was estimated to be at least 0.2% of patients based on an estimated exposure of about 57,300 patients from June 2003 through December 2006...
January 2016: AAPS Journal
https://www.readbyqxmd.com/read/26155196/prevalence-of-perennial-severe-allergic-asthma-in-italy-and-effectiveness-of-omalizumab-in-its-management-proxima-an-observational-2-phase-patient-reported-outcomes-study
#12
Giorgio Walter Canonica, Marta Bartezaghi, Raffaele Marino, Laura Rigoni
BACKGROUND: We designed the PROXIMA study (Patient-Reported Outcomes and Xolair(®) In the Management of Asthma) to determine the proportion of patients with severe asthma sensitive to perennial allergens, and to evaluate asthma control and treatment adherence up to 12 months in patients treated with omalizumab in Italian population. In addition, an ancillary study was designed to explore protein biomarkers and characterize them in relation to severe allergic asthma and treatment effects by proteomic approach...
2015: Clinical and Molecular Allergy: CMA
https://www.readbyqxmd.com/read/26021894/omalizumab-adherence-in-an-observational-study-of-patients-with-moderate-to-severe-allergic-asthma
#13
MULTICENTER STUDY
Susan L Janson, Paul G Solari, Benjamin Trzaskoma, Hubert Chen, Tmirah Haselkorn, James L Zazzali
BACKGROUND: Adherence to omalizumab is not well characterized and its association with asthma control has not been well established. OBJECTIVE: To evaluate adherence in patients initiating omalizumab in the Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate to Severe Asthma (EXCELS) observational study. METHODS: Adherence was assessed over 5 years using the proportion of patients who missed any dose, rates of doses missed, and proportions of patients with good (<10% doses missed) or poor (≥30% doses missed) adherence...
June 2015: Annals of Allergy, Asthma & Immunology
https://www.readbyqxmd.com/read/25632648/omalizumab-xolair-for-the-treatment-of-chronic-idiopathic-urticarial
#14
REVIEW
Noah Scheinfeld
No abstract text is available yet for this article.
September 2014: Skinmed
https://www.readbyqxmd.com/read/25566680/omalizumab-for-the-treatment-of-chronic-urticaria
#15
REVIEW
Torsten Zuberbier, Marcus Maurer
Urticaria is a common and often debilitating dermatological condition defined by the sudden appearance of wheals, angioedema or both. It is further classified into specific subtypes based on duration and specific triggers. Awareness and understanding of urticaria are important to ensure a correct initial diagnosis and initiate appropriate guideline-based treatment outlining a stepwise approach. However, in chronic urticaria, approximately 50% of patients are refractory to the first step, the use of licensed doses of second-generation H1-antihistamines...
February 2015: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/25441639/the-xolair-pregnancy-registry-expect-the-safety-of-omalizumab-use-during-pregnancy
#16
Jennifer Namazy, Michael D Cabana, Angela E Scheuerle, John M Thorp, Hubert Chen, Gillis Carrigan, Yan Wang, Joachim Veith, Elizabeth B Andrews
BACKGROUND: For many asthma medications, pregnancy safety data remains insufficient. OBJECTIVE: The omalizumab pregnancy registry, EXPECT, evaluates maternal, pregnancy, and infant outcomes after exposure to omalizumab, including incidence of congenital anomalies. METHODS: EXPECT is a prospective, observational study of pregnant women exposed to ≥1 dose of omalizumab within 8 weeks prior to conception or at any time during pregnancy. Primary outcome measures include rates of live births, elective terminations, stillbirths, and congenital anomalies...
February 2015: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/25291953/omalizumab-anti-ige-therapy-increases-blood-glucose-levels-in-severe-persistent-allergic-asthma-patients-with-diabetes-mellitus-18-month-follow-up
#17
Arzu Didem Yalcin, Reginald M Gorczynski, Aykut Cilli, Ludwig Strauss
BACKGROUND: Therapeutic anti-IgE antibodies (Xolair, omalizumab) able to reduce free IgE levels and to block the binding of IgE to Fcepsilon RI without cross-linking IgE and triggering degranulation of IgE-sensitised cells have been developed. METHODS: We had two male patients of severe persistent allergic asthma with type-2 diabetes mellitus at the ages of 57 and 52 and who had suffered a side-effect of increased blood glucose level that caused a need for an extra insulin injection to control the hyperglycemia...
2014: Clinical Laboratory
https://www.readbyqxmd.com/read/25281265/asthma-control-in-severe-asthmatics-under-treatment-with-omalizumab-a-cross-sectional-observational-study-in-italy
#18
Federica Novelli, Manuela Latorre, Letizia Vergura, Maria Filomena Caiaffa, Gianna Camiciottoli, Gabriella Guarnieri, Andrea Matucci, Luigi Macchia, Andrea Vianello, Alessandra Vultaggio, Alessandro Celi, Mario Cazzola, Pierluigi Paggiaro
Few data are available on the proportion of asthmatics achieving a good asthma control (according GINA guidelines) and on the level of airway inflammation during omalizumab treatment. The aim of this cross-sectional national observational study was to assess the level of control (according to GINA guidelines) achieved in a group of asthmatics on omalizumab treatment, and to characterize the factors that influence the lack of control. We studied 306 asthmatics under omalizumab treatment for a median of 32 months (range 4-120)...
April 2015: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/25217402/omalizumab-a-review-of-its-use-in-patients-with-chronic-spontaneous-urticaria
#19
REVIEW
Paul L McCormack
Omalizumab (Xolair(®)) is a humanized, recombinant, IgG, anti-IgE monoclonal antibody that binds to the Fc region of free IgE and prevents it from binding to its high-affinity receptor (FcεR1) on mast cells and basophils. This reduction in free IgE leads to a reduction in mast cell/basophil degranulation and the release of histamine, and to the down-regulation of FcεR1 receptors on these cells. Omalizumab does not bind to cell-bound IgE or to IgG. In well-controlled clinical trials in patients with chronic spontaneous urticaria and persistent symptoms despite background treatment with antihistamines, add-on therapy with subcutaneous omalizumab 300 mg every 4 weeks for 12 or 24 weeks significantly reduced the severity of itching, and the number and size of hives, and increased patients' health-related quality of life and the proportion of days free from angioedema compared with placebo...
September 2014: Drugs
https://www.readbyqxmd.com/read/25050054/pharmaceutical-approval-update
#20
Marvin M Goldenberg
Apremilast (Otezla) for active psoriatic arthritis, omalizumab (Xolair) for chronic idiopathic urticaria, and grass pollen allergen extract (Oralair) for grass pollen-induced allergic rhinitis with or without conjunctivitis.
June 2014: P & T: a Peer-reviewed Journal for Formulary Management
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