Omalizumab In Severe Allergic Asthma Research Articles

Effectiveness of Omalizumab in Severe Allergic Asthma: A Retrospective UK Real-World Study

Objective. The aim of this study was to evaluate the “real world” effects of the monoclonal antibody omalizumab (OMB) when used to treat severe persistent allergic asthma in UK clinical practice. Methods. A 10-center retrospective observational study was carried out to compare oral corticosteroid (OCS) use and exacerbation frequency in 12 months pre- versus post-OMB initiation in 136 patients aged ≥12 years with severe persistent allergic asthma. All patients received ≥1 dose of OMB. Patients who had received OMB in a clinical trial were excluded. Data were obtained from hospital and if necessary general practitioners’ (GPs’) records on OCS use, lung function, hospital resource use, and routinely used quality of life (QoL) measures at baseline (pre-OMB), 16 weeks, and up to 12 months post-OMB initiation. Results. Mean total quantity of OCS prescribed per year decreased by 34% between the 12 months pre- and post-OMB initiation. During the 12 months post-OMB initiation, 87 patients (64%) stopped/reduced OCS use by 20% or more and 66 (49%) stopped OCS completely. Mean percent predicted forced expiratory volume in one second (FEV1) increased from 66.0% at baseline to 75.2% at week 16 of OMB therapy. The number of asthma exacerbations decreased by 53% during the 12 months post-initiation. Accident and emergency visits reduced by 70% and hospitalizations by 61% in the 12 months post-OMB initiation. Conclusion. This retrospective analysis showed a reduction in exacerbations and improved QoL as per previous studies with OMB. However, the total reduction in annual steroid burden and improved lung function in this severely ill group of patients taking regular or frequent OCS is greater than that seen in previous trials.

MUC5B and Pulmonary Fibrosis, Omalizumab for Severe Allergic Asthma, and Interstitial Lung Abnormalities in Smokers with Emphysema

MUC5B and Pulmonary Fibrosis, Omalizumab for Severe Allergic Asthma, and Interstitial Lung Abnormalities in Smokers with Emphysema

Omalizumab Reduces Corticosteroid Use in Patients with Severe Allergic Asthma: Real-Life Experience in Israel

Objective. Approved by the FDA in 2003, omalizumab is the first recombinant humanized monoclonal anti-immunoglobulin E antibody developed for the treatment of allergic asthma. Due to the heterogeneity of asthma symptoms, investigation of the efficacy of omalizumab in patients outside controlled trials is particularly important. The purpose of the current study was to evaluate the efficacy of omalizumab as an add-on treatment for allergic asthma in a real-life setting in Israel. Methods. This was a retrospective study based on patient records and computerized database for drug dispensing, emergency room visits, and hospital admissions. Results. The sample comprised 33 individuals (18 men, 15 women; mean age 50.0 ± 12.2, range 25–79) who were treated with omalizumab for severe allergic asthma for a duration of at least 16 weeks. After the initiation of omalizumab therapy, the number of patients who used oral or injected corticosteroids decreased (p < .003, .03, respectively), as did the median dosage of oral corticosteroids (p < .02). Visits to the emergency room decreased from an incidence of 0.526 visits per person-year to an incidence of 0.246 per person-year (p < .05). No adverse reactions to omalizumab were observed. Conclusion. Omalizumab as an add-on therapy reduced the use of corticosteroids and improved the control of asthma, as evidenced by reduced asthma-related emergency room visits. This study supports both controlled and uncontrolled studies that have demonstrated the efficacy and safety of omalizumab, and particularly those that demonstrated effectiveness among severe asthma patients. “Real-life” studies are important to identify patients who will most benefit from omalizumab therapy.

P108 Omalizumab for severe allergic asthma: cost-effective or priceless?

BackgroundOmalizumab is licensed for the treatment of severe allergic asthma to help reduce severe exacerbations. However the decision as to whether to consider Omalizumab therapy is based on a 16...

Omalizumab for severe allergic asthma: cost effective all round?

Omalizumab for severe allergic asthma: cost effective all round?

Omalizumab in Severe Allergic Asthma Inadequately Controlled With Standard Therapy

Inhaled corticosteroids (ICS) and long-acting β(2)-agonists (LABAs) are recommended in patients with asthma that is not well-controlled; however, many patients continue to have inadequately controlled asthma despite this therapy. To evaluate the efficacy and safety of omalizumab in patients with inadequately controlled severe asthma who are receiving high-dose ICS and LABAs, with or without additional controller therapy. Prospective, multicenter, randomized, parallel-group, double-blind, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00314575). 193 investigational sites in the United States and 4 sites in Canada. 850 patients aged 12 to 75 years who had inadequately controlled asthma despite treatment with high-dose ICS plus LABAs, with or without other controllers. Omalizumab (n = 427) or placebo (n = 423) was added to existing medication regimens for 48 weeks. The primary end point was the rate of protocol-defined exacerbations over the study period. Secondary efficacy end points included the change from baseline to week 48 in mean daily number of puffs of albuterol, mean total asthma symptom score, and mean overall score on the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]). Safety end points included the frequency and severity of treatment-emergent adverse events. During 48 weeks, the rate of protocol-defined asthma exacerbations was significantly reduced for omalizumab compared with placebo (0.66 vs. 0.88 per patient; P = 0.006), representing a 25% relative reduction (incidence rate ratio, 0.75 [95% CI, 0.61 to 0.92]). Omalizumab improved mean AQLQ(S) scores (0.29 point [CI, 0.15 to 0.43]), reduced mean daily albuterol puffs (-0.27 puff/d [CI, -0.49 to -0.04 puff/d]), and decreased mean asthma symptom score (-0.26 [CI, -0.42 to -0.10]) compared with placebo during the 48-week study period. The incidence of adverse events (80.4% vs. 79.5%) and serious adverse events (9.3% vs. 10.5%) were similar in the omalizumab and placebo groups, respectively. The results are limited by early patient discontinuation (20.8%). The study was not powered to detect rare safety events or the treatment effect in the oral corticosteroid subgroup. In this study, omalizumab provided additional clinical benefit for patients with severe allergic asthma that is inadequately controlled with high-dose ICS and LABA therapy. Genentech and Novartis Pharmaceuticals.

Understanding the pathophysiology of severe asthma to generate new therapeutic opportunities

Although asthma is defined in terms of reversibility of airflow obstruction, as the disease becomes more severe and chronic, it adopts different characteristics, including a degree of fixed airflow obstruction and corticosteroid refractoriness. Underlying these phenotypes is evidence of airway wall remodeling, which should be distinguished from the increase in smooth muscle linked to airways hyperresponsiveness. Aberrant epithelial-mesenchymal communication leads to a chronic wound scenario, which is characterized by activation of the epithelial-mesenchymal trophic unit, epithelial damage, the laying down of new matrix, and greater involvement of neutrophils in the inflammatory response. In allergic asthmatic patients who remain symptomatic despite high-dose corticosteroid therapy, blockade of IgE with omalizumab confers appreciable clinical benefit. Chronic severe asthma is also accompanied by a marked increase in TNF-alpha production that might contribute to corticosteroid refractoriness. Based on this, TNF blockade with the soluble fusion protein entanercept produces improvement in asthma symptoms, lung function, and quality of life paralleled by a marked reduction in airways hyperresponsiveness. Identification of novel susceptibility genes, such as a disintegrin and metalloprotease 33 (ADAM33), will provide further targets against which to direct novel therapies for asthma, especially at the more severe end of the disease spectrum.