Omalizumab In Severe Allergic Asthma Research Articles

Specific IgE Response and Omalizumab Responsiveness in Severe Allergic Asthma.

Omalizumab has demonstrated clinical efficacy in patients with severe allergic asthma sensitized to perennial allergens and/or severe pollinosis through inhibition of IgE-dependent allergic response. When considering the "one airway, one disease" concept, sensitization to pollen could predict responsiveness to omalizumab. This study aimed to assess whether the pretreatment specific IgE response could be a predictor of responsiveness to omalizumab in severe allergic asthma sensitized to perennial allergens. In this retrospective study, 41 adult patients with severe allergic asthma sensitized to perennial allergens (27 females; mean age 59 years) who had completed 52-week omalizumab treatment were enrolled. The Global Evaluation of Treatment Effectiveness was performed, and demographic characteristics and the positive ratios of specific IgE responses classified into five subgroups (pollen, dust mite, house dust, mold, and animal dander) were compared between responders and non-responders. Multivariate logistic regression analyses were performed to identify predictors of responsiveness to omalizumab. Thirty-one patients (76%) were identified as responders. The number of sensitized aeroallergen subgroups and sensitization to pollens were significantly higher in responders than in non-responders (both p<0.05). Multivariate logistic regression analysis showed that sensitization to pollen (OR = 8.41, p = 0.02) was independently associated with the effectiveness of omalizumab. Pretreatment serum pollen-specific IgE could be a predictor of responsiveness to omalizumab.

A Pilot Study of Omalizumab to Treat Severe Allergic Asthma in South Indian Population

Background: Asthma is a respiratory disease that affects your lungs. In asthma, airways of the lungs constrict due to swelling and accumulation of mucus. Newer remedies known as targeted therapies have evolved as a result of advancements in medical research, greatly relieving these patients. The biologics used in the severe allergic asthma is Omalizumab.&#x0D; Purpose: Demonstrating the clinical efficacy of Omalizumab in severe allergic asthma by reducing exacerbation rates and increasing quality of life.&#x0D; Methods: A single-arm prospective pilot study of omalizumab in severe allergic asthma was conducted in a tertiary care hospital for the duration of one year with the help of Asthma Quality of Life Questionnaire (AQLQ).&#x0D; Results and discussions: On an initial dose of omalizumab of 150 mg in 2 vials subcutaneously every month for 6 months, among our study population, 45% of the patients had their symptoms improve more than they had with prior medications. Results show that the patient's overall score has improved by nearly 50%. This shows that omalizumab improves the quality of life of severe asthmatic patients.&#x0D; Conclusion: Patients treated with omalizumab have improved their clinical conditions and quality of life, and it can prevent exacerbations by controlling the severity of the condition.&#x0D; Keywords: AQLQ, Allergic asthma, Exacerbation, IgE, Omalizumab.

Real-Life Effectiveness of Benralizumab, Mepolizumab and Omalizumab in Severe Allergic Asthma Associated with Nasal Polyps.

Biological therapies are available for the treatment of the severe allergic asthma (SAA) with blood eosinophil count ≥ 0.3 × 109/L. Several of them also showed benefits on nasal polyps (NP), one of the most frequent comorbidities of the severe asthma, but comparative studies on their effectiveness in the association SAA-NP are currently lacking. The aim of this study is to compare the effectiveness of benralizumab, mepolizumab and omalizumab in patients with SAA-NP in real-life settings. A retrospective, observational, multicenter real-life study was realized including patients with SAA-NP treated by benralizumab, mepolizumab or omalizumab for 6months. We analysed the nasal and respiratory symptoms, the number of asthma attacks and salbutamol use/week, acute sinusitis and severe exacerbation rates, the asthma control score, the lung function parameters, the NP endoscopic score, the sinus imaging and the blood eosinophil count 6months before and after treatment. Seventy-two patients with SAA-NP were included: 16 treated by benralizumab, 21 by mepolizumab and 35 by omalizumab. After 6months of treatment, almost all studied parameters were improved (except sinus imaging) with a greater effect of omalizumab on the nasal pruritus (p = 0.001) and more benefits of benralizumab on exacerbations rate, asthma attacks per week and lung function (all p < 0.05). Benralizumab and mepolizumab were more effective to improve the NP endoscopic score and the blood eosinophil count (both p < 0.001). All three biological therapies showed effectiveness by improving asthma and nasal outcomes in patients with SAA-NP. Several differences have been found that should be confirmed by larger comparative studies.

Cost-Effectiveness Analysis of Omalizumab for Severe Allergic Asthma in Japan Using Real-World Evidence

ObjectivesOmalizumab is a recommended add-on therapy for patients with severe allergic asthma who remain uncontrolled despite treatment with standard of care (SoC). This study evaluated the cost-effectiveness of omalizumab compared with SoC applying real-world clinical outcomes in adult patients with severe allergic asthma in Japan. MethodsA validated Markov model was adapted for Japan and compared the cost-effectiveness of omalizumab as an add-on therapy to SoC versus SoC alone using the most recently updated price of omalizumab. A Japanese real-world postmarketing surveillance and a pivotal randomized clinical trial were used as inputs for clinical effectiveness. Japanese life tables and literature were accessed for mortality data and unit costs were extracted from a Japanese insurance claims database. Quality of life data were retrieved from the clinical trial. ResultsIn the base case, the incremental cost-effectiveness ratio for omalizumab add-on therapy was ¥2.85 million per quality-adjusted life-year gained (approximately €21 000; 1€ = ¥133.26) compared with SoC alone. The model appeared to be most sensitive to changes in clinically significant severe exacerbation fatality, day-to-day asthma symptom utilities for SoC, discount rates for benefits, day-to-day asthma symptom utilities for omalizumab responders, time horizon, and the annual cost of omalizumab. The results of the probabilistic sensitivity analysis showed that the probability of omalizumab being cost-effective was 93% to 98% at a threshold of ¥5 to ¥6 million (willingness-to-pay for 1 quality-adjusted life-year). ConclusionsOmalizumab add-on therapy is cost-effective compared with SoC alone in Japan in severe allergic asthma population who are uncontrolled with high-dose inhaled corticosteroid and other controllers.

Omalizumab Restores Response to Corticosteroids in Patients with Eosinophilic Chronic Rhinosinusitis and Severe Asthma.

Eosinophilic chronic rhinosinusitis (ECRS), which is a subgroup of chronic rhinosinusitis with nasal polyps, is characterized by eosinophilic airway inflammation extending across both the upper and lower airways. Some severe cases are refractory even after endoscopic sinus surgery, likely because of local steroid insensitivity. Although real-life studies indicate that treatment with omalizumab for severe allergic asthma improves the outcome of coexistent ECRS, the underlying mechanisms of omalizumab in eosinophilic airway inflammation have not been fully elucidated. Twenty-five patients with ECRS and severe asthma who were refractory to conventional treatments and who received omalizumab were evaluated. Nineteen of twenty-five patients were responsive to omalizumab according to physician-assessed global evaluation of treatment effectiveness. In the responders, the levels of peripheral blood eosinophils and fractionated exhaled nitric oxide (a marker of eosinophilic inflammation) and of CCL4 and soluble CD69 (markers of eosinophil activation) were reduced concomitantly with the restoration of corticosteroid sensitivity. Omalizumab restored the eosinophil-peroxidase-mediated PP2A inactivation and steroid insensitivity in BEAS-2B. In addition, the local inflammation simulant model using BEAS-2B cells incubated with diluted serum from each patient confirmed omalizumab’s effects on restoration of corticosteroid sensitivity via PP2A activation; thus, omalizumab could be a promising therapeutic option for refractory eosinophilic airway inflammation with corticosteroid resistance.

Real-World Effectiveness of Omalizumab in Severe Allergic Asthma: A Meta-Analysis of Observational Studies

Assessment of clinical outcomes in the real-world corroborates findings from randomized controlled trials (RCTs). This meta-analysis evaluated real-world data of omalizumab on treatment response, lung function, exacerbations, oral corticosteroid (OCS) use, patient-reported outcomes (PROs), health care resource utilization (HCRU), and school/work absenteeism at 4, 6, and 12 months after treatment. Observational studies in patients with severe allergic asthma (≥6 years) treated with omalizumab for ≥16 weeks, published from January 2005 to October 2018, were retrieved from PubMed, Embase, and Cochrane. A random-effects model was used to assess heterogeneity. In total, 86 publications were included. Global evaluation of treatment effectiveness (GETE) was good/excellent in 77% patients at 16 weeks (risk difference: 0.77; 95% confidence interval [CI]: 0.70-0.84; I2= 96%) and in 82% patients at 12 months (0.82, 0.73-0.91; 97%). The mean improvement in forced expiratory volume in 1 second was 160, 220, and 250 mL at 16 weeks, 6 months, and 12 months, respectively. There was a decrease in Asthma Control Questionnaire score at 16 weeks (-1.14), 6 months (-1.56), and 12 months (-1.13) after omalizumab therapy. Omalizumab significantly reduced annualized rate of severe exacerbations (risk ratio [RR]: 0.41, 95% CI: 0.30-0.56; I2= 96%), proportion of patients receiving OCS (RR: 0.59, 95% CI: 0.47-0.75; I2= 96%), and number of unscheduled physician visits (mean difference:-2.34, 95% CI:-3.54 to-1.13; I2= 98%) at 12 months versus baseline. The consistent improvements in GETE, lung function, and PROs, and reductions in asthma exacerbations, OCS use, and HCRU with add-on omalizumab in real-life confirm and complement the efficacy data of RCTs.

Effectiveness of omalizumab in patients with severe allergic asthma with and without chronic rhinosinusitis with nasal polyps: a PROXIMA study post hoc analysis

BackgroundA significant proportion of patients with severe asthma may also suffer from nasal polyposis, which is commonly defined as chronic rhinosinusitis with nasal polyps (CRSwNP), the presence of which may adversely affect asthma treatment outcomes. The biologic agent omalizumab is effective as add-on therapy in patients with severe allergic asthma. The aim of this post hoc analysis of the PROXIMA study was to compare the efficacy of omalizumab between patients with severe allergic asthma, with and without comorbid CRSwNP.MethodsPROXIMA was a prospective observational 2-part study conducted in Italy in adult patients with severe allergic asthma, where, in the second part, patients eligible for add-on omalizumab initiated treatment for 12 months. Patient baseline data such as comorbidities and history of exacerbations were collected. Outcomes were asthma control (Asthma Control Questionnaire [ACQ]), lung function (forced expiratory volume in 1 s [FEV1]) and exacerbation rate. The post hoc analysis compared these outcomes between the cohort with comorbid CRSwNP and the cohort without CRSwNP.ResultsOf 123 patients included in this analysis, 17 (13.8%) were in the CRSwNP cohort. There was no significant difference between cohorts in baseline clinical characteristics or in change from baseline at 12 months in ACQ values, % of predicted FEV1 or annual asthma exacerbation rate, although results were numerically in favor of the CRSwNP cohort versus the non-CRSwNP cohort. The proportion of patients who achieved an improvement in all three outcomes was numerically greater in the CRSwNP cohort (35.7% vs 23.0%).ConclusionsIn an observational real-world setting, add-on omalizumab for severe allergic asthma was effective in improving asthma control, lung function and in reducing exacerbations, including in those patients with CRSwNP.

Effectiveness of Omalizumab in Severe Allergic Asthma and Nasal Polyposis: A Real-Life Study.

Omalizumab is a human anti-IgE antibody approved for the treatment of severe allergic asthma (SAA). However, its effectiveness in SAA associated with chronic rhinosinusitis with nasal polyposis (CRSNP+) is less well documented. Objective: The aim of this study was to evaluate the real-life effectiveness of omalizumab in patients with SAA and CRSNP+ who tolerated and did not tolerate aspirin. We performed a retrospective, observational, multicenter, real-life study of patients with SAA and CRSNP+ treated with omalizumab for 6 months. Asthma outcome parameters (symptoms, number of salbutamol rescues/wk, number of moderate/severe exacerbations, Asthma Control Test score, and lung function), sinonasal outcome parameters (symptoms, number of episodes of acute rhinosinusitis, sinus computed tomography images, nasal polyps endoscopy score), and serum eosinophil levels were analyzed 6 months before and after treatment with omalizumab. Twenty-four adult patients were included (9 with documented aspirin intolerance). All respiratory parameters were significantly improved by the treatment. In parallel, a significant improvement was observed in sinonasal clinical outcomes and sinus computed tomography images, with no major effect on the nasal polyps endoscopy score. The serum eosinophil count decreased significantly after 6 months of treatment with omalizumab. Treatment of SAA with omalizumab improves the outcome of associated CRSNP+, thus supporting the concept of a "one airway disease".

The use of Omalizumab in Severe Allergic Asthma and Chronic Spontaneous Urticaria: real-life experience

The use of Omalizumab in Severe Allergic Asthma and Chronic Spontaneous Urticaria: real-life experience

Correction: Omalizumab in Severe Allergic Asthma.

Correction: Omalizumab in Severe Allergic Asthma.

Self-reported satisfaction of patients receiving omalizumab for severe allergic asthma in Malta

Treatment satisfaction is of utmost importance for ensuring adherence. Omalizumab is administered long-term if effective and well-tolerated in a hospital setting. The aim was to evaluate treatment satisfaction with omalizumab in Malta and to identify factors that may influence patients’ satisfaction.A questionnaire was distributed to all asthmatic adult patients receiving omalizumab for at least one year. The questionnaire included demographic data, dosing regimen, asthma control test and the 14-item English version of the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4. The TSQM 1.4 domain scores range from 0 to 100. Higher scores represent higher satisfaction.Our cohort included 33 patients (52% males), mean age 53.7 ± 11 years, mean baseline IgE level 510.6IU/ml, mean duration of treatment 3.8 ± 1.98 years and mean number of injections per month 4.6 ± 2.6. Median TSQM scores were as follows: graded effectiveness 78%, graded side effects 100%, graded convenience 74.2% and overall satisfaction 76%. Regression analysis showed that convenience score, effectiveness score and ACT score were significantly associated with global satisfaction.Global satisfaction scored high among the Maltese cohort of patients despite the inconvenience and side effects associated with receiving omalizumab. This is an add-on beneficial effect to the efficacy and effectiveness already been achieved with this medication.

Omalizumab in children with severe allergic disease: a case series

BackgroundCurrently, severe allergic asthma and food allergy in children represent an important public health problem with medical, psychosocial and economic impacts. Omalizumab is a humanized monoclonal anti-IgE antibody, approved for refractory allergic asthma and chronic urticaria. It has been widely used in clinical practice as add-on therapy in patients with severe uncontrolled allergic asthma. In recent years there has seen the emergence of an allergic epidemic with increasing food allergy, which represents the main cause of anaphylaxis in children. The standard of care for food allergy is strictly dietary allergen avoidance and emergency treatment, but recent clinical trials have suggested that omalizumab may have a role to play as an adjuvant to oral immunotherapy (OIT). We present a case series of patients treated at our institution with omalizumab for severe allergic asthma and food allergy.MethodsPatients received omalizumab according to a standard reference nomogram after failing standard therapies. In children with comorbid severe food allergy, omalizumab was administered in conjunction with an oral immunotherapy protocol.ResultsOmalizumab was effective in controlling symptoms of allergic asthma, allergic rhinitis and rhinosinusitis, but not eosinophilic esophagitis, while aiding successful oral desensitization of comorbid severe food allergies.ConclusionsOmalizumab appears to be an excellent therapeutic option in children with inadequately controlled severe allergic asthma, allergic rhinitis and rhinosinusitis, with or without food allergy.

Omalizumab treats chronic rhinosinusitis with nasal polyps and asthma together-a real life study

Chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma often coexist and thus treating both with one intervention is an attractive strategy. To prospectively evaluate whether treatment with the monoclonal antibody against IgE Omalizumab for severe allergic asthma also effectively treats co-existent CRSwNP. SNOT-22 and the ACQ-7 scores were recorded at 4 and 16 weeks of treatment in a cohort of patients with both CRSwNP and severe refractory allergic asthma treated with Omalizumab (n=13) according to UK guidelines for their severe asthma. SNOT-22 in a surgery only treated CRSwNP with asthma group (n=24) was compared. Rapid improvement was seen at 4 weeks and 16 weeks of treatment in both CRSwNP and asthma control. The improvement in CRSwNP with Omalizumab was similar to that seen in a group of patients who received upper airway surgery. Omalizumab treatment for severe allergic asthma also improves co-existent CRSwNP. Further clinical studies of current and emerging biological agents for severe asthma should include upper airway outcomes. These agents may be effective for severe CRSwNP and comparative studies with surgery are warranted.

Real-life Effectiveness of Omalizumab in Severe Allergic Asthma Above the Recommended Dosing Range Criteria

To determine if omalizumab (anti-IgE) above the standard dosing ranges can be beneficial in severe asthmatics and compare responses to patients who are within normal dosing ranges.In Australia, most patients receiving government-funded omalizumab are enrolled in the Australian Xolair Registry. This registry includes 21 sites, with patients ≥12 years old who have severe, uncontrolled asthma; patients with serum IgE levels ≥76 IU/mL; and patients who have failed to achieve adequate control with optimized asthma therapy.Registry data were obtained (including demographics, medical history, disease status and control, current treatment, lung function, medical resource use, and patient-reported outcomes) by using the Asthma Control Questionnaire (ACQ-5) and the Asthma Quality of Life Questionnaire (AQLQ). Patients were assessed at 6, 12, 18, and 24 months after starting omalizumab. Participants were classified according to their baseline weight and/or IgE level and whether these variables were above or within the standard dosing table (Australia and the US use the same dosing tables). The primary outcome measured was the change in symptom control as measured by the ACQ-5. Secondary outcomes measured were changes in the AQLQ mean score and pre- and postbronchodilator forced expiratory volume in 1 second (FEV1). In a small portion of patients, changes in hospital admissions and exacerbations were also evaluated.A total of 179 participants were included, with 55 (31%) dosing above the standard dosing and 124 (69%) within standard dosing. Above-range participants had higher baseline IgE levels (812 IU/mL; range 632–1747) compared with in-range participants (209 IU/mL; range 134–306). Baseline AQLQ scores were significantly lower for above-range asthmatics versus in-range patients (3.21 [SD 1.14] vs 4.01 [SD 1.21, P = .02]). Above-range participants received a median dose of omalizumab of 750 mg (IQR 650–750) compared with in-range participants who received a median dose of 450 mg (IQR 300–600). After 6 months of therapy, there was a statistically significant improvement in ACQ-5 scores for both the above-range group (3.61 to 2.10, P < .0001) and the in-range group (3.47 to 1.93, P < .0001). AQLQ also reflected statistical improvement for both groups (above-range group: 3.22 to 4.41; in-range group: 3.71 to 4.88, P < .0001). Above-range participants demonstrated statistically significant improvements in pre- and postbronchodilator FEV1 that were similar to the changes seen for the in-range participants. There was no difference in the exacerbation rate for either group.Omalizumab dosing (750 mg monthly) in severe asthmatic patients who are above established criteria because of weight or baseline IgE levels demonstrate significantly improved symptom control, quality of life measures, and lung function, and these improvements are similar to changes seen in individuals treated with in-range doses.These results provide literature support for above-range dosing of omalizumab (Xolair) for severe asthmatic patients. According to EPR-3 for asthma management, severe allergic asthmatic patients who are poorly controlled on combination therapy are good candidates for targeted therapy with this monoclonal antibody. Dose and frequency of omalizumab in the US are based on weight and total IgE level, leading to a higher calculated dose for patients with either a higher starting IgE level or elevated body weight. Patients with severe persistent asthma who are highly atopic experience significant costs and morbidity, with decreased options for asthma treatment if their IgE level is too high. Additional studies of omalizumab dosing for this group of patients are needed to further support its benefit.

“Real-life” Effectiveness Studies of Omalizumab in Adult Patients with Severe Allergic Asthma: Meta-analysis

After the approval of omalizumab for severe allergic asthma, a total of 25 studies have evaluated the effectiveness of omalizumab under "real-life" conditions of heterogeneity in patients, clinicians, sites, and treatment patterns. We conducted a meta-analysis to evaluate the effectiveness of omalizumab focusing on treatment response, lung function, quality of life, symptom control, corticosteroid use, and exacerbations and hospitalizations at 4-6, 12, and 24 months. We searched PubMed and Embase for real-life studies on omalizumab in severe asthma published up to 2015. Three effect size types were extracted: single-point proportions; mean ± SD of change relative to baseline as raw numbers and standardized as Cohen's d; and changes in proportions of patients as relative risk. Random-effects meta-analyses were performed to account for within- and between-study heterogeneity. Studies were weighted by the DerSimonian and Laird method. Per data available at the 3 time points, omalizumab therapy was consistently associated with large proportions of patients classified as "good" to "excellent" treatment responders (Global Evaluation of Treatment Effectiveness scale); improvements in forced expiratory volume in 1 second, quality of life (Asthma-related Quality-of-Life Questionnaire scale), and asthma symptom control (Asthma Control Test scale); reductions in oral and inhaled corticosteroid (ICS) use; and reductions in exacerbations and hospitalizations. This meta-analysis of noncontrolled studies documents the real-life pharmacotherapeutic effectiveness of omalizumab, as add-on treatment to ICS ± long-acting β2-agonistsagents, in improving outcomes in patients with severe allergic asthma under conditions of heterogeneity in patients, clinicians, sites, and treatment patterns. The results mirror, complement, and extend the efficacy data from randomized controlled trials.

Omalizumab treats chronic rhinosinusitis with nasal polyps and asthma together-a real life study.

Chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma often coexist and thus treating both with one intervention is an attractive strategy. To prospectively evaluate whether treatment with the monoclonal antibody against IgE Omalizumab for severe allergic asthma also effectively treats co-existent CRSwNP. SNOT-22 and the ACQ-7 scores were recorded at 4 and 16 weeks of treatment in a cohort of patients with both CRSwNP and severe refractory allergic asthma treated with Omalizumab (n=13) according to UK guidelines for their severe asthma. SNOT-22 in a surgery only treated CRSwNP with asthma group (n=24) was compared. Rapid improvement was seen at 4 weeks and 16 weeks of treatment in both CRSwNP and asthma control. The improvement in CRSwNP with Omalizumab was similar to that seen in a group of patients who received upper airway surgery. Omalizumab treatment for severe allergic asthma also improves co-existent CRSwNP. Further clinical studies of current and emerging biological agents for severe asthma should include upper airway outcomes. These agents may be effective for severe CRSwNP and comparative studies with surgery are warranted.

Real-life effectiveness of omalizumab in severe allergic asthma above the recommended dosing range criteria.

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. About 62% of patients receiving government-subsidized omalizumab are enrolled in the Australian Xolair Registry (AXR). To determine whether AXR participants above the recommended dosing ranges benefit from omalizumab and to compare their response to within-range participants. Data were stratified according to dose range status (above-range or within-range). Further sub-analyses were conducted according to the reason for being above the dosing range (IgE only vs. IgE and weight). Data for 179 participants were analysed. About 55 (31%) were above recommended dosing criteria; other characteristics were similar to within-range participants. Above-range participants had higher baseline IgE [812 (IQR 632, 1747) IU/mL vs. 209 (IQR 134, 306) IU/mL] and received higher doses of omalizumab [750 (IQR 650, 750) mg] compared to within-range participants [450 (IQR, 300, 600) mg]. At 6 months, improvements in Juniper 5-item Asthma Control Questionnaire (ACQ-5, 3.61 down to 2.01 for above-range, 3.47 down to 1.93 for within-range, P < 0.0001 for both) and Asthma Quality of Life Questionnaire (AQLQ mean score (3.22 up to 4.41 for above-range, 3.71 up to 4.88 for within-range, P < 0.0001) were observed in both groups. Forced expiratory volume in one second (FEV1 ) improved among above-range participants. There was no difference in response between above-range and within-range participants. Above-range participants due to either IgE alone or IgE and weight had similar improvements in ACQ-5, AQLQ and FEV1 . Patients with severe allergic asthma above recommended dosing criteria for omalizumab have significantly improved symptom control, quality of life and lung function to a similar degree to within-range participants, achieved without dose escalation above 750 mg.

Omalizumab for severe allergic asthma: a life changing drug?

Omalizumab for severe allergic asthma: a life changing drug?

Omalizumab for severe allergic asthma in clinical trials and real-life studies: What we know and what we should address

Randomized clinical trials (RCTs) are the gold standard for the assessment of any therapeutic intervention. Real-life (R-L) studies are needed to verify the provided results beyond the experimental setting. This review aims at comparing RCTs and R-L studies on omalizumab in adult severe allergic asthma, in order to highlight the concurring results and the discordant/missing data.The results of a selective literature research, including “omalizumab, controlled studies, randomized trial, real-life studies” as key words are discussed.Though some similarities between RCTs and R-L studies strengthen omalizumab efficacy and safety outcomes, significant differences concerning study population features, follow-up duration, local adverse events and drop-out rate for treatment inefficacy emerge between the two study categories. Furthermore the comparative analysis between RCTs and R-L studies highlights the need for further research, concerning in particular long-term effects of omalizumab and its impact on asthma comorbidities.

Comparision Between Treatment Persistence With Omalizumab in Severe Allergic Asthma and Subcutaneous Immunotherapy in Severe Allergic Rhinitis

SESSION TITLE: Asthma Posters