Treatment Of Severe Allergic Asthma Research Articles

Evaluation of the clinical features and laboratory data of patients with severe asthma classified as super-responder or non super-responder to omalizumab treatment: a single-center real-life study

Introduction Omalizumab is used for the treatment of severe allergic asthma. Objective The aim of this study was to evaluate the clinical features and laboratory data of patients with severe allergic asthma classified as super-responder or non super-responder to omalizumab. Methods Comparisons were made of the laboratory data and clinical features of patients with severe allergic asthma. Patients who had no asthma exacerbation, no oral corticosteroid (OCS) use, asthma control test (ACT) score >20 and forced expiratory volume in 1 s (FEV1) >80% were considered super-responder after omalizumab. Results A total of 90 patients were included in the study, comprising 19 (21.1%) males. The age at onset of asthma, allergic rhinitis rate, number of endoscopic sinus surgeries (ESS), intranasal corticosteroid (INS) use, baseline FEV 1 (%) and ACT score were significantly higher in the omalizumab super-responder group (p = 0.013, p = 0.015, p = 0.002, p = 0.001, p = 0.001 and p < 0.001, respectively). The duration of asthma, rate of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), regular use of OCS, baseline eosinophil count and eosinophil-to-lymphocyte ratio were significantly higher in the omalizumab non super-responder group (p = 0.015, p < 0.001, p = 0.004, p < 0.001 and p < 0.001, respectively). Blood eosinophil count (AUC: 0.187, p < 0.001), eosinophil-to-lymphocyte ratio (AUC: 0.150, p < 0.001) and FEV1 (%) (AUC:0.779, p = 0.001) were determined to have diagnostic value in predicting the treatment response to omalizumab of patients with severe allergic asthma. Conclusion High-blood eosinophil levels, CRSwNP and low pretreatment lung capacity may affect omalizumab treatment response in patients with severe allergic asthma. These results should be supported by further multicenter real-life studies.

Impact of omalizumab therapy on the course of COVID-19 in a patient with severe asthma: A case report

IntroductionVarious risk factors have been attributed to coronavirus disease 19 (COVID-19) severity. Omalizumab as an immunoglobulin E blocker that enhances anti-viral immunity might be a potential cytokine storm trigger.AimOur goal was to investigate if the treatment with omalizumab due to severe asthma is a risk factor of severe COVID-19 pneumonia and if severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can trigger asthma exacerbation.Case studyWe report the case of a 65-year-old patient with severe allergic asthma receiving treatment with omalizumab for last 8 months with good results, who in December 2020 was infected with SARS-CoV-2. The patient was not vaccinated against COVID-19 (no vaccine was available at that time), and had comorbidities.Results and discussionCOVID-19 course of presented patient was asymptomatic and resolved quickly without the need for hospitalization or asthma exacerbation. There was a slightly worse score on the asthma control questionnaire after COVID-19 resolution (2.1 point vs. 1.5 points) and a threefold increase in eosinophil counts (660 cell/µL vs. 230 cell/µL). However, no wheezing or deterioration in pulmonary function tests were found. A computed tomography of the chest revealed only minor densities of pulmonary parenchyma and thickened walls of bronchi.ConclusionsOmalizumab used in the treatment of severe allergic asthma proved to be safe and beneficial for the course of COVID-19 in the case reported. Simultaneously, SARS-CoV-2 was not a factor for asthma exacerbation.

EE554 Costs Comparison Between Dupilumab and Omalizumab in the Treatment of Severe Allergic Asthma in the Brazilian Private Healthcare Perspective

EE554 Costs Comparison Between Dupilumab and Omalizumab in the Treatment of Severe Allergic Asthma in the Brazilian Private Healthcare Perspective

Real-world effectiveness of omalizumab for severe allergic asthma treatment in Colombia

BackgroundThe allergic phenotype is responsible for more than 50% of severe asthma cases. In a stepwise approach, add-on treatments such as anti-IgE are used for severe allergic asthma (SAA). This study was aimed to describe the real-world effectiveness of omalizumab in adult and pediatric patients with SAA in Colombia.MethodsThis was an observational, non-interventional, retrospective study. Data from patients with SAA that received at least one month of treatment with omalizumab was obtained from medical records at eight sites in Colombia. Time-zero (t − 0) was defined as the date of initiation of omalizumab, and data was gathered for a 12-month period before t − 0 and a 12-month period after t − 0. Clinical outcomes, including exacerbations, were assessed at 6 and 12 months. Effectiveness of omalizumab was evaluated in terms of the reduction of the risk of exacerbations (annualized rate).ResultsWe included 143 patients with SAA. There was a decrease of 72.4% of the annualized rate of clinically significant asthma exacerbations during the year after omalizumab (from 1.74 before to 0.48 after) with a substantial reduction of the risk of exacerbations by 56.7% (RR [95% CI] 0.43 [0.30–0.63] p < 0,001).ConclusionThe use of omalizumab in Colombia as a treatment for SAA notably reduced the risk of clinically significant exacerbations. This study is the first to evaluate omalizumab real-life effectiveness in pediatric and adult patients in the country.

Off-label use of omalizumab in a 6-year-old child with severe atopic dermatitis.

Background: Atopic dermatitis (AD) is a common chronic inflammatory skin disorder that affects up to 3% of adults and 15%-20% of children across the world. Although the mainstay of treatment is topical corticosteroids and/or calcineurin inhibitors, a majority of patients will not achieve a control of their condition and will need systemic treatment with steroids and immunosuppressants (1). Omalizumab is a humanized anti-IgE antibody licensed by the European Medical Agency for treatment of severe allergic asthma and spontaneous chronic urticaria in children older than 6 and 12 years, respectively; and a promising efficacy of omalizumab in the treatment of severe refractory AD has been shown by the ADAPT randomized clinical trial (2).Case report: A 6-year-old male patient being treated and followed at a pediatric dermatology clinic for a diagnosis of AD since the age of 3 years, showed unresponsive disease to different topical treatment options and non-pharmacological measures. The patient was referred to our clinic for systemic treatment when his SCORAD index was 70/103. At our immunology clinic, we did an extensive workup to unveil a comorbid or underlying disease. His labs showed high IgE levels at 2500 IU/mL, hypereosinophilia, and normal IgA, IgM, and lymphocyte subsets. We started him on different lines of immunosuppressants, including cyclosporine, prednisolone, tacrolimus, and intensive topical treatment; however, the patient did not show any noticeable response for 2 years. We then started him on omalizumab 300 mg twice weekly, and the SCORAD index dropped to 57 at 12 weeks and 55 at 18 weeks. The drug is still well tolerated, and we were able to stop systemic steroids at 15 weeks of treatment.Conclusion: Off-label use of omalizumab in a 6-year-old child with refractory severe AD was effective and safe in controlling the disease even though conventional systemic immunosuppressants proved ineffective.

Time course of disease characteristics in patients with severe allergic asthma starting treatment with omalizumab

Omalizumab is approved for the treatment of severe allergic asthma, but not all patients indicated for this treatment respond well.1,2 Currently, patients are considered as nonresponders if no clinical benefits are established within 16 weeks since the onset of treatment.3 Because airway inflammation is a cardinal feature of asthma,4 we reasoned that early changes in its level may determine the subsequent course of the disease. We recruited for this real-life pilot study biologic therapy–naive patients with asthma eligible for omalizumab by the stringent criteria of the National Health Insurance Fund and followed them up for a period of 18 weeks: 2 weeks run-in and 16 weeks of treatment.

‘Real-world’ effectiveness of omalizumab in adults with severe allergic asthma: a meta-analysis

ABSTRACT Background: Severe asthma affects 5–10% of the 350 million people with asthma worldwide. Findings from the authors’ previous meta-analysis supported omalizumab use as an adjuvant treatment for severe allergic asthma. The publication of fourteen new articles necessitates an update of the meta-analysis. Objective: To evaluate the ‘real-world’ effectiveness of omalizumab in the treatment of acute allergic asthma in adults by calculating pooled effects estimates from data in published articles. Methods: Articles on omalizumab effectiveness in ‘real-world’ settings were identified. Effect sizes, including point estimates of the proportion of patients who met a given criteria, mean improvements relative to baseline, and change in the proportion of patients requiring oral corticosteroids compared to baseline were extracted. Meta-analysis of proportions was conducted to pool effect sizes based on proportions. Standardized mean differences (Hedges’ g) were calculated from means and standard deviations. Relative risk was calculated from changes in proportions. Variability within and between studies was evaluated. Results: Omalizumab increases the percentage of individuals rated ‘good’ or ‘excellent’ on the Global Evaluation of Treatment Effectiveness Scale. Omalizumab also improves respiratory function, quality-of-life, and asthma control while reducing medication usage, exacerbations, hospitalizations, and adverse events. Conclusion: ‘Real-world’ evidence continues to support the use of omalizumab as adjuvant treatment for severe allergic asthma.

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 Long-Term Effectiveness and Safety of Omalizumab on Patient- and Physician-Reported Asthma Control: A Three-Year, Real-Life Observational Study.

Allergic asthma is a chronic inflammatory disease caused by immunoglobulin E (IgE)-mediated allergy. Omalizumab is a monoclonal anti-IgE antibody for the treatment of severe allergic asthma (SAA). The primary objective of the study was to assess asthma-related control in patients with SAA receiving omalizumab therapy. Secondary objectives included quality of life, treatment effectiveness, rate of severe exacerbations, and safety. This was a prospective, multi-centre, non-interventional study to assess patient-related long-term outcomes of omalizumab treatment in Germany. This 3-year study enrolled patients aged ≥ 18years with SAA. Asthma control was assessed using the asthma control questionnaire (ACQ-6) and physician-assessed global evaluation of treatment effectiveness (GETE). Exacerbations were recorded, and quality of life was assessed using the mini-asthma quality of life questionnaire (mini-AQLQ). Of 161 patients screened, 153 participated in this study. Most patients (92.2%) had been receiving prior omalizumab therapy for mean (SD) 2.9 (2.3) years. Omalizumab slightly decreased mean ACQ-6 score from 2.0 (1.22) at baseline to 1.7 (1.23) at the end of the 3-year treatment period [difference: -0.18 (1.07), P = 0.340]. Post-hoc analyses of ACQ-6 for the small number of treatment-naïve patients showed a decrease in mean (SD) ACQ-6 from 2.7 (1.08) at baseline to 1.4 (1.40) after 3years of omalizumab treatment. Mini-AQLQ increased from 4.5 (1.26) at baseline to 4.7 (1.48) after 3years [difference: 0.26 (1.35), P = 0.186]. GETE was reported as excellent or good for most patients (67.46-84.69%) and more than two-thirds had no severe exacerbation. There were no unexpected safety signals during the study period and no tachyphylaxis was observed. In conclusion, despite most patients receiving prior omalizumab treatment for approximately 3years, there was no decrease in effectiveness or safety over the subsequent 3years during this study. This supports the long-term use of omalizumab in maintaining asthma control and quality of life. Novartis Pharma GmbH, Germany.

Variability in total serum IgE over 1\xa0year in severe asthmatics

BackgroundImmunoglobulin E (IgE) is the treatment target of omalizumab, a monoclonal antibody indicated in the treatment of severe allergic asthma. Long-term variability of serum total IgE (sIgEtot) in asthmatics remains poorly documented.MethodsIn this prospective study, sIgEtot levels were measured over 1 year at 7 time points in 41 severe asthmatics treated with high-dose of inhaled corticosteroids and long-acting β2 agonists. 33 patients were atopic based on at least one positive RAST to common aeroallergens. Patients were divided into three groups according to their baseline sIgEtot level: low (< 76 IU/mL; n = 10), intermediate (76–700 IU/mL; n = 20) or high (> 700 IU/mL; n = 11). Patients also completed the six-item Juniper Asthma Control Questionnaire (ACQ6). The sIgEtot variability and factors predictive for this variability were studied, as well as ACQ6 outcomes.ResultsThe variation in sIgEtot level was mostly the consequence of between patient-variability, which represented 96%, 71% and 96% of the total variability in the low, intermediate and high sIgEtot subgroups, respectively. The residual within-patient variability was therefore limited. In 10/41 patients, sIgEtot levels increased or decreased, for at least one visit, beyond the predefined range of the subgroups to which they were assigned (< 76 IU/mL; 76–700 IU/mL; > 700 IU/mL). There was a significant but weak correlation between sIgEtot and ACQ6 score over all time points (r = 0.15, p = 0.02), but sIgEtot failed to associate with severe exacerbation. sIgEtot decreased by 3% with any additional year of age for the whole group (p = 0.01) and increased by 5% per one unit of allergen exposure score in atopic patients (p = 0.002).ConclusionIn severe asthmatics, limited within-patient variability of sIgEtot levels was observed over 1 year as opposed to marked between-subject variability. sIgEtot decreases with age. Variation in sIgEtot weakly associates with asthma control but not with exacerbation.

Omalizumab may decrease the thickness of the reticular basement membrane and fibronectin deposit in the bronchial mucosa of severe allergic asthmatics

Introduction: Immunoglobulin E is an important modulator of the inflammatory reaction in allergic asthma. It also contributes to airway remodeling in the course of the disease. The authors evaluated airway structural changes in severe allergic asthma during the omalizumab therapy. Patients and methods: The study included 13 patients with severe allergic asthma treated with omalizumab for at least one year. In each patient clinical, laboratory, and spirometry parameters were evaluated before and after the treatment. In addition, bronchoscopy with bronchial mucosa biopsy and bronchoalveolar lavage was performed. The basal lamina thickness, inflammatory cell infiltration, fibronectin, as well as type I and III collagen accumulation were assessed in bronchial mucosa specimens, together with the assessment of bronchoalveolar lavage cellularity. Results: The omalizumab therapy led to a decrease in the basal lamina thickness (p = 0.002), and to a reduction in fibronectin (p = 0.02), but not collagen deposits in the bronchial mucosa. The decrease in fibronectin accumulation was associated with an improvement in asthma control and quality of life (p = 0.01, both), and a diminished dose of systemic corticosteroids (p = 0.001). It was also associated with a tendency towards reduction of the eosinophil count in the peripheral blood, bronchoalveolar lavage fluid, and bronchial mucosa specimens. Conclusion: Our study has shown that omalizumab, effective in the treatment of severe allergic asthma, may also decrease unfavorable structural airway changes in allergic asthmatics, at least with respect to the fibronectin deposit and an increased thickness of the basal lamina. However, more extensive observational studies are needed to verify the above hypothesis.

Re-exploring immune-related side effects of docetaxel in an observational study: Blood hypereosinophilia.

Docetaxel is a major anticancer drug that can induce hypersensitivity reactions leading to deleterious treatment interruptions. Blood hypereosinophilia could be a biological sign, potentially lethal, of delayed visceral hypersensitivity reactions. We hypothesized this biological event is probably underreported. In this prospective observational study, we followed up 149 patients treated with docetaxel monotherapy for breast or lung cancer. For each patient, blood eosinophil counts were recorded during docetaxel treatment and up to 3 months after the end of docetaxel treatment. For all patients, blood eosinophil counts significantly increased under docetaxel chemotherapy (P < 0.01). Seven percent had persistent eosinophilia after the end of treatment. Four patients had blood eosinophil counts over 1000/mm3 with severe cardiac, cutaneous and digestive toxicities, and docetaxel imputability was confirmed using drug‐imputability scales. For two of these four patients, tissue biopsies were performed during the time of hypereosinophilia and of severe toxicities. Specific immunostainings and electron microscopy found numerous degranulating mast cells and eosinophils. Our study demonstrated that eosinophilia is frequent under docetaxel and could lead to severe complications, implicating eosinophils and mast cells, and possibly IgE. One way of treating hypersensitivity reactions could be by targeting IgEs with omalizumab, an anti‐IgE monoclonal antibody approved for the treatment of severe allergic asthma, and successfully used in food and poison‐induced anaphylactic reactions.

Omalizumab as alternative to chronic use of oral corticosteroids in severe asthma.

Systemic/oral corticosteroids (OCS) have been used for decades in the management of acute asthma exacerbations and chronically in patients with uncontrolled severe asthma. However, while OCS are effective at treating acute exacerbations, there is only empirical evidence regarding the efficacy of OCS at reducing the rate of exacerbations. Evidence, although scarce, is suggestive of high exacerbation rates in severe asthma patients even when receiving maintenance treatment with OCS. In addition, use of OCS is associated with undesirable effects. Despite all this, physicians have continued to use OCS for managing severe asthma and acute exacerbation due to the lack of availability of effective alternatives. Fortunately, in the last decade several biologics have been proven safe and effective for patients with uncontrolled severe asthma. This has led to the Global Initiative for Asthma (GINA) recommending the use of biologics, instead of maintenance OCS, in patients with severe asthma (GINA Step 5). These include one biologic targeting immunoglobulin E (IgE) (omalizumab), and different biologics targeting interleukin-5 (IL-5), the IL-5 receptor (IL-5R) or IL-4 receptor α-unit (IL-4R α), including mepolizumab (subcutaneous), reslizumab (intravenous), benralizumab (subcutaneous) and dupilumab (subcutaneous). Omalizumab for the treatment of severe allergic asthma reduces exacerbations, irrespective of blood eosinophil levels. Anti-IL-5/IL-5R biologics are indicated in patients with severe eosinophilic asthma and repetitive exacerbations, irrespective of the presence or absence of allergy. Recently, an anti-IL4Rα biologic has been approved by the FDA for eosinophilic phenotype or oral corticosteroid-dependent asthma. Finally, physicians should consider using biologics as an alternative to chronic OCS therapy.

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.

Omalizumab, the first available antibody for biological treatment of severe asthma: more than a decade of real-life effectiveness.

Omalizumab was the first, and for a long time the only available monoclonal antibody for the add-on treatment of severe allergic asthma. In particular, omalizumab selectively targets human immunoglobulin (Ig)E, forming small-size immune complexes that inhibit IgE binding to its high- and low-affinity receptors. Therefore, omalizumab effectively blunts the immune response in atopic asthmatic patients, thus significantly improving the control of asthma symptoms and successfully preventing disease exacerbations. These very positive effects of omalizumab make it possible to drastically decrease both referrals to the emergency room and hospitalizations for asthma exacerbations. Such important therapeutic actions of omalizumab have been documented by several randomized clinical trials, and especially by more than 10 years of real-life experience in daily clinical practice. Omalizumab can also interfere with airway remodelling by inhibiting the activation of IgE receptors located on structural cells such as bronchial epithelial cells and airway smooth muscle cells. Moreover, omalizumab is characterized by a very good safety and tolerability profile. Hence, omalizumab represents a valuable therapeutic option for the add-on biological treatment of severe allergic asthma.

The effect of omalizumab treatment on severe allergic asthma and allergic comorbidities: real-life experience from the Czech Anti-IgE Registry

IntroductionOmalizumab is indicated for the treatment of severe allergic asthma (SAA) and chronic spontaneous urticaria, although a number of studies have confirmed the effectiveness of this therapy also for other IgE-mediated diseases.AimTo assess the impact of anti-IgE therapy on SAA and comorbid IgE-mediated allergic diseases in patients treated with omalizumab for SAA enrolled in the CAR (Czech Anti-IgE Registry).Material and methodsThree hundred and ten patients with SAA treated with omalizumab were enrolled in the CAR. Two hundred and twenty-nine individuals were evaluated after 12 months of omalizumab treatment for asthma control test (ACT), examination of fractional exhaled nitric oxide (FENO), forced expiratory volume in 1 s (FEV1), the use of systemic corticosteroids, side effects of treatment and clinical effect of omalizumab on allergic comorbidities (allergic rhinitis, chronic urticaria, atopic dermatitis and food allergy).ResultsAfter 12 months of treatment with omalizumab, patients experienced a significant improvement of ACT and FEV1, reduction of FENO, use of systemic corticosteroids for asthma exacerbations and dose of maintenance oral corticosteroid therapy. The positive effect of treatment with omalizumab was observed in 82.2% of patients with allergic rhinitis, in 85.7% of patients with chronic urticaria, in 82.1% of patients with atopic dermatitis, and in 67.3% of patients with food allergy.ConclusionsIn the CAR registry, patients with SAA treated with omalizumab showed a significant positive effect of anti-IgE therapy not only on the asthma control, but also on allergic comorbidities.

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.

Impact of omalizumab on treatment of severe allergic asthma in UK clinical practice: a UK multicentre observational study (the APEX II study)

ObjectiveTo describe the impact of omalizumab on asthma management in patients treated as part of normal clinical practice in the UK National Health Service (NHS).DesignA non-interventional, mixed methodology study, combining...

Effectiveness of the Polish program for the treatment of severe allergic asthma with omalizumab: a single-center experience.

BackgroundA national program for the treatment of severe allergic (IgE-dependent) asthma with omalizumab (OMA) was implemented in Poland in 2013. This observational study evaluated the effectiveness of the Polish OMA program and monitored asthma control after treatment discontinuation.MethodsIn the first year of the program, 53 patients (23 new/30 continuing treatment) received OMA in the Barlicki Hospital, Poland. Patients were evaluated at baseline and after 16 weeks of OMA treatment by spirometry, mean dose of inhaled corticosteroids (ICS) and oral corticosteroids (OCS), number of asthma exacerbations, the Asthma Control Questionnaire (ACQ), and the Asthma Quality of Life Questionnaire (AQLQ). OMA treatment responses were determined using the global effectiveness of treatment evaluation scale. Fourteen patients ceased OMA treatment following ≥36 months of therapy and entered follow up.ResultsAll patients treated with OMA de novo for at least 16 weeks had a decrease in asthma exacerbations and showed a good (15/16, 94 %) or an excellent (1/16, 6 %) response to treatment. We observed a reduction in OCS dose (≥5 mg/day) in 14/16 (88 %) patients. ACQ and AQLQ scores improved by ≥0.5 points in 15/16 (94 %) and 14/16 (88 %) patients, respectively. After OMA cessation, 11/14 (79 %) patients showed worsening of asthma control and severe exacerbations.ConclusionsPatients in the OMA program show significant benefits, including reduced use of OCS, improved asthma control and quality of life. After OMA discontinuation, frequent severe exacerbations were observed primarily in patients whose asthma was previously uncontrolled by high OCS doses.

'Real-life' effectiveness studies of omalizumab in adult patients with severe allergic asthma: systematic review.

We reviewed 24 'real-life' effectiveness studies of omalizumab in the treatment of severe allergic asthma that included 4117 unique patients from 32 countries with significant heterogeneity in patients, clinicians and settings. The evidence underscores the short- and long-term benefit of anti-IgE therapy in terms of the following: improving lung function; achieving asthma control and reducing symptomatology, severe exacerbations and associated work/school days lost; reducing healthcare resource utilizations, in particular hospitalizations, hospital lengths of stay and accident specialist or emergency department visits; reducing or discontinuing other asthma medications; and improving quality of life - thus confirming, complementing and extending evidence from randomized trials. Thus, omalizumab therapy is associated with signal improvements across the full objective and subjective burden of illness chain of severe allergic asthma. Benefits of omalizumab may extend up to 2-4 years, and the majority of omalizumab-treated patients may benefit for many years. Omalizumab has positive short- and long-term safety profiles similar to what is known from randomized clinical trials. Initiated patients should be monitored for treatment response at 16 weeks. Those showing positive response at that time are highly likely to show sustained treatment response and benefit in terms of clinical, quality of life and health resource utilization outcomes.