Real-life rapidity of benralizumab effects in patients with severe allergic eosinophilic asthma: Assessment of blood eosinophils, symptom control, lung function and oral corticosteroid intake after the first drug dose

2019 ◽  
Vol 58 ◽  
pp. 101830 ◽  
Author(s):  
Corrado Pelaia ◽  
Maria Teresa Busceti ◽  
Alessandro Vatrella ◽  
Giuseppe Francesco Rago ◽  
Claudia Crimi ◽  
...  
Keyword(s):  
Lung Function ◽  
Oral Corticosteroid ◽  
Symptom Control ◽  
Real Life ◽  
Drug Dose ◽  
Eosinophilic Asthma ◽  
Blood Eosinophils

scholarly journals Effects of the first three doses of benralizumab on symptom control, lung function, blood eosinophils, oral corticosteroid intake, and nasal polyps in a patient with severe allergic asthma

2020 ◽  
Vol 8 ◽  
pp. 2050313X2090696 ◽  
Author(s):  
Corrado Pelaia ◽  
Maria Teresa Busceti ◽  
Alessandro Vatrella ◽  
Marco Ciriolo ◽  
Eugenio Garofalo ◽  
...  
Keyword(s):  
Nasal Polyps ◽  
Oral Corticosteroid ◽  
Inhaled Corticosteroids ◽  
Symptom Control ◽  
Serum Levels ◽  
Forced Expiratory Volume ◽  
High Serum ◽  
Asthma Control Test ◽  
Eosinophilic Asthma ◽  
Blood Eosinophils

Severe allergic eosinophilic asthma can be characterized by inadequate control, despite the regular use of high dosages of inhaled corticosteroids/long-acting β2-adrenergic agonists combinations, and the very frequent utilization of oral corticosteroids. Therefore, under these circumstances, an add-on biological treatment with monoclonal antibodies directed against suitable molecular targets, involved in the pathobiology of type-2 airway inflammation, is very useful. Within such a context, our case report refers to a 46-year-old woman with severe allergic eosinophilic asthma and relapsing nasal polyps, not eligible to add-on biological therapy with omalizumab because of her very high serum levels of immunoglobulins E (IgE). She is currently under treatment with the humanized monoclonal antibody benralizumab (30 mg subcutaneous injection, administered every 4 weeks for the first three doses, and every 8 weeks thereafter), an eosinophil-depleting anti-interleukin-5-receptor biologic. Our patient experienced relevant clinical and functional improvements already after the first dose, and subsequently striking changes were recorded after the second and third doses, including remarkable increases in asthma control test scores and forced expiratory volume in 1 s values, associated with a complete depletion of blood eosinophils and the interruption of oral corticosteroid intake, as well as with the concomitant disappearance of nasal polyps after the second dose. In conclusion, this case study suggests that benralizumab can exert a very rapid and effective therapeutic action in patients with severe eosinophilic asthma and nasal polyposis.

scholarly journals Mepolizumab effectiveness in patients with severe eosinophilic asthma and co-presence of bronchiectasis: a real-world retrospective pilot study

2020 ◽  
Author(s):  
Claudia Crimi ◽  
Raffaele Campisi ◽  
Santi Nolasco ◽  
Giulia Cacopardo ◽  
Rossella Intravaia ◽  
...  
Keyword(s):  
Pilot Study ◽  
Lung Function ◽  
Real Life ◽  
Specific Effect ◽  
List Type ◽  
Asthma Control Test ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Asthma Symptoms ◽  
Blood Eosinophils

AbstractBackgroundThe association of bronchiectasis (BE) in patients with severe eosinophilic asthma (SEA) is quite frequent. Mepolizumab is a well-recognized treatment for SEA; we aim to evaluate its effectiveness in SEA patients with and without BE in real-life.MethodsWe performed a single-center retrospective pilot study, including patients with SEA treated with mepolizumab for one year. Asthma control test (ACT), lung function, annual exacerbations rate, oral corticosteroid dosage, FeNO, chronic mucous secretions, blood and sputum eosinophils were recorded at baseline and after 6 and 12 months.Resultswe included 32 patients (mean age: 52.3±10, 59% female). 50% showed co-presence of bronchiectasis, (SEA+BE). Significant improvements were found in ACT [(13.8±4.6 to 20.7±4.1, p=0.0009) and (13±4.8 to 20.7±4.6, p=0.0003)], annual exacerbations rate [from 7 (4-12) to 0 (0.00-0.75) and from 8 (4-12) to 0 (0-1), p<0.0001], and blood eosinophils count [748 cells/μL (400-1250) vs. 84 cells/μL (52.5-100), and from 691 cells/μL (405-798) vs. 60 cells/μL (41-105), p<0.0001] in SEA and SEA+BE group respectively, already after 6 months of treatment. A reduction in daily oral corticosteroids intake at 12 months was shown [from 15 mg (0-25) to 0 mg (0-0), p=0.003 and from 8.8 mg (0-25) to 0 mg (0-0) (p=0.01)] in both SEA and SEA+BE, respectively. Similar results were found, comparing SEA+BE patients based on the severity of bronchiectasis.ConclusionsMepolizumab effectively improves asthma symptoms control, reducing annual exacerbations and corticosteroid intake in all patients with SEA, even in the subgroup with coexisting bronchiectasis, independently of their severity.HighlightsMepolizumab is effective in the treatment of severe eosinophilic asthma (SEA) in clinical trials and real-life studies.Bronchiectasis is a frequent comorbidity in patients with severe eosinophilic asthma.Mepolizumab proved to be effective in improving asthma symptoms control, mucus hypersecretion, lung function, and reducing sputum and blood eosinophils, corticosteroids dependency and annual exacerbations both in severe eosinophilic asthma patients with or without co-presence of bronchiectasis.Mepolizumab showed to be effective in patients with asthma and co-presence of bronchiectasis, regardless of BE severity.Assessing the co-presence and severity of bronchiectasis may help clinicians select the right biologic for a prompt treatment-specific effect.

Biologics for oral corticosteroid-dependent asthma

2020 ◽  
Vol 41 (3) ◽  
pp. 151-157
Author(s):  
İnsu Yılmaz
Keyword(s):  
Severe Asthma ◽  
Oral Corticosteroid ◽  
Real Life ◽  
Severe Atopic Dermatitis ◽  
Double Blind ◽  
Eosinophilic Asthma ◽  
Asthma Phenotype ◽  
Severe Eosinophilic Asthma ◽  
Term Administration

Background: Oral corticosteroid (OCS) dependent asthma is one of the severe asthma phenotypes that requires personalized treatment. Objective: To review the role of biologic treatments in OCS-dependent asthma. Methods: A nonsystematic review was performed of emerging multiple novel biologics for potential treatment of OCS-dependent asthma. Results: The serious adverse effects of OCS can be seen as a result of their regular long-term administration. Anti‐interleukin (IL) 5 (mepolizumab), anti‐IL-5R (benralizumab), and anti‐IL-4Rα (dupilumab) are the therapies of choice for OCS-dependent severe asthma. Results of studies showed the efficacy of mepolizumab, benralizumab, and dupilumab, especially in patients with the OCS-dependent severe eosinophilic asthma phenotype and with nasal polyps. Dupilumab may be the therapy of choice of monoclonal antibodies in cases of moderate-severe atopic dermatitis accompanied by OCS-dependent severe asthma. For reslizumab and omalizumab, placebo controlled double-blind studies conducted with OCS-dependent patient populations are needed. Conclusion: Biologics are effective in the “OCS-dependent asthma” phenotype as add-on therapy. It seems that chronic OCS use in OCS-dependent asthma will be replaced by biologic agents that specifically target type 2 inflammation, along with a much better safety profile. However, real-life studies that compare these biologics in OCS-dependent severe asthma are urgently needed.

scholarly journals The Benefit of Benralizumab Monoclonal Antibody Treatment for Severe Eosinophilic Asthma in a Case Series (Pulmonology Clinic Târgu Mureș, Romania)

2021 ◽  
Vol 6 (3) ◽  
pp. 157-161
Author(s):  
Nimród László ◽  
Hédy Katalin Sárközy ◽  
Cristina Alexandra Man ◽  
Edith Simona Ianoși ◽  
Botond Mátyás ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Asthma Control ◽  
Symptom Control ◽  
Real Life ◽  
Case Series ◽  
High Dose ◽  
Antibody Treatment ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Eosinophil Counts

Abstract Background: Monoclonal antibody therapy is currently an additional treatment option to reduce exacerbations and improve symptom control in patients with severe eosinophilic asthma (SEA) that is uncontrolled despite treatment with high-dose inhaled corticosteroids and long-acting beta-2 agonists. Benralizumab, a monoclonal antibody that binds to the interleukin-5 receptor (IL-5), significantly reduces symptoms and annual exacerbations, as well as the use of systemic corticosteroids in patients with SEA. However, few studies are available on the effectiveness of this biological treatment in real life. The aim of this case series was to evaluate the efficacy of benralizumab by analyzing changes in clinical parameters and blood eosinophils in patients with SEA. Methods: We analyzed four patients with SEA who started treatment with benralizumab. The history of symptoms and exacerbations, eosinophil counts, data regarding the oral corticosteroid dose, need for rescue treatment, spirometry measurements and asthma control questionnaires (ACT) regarding the level of asthma control were recorded. A positive response to treatment was defined by a significant reduction in eosinophil counts, increased ACT scores, and lower rates of exacerbations. Results and conclusions: Benralizumab monoclonal antibody was effective in all four patients. This was shown by a reduction in exacerbation rates, symptom severity, and lower dose of oral corticosteroids and rescue medication. This novel treatment was well tolerated by the analyzed patients, thus indicating that benralizumab is an attractive choice for patients due to eosinophilic count reduction as well as the less frequent dosing schedule. However, further studies are required, on larger populations.

scholarly journals Effectiveness of Benralizumab in Improving the Quality of Life of Severe Eosinophilic Asthmatic Patients: Our Real-Life Experience

2021 ◽  
Vol 12 ◽  
Author(s):  
Giulia Scioscia ◽  
Giovanna Elisiana Carpagnano ◽  
Carla Maria Irene Quarato ◽  
Donato Lacedonia ◽  
Sonia Santamaria ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Function ◽  
Asthma Control ◽  
Severe Asthma ◽  
Life Experience ◽  
Real Life ◽  
Eosinophilic Inflammation ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma

Background: Severe eosinophilic asthma decreases lung function and causes worsen symptoms, often forcing recurrent maintenance corticosteroid use. The aim of our real-life study was to evaluate the effectiveness of an add-on treatment with benralizumab in patients with severe eosinophilic asthma, paying particular attention to the impact on their quality of life (QoL).Materials and methods: In this prospective study, 10 outpatients with severe eosinophilic asthma were added-on with benralizumab and followed-up in our severe asthma clinic after 12 and 24 weeks. At each patient visit, pre-bronchodilator FEV1 and inflammatory markers were recorded. Variations in asthma symptoms control and QoL perception was assessed by validated questionnaires.Results: All the subjects experienced a marked reduction of nocturnal and diurnal symptoms over time and were able to stop using OCS, as documented by the improvement in Asthma control test (ACT) and Asthma Control Questionnaire score. Similarly, we recorded a statistically significant increase in patient’s QoL perception in EQ-VAS, EQ-5D-3L and Asthma Quality of Life Questionnaire (AQLQ) assessment (p &lt; 0.05). Simultaneously we recorded a significant reduction in eosinophilic inflammation, an improvement in pre-bronchodilator FEV1. These results appear to be in line with those already obtained in the previous randomized controlled trials (RCTs).Conclusion: Our 24-weeks real life experience supports the effectiveness of an add-on treatment with benralizumab in reducing eosinophilic inflammation and OCS-use, increasing lung function and improving control of nocturnal and diurnal symptoms, as well as restoring severe asthma patients to a better QoL.

Mepolizumab Effectiveness and Allergic Status in Real Life

2020 ◽  
pp. 1-8
Author(s):  
Bruno Sposato ◽  
Marco Scalese ◽  
Gianna Camiciottoli ◽  
Giovanna Elisiana Carpagnano ◽  
Corrado Pelaia ◽  
...  
Keyword(s):  
Oral Corticosteroid ◽  
Real Life ◽  
Blood Eosinophil ◽  
Test Results ◽  
Asthma Control Test ◽  
Eosinophilic Asthma ◽  
Prick Test ◽  
Significant Relationships ◽  
Therapeutic Choice ◽  
Β2 Agonists

<b><i>Background:</i></b> It is not clear whether mepolizumab is differently effective in allergic and nonallergic severe eosinophilic asthmatics (SEA) in real life. <b><i>Objective:</i></b> We tested mepolizumab effectiveness in allergic/nonallergic SEA in real life. A strict criterion to identify the 2 phenotypes was used. <b><i>Method:</i></b> We retrospectively considered 134 consecutive patients divided into allergic, with a positivity to at least 1 allergen to prick tests and/or IgE values ≥100 UI/mL (severe allergic eosinophilic asthma [SAEA]; <i>n</i>: 97–72.4%), and nonallergic, with no prick test results and normal IgE levels &#x3c;100 UI/mL (severe nonallergic eosinophilic asthma [SNAEA]; <i>n</i>: 37–27.6%). They had taken mepolizumab for at least 6 months. <b><i>Results:</i></b> After 10.9 ± 3.7 months, improvements in FEV<sub>1</sub>%, FEF<sub>25–75</sub>%, exacerbation numbers, blood eosinophil (BE) counts, fractional exhaled nitric oxide (FENO) (ppb), percentages of patients that stopped/reduced short-acting β2-agonists (SABAs) or oral corticosteroid (OC), observed after treatment, were similar in both groups. Only Asthma Control Test (ACT) increases were higher in SNAEA (8 [5–9]) than in SAEA (5 [2.5–8.5]; <i>p</i> = 0.016). However, no differences were found after treatment in percentages of subjects with ACT ≥20, as well as with FEV<sub>1</sub> &#x3e;80%, FEF<sub>25–75</sub> &#x3e;65%, exacerbations ≤2, BE &#x3c;300 cells/µL, and FENO &#x3c;25 ppb between SAEA and SNAEA. Besides, no significant relationships were found, comparing SNAEA with SAEA, for FEV<sub>1</sub>% (β = −0.110; <i>p</i> = 0.266), FEF<sub>25–75</sub>% (β = −0.228; <i>p</i> = 0.06), BE counts (β = −0.012; <i>p</i> = 0.918), FENO (β = 0.234; <i>p</i> = 0.085), ACT (β = 0.046; <i>p</i> = 0.660), and exacerbations (β = −0.070; <i>p</i> = 0.437). No different associations between lung function and SNAEA occurrence when compared to SAEA condition (FEV<sub>1</sub> &#x3e;80%: OR = 1.04 [95% CI: 0.43–2.55], <i>p</i> = 0.923; FEF<sub>25–75</sub> &#x3e;65%: OR = 0.41 [95% CI: 0.08–2.03], <i>p</i> = 0.272) were detected. Neither all other parameters, such as ACT &#x3e;20 (OR = 0.73 [95% CI: 0.32–1.63], <i>p</i> = 0.440), presence of exacerbations (OR = 1.35 [95% CI: 0.55–3.27], <i>p</i> = 0.512), SABA discontinuation (OR = 1.16 [95% CI: 0.40–3.39], <i>p</i> = 0.790), and OC cessation/reduction (OR = 3.44 [95% CI: 0.40–29.27], <i>p</i> = 0.258), were differently associated with 1 or the other phenotype. <b><i>Conclusion:</i></b> Mepolizumab can be considered as a valid therapeutic choice for either allergic or nonallergic SEA in real life.

scholarly journals Switch from Omalizumab to Benralizumab in Allergic Patients with Severe Eosinophilic Asthma: A Real-Life Experience from Southern Italy

Biomedicines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1822
Author(s):  
Corrado Pelaia ◽  
Claudia Crimi ◽  
Santi Nolasco ◽  
Giovanna Elisiana Carpagnano ◽  
Raffaele Brancaccio ◽  
...  
Keyword(s):  
Life Experience ◽  
Symptom Control ◽  
Real Life ◽  
Forced Expiratory Volume ◽  
Blood Eosinophil ◽  
Asthma Control Test ◽  
Biologic Treatment ◽  
Eosinophilic Asthma ◽  
Exacerbation Rate ◽  
Severe Eosinophilic Asthma

Background. The wide availability of monoclonal antibodies for the add-on therapy of severe asthma currently allows for the personalization of biologic treatment by selecting the most appropriate drug for each patient. However, subjects with overlapping allergic and eosinophilic phenotypes can be often eligible to more than one biologic, so that the first pharmacologic choice can be quite challenging for clinicians. Within such a context, the aim of our real-life investigation was to verify whether allergic patients with severe eosinophilic asthma, not adequately controlled by an initial biologic treatment with omalizumab, could experience better therapeutic results from a pharmacologic shift to benralizumab. Patients and methods. Twenty allergic patients with severe eosinophilic asthma, unsuccessfully treated with omalizumab and then switched to benralizumab, were assessed for at least 1 year in order to detect eventual changes in disease exacerbations, symptom control, oral corticosteroid intake, lung function, and blood eosinophils. Results. In comparison to the previous omalizumab therapy, after 1 year of treatment with benralizumab our patients experienced significant improvements in asthma exacerbation rate (p < 0.01), rescue medication need (p < 0.001), asthma control test (ACT) score (p < 0.05), forced expiratory volume in the first second (FEV1) (p < 0.05), and blood eosinophil count (p < 0.0001). Furthermore, with respect to the end of omalizumab treatment, the score of sino-nasal outcome test-22 (SNOT-22) significantly decreased after therapy with benralizumab (p < 0.05). Conclusion. The results of this real-life study suggest that the pharmacologic shift from omalizumab to benralizumab can be a valuable therapeutic approach for allergic patients with severe eosinophilic asthma, not adequately controlled by anti-IgE treatment.

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