scholarly journals Switching from omalizumab to mepolizumab: real-life experience from Southern Italy

2020 ◽  
Vol 14 ◽  
pp. 175346662092923 ◽  
Author(s):  
Giovanna Elisiana Carpagnano ◽  
Corrado Pelaia ◽  
Maria D’Amato ◽  
Nunzio Crimi ◽  
Nicola Scichilone ◽  
...  
Keyword(s):  
Allergic Asthma ◽  
Severe Asthma ◽  
Southern Italy ◽  
Life Experience ◽  
Real Life ◽  
Forced Expiratory Volume ◽  
Asthma Control Test ◽  
Eosinophilic Asthma ◽  
Life Study ◽  
First Choice

Background: Current availability of several biologic treatments for severe asthma makes it possible to choose the most appropriate for each patient. Sometimes a good percentage of patients with severe asthma may be eligible for biologics that target either the allergic phenotype or the eosinophilic one, but not all respond to that selected as first choice. The aim of our real-life study was to assess whether, for patients with severe eosinophilic allergic asthma, not previously controlled by the anti-IgE omalizumab, the shift to another biologic targeting interleukin-5, such as mepolizumab, may represent a good therapeutic choice. Methods: A total of 41 consecutive patients with severe, persistent allergic, eosinophilic asthma, uncontrolled despite treatment with omalizumab, were enrolled in seven certified Clinical Respiratory Units of Southern Italy (Catania, Catanzaro, Foggia, Bari, Palermo, and two University Respiratory Units of Naples) and shifted to mepolizumab without a wash-out period. Data at baseline, after at least 12 months of therapy with omalizumab, and after at least 12 months of treatment with mepolizumab were collected. Results: After at least 12 months of therapy with mepolizumab, patients experienced a significant decrease in the number of exacerbations/year (5.8 ± 1.8 versus 0.7 ± 0.9, p < 0.0001), an increment of asthma control test score (12 ± 2.7 versus 21.9 ± 2.7, p < 0.0001), an increase in pre-bronchodilator forced expiratory volume in 1 s (1.56 ± 0.45 l versus 1.86 ± 0.52 l, p < 0.0001), and a reduction of blood eosinophils (584 ± 196 cells/µl versus 82 ± 56 cells/µl, p < 0.0001). The percentage of patients who were dependent on corticosteroids significantly decreased from 46% at baseline to 5% during treatment with mepolizumab. Conclusion: Results of our real-life multicentric experience confirms that the shift to mepolizumab could be a good therapeutic strategy in severe eosinophilic allergic asthma not previously controlled by omalizumab. The reviews of this paper are available via the supplemental material section.

scholarly journals Predictors of reversible airway obstruction with omalizumab in severe asthma: a real-life study

2019 ◽  
Vol 13 ◽  
pp. 175346661984127 ◽  
Author(s):  
Paolo Solidoro ◽  
Filippo Patrucco ◽  
Francesca de Blasio ◽  
Luisa Brussino ◽  
Michela Bellocchia ◽  
...  
Keyword(s):  
Airway Obstruction ◽  
Allergic Asthma ◽  
Severe Asthma ◽  
Airway Remodeling ◽  
Real Life ◽  
Forced Expiratory Volume ◽  
Life Study ◽  
Reversible Airway Obstruction ◽  
Number Of Patients ◽  
Severe Allergic Asthma

Background: Omalizumab may modulate airway remodeling in severe asthma. Using forced expiratory volume in 1 second (FEV1) as a surrogate of airway remodeling, we aimed to investigate if an omalizumab add-on in severe allergic asthma may lead to a persistent reversal of airway obstruction and to evaluate the potential biomarkers of airway obstruction reversibility. Methods: Data were collected before (T0) and after omalizumab add-on for 1 year (T1, 32 patients), 2 years (T2, 26 patients) and 4 years (T4, 13 patients). All patients had baseline FEV1 below 80 % predicted (60.5 ± 12.5 %). After omalizumab, 18 patients showed FEV1 normalization (reversible airway obstruction; RAO+) already at T1 (88.7 ± 14.9 %, p < 0.0001) that persisted up to T4 (83.2 ± 7.9, p < 0.01), while 14 patients (RAO−) had FEV1 persistently decreased, from T1 (65.2 ± 8.4%, p < 0.05) up to T4 (61.4 ± 6.2%, not significant). Both groups had significant improvement of symptoms and exacerbations after omalizumab at T1, which persisted up to T4. The comparison between pretreatment characteristics of the two groups showed that RAO+ patients, had higher values of circulating eosinophils, exhaled nitric oxide (FENO), prevalence of rhinitis and nasal polyps, need of oral corticosteroids, shorter asthma duration, higher FEV1 and response to albuterol test. The optimal cut-off points predicting FEV1 normalization after omalizumab add-on were 30.5 ppb for FENO and 305 cells/µl for eosinophils. Conclusions: This study suggests that omalizumab add-on contributes to the persistent reversal of airway obstruction in a consistent number of patients with severe allergic asthma, and this beneficial effect is predicted by elevated pretreatment FENO and circulating eosinophils.

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.

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.

scholarly journals Effectiveness of mepolizumab in a real-life cohort of patients with severe refractory eosinophilic asthma and multiple comorbidities

2020 ◽  
Author(s):  
Claudia Crimi ◽  
Raffaele Campisi ◽  
Giulia Cacopardo ◽  
Rossella Intravaia ◽  
Santi Nolasco ◽  
...  
Keyword(s):  
Treatment Response ◽  
Real Life ◽  
Forced Expiratory Volume ◽  
Blood Eosinophil ◽  
Asthma Control Test ◽  
Eosinophilic Asthma ◽  
Life Effectiveness ◽  
Blood Eosinophil Count ◽  
Severe Eosinophilic Asthma ◽  
Act Score

AbstractBACKGROUNDPatients with severe asthma often suffer from comorbidities whose impact on the course of biological therapy has not been elucidated yet.OBJECTIVETo evaluate real-life effectiveness and the presence/absence of predictors of treatment response in patients with one or more comorbidities who received mepolizumab (MEPO) for the treatment of severe eosinophilic asthma (EA).METHODSHealth records of 31 patients were retrospectively analyzed. Asthma control test (ACT) score, blood eosinophil count, forced expiratory volume in 1 second (FEV1), FEV1% of predicted and FEV1/FVC (Forced Vital Capacity) ratio, oral corticosteroid (OCS) dosage and exacerbations were recorded at baseline (T0), after 3 (T1), 6 (T3), nine (T6) and 12 months (T12). A clinical response was defined as: i) 30% exacerbation decrease; ii) 80% blood eosinophilia reduction; iii) 3 point ACT increase; iv) FEV1 increase ≥ 200 mL.RESULTSAt T12 blood eosinophil level decreased by 89.89% (p>0.0001), an improvement in ACT of 3 points from baseline was recorded in 80.65% of patients (p>0.0001) and 96.77% of patients reduced by minimum 30% the number of exacerbations (p>0.0001). 84% of patients discontinued OCS (p>0.0001). FEV1 increased by 0.22 (p=0.0224) while FEV1/FVC was statistically significant only at T1. No significant differences were generally found among patients with a specific comorbidity. The number of comorbidities did not influence treatment response. Neither the comorbidities nor other characteristics (sex, BMI, age, smoking, baseline eosinophil level) influenced treatment response.CONCLUSIONSMEPO in patients with severe EA is effective regardless of the presence of one or more comorbidities.

Real-World Data Evaluation Of Total IgE, Specific IgE And Omalizumab Therapy In A Cohort Of Allergic Asthma Patients Treated In A Community-Based Practice

2020 ◽  
Author(s):  
Fortune O Alabi
Keyword(s):  
Allergic Asthma ◽  
Specific Ige ◽  
Forced Expiratory Volume ◽  
Act Scores ◽  
Asthma Control Test ◽  
Real World Data ◽  
Total Ige ◽  
Prick Test ◽  
Negative Results ◽  
Asthma Patients

Objective: In this study, we: (1) evaluated the correlation between total IgE and the presence of specific IgE; (2) compared the characteristics of patients with positive specific IgE to those with negative specific IgE; and, (3) analyzed the allergic testing results of patients on omalizumab and reported the effect of omalizumab on forced expiratory volume (FEV1) and asthma control test (ACT) results. Methods: Data from patients diagnosed with allergic asthma and seen at Florida Lung, Asthma & Sleep Specialists (FLASS) between January 2016 and June 2019 were analyzed. Parameters evaluated were total IgE, and levels of specific IgE to antigens in the ImmunoCAP test and skin prick test (SPT). Additional parameters for patients on omalizumab therapy for at least 6 months were FEV1, % predicted FEV1 and ACT results. Results: A total of 475 patients (114 males, 361 females) met the inclusion criteria. The mean age was 53 years (range: 17 to 89 years). Of these, 36 patients were not included in the analysis due to incomplete data. Mean total IgE was higher in patients with positive ImmunoCAP results compared to those with negative results (396 KU/L vs. 81.3 KU/L). There was a significant positive correlation between total IgE and levels of positive specific IgE in the ImmunoCAP test (p<0.0001, r=0.36, n=213 patients). The correlation between total IgE and levels of positive allergens in SPT was not significant (p=0.15, n=44 patients) Two positive reactions to allergens were seen in 22% of ImmunoCAP tests and 13% of SPT tests. There was no statistically significant improvement in FEV1 (p=0.097, CI -0.17 to 0.02) and % predicted FEV1 (p=0.109, CI -6.63 to 0.70) in patients who used omalizumab for at least 6 months. There was a statistically significant improvement in ACT scores (p=0.031, CI -4.21 to -0.21) in patients who used omalizumab for at least 6 months. Conclusion: Allergic asthma could be seen in patients who had an absence of specific IgE in ImmunoCAP and a negative reaction to SPT. The benefit of omalizumab therapy is not limited to allergic asthma patients with positive specific IgE.

Results in clinical practice in the treatment of severe eosinophilic asthma with mepolizumab: a real-life study

2021 ◽  
pp. 1-7
Author(s):  
Ana Isabel Enríquez-Rodríguez ◽  
Tamara Hermida Valverde ◽  
Pedro Romero Álvarez ◽  
Francisco Julián López-González ◽  
Jose Antonio Gullón Blanco ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real Life ◽  
Eosinophilic Asthma ◽  
Life Study ◽  
Severe Eosinophilic Asthma ◽  
Real Life Study

Omalizumab discontinuation in children with severe allergic asthma: An observational real‐life study

Allergy ◽  
2019 ◽  
Vol 74 (5) ◽  
pp. 999-1003 ◽  
Author(s):  
Antoine Deschildre ◽  
Juliette Roussel ◽  
Elodie Drumez ◽  
Rola Abou‐Taam ◽  
Cinthia Rames ◽  
...  
Keyword(s):  
Allergic Asthma ◽  
Real Life ◽  
Life Study ◽  
Severe Allergic Asthma ◽  
Real Life Study

Mepolizumab in the treatment of severe asthma with nasal polyposis: real-life study

2021 ◽  
Author(s):  
Sara Maria da Costa Martins ◽  
Eduarda Tinoco ◽  
Bruno Cabrita ◽  
Daniela Machado ◽  
Inês Franco ◽  
...  
Keyword(s):  
Severe Asthma ◽  
Nasal Polyposis ◽  
Real Life ◽  
Life Study ◽  
Real Life Study

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 Omalizumab effectiveness in patients with severe allergic asthma according to blood eosinophil count: the STELLAIR study

2018 ◽  
Vol 51 (5) ◽  
pp. 1702523 ◽  
Author(s):  
Marc Humbert ◽  
Camille Taillé ◽  
Laurence Mala ◽  
Vincent Le Gros ◽  
Jocelyne Just ◽  
...  
Keyword(s):  
Allergic Asthma ◽  
Eosinophil Count ◽  
Response Rate ◽  
Real Life ◽  
Blood Eosinophil ◽  
Exacerbation Rate ◽  
Blood Eosinophil Count ◽  
Life Study ◽  
Severe Allergic Asthma ◽  
Blood Eosinophils

Omalizumab is a monoclonal anti-IgE antibody used to treat severe allergic asthma (SAA). The aim of the STELLAIR study was to determine the importance of pre-treatment blood eosinophil count as a predictive measure for response to omalizumab.This retrospective real-life study was conducted in France between December 2015 and September 2016 using medical records of SAA omalizumab-treated patients. Response to omalizumab was assessed by three criteria: physician evaluation, reduction of ≥40% in annual exacerbation rate and a combination of both. Response rate was calculated according to blood eosinophil count measured in the year prior to omalizumab initiation.872 SAA omalizumab-treated patients were included by 78 physicians (723 adults (age ≥18 years) and 149 minors (age 6–17 years)). Blood eosinophil count was ≥300 cells·µL−1 in 52.1% of adults and 73.8% of minors. By physician evaluation, 67.2% of adults and 77.2% of minors were responders and 71.1% adults and 78.5% minors had a ≥40% reduction in the exacerbation rate. In adults, the response rate for combined criteria was 58.4% (95% CI 53.2–63.4%) for blood eosinophils ≥300 cells·µL−1 (n=377) and 58.1% (95% CI 52.7–63.4%) for blood eosinophils <300 cells·µL−1 (n=346).This study shows that a large proportion of patients with SAA have a blood eosinophil count ≥300 cells·µL−1, and suggests that omalizumab effectiveness is similar in “high” and “low” eosinophil subgroups.

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