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 ◽  
...  

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.

2020 ◽  
Vol 34 ◽  
pp. 205873842095085 ◽  
Author(s):  
Nicola Lombardo ◽  
Corrado Pelaia ◽  
Marco Ciriolo ◽  
Marcello Della Corte ◽  
Giovanna Piazzetta ◽  
...  

The aim of this study has been to evaluate the efficacy of the IL-5 receptor blocker benralizumab on chronic rhinosinusitis with nasal polyposis (CRSwNP), associated with severe eosinophilic allergic asthma. Ten patients with severe eosinophilic allergic asthma and CRSwNP were enrolled. Sino-nasal outcome test (SNOT-22), numerical rating scale (NRS), endoscopic nasal polyp score, Lund Mackey CT (computed tomography) score, and blood eosinophil count were measured at baseline and after 24 weeks of treatment with benralizumab. All the above clinical, endoscopic, imaging, and hematological parameters significantly improved after 24 weeks of treatment with benralizumab. In particular, SNOT-22 decreased from 61.10 ± 17.20 to 26.30 ± 19.74 ( P < 0.001), NRS decreased from 7.20 ± 1.55 to 3.40 ± 2.22 ( P < 0.001), the endoscopic polyp nasal score decreased from 4.20 ± 1.32 to 2.50 ± 1.78 ( P < 0.001), the Lund-Mackay CT score decreased from 16.60 ± 5.50 to 6.90 ± 5.99 ( P < 0.001), and blood eosinophil count decreased from 807.3 ± 271.1 cells/μL to 0 cells/μL ( P < 0.0001). These results strongly suggest that benralizumab exerted a very effective therapeutic action on CRSwNP associated with severe asthma, thus improving nasal symptoms and decreasing polyp size.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Osman Savran ◽  
Nina Godtfredsen ◽  
Torben Sørensen ◽  
Christian Jensen ◽  
Charlotte Suppli Ulrik

Abstract Background and objective Inhaled corticosteroid (ICS) therapy for COPD should be guided by exacerbations and blood-eosinophils according to the GOLD 2020 strategy document. In the present study, we applied these recent recommendations in a large cohort of COPD patients recruited from general practice. Methods The participating general practitioners (n = 144) recruited patients with a diagnosis of COPD currently prescribed ICS and reported data on exacerbation history and blood-eosinophils. Clinical variables were compared using two-sample t-tests. Results The study cohort comprised 1,567 COPD patients (44% males and mean age 72 years). In the past 12 months, 849 (54%) of the COPD patients currently prescribed ICS had no exacerbation, whereas 383 (24%) and 328 (21%) patients, respectively, had a history of one exacerbation and two or more exacerbations. Compared to patients with one or no exacerbation, patients with ≥ 2 exacerbations (21%) per year reported more dyspnea (p < 0.001) and had higher degree of airflow obstruction (p < 0.001). Among patients with no and at least one exacerbation within the preceding 12 months, 30% and 26%, respectively, had a blood-eosinophil count ≥ 0.3 × 109/L. In patients with two or more exacerbations within the last 12 months, 77% had a blood-eosinophil count of ≥ 0.1 × 109/L. Furthermore, 166 patients (11%) had at least one hospital admission due to COPD exacerbation, and a blood-eosinophil count of ≥ 0.1 × 109/L. Conclusion This study of a large cohort of COPD patients currently prescribed inhaled corticosteroids suggests the need for re-evaluating the management strategy to increase benefit and reduce adverse effects of ICS treatment in COPD patients managed in primary care.


2021 ◽  
Author(s):  
Osman Savran ◽  
Nina Skavlan Godtfredsen ◽  
Torben Sørensen ◽  
Christian Jensen ◽  
Charlotte Ulrik

Abstract Background and objective: Inhaled corticosteroid (ICS) therapy for COPD should be guided by exacerbations and blood-eosinophils according to the GOLD 2020 strategy document. In the present study, we applied these recent recommendations in a large cohort of COPD patients recruited from general practice. Methods: The participating general practitioners (n = 144) recruited patients with a diagnosis of COPD currently prescribed ICS and reported data on exacerbation history and blood-eosinophils. Clinical variables were compared using two-sample t-tests. Results: The study cohort comprised 1,567 COPD patients (44% males and mean age 72 years). In the past 12 months, 849 (54%) of the COPD patients currently prescribed ICS had no exacerbation, whereas 383 (24%) and 328 (21%) patients, respectively, had a history of one exacerbation and two or more exacerbations. Compared to patients with one or no exacerbation, patients with ≥2 exacerbations (21%) per year reported more dyspnea (p<0.001) and had higher degree of airflow obstruction (p<0.001). Among patients with no and at least one exacerbation within the preceding 12 months, 30% and 26%, respectively, had a blood-eosinophil count ≥ 0.3 x 109/L. In patients with two or more exacerbations within the last 12 months, 77% had a blood-eosinophil count of ≥ 0.1 x 109/L. Furthermore, 166 patients (11%) had at least one hospital admission due to COPD exacerbation, and a blood-eosinophil count of ≥ 0.1 x 109/L.Conclusion: This study of a large cohort of COPD patients currently prescribed inhaled corticosteroids suggests the need for re-evaluating the management strategy to increase benefit and reduce adverse effects of ICS treatment in COPD patients managed in primary care.


2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Dave Singh ◽  
Jadwiga A. Wedzicha ◽  
Salman Siddiqui ◽  
Alberto de la Hoz ◽  
Wenqiong Xue ◽  
...  

Abstract Background Chronic obstructive pulmonary disease (COPD) is characterised by progressive airflow limitation and chronic inflammation. Predicting exacerbations of COPD, which contribute to disease progression, is important to guide preventative treatment and improve outcomes. Blood eosinophils are a biomarker for patient responsiveness to inhaled corticosteroids (ICS); however, their effectiveness as a predictive biomarker for COPD exacerbations is unclear. Methods This post hoc analysis pooled data from 11 Boehringer Ingelheim-sponsored Phase III and IV randomised COPD studies with similar methodologies. Exacerbation data were collected from these studies, excluding patients from the ICS withdrawal arm of the WISDOM® study. Patients were grouped according to their baseline blood eosinophil count, baseline ICS use and number of exacerbations in the year prior to each study. Results Exacerbation rate data and baseline eosinophil count were available for 22,125 patients; 45.6% presented with a baseline blood eosinophil count of ≤ 150 cells/μL, 34.3% with 150–300 cells/μL and 20.1% with > 300 cells/μL. The lowest exacerbation rates were observed in patients with ≤ 150 cells/μL, with small increases in exacerbation rate observed with increasing eosinophil count. When stratified by exacerbation history, the annual rate of exacerbations for patients with 0 exacerbations in the previous year increased in line with increasing eosinophil counts (0.38 for ≤ 150 cells/μL, 0.39 for 150–300 cells/μL and 0.44 for > 300 cells/μL respectively). A similar trend was identified for patients with one exacerbation in the previous year, 0.62, 0.66 and 0.67 respectively. For patients with ≥ 2 exacerbations, exacerbation rates fluctuated between 1.02 (≤ 150 cells/μL) to 1.10 (150–300 cells/μL) and 1.07 (> 300 cells/μL). Higher exacerbation rates were noted in patients treated with ICS at baseline (range 0.75 to 0.82 with increasing eosinophil count) compared with patients not on ICS (range 0.45 to 0.49). Conclusion We found no clinically important relationship between baseline blood eosinophil count and exacerbation rate. Hence, the current analysis does not support the use of blood eosinophils to predict exacerbation risk; however, previous exacerbation history was found to be a more reliable predictor of future exacerbations. Trial registration ClinicalTrials.gov Identifiers: NCT00168844, NCT00168831, NCT00387088, NCT00782210, NCT00782509, NCT00793624, NCT00796653, NCT01431274, NCT01431287, NCT02296138 and NCT00975195. Graphical abstract


2020 ◽  
Author(s):  
Osman Savran ◽  
Nina Skavlan Godtfredsen ◽  
Torben Sørensen ◽  
Christian Jensen ◽  
Charlotte Ulrik

Abstract Background and objective: Inhaled corticosteroid (ICS) therapy for COPD should be guided by exacerbations and blood-eosinophils according to the GOLD 2020 strategy document. In the present study, we applied these recent recommendations in a large cohort of COPD patients recruited from general practice.Methods: The participating general practitioners (n = 144) recruited patients with a diagnosis of COPD currently prescribed ICS and reported data on exacerbation history and blood-eosinophils. Clinical variables were compared using two-sample t-tests.Results: The study cohort comprised 1,567 COPD patients (44% males and mean age 72 years). In the past 12 months, 849 (54%) of the COPD patients currently prescribed ICS had no exacerbation, whereas 383 (24%) and 328 (21%) patients, respectively, had a history of one exacerbation and two or more exacerbations. Compared to patients with one or no exacerbation, patients with ≥2 exacerbations (21%) per year reported more dyspnea (p<0.001) and had higher degree of airflow obstruction (p<0.001). Among patients with no and at least one exacerbation within the preceding 12 months, 30% and 26%, respectively, had a blood-eosinophil count ≥ 0.3 x 109/L. In patients with two or more exacerbations within the last 12 months, 77% had a blood-eosinophil count of ≥ 0.1 x 109/L. Furthermore, 166 patients (11%) had at least one hospital admission due to COPD exacerbation, and a blood-eosinophil count of ≥ 0.1 x 109/L.Conclusion: This study of a large cohort of COPD patients currently prescribed inhaled corticosteroids suggests the need for re-evaluating the management strategy to increase benefit and reduce adverse effects of ICS treatment in COPD patients managed in primary care.


2020 ◽  
Author(s):  
Osman Savran ◽  
Nina Skavlan Godtfredsen ◽  
Torben Sørensen ◽  
Christian Jensen ◽  
Charlotte Ulrik

Abstract Background and objective Inhaled corticosteroid (ICS) therapy for COPD should be guided by exacerbations and blood eosinophils according to the GOLD 2020 strategy document. In the present study, we applied these recent recommendations in a large cohort of COPD patients recruited from general practice. Methods The participating general practitioners (n = 144) recruited patients with a diagnosis of COPD currently prescribed ICS and reported data on exacerbation history and blood-eosinophils. Clinical variables were compared using multinomial logistic regression. Results The study cohort comprised 1,567 COPD patients (44% males and mean age 73 years). In the past 12 months, 849 (54%) of the COPD patients currently prescribed ICS had had no exacerbation, whereas 383 (24%) and 328 (21%) patients, respectively, had a history of one exacerbation and two or more exacerbations. Compared to patients with one or no exacerbation, patients with ≥2 exacerbations (21%) per year reported more respiratory symptoms (p<0.001). Among patients with no and at least one exacerbation within the preceding 12 months, 30% and 27%, respectively, had a blood-eosinophil count ≥ 0.3 x 10 9 /L. In patients with two or more exacerbations within the last 12 months, 77% had a blood-eosinophil count of ≥ 0.1 x 10 9 /L. Furthermore, 166 patients (11%) had at least one hospital admission due to COPD exacerbation, and a blood-eosinophil count of ≥ 0.1 x 10 9 /L. Conclusion This study of a large cohort of COPD patients currently prescribed inhaled corticosteroids suggest the need for re-evaluating the management strategy to increase benefit and reduce adverse effects of ICS treatment in COPD patients managed in primary care.


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

2021 ◽  
pp. 1-12
Author(s):  
Hirofumi Watanabe ◽  
Toshihiro Shirai ◽  
Keita Hirai ◽  
Taisuke Akamatsu ◽  
Hiromasa Nakayasu ◽  
...  

2020 ◽  
Vol 21 (3) ◽  
pp. 889 ◽  
Author(s):  
Koichi Ando ◽  
Akihiko Tanaka ◽  
Hironori Sagara

No head-to-head trials have compared the efficacy and safety between the licensed dosage and administration dosage of dupilumab and benralizumab for inadequately controlled asthma. We conducted an indirect treatment comparison to estimate differences in the efficacy and safety between dupilumab and benralizumab for inadequately controlled asthma using the Bayesian approach. The primary efficacy endpoint was annual exacerbation rate (AER). A subgroup analysis by blood eosinophil count was also performed. The primary safety endpoint was the incidence of any adverse events (AAEs). The results demonstrate that there was no significant difference in the AER between dupilumab and benralizumab in overall patients and the subgroup with the blood eosinophil count of <150. However, the AER was significantly lower in the dupilumab group than in the benralizumab group in the subgroup with a blood eosinophil count of ≥150 but <300, and ≥300 with the rate ratio and 95% credible interval of 0.51 (0.29–0.92) and 0.58 (0.39–0.84), respectively. There was no significant difference in the AAEs between the dupilumab and benralizumab groups. This indirect treatment comparison indicates that dupilumab is superior to benralizumab in patients with inadequately controlled asthma having higher blood eosinophil counts. A direct comparison is required to provide definitive evidence. Systematic Review Registration: UMIN-CTR no. UMIN000036256.


2019 ◽  
Vol 13 ◽  
pp. 175346661984127 ◽  
Author(s):  
Paolo Solidoro ◽  
Filippo Patrucco ◽  
Francesca de Blasio ◽  
Luisa Brussino ◽  
Michela Bellocchia ◽  
...  

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.


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