scholarly journals Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Dave Singh ◽  
Jadwiga A. Wedzicha ◽  
Salman Siddiqui ◽  
Alberto de la Hoz ◽  
Wenqiong Xue ◽  
...  
Keyword(s):  
Eosinophil Count ◽  
Phase Iii ◽  
Airflow Limitation ◽  
Blood Eosinophil ◽  
Exacerbation Rate ◽  
Blood Eosinophil Count ◽  
Pooled Data ◽  
Link Type ◽  
Exacerbation Risk ◽  
Blood Eosinophils

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

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.

scholarly journals COPD patients prescribed inhaled corticosteroid in primary care: time for re-assessment based on exacerbation rate and blood eosinophils?

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Osman Savran ◽  
Nina Godtfredsen ◽  
Torben Sørensen ◽  
Christian Jensen ◽  
Charlotte Suppli Ulrik
Keyword(s):  
Primary Care ◽  
Eosinophil Count ◽  
Large Cohort ◽  
Blood Eosinophil ◽  
Study Cohort ◽  
Inhaled Corticosteroid ◽  
Exacerbation Rate ◽  
Blood Eosinophil Count ◽  
Copd Patients ◽  
Blood Eosinophils

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.

scholarly journals COPD patients prescribed inhaled corticosteroid in primary care – Time for re-assessment based on exacerbation rate and blood eosinophils?

2021 ◽  
Author(s):  
Osman Savran ◽  
Nina Skavlan Godtfredsen ◽  
Torben Sørensen ◽  
Christian Jensen ◽  
Charlotte Ulrik
Keyword(s):  
Primary Care ◽  
Eosinophil Count ◽  
Large Cohort ◽  
Blood Eosinophil ◽  
Study Cohort ◽  
Inhaled Corticosteroid ◽  
Exacerbation Rate ◽  
Blood Eosinophil Count ◽  
Copd Patients ◽  
Blood Eosinophils

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.

scholarly journals COPD patients prescribed inhaled corticosteroid in primary care – Time for re-assessment based on exacerbation rate and blood eosinophils?

2020 ◽  
Author(s):  
Osman Savran ◽  
Nina Skavlan Godtfredsen ◽  
Torben Sørensen ◽  
Christian Jensen ◽  
Charlotte Ulrik
Keyword(s):  
Primary Care ◽  
Eosinophil Count ◽  
Large Cohort ◽  
Blood Eosinophil ◽  
Study Cohort ◽  
Inhaled Corticosteroid ◽  
Exacerbation Rate ◽  
Blood Eosinophil Count ◽  
Copd Patients ◽  
Blood Eosinophils

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.

scholarly journals COPD patients prescribed inhaled corticosteroid in primary care – Time for re-assessment based on exacerbation rate and blood eosinophils?

2020 ◽  
Author(s):  
Osman Savran ◽  
Nina Skavlan Godtfredsen ◽  
Torben Sørensen ◽  
Christian Jensen ◽  
Charlotte Ulrik
Keyword(s):  
Primary Care ◽  
Eosinophil Count ◽  
Large Cohort ◽  
Blood Eosinophil ◽  
Study Cohort ◽  
Inhaled Corticosteroid ◽  
Exacerbation Rate ◽  
Blood Eosinophil Count ◽  
Copd Patients ◽  
Blood Eosinophils

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.

scholarly journals Comparative Efficacy and Safety of Dupilumab and Benralizumab in Patients with Inadequately Controlled Asthma: A Systematic Review

2020 ◽  
Vol 21 (3) ◽  
pp. 889 ◽  
Author(s):  
Koichi Ando ◽  
Akihiko Tanaka ◽  
Hironori Sagara
Keyword(s):  
Systematic Review ◽  
Eosinophil Count ◽  
Blood Eosinophil ◽  
Efficacy And Safety ◽  
Exacerbation Rate ◽  
Blood Eosinophil Count ◽  
Indirect Treatment Comparison ◽  
Treatment Comparison ◽  
Significant Difference ◽  
Indirect Treatment

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.

scholarly journals Blood eosinophil count and exacerbation risk in patients with COPD

2017 ◽  
Vol 50 (1) ◽  
pp. 1700761 ◽  
Author(s):  
Marjan Kerkhof ◽  
Samatha Sonnappa ◽  
Dirkje S. Postma ◽  
Guy Brusselle ◽  
Alvar Agustí ◽  
...  
Keyword(s):  
Eosinophil Count ◽  
Blood Eosinophil ◽  
Blood Eosinophil Count ◽  
Exacerbation Risk

scholarly journals Blood eosinophil count, a marker of inhaled corticosteroid effectiveness in preventing COPD exacerbations in post-hoc RCT and observational studies: systematic review and meta-analysis

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Timothy H. Harries ◽  
Victoria Rowland ◽  
Christopher J. Corrigan ◽  
Iain J. Marshall ◽  
Lucy McDonnell ◽  
...  
Keyword(s):  
Systematic Review ◽  
Eosinophil Count ◽  
Observational Studies ◽  
Independent Effect ◽  
Blood Eosinophil ◽  
Blood Eosinophil Count ◽  
Exacerbation Risk ◽  
Long Acting ◽  
Post Hoc

Abstract Background Blood eosinophil count has been proposed as a predictor of response to inhaled corticosteroid (ICS) in the prevention of acute exacerbations of COPD. An optimal threshold of blood eosinophil count for prescribing ICS has not been agreed. Doubt has been cast on the role by observational studies. The role of inhaled corticosteroids in this relationship, independent of long-acting bronchodilators, has not been examined. Methods We conducted a systematic review of post-hoc analyses of randomised controlled trials (RCTs) and observational studies examining three blood eosinophil thresholds and the independent role of ICS. Included studies were categorised by the form (relative or absolute count) and cut point of eosinophil threshold used. Thresholds assessed were relative eosinophil count of 2%, and absolute counts of 150 cells/μL and 300 cells/μL. Three meta-analyses of the effect of ICS use in post-hoc analyses of RCTs based on these counts were carried out. Initial analysis included all studies of ICS vs. any non-ICS regimen. Further analysis examined the effect of ICS, independent of the effect of long-acting bronchodilators. Results Sixteen studies examined the association between blood eosinophil count and response of exacerbation risk to ICS, in COPD patients. Eleven studies (25,881 patients) were post-hoc analyses of RCTs. Five studies (109,704 patients) were retrospective observational studies. The independent effect of ICS on the reduction of exacerbation risk was 20% at ≥2% blood eosinophil threshold (RR, 0.80; 95% CI, 0.74–0.85), 35% at ≥150 cells/μL blood eosinophil threshold (RR, 0.65; 0.52–0.79), and 39% at ≥300 cells/μL blood eosinophil threshold (RR, 0.61; 0.44–0.78). No association was found in four out of five observational studies. Conclusion This is the first systematic review to assess, in post-hoc analyses of RCTs, the independent effect of ICS in reducing the risk of COPD exacerbation across a range of blood eosinophil thresholds. Association between ICS prescription and reduced exacerbation risk at these thresholds was confirmed. The lack of association found in the observational studies questions the relevance of these observations to a “real world” COPD population. To clarify the clinical utility of this biomarker, the association should be tested in prospective effectiveness studies.

Sign in / Sign up

Export Citation Format

Share Document