Defining the Efficacy of Omalizumab in Nasal Polyposis: A POLYP 1 and POLYP 2 Subgroup Analysis

2021 ◽  
pp. 194589242110304
Author(s):  
Cecelia Damask ◽  
Meng Chen ◽  
Cecile T. J. Holweg ◽  
Bongin Yoo ◽  
Lauren A. Millette ◽  
...  
Keyword(s):  
Eosinophil Count ◽  
Mean Difference ◽  
Response To Therapy ◽  
Blood Eosinophil ◽  
Patient Factors ◽  
Blood Eosinophil Count ◽  
Aspirin Sensitivity ◽  
Patient Reported ◽  
Asthma Status ◽  
Snot 22

Background Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous disease with variable underlying pathophysiologies. Numerous patient factors have been linked to differences in disease severity, control, and response to treatment, including asthma status, aspirin sensitivity, previous sinonasal surgery, and blood eosinophil levels. Objective The present study examines the efficacy of the anti-immunoglobulin E therapy, omalizumab, versus placebo in patients with CRSwNP from the replicate POLYP 1 (NCT03280550) and POLYP 2 (NCT03280537) trials, grouped by inherent patient characteristics to determine the response to therapy. Methods Patients in prespecified subgroups from POLYP 1 and POLYP 2 (studies pooled for analysis) were examined. Subgroups included blood eosinophil count at baseline (>300 or ≤300 cells/μL), previous sinonasal surgery (yes or no), asthma status (yes or no), and aspirin sensitivity status (yes or no). Subgroups were examined for subgroup-specific adjusted mean difference (95% confidence interval [CI]) (omalizumab–placebo) in change from baseline at week 24 in Nasal Congestion Score (NCS), Nasal Polyp Score (NPS), Sino-Nasal Outcome Test-22 (SNOT-22), Total Nasal Symptom Score (TNSS), and University of Pennsylvania Smell Identification Test (UPSIT). Results Adjusted mean difference (95% CI) (omalizumab–placebo) in NCS, NPS, SNOT-22, TNSS, and UPSIT change from baseline at week 24 consistently favored omalizumab treatment over placebo in patients with blood eosinophil count >300 and ≤300 cells/μL, with or without previous sinonasal surgery, asthma, and aspirin sensitivity. Conclusion Together, these data suggest broad efficacy of omalizumab across clinical and patient-reported outcomes in patients with CRSwNP, independent of the underlying patient factors examined, including those with high eosinophil levels and those who have undergone previous surgery, which are associated with high recurrence. Clinical Trial Registration ClinicalTrials.gov identifiers: POLYP 1: ClinicalTrials.gov identifier NCT03280550 ( https://clinicaltrials.gov/ct2/show/NCT03280550 ); POLYP 2: ClinicalTrials.gov identifier NCT03280537 ( https://clinicaltrials.gov/ct2/show/NCT03280537 ).

scholarly journals Real-life effects of benralizumab on allergic chronic rhinosinusitis and nasal polyposis associated with severe asthma

2020 ◽  
Vol 34 ◽  
pp. 205873842095085 ◽  
Author(s):  
Nicola Lombardo ◽  
Corrado Pelaia ◽  
Marco Ciriolo ◽  
Marcello Della Corte ◽  
Giovanna Piazzetta ◽  
...  
Keyword(s):  
Allergic Asthma ◽  
Chronic Rhinosinusitis ◽  
Severe Asthma ◽  
Eosinophil Count ◽  
Nasal Polyposis ◽  
Rating Scale ◽  
Real Life ◽  
Blood Eosinophil ◽  
Blood Eosinophil Count ◽  
Snot 22

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.

Point-of-care blood eosinophil count in a severe asthma clinic setting

2017 ◽  
Vol 119 (1) ◽  
pp. 16-20 ◽  
Author(s):  
Enrico Heffler ◽  
Giovanni Terranova ◽  
Carlo Chessari ◽  
Valentina Frazzetto ◽  
Claudia Crimi ◽  
...  
Keyword(s):  
Severe Asthma ◽  
Eosinophil Count ◽  
Point Of Care ◽  
Blood Eosinophil ◽  
Blood Eosinophil Count ◽  
Clinic Setting

scholarly journals Blood eosinophil count to predict bronchial eosinophilic inflammation in COPD

2016 ◽  
Vol 47 (5) ◽  
pp. 1562-1564 ◽  
Author(s):  
Florence Schleich ◽  
Jean-Louis Corhay ◽  
Renaud Louis
Keyword(s):  
Eosinophil Count ◽  
Blood Eosinophil ◽  
Eosinophilic Inflammation ◽  
Blood Eosinophil Count

Clinical variables and protein biomarkers associated with blood eosinophil count and asthma in young adults

2021 ◽  
Author(s):  
Maura Kere ◽  
Sophia Björkander ◽  
Susanna Klevebro ◽  
Maria Ödling ◽  
Sandra Ekström ◽  
...  
Keyword(s):  
Young Adults ◽  
Eosinophil Count ◽  
Blood Eosinophil ◽  
Protein Biomarkers ◽  
Blood Eosinophil Count ◽  
Clinical Variables

scholarly journals Longitudinal stability of blood eosinophil count strata in the COPD COSYCONET cohort

2018 ◽  
Vol Volume 13 ◽  
pp. 2999-3002 ◽  
Author(s):  
Timm Greulich ◽  
Sina Mager ◽  
Tanja Lucke ◽  
Andreas Rembert Koczulla ◽  
Robert Bals ◽  
...  
Keyword(s):  
Eosinophil Count ◽  
Blood Eosinophil ◽  
Longitudinal Stability ◽  
Blood Eosinophil Count

Evaluation of the peripheral blood eosinophil count as a predictor for fractional exhaled nitric oxide or bronchodilator reversibility test outcome

2021 ◽  
Vol 42 (3) ◽  
pp. 228-234
Author(s):  
Bo Zhao ◽  
Haiming Zheng ◽  
Xiaopan Li ◽  
Rui Zheng
Keyword(s):  
Nitric Oxide ◽  
Roc Curve ◽  
Peripheral Blood ◽  
Eosinophil Count ◽  
Blood Eosinophil ◽  
Test Results ◽  
Fractional Exhaled Nitric Oxide ◽  
Peripheral Blood Eosinophil ◽  
Blood Eosinophil Count ◽  
Feno Level

Objective: This study aimed to explore the usefulness of the peripheral blood eosinophil count (PBEC) in assessing the level of fractional exhaled nitric oxide (FeNO) and predicting bronchodilation test results. Methods: We retrospectively analyzed the data of 384 outpatients who underwent FeNO measurement at our Department of Respiratory and Critical Care Medicine from March to June 2019. The FeNO level was compared among different PBECs to explore the association among them. Furthermore, the sensitivity and specificity of PBECs in predicting bronchodilation test results were assessed by using receiver operating characteristic (ROC) curve analysis. Results: There was a moderate correlation between PBECs and FeNO levels (r = 0.414; p < 0.05). In the subjects with PBECs ≥ 0.3 × 109/L, the median FeNO level was 39 ppb (interquartile range, 22.5‐65.5 ppb), significantly higher than in the subjects with PBECs < 0.3 × 109/L. The area under the ROC curve was 0.707 (p < 0.05). The maximum Youden index (0.348) was at PBECs = 0.205 × 109/L, which achieved sensitivity and specificity of 63% and 71.8%, respectively. Conclusion: PBECs ≥ 0.3 × 109/L can predict a positive bronchodilation test result and a high FeNO level, with a probability of 50% in the subjects with chronic cough and shortness of breath; in the absence of corresponding symptoms and a low PBEC, the predictive value was small. For hospitals not able to conduct FeNO measurements, for outpatients with poor economic conditions, and for patients with confirmed or suspected novel coronavirus disease 2019, the PBEC, in conjunction with a patient's clinical symptoms, can improve the diagnostic accuracy of allergic asthma and assessment of airway inflammation while reducing the risk of infection.

Blood eosinophil count and FeNO to predict benralizumab effectiveness in real-life severe asthma patients

2021 ◽  
pp. 1-12
Author(s):  
Hirofumi Watanabe ◽  
Toshihiro Shirai ◽  
Keita Hirai ◽  
Taisuke Akamatsu ◽  
Hiromasa Nakayasu ◽  
...  
Keyword(s):  
Severe Asthma ◽  
Eosinophil Count ◽  
Real Life ◽  
Blood Eosinophil ◽  
Blood Eosinophil Count ◽  
Asthma Patients

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.

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