A Phase 3 interventional study of Benralizumab (Medi-563) and Placebo in Asthma, sponsored by AstraZeneca. Completed at 213 sites in 14 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during the 24-week treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps. The study design has been updated to include a 56-week open label ANDHI in Practice (ANDHI IP) sub study upon the completion of the 24-week double-blind period of the ANDHI study.
This is a Phase IIIb, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and the safety of repeat dosing of benralizumab 30 mg subcutaneous (sc) versus placebo on top of standard of care asthma therapy in patients with severe uncontrolled asthma. Approximately 630 patients with peripheral blood eosinophil counts ≥150 cells/μL will be randomized 2:1 to receive benralizumab 30 mg sc or matched placebo for 24 weeks.
After enrolment, eligible patients will enter an up to 42-day screening/run-in period. Patients who meet eligibility criteria will be randomized 2:1 on Day 0 to receive either benralizumab or placebo every 56 days (every 8 weeks) through Week 16, with end of treatment (EOT) at Day 168 (Week 24). At the completion of the 24-week doubleblind period of the ANDHI study, eligible patients in benralizumab and placebo arm may enter a 56-week open label period (ANDHI in Practice [ANDHI IP] substudy), in which concomitant asthma therapies will be tapered as directed by the protocol in those patients who achieve and maintain asthma control (defined as ACQ6 score \<1.5 and no clinically significant asthma exacerbations that required a burst of systemic corticosteroid or a hospitalization due to asthma between reduction visits) with add-on benralizumab.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 660 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Excessive variability in lung function by satisfying ≥ 1 of the following criteria:
Peripheral blood eosinophil count either:
OR
≥150 to \<300 cells/μL assessed by central laboratory at either Visit 1 or Visit 2, IF ≥1 of the following 5 clinical criteria (a to e) is met:
For inclusion in the open label ANDHI IP sub study patients should meet the following criteria:
Exclusion Criteria:
Exclusion criteria for the open label ANDHI IP sub study:
Patients should not enter the open label ANDHI IP sub study if any of the following exclusion criteria are fulfilled. Each exclusion criterion should be reviewed in all potential participants, including those who transition directly from the double-blind period and those with a delay between completing the EOT Visit 11 and the first open label visit (Visit 13).
Benralizumab (Medi563) Administered subcutaneously at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days) In the open label ANDHI IP sub study, all patients will receive benralizumab subcutaneously at Day 168 (Week 24), Day 196 (Week 28), Day 224 (Week 32), Day 280 (Week 40), Day 336 (Week 48), Day 392 (Week 56), Day 448 (Week 64), and Day 504 (Week 72).
Drug: Benralizumab (Medi-563)
Administered subcutaneously at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days)
Drug: Placebo
30mg Benralizumab administered as a subcutaneous injection at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days) In the open label ANDHI IP sub study, all patients will receive benralizumab subcutaneously at Day 168 (Week 24), Day 196 (Week 28), Day 224 (Week 32), Day 280 (Week 40), Day 336 (Week 48), Day 392 (Week 56), Day 448 (Week 64), and Day 504 (Week 72).
Placebo administered as a subcutaneous injection at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days)
Annualized Rate of Asthma Exacerbations Over the Treatment Period (up to Week 24)
An asthma exacerbation was defined as a worsening of asthma that led to any of the following: * Use of systemic corticosteroids (or temporary increase in stable oral corticosteroids \[OCS\] background dose) for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. * An emergency room/urgent care visit (defined as evaluation and treatment for \< 24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above). * An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours) due to asthma. Annual exacerbation rate = 365.25\*total number of exacerbations / total duration of follow-up within the treatment group. Annual asthma exacerbation rates over the 24-week period were estimated using a negative binomial model.
Time frame: Baseline (Week 0) up to Week 24
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Total Score to the EOT (Week 24)
The SGRQ is a 50-item patient-reported outcome instrument which measures the health status of patients with airway obstruction diseases. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ total score indicates the impact of disease on overall health status and is expressed as a percentage of overall impairment (scores range from 0 to100, with 100 representing worst possible health status and 0 indicating the best possible health status). The least squares (LS) mean change from baseline in SGRQ total score at Week 24 is presented.
Time frame: Baseline (Week 0) and Week 24
Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in First Second (FEV1) to the EOT (Week 24)
Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorized delegate according to American Thoracic Society/European Respiratory Society guidelines. The LS mean change from baseline in pre-BD FEV1 at Week 24 is presented.
Time frame: Baseline (Week 0) and Week 24
Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score to the EOT (Week 24)
The ACQ-6 is a shortened version of the ACQ that assesses asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath and wheezing) and short-acting β-2 receptor agonist use. Patients were asked to recall the status of their asthma during the previous week and respond to the questions of the ACQ-6 on a 7-point scale. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is computed as the mean of the responses from all the items in the questionnaire. Mean scores of ≤0.75 indicated well-controlled asthma, scores between 0.75 and \<1.5 indicated partly-controlled asthma, and a score ≥1.5 indicated not well-controlled asthma. The LS mean change from baseline in ACQ-6 score at Week 24 is presented.
Time frame: Baseline (Week 0) and Week 24
Time to First Asthma Exacerbation (up to Week 24)
Time to first asthma exacerbation was derived as follows: Start date of first asthma exacerbation - Date of randomization + 1. The time to first asthma exacerbation for patients who did not experience an asthma exacerbation during the treatment period was censored at the EOT visit (Week 24) for patients who completed the study. Patients who withdrew from the study or were lost to follow-up before the EOT visit were censored at the last visit date after which an exacerbation could not be assessed. The median time to first asthma exacerbation was not calculated, so the number of patients who experienced an asthma exacerbation is presented for the measured values.
Time frame: Baseline (Week 0) up to Week 24
Change From Run-in Baseline Home Peak Expiratory Flow (PEF) (Morning and Evening) to the EOT (Week 24)
Home PEF testing was performed by the patient each morning after awakening and before taking their morning asthma medications, and each evening using a peak flow meter. Measurements were taken at approximately the same time each day and recorded in the Asthma Daily Diary. The maximum of the 3 measurements performed every morning and evening were used in the calculation of the weekly means. A weekly mean was calculated as the sum of all non-missing daily measures over the 7 sequential days divided by the number of non-missing daily measures. If more than 3 daily measures (\> 50%) within a period were missing, then the weekly mean for that period was set to 'missing'. Change from run-in baseline in weekly means for morning PEF and evening PEF are presented. Baseline was the average for data collected over the last 7 days of the run-in period prior to randomization.
Time frame: Run-in baseline (from Day -28 to Day 0) and Week 24
Change From Baseline in Short Form 36-item Health Survey, Version 2 (SF-36v2) to the EOT (Week 24)
The SF-36v2 is a 36-item survey of functional health and well-being, with a 1 week recall period. The 8-domain profile consists of the following subscales: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The physical and mental health component summary scores are computed from subscale scores to give a broader metric of physical and mental health-related quality of life. Each domain score, as well as the physical and mental component scores, were scored on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Norm-based scoring was used to calculate the 8 SF-36v2 subscales and the 2 component scores. The LS mean change from baseline in each of the SF-36 subscale and component summary scores at Week 24 are presented.
Time frame: Baseline (Week 0) and Week 24
Patient Global Impression of Severity (PGI-S): Responder Status at the EOT (Week 24)
The PGI-S is a single question asking the patient to rate the overall severity of their symptoms using a 6-point categorical response scale from 0 to 5 where 0=no symptoms and 5=very severe symptoms. Higher scores indicate a worse outcome. Improvement was defined as a PGI-S at EOT (Week 24) better than PGI-S at baseline. Important improvement was defined as PGI-S at baseline = moderate symptoms or severe symptoms or very severe symptoms shifting to PGI-S at EOT = no symptoms or very mild symptoms or mild symptoms. Patients with missing data at the EOT visit who did not complete the study were considered non-responders. For patients who completed the study with missing data at EOT (Week 24), their last evaluable post-baseline score was used to define responder status. The percentage of patients for each of the indicated PGI-S responder categories are presented.
Time frame: Baseline (Week 0) and Week 24
Clinician Global Impression of Change (CGI-C) and Patient Global Impression of Change (PGI-C): Responder Status at the EOT (Week 24)
The Investigator (clinician) and the patient were asked separately to rate the degree of change in the overall asthma status compared to the start of treatment, i.e. baseline randomization visit. A 7-point rating scale was used for the CGI-C (rated by Investigator) and PGI-C (rated by patient) where: 1=Very Much Improved; 2=Much Improved; 3=Minimally Improved; 4=No Changes; 5=Minimally Worse; 6=Much Worse, and 7=Very Much Worse. Higher scores indicate a worse outcome. Responder category definitions: Much improved = (Much improved, Very much improved); Very much improved = (Very much improved). Patients with missing data at the EOT visit who did not complete the study were considered non-responders. For patients who completed the study with missing data at EOT (Week 24), their last evaluable post-baseline score was used to define responder status. The percentage of patients for each of the indicated CGI-C and PGI-C responder categories are presented.
Time frame: Baseline (Week 0) and Week 24
Change From Baseline in Predominant Symptom and Impairment Assessment (PSIA) Severity Score for Average of Top 3 Ranked Symptoms/Impairments and for Top Ranked Symptom/Impairment at the EOT (Week 24)
For part 1 of the PSIA only administered at baseline, patients reviewed 8 concepts (including cardinal asthma symptoms, activities, awakenings, triggers) and selected those which were typically bothersome. Based on part 1 selections, part 2 of the PSIA produced a rank ordered list of bothersome concepts individualized per the patient for subsequent evaluation. For part 3 of the PSIA assessed at baseline and during the study, patients recorded the severity of each selected symptom or impairment using an 11-point numeric rating scale where: 0=Did not experience and 10=Worst I can imagine. Higher scores indicate a worse outcome. The LS mean change from baseline in PSIA severity score for the indicated categories at Week 24 are presented. A negative change from baseline indicates an improvement in symptoms. Note: Average PSIA was calculated only where all of top 3 ranked symptoms/impairments were available, otherwise average was set to missing.
Time frame: Baseline (Week 0) and Week 24
Change From Baseline in the Sino-Nasal Outcome Test Item 22 (SNOT-22) Total Score to the EOT (Week 24)
The 22-item SNOT 22 questionnaire was used to assess the rhinosinusitis health status and quality of life of patients with baseline chronic rhinosinusitis with nasal polyposis. The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110. Higher scores indicate poorer outcomes. The LS mean changes from baseline in SNOT-22 total score in patients in the chronic rhinosinusitis with nasal polyposis sub-study analysis set at Week 24 are presented.
Time frame: Baseline (Week 0) and Week 24
Patients with severe uncontrolled asthma and peripheral blood eosinophil counts of ≥150 cells/microliter (μL) (with major subgroups of 150-300 cells/μL plus clinical features and ≥300 cells/μL) were recruited to 221 centers in 14 countries. Patients were randomized in a 2:1 ratio to receive benralizumab or matched placebo for 24 weeks. Results are reported for the double-blind period of the study (data cut-off: 12 Sep 2019).
| Milestone | Benralizumab | Placebo |
|---|---|---|
| Started | 431 | 229 |
| Received treatment | 427 | 229 |
| Completed | 398 | 218 |
| Not completed | 33 | 11 |
| Withdrew: Adverse event | 7 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Protocol-specified withdrawal criterion | 2 | 1 |
| Withdrew: Withdrawal by subject | 17 | 5 |
| Withdrew: Other | 2 | 2 |
| Withdrew: Randomized in error | 4 | 0 |
An asthma exacerbation was defined as a worsening of asthma that led to any of the following: * Use of systemic corticosteroids (or temporary increase in stable oral corticosteroids \[OCS\] background dose) for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. * An emergency room/urgent care visit (defined as evaluation and treatment for \< 24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above). * An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours) due to asthma. Annual exacerbation rate = 365.25\*total number of exacerbations / total duration of follow-up within the treatment group. Annual asthma exacerbation rates over the 24-week period were estimated using a negative binomial model.
| Events/year | Benralizumab | Placebo |
|---|---|---|
| Annualized Rate of Asthma Exacerbations Over the Treatment Period (up to Week 24) | 0.94 (0.79 to 1.12) | 1.86 (1.54 to 2.24) |
The SGRQ is a 50-item patient-reported outcome instrument which measures the health status of patients with airway obstruction diseases. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ total score indicates the impact of disease on overall health status and is expressed as a percentage of overall impairment (scores range from 0 to100, with 100 representing worst possible health status and 0 indicating the best possible health status). The least squares (LS) mean change from baseline in SGRQ total score at Week 24 is presented.
| Scores on a scale | Benralizumab | Placebo |
|---|---|---|
| Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Total Score to the EOT (Week 24) | -23.06 ± 1.00 | -14.94 ± 1.34 |
Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorized delegate according to American Thoracic Society/European Respiratory Society guidelines. The LS mean change from baseline in pre-BD FEV1 at Week 24 is presented.
| Liters (L) | Benralizumab | Placebo |
|---|---|---|
| Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in First Second (FEV1) to the EOT (Week 24) | 0.30 ± 0.02 | 0.14 ± 0.03 |
The ACQ-6 is a shortened version of the ACQ that assesses asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath and wheezing) and short-acting β-2 receptor agonist use. Patients were asked to recall the status of their asthma during the previous week and respond to the questions of the ACQ-6 on a 7-point scale. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is computed as the mean of the responses from all the items in the questionnaire. Mean scores of ≤0.75 indicated well-controlled asthma, scores between 0.75 and \<1.5 indicated partly-controlled asthma, and a score ≥1.5 indicated not well-controlled asthma. The LS mean change from baseline in ACQ-6 score at Week 24 is presented.
| Scores on a scale | Benralizumab | Placebo |
|---|---|---|
| Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score to the EOT (Week 24) | -1.47 ± 0.06 | -1.01 ± 0.08 |
Time to first asthma exacerbation was derived as follows: Start date of first asthma exacerbation - Date of randomization + 1. The time to first asthma exacerbation for patients who did not experience an asthma exacerbation during the treatment period was censored at the EOT visit (Week 24) for patients who completed the study. Patients who withdrew from the study or were lost to follow-up before the EOT visit were censored at the last visit date after which an exacerbation could not be assessed. The median time to first asthma exacerbation was not calculated, so the number of patients who experienced an asthma exacerbation is presented for the measured values.
| Participants | Benralizumab | Placebo |
|---|---|---|
| Time to First Asthma Exacerbation (up to Week 24) | 123 | 107 |
Home PEF testing was performed by the patient each morning after awakening and before taking their morning asthma medications, and each evening using a peak flow meter. Measurements were taken at approximately the same time each day and recorded in the Asthma Daily Diary. The maximum of the 3 measurements performed every morning and evening were used in the calculation of the weekly means. A weekly mean was calculated as the sum of all non-missing daily measures over the 7 sequential days divided by the number of non-missing daily measures. If more than 3 daily measures (\> 50%) within a period were missing, then the weekly mean for that period was set to 'missing'. Change from run-in baseline in weekly means for morning PEF and evening PEF are presented. Baseline was the average for data collected over the last 7 days of the run-in period prior to randomization.
| L/minute | Benralizumab | Placebo |
|---|---|---|
| Morning | 27.17 ± 3.98 | 7.06 ± 5.49 |
| Evening | 16.47 ± 4.04 | -6.61 ± 5.54 |
The SF-36v2 is a 36-item survey of functional health and well-being, with a 1 week recall period. The 8-domain profile consists of the following subscales: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The physical and mental health component summary scores are computed from subscale scores to give a broader metric of physical and mental health-related quality of life. Each domain score, as well as the physical and mental component scores, were scored on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Norm-based scoring was used to calculate the 8 SF-36v2 subscales and the 2 component scores. The LS mean change from baseline in each of the SF-36 subscale and component summary scores at Week 24 are presented.
| Scores on a scale | Benralizumab | Placebo |
|---|---|---|
| Physical functioning | 17.76 ± 1.21 | 12.42 ± 1.59 |
| Role limitations due to physical health | 17.62 ± 1.34 | 10.82 ± 1.76 |
| Bodily pain | 6.44 ± 1.37 | 3.37 ± 1.79 |
| General health perceptions | 12.92 ± 1.01 | 7.29 ± 1.34 |
| Vitality | 12.04 ± 1.10 | 6.53 ± 1.44 |
| Social functioning | 12.44 ± 1.34 | 9.32 ± 1.75 |
| Role limitations due to emotional problems | 8.23 ± 1.18 | 5.79 ± 1.55 |
| Mental health | 5.57 ± 0.90 | 3.89 ± 1.18 |
| Physical health component summary score | 6.09 ± 0.46 | 3.77 ± 0.60 |
| Mental health component summary score | 2.87 ± 0.48 | 1.99 ± 0.64 |
The PGI-S is a single question asking the patient to rate the overall severity of their symptoms using a 6-point categorical response scale from 0 to 5 where 0=no symptoms and 5=very severe symptoms. Higher scores indicate a worse outcome. Improvement was defined as a PGI-S at EOT (Week 24) better than PGI-S at baseline. Important improvement was defined as PGI-S at baseline = moderate symptoms or severe symptoms or very severe symptoms shifting to PGI-S at EOT = no symptoms or very mild symptoms or mild symptoms. Patients with missing data at the EOT visit who did not complete the study were considered non-responders. For patients who completed the study with missing data at EOT (Week 24), their last evaluable post-baseline score was used to define responder status. The percentage of patients for each of the indicated PGI-S responder categories are presented.
| Percentage of patients | Benralizumab | Placebo |
|---|---|---|
| Improvement | 61.7 | 53.5 |
| Important improvement | 45.5 | 38.0 |
The Investigator (clinician) and the patient were asked separately to rate the degree of change in the overall asthma status compared to the start of treatment, i.e. baseline randomization visit. A 7-point rating scale was used for the CGI-C (rated by Investigator) and PGI-C (rated by patient) where: 1=Very Much Improved; 2=Much Improved; 3=Minimally Improved; 4=No Changes; 5=Minimally Worse; 6=Much Worse, and 7=Very Much Worse. Higher scores indicate a worse outcome. Responder category definitions: Much improved = (Much improved, Very much improved); Very much improved = (Very much improved). Patients with missing data at the EOT visit who did not complete the study were considered non-responders. For patients who completed the study with missing data at EOT (Week 24), their last evaluable post-baseline score was used to define responder status. The percentage of patients for each of the indicated CGI-C and PGI-C responder categories are presented.
| Percentage of patients | Benralizumab | Placebo |
|---|---|---|
| CGI-C: Much improved | 52.9 | 35.2 |
| CGI-C: Very much improved | 15.0 | 4.8 |
| PGI-C: Much improved | 55.9 | 38.2 |
| PGI-C: Very much improved | 37.7 | 16.7 |
For part 1 of the PSIA only administered at baseline, patients reviewed 8 concepts (including cardinal asthma symptoms, activities, awakenings, triggers) and selected those which were typically bothersome. Based on part 1 selections, part 2 of the PSIA produced a rank ordered list of bothersome concepts individualized per the patient for subsequent evaluation. For part 3 of the PSIA assessed at baseline and during the study, patients recorded the severity of each selected symptom or impairment using an 11-point numeric rating scale where: 0=Did not experience and 10=Worst I can imagine. Higher scores indicate a worse outcome. The LS mean change from baseline in PSIA severity score for the indicated categories at Week 24 are presented. A negative change from baseline indicates an improvement in symptoms. Note: Average PSIA was calculated only where all of top 3 ranked symptoms/impairments were available, otherwise average was set to missing.
| Scores on a scale | Benralizumab | Placebo |
|---|---|---|
| Average of top 3 ranked | -2.97 ± 0.14 | -1.82 ± 0.19 |
| Top ranked | -3.02 ± 0.15 | -1.87 ± 0.20 |
The 22-item SNOT 22 questionnaire was used to assess the rhinosinusitis health status and quality of life of patients with baseline chronic rhinosinusitis with nasal polyposis. The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110. Higher scores indicate poorer outcomes. The LS mean changes from baseline in SNOT-22 total score in patients in the chronic rhinosinusitis with nasal polyposis sub-study analysis set at Week 24 are presented.
| Scores on a scale | Benralizumab | Placebo |
|---|---|---|
| Change From Baseline in the Sino-Nasal Outcome Test Item 22 (SNOT-22) Total Score to the EOT (Week 24) | -19.02 ± 2.27 | -10.11 ± 3.04 |
Collected over Adverse event (AE) data is reported for the on-treatment period + follow-up (up to a maximum of 24 weeks). Assessed until 12 Sep 2019 analysis cut-off date.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Benralizumab | 0/427 (0%) | 23/427 (5.4%) | 136/427 (31.9%) |
| Placebo | 0/229 (0%) | 25/229 (10.9%) | 78/229 (34.1%) |
| Event | Benralizumab | Placebo |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 9/427 | 9/229 |
| PneumoniaInfections and infestations | 2/427 | 2/229 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/427 | 2/229 |
| Atrial fibrillationCardiac disorders | 0/427 | 1/229 |
| CellulitisInfections and infestations | 0/427 | 1/229 |
| GastroenteritisInfections and infestations | 0/427 | 1/229 |
| Respiratory tract infectionInfections and infestations | 0/427 | 1/229 |
| Urinary tract infectionInfections and infestations | 0/427 | 1/229 |
| Hyperglycaemic hyperosmolar nonketotic syndromeMetabolism and nutrition disorders | 0/427 | 1/229 |
| HypokalaemiaMetabolism and nutrition disorders | 0/427 | 1/229 |
| Event | Benralizumab | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 37/427 | 7/229 |
| BronchitisInfections and infestations | 22/427 | 18/229 |
| NasopharyngitisInfections and infestations | 30/427 | 17/229 |
| SinusitisInfections and infestations | 28/427 | 12/229 |
| PyrexiaGeneral disorders | 26/427 | 5/229 |
| CoughRespiratory, thoracic and mediastinal disorders | 14/427 | 13/229 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 7/427 | 13/229 |
| Upper respiratory tract infectionInfections and infestations | 17/427 | 12/229 |
All patients in the full analysis set (FAS) who received any investigational product (IP) were included in the baseline analysis.
| Age, Continuous(years) | Benralizumab | Placebo | Total |
|---|---|---|---|
| Mean | 52.5 ± 12.69 | 53.3 ± 12.52 | 52.8 ± 12.63 |
| Sex: Female, Male(Participants) | Benralizumab | Placebo | Total |
|---|---|---|---|
| Female | 263 | 136 | 399 |
| Male | 164 | 93 | 257 |
| Ethnicity (NIH/OMB)(Participants) | Benralizumab | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 49 | 25 | 74 |
| Not Hispanic or Latino | 318 | 172 | 490 |
| Unknown or Not Reported | 60 | 32 | 92 |
| Race/Ethnicity, Customized(Participants) | Benralizumab | Placebo | Total |
|---|---|---|---|
| White | 314 | 168 | 482 |
| Black or African American | 35 | 18 | 53 |
| Asian | 11 | 7 | 18 |
| Native Hawaiian or other Pacific Islander | 0 | 1 | 1 |
| Other | 5 | 2 | 7 |
| Missing | 62 | 33 | 95 |
| Screening eosinophil count group (cells/µL)(Participants) | Benralizumab | Placebo | Total |
|---|---|---|---|
| ≥ 150 - < 300 | 129 | 63 | 192 |
| ≥ 300 | 297 | 165 | 462 |
| Missing | 1 | 1 | 2 |
| Baseline eosinophil count group (cells/μL)(Participants) | Benralizumab | Placebo | Total |
|---|---|---|---|
| < 300 | 146 | 74 | 220 |
| ≥ 300 - < 450 | 105 | 56 | 161 |
| ≥ 450 | 176 | 99 | 275 |
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