Asthma
Conditions
Keywords
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases
Brief summary
The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.
Detailed description
After a minimum of 1200 patients have been enrolled in this study, subsequent patients (up to a maximum of 2200 total for the study), who complete a minimum of 16 weeks, and no more than 40 weeks, in this study, will be given the option to transition to an open-label safety extension study, Study D3250C00037 (MELTEMI). Adolescent patients, patients from Japan and South Korea, and any patient who chooses not to enter Study D3250C00037 will remain in this study through IPD or EOT and FU. At the time of the first interim analysis in Japanese patients, the study regimen for all patients will become unblinded to AstraZeneca for data analysis purposes. Study conduct and blinding at the site and patient level will remain unchanged.
Interventions
BIOLOGICALBenralizumab
Benralizumab administered subcutaneously
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Informed consent (and/or assent as applicable locally) for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent(s)/guardian(s)) and according to international guidelines and/or applicable European Union guidelines. 2. Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo. 3. Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after last dose of Investigational Product (IP). 4. For WOCBP only: Have a negative urine pregnancy test prior to administration of Investigational Product (IP) at Visit 1. 5. All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.
Exclusion criteria
1. Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric or major physical impairment that is not stable in the opinion of the Investigator and could: * Affect the safety of the patient throughout the study * Influence the findings of the studies or their interpretations * Impede the patient's ability to complete the entire duration of study 2. A helminth parasitic infection diagnosed during a predecessor study that has either not been treated, has been incompletely treated or has failed to respond to standard of care therapy 3. Any clinically significant change in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a predecessor study which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or interfere with the patient's ability to complete the entire duration of the study 4. Current malignancy or malignancy that developed during a predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded). 5. Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the investigational product 6. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1 7. Planned major surgical procedures during the conduct of the study 8. Previous participation in the present study 9. Concurrent enrolment in another clinical trial 10. AstraZeneca staff involved in the planning and/or conduct of the study 11. Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals 12. Patients with major protocol deviations in any of the predecessor studies at the discretion of the Sponsor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Week 108 | Change from baseline in hematologic lab parameter of Basophils. |
| Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients | Week 56 | Change from baseline in hematologic lab parameter of Basophils. |
| Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients | Week 56 | Change from baseline in hematologic lab parameter of Leukocytes. |
| Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Week 108 | Change from baseline in hematologic lab parameter of Leukocytes. |
| Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients | Week 56 | Change from baseline in hematologic lab parameter of Lymphocytes. |
| Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Week 108 | Change from baseline in hematologic lab parameter of Lymphocytes. |
| Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients | Week 56 | Change from baseline in hematologic lab parameter of Neutrophils. |
| Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Week 108 | Change from baseline in hematologic lab parameter of Neutrophils. |
| Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients | Week 56 | Change from baseline in hematologic lab parameter of Eosinophils. |
| Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Week 108 | Change from baseline in hematologic lab parameter of Eosinophils. |
| Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients | Week 56 | Change from baseline in chemistry tests ALT. |
| Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Week 108 | Change from baseline in hematologic lab parameter of ALT. |
| Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients | Week 56 | Change from baseline in chemistry tests AST. |
| Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Week 108 | Change from baseline in hematologic lab parameter of AST. |
| Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients | Week 56 | Change from baseline in chemistry test Bilirubin. |
| Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Week 108 | Change from baseline in hematologic lab parameter of Bilirubin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ) | Week 56 | The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage. |
| Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | Week 108 | The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage. |
| Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Week 68 | The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. |
| Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Week 108 | The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. |
| Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period | From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose) | Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma |
| Number of Overall Patients With Asthma Exacerbations During Study Period | From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose) | Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit |
| Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Week 0 and Week 56 | Endpoint: Pharmacokinetic (PK) parameters |
| Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) | Baseline and Week 108 | Endpoint: Pharmacokinetic (PK) parameters |
| Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period | Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study |
| Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | From week 0 to week 108 study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period | Assessments for the presence of ADA and nAb throughout study |
| Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Baseline and Week 108 | Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma |
| Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose) | Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit |
| Change From Baseline in Pre-bronchodilator FEV1 (L) | Week 56 | Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1). |
| Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Week 108 | Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1). |
| Change From Baseline in Post-bronchodilator FEV1 (L) | Week 56 | Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1). |
| Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Week 108 | Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1). |
| Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Week 56 | Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses. |
| Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Week 108 | Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses. |
| Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Week 56 | Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement. |
| Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Week 108 | Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement. |
| Change of Blood Eosinophil Levels' Measurement in Overall Patients | Week 56 | Change from baseline to Week 56 in Blood eosinophils |
| Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Week 108 | Change from baseline to Week 108 in Blood eosinophils. |
| Change From Baseline in EQ-5D-5L Visual Analog Scale | Week 56 | The questionnaire included a visual analog scale (VAS) score, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement. |
| Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Week 108 | The questionnaire included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement. |
| Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Week 68 | The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage. |
| Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Week 108 | The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage. |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Czechia, France, Germany, Japan, Peru, Philippines, Poland, Romania, Russia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States, Vietnam
Participant flow
Recruitment details
2133 patients entered BORA. 10 were excluded due to a GCP breach. Of remaining 2123 patients, 1926 entered from SIROCCO/CALIMA and 197 from ZONDA. 2 patients were not treated, and a total of 447 patients (348 SIROCCO/CALIMA and 99 ZONDA) were later enrolled into MELTEMI without completing the follow-up in BORA, so not in the main analyses.
Pre-assignment details
953 participants from SIROCCO/CALIMA receive benralizumab 30 mg at every 4 weeks during BORA. 971 participants from SIROCCO/CALIMA receive treatment at every 8 weeks during BORA. 100 participants from ZONDA receive treatment at every 4 weeks during BORA. 97 participants from study ZONDA receive treatment at every 8 weeks during BORA.
Participants by arm
| Arm | Count |
|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks | 783 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks | 793 |
| ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks | 49 |
| ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks | 49 |
| Total | 1,674 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 4 | 0 | 0 |
| Overall Study | Death | 5 | 4 | 0 | 1 |
| Overall Study | eg. not made to the visit | 7 | 4 | 0 | 1 |
| Overall Study | Eligibility criteria not fulfilled | 0 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 5 | 12 | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 2 | 0 | 0 |
| Overall Study | study specific discount. criteria | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 20 | 20 | 7 | 1 |
Baseline characteristics
| Characteristic | SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | ZONDA - Benralizumab 30 mg q.4 Weeks | ZONDA - Benralizumab 30 mg q.8 Weeks | Total |
|---|---|---|---|---|---|
| Age, Continuous | 51.1 Years STANDARD_DEVIATION 13.79 | 48.9 Years STANDARD_DEVIATION 15.53 | 49.7 Years STANDARD_DEVIATION 10.35 | 52.7 Years STANDARD_DEVIATION 8.9 | 50.1 Years STANDARD_DEVIATION 14.48 |
| Race/Ethnicity, Customized Asian | 138 Participants | 136 Participants | 4 Participants | 6 Participants | 284 Participants |
| Race/Ethnicity, Customized Black and African American | 16 Participants | 19 Participants | 0 Participants | 1 Participants | 36 Participants |
| Race/Ethnicity, Customized Other | 30 Participants | 26 Participants | 0 Participants | 0 Participants | 56 Participants |
| Race/Ethnicity, Customized White | 599 Participants | 612 Participants | 45 Participants | 42 Participants | 1298 Participants |
| Sex: Female, Male Female | 503 Participants | 470 Participants | 27 Participants | 29 Participants | 1029 Participants |
| Sex: Female, Male Male | 280 Participants | 323 Participants | 22 Participants | 20 Participants | 645 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 783 | 4 / 793 | 0 / 49 | 1 / 49 |
| other Total, other adverse events | 415 / 783 | 409 / 793 | 33 / 49 | 38 / 49 |
| serious Total, serious adverse events | 102 / 783 | 94 / 793 | 10 / 49 | 9 / 49 |
Outcome results
Primary
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in chemistry tests ALT.
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients | -0.007 ukat/L | Standard Deviation 0.2102 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients | 0.017 ukat/L | Standard Deviation 0.4651 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients | -0.064 ukat/L | Standard Deviation 0.3547 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients | -0.023 ukat/L | Standard Deviation 0.194 |
Primary
Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of ALT.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | 0.048 ukat/L | Standard Deviation 0.2195 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | 0.034 ukat/L | Standard Deviation 0.2312 |
Primary
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in chemistry tests AST.
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients | -0.005 ukat/L | Standard Deviation 0.1431 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients | 0.004 ukat/L | Standard Deviation 0.3303 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients | -0.027 ukat/L | Standard Deviation 0.2291 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients | -0.026 ukat/L | Standard Deviation 0.1178 |
Primary
Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of AST.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | -0.006 ukat/L | Standard Deviation 0.1196 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | -0.013 ukat/L | Standard Deviation 0.1297 |
Primary
Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Basophils.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | -0.006 10^9 cells/L | Standard Deviation 0.0145 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | 0.001 10^9 cells/L | Standard Deviation 0.0208 |
Primary
Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Basophils.
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients | -0.005 10^9 cells/L | Standard Deviation 0.0223 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients | -0.005 10^9 cells/L | Standard Deviation 0.0239 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients | -0.007 10^9 cells/L | Standard Deviation 0.0283 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients | -0.005 10^9 cells/L | Standard Deviation 0.0244 |
Primary
Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Bilirubin.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | 2.221 umol/L | Standard Deviation 8.3453 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | 0.202 umol/L | Standard Deviation 3.6575 |
Primary
Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in chemistry test Bilirubin.
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients | 0.187 umol/L | Standard Deviation 3.6261 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients | 0.391 umol/L | Standard Deviation 3.9945 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients | 0.146 umol/L | Standard Deviation 2.8094 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients | 0.279 umol/L | Standard Deviation 3.8765 |
Primary
Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Eosinophils.
Time frame: Week 108
Population: Full analysis set, adolescents only(studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | -0.1294 10^9 cells/L | Standard Deviation 0.27973 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | -0.1838 10^9 cells/L | Standard Deviation 0.3381 |
Primary
Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Eosinophils.
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients | -0.1220 10^9 cells/L | Standard Deviation 0.30599 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients | -0.1271 10^9 cells/L | Standard Deviation 0.26161 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients | -0.1451 10^9 cells/L | Standard Deviation 0.30766 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients | -0.1664 10^9 cells/L | Standard Deviation 0.35139 |
Primary
Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Leukocytes.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | -0.487 10^9 cells/L | Standard Deviation 1.7289 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | -0.079 10^9 cells/L | Standard Deviation 1.8432 |
Primary
Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Leukocytes.
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients | -0.344 10^9 cells/L | Standard Deviation 2.0412 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients | -0.128 10^9 cells/L | Standard Deviation 1.8614 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients | -0.808 10^9 cells/L | Standard Deviation 1.8177 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients | -0.507 10^9 cells/L | Standard Deviation 3.3612 |
Primary
Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Lymphocytes.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | -0.180 10^9 cells/L | Standard Deviation 0.6946 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | -0.070 10^9 cells/L | Standard Deviation 0.6671 |
Primary
Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Lymphocytes.
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients | -0.032 10^9 cells/L | Standard Deviation 0.6242 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients | 0.003 10^9 cells/L | Standard Deviation 0.5402 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients | -0.093 10^9 cells/L | Standard Deviation 0.6403 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients | 0.007 10^9 cells/L | Standard Deviation 0.6864 |
Primary
Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Neutrophils.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | -0.451 10^9 cells/L | Standard Deviation 1.7645 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | 0.242 10^9 cells/L | Standard Deviation 1.8469 |
Primary
Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Neutrophils.
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients | -0.171 10^9 cells/L | Standard Deviation 1.8746 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients | 0.013 10^9 cells/L | Standard Deviation 1.7024 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients | -0.501 10^9 cells/L | Standard Deviation 1.7096 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients | -0.368 10^9 cells/L | Standard Deviation 3.2057 |
Secondary
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)
The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time frame: Week 68
Population: Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; all patients enrolled from ZONDA.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Sirocco/Calima patients with eos>=300/μL-wk 68 | 26.6 percentage | Standard Deviation 26.14 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Sirocco/Calima patients with eos<300/μL-wk 68 | 33.6 percentage | Standard Deviation 26.55 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Sirocco/Calima patients with eos>=300/μL-wk 68 | 24.4 percentage | Standard Deviation 25.26 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Sirocco/Calima patients with eos<300/μL-wk 68 | 32.7 percentage | Standard Deviation 26.58 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Zonda Patients-wk 68 | 28.4 percentage | Standard Deviation 27.85 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Zonda Patients-wk 68 | 39.0 percentage | Standard Deviation 34.36 |
Secondary
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 7.1 Percentage | Standard Deviation 11.13 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 10.0 Percentage | Standard Deviation 14.14 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 5.0 Percentage | Standard Deviation 9.26 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 20.0 Percentage | — |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 6.0 Percentage | Standard Deviation 9.86 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 13.3 Percentage | Standard Deviation 11.55 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 5.4 Percentage | Standard Deviation 8.77 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 14.2 Percentage | Standard Deviation 18.81 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 19.2 Percentage | Standard Deviation 24.31 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 11.5 Percentage | Standard Deviation 10.68 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 12.3 Percentage | Standard Deviation 19.25 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 12.8 Percentage | Standard Deviation 14.87 |
Secondary
Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients
Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses.
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count\>=300/uL, and \<300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Sirocco/Calima patients with eos>=300/μL | -0.04 Score on a scale | Standard Deviation 0.83 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Sirocco/Calima patients with eos<300/μL | -0.16 Score on a scale | Standard Deviation 0.9 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Sirocco/Calima patients with eos>=300/μL | -0.20 Score on a scale | Standard Deviation 1.04 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Sirocco/Calima patients with eos<300/μL | -0.12 Score on a scale | Standard Deviation 0.8 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Sirocco/Calima patients with eos>=300/μL | -0.09 Score on a scale | Standard Deviation 0.91 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Sirocco/Calima patients with eos<300/μL | -0.15 Score on a scale | Standard Deviation 0.86 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Sirocco/Calima patients with eos<300/μL | -0.10 Score on a scale | Standard Deviation 0.83 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Sirocco/Calima patients with eos>=300/μL | -0.06 Score on a scale | Standard Deviation 0.82 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Sirocco/Calima patients with eos>=300/μL | -0.25 Score on a scale | Standard Deviation 1.06 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Sirocco/Calima patients with eos<300/μL | -0.09 Score on a scale | Standard Deviation 1.06 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Sirocco/Calima patients with eos>=300/μL | -0.12 Score on a scale | Standard Deviation 0.91 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Sirocco/Calima patients with eos<300/μL | -0.10 Score on a scale | Standard Deviation 0.9 |
| ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Number of Zonda Patients | -0.05 Score on a scale | Standard Deviation 0.89 |
| ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Number of Zonda Patients | -0.61 Score on a scale | Standard Deviation 0.74 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Number of Zonda Patients | -0.21 Score on a scale | Standard Deviation 0.87 |
| ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Number of Zonda Patients | 0.15 Score on a scale | Standard Deviation 1.02 |
| ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Number of Zonda Patients | -0.43 Score on a scale | Standard Deviation 1 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Number of Zonda Patients | -0.05 Score on a scale | Standard Deviation 1.04 |
Secondary
Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)
Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.26 Score on a scale | Standard Deviation 0.53 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | -0.50 Score on a scale | Standard Deviation 0.24 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.06 Score on a scale | Standard Deviation 0.49 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | -1.83 Score on a scale | — |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.16 Score on a scale | Standard Deviation 0.5 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.94 Score on a scale | Standard Deviation 0.79 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | -0.14 Score on a scale | Standard Deviation 0.51 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | -0.21 Score on a scale | Standard Deviation 0.78 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | -0.10 Score on a scale | Standard Deviation 1.38 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | -0.21 Score on a scale | Standard Deviation 0.77 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | -0.12 Score on a scale | Standard Deviation 1.02 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | -0.21 Score on a scale | Standard Deviation 0.76 |
Secondary
Change From Baseline in EQ-5D-5L Visual Analog Scale
The questionnaire included a visual analog scale (VAS) score, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count\>=300/uL, and \<300/uL; all patients enrolled from ZONDA.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale | Sirocco/Calima patients with eos>=300/μL | 6.08 Score on a scale | Standard Deviation 15.68 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale | Sirocco/Calima patients with eos<300/μL | 4.38 Score on a scale | Standard Deviation 14.99 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale | Sirocco/Calima patients with eos>=300/μL | 6.02 Score on a scale | Standard Deviation 17.68 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale | Sirocco/Calima patients with eos<300/μL | 6.69 Score on a scale | Standard Deviation 15.96 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale | Number of Zonda Patients | 5.00 Score on a scale | Standard Deviation 10.35 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale | Number of Zonda Patients | 1.36 Score on a scale | Standard Deviation 13.58 |
Secondary
Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)
The questionnaire included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 5.43 Score on a scale | Standard Deviation 9.73 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 22.00 Score on a scale | Standard Deviation 12.73 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 6.63 Score on a scale | Standard Deviation 15.53 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | -4.00 Score on a scale | — |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 6.07 Score on a scale | Standard Deviation 12.71 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 13.33 Score on a scale | Standard Deviation 17.5 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 11.54 Score on a scale | Standard Deviation 26.95 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 10.18 Score on a scale | Standard Deviation 32.69 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 9.83 Score on a scale | Standard Deviation 13.87 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 5.08 Score on a scale | Standard Deviation 10.45 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 10.72 Score on a scale | Standard Deviation 21.26 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 7.52 Score on a scale | Standard Deviation 23.39 |
Secondary
Change From Baseline in Post-bronchodilator FEV1 (L)
Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. Only summarize for patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count\>=300/uL, and \<300/uL; separated by predecessor treatment groups. Patients from Study ZONDA are not summarized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos<300/μL | -0.058 L | Standard Deviation 0.379 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos>=300/μL | -0.066 L | Standard Deviation 0.28 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos<300/μL | -0.024 L | Standard Deviation 0.289 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos>=300/μL | 0.089 L | Standard Deviation 0.455 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos>=300/μL | -0.015 L | Standard Deviation 0.354 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos<300/μL | -0.046 L | Standard Deviation 0.35 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos>=300/μL | -0.029 L | Standard Deviation 0.281 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos<300/μL | -0.043 L | Standard Deviation 0.273 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Post-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos>=300/μL | 0.045 L | Standard Deviation 0.401 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Post-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos<300/μL | 0.049 L | Standard Deviation 0.394 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos<300/μL | -0.015 L | Standard Deviation 0.316 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos>=300/μL | -0.004 L | Standard Deviation 0.329 |
Secondary
Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.375 L | Standard Deviation 0.474 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | -0.062 L | Standard Deviation 0.537 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | -0.305 L | Standard Deviation 0.394 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.880 L | — |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.543 L | Standard Deviation 0.444 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | -0.201 L | Standard Deviation 0.458 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.603 L | Standard Deviation 0.749 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | -0.006 L | Standard Deviation 0.327 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.279 L | Standard Deviation 0.659 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.218 L | Standard Deviation 0.536 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.111 L | Standard Deviation 0.454 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.448 L | Standard Deviation 0.712 |
Secondary
Change From Baseline in Pre-bronchodilator FEV1 (L)
Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count\>=300/uL, and \<300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos<300/μL | -0.021 L | Standard Deviation 0.376 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos>=300/μL | -0.006 L | Standard Deviation 0.295 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos<300/μL | -0.011 L | Standard Deviation 0.28 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos>=300/μL | 0.131 L | Standard Deviation 0.422 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos>=300/μL | 0.038 L | Standard Deviation 0.346 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos<300/μL | -0.017 L | Standard Deviation 0.345 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos<300/μL | -0.015 L | Standard Deviation 0.293 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos>=300/μL | 0.019 L | Standard Deviation 0.317 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Pre-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos>=300/μL | 0.081 L | Standard Deviation 0.419 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Pre-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos<300/μL | 0.030 L | Standard Deviation 0.35 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos>=300/μL | 0.040 L | Standard Deviation 0.356 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L) | Sirocco/Calima patients with eos<300/μL | -0.001 L | Standard Deviation 0.312 |
| ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 | Change From Baseline in Pre-bronchodilator FEV1 (L) | Number of Zonda Patients | 0.013 L | Standard Deviation 0.354 |
| ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo | Change From Baseline in Pre-bronchodilator FEV1 (L) | Number of Zonda Patients | 0.167 L | Standard Deviation 0.533 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L) | Number of Zonda Patients | 0.057 L | Standard Deviation 0.412 |
| ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Change From Baseline in Pre-bronchodilator FEV1 (L) | Number of Zonda Patients | -0.093 L | Standard Deviation 0.28 |
| ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Pre-bronchodilator FEV1 (L) | Number of Zonda Patients | 0.138 L | Standard Deviation 0.329 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L) | Number of Zonda Patients | -0.012 L | Standard Deviation 0.314 |
Secondary
Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.205 L | Standard Deviation 0.289 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.325 L | Standard Deviation 0.431 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | -0.189 L | Standard Deviation 0.354 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 1.140 L | — |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | -0.020 L | Standard Deviation 0.375 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.597 L | Standard Deviation 0.561 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.578 L | Standard Deviation 0.608 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.047 L | Standard Deviation 0.34 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.413 L | Standard Deviation 0.375 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.240 L | Standard Deviation 0.519 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.496 L | Standard Deviation 0.502 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.147 L | Standard Deviation 0.444 |
Secondary
Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)
Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement.
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count\>=300/uL, and \<300/uL; all patients enrolled from ZONDA.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Sirocco/Calima patients with eos<300/μL | 0.11 Score on a scale | Standard Deviation 0.84 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Sirocco/Calima patients with eos>=300/μL | 0.02 Score on a scale | Standard Deviation 0.8 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Sirocco/Calima patients with eos<300/μL | 0.03 Score on a scale | Standard Deviation 0.89 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Sirocco/Calima patients with eos>=300/μL | 0.21 Score on a scale | Standard Deviation 0.98 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Sirocco/Calima patients with eos>=300/μL | 0.08 Score on a scale | Standard Deviation 0.87 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Sirocco/Calima patients with eos<300/μL | 0.09 Score on a scale | Standard Deviation 0.85 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Sirocco/Calima patients with eos<300/μL | 0.15 Score on a scale | Standard Deviation 0.9 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Sirocco/Calima patients with eos>=300/μL | 0.08 Score on a scale | Standard Deviation 0.91 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Sirocco/Calima patients with eos>=300/μL | 0.26 Score on a scale | Standard Deviation 1 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Sirocco/Calima patients with eos<300/μL | 0.02 Score on a scale | Standard Deviation 1.06 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Sirocco/Calima patients with eos>=300/μL | 0.15 Score on a scale | Standard Deviation 0.94 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Sirocco/Calima patients with eos<300/μL | 0.11 Score on a scale | Standard Deviation 0.95 |
| ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Number of Zonda Patients | 0.13 Score on a scale | Standard Deviation 0.93 |
| ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Number of Zonda Patients | 0.43 Score on a scale | Standard Deviation 0.91 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Number of Zonda Patients | 0.22 Score on a scale | Standard Deviation 0.92 |
| ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Number of Zonda Patients | -0.04 Score on a scale | Standard Deviation 0.94 |
| ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Number of Zonda Patients | 0.40 Score on a scale | Standard Deviation 1.03 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Number of Zonda Patients | 0.11 Score on a scale | Standard Deviation 0.98 |
Secondary
Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)
Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.60 Score on a scale | Standard Deviation 1.22 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.64 Score on a scale | Standard Deviation 0.55 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | -0.11 Score on a scale | Standard Deviation 0.21 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 1.53 Score on a scale | — |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.25 Score on a scale | Standard Deviation 0.92 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.94 Score on a scale | Standard Deviation 0.65 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.52 Score on a scale | Standard Deviation 0.37 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.58 Score on a scale | Standard Deviation 1.01 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.06 Score on a scale | Standard Deviation 0.59 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.27 Score on a scale | Standard Deviation 0.77 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 0.29 Score on a scale | Standard Deviation 0.54 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0.42 Score on a scale | Standard Deviation 0.89 |
Secondary
Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).
Change from baseline to Week 108 in Blood eosinophils.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Sirocco/Calima patients with eos<300/μL | 160.0 cell/uL | — |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Sirocco/Calima patients with eos>=300/μL | 78.3 cell/uL | Standard Deviation 192.19 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Sirocco/Calima patients with eos>=300/μL | -356.7 cell/uL | Standard Deviation 215.47 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Sirocco/Calima patients with eos<300/μL | -150.0 cell/uL | — |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Sirocco/Calima patients with eos>=300/μL | -139.2 cell/uL | Standard Deviation 299.16 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Sirocco/Calima patients with eos<300/μL | 5.0 cell/uL | Standard Deviation 219.2 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Sirocco/Calima patients with eos>=300/μL | -163.6 cell/uL | Standard Deviation 502.76 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Sirocco/Calima patients with eos<300/μL | -2.0 cell/uL | Standard Deviation 9.19 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Sirocco/Calima patients with eos>=300/μL | -332.9 cell/uL | Standard Deviation 349.89 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Sirocco/Calima patients with eos<300/μL | -204.4 cell/uL | Standard Deviation 152.32 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Sirocco/Calima patients with eos<300/μL | -97.9 cell/uL | Standard Deviation 145.4 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Sirocco/Calima patients with eos>=300/μL | -229.4 cell/uL | Standard Deviation 446.21 |
Secondary
Change of Blood Eosinophil Levels' Measurement in Overall Patients
Change from baseline to Week 56 in Blood eosinophils
Time frame: Week 56
Population: Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count\>=300/uL, and \<300/uL; all patients enrolled from ZONDA; separate by predecessor treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Sirocco/Calima patients with eos<300/μL | 15.7 cell/uL | Standard Deviation 87.04 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Sirocco/Calima patients with eos>=300/μL | 4.9 cell/uL | Standard Deviation 177.42 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Sirocco/Calima patients with eos<300/μL | -222.1 cell/uL | Standard Deviation 325.03 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Sirocco/Calima patients with eos>=300/μL | -449.6 cell/uL | Standard Deviation 360.6 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Sirocco/Calima patients with eos>=300/μL | -148.6 cell/uL | Standard Deviation 332.91 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Sirocco/Calima patients with eos<300/μL | -68.4 cell/uL | Standard Deviation 234.4 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Sirocco/Calima patients with eos<300/μL | -2.9 cell/uL | Standard Deviation 59.11 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Sirocco/Calima patients with eos>=300/μL | -10.1 cell/uL | Standard Deviation 134.7 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Sirocco/Calima patients with eos>=300/μL | -422.5 cell/uL | Standard Deviation 330.01 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Sirocco/Calima patients with eos<300/μL | -217.4 cell/uL | Standard Deviation 198.56 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Sirocco/Calima patients with eos>=300/μL | -154.1 cell/uL | Standard Deviation 297.34 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Sirocco/Calima patients with eos<300/μL | -74.7 cell/uL | Standard Deviation 160.29 |
| ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Number of Zonda Patients | 2.5 cell/uL | Standard Deviation 69.85 |
| ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Number of Zonda Patients | -520.9 cell/uL | Standard Deviation 360.79 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Number of Zonda Patients | -145.1 cell/uL | Standard Deviation 307.66 |
| ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Number of Zonda Patients | -17.0 cell/uL | Standard Deviation 107.48 |
| ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Number of Zonda Patients | -435.3 cell/uL | Standard Deviation 468.64 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Number of Zonda Patients | -166.4 cell/uL | Standard Deviation 351.39 |
Secondary
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)
The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.
Time frame: Week 56
Population: Full analysis set, adolescents, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count\>=300/uL, and \<300/uL; all patients enrolled from ZONDA.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ) | Sirocco/Calima patients with eos>=300/μL-wk 56 | 3.8 Percentage | Standard Deviation 7.44 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ) | Sirocco/Calima patients with eos<300/μL-wk 56 | 5.0 Percentage | Standard Deviation 7.07 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ) | Sirocco/Calima patients with eos>=300/μL-wk 56 | 15.2 Percentage | Standard Deviation 20.69 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ) | Sirocco/Calima patients with eos<300/μL-wk 56 | 17.1 Percentage | Standard Deviation 20.06 |
Secondary
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)
The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 21.5 Percentage | Standard Deviation 30.41 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 4.9 Percentage | Standard Deviation 6.82 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 15.2 Percentage | Standard Deviation 17.55 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 9.5 Percentage | Standard Deviation 12.98 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 21.5 Percentage | Standard Deviation 30.41 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 5.4 Percentage | Standard Deviation 8.32 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 12.5 Percentage | Standard Deviation 18.1 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 18.6 Percentage | Standard Deviation 27.94 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 10.6 Percentage | Standard Deviation 11.68 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 11.5 Percentage | Standard Deviation 14.66 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 12.3 Percentage | Standard Deviation 21.62 |
Secondary
Number of Overall Patients With Asthma Exacerbations During Study Period
Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit
Time frame: From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)
Population: Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period | Sirocco/Calima patients with eos<300/μL | Number of exacerbation | 69 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period | Sirocco/Calima patients with eos>=300/μL | Number of exacerbation | 99 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period | Sirocco/Calima patients with eos<300/μL | Number of exacerbation | 44 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period | Sirocco/Calima patients with eos>=300/μL | Number of exacerbation | 60 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period | Sirocco/Calima patients with eos>=300/μL | Number of exacerbation | 159 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period | Sirocco/Calima patients with eos<300/μL | Number of exacerbation | 113 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period | Sirocco/Calima patients with eos<300/μL | Number of exacerbation | 65 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period | Sirocco/Calima patients with eos>=300/μL | Number of exacerbation | 104 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Number of Overall Patients With Asthma Exacerbations During Study Period | Sirocco/Calima patients with eos>=300/μL | Number of exacerbation | 66 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Number of Overall Patients With Asthma Exacerbations During Study Period | Sirocco/Calima patients with eos<300/μL | Number of exacerbation | 32 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period | Sirocco/Calima patients with eos>=300/μL | Number of exacerbation | 170 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period | Sirocco/Calima patients with eos<300/μL | Number of exacerbation | 97 Participants |
| ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 | Number of Overall Patients With Asthma Exacerbations During Study Period | Zonda Patients with asthma exacerbations | Number of exacerbation | 12 Participants |
| ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo | Number of Overall Patients With Asthma Exacerbations During Study Period | Zonda Patients with asthma exacerbations | Number of exacerbation | 5 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period | Zonda Patients with asthma exacerbations | Number of exacerbation | 17 Participants |
| ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Number of Overall Patients With Asthma Exacerbations During Study Period | Zonda Patients with asthma exacerbations | Number of exacerbation | 13 Participants |
| ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo | Number of Overall Patients With Asthma Exacerbations During Study Period | Zonda Patients with asthma exacerbations | Number of exacerbation | 11 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period | Zonda Patients with asthma exacerbations | Number of exacerbation | 24 Participants |
Secondary
Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)
Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit
Time frame: From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | Number of exacerbation | 2 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | Number of exacerbation | 0 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | Number of exacerbation | 6 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | Number of exacerbation | 0 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | Number of exacerbation | 8 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | Number of exacerbation | 0 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | Number of exacerbation | 3 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | Number of exacerbation | 5 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | Number of exacerbation | 5 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | Number of exacerbation | 6 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | Number of exacerbation | 8 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | Number of exacerbation | 11 Participants |
Secondary
Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period
Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma
Time frame: From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)
Population: Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count\>=300/uL, and \<300/uL; all patients enrolled from ZONDA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period | Sirocco/Calima patients with eos>=300/μL | 193 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period | Sirocco/Calima patients with eos<300/μL | 118 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period | Sirocco/Calima patients with eos>=300/μL | 198 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period | Sirocco/Calima patients with eos<300/μL | 102 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period | Number of Zonda Patients | 20 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period | Number of Zonda Patients | 25 Participants |
Secondary
Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA)
Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma
Time frame: Baseline and Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 2 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 0 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 5 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 1 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 7 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 1 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 7 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 7 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 7 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 5 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL | 14 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL | 12 Participants |
Secondary
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study
Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study
Time frame: From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period
Population: Full analysis set, excluding MELTEMI patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Transiently Positive | 22 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | nAb positive | 57 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Only post-baseline positive | 48 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Positive at any visit | 80 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | ADA incidence | 44 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Newly Persistently Positive | 28 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Stable persistently positive | 21 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Base- and Post-baseline Positive | 23 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Only baseline positive | 9 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Newly treatment-induced positive | 38 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | ADA treatment boosted positive | 6 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Decreased in titre | 17 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Base- and Post-baseline Positive | 41 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Decreased in titre | 9 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Stable persistently positive | 29 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | ADA incidence | 47 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Transiently Positive | 26 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Only post-baseline positive | 48 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Positive at any visit | 93 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | ADA treatment boosted positive | 6 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Newly treatment-induced positive | 41 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Newly Persistently Positive | 34 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | nAb positive | 75 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Only baseline positive | 4 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Only post-baseline positive | 2 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Positive at any visit | 4 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Base- and Post-baseline Positive | 2 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Newly Persistently Positive | 1 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Stable persistently positive | 2 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Newly treatment-induced positive | 2 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | ADA treatment boosted positive | 0 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Decreased in titre | 2 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | ADA incidence | 2 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Transiently Positive | 1 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Only baseline positive | 0 Participants |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | nAb positive | 3 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | ADA treatment boosted positive | 1 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Newly treatment-induced positive | 2 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Positive at any visit | 8 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Transiently Positive | 3 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Stable persistently positive | 2 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Newly Persistently Positive | 3 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | nAb positive | 4 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Only baseline positive | 0 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Only post-baseline positive | 1 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Decreased in titre | 1 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Base- and Post-baseline Positive | 4 Participants |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | ADA incidence | 3 Participants |
Secondary
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA)
Assessments for the presence of ADA and nAb throughout study
Time frame: From week 0 to week 108 study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Decreased in titre | 0 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Base- and Post-baseline Positive | 0 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Only post-baseline positive | 1 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Stable persistently positive | 0 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | ADA incidence | 1 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Positive at any visit | 1 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Transiently Positive | 1 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Newly treatment-induced positive | 1 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Only baseline positive | 0 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | ADA treatment boosted positive | 0 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | nAb positive | 1 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Newly Persistently Positive | 0 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | nAb positive | 5 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Positive at any visit | 5 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Base- and Post-baseline Positive | 3 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Newly Persistently Positive | 2 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Stable persistently positive | 3 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | ADA treatment boosted positive | 2 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Decreased in titre | 2 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Only post-baseline positive | 2 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | ADA incidence | 3 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Transiently Positive | 0 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Only baseline positive | 0 Participants |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Newly treatment-induced positive | 1 Participants |
Secondary
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study
Endpoint: Pharmacokinetic (PK) parameters
Time frame: Week 0 and Week 56
Population: All patients who received benralizumab, from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least 1 quantifiable serum PK observation post the first dose were included in the PK analysis dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Baseline | 714.25 ng/mL |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Week 56 | 930.04 ng/mL |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Baseline | NA ng/mL |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Week 56 | 865.93 ng/mL |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Baseline | 142.92 ng/mL |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Week 56 | 173.95 ng/mL |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Baseline | NA ng/mL |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Week 56 | 162.03 ng/mL |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Baseline | 964.21 ng/mL |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Week 56 | 823.62 ng/mL |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Baseline | NA ng/mL |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Week 56 | 1160.58 ng/mL |
| ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Week 56 | 247.26 ng/mL |
| ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Baseline | 692.91 ng/mL |
| ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Baseline | NA ng/mL |
| ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Week 56 | 139.35 ng/mL |
Secondary
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)
Endpoint: Pharmacokinetic (PK) parameters
Time frame: Baseline and Week 108
Population: All adolescent patients (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents)who received benralizumab, from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least 1 quantifiable serum PK observation post the first dose were included in the PK analysis dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) | Baseline | 725.55 ng/mL |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) | Week 108 | 383.73 ng/mL |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) | Week 108 | 853.51 ng/mL |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) | Baseline | NA ng/mL |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) | Baseline | 218.53 ng/mL |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) | Week 108 | 436.85 ng/mL |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) | Baseline | NA ng/mL |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) | Week 108 | 524.39 ng/mL |
Secondary
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)
The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.
Time frame: Week 68
Population: Full analysis set, adults, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; all patients enrolled from ZONDA.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Sirocco/Calima patients with eos>=300/μL-wk 68 | 23.3 percentage | Standard Deviation 26.18 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Sirocco/Calima patients with eos<300/μL-wk 68 | 32.7 percentage | Standard Deviation 27.55 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Sirocco/Calima patients with eos>=300/μL-wk 68 | 21.0 percentage | Standard Deviation 25.54 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Sirocco/Calima patients with eos<300/μL-wk 68 | 25.8 percentage | Standard Deviation 24.05 |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Zonda Patients-wk 68 | 18.9 percentage | Standard Deviation 24.94 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI) | Zonda Patients-wk 68 | 21.0 percentage | Standard Deviation 27.13 |
Secondary
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.
Time frame: Week 108
Population: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 0.0 Percentage | Standard Deviation 0 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 10.0 Percentage | — |
| ZONDA - Benralizumab 30 mg q.4 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 3 Percentage | Standard Deviation 3.3 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 0.0 Percentage | Standard Deviation 0 |
| ZONDA - Benralizumab 30 mg q.8 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 20.0 Percentage | — |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 10.0 Percentage | — |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 13.3 Percentage | Standard Deviation 5.77 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos<300/μL-wk-108 | 8.0 Percentage | Standard Deviation 8.37 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | Sirocco/Calima patients with eos>=300/μL-wk 108 | 15.0 Percentage | Standard Deviation 7.07 |