Trial Outcomes & Findings for A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA (NCT NCT02258542)

NCT ID: NCT02258542

Last Updated: 2019-08-21

Results Overview

Change from baseline in hematologic lab parameter of Basophils.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2133 participants

Primary outcome timeframe

Week 56

Results posted on

2019-08-21

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Overall Study STARTED	953	973	100	97
Overall Study Treated	953	971	100	97
Overall Study Adolescents Only	25	61	0	0
Overall Study COMPLETED	911	924	92	92
Overall Study NOT COMPLETED	42	49	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Overall Study eg. not made to the visit	7	4	0	1
Overall Study study specific discount. criteria	1	1	0	0
Overall Study Withdrawal by Subject	20	20	7	1
Overall Study Lost to Follow-up	5	12	1	2
Overall Study Death	5	4	0	1
Overall Study Adverse Event	3	4	0	0
Overall Study Protocol Violation	1	2	0	0
Overall Study Eligibility criteria not fulfilled	0	2	0	0

Baseline Characteristics

Full analysis set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=783 Participants Benralizumab administered subcutaneously every 4 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=793 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=49 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=49 Participants Benralizumab administered subcutaneously every 8 weeks	Total n=1674 Participants Total of all reporting groups
Race/Ethnicity, Customized Black and African American	16 Participants n=99 Participants • Full analysis set	19 Participants n=107 Participants • Full analysis set	0 Participants n=206 Participants • Full analysis set	1 Participants n=7 Participants • Full analysis set	36 Participants n=31 Participants • Full analysis set
Race/Ethnicity, Customized Asian	138 Participants n=99 Participants • Full analysis set	136 Participants n=107 Participants • Full analysis set	4 Participants n=206 Participants • Full analysis set	6 Participants n=7 Participants • Full analysis set	284 Participants n=31 Participants • Full analysis set
Race/Ethnicity, Customized Other	30 Participants n=99 Participants • Full analysis set	26 Participants n=107 Participants • Full analysis set	0 Participants n=206 Participants • Full analysis set	0 Participants n=7 Participants • Full analysis set	56 Participants n=31 Participants • Full analysis set
Age, Continuous	51.1 Years STANDARD_DEVIATION 13.79 • n=99 Participants • Full analysis set, excluding MELTEMI patients	48.9 Years STANDARD_DEVIATION 15.53 • n=107 Participants • Full analysis set, excluding MELTEMI patients	49.7 Years STANDARD_DEVIATION 10.35 • n=206 Participants • Full analysis set, excluding MELTEMI patients	52.7 Years STANDARD_DEVIATION 8.90 • n=7 Participants • Full analysis set, excluding MELTEMI patients	50.1 Years STANDARD_DEVIATION 14.48 • n=31 Participants • Full analysis set, excluding MELTEMI patients
Sex: Female, Male Female	503 Participants n=99 Participants • Full analysis set, exclude MELTEMI patients	470 Participants n=107 Participants • Full analysis set, exclude MELTEMI patients	27 Participants n=206 Participants • Full analysis set, exclude MELTEMI patients	29 Participants n=7 Participants • Full analysis set, exclude MELTEMI patients	1029 Participants n=31 Participants • Full analysis set, exclude MELTEMI patients
Sex: Female, Male Male	280 Participants n=99 Participants • Full analysis set, exclude MELTEMI patients	323 Participants n=107 Participants • Full analysis set, exclude MELTEMI patients	22 Participants n=206 Participants • Full analysis set, exclude MELTEMI patients	20 Participants n=7 Participants • Full analysis set, exclude MELTEMI patients	645 Participants n=31 Participants • Full analysis set, exclude MELTEMI patients
Race/Ethnicity, Customized White	599 Participants n=99 Participants • Full analysis set	612 Participants n=107 Participants • Full analysis set	45 Participants n=206 Participants • Full analysis set	42 Participants n=7 Participants • Full analysis set	1298 Participants n=31 Participants • Full analysis set

PRIMARY outcome

Timeframe: 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.

Change from baseline in hematologic lab parameter of Basophils.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=703 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=691 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=39 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=42 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients	-0.005 10^9 cells/L Standard Deviation 0.0239	-0.005 10^9 cells/L Standard Deviation 0.0223	-0.007 10^9 cells/L Standard Deviation 0.0283	-0.005 10^9 cells/L Standard Deviation 0.0244	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Change from baseline in hematologic lab parameter of Basophils.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=45 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=16 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	0.001 10^9 cells/L Standard Deviation 0.0208	-0.006 10^9 cells/L Standard Deviation 0.0145	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Change from baseline in hematologic lab parameter of Leukocytes.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=710 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=695 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=39 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=42 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients	-0.128 10^9 cells/L Standard Deviation 1.8614	-0.344 10^9 cells/L Standard Deviation 2.0412	-0.808 10^9 cells/L Standard Deviation 1.8177	-0.507 10^9 cells/L Standard Deviation 3.3612	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 108

Change from baseline in hematologic lab parameter of Leukocytes.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=47 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=16 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	-0.079 10^9 cells/L Standard Deviation 1.8432	-0.487 10^9 cells/L Standard Deviation 1.7289	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Change from baseline in hematologic lab parameter of Lymphocytes.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=703 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=691 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=39 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=42 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients	0.003 10^9 cells/L Standard Deviation 0.5402	-0.032 10^9 cells/L Standard Deviation 0.6242	-0.093 10^9 cells/L Standard Deviation 0.6403	0.007 10^9 cells/L Standard Deviation 0.6864	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 108

Change from baseline in hematologic lab parameter of Lymphocytes.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=45 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=16 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	-0.070 10^9 cells/L Standard Deviation 0.6671	-0.180 10^9 cells/L Standard Deviation 0.6946	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Change from baseline in hematologic lab parameter of Neutrophils.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=703 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=691 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=39 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=42 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients	0.013 10^9 cells/L Standard Deviation 1.7024	-0.171 10^9 cells/L Standard Deviation 1.8746	-0.501 10^9 cells/L Standard Deviation 1.7096	-0.368 10^9 cells/L Standard Deviation 3.2057	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 108

Change from baseline in hematologic lab parameter of Neutrophils.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=45 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=16 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	0.242 10^9 cells/L Standard Deviation 1.8469	-0.451 10^9 cells/L Standard Deviation 1.7645	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Change from baseline in hematologic lab parameter of Eosinophils.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=703 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=691 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=39 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=42 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients	-0.1271 10^9 cells/L Standard Deviation 0.26161	-0.1220 10^9 cells/L Standard Deviation 0.30599	-0.1451 10^9 cells/L Standard Deviation 0.30766	-0.1664 10^9 cells/L Standard Deviation 0.35139	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Change from baseline in hematologic lab parameter of Eosinophils.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=45 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=16 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	-0.1838 10^9 cells/L Standard Deviation 0.3381	-0.1294 10^9 cells/L Standard Deviation 0.27973	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Change from baseline in chemistry tests ALT.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=712 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=684 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=37 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=43 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients	0.017 ukat/L Standard Deviation 0.4651	-0.007 ukat/L Standard Deviation 0.2102	-0.064 ukat/L Standard Deviation 0.3547	-0.023 ukat/L Standard Deviation 0.1940	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 108

Change from baseline in hematologic lab parameter of ALT.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=51 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=17 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	0.034 ukat/L Standard Deviation 0.2312	0.048 ukat/L Standard Deviation 0.2195	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Change from baseline in chemistry tests AST.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=712 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=684 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=37 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=43 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients	0.004 ukat/L Standard Deviation 0.3303	-0.005 ukat/L Standard Deviation 0.1431	-0.027 ukat/L Standard Deviation 0.2291	-0.026 ukat/L Standard Deviation 0.1178	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 108

Change from baseline in hematologic lab parameter of AST.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=50 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=17 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	-0.013 ukat/L Standard Deviation 0.1297	-0.006 ukat/L Standard Deviation 0.1196	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Change from baseline in chemistry test Bilirubin.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=712 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=685 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=37 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=43 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients	0.391 umol/L Standard Deviation 3.9945	0.187 umol/L Standard Deviation 3.6261	0.146 umol/L Standard Deviation 2.8094	0.279 umol/L Standard Deviation 3.8765	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 108

Change from baseline in hematologic lab parameter of Bilirubin.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=51 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=17 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	0.202 umol/L Standard Deviation 3.6575	2.221 umol/L Standard Deviation 8.3453	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=265 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=518 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=783 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=512 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=281 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=793 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 n=31 Participants Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo n=18 Participants Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks n=49 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 n=31 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo n=18 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks n=49 Participants Benralizumab administered subcutaneously every 8 weeks
Number of Overall Patients With Asthma Exacerbations During Study Period Sirocco/Calima patients with eos>=300/μL · Number of exacerbation	60 Participants	99 Participants	159 Participants	104 Participants	66 Participants	170 Participants	—	—	—	—	—	—
Number of Overall Patients With Asthma Exacerbations During Study Period Sirocco/Calima patients with eos<300/μL · Number of exacerbation	44 Participants	69 Participants	113 Participants	65 Participants	32 Participants	97 Participants	—	—	—	—	—	—
Number of Overall Patients With Asthma Exacerbations During Study Period Zonda Patients with asthma exacerbations · Number of exacerbation	—	—	—	—	—	—	12 Participants	5 Participants	17 Participants	13 Participants	11 Participants	24 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=11 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=14 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=25 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=32 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=29 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=61 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	2 Participants	8 Participants	3 Participants	5 Participants	8 Participants	—	—	—	—	—	—
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	0 Participants	0 Participants	5 Participants	6 Participants	11 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=221 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=444 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=665 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=440 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=220 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=660 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 n=31 Participants Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo n=18 Participants Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks n=38 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 n=28 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo n=15 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks n=43 Participants Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Pre-bronchodilator FEV1 (L) Sirocco/Calima patients with eos>=300/μL	0.131 L Standard Deviation 0.422	-0.006 L Standard Deviation 0.295	0.038 L Standard Deviation 0.346	0.019 L Standard Deviation 0.317	0.081 L Standard Deviation 0.419	0.040 L Standard Deviation 0.356	—	—	—	—	—	—
Change From Baseline in Pre-bronchodilator FEV1 (L) Sirocco/Calima patients with eos<300/μL	-0.011 L Standard Deviation 0.280	-0.021 L Standard Deviation 0.376	-0.017 L Standard Deviation 0.345	-0.015 L Standard Deviation 0.293	0.030 L Standard Deviation 0.350	-0.001 L Standard Deviation 0.312	—	—	—	—	—	—
Change From Baseline in Pre-bronchodilator FEV1 (L) Number of Zonda Patients	—	—	—	—	—	—	0.013 L Standard Deviation 0.354	0.167 L Standard Deviation 0.533	0.057 L Standard Deviation 0.412	-0.093 L Standard Deviation 0.280	0.138 L Standard Deviation 0.329	-0.012 L Standard Deviation 0.314

SECONDARY outcome

Timeframe: Week 108

Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=9 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=8 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=17 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=25 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=26 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=51 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	0.205 L Standard Deviation 0.289	-0.020 L Standard Deviation 0.375	0.578 L Standard Deviation 0.608	0.413 L Standard Deviation 0.375	0.496 L Standard Deviation 0.502	—	—	—	—	—	—
Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) Sirocco/Calima patients with eos<300/μL	1.140 L Standard Deviation NA Only 1 participants, not able to calculate Standard deviation.	0.325 L Standard Deviation 0.431	0.597 L Standard Deviation 0.561	0.047 L Standard Deviation 0.340	0.240 L Standard Deviation 0.519	0.147 L Standard Deviation 0.444	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=220 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=439 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=659 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=438 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=214 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=652 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Post-bronchodilator FEV1 (L) Sirocco/Calima patients with eos>=300/μL	0.089 L Standard Deviation 0.455	-0.066 L Standard Deviation 0.280	-0.015 L Standard Deviation 0.354	-0.029 L Standard Deviation 0.281	0.045 L Standard Deviation 0.401	-0.004 L Standard Deviation 0.329	—	—	—	—	—	—
Change From Baseline in Post-bronchodilator FEV1 (L) Sirocco/Calima patients with eos<300/μL	-0.024 L Standard Deviation 0.289	-0.058 L Standard Deviation 0.379	-0.046 L Standard Deviation 0.350	-0.043 L Standard Deviation 0.273	0.049 L Standard Deviation 0.394	-0.015 L Standard Deviation 0.316	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 108

Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=9 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=8 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=17 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=25 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=26 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=51 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	-0.062 L Standard Deviation 0.537	-0.201 L Standard Deviation 0.458	0.603 L Standard Deviation 0.749	0.279 L Standard Deviation 0.659	0.448 L Standard Deviation 0.712	—	—	—	—	—	—
Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) Sirocco/Calima patients with eos<300/μL	0.880 L Standard Deviation NA Only 1 participants, not able to calculate SD	0.375 L Standard Deviation 0.474	0.543 L Standard Deviation 0.444	-0.006 L Standard Deviation 0.327	0.218 L Standard Deviation 0.536	0.111 L Standard Deviation 0.454	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=224 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=447 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=671 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=444 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=220 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=664 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 n=28 Participants Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo n=11 Participants Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks n=39 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 n=28 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo n=15 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks n=43 Participants Benralizumab administered subcutaneously every 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	-0.04 Score on a scale Standard Deviation 0.83	-0.09 Score on a scale Standard Deviation 0.91	-0.06 Score on a scale Standard Deviation 0.82	-0.25 Score on a scale Standard Deviation 1.06	-0.12 Score on a scale Standard Deviation 0.91	—	—	—	—	—	—
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 0.80	-0.16 Score on a scale Standard Deviation 0.90	-0.15 Score on a scale Standard Deviation 0.86	-0.10 Score on a scale Standard Deviation 0.83	-0.09 Score on a scale Standard Deviation 1.06	-0.10 Score on a scale Standard Deviation 0.90	—	—	—	—	—	—
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	-0.61 Score on a scale Standard Deviation 0.74	-0.21 Score on a scale Standard Deviation 0.87	0.15 Score on a scale Standard Deviation 1.02	-0.43 Score on a scale Standard Deviation 1.00	-0.05 Score on a scale Standard Deviation 1.04

SECONDARY outcome

Timeframe: Week 108

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=9 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=9 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=18 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=25 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=26 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=51 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	0.26 Score on a scale Standard Deviation 0.53	0.16 Score on a scale Standard Deviation 0.50	-0.14 Score on a scale Standard Deviation 0.51	-0.10 Score on a scale Standard Deviation 1.38	-0.12 Score on a scale Standard Deviation 1.02	—	—	—	—	—	—
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 Standard Deviation NA Only one participant, not able to calculate SD.	-0.50 Score on a scale Standard Deviation 0.24	0.94 Score on a scale Standard Deviation 0.79	-0.21 Score on a scale Standard Deviation 0.78	-0.21 Score on a scale Standard Deviation 0.77	-0.21 Score on a scale Standard Deviation 0.76	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=224 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=444 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=668 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=442 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=220 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=662 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 n=26 Participants Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo n=11 Participants Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks n=37 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 n=28 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo n=15 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks n=43 Participants Benralizumab administered subcutaneously every 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	0.11 Score on a scale Standard Deviation 0.84	0.09 Score on a scale Standard Deviation 0.85	0.15 Score on a scale Standard Deviation 0.90	0.02 Score on a scale Standard Deviation 1.06	0.11 Score on a scale Standard Deviation 0.95	—	—	—	—	—	—
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	0.43 Score on a scale Standard Deviation 0.91	0.22 Score on a scale Standard Deviation 0.92	-0.04 Score on a scale Standard Deviation 0.94	0.40 Score on a scale Standard Deviation 1.03	0.11 Score on a scale Standard Deviation 0.98
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	0.02 Score on a scale Standard Deviation 0.80	0.08 Score on a scale Standard Deviation 0.87	0.08 Score on a scale Standard Deviation 0.91	0.26 Score on a scale Standard Deviation 1.00	0.15 Score on a scale Standard Deviation 0.94	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 108

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=8 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=9 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=17 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=25 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=26 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=51 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	0.60 Score on a scale Standard Deviation 1.22	0.25 Score on a scale Standard Deviation 0.92	0.52 Score on a scale Standard Deviation 0.37	0.06 Score on a scale Standard Deviation 0.59	0.29 Score on a scale Standard Deviation 0.54	—	—	—	—	—	—
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 Standard Deviation NA Only one participants, not able to calculate SD.	0.64 Score on a scale Standard Deviation 0.55	0.94 Score on a scale Standard Deviation 0.65	0.58 Score on a scale Standard Deviation 1.01	0.27 Score on a scale Standard Deviation 0.77	0.42 Score on a scale Standard Deviation 0.89	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 56

Change from baseline to Week 56 in Blood eosinophils

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=237 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=454 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=691 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=461 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=242 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=703 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 n=28 Participants Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo n=11 Participants Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks n=39 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 n=27 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo n=15 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks n=42 Participants Benralizumab administered subcutaneously every 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	4.9 cell/uL Standard Deviation 177.42	-148.6 cell/uL Standard Deviation 332.91	-10.1 cell/uL Standard Deviation 134.7	-422.5 cell/uL Standard Deviation 330.01	-154.1 cell/uL Standard Deviation 297.34	—	—	—	—	—	—
Change of Blood Eosinophil Levels' Measurement in Overall Patients Sirocco/Calima patients with eos<300/μL	-222.1 cell/uL Standard Deviation 325.03	15.7 cell/uL Standard Deviation 87.04	-68.4 cell/uL Standard Deviation 234.40	-2.9 cell/uL Standard Deviation 59.11	-217.4 cell/uL Standard Deviation 198.56	-74.7 cell/uL Standard Deviation 160.29	—	—	—	—	—	—
Change of Blood Eosinophil Levels' Measurement in Overall Patients Number of Zonda Patients	—	—	—	—	—	—	2.5 cell/uL Standard Deviation 69.85	-520.9 cell/uL Standard Deviation 360.79	-145.1 cell/uL Standard Deviation 307.66	-17.0 cell/uL Standard Deviation 107.48	-435.3 cell/uL Standard Deviation 468.64	-166.4 cell/uL Standard Deviation 351.39

SECONDARY outcome

Timeframe: Week 108

Change from baseline to Week 108 in Blood eosinophils.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=7 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=7 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=14 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=21 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=16 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=37 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	78.3 cell/uL Standard Deviation 192.19	-139.2 cell/uL Standard Deviation 299.16	-163.6 cell/uL Standard Deviation 502.76	-332.9 cell/uL Standard Deviation 349.89	-229.4 cell/uL Standard Deviation 446.21	—	—	—	—	—	—
Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). Sirocco/Calima patients with eos<300/μL	-150.0 cell/uL Standard Deviation NA Only one participants, not able to calculate SD.	160.0 cell/uL Standard Deviation NA Only one participants, not able to calculate SD.	5.0 cell/uL Standard Deviation 219.20	-2.0 cell/uL Standard Deviation 9.19	-204.4 cell/uL Standard Deviation 152.32	-97.9 cell/uL Standard Deviation 145.40	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=709 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=682 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=21 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=28 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	6.08 Score on a scale Standard Deviation 15.68	—	—	—	—	—	—	—	—	—	—
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	4.38 Score on a scale Standard Deviation 14.99	—	—	—	—	—	—	—	—	—	—
Change From Baseline in EQ-5D-5L Visual Analog Scale Number of Zonda Patients	—	—	5.00 Score on a scale Standard Deviation 10.35	1.36 Score on a scale Standard Deviation 13.58	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=9 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=9 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=18 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=24 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=24 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=48 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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 Standard Deviation NA Only one participants, not able to calculate SD.	22.00 Score on a scale Standard Deviation 12.73	13.33 Score on a scale Standard Deviation 17.50	10.18 Score on a scale Standard Deviation 32.69	5.08 Score on a scale Standard Deviation 10.45	7.52 Score on a scale Standard Deviation 23.39	—	—	—	—	—	—
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	5.43 Score on a scale Standard Deviation 9.73	6.07 Score on a scale Standard Deviation 12.71	11.54 Score on a scale Standard Deviation 26.95	9.83 Score on a scale Standard Deviation 13.87	10.72 Score on a scale Standard Deviation 21.26	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=313 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=349 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=19 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=20 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	23.3 percentage Standard Deviation 26.18	—	—	—	—	—	—	—	—	—	—
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	32.7 percentage Standard Deviation 27.55	—	—	—	—	—	—	—	—	—	—
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI) Zonda Patients-wk 68	—	—	18.9 percentage Standard Deviation 24.94	21.0 percentage Standard Deviation 27.13	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 108

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=1 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=2 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=3 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=3 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=4 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=7 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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 0.00	13.3 Percentage Standard Deviation 5.77	8.0 Percentage Standard Deviation 8.37	—	—	—	—	—	—
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 Standard Deviation NA Only one participant, not able to calculate SD.	0.0 Percentage Standard Deviation 0.00	3 Percentage Standard Deviation 3.3	20.0 Percentage Standard Deviation NA Only one participant, not able to calculate SD.	10.0 Percentage Standard Deviation NA Only one participant, not able to calculate SD.	15.0 Percentage Standard Deviation 7.07	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=48 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=10 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	3.8 Percentage Standard Deviation 7.44	—	—	—	—	—	—	—	—	—	—
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ) Sirocco/Calima patients with eos<300/μL-wk 56	17.1 Percentage Standard Deviation 20.06	5.0 Percentage Standard Deviation 7.07	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 108

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=4 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=7 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=11 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=19 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=21 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=40 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	4.9 Percentage Standard Deviation 6.82	9.5 Percentage Standard Deviation 12.98	5.4 Percentage Standard Deviation 8.32	18.6 Percentage Standard Deviation 27.94	12.3 Percentage Standard Deviation 21.62	—	—	—	—	—	—
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	21.5 Percentage Standard Deviation 30.41	12.5 Percentage Standard Deviation 18.10	10.6 Percentage Standard Deviation 11.68	11.5 Percentage Standard Deviation 14.66	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=674 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=697 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=38 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=41 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	26.6 percentage Standard Deviation 26.14	—	—	—	—	—	—	—	—	—	—
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	33.6 percentage Standard Deviation 26.55	—	—	—	—	—	—	—	—	—	—
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI) Zonda Patients-wk 68	—	—	28.4 percentage Standard Deviation 27.85	39.0 percentage Standard Deviation 34.36	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=9 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=9 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=18 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=25 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=26 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=50 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	7.1 Percentage Standard Deviation 11.13	6.0 Percentage Standard Deviation 9.86	5.4 Percentage Standard Deviation 8.77	19.2 Percentage Standard Deviation 24.31	12.3 Percentage Standard Deviation 19.25	—	—	—	—	—	—
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 Standard Deviation NA Only one participant, not able to calculate SD.	10.0 Percentage Standard Deviation 14.14	13.3 Percentage Standard Deviation 11.55	14.2 Percentage Standard Deviation 18.81	11.5 Percentage Standard Deviation 10.68	12.8 Percentage Standard Deviation 14.87	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=793 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=783 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=49 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=49 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	193 Participants	—	—	—	—	—	—	—	—	—	—
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	118 Participants	—	—	—	—	—	—	—	—	—	—
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	25 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Week 108

Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=11 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=14 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=25 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=32 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=29 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=61 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 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	2 Participants	7 Participants	7 Participants	7 Participants	14 Participants	—	—	—	—	—	—
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	0 Participants	1 Participants	7 Participants	5 Participants	12 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Endpoint: Pharmacokinetic (PK) parameters

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=263 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=514 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=511 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=279 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo n=31 Participants Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=16 Participants Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 n=31 Participants Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo n=17 Participants Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study Baseline	NA ng/mL Concentration \<LLOQ (Lower Limit of Quantification)	714.25 ng/mL Interval 624.48 to 816.93	142.92 ng/mL Interval 124.08 to 164.63	NA ng/mL Concentration \<LLOQ	964.21 ng/mL Interval 589.87 to 1576.11	NA ng/mL Concentration \<LLOQ	692.91 ng/mL Interval 428.49 to 1120.5	NA ng/mL Concentration \<LLOQ	—	—	—	—
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study Week 56	865.93 ng/mL Interval 721.5 to 1039.27	930.04 ng/mL Interval 825.89 to 1047.33	173.95 ng/mL Interval 151.81 to 199.33	162.03 ng/mL Interval 132.31 to 195.43	823.62 ng/mL Interval 476.98 to 1422.17	1160.58 ng/mL Interval 833.77 to 1615.49	247.26 ng/mL Interval 165.87 to 368.57	139.35 ng/mL Interval 61.9 to 313.7	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Endpoint: Pharmacokinetic (PK) parameters

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=11 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=14 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=32 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=29 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) Baseline	NA ng/mL PK concentration \<LLOQ (Lower limit of quantification)	725.55 ng/mL Interval 231.38 to 2275.13	218.53 ng/mL Interval 126.53 to 377.42	NA ng/mL PK concentration \<LLOQ	—	—	—	—	—	—	—	—
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) Week 108	853.51 ng/mL Interval 260.26 to 2799.03	383.73 ng/mL Interval 30.9 to 4764.79	436.85 ng/mL Interval 185.36 to 1029.59	524.39 ng/mL Interval 287.72 to 955.74	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=793 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=783 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks n=49 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks n=49 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study Positive at any visit	93 Participants	80 Participants	4 Participants	8 Participants	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study Base- and Post-baseline Positive	41 Participants	23 Participants	2 Participants	4 Participants	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study Newly Persistently Positive	34 Participants	28 Participants	1 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study Stable persistently positive	29 Participants	21 Participants	2 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study Newly treatment-induced positive	41 Participants	38 Participants	2 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study ADA treatment boosted positive	6 Participants	6 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study Decreased in titre	9 Participants	17 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study Only post-baseline positive	48 Participants	48 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study ADA incidence	47 Participants	44 Participants	2 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study Transiently Positive	26 Participants	22 Participants	1 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study Only baseline positive	4 Participants	9 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study nAb positive	75 Participants	57 Participants	3 Participants	4 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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).

Assessments for the presence of ADA and nAb throughout study

Outcome measures

Outcome measures
Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n=61 Participants Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n=25 Participants Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks	ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.4 Weeks Benralizumab administered subcutaneously every 4 weeks	ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment	ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment	ZONDA - Benralizumab 30 mg q.8 Weeks Benralizumab administered subcutaneously every 8 weeks
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) Transiently Positive	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) Positive at any visit	5 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) Base- and Post-baseline Positive	3 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) Newly Persistently Positive	2 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) Stable persistently positive	3 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) Newly treatment-induced positive	1 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) ADA treatment boosted positive	2 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) Decreased in titre	2 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) Only post-baseline positive	2 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) ADA incidence	3 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) Only baseline positive	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) nAb positive	5 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—

Adverse Events

SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks

Serious events: 102 serious events

Other events: 415 other events

Deaths: 5 deaths

SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks

Serious events: 94 serious events

Other events: 409 other events

Deaths: 4 deaths

ZONDA - Benralizumab 30 mg q.4 Weeks

Serious events: 10 serious events

Other events: 33 other events

Deaths: 0 deaths

ZONDA - Benralizumab 30 mg q.8 Weeks

Serious events: 9 serious events

Other events: 38 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Ubaldo Martin, Global Clinical Lead Benralizumab

AstraZeneca

Phone: +1 301 398 0163

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee ≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ's Confidential Information without AZ's written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.
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