Trial Outcomes & Findings for Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis (NCT NCT03401229)

Last Updated: 2021-10-12

Results Overview

Change from baseline in total nasal polyps score (NPS) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The total NPS was the sum of the right and left nostril scores and maximum total NPS is 8, as evaluated by nasal endoscopy and the left and right score were based on central read with scale from 0 to 4 where higher score reflects heavier bilateral nasal polyp burden. Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

413 participants

Primary outcome timeframe

Baseline to week 40

Results posted on

2021-10-12

Participant Flow

413 participants were randomized to receive treatment in study D3250C00001 (OSTRO) with benralizumab 30 mg or placebo. Of the 413 patients randomized, 410 (99.3%) received treatment with study drug. 207 (50.5%) patients received benralizumab 30 mg and 203 (49.5%) patients received placebo

In OSTRO, at the first visit, ie, the enrollment visit 1, patients were evaluated regarding the protocol mandated inclusion and exclusion criteria. After enrolment, eligible patients entered a 5-week screening/run in period on a stable dose of study provided Mometasone Furoate Nasal Spray (MFNS).

Participant milestones

Participant milestones
Measure	Benra 30 mg Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Overall Study STARTED	207	203
Overall Study COMPLETED	167	166
Overall Study NOT COMPLETED	40	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Benra 30 mg Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Overall Study Lost to Follow-up	2	1
Overall Study Other	1	3
Overall Study Adverse Event	8	6
Overall Study Withdrawal by Subject	29	26
Overall Study COVID-19	0	1

Baseline Characteristics

Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Benra 30 mg n=207 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=203 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Total n=410 Participants Total of all reporting groups
Age, Continuous	50.1 Years STANDARD_DEVIATION 12.38 • n=93 Participants	50.2 Years STANDARD_DEVIATION 13.91 • n=4 Participants	50.2 Years STANDARD_DEVIATION 13.14 • n=27 Participants
Sex: Female, Male Female	65 Participants n=93 Participants	82 Participants n=4 Participants	147 Participants n=27 Participants
Sex: Female, Male Male	142 Participants n=93 Participants	121 Participants n=4 Participants	263 Participants n=27 Participants
Race/Ethnicity, Customized White	197 Participants n=93 Participants	190 Participants n=4 Participants	387 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=93 Participants	8 Participants n=4 Participants	12 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Asian	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to week 40

Population: Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=187 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=187 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in Total NPS at Week 40	-0.36 Score on a scale Standard Deviation 1.66	0.17 Score on a scale Standard Deviation 1.18

PRIMARY outcome

Timeframe: Baseline to week 40

Change from baseline in nasal blockage score (NBS) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The NBS was captured by an item in NPSD. Patients were asked to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0-none; 1-mild; 2-moderate; 3-severe. The NBS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=181 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in NBS at Week 40	-0.68 Score on a scale Standard Deviation 1.02	-0.41 Score on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: Baseline to week 40

Change from baseline in SinoNasal outcome test (SNOT-22) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The SNOT-22 is a condition specific health-related quality of life assessment which captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal conditions. The total score is the sum of item scores and has a range from 0 to 110 (higher scores indicate poorer outcomes). Baseline was the last valid value on or prior to the date of randomization. Data collected after NP surgery and/or SCS\_NP were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=193 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=190 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in SNOT-22 at Week 40	-15.2 Score on a scale Standard Deviation 30.47	-10.7 Score on a scale Standard Deviation 31.64

SECONDARY outcome

Timeframe: Baseline to week 56

Population: Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Number of patients analyzed is number of patients who had NP surgery and/or SCS use.

The cumulative percentage and the corresponding 95% CI are based on the Kaplan-Meier estimates. Patients can have more than 1 rescue category during the study, and the first rescue per patient is considered. The time to first nasal polyposis (NP) surgery and/or systemic corticosteroids (SCS) use for NP up to week 56 was calculated based on the earliest occurrence of NP surgery and/or SCS use for NP and was calculated as follows: Time to first NP surgery and/or SCS use for NP = Earlier of (Start date of first NP surgery, Start date of first SCS use for NP) - date of randomization + 1. For patients who did not experience any surgery or SCS use for NP, the time to event was censored at earlier of (date of their week 56 visit, date of discontinuation).

Outcome measures

Outcome measures
Measure	Benra 30 mg n=207 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=203 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Time to First NP Surgery and/or SCS Use for NP to Week 56	35.5 months Interval 29.3 to 42.5	46.5 months Interval 39.7 to 53.8

SECONDARY outcome

Timeframe: Baseline to week 56

Population: Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Number of patients analyzed is number of patients who had NP surgery.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=207 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=203 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Time to the First NP Surgery up to Week 56	16.6 months Interval 12.1 to 22.5	19.5 months Interval 14.5 to 25.9

SECONDARY outcome

Timeframe: Baseline to week 40

Change from baseline in difficulty with sense of smell (DSS) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The DSS is captured by an item in the NPSD. Severity of worst difficulty with sense of smell over the past 24 hours was rated with response options: 0-none; 1-mild; 2-moderate; 3-severe. The DSS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids use for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=181 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in DSS at Week 40	-0.34 Score on a scale Standard Deviation 0.74	-0.16 Score on a scale Standard Deviation 0.65

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in total nasal polyps score (NPS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The total NPS is the sum of the right and left nostril scores, as evaluated by nasal endoscopy and the left and right score are based on central read with scale from 0 to 4 where higher score reflects heavier bilateral nasal polyp burden. Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=161 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=171 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in NPS at Week 56	-0.22 Score on a scale Standard Deviation 1.76	0.18 Score on a scale Standard Deviation 1.44

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in nasal blockage score (NBS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The NBS is captured by an item in the NPSD. Patients were asked to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0-none; 1-mild; 2-moderate; 3-severe. The NBS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=179 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=175 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in NBS at Week 56	-0.68 Score on a scale Standard Deviation 1.03	-0.38 Score on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in SinoNasal outcome test (SNOT-22) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The SNOT-22 is a condition specific health-related quality of life assessment which captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal conditions. The total score is range from 0 to 110 (higher scores indicate poorer outcomes). Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=190 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=184 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in SNOT-22 at Week 56	-15.1 Score on a scale Standard Deviation 33.55	-7.9 Score on a scale Standard Deviation 33.22

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in difficulty with sense of smell (DSS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The DSS is captured by an item in the NPSD with response options: 0-none; 1-mild; 2-moderate; 3-severe to rate the severity of their worst difficulty with sense of smell over past 24 hours. The DSS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=179 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=175 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in DSS at Week 56	-0.39 Score on a scale Standard Deviation 0.79	-0.21 Score on a scale Standard Deviation 0.65

SECONDARY outcome

Timeframe: Baseline to EOT/IPD, up to 56 weeks

Population: CT analysis set and patients with a baseline CT who are rescued by SCS\_NP by week 56

Change from baseline in Computed tomography (CT) Lund Mackay Score (LMS) at end of treatment (EOT)/investigational product discontinuation (IPD) was defined as the endpoint value at EOT/IPD minus the baseline value. The LMS evaluates the patency using a 0-2 scale (0-normal; 1-partial opacification; and 2-total opacification) of each sinus (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side). The osteomeatal complex is graded as 0- not occluded or 2-occluded. The total CT score is the sum of the scores from all the sinus and ranges from 0 to 24. The minimum is 0 and higher score indicates worse outcome. The analysis used the data collected after systemic corticosteroids for nasal polyposis (SCS\_NP). A composite strategy was used for NP surgery. If a patient had NP surgery before EOT/IPD CT scan, the data was censored after the time of the first NP surgery and the worst possible value (WP) was imputed in its place.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=81 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=84 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in LMS at EOT/IPD	-0.93 Score on a scale Standard Deviation 5.06	-0.20 Score on a scale Standard Deviation 4.20

SECONDARY outcome

Timeframe: Baseline to week 56

The percentage of patients who had nasal polyposis (NP) surgery or systemic corticosteroids use for nasal polyposis (SCS\_NP) surgery up to week 56 was summarized and analyzed using the Cochran-Mantel-Haenszel test stratified by region (US vs non-US) and baseline comorbid asthma status (yes vs no).

Outcome measures

Outcome measures
Measure	Benra 30 mg n=207 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=203 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Percentage of Subjects With NP Surgery	33 Participants	37 Participants

SECONDARY outcome

Timeframe: Baseline to week 56

The percentage of patients who had systemic corticosteroids (SCS) use for nasal polyposis (NP) surgery up to week 56 was summarized and analyzed using the Cochran-Mantel-Haenszel test stratified by region (US vs non-US) and baseline comorbid asthma status (yes vs no).

Outcome measures

Outcome measures
Measure	Benra 30 mg n=207 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=203 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Percentage of Subjects With SCS_NP	52 Participants	66 Participants

SECONDARY outcome

Timeframe: Baseline to week 56

Outcome measures

Outcome measures
Measure	Benra 30 mg n=207 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=203 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Percentage of Subjects With NP Surgery or SCS_NP	72 Participants	91 Participants

SECONDARY outcome

Timeframe: Baseline to week 56

The cumulative percentage and the corresponding 95% CI are based on the Kaplan-Meier estimates. Patients can have more than 1 rescue category during the study, and the first rescue per patient is considered. The time to first systemic corticosteroids for use for nasal polyposis (SCS\_NP) up to week 56 was calculated based on the earliest occurrence of SCS\_ NP and was calculated as follows: Time to first SCS\_NP = Earlier of (Start date of first SCS use for NP) - date of randomization + 1. For patients who did not experience any SCS use for NP, the time to event was censored at earlier of (date of their week 56 visit, date of discontinuation). The time to first SCS use for NP surgery was analyzed using a Cox proportional hazard model with treatment arm, region (US vs non-US) and baseline comorbid asthma status (yes vs no) as covariates. A hazard ratio less than 1 indicates a lower rate of incidence for subjects on benra.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=207 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=203 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Time to First SCS_NP up to Week 56	25.7 months Interval 20.2 to 32.3	33.5 months Interval 27.3 to 40.7

SECONDARY outcome

Timeframe: Baseline to week 56

The total number of courses of systemic corticosteroids (SCS) use for nasal polyposis (NP) was summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=207 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=203 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Total Number of Courses of SCS for NP	1.7 number of courses Standard Deviation 0.93	1.6 number of courses Standard Deviation 0.89

SECONDARY outcome

Timeframe: Baseline to week 56

The total systemic corticosteroids (SCS) for nasal polyposis (NP) dose used (mg) was summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=207 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=203 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Total SCS_NP Dose (a) Used (mg)	1083.2 milligrams Standard Deviation 4044.29	435.2 milligrams Standard Deviation 441.57

SECONDARY outcome

Timeframe: Baseline to week 56

The total duration of systemic corticosteroids (SCS) for nasal polyposis (NP) in days was summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=207 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=203 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Total Duration of SCS_NP (Days)	17.6 days Standard Deviation 12.45	20.1 days Standard Deviation 34.68

SECONDARY outcome

Timeframe: Baseline to week 56

Annual systemic corticosteroids for nasal polyposis (SCS\_NP) use rate =365.25×total number of courses of SCS\_NP /total duration of follow-up within the treatment group (days). The estimated annual event rates, absolute differences, rate ratio and the corresponding confidence interval were based on a negative binomial model including covariates treatment group, region (US/non-US) and prior use of SCS\_NP with total number of courses of SCS\_NP as the outcome and the log of each subject's corresponding follow-up time up to week 56 as an offset variable in the model to adjust for subject's having different exposure times during which the events occur.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=207 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=203 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Annual SCS_NP Use Rate Comparison by Period, Negative Binomial Model	0.40 number of courses for each patient Interval 0.3 to 0.52	0.50 number of courses for each patient Interval 0.38 to 0.65

SECONDARY outcome

Timeframe: Baseline to week 40

Change from baseline in total symptom score (TSS) at week 40 was defined as the endpoint at week 40 minus baseline value. The TSS is defined as sum of first 8 NPSD components. Severity of each nasal symptoms over the past 24 hours is rated using response options: 0-none; 1-mild; 2-moderate; 3-severe. The TSS and the change from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily TSS responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for nasal polyposis (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming MAR were used to build the complete imputation datasets for the analysis.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=181 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in TSS at Week 40	-3.20 Score on a scale Standard Deviation 6.90	-1.38 Score on a scale Standard Deviation 6.29

SECONDARY outcome

Timeframe: Baseline to week 40

Change from baseline in difficulty with sleeping due to nasal symptoms score at week 40 was defined as the endpoint at week 40 minus baseline value. The score was captured by an item in NPSD. The severity of difficulty with sleeping due to nasal symptoms over past 24 hours was rated using options: 0-none; 1-mild; 2-moderate; 3-severe. The score and change from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for nasal polyposis (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=181 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in Difficulty With Sleeping Due to Nasal Symptoms at Week 40	-0.39 Score on a scale Standard Deviation 1.06	-0.19 Score on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: Baseline to week 40

Change from baseline in difficulty with daily activities due to nasal symptoms score at week 40 was defined as the endpoint at week 40 minus baseline value. The score was captured by an item in NPSD. The severity of difficulty with daily activities due to nasal symptoms over the past 24 hours was rated using options: 0-none; 1-mild; 2-moderate; 3-severe. The score and change from baseline were summarized every two weeks (bi-weekly). Baseline was average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for nasal polyposis (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming MAR were used to build the complete imputation datasets for the analysis.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=181 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in Difficulty With Daily Activities Due to Nasal Symptoms at Week 40	-0.35 Score on a scale Standard Deviation 1.04	-0.11 Score on a scale Standard Deviation 0.99

SECONDARY outcome

Timeframe: Baseline to week 40

Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score at week 40 was defined as the endpoint value at week 40 minus the baseline value. The UPSIT is quantitative test of olfactory function. Scores were based on number of correctly identified odors (score range 0 to 40). Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for nasal polyposis (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=109 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=89 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in UPSIT Score in Males at Week 40	-0.20 Score on a scale Standard Deviation 10.29	0.09 Score on a scale Standard Deviation 8.05

SECONDARY outcome

Timeframe: Baseline to week 40

Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score at week 40 was defined as the endpoint value at week 40 minus the baseline value. The UPSIT is quantitative test of olfactory function. Scores are based on number of correctly identified odors (score range 0 to 40). Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for nasal polyposis (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=53 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=74 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in UPSIT Score in Females at Week 40	1.66 Score on a scale Standard Deviation 8.86	-1.32 Score on a scale Standard Deviation 7.66

SECONDARY outcome

Timeframe: Baseline to EOT/IPD, up to 56 weeks

Population: CT analysis set and patients with a baseline CT who are rescued by SCS\_NP by week 56. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis.

Change from baseline in sinus severity score at end of treatment (EOT)/investigational product discontinuation (IPD) was defined as the endpoint value at EOT/IPD minus the baseline value. Quantitative assessment of sinus CT image data was used to derive an objective measure of sinus disease burden called sinus severity score. The sinus severity score is defined as (sinus mucosal volume)/(sinus mucosal volume + sinus air volume)×100. A composite strategy was used for NP surgery. If a patient had NP surgery before EOT/IPD CT scan, the data was censored after the time of the first NP surgery and the worst possible value (WP) was imputed in its place. In calculation of summary statistics (mean and standard deviation), the WP for NP surgery rescued subjects was applied. In ANCOVA, following WP (WP for NP surgery rescued subjects), model included treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=86 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=84 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in Sinus Severity Score at EOT/IPD	-3.48 Score on a scale Standard Deviation 24.24	0.79 Score on a scale Standard Deviation 17.29

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in SF-36v2 physical component summary (PCS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. PCS score is computed from 8 subscale scores to give a broader metric of physical health-related quality of life. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=185 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in SF-36v2 Physical Component Summary at Week 56	-1.557 Score on a scale Standard Deviation 17.7075	-3.185 Score on a scale Standard Deviation 17.4189

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in SF-36v2 mental component summary (MCS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. MCS score is computed from 8 subscale scores to give a broader metric of mental health-related quality of life. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=185 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in SF-36v2 Mental Component Summary at Week 56	-2.263 Score on a scale Standard Deviation 18.4094	-4.182 Score on a scale Standard Deviation 19.3697

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in SF-36v2 physical functioning score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. Physical functioning is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=185 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in SF-36v2 Physical Functioning at Week 56	0.080 Score on a scale Standard Deviation 14.8681	-0.911 Score on a scale Standard Deviation 14.6581

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in SF-36v2 role limitations due to physical health score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. Role limitations due to physical health is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=185 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in SF-36v2 Role Limitations Due to Physical Health at Week 56	1.576 Score on a scale Standard Deviation 13.4610	0.025 Score on a scale Standard Deviation 13.3886

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in SF-36v2 bodily pain score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. Bodily pain is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=185 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in SF-36v2 Bodily Pain at Week 56	0.982 Score on a scale Standard Deviation 15.0935	-1.066 Score on a scale Standard Deviation 15.3689

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in SF-36v2 general health perceptions score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. General health perceptions is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing are excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=185 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in SF-36v2 General Health Perceptions at Week 56	0.445 Score on a scale Standard Deviation 14.2295	-1.064 Score on a scale Standard Deviation 13.6387

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in SF-36v2 vitality score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. Vitality is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=185 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in SF-36v2 Vitality at Week 56	1.913 Score on a scale Standard Deviation 12.9999	-0.594 Score on a scale Standard Deviation 13.5861

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in SF-36v2 social functioning score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 are used to compute an 8-domain profile of functional health and well-being scores. Social functioning is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=185 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in SF-36v2 Social Functioning at Week 56	0.262 Score on a scale Standard Deviation 15.1786	-1.247 Score on a scale Standard Deviation 15.9512

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in SF-36v2 role limitations due to emotional problems score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. Role limitations due to emotional problems is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=185 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in SF-36v2 Role Limitations Due to Emotional Problems at Week 56	-0.492 Score on a scale Standard Deviation 17.1261	-1.825 Score on a scale Standard Deviation 16.6618

SECONDARY outcome

Timeframe: Baseline to week 56

Change from baseline in SF-36v2 mental health score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. Mental health is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied.

Outcome measures

Outcome measures
Measure	Benra 30 mg n=191 Participants Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=185 Participants Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Change From Baseline in SF-36v2 Mental Health at Week 56	-1.506 Score on a scale Standard Deviation 16.5930	-3.308 Score on a scale Standard Deviation 17.2382

Adverse Events

Benra 30 mg

Serious events: 25 serious events

Other events: 64 other events

Deaths: 0 deaths

Placebo

Serious events: 19 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Benra 30 mg n=207 participants at risk Benra administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.	Placebo n=203 participants at risk Placebo administered every 4 weeks for the first 3 doses - Weeks 0, 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48.
Infections and infestations Nasopharyngitis	17.9% 37/207 • Number of events 57 • From first dose of study drug until end of study, up to 603 days. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : All randomized participants who received at least one dose of study drug.	21.2% 43/203 • Number of events 54 • From first dose of study drug until end of study, up to 603 days. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : All randomized participants who received at least one dose of study drug.
Infections and infestations Viral upper respiratory tract infection	3.4% 7/207 • Number of events 9 • From first dose of study drug until end of study, up to 603 days. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : All randomized participants who received at least one dose of study drug.	6.9% 14/203 • Number of events 15 • From first dose of study drug until end of study, up to 603 days. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : All randomized participants who received at least one dose of study drug.
Nervous system disorders Headache	3.4% 7/207 • Number of events 9 • From first dose of study drug until end of study, up to 603 days. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : All randomized participants who received at least one dose of study drug.	7.9% 16/203 • Number of events 18 • From first dose of study drug until end of study, up to 603 days. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	10.1% 21/207 • Number of events 30 • From first dose of study drug until end of study, up to 603 days. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : All randomized participants who received at least one dose of study drug.	14.8% 30/203 • Number of events 54 • From first dose of study drug until end of study, up to 603 days. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : All randomized participants who received at least one dose of study drug.

Additional Information

Maria Jison, MD Global Clinical Head, FASENRA, Late-stage R&I

AstraZeneca

Phone: +13013980340

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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