Eosinophilic Granulomatous Vasculitis
Conditions
Keywords
Benralizumab, Inhaled corticosteroids, Eosinophilic Granulomatous Vasculitis
Brief summary
This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC (earlier enrolled patients may therefore be in the OLE for longer than 1 year).
Interventions
BIOLOGICALBenralizumab
30 mg/mL solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC)
BIOLOGICALMepolizumab
3x100 mg vials of powder for solution for injection reconstituted into 3 separate 1 mL syringes for administration on each dosing occasion. Injection volume per syringe is 1 mL. Mepolizumab active solution will be administered subcutaneously (SC)
BIOLOGICALPlacebo to Mepolizumab
Matching placebo: 0.9% sodium chloride, solutions for injection in 1mL syringes (3 syringes will be used on each dosing occasion). Injection volume per syringe is 1mL. Placebo to Mepolizumban will be administered subcutaneously (SC)
BIOLOGICALPlacebo to Benralizumab
Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC)
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects age 18 years or older. 2. EGPA diagnosis based on history or presence asthma and eosinophilia (\>1.0x10\^9/L and/or \>10% of leucocytes) and at least 2 of; biopsy with eosinophilic vasculitis or perivascular/granulomatous inflammation; mono-or polyneuropathy, non-fixed pulmonary infiltrates, sino-nasal abnormality; cardiomyopathy; glomerulonephritis; alveolar haemorrhage; palpable purpura; anti neutrophil cytoplasmic anti-body (ANCA) positivity (Myeloperoxidase or proteinease 3). 3. History of relapsing (at least 1 confirmed EGPA relapse within last 2 years and \> 12 weeks prior to screening), or refractory (failure to attain remission, defined as BVAS=0 and oral corticosteroid (OCS) dose \<=7.5 mg/day of prednisolone or equivalent, following standard induction regimen for at least 3 months and within 6 months prior to screening, or recurrence of symptoms upon OCS tapering at any dose of ≥7.5 mg/day prednisolone or equivalent. If induction with glucocorticoidsalone, patient must have failed to attain remission after 3 months and the glucocorticoid dose must be ≥15 mg/day prednisolone or equivalent for the 4 weeks prior to randomization. 4. Must be on a stable dose of oral prednisolone or prednisone of ≥7.5 mg/day (but not \>50mg/day) for at least 4 weeks prior to randomization. 5. If receiving immunosuppressive therapy (excluding cyclophosphamide) the dose must be stable for the 4 weeks prior to randomization and during the study (dose reductions for safety reasons will be permitted). 6. QTc(F)\<450 msec or QTc(F)\<480 msec for patients with bundle branch block. 7. Females of childbearing potential must use an acceptable method of birth control from randomization for at least 12 weeks after the last study drug administration.
Exclusion criteria
1. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) 2. Organ or life-threatening EGPA \< 3 months prior to screening 3. Currently pregnant or breastfeeding, or planning to become pregnant during study participation. 4. Current malignancy or history of malignancy, unless received curative therapy \>5 years ago, or \>1 year ago for basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix 5. An untreated or refractory helminth parasitic infection \< 24 weeks prior to screening 6. Unstable liver disease 7. Severe or clinically significant, uncontrolled cardiovascular disease 8. Other concurrent disease that may put the patient at risk, or may influence the results of the study, or the patients' ability to complete entire duration of the study 9. Chronic or ongoing infectious disease requiring systemic anti-infective treatment 10. Known immunodeficiency disorder or positive HIV test 11. Prior receipt of mepolizumab, reslizumab, dupilumab or benralizumab. Receipt of intravenous/intramuscular/subcutaneous corticosteroids within 4 weeks prior to randomization, receipt of omalizumab within 130 days prior to screening, rituximab within 6 months prior to screening (or B-cells not recovered), interferon-α or alemtuzumab within 6 months prior to screening, receipt of anti-tumor necrosis factor therapy within 12 weeks prior to screening or an investigational non-biologic product within 30 days or 5 half-lives prior to screening, whichever is longer. Receipt of any other marketed or investigational biologic products within 4 months or 5 half-lives prior to screening, whichever is longer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48 | Week 36 and Week 48 | Percentage of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 4 mg/day (main remission definition) at both Weeks 36 and 48. |
| Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48 | Week 36 and Week 48 | Supportive endpoint: Proportion of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 7.5 mg/day (supportive remission definition) at both Weeks 36 and 48. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Accrued Duration of Remission During DB Treatment Period | from baseline to end of DB period, 52 Weeks. | Total accrued duration of remission for the following categories: 0 week, \> 0 to \< 12 week, 12 to \< 24 week, 24 to \< 36 week, ≥ 36 week. |
| Total Accrued Duration of Sustained Remission During DB Treatment Period | from baseline to end of DB period, 52 Weeks | Total accrued duration of sustained remission for the following categories: 0 week, \> 0 to \< 12 week, 12 to \< 24 week, 24 to \< 36 week, ≥ 36 week. |
| Proportion of Patients Who Have Achieved Remission Within the First 24 Weeks and Remained in Remission for Remainder of the Double-blind Treatment Period | from baseline to end of DB period, 52 Weeks | Proportion of patients who have achieved remission within the first 24 weeks and remained in remission for remainder of the double-blind treatment period |
| Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | from baseline to end of DB period, 52 Weeks | Birmingham Vasculitis Activity Score (BVAS) change from baseline by timepoint up to week 52. The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The total score on all 9 organ systems gives an indication of the disease activity of each patient at the time of scoring. Total scores range from 0 to 63, with higher scores indicating more active vasculitis. |
| Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | from baseline to end of DB period, 52 Weeks | Pre-bronchodilator (BD) Forced Expiratory Volume during first second (FEV1) change from baseline by timepoint up to week 52 |
| Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | from baseline to end of DB period, 52 Weeks | Pre-bronchodilator (BD) Forced vital capacity (FVC) change from baseline by timepoint up to week 52 |
| Change From Baseline in Vasculitis Damage Index (VDI) | from baseline to end of DB period, 52 Weeks | Vasculitis Damage Index (VDI) change from baseline by timepoint up to week 52. The VDI is divided into 11 organ systems and records items of damage, due to vasculitis, treatment or unrelated, that have occurred since the onset of vasculitis. Completion of the form provides a numerical score, ranging from 0 to 64, with a higher score indicating more damage. |
| Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | from baseline to end of DB period, 52 Weeks | Asthma Control Questionnaire (6-item version) (ACQ-6) change from baseline by timepoint up to week 52. The ACQ-6 score is calculated by taking the mean of 6 equally weighted domains, with a range of 0 (well controlled) to 6 (extremely poorly controlled). |
| Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | from baseline to end of DB period, 52 Weeks | Short Form 36-item health survey (version 2, acute recall) (SF-36v2) component Physical Component Summary (PCS) change from baseline by timepoint up to week 52. PCS score ranges from 10.8 to 75.5, where a higher score indicates better health. |
| Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | from baseline to end of DB period, 52 Weeks | Short Form 36-item health survey (version 2, acute recall) (SF-36v2) component Mental Component Summary (MCS) change from baseline by timepoint up to week 52. MCS score ranges from 5.6 to 69.7, where a higher score indicates better health. |
| Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | from baseline to end of DB period, 52 Weeks | Sino-nasal Outcome Test-22 (SNOT-22) total score change from baseline by timepoint up to week 52. Patient reported symptom severity and symptom impact over the previous 2 weeks on 22 items are captured via a 6-point scale (0 = no problem to 5 = problem as bad as it can be). The total score is the sum of item scores and ranges from 0 to 110 (higher scores indicate poorer outcomes). |
| Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | from baseline to end of DB period, 52 Weeks | Sino-nasal Symptoms Questionnaire (SSQ) scores : symptom runny nose by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe). |
| Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | from baseline to end of DB period, 52 Weeks | Sino-nasal Symptoms Questionnaire (SSQ) scores : symptom Post-nasal discharge by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe). |
| Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | from baseline to end of DB period, 52 Weeks | Sino-nasal Symptoms Questionnaire (SSQ) scores: symptom Facial pain/pressure by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe). |
| Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | from baseline to end of DB period, 52 Weeks | Sino-nasal Symptoms Questionnaire (SSQ) scores: symptom Loss or reduction in sense of taste/smell by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe). |
| Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | from baseline to end of DB period, 52 Weeks | Sino-nasal Symptoms Questionnaire (SSQ) scores: symptom Blockage/congestion of nose by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe). |
| Patient Global Impression of Severity (PGIS) Category | from baseline to end of DB period, 52 Weeks | Patient Global Impression of Severity (PGIS) category by timepoint |
| Patient Global Impression of Change (PGIC) Category | from baseline to week 4 | Patient Global Impression of Change (PGIC) category by timepoint |
| WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | from baseline to end of DB period, 52 Weeks | The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Subscale: Absenteeism (work time missed) (%) score, range 0-100. |
| WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | from baseline to end of DB period, 52 Weeks | The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Presenteeism (%) score. |
| WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | from baseline to end of DB period, 52 Weeks | The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Work productivity loss (%) score, range 0-100. |
| WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | from baseline to end of DB period, 52 Weeks | The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Activity impairment (%) score, range 0-100. |
| Absolute Eosinophil Count, Change From Baseline | from baseline to end of DB period, 52 Weeks | Absolute eosinophil count, change from baseline by timepoint up to week 52 |
| Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | from baseline to end of DB period, 52 Weeks | Time from randomization to first Eosinophilic Granulomatosis with Polyangiitis (EGPA) relapse, where relapse is defined as any of the following: * Active vasculitis (BVAS \> 0); OR * Active asthma symptoms and/or signs with a corresponding worsening in ACQ-6 score; OR * Active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions; warranting any of the following: * An increased dose of OCS therapy to \> 4 mg/day prednisolone total daily dose; OR * An increased dose or addition of immunosuppressive therapy; OR * Hospitalization related to EGPA worsening Calculated using the Kaplan-Meier technique. |
| Annualized Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse Rate | from baseline to end of DB period, 52 Weeks | Annualized Eosinophilic Granulomatosis with Polyangiitis (EGPA) relapse rate through end of DB treatment period. The estimate of annualized relapse rate (relapses per year) and the corresponding 95% CIs were calculated using a negative binomial model. The response variable in the model is the number of relapses experienced by a subject up to Week 52. The logarithm of the subject's corresponding follow-up time up to Week 52 was used as an offset variable to adjust for subjects having different follow-up times during which the events occur. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region. |
| Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52 | last 4 weeks of DB period | Average daily dose of prednisolone/prednisone and change from baseline during Week 48 through 52, or last 28 days prior to last double-blind assessment for those that withdrew |
| Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Proportion of patients with average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: 0 mg; \>0 to ≤ 4 mg; \> 4 to ≤ 7.5 mg and \> 7.5 mg |
| Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Percentage reduction from baseline in average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: no reduction or withdrawal from treatment; \< 25% reduction; 25 to \< 50% reduction; 50 to \<75% reduction; 75 to \< 100% reduction; 100% reduction. |
| Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Proportion of subjects with reduction from baseline in average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: \>= 50% reduction; 100% reduction; OCS dose \<= 4 mg/day. |
| Proportion of Subjects Who Achieve Clinical Benefit | from baseline to end of DB period, 52 Weeks | Proportion of subjects who achieved any clinical benefit definition 1 (defined as any of the following: * Main remission at any time in DB period * \>= 50% reduction in OCS dose in Weeks 48 to 52 * EGPA relapse free in DB period) and subjects who achieved complete response definition 1 (defined as meeting all the definition 1 criteria above.) |
Countries
Belgium, Canada, France, Germany, Israel, Italy, Japan, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORMichael Wechsler, MD
National Jewish Health, 1400 Jackson St Denver, CO 80206
Participant flow
Recruitment details
140 participants were randomized to receive treatment in study D3253C00001 (MANDARA) with benralizumab 30 mg or mepolizumab 300 mg. Of the 140 patients randomized, 140 (100%) received treatment with study drug. 70 (50%) patients received benralizumab 30 mg and 70 (50%) patients received mepolizumab 300 mg.
Pre-assignment details
All patients completed a screening period of 1-4 weeks during which inclusion/exclusion criteria was assessed, disease activity, corticosteroid medication usage and patient reported outcomes were recorded, medical history and clinical laboratory were taken. All patients who entered open label extension period received benralizumab 30 mg during open label extension period.
Participants by arm
| Arm | Count |
|---|---|
| Benralizumab 30 mg Benralizumab and matching placebo injections delivered subcutaneously every 4 weeks | 70 |
| Mepolizumab 300 mg Mepolizumab and matching placebo injection delivered subcutaneously every 4 weeks | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Benralizumab 30 mg | Mepolizumab 300 mg | Total |
|---|---|---|---|
| Age, Continuous | 52.0 years STANDARD_DEVIATION 13.9 | 52.7 years STANDARD_DEVIATION 14.38 | 52.3 years STANDARD_DEVIATION 14.1 |
| Age, Customized >= 18 to <= 65 years | 57 participants | 59 participants | 116 participants |
| Age, Customized > 65 years | 13 participants | 11 participants | 24 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 67 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 9 participants | 8 participants | 17 participants |
| Race/Ethnicity, Customized Not reported | 5 participants | 3 participants | 8 participants |
| Race/Ethnicity, Customized Other | 3 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized White | 53 participants | 57 participants | 110 participants |
| Region of Enrollment Japan | 4 participants | 4 participants | 8 participants |
| Region of Enrollment North America | 16 participants | 16 participants | 32 participants |
| Region of Enrollment Rest of World | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 45 Participants | 39 Participants | 84 Participants |
| Sex: Female, Male Male | 25 Participants | 31 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 70 | 0 / 66 | 1 / 62 |
| other Total, other adverse events | 46 / 70 | 56 / 70 | 43 / 66 | 46 / 62 |
| serious Total, serious adverse events | 4 / 70 | 9 / 70 | 10 / 66 | 13 / 62 |
Outcome results
Primary
Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48
Percentage of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 4 mg/day (main remission definition) at both Weeks 36 and 48.
Time frame: Week 36 and Week 48
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Benralizumab 30 mg | Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48 | 40 Participants |
| Mepolizumab 300 mg | Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48 | 40 Participants |
p-value: 0.877395% CI: [-0.1411, 0.1653]Regression, Logistic
Primary
Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48
Supportive endpoint: Proportion of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 7.5 mg/day (supportive remission definition) at both Weeks 36 and 48.
Time frame: Week 36 and Week 48
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Benralizumab 30 mg | Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48 | 55 Participants |
| Mepolizumab 300 mg | Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48 | 52 Participants |
95% CI: [-0.0746, 0.1834]Regression, Logistic
Secondary
Absolute Eosinophil Count, Change From Baseline
Absolute eosinophil count, change from baseline by timepoint up to week 52
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 52 | 0.10 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 1 | 0.15 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 4 | 0.14 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 8 | 0.10 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 12 | 0.11 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 16 | 0.11 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 20 | 0.10 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 24 | 0.14 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 25 | 0.14 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 28 | 0.10 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 32 | 0.12 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 36 | 0.11 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 40 | 0.09 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 44 | 0.10 cells*10^9/L |
| Benralizumab 30 mg | Absolute Eosinophil Count, Change From Baseline | week 48 | 0.10 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 52 | 0.26 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 25 | 0.23 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 1 | 0.39 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 40 | 0.22 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 4 | 0.30 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 28 | 0.24 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 8 | 0.23 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 48 | 0.24 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 12 | 0.25 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 32 | 0.22 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 16 | 0.24 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 44 | 0.24 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 20 | 0.23 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 36 | 0.26 cells*10^9/L |
| Mepolizumab 300 mg | Absolute Eosinophil Count, Change From Baseline | week 24 | 0.24 cells*10^9/L |
Secondary
Annualized Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse Rate
Annualized Eosinophilic Granulomatosis with Polyangiitis (EGPA) relapse rate through end of DB treatment period. The estimate of annualized relapse rate (relapses per year) and the corresponding 95% CIs were calculated using a negative binomial model. The response variable in the model is the number of relapses experienced by a subject up to Week 52. The logarithm of the subject's corresponding follow-up time up to Week 52 was used as an offset variable to adjust for subjects having different follow-up times during which the events occur. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Benralizumab 30 mg | Annualized Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse Rate | 0.50 relapses per year |
| Mepolizumab 300 mg | Annualized Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse Rate | 0.49 relapses per year |
Comparison: relapse95% CI: [0.56, 1.9]negative binomial model
Secondary
Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52
Average daily dose of prednisolone/prednisone and change from baseline during Week 48 through 52, or last 28 days prior to last double-blind assessment for those that withdrew
Time frame: last 4 weeks of DB period
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52 | average daily dose | 3.01 mg | Standard Deviation 3.776 |
| Benralizumab 30 mg | Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52 | change from baseline of average daily dose | -8.08 mg | Standard Deviation 4.575 |
| Mepolizumab 300 mg | Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52 | average daily dose | 3.43 mg | Standard Deviation 4.124 |
| Mepolizumab 300 mg | Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52 | change from baseline of average daily dose | -7.52 mg | Standard Deviation 7.07 |
Secondary
Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6)
Asthma Control Questionnaire (6-item version) (ACQ-6) change from baseline by timepoint up to week 52. The ACQ-6 score is calculated by taking the mean of 6 equally weighted domains, with a range of 0 (well controlled) to 6 (extremely poorly controlled).
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 9-12 | -0.55 score |
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 29-32 | -0.56 score |
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 25-28 | -0.65 score |
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 33-36 | -0.57 score |
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 13-16 | -0.62 score |
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 37-40 | -0.57 score |
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 5-8 | -0.56 score |
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 41-44 | -0.58 score |
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 17-20 | -0.59 score |
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 45-48 | -0.61 score |
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 1-4 | -0.34 score |
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 49-52 | -0.57 score |
| Benralizumab 30 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 21-24 | -0.59 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 49-52 | -0.61 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 1-4 | -0.31 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 5-8 | -0.49 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 9-12 | -0.52 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 13-16 | -0.48 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 17-20 | -0.47 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 25-28 | -0.49 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 29-32 | -0.50 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 33-36 | -0.55 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 37-40 | -0.54 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 41-44 | -0.60 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 45-48 | -0.64 score |
| Mepolizumab 300 mg | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | week 21-24 | -0.53 score |
Secondary
Change From Baseline in Birmingham Vasculitis Activity Score (BVAS)
Birmingham Vasculitis Activity Score (BVAS) change from baseline by timepoint up to week 52. The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The total score on all 9 organ systems gives an indication of the disease activity of each patient at the time of scoring. Total scores range from 0 to 63, with higher scores indicating more active vasculitis.
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 12 | -1.79 scores on a scale |
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 32 | -1.92 scores on a scale |
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 20 | -1.73 scores on a scale |
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 36 | -1.98 scores on a scale |
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 8 | -1.33 scores on a scale |
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 40 | -1.84 scores on a scale |
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 24 | -1.59 scores on a scale |
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 44 | -1.84 scores on a scale |
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 16 | -1.85 scores on a scale |
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 48 | -1.80 scores on a scale |
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 28 | -1.94 scores on a scale |
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 52 | -1.85 scores on a scale |
| Benralizumab 30 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 4 | -1.19 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 52 | -1.32 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 4 | -1.14 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 8 | -1.74 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 12 | -1.66 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 16 | -1.80 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 20 | -1.82 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 24 | -1.74 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 28 | -1.95 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 32 | -1.93 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 36 | -1.65 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 40 | -1.89 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 44 | -1.96 scores on a scale |
| Mepolizumab 300 mg | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | week 48 | -1.92 scores on a scale |
Secondary
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS)
Short Form 36-item health survey (version 2, acute recall) (SF-36v2) component Mental Component Summary (MCS) change from baseline by timepoint up to week 52. MCS score ranges from 5.6 to 69.7, where a higher score indicates better health.
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 1 | 0.90 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 4 | 0.06 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 8 | 0.64 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 12 | 0.04 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 16 | 0.29 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 28 | -0.03 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 40 | 0.77 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 52 | 1.13 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 52 | 2.19 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 1 | -0.13 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 16 | 2.18 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 4 | 0.58 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 40 | 2.39 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 8 | 1.05 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 28 | 2.03 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | week 12 | 1.44 score |
Secondary
Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS)
Short Form 36-item health survey (version 2, acute recall) (SF-36v2) component Physical Component Summary (PCS) change from baseline by timepoint up to week 52. PCS score ranges from 10.8 to 75.5, where a higher score indicates better health.
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 1 | 0.68 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 16 | 1.24 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 8 | 1.56 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 4 | 1.18 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 40 | 1.73 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 12 | 1.30 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 52 | 0.29 score |
| Benralizumab 30 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 28 | 1.54 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 52 | 2.45 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 1 | 0.88 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 4 | 1.11 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 8 | 1.46 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 12 | 1.31 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 16 | 1.85 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 28 | 2.12 score |
| Mepolizumab 300 mg | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | week 40 | 2.28 score |
Secondary
Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score
Sino-nasal Outcome Test-22 (SNOT-22) total score change from baseline by timepoint up to week 52. Patient reported symptom severity and symptom impact over the previous 2 weeks on 22 items are captured via a 6-point scale (0 = no problem to 5 = problem as bad as it can be). The total score is the sum of item scores and ranges from 0 to 110 (higher scores indicate poorer outcomes).
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 12 | -5.30 score |
| Benralizumab 30 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 28 | -7.89 score |
| Benralizumab 30 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 8 | -5.79 score |
| Benralizumab 30 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 40 | -5.05 score |
| Benralizumab 30 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 16 | -6.04 score |
| Benralizumab 30 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 52 | -5.98 score |
| Benralizumab 30 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 4 | -4.34 score |
| Mepolizumab 300 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 52 | -6.35 score |
| Mepolizumab 300 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 4 | -4.32 score |
| Mepolizumab 300 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 8 | -6.42 score |
| Mepolizumab 300 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 12 | -6.35 score |
| Mepolizumab 300 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 16 | -6.04 score |
| Mepolizumab 300 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 28 | -7.59 score |
| Mepolizumab 300 mg | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | week 40 | -8.33 score |
Secondary
Change From Baseline in Vasculitis Damage Index (VDI)
Vasculitis Damage Index (VDI) change from baseline by timepoint up to week 52. The VDI is divided into 11 organ systems and records items of damage, due to vasculitis, treatment or unrelated, that have occurred since the onset of vasculitis. Completion of the form provides a numerical score, ranging from 0 to 64, with a higher score indicating more damage.
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Benralizumab 30 mg | Change From Baseline in Vasculitis Damage Index (VDI) | week 24 | 0.06 score |
| Benralizumab 30 mg | Change From Baseline in Vasculitis Damage Index (VDI) | week 52 | 0.13 score |
| Mepolizumab 300 mg | Change From Baseline in Vasculitis Damage Index (VDI) | week 24 | 0.04 score |
| Mepolizumab 300 mg | Change From Baseline in Vasculitis Damage Index (VDI) | week 52 | 0.10 score |
Secondary
Patient Global Impression of Change (PGIC) Category
Patient Global Impression of Change (PGIC) category by timepoint
Time frame: from baseline to week 4
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 2 | Much better | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 1 | Moderately better | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 1 | A little better | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 1 | About the same | 45 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 1 | A little worse | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 1 | Moderately worse | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 1 | Much worse | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 1 | Missing | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 1 | Much better | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 2 | Moderately better | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 2 | A little better | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 2 | About the same | 38 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 2 | A little worse | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 2 | Moderately worse | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 2 | Much worse | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 2 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 3 | Much better | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 3 | Moderately better | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 3 | A little better | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 3 | About the same | 36 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 3 | A little worse | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 3 | Moderately worse | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 3 | Much worse | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 3 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 4 | Much better | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 4 | Moderately better | 5 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 4 | A little better | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 4 | About the same | 35 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 4 | A little worse | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 4 | Moderately worse | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 4 | Much worse | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Change (PGIC) Category | week 4 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 4 | Missing | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 1 | Much better | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 3 | Much better | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 1 | Moderately better | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 4 | Much better | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 1 | A little better | 21 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 3 | Moderately better | 7 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 1 | About the same | 39 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 4 | A little worse | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 1 | A little worse | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 3 | A little better | 27 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 1 | Moderately worse | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 4 | Moderately better | 12 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 1 | Much worse | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 3 | About the same | 27 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 1 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 4 | Much worse | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 2 | Much better | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 3 | A little worse | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 2 | Moderately better | 6 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 4 | A little better | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 2 | A little better | 22 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 3 | Moderately worse | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 2 | About the same | 33 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 4 | Moderately worse | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 2 | A little worse | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 3 | Much worse | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 2 | Moderately worse | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 4 | About the same | 31 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 2 | Much worse | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 3 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Change (PGIC) Category | week 2 | Missing | 5 Participants |
Secondary
Patient Global Impression of Severity (PGIS) Category
Patient Global Impression of Severity (PGIS) category by timepoint
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | Moderate | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | Mild | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | Moderate | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | Severe | 5 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | Very severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | No symptoms | 8 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | Missing | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | No symptoms | 12 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | No symptoms | 8 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | No symptoms | 12 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | Very mild | 22 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | Very mild | 20 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | Mild | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | Moderate | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | Mild | 24 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | Severe | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | Very mild | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | Moderate | 13 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | Missing | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | No symptoms | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | Very mild | 26 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | Mild | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | Mild | 13 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | Moderate | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | Severe | 5 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | Missing | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | Moderate | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | Missing | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | No symptoms | 8 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | No symptoms | 13 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | Moderate | 12 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | Very mild | 19 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | Very mild | 25 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | Mild | 19 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | Moderate | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | Mild | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | Severe | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | Missing | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | Moderate | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | Missing | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | No symptoms | 8 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | Severe | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | Very mild | 29 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | Very mild | 24 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | Mild | 20 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | Missing | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | Moderate | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | No symptoms | 11 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | Very severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | No symptoms | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | Missing | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | No symptoms | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | No symptoms | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | Very mild | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | Very mild | 25 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | Very mild | 23 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | Mild | 20 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | Mild | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | Moderate | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | Very mild | 20 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | Severe | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | Moderate | 21 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | Very mild | 26 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | Missing | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | Severe | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | No symptoms | 11 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | Mild | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | Very mild | 25 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | Mild | 19 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | Moderate | 10 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | Severe | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | Moderate | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | Missing | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | No symptoms | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | No symptoms | 12 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | Mild | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | Very mild | 25 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | Very mild | 26 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | Mild | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | Severe | 5 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | Moderate | 11 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | Mild | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | Severe | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | Mild | 13 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | Moderate | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | Missing | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | Very severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | No symptoms | 10 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | Severe | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | Very mild | 28 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | Moderate | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | Mild | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | Moderate | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | Missing | 9 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | Severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | Mild | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | Missing | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | No symptoms | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | No symptoms | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | baseline | No symptoms | 8 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | Very mild | 21 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | Very mild | 21 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | Severe | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | Mild | 24 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | Missing | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | baseline | Very mild | 8 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | No symptoms | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | Moderate | 13 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | Very mild | 28 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | Very severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | Mild | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | Moderate | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | baseline | Mild | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | Very severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | Moderate | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | No symptoms | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | baseline | Moderate | 28 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | Very mild | 22 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | No symptoms | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | Mild | 25 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | Missing | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | Moderate | 11 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | Very mild | 27 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | Severe | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | baseline | Severe | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | Mild | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | Severe | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | No symptoms | 8 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | Moderate | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | Very mild | 22 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | baseline | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | Mild | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | Moderate | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | No symptoms | 12 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | Severe | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | baseline | Missing | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | Missing | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | No symptoms | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | Severe | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | Very mild | 25 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | No symptoms | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | Mild | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | No symptoms | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | Moderate | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | Very mild | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | Severe | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | Very mild | 20 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | Mild | 19 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | Very mild | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | No symptoms | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | Moderate | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | Very mild | 23 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | Mild | 22 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | Moderate | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | Mild | 21 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | No symptoms | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | Mild | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | Missing | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | Very mild | 26 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | No symptoms | 8 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | Moderate | 24 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | Very mild | 27 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | Mild | 22 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | Mild | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | Moderate | 13 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | Moderate | 11 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | Severe | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | Moderate | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | No symptoms | 10 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | Very mild | 25 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | Mild | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | Moderate | 13 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | Very severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | No symptoms | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | Missing | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | Missing | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | Very mild | 29 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | No symptoms | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | Very mild | 26 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | Mild | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | Mild | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | No symptoms | 12 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | Moderate | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | Moderate | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | Missing | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | Very mild | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | No symptoms | 5 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | Very mild | 28 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | Mild | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | Missing | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | Moderate | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | Mild | 21 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | No symptoms | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | Missing | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | Very mild | 31 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | No symptoms | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | Moderate | 20 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | Very mild | 25 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | Mild | 12 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | Mild | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | Missing | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | Moderate | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | Moderate | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | Severe | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | Missing | 5 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | No symptoms | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | No symptoms | 5 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | Very mild | 30 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | Mild | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | Moderate | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | No symptoms | 10 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | No symptoms | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | Missing | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | Very mild | 23 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | No symptoms | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | Mild | 23 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | Very mild | 20 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | Mild | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | Mild | 24 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | No symptoms | 9 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | Moderate | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | Moderate | 19 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | Very mild | 29 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | Severe | 5 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | Missing | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | Very mild | 23 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | No symptoms | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | Very mild | 25 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | Very mild | 25 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | Mild | 20 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | Moderate | 13 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | Mild | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | No symptoms | 13 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | Mild | 12 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | Missing | 5 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | Very mild | 23 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | No symptoms | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | Moderate | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | Very mild | 23 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | Mild | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | Mild | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | Moderate | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | Moderate | 19 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | Severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | Missing | 5 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | No symptoms | 9 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | Very mild | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | Moderate | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | Mild | 21 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | Missing | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | Moderate | 13 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | No symptoms | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | No symptoms | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | Very severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | Mild | 16 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | Missing | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | Very mild | 27 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | No symptoms | 6 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | Very mild | 17 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | Very mild | 24 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | Mild | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | Mild | 19 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | Severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | Moderate | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | Moderate | 18 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | Mild | 15 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | Severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | Missing | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | Moderate | 14 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | No symptoms | 8 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | Very severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | Very mild | 21 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | Moderate | 26 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | Mild | 22 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | Missing | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | Moderate | 13 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | Very severe | 1 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | Severe | 2 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | No symptoms | 7 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | Very severe | 0 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | Severe | 3 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | Missing | 4 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | Very mild | 27 Participants |
| Benralizumab 30 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | No symptoms | 9 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | Mild | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | Severe | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | Mild | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | Moderate | 14 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | Severe | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | Missing | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | No symptoms | 9 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | Very mild | 33 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | Severe | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | Mild | 18 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | Moderate | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | Severe | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | No symptoms | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | Very mild | 27 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | Mild | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | Moderate | 7 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 46 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | No symptoms | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | Very mild | 27 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | Mild | 11 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | Moderate | 7 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 47 | Missing | 6 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | No symptoms | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | Very mild | 23 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | Mild | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | Moderate | 9 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 48 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | No symptoms | 14 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | Very mild | 25 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | Mild | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | Moderate | 10 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | Severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 49 | Missing | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | No symptoms | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | Very mild | 26 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | Mild | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | Moderate | 8 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | Severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | Very severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 50 | Missing | 6 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | No symptoms | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | Very mild | 25 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | Mild | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | Moderate | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 51 | Missing | 9 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | No symptoms | 11 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | Very mild | 18 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | Mild | 19 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | Moderate | 12 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | Severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 52 | Missing | 9 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | baseline | No symptoms | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | baseline | Very mild | 19 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | baseline | Mild | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | baseline | Moderate | 26 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | baseline | Severe | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | baseline | Very severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | baseline | Missing | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | No symptoms | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | Very mild | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | Mild | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | Moderate | 26 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | Severe | 6 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 1 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | No symptoms | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | Very mild | 27 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | Mild | 11 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | Moderate | 18 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | Severe | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | Very severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 2 | Missing | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | No symptoms | 8 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | Very mild | 24 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | Mild | 19 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | No symptoms | 8 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | Very mild | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | Mild | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | Moderate | 23 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | Severe | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 4 | Missing | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | No symptoms | 6 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 5 | Very mild | 31 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | Mild | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | Moderate | 9 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | Severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | Very severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 6 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | No symptoms | 12 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | Very mild | 23 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | Mild | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | Moderate | 10 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | Severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | Very severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 7 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | No symptoms | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | Very mild | 24 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | Mild | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | Moderate | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | Severe | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | Very severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 8 | Missing | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | No symptoms | 14 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | Very mild | 22 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | Mild | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | Moderate | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 9 | Missing | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | No symptoms | 11 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | Very mild | 24 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | Mild | 22 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | Moderate | 7 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 10 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | No symptoms | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | Very mild | 24 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | Mild | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | Moderate | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | Severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 11 | Missing | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | No symptoms | 8 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | Very mild | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | Mild | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | Moderate | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 12 | Missing | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | No symptoms | 9 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | Very mild | 24 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | Mild | 18 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | Moderate | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | Severe | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 13 | Missing | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | No symptoms | 11 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | Very mild | 24 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | Mild | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | Moderate | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | Severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | Very severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 14 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | No symptoms | 11 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | Very mild | 23 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | Mild | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | Moderate | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | Severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 15 | Missing | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | No symptoms | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | Very mild | 21 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | Mild | 26 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | Moderate | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | Severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | Very severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 16 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | No symptoms | 6 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | Very mild | 28 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | Mild | 19 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | Moderate | 11 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | Very severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 17 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | No symptoms | 7 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | Very mild | 28 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | Mild | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | Moderate | 18 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 18 | Missing | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | No symptoms | 11 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | Very mild | 25 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | Mild | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | Moderate | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | Severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | Very severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 19 | Missing | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | No symptoms | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | Very mild | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | Mild | 21 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | Moderate | 11 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | Severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | Very severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 20 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | No symptoms | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | Very mild | 24 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | Mild | 12 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | Moderate | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 21 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | No symptoms | 12 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | Very mild | 24 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | Mild | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | Moderate | 12 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | Severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 22 | Missing | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | No symptoms | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | Severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | Very mild | 24 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | Mild | 19 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | Moderate | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | Severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 23 | Missing | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | No symptoms | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | Very mild | 22 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | Mild | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | Moderate | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 24 | Missing | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | No symptoms | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | Very mild | 22 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | Mild | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | Moderate | 14 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 25 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | No symptoms | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | Very mild | 22 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | Mild | 14 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | Moderate | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | Very severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 26 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | No symptoms | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | Very mild | 21 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | Mild | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | Moderate | 10 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 27 | Missing | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | No symptoms | 9 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | Very mild | 21 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 28 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | No symptoms | 12 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | Very mild | 21 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | Mild | 19 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | Moderate | 10 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | Severe | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 29 | Missing | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | No symptoms | 18 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | Very mild | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | Mild | 18 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | Moderate | 9 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | Very severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 30 | Missing | 6 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | No symptoms | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | Very mild | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | Mild | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | Moderate | 11 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 31 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | No symptoms | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | Very mild | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | Mild | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | Moderate | 8 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | Severe | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 32 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | No symptoms | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | Very mild | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | Mild | 14 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | Moderate | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | Severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 33 | Missing | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | No symptoms | 14 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | Very mild | 18 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | Mild | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | Moderate | 11 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 34 | Missing | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | No symptoms | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | Very mild | 20 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | Mild | 18 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | Moderate | 10 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 35 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | No symptoms | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | Very mild | 22 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | Mild | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | Moderate | 12 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | Severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 36 | Missing | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | No symptoms | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | Very mild | 21 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | Mild | 14 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | Moderate | 11 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | Very severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 37 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | No symptoms | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | Very mild | 24 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | Mild | 10 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | Moderate | 12 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | Severe | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 38 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | No symptoms | 19 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | Very mild | 23 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 3 | Moderate | 13 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | Moderate | 9 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 39 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | No symptoms | 10 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | Very mild | 18 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | Mild | 18 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | Moderate | 14 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | Severe | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | Very severe | 1 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 40 | Missing | 6 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | No symptoms | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | Very mild | 23 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | Mild | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | Moderate | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | Severe | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 41 | Missing | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | No symptoms | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | Very mild | 26 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | Mild | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | Moderate | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | Severe | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 42 | Missing | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | No symptoms | 15 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | Very mild | 27 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | Mild | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | Moderate | 6 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | Severe | 2 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 43 | Missing | 4 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | No symptoms | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | Very mild | 23 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | Mild | 17 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | Moderate | 6 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | Severe | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 44 | Missing | 5 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | No symptoms | 16 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | Very mild | 26 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | Mild | 14 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | Moderate | 8 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | Severe | 3 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | Very severe | 0 Participants |
| Mepolizumab 300 mg | Patient Global Impression of Severity (PGIS) Category | week 45 | Missing | 3 Participants |
Secondary
Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
Percentage reduction from baseline in average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: no reduction or withdrawal from treatment; \< 25% reduction; 25 to \< 50% reduction; 50 to \<75% reduction; 75 to \< 100% reduction; 100% reduction.
Time frame: last 4 weeks of DB period
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Benralizumab 30 mg | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | no reduction or withdrawal from IP before week 48 | 3 Participants |
| Benralizumab 30 mg | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | 25 to <50% reduction | 8 Participants |
| Benralizumab 30 mg | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | 100% reduction | 29 Participants |
| Benralizumab 30 mg | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | 50 to <75% reduction | 19 Participants |
| Benralizumab 30 mg | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | <25% reduction | 0 Participants |
| Benralizumab 30 mg | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | 75 to <100% reduction | 11 Participants |
| Mepolizumab 300 mg | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | 100% reduction | 18 Participants |
| Mepolizumab 300 mg | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | 75 to <100% reduction | 17 Participants |
| Mepolizumab 300 mg | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | no reduction or withdrawal from IP before week 48 | 7 Participants |
| Mepolizumab 300 mg | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | <25% reduction | 2 Participants |
| Mepolizumab 300 mg | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | 25 to <50% reduction | 9 Participants |
| Mepolizumab 300 mg | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | 50 to <75% reduction | 17 Participants |
95% CI: [0.96, 3.22]proportional odds model
Secondary
Proportion of Patients Who Have Achieved Remission Within the First 24 Weeks and Remained in Remission for Remainder of the Double-blind Treatment Period
Proportion of patients who have achieved remission within the first 24 weeks and remained in remission for remainder of the double-blind treatment period
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Benralizumab 30 mg | Proportion of Patients Who Have Achieved Remission Within the First 24 Weeks and Remained in Remission for Remainder of the Double-blind Treatment Period | main remission | 28 Participants |
| Benralizumab 30 mg | Proportion of Patients Who Have Achieved Remission Within the First 24 Weeks and Remained in Remission for Remainder of the Double-blind Treatment Period | supportive remission | 41 Participants |
| Mepolizumab 300 mg | Proportion of Patients Who Have Achieved Remission Within the First 24 Weeks and Remained in Remission for Remainder of the Double-blind Treatment Period | main remission | 27 Participants |
| Mepolizumab 300 mg | Proportion of Patients Who Have Achieved Remission Within the First 24 Weeks and Remained in Remission for Remainder of the Double-blind Treatment Period | supportive remission | 40 Participants |
Comparison: main remission95% CI: [-0.093, 0.2037]Regression, Logistic
Comparison: supportive remission95% CI: [-0.1021, 0.1956]Regression, Logistic
Secondary
Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
Proportion of patients with average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: 0 mg; \>0 to ≤ 4 mg; \> 4 to ≤ 7.5 mg and \> 7.5 mg
Time frame: last 4 weeks of DB period
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Benralizumab 30 mg | Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | 0 | 29 Participants |
| Benralizumab 30 mg | Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | >0 to <=4.0 mg | 19 Participants |
| Benralizumab 30 mg | Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | >4.0 to <=7.5 mg | 15 Participants |
| Benralizumab 30 mg | Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | >7.5 mg | 7 Participants |
| Mepolizumab 300 mg | Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | >7.5 mg | 8 Participants |
| Mepolizumab 300 mg | Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | 0 | 19 Participants |
| Mepolizumab 300 mg | Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | >4.0 to <=7.5 mg | 13 Participants |
| Mepolizumab 300 mg | Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | >0 to <=4.0 mg | 30 Participants |
95% CI: [0.75, 2.54]proportional odds model
Secondary
Proportion of Subjects Who Achieve Clinical Benefit
Proportion of subjects who achieved any clinical benefit definition 1 (defined as any of the following: * Main remission at any time in DB period * \>= 50% reduction in OCS dose in Weeks 48 to 52 * EGPA relapse free in DB period) and subjects who achieved complete response definition 1 (defined as meeting all the definition 1 criteria above.)
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Benralizumab 30 mg | Proportion of Subjects Who Achieve Clinical Benefit | any clinical benefit-definition 1 | 66 Participants |
| Benralizumab 30 mg | Proportion of Subjects Who Achieve Clinical Benefit | Complete response - definition 1 | 43 Participants |
| Mepolizumab 300 mg | Proportion of Subjects Who Achieve Clinical Benefit | any clinical benefit-definition 1 | 63 Participants |
| Mepolizumab 300 mg | Proportion of Subjects Who Achieve Clinical Benefit | Complete response - definition 1 | 39 Participants |
Comparison: any clinical response-definition 195% CI: [-0.0422, 0.1341]Regression, Logistic
Comparison: complete response-definition 195% CI: [-0.0732, 0.2312]Regression, Logistic
Secondary
Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52
Proportion of subjects with reduction from baseline in average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: \>= 50% reduction; 100% reduction; OCS dose \<= 4 mg/day.
Time frame: last 4 weeks of DB period
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Benralizumab 30 mg | Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | >=50% reduction | 59 Participants |
| Benralizumab 30 mg | Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | 100% reduction | 29 Participants |
| Benralizumab 30 mg | Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | OCS dose <=4 mg/day | 48 Participants |
| Mepolizumab 300 mg | Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | >=50% reduction | 52 Participants |
| Mepolizumab 300 mg | Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | 100% reduction | 18 Participants |
| Mepolizumab 300 mg | Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | OCS dose <=4 mg/day | 49 Participants |
Comparison: \>=50% reduction95% CI: [-0.0225, 0.2383]Regression, Logistic
Comparison: 100% reduction95% CI: [0.0067, 0.3017]Regression, Logistic
Comparison: OCS dose \<=4 mg/day95% CI: [-0.1555, 0.1418]Regression, Logistic
Secondary
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose
Sino-nasal Symptoms Questionnaire (SSQ) scores: symptom Blockage/congestion of nose by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 49-52 | 1.5 score | Standard Deviation 1.07 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 37-40 | 1.6 score | Standard Deviation 1.01 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | baseline | 1.3 score | Standard Deviation 1.07 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 1-4 | 1.5 score | Standard Deviation 0.99 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 5-8 | 1.5 score | Standard Deviation 0.96 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 13-16 | 1.6 score | Standard Deviation 1.14 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 17-20 | 1.7 score | Standard Deviation 1.12 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 21-24 | 1.6 score | Standard Deviation 1.06 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 25-28 | 1.4 score | Standard Deviation 1.03 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 29-32 | 1.5 score | Standard Deviation 0.99 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 33-36 | 1.5 score | Standard Deviation 0.92 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 41-44 | 1.5 score | Standard Deviation 1.08 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 45-48 | 1.5 score | Standard Deviation 1.13 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 9-12 | 1.5 score | Standard Deviation 0.9 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 29-32 | 1.4 score | Standard Deviation 1.13 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 21-24 | 1.3 score | Standard Deviation 1.05 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 17-20 | 1.4 score | Standard Deviation 1.04 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 37-40 | 1.3 score | Standard Deviation 1.14 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 49-52 | 1.3 score | Standard Deviation 1.03 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 41-44 | 1.2 score | Standard Deviation 0.96 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | baseline | 1.4 score | Standard Deviation 1.15 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 33-36 | 1.3 score | Standard Deviation 1.09 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 1-4 | 1.4 score | Standard Deviation 0.96 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 25-28 | 1.4 score | Standard Deviation 1.03 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 5-8 | 1.4 score | Standard Deviation 1.03 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 9-12 | 1.3 score | Standard Deviation 1 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 45-48 | 1.3 score | Standard Deviation 1.11 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Blockage/Congestion of Nose | week 13-16 | 1.4 score | Standard Deviation 1.09 |
Secondary
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure
Sino-nasal Symptoms Questionnaire (SSQ) scores: symptom Facial pain/pressure by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 9-12 | 0.9 score | Standard Deviation 1.01 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 49-52 | 0.7 score | Standard Deviation 0.9 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | baseline | 0.7 score | Standard Deviation 0.95 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 1-4 | 0.9 score | Standard Deviation 0.97 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 5-8 | 0.9 score | Standard Deviation 1.08 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 13-16 | 0.8 score | Standard Deviation 0.93 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 17-20 | 0.9 score | Standard Deviation 0.97 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 21-24 | 0.8 score | Standard Deviation 0.88 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 25-28 | 0.7 score | Standard Deviation 0.95 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 29-32 | 0.7 score | Standard Deviation 0.89 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 33-36 | 0.6 score | Standard Deviation 0.86 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 37-40 | 0.8 score | Standard Deviation 1.01 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 41-44 | 0.7 score | Standard Deviation 0.92 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 45-48 | 0.7 score | Standard Deviation 0.9 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 33-36 | 0.6 score | Standard Deviation 0.89 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 9-12 | 0.8 score | Standard Deviation 0.88 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 45-48 | 0.7 score | Standard Deviation 0.98 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 21-24 | 0.6 score | Standard Deviation 0.81 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 41-44 | 0.6 score | Standard Deviation 0.82 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | baseline | 0.6 score | Standard Deviation 0.94 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 25-28 | 0.6 score | Standard Deviation 0.89 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 1-4 | 0.8 score | Standard Deviation 0.99 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 37-40 | 0.6 score | Standard Deviation 0.82 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 5-8 | 0.8 score | Standard Deviation 0.93 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 29-32 | 0.6 score | Standard Deviation 0.9 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 13-16 | 0.6 score | Standard Deviation 0.8 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 49-52 | 0.6 score | Standard Deviation 0.87 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Facial Pain/Pressure | week 17-20 | 0.7 score | Standard Deviation 0.93 |
Secondary
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell
Sino-nasal Symptoms Questionnaire (SSQ) scores: symptom Loss or reduction in sense of taste/smell by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 21-24 | 1.4 score | Standard Deviation 1.44 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | baseline | 1.3 score | Standard Deviation 1.32 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 1-4 | 1.3 score | Standard Deviation 1.36 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 5-8 | 1.2 score | Standard Deviation 1.28 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 9-12 | 1.2 score | Standard Deviation 1.29 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 13-16 | 1.3 score | Standard Deviation 1.32 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 17-20 | 1.3 score | Standard Deviation 1.36 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 25-28 | 1.3 score | Standard Deviation 1.39 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 29-32 | 1.4 score | Standard Deviation 1.34 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 33-36 | 1.4 score | Standard Deviation 1.39 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 37-40 | 1.5 score | Standard Deviation 1.38 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 41-44 | 1.5 score | Standard Deviation 1.43 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 45-48 | 1.5 score | Standard Deviation 1.44 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 49-52 | 1.5 score | Standard Deviation 1.4 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 37-40 | 1.1 score | Standard Deviation 1.31 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 25-28 | 1.1 score | Standard Deviation 1.37 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | baseline | 1.2 score | Standard Deviation 1.43 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 45-48 | 1.1 score | Standard Deviation 1.36 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 1-4 | 1.2 score | Standard Deviation 1.45 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 29-32 | 1.0 score | Standard Deviation 1.38 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 5-8 | 1.1 score | Standard Deviation 1.35 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 41-44 | 1.0 score | Standard Deviation 1.29 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 9-12 | 1.0 score | Standard Deviation 1.36 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 33-36 | 1.1 score | Standard Deviation 1.35 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 13-16 | 1.1 score | Standard Deviation 1.41 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 49-52 | 1.1 score | Standard Deviation 1.35 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 17-20 | 1.1 score | Standard Deviation 1.32 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Loss or Reduction in Sense of Taste/Smell | week 21-24 | 1.2 score | Standard Deviation 1.33 |
Secondary
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge
Sino-nasal Symptoms Questionnaire (SSQ) scores : symptom Post-nasal discharge by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 33-36 | 1.1 score | Standard Deviation 0.88 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 9-12 | 1.2 score | Standard Deviation 1.01 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 17-20 | 1.2 score | Standard Deviation 0.99 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 13-16 | 1.2 score | Standard Deviation 0.96 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 25-28 | 1.1 score | Standard Deviation 1.05 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 29-32 | 1.1 score | Standard Deviation 0.97 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | baseline | 1.1 score | Standard Deviation 1 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 37-40 | 1.2 score | Standard Deviation 0.96 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 21-24 | 1.2 score | Standard Deviation 0.93 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 41-44 | 1.1 score | Standard Deviation 1.05 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 5-8 | 1.2 score | Standard Deviation 0.94 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 45-48 | 1.1 score | Standard Deviation 1.03 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 49-52 | 1.1 score | Standard Deviation 0.96 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 1-4 | 1.4 score | Standard Deviation 0.88 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 49-52 | 1.0 score | Standard Deviation 0.95 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 1-4 | 1.3 score | Standard Deviation 1 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 17-20 | 1.3 score | Standard Deviation 0.99 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 21-24 | 1.2 score | Standard Deviation 0.98 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 25-28 | 1.1 score | Standard Deviation 0.88 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 33-36 | 1.0 score | Standard Deviation 0.95 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 45-48 | 1.0 score | Standard Deviation 0.89 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | baseline | 1.2 score | Standard Deviation 1.06 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 5-8 | 1.2 score | Standard Deviation 0.85 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 9-12 | 1.2 score | Standard Deviation 0.98 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 13-16 | 1.2 score | Standard Deviation 0.94 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 29-32 | 1.1 score | Standard Deviation 0.99 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 37-40 | 0.9 score | Standard Deviation 0.81 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Post-nasal Discharge | week 41-44 | 0.9 score | Standard Deviation 0.83 |
Secondary
Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose
Sino-nasal Symptoms Questionnaire (SSQ) scores : symptom runny nose by timepoint. For the SSQ, participants rate each symptom against the following categories: very severe, severe, moderate, mild, none. Higher scores indicate greater severity (0 = none to 4 = very severe).
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 13-16 | 1.4 score | Standard Deviation 0.99 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 17-20 | 1.3 score | Standard Deviation 0.98 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 45-48 | 1.3 score | Standard Deviation 0.98 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 49-52 | 1.2 score | Standard Deviation 0.98 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | baseline | 1.0 score | Standard Deviation 0.85 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 1-4 | 1.4 score | Standard Deviation 0.95 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 5-8 | 1.3 score | Standard Deviation 0.92 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 9-12 | 1.4 score | Standard Deviation 1 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 21-24 | 1.3 score | Standard Deviation 0.88 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 25-28 | 1.1 score | Standard Deviation 0.95 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 29-32 | 1.2 score | Standard Deviation 0.9 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 33-36 | 1.3 score | Standard Deviation 0.87 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 37-40 | 1.3 score | Standard Deviation 0.96 |
| Benralizumab 30 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 41-44 | 1.1 score | Standard Deviation 0.86 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 33-36 | 1.0 score | Standard Deviation 0.9 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 13-16 | 1.2 score | Standard Deviation 0.92 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 9-12 | 1.0 score | Standard Deviation 0.88 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 37-40 | 1.0 score | Standard Deviation 0.87 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 17-20 | 1.1 score | Standard Deviation 0.96 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 45-48 | 0.9 score | Standard Deviation 0.87 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 29-32 | 1.1 score | Standard Deviation 0.99 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 49-52 | 1.0 score | Standard Deviation 0.96 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 21-24 | 1.2 score | Standard Deviation 0.86 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | baseline | 1.2 score | Standard Deviation 1 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 41-44 | 0.9 score | Standard Deviation 0.76 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 1-4 | 1.2 score | Standard Deviation 0.97 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 25-28 | 1.2 score | Standard Deviation 0.9 |
| Mepolizumab 300 mg | Sino-nasal Symptoms Questionnaire (SSQ) Scores: Symptom Runny Nose | week 5-8 | 1.0 score | Standard Deviation 0.86 |
Secondary
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L)
Pre-bronchodilator (BD) Forced Expiratory Volume during first second (FEV1) change from baseline by timepoint up to week 52
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Benralizumab 30 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | week 24 | 0.11 L |
| Benralizumab 30 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | week 48 | 0.03 L |
| Benralizumab 30 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | week 36 | 0.10 L |
| Benralizumab 30 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | week 52 | 0.06 L |
| Benralizumab 30 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | week 12 | 0.13 L |
| Mepolizumab 300 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | week 52 | 0.01 L |
| Mepolizumab 300 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | week 12 | 0.11 L |
| Mepolizumab 300 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | week 24 | 0.13 L |
| Mepolizumab 300 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | week 36 | 0.11 L |
| Mepolizumab 300 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | week 48 | 0.06 L |
Secondary
Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L)
Pre-bronchodilator (BD) Forced vital capacity (FVC) change from baseline by timepoint up to week 52
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Benralizumab 30 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | week 24 | 0.09 L |
| Benralizumab 30 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | week 48 | 0.03 L |
| Benralizumab 30 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | week 36 | 0.05 L |
| Benralizumab 30 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | week 52 | 0.01 L |
| Benralizumab 30 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | week 12 | 0.13 L |
| Mepolizumab 300 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | week 52 | -0.04 L |
| Mepolizumab 300 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | week 12 | 0.05 L |
| Mepolizumab 300 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | week 24 | 0.04 L |
| Mepolizumab 300 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | week 36 | 0.03 L |
| Mepolizumab 300 mg | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | week 48 | 0.00 L |
Secondary
Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse
Time from randomization to first Eosinophilic Granulomatosis with Polyangiitis (EGPA) relapse, where relapse is defined as any of the following: * Active vasculitis (BVAS \> 0); OR * Active asthma symptoms and/or signs with a corresponding worsening in ACQ-6 score; OR * Active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions; warranting any of the following: * An increased dose of OCS therapy to \> 4 mg/day prednisolone total daily dose; OR * An increased dose or addition of immunosuppressive therapy; OR * Hospitalization related to EGPA worsening Calculated using the Kaplan-Meier technique.
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benralizumab 30 mg | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | relapse-percent subject with at least 1 relapse by week 16 | 5.71 percentage of subjects |
| Benralizumab 30 mg | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | relapse-percent subject with at least 1 relapse by week 32 | 17.14 percentage of subjects |
| Benralizumab 30 mg | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | relapse-percent subject with at least 1 relapse by week 52 | 30.00 percentage of subjects |
| Benralizumab 30 mg | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | major relapse-percent subject with at least 1 relapse by week 16 | 0 percentage of subjects |
| Benralizumab 30 mg | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | major relapse-percent subject with at least 1 relapse by week 32 | 0 percentage of subjects |
| Benralizumab 30 mg | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | major relapse-percent subject with at least 1 relapse by week 52 | 0 percentage of subjects |
| Mepolizumab 300 mg | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | major relapse-percent subject with at least 1 relapse by week 32 | 0 percentage of subjects |
| Mepolizumab 300 mg | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | relapse-percent subject with at least 1 relapse by week 16 | 4.29 percentage of subjects |
| Mepolizumab 300 mg | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | major relapse-percent subject with at least 1 relapse by week 16 | 0 percentage of subjects |
| Mepolizumab 300 mg | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | relapse-percent subject with at least 1 relapse by week 32 | 20.24 percentage of subjects |
| Mepolizumab 300 mg | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | major relapse-percent subject with at least 1 relapse by week 52 | 2.94 percentage of subjects |
| Mepolizumab 300 mg | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | relapse-percent subject with at least 1 relapse by week 52 | 29.10 percentage of subjects |
Comparison: relapse95% CI: [0.53, 1.82]Regression, Cox
Secondary
Total Accrued Duration of Remission During DB Treatment Period
Total accrued duration of remission for the following categories: 0 week, \> 0 to \< 12 week, 12 to \< 24 week, 24 to \< 36 week, ≥ 36 week.
Time frame: from baseline to end of DB period, 52 Weeks.
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Benralizumab 30 mg | Total Accrued Duration of Remission During DB Treatment Period | main remission | 0 week | 9 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Remission During DB Treatment Period | main remission | >0 to <12 weeks | 13 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Remission During DB Treatment Period | main remission | 12 to <24 weeks | 8 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Remission During DB Treatment Period | main remission | 24 to <36 weeks | 20 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Remission During DB Treatment Period | main remission | >=36 weeks | 20 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Remission During DB Treatment Period | supportive remission | 0 week | 2 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Remission During DB Treatment Period | supportive remission | >0 to <12 weeks | 2 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Remission During DB Treatment Period | supportive remission | 12 to <24 weeks | 5 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Remission During DB Treatment Period | supportive remission | 24 to <36 weeks | 16 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Remission During DB Treatment Period | supportive remission | >=36 weeks | 45 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Remission During DB Treatment Period | supportive remission | 12 to <24 weeks | 4 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Remission During DB Treatment Period | main remission | 0 week | 15 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Remission During DB Treatment Period | supportive remission | 0 week | 4 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Remission During DB Treatment Period | main remission | >0 to <12 weeks | 10 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Remission During DB Treatment Period | supportive remission | >=36 weeks | 44 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Remission During DB Treatment Period | main remission | 12 to <24 weeks | 8 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Remission During DB Treatment Period | supportive remission | >0 to <12 weeks | 3 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Remission During DB Treatment Period | main remission | 24 to <36 weeks | 19 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Remission During DB Treatment Period | supportive remission | 24 to <36 weeks | 15 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Remission During DB Treatment Period | main remission | >=36 weeks | 18 Participants |
Comparison: main remission95% CI: [0.72, 2.4]Proportional Odds Model
Comparison: supportive remission95% CI: [0.55, 2.29]Proportional Odds Model
Secondary
Total Accrued Duration of Sustained Remission During DB Treatment Period
Total accrued duration of sustained remission for the following categories: 0 week, \> 0 to \< 12 week, 12 to \< 24 week, 24 to \< 36 week, ≥ 36 week.
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Benralizumab 30 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained supportive remission | 0 week | 2 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained supportive remission | >0 to <12 weeks | 5 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained main remission | 0 week | 9 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained main remission | >0 to <12 weeks | 15 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained main remission | 12 to <24 weeks | 11 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained main remission | 24 to <36 weeks | 16 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained main remission | >=36 weeks | 19 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained supportive remission | 12 to <24 weeks | 8 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained supportive remission | 24 to <36 weeks | 18 Participants |
| Benralizumab 30 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained supportive remission | >=36 weeks | 37 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained supportive remission | 12 to <24 weeks | 10 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained supportive remission | 0 week | 4 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained main remission | 24 to <36 weeks | 18 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained supportive remission | >0 to <12 weeks | 6 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained supportive remission | >=36 weeks | 36 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained main remission | 0 week | 15 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained main remission | >=36 weeks | 16 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained main remission | >0 to <12 weeks | 13 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained supportive remission | 24 to <36 weeks | 14 Participants |
| Mepolizumab 300 mg | Total Accrued Duration of Sustained Remission During DB Treatment Period | sustained main remission | 12 to <24 weeks | 8 Participants |
Comparison: sustained main remission95% CI: [0.74, 2.44]Proportional Odds Model
Comparison: sustained supportive remission95% CI: [0.64, 2.34]Proportional Odds Model
Secondary
WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%)
The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Subscale: Absenteeism (work time missed) (%) score, range 0-100.
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 12 | 6.59 score | Standard Deviation 23.328 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 28 | 4.16 score | Standard Deviation 17.279 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 8 | 0.71 score | Standard Deviation 21.429 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 40 | -1.29 score | Standard Deviation 17.181 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 16 | 12.43 score | Standard Deviation 28.205 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 52 | 9.02 score | Standard Deviation 23.971 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 4 | -1.24 score | Standard Deviation 22.167 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 52 | -10.99 score | Standard Deviation 40.272 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 4 | -5.46 score | Standard Deviation 25.387 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 8 | -7.75 score | Standard Deviation 28.68 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 12 | -8.88 score | Standard Deviation 30.513 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 16 | -7.94 score | Standard Deviation 36.95 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 28 | -3.59 score | Standard Deviation 40.441 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Absenteeism (%) | week 40 | -5.02 score | Standard Deviation 35.641 |
Secondary
WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%)
The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Activity impairment (%) score, range 0-100.
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 12 | -4.56 score | Standard Deviation 20.62 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 28 | -4.41 score | Standard Deviation 22.419 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 8 | -3.53 score | Standard Deviation 21.144 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 40 | -7.58 score | Standard Deviation 20.234 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 16 | -3.24 score | Standard Deviation 21.402 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 52 | -3.28 score | Standard Deviation 27.083 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 4 | -3.97 score | Standard Deviation 20.815 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 52 | -7.78 score | Standard Deviation 25.492 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 4 | -3.38 score | Standard Deviation 19.745 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 8 | -4.71 score | Standard Deviation 23.466 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 12 | -3.97 score | Standard Deviation 20.453 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 16 | -6.42 score | Standard Deviation 25.268 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 28 | -6.31 score | Standard Deviation 27.419 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Activity Impairment (%) | week 40 | -4.46 score | Standard Deviation 20.235 |
Secondary
WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100.
The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Presenteeism (%) score.
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 8 | -2.58 score | Standard Deviation 15.485 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 16 | 2.59 score | Standard Deviation 22.29 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 28 | -2.41 score | Standard Deviation 19.022 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 40 | -3.91 score | Standard Deviation 17.252 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 12 | -2.00 score | Standard Deviation 12.247 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 52 | 4.80 score | Standard Deviation 34.535 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 4 | -7.42 score | Standard Deviation 15.268 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 52 | -6.19 score | Standard Deviation 18.568 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 28 | 3.46 score | Standard Deviation 22.793 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 4 | 0.36 score | Standard Deviation 16.439 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 8 | 6.43 score | Standard Deviation 14.457 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 12 | 3.20 score | Standard Deviation 20.355 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 16 | 2.31 score | Standard Deviation 17.043 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint up to Week 52: Subscale: Presenteeism (Impairment at Work) (%), Range 0-100. | week 40 | 0.43 score | Standard Deviation 10.215 |
Secondary
WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%)
The Work Productivity and Activity Impairment questionnaire (WPAI-GH) has 6 questions which address absenteeism, presenteeism (reduced effectiveness while working), overall work productivity loss (absenteeism plus presenteeism), and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (a higher percentage indicating greater impairment and less productivity). Work productivity loss (%) score, range 0-100.
Time frame: from baseline to end of DB period, 52 Weeks
Population: Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 16 | 8.09 score | Standard Deviation 31.026 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 28 | 0.05 score | Standard Deviation 25.844 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 8 | -0.53 score | Standard Deviation 23.935 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 40 | -3.02 score | Standard Deviation 23.35 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 4 | -7.35 score | Standard Deviation 22.397 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 52 | 5.82 score | Standard Deviation 33.761 |
| Benralizumab 30 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 12 | 1.47 score | Standard Deviation 19.235 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 52 | -4.47 score | Standard Deviation 27.803 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 16 | 5.31 score | Standard Deviation 23.864 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 4 | 2.14 score | Standard Deviation 14.775 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 8 | 6.26 score | Standard Deviation 19.154 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 28 | 6.87 score | Standard Deviation 24.114 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 40 | 0.67 score | Standard Deviation 14.14 |
| Mepolizumab 300 mg | WPAI-GH Endpoint, Change From Baseline by Timepoint: Work Productivity Loss (%) | week 12 | 1.24 score | Standard Deviation 24.149 |