Asthma
Conditions
Brief summary
Primary Objective: To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life. * To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.
Detailed description
The total duration of study period for each participant is 67 to 69 weeks, including a screening period of 3 to 5 weeks, treatment period of 52 weeks, and post-treatment follow-up period of 12 weeks.
Interventions
DRUGDupilumab
Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
DRUGPlacebo
Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)
DRUGAlbuterol/Salbutamol
Oral inhalation as needed
Oral inhalation as needed
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Adults and adolescent participants with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria: a) Existing treatment with medium to high dose ICS (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month prior to Visit 1. i) Note for Japan: for participants aged 18 years and older, ICS must be on ≥200 mcg of fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS must be ≥100 mcg of fluticasone propionate twice daily or equivalent). ii) Participants requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to Visit 1.
Exclusion criteria
* Participants \<12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, participant recruitment will be restricted to those who are ≥18 years of age). * Weight is less than 30 kilograms. * Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function. * A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit). * Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care. * Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, computed tomography \[CT\], magnetic resonance imaging \[MRI\]) available within 3 months prior to screening to exclude participants with suspected active or untreated latent tuberculosis. * Current smoker or cessation of smoking within 6 months prior to Visit 1. * Previous smoker with a smoking history \>10 pack-years. * Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population | Baseline to Week 52 | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. |
| Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Baseline, Week 12 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | Baseline, Week 12 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
| Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Baseline to Week 52 | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. |
| Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Baseline, Week 12 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
| Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L | Baseline to Week 52 | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. |
| Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline | Baseline to Week 52 | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. |
| Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L | Baseline, Week 12 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
| Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline | Baseline, Week 12 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
| Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Baseline, Week 24 | The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life. |
| Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Baseline, Week 24 | The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life. |
| Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Baseline, Week 24 | The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. |
| Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population | Baseline to Week 52 | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations (resulted hospitalization or emergency room visit) that occurred during the treatment period divided by the total number of participant-years treated. |
| Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Baseline, Week 12 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
| Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline | Baseline, Week 12 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
| Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | Baseline, Week 12 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
| Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 24, 36, and 52 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
| Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 24, 36, and 52 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
| Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
| Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population | Baseline, Week 12 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
| Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. |
| Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | FEF is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF25-75% is defined as the mean forced expiratory flow between the 25% and 75% of the FVC. |
| Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. |
| Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population | Baseline to Week 52 | LOAC was defined as any of the following: \>=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS \>=4 times the dose at randomization; use of systemic corticosteroids for \>=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated. |
| Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Baseline up to Week 52 | The time to first severe exacerbation was defined as follows: date of the first event - randomization date +1. For participants who had no event on or before Visit 18 (Week 52) or last contact date, the time was censored at the date of Visit 18 or the last contact date, whichever was earlier. The median time to first severe exacerbation was not estimated; therefore, the probability of severe exacerbation at Weeks 12, 24, 36, and 52, are presented as the descriptive statistics. |
| Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Baseline up to Week 52 | The time to first LOAC event was defined as follows: date of the first event - first dose date +1. For participants who had no event on or before last dose date + 14 days or last contact date, the time was censored at the last dose date + 14 days or the last contact date, whichever was earlier. |
| Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 12, 36, and 52 | The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. |
| Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | The ACQ-7 has 7 questions, the first 5 questions assess the most common asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze plus short-acting bronchodilator use, and FEV1 (pre-bronchodilator % predicted). Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). Clinic staff scored the FEV1% predicted on a 7-point scale. The questions were equally weighted and the ACQ-7 total score was mean of the scores of all 7 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. |
| Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0= No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma. |
| Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual. |
| Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night. |
| Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded daily by the participants in an electronic diary/peak expiratory flow (PEF) meter. In the case that Nebulizer solutions were used as an alternative delivery method, the nebulizer dose was converted to number of puffs as per following conversion factor: salbutamol/albuterol nebulizer solution (2.5 mg) corresponds to 4 puffs. |
| Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Baseline, Weeks 12, 36, and 52 | The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life. |
| Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Baseline, Weeks 12, 24, 36, and 52 | EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Baseline, Weeks 12, 24, 36, and 52 | The HADS is a general scale to detect states of anxiety and depression already used and validated in asthma, which includes HADS-A and HADS-D subscales. The instrument is comprised of 14 items: 7 related to anxiety (HADS-A) and 7 to depression (HADS-D). Each item on the questionnaire is scored from 0-3. The anxiety/depression score is the sum of the scores of the 7 related items; one can score between 0 and 21 for either anxiety or depression. And the total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher anxiety/depression complains. |
| Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Baseline, Weeks 12, 24, 36, and 52 | The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life. |
| Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Baseline, Weeks 12, 24, 36, and 52 | RQLQ(S)+12 is a self-administered questionnaire with standardized activities developed to measure health-related quality of life signs and symptoms that are most problematic in those 12 to 75 years of age, as a result of perennial or seasonal allergic rhinitis. There are 28 items on RQLQ(S) in 7 domains: activities (3 items), sleep (3 items), non-nose/eye symptoms (7 items), practical problems (3 items), nasal symptoms (4 items), eye symptoms (4 items) and emotional (4 items). RQLQ(S)+12 responses are based on 7-point likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). Individual items within RQLQ(S)+12 are equally weighted. The overall score is calculated as the mean score of all items. Higher scores indicated more health-related quality of life impairment (lower scores better). |
| Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 | The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. |
| Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L | Baseline to Week 52 | A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. |
Countries
Argentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
4148 participants were screened from Apr 2015-Sep 2016. 1902 were randomized at 321 centers/22 countries. 2246 were screen failures. 1897 participants were treated; some received a different treatment than that assigned at randomization and for adverse event (AE) analysis were allocated to treatment actually received (see footnotes in below table)
Pre-assignment details
Randomization was stratified by age (\<18 years, \>=18 years), blood eosinophil count(\<0.3 Giga/L, \>=0.3 Giga/L), ICS dose level (medium, high), and country. Assignment to arms was done centrally using Interactive Voice/Web Response System in 2:2:1:1 ratio to Dupilumab 200 mg q2w, Dupilumab 300 mg q2w, Placebo (for 200 mg)q2w, Placebo (for 300 mg)q2w
Participants by arm
| Arm | Count |
|---|---|
| Placebo (for Dupilumab 200 mg) q2w 2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. | 317 |
| Dupilumab 200 mg q2w 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. | 631 |
| Placebo (for Dupilumab 300 mg) q2w 2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. | 321 |
| Dupilumab 300 mg q2w 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines (second or third controller therapy). Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. | 633 |
| Total | 1,902 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 9 | 7 | 1 | 12 |
| Overall Study | Other than specified above | 12 | 37 | 17 | 37 |
| Overall Study | Poor compliance to protocol | 1 | 1 | 2 | 2 |
Baseline characteristics
| Characteristic | Dupilumab 300 mg q2w | Total | Dupilumab 200 mg q2w | Placebo (for Dupilumab 200 mg) q2w | Placebo (for Dupilumab 300 mg) q2w |
|---|---|---|---|---|---|
| Age, Continuous | 47.7 years STANDARD_DEVIATION 15.6 | 47.9 years STANDARD_DEVIATION 15.3 | 47.9 years STANDARD_DEVIATION 15.3 | 48.2 years STANDARD_DEVIATION 15.6 | 48.2 years STANDARD_DEVIATION 14.7 |
| Age, Customized Adolescents (12-17 years) | 34 Participants | 107 Participants | 34 Participants | 21 Participants | 18 Participants |
| Age, Customized Adults (18-64 years) | 516 Participants | 1544 Participants | 512 Participants | 253 Participants | 263 Participants |
| Age, Customized From 65-84 years | 83 Participants | 251 Participants | 85 Participants | 43 Participants | 40 Participants |
| Blood Eosinophil Group >=0.15 - <0.3 Giga/L | 175 Participants | 527 Participants | 173 Participants | 84 Participants | 95 Participants |
| Blood Eosinophil Group <0.15 Giga/L | 181 Participants | 542 Participants | 193 Participants | 85 Participants | 83 Participants |
| Blood Eosinophil Group >=0.3 Giga/L | 277 Participants | 831 Participants | 264 Participants | 148 Participants | 142 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 159 Participants | 490 Participants | 171 Participants | 81 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 474 Participants | 1412 Participants | 460 Participants | 236 Participants | 242 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| ICS Dose Level High | 323 Participants | 979 Participants | 317 Participants | 172 Participants | 167 Participants |
| ICS Dose Level Low | 7 Participants | 15 Participants | 4 Participants | 1 Participants | 3 Participants |
| ICS Dose Level Medium | 303 Participants | 908 Participants | 310 Participants | 144 Participants | 151 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian/Oriental | 79 Participants | 223 Participants | 78 Participants | 33 Participants | 33 Participants |
| Race/Ethnicity, Customized Black/of African descent | 21 Participants | 80 Participants | 33 Participants | 14 Participants | 12 Participants |
| Race/Ethnicity, Customized Caucasian/White | 529 Participants | 1577 Participants | 510 Participants | 265 Participants | 273 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 20 Participants | 9 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Female | 394 Participants | 1197 Participants | 387 Participants | 198 Participants | 218 Participants |
| Sex: Female, Male Male | 239 Participants | 705 Participants | 244 Participants | 119 Participants | 103 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 | 3 / 313 | 1 / 631 | 0 / 321 | 5 / 632 |
| other Total, other adverse events | 185 / 313 | 363 / 631 | 197 / 321 | 378 / 632 |
| serious Total, serious adverse events | 26 / 313 | 51 / 631 | 28 / 321 | 56 / 632 |
Outcome results
Primary
Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Week 12
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Baseline | 1.76 liter | Standard Deviation 0.61 |
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Change at Week 12 | 0.15 liter | Standard Deviation 0.36 |
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Week 12 | 1.92 liter | Standard Deviation 0.7 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Baseline | 1.78 liter | Standard Deviation 0.62 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Change at Week 12 | 0.28 liter | Standard Deviation 0.45 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Week 12 | 2.07 liter | Standard Deviation 0.76 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Week 12 | 1.93 liter | Standard Deviation 0.68 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Baseline | 1.75 liter | Standard Deviation 0.57 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Change at Week 12 | 0.18 liter | Standard Deviation 0.39 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Baseline | 1.78 liter | Standard Deviation 0.6 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Change at Week 12 | 0.31 liter | Standard Deviation 0.43 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population | Week 12 | 2.09 liter | Standard Deviation 0.7 |
Comparison: Analysis was performed using mixed-effect model with repeated measures (MMRM) model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 2 of testing order.p-value: <0.000195% CI: [0.08, 0.18]Mixed Models Analysis
Comparison: Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 4 of testing order.p-value: <0.000195% CI: [0.08, 0.19]Mixed Models Analysis
Primary
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Time frame: Baseline to Week 52
Population: Analysis was performed on ITT population that included all randomized population analyzed according to the treatment group allocated by randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population | 0.871 Exacerbation per participant-year |
| Dupilumab 200 mg q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population | 0.456 Exacerbation per participant-year |
| Placebo (for Dupilumab 300 mg) q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population | 0.970 Exacerbation per participant-year |
| Dupilumab 300 mg q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population | 0.524 Exacerbation per participant-year |
Comparison: Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 1 of testing order.p-value: <0.000195% CI: [0.43, 0.68]Negative binomial regression model
Comparison: Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 3 of testing order.p-value: <0.000195% CI: [0.413, 0.662]Negative binomial regression model
Secondary
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Week 12
Population: Analysis was performed ITT population with baseline eosinophil \>=0.15 Giga/L. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | Baseline | 1.77 liter | Standard Deviation 0.63 |
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | Change at Week 12 | 0.17 liter | Standard Deviation 0.36 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | Change at Week 12 | 0.34 liter | Standard Deviation 0.46 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | Baseline | 1.81 liter | Standard Deviation 0.63 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | Baseline | 1.75 liter | Standard Deviation 0.55 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | Change at Week 12 | 0.21 liter | Standard Deviation 0.38 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | Baseline | 1.79 liter | Standard Deviation 0.59 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | Change at Week 12 | 0.35 liter | Standard Deviation 0.45 |
Comparison: Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 7 of testing order.p-value: <0.000195% CI: [0.09, 0.21]Mixed Models Analysis
Secondary
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Week 12
Population: Analysis was performed ITT population with baseline eosinophil \<0.3 Giga/L. 'Overall number of participants analysed'=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L | 0.12 liter | Standard Deviation 0.32 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L | 0.21 liter | Standard Deviation 0.43 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L | 0.17 liter | Standard Deviation 0.39 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L | 0.21 liter | Standard Deviation 0.41 |
Secondary
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Week 12
Population: Analysis was performed ITT population with baseline eosinophil \>=0.3 Giga/L. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Baseline | 1.78 liter | Standard Deviation 0.66 |
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Change at Week 12 | 0.19 liter | Standard Deviation 0.39 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Change at Week 12 | 0.39 liter | Standard Deviation 0.45 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Baseline | 1.81 liter | Standard Deviation 0.64 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Baseline | 1.73 liter | Standard Deviation 0.54 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Change at Week 12 | 0.20 liter | Standard Deviation 0.4 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Baseline | 1.75 liter | Standard Deviation 0.59 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Change at Week 12 | 0.43 liter | Standard Deviation 0.43 |
Comparison: Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 9 of testing order.p-value: <0.000195% CI: [0.16, 0.32]Mixed Models Analysis
Secondary
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Week 12
Population: Analysis was performed on ITT population with high dose ICS at baseline. 'Overall number of participants analysed'=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline | 0.14 liter | Standard Deviation 0.34 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline | 0.27 liter | Standard Deviation 0.42 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline | 0.20 liter | Standard Deviation 0.4 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline | 0.32 liter | Standard Deviation 0.43 |
Secondary
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Weeks 2, 4, 8, 24, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 2 | 0.08 liter | Standard Deviation 0.35 |
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 4 | 0.13 liter | Standard Deviation 0.35 |
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 8 | 0.15 liter | Standard Deviation 0.38 |
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 24 | 0.13 liter | Standard Deviation 0.4 |
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 36 | 0.14 liter | Standard Deviation 0.41 |
| Placebo (for Dupilumab 200 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 52 | 0.12 liter | Standard Deviation 0.38 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 52 | 0.31 liter | Standard Deviation 0.5 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 24 | 0.31 liter | Standard Deviation 0.45 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 2 | 0.22 liter | Standard Deviation 0.38 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 8 | 0.28 liter | Standard Deviation 0.42 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 4 | 0.24 liter | Standard Deviation 0.4 |
| Dupilumab 200 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 36 | 0.31 liter | Standard Deviation 0.48 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 4 | 0.13 liter | Standard Deviation 0.34 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 8 | 0.19 liter | Standard Deviation 0.4 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 24 | 0.19 liter | Standard Deviation 0.44 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 52 | 0.20 liter | Standard Deviation 0.42 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 36 | 0.21 liter | Standard Deviation 0.42 |
| Placebo (for Dupilumab 300 mg) q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 2 | 0.10 liter | Standard Deviation 0.34 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 36 | 0.32 liter | Standard Deviation 0.45 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 52 | 0.32 liter | Standard Deviation 0.44 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 4 | 0.27 liter | Standard Deviation 0.41 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 24 | 0.30 liter | Standard Deviation 0.44 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 2 | 0.25 liter | Standard Deviation 0.4 |
| Dupilumab 300 mg q2w | Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 8 | 0.29 liter | Standard Deviation 0.43 |
Secondary
Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population
LOAC was defined as any of the following: \>=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS \>=4 times the dose at randomization; use of systemic corticosteroids for \>=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.
Time frame: Baseline to Week 52
Population: Analysis was performed on ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population | 2.972 LOAC per participant-year |
| Dupilumab 200 mg q2w | Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population | 1.853 LOAC per participant-year |
| Placebo (for Dupilumab 300 mg) q2w | Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population | 2.965 LOAC per participant-year |
| Dupilumab 300 mg q2w | Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population | 1.740 LOAC per participant-year |
Secondary
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Time frame: Baseline to Week 52
Population: Analysis was performed ITT population with baseline eosinophil \>=0.15 Giga/L.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L | 1.007 Exacerbation per participant-year |
| Dupilumab 200 mg q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L | 0.445 Exacerbation per participant-year |
| Placebo (for Dupilumab 300 mg) q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L | 1.081 Exacerbation per participant-year |
| Dupilumab 300 mg q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L | 0.434 Exacerbation per participant-year |
Comparison: Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 6 of testing order.p-value: <0.000195% CI: [0.307, 0.526]Negative binomial regression model
Secondary
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Time frame: Baseline to Week 52
Population: Analysis was performed on ITT population with baseline eosinophil \<0.3 Giga/L.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L | 0.675 Exacerbation per participant-year |
| Dupilumab 200 mg q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L | 0.512 Exacerbation per participant-year |
| Placebo (for Dupilumab 300 mg) q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L | 0.732 Exacerbation per participant-year |
| Dupilumab 300 mg q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L | 0.610 Exacerbation per participant-year |
Comparison: Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 10 of testing order.p-value: 0.259995% CI: [0.608, 1.144]Negative binomial regression model
Secondary
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Time frame: Baseline to Week 52
Population: Analysis was performed on ITT population with baseline eosinophil \>=0.3 Giga/L.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L | 1.081 Exacerbation per participant-year |
| Dupilumab 200 mg q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L | 0.370 Exacerbation per participant-year |
| Placebo (for Dupilumab 300 mg) q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L | 1.236 Exacerbation per participant-year |
| Dupilumab 300 mg q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L | 0.403 Exacerbation per participant-year |
Comparison: Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 8 of testing order.p-value: <0.000195% CI: [0.234, 0.454]Negative binomial regression model
Secondary
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Time frame: Baseline to Week 52
Population: Analysis was performed on ITT population with high dose ICS at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline | 1.040 Exacerbation per participant-year |
| Dupilumab 200 mg q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline | 0.560 Exacerbation per participant-year |
| Placebo (for Dupilumab 300 mg) q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline | 1.038 Exacerbation per participant-year |
| Dupilumab 300 mg q2w | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline | 0.639 Exacerbation per participant-year |
Secondary
Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations (resulted hospitalization or emergency room visit) that occurred during the treatment period divided by the total number of participant-years treated.
Time frame: Baseline to Week 52
Population: Analysis was performed on ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population | 0.081 Exacerbation per participant-year |
| Dupilumab 200 mg q2w | Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population | 0.043 Exacerbation per participant-year |
| Placebo (for Dupilumab 300 mg) q2w | Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population | 0.034 Exacerbation per participant-year |
| Dupilumab 300 mg q2w | Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population | 0.025 Exacerbation per participant-year |
Secondary
Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis
The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.
Time frame: Baseline, Weeks 12, 24, 36, and 52
Population: Analysis was performed on ITT population with bilateral nasal polyposis/chronic rhinosinusitis. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 12 | -6.82 scores on a scale | Standard Deviation 17.19 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 24 | -7.21 scores on a scale | Standard Deviation 17.1 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 36 | -6.10 scores on a scale | Standard Deviation 19.03 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 52 | -6.95 scores on a scale | Standard Deviation 17.1 |
| Dupilumab 200 mg q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 52 | -15.78 scores on a scale | Standard Deviation 17.72 |
| Dupilumab 200 mg q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 36 | -15.23 scores on a scale | Standard Deviation 18.2 |
| Dupilumab 200 mg q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 24 | -14.68 scores on a scale | Standard Deviation 18.77 |
| Dupilumab 200 mg q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 12 | -13.55 scores on a scale | Standard Deviation 16.85 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 36 | -8.51 scores on a scale | Standard Deviation 20.36 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 52 | -9.98 scores on a scale | Standard Deviation 18.01 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 24 | -9.55 scores on a scale | Standard Deviation 16.04 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 12 | -11.30 scores on a scale | Standard Deviation 16.11 |
| Dupilumab 300 mg q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 52 | -19.81 scores on a scale | Standard Deviation 22.39 |
| Dupilumab 300 mg q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 12 | -16.07 scores on a scale | Standard Deviation 20.54 |
| Dupilumab 300 mg q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 24 | -17.41 scores on a scale | Standard Deviation 20.81 |
| Dupilumab 300 mg q2w | Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis | Change at Week 36 | -18.86 scores on a scale | Standard Deviation 21.34 |
Secondary
Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population
The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Time frame: Baseline, Weeks 2, 4, 8, 12, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 36 | -1.21 scores on a scale | Standard Deviation 1.01 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 52 | -1.07 scores on a scale | Standard Deviation 1.08 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 4 | -0.76 scores on a scale | Standard Deviation 0.9 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 2 | -0.52 scores on a scale | Standard Deviation 0.85 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 8 | -0.94 scores on a scale | Standard Deviation 0.96 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 12 | -0.98 scores on a scale | Standard Deviation 1 |
| Dupilumab 200 mg q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 12 | -1.33 scores on a scale | Standard Deviation 1.03 |
| Dupilumab 200 mg q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 4 | -1.07 scores on a scale | Standard Deviation 0.98 |
| Dupilumab 200 mg q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 8 | -1.26 scores on a scale | Standard Deviation 1.03 |
| Dupilumab 200 mg q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 2 | -0.88 scores on a scale | Standard Deviation 0.91 |
| Dupilumab 200 mg q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 36 | -1.50 scores on a scale | Standard Deviation 1.14 |
| Dupilumab 200 mg q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 52 | -1.50 scores on a scale | Standard Deviation 1.05 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 4 | -0.77 scores on a scale | Standard Deviation 1.01 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 36 | -1.22 scores on a scale | Standard Deviation 1.09 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 12 | -1.09 scores on a scale | Standard Deviation 1.09 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 2 | -0.58 scores on a scale | Standard Deviation 0.97 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 52 | -1.25 scores on a scale | Standard Deviation 1.05 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 8 | -1.05 scores on a scale | Standard Deviation 1.04 |
| Dupilumab 300 mg q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 52 | -1.50 scores on a scale | Standard Deviation 1.08 |
| Dupilumab 300 mg q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 2 | -0.89 scores on a scale | Standard Deviation 0.94 |
| Dupilumab 300 mg q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 4 | -1.06 scores on a scale | Standard Deviation 1.01 |
| Dupilumab 300 mg q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 8 | -1.24 scores on a scale | Standard Deviation 1.06 |
| Dupilumab 300 mg q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 12 | -1.35 scores on a scale | Standard Deviation 1.06 |
| Dupilumab 300 mg q2w | Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population | Change at Week 36 | -1.52 scores on a scale | Standard Deviation 1.09 |
Secondary
Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L
The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Time frame: Baseline, Week 24
Population: Analysis was performed on ITT population with baseline eosinophil \>=0.3 Giga/L. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Baseline | 4.24 scores on a scale | Standard Deviation 0.98 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Change at Week 24 | 0.97 scores on a scale | Standard Deviation 1.01 |
| Dupilumab 200 mg q2w | Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Change at Week 24 | 1.39 scores on a scale | Standard Deviation 1.15 |
| Dupilumab 200 mg q2w | Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Baseline | 4.24 scores on a scale | Standard Deviation 1.11 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Baseline | 4.21 scores on a scale | Standard Deviation 0.97 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Change at Week 24 | 1.02 scores on a scale | Standard Deviation 1.25 |
| Dupilumab 300 mg q2w | Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Baseline | 4.36 scores on a scale | Standard Deviation 1.05 |
| Dupilumab 300 mg q2w | Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L | Change at Week 24 | 1.30 scores on a scale | Standard Deviation 1.15 |
Secondary
Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population
The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Time frame: Baseline, Weeks 12, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Change at Week 12 | 0.90 scores on a scale | Standard Deviation 0.97 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Change at Week 52 | 1.00 scores on a scale | Standard Deviation 1.12 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Change at Week 36 | 1.05 scores on a scale | Standard Deviation 1.08 |
| Dupilumab 200 mg q2w | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Change at Week 12 | 1.09 scores on a scale | Standard Deviation 1.03 |
| Dupilumab 200 mg q2w | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Change at Week 52 | 1.28 scores on a scale | Standard Deviation 1.16 |
| Dupilumab 200 mg q2w | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Change at Week 36 | 1.26 scores on a scale | Standard Deviation 1.17 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Change at Week 36 | 1.08 scores on a scale | Standard Deviation 1.16 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Change at Week 12 | 0.94 scores on a scale | Standard Deviation 1.01 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Change at Week 52 | 1.02 scores on a scale | Standard Deviation 1.1 |
| Dupilumab 300 mg q2w | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Change at Week 12 | 1.09 scores on a scale | Standard Deviation 1.09 |
| Dupilumab 300 mg q2w | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Change at Week 52 | 1.34 scores on a scale | Standard Deviation 1.16 |
| Dupilumab 300 mg q2w | Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population | Change at Week 36 | 1.33 scores on a scale | Standard Deviation 1.15 |
Secondary
Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population
The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Time frame: Baseline, Week 24
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Change at Week 24 | -1.06 scores on a scale | Standard Deviation 1.01 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Week 24 | 1.67 scores on a scale | Standard Deviation 1.06 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Baseline | 2.71 scores on a scale | Standard Deviation 0.73 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Week 24 | 1.33 scores on a scale | Standard Deviation 1.05 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Baseline | 2.76 scores on a scale | Standard Deviation 0.8 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Change at Week 24 | -1.43 scores on a scale | Standard Deviation 1.05 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Baseline | 2.77 scores on a scale | Standard Deviation 0.77 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Week 24 | 1.58 scores on a scale | Standard Deviation 1.08 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Change at Week 24 | -1.19 scores on a scale | Standard Deviation 1.1 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Week 24 | 1.37 scores on a scale | Standard Deviation 1.1 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Change at Week 24 | -1.38 scores on a scale | Standard Deviation 1.1 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population | Baseline | 2.77 scores on a scale | Standard Deviation 0.76 |
Secondary
Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
The ACQ-7 has 7 questions, the first 5 questions assess the most common asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze plus short-acting bronchodilator use, and FEV1 (pre-bronchodilator % predicted). Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). Clinic staff scored the FEV1% predicted on a 7-point scale. The questions were equally weighted and the ACQ-7 total score was mean of the scores of all 7 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.46 scores on a scale | Standard Deviation 0.7 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -1.04 scores on a scale | Standard Deviation 0.84 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.89 scores on a scale | Standard Deviation 0.91 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.65 scores on a scale | Standard Deviation 0.76 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.91 scores on a scale | Standard Deviation 0.92 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.81 scores on a scale | Standard Deviation 0.8 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.85 scores on a scale | Standard Deviation 0.83 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -1.32 scores on a scale | Standard Deviation 1.01 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -1.17 scores on a scale | Standard Deviation 0.9 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -1.11 scores on a scale | Standard Deviation 0.9 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -1.25 scores on a scale | Standard Deviation 0.92 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -1.32 scores on a scale | Standard Deviation 0.91 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.94 scores on a scale | Standard Deviation 0.85 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.79 scores on a scale | Standard Deviation 0.77 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.92 scores on a scale | Standard Deviation 0.93 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.50 scores on a scale | Standard Deviation 0.8 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.65 scores on a scale | Standard Deviation 0.85 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.90 scores on a scale | Standard Deviation 0.89 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -1.01 scores on a scale | Standard Deviation 0.96 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -1.05 scores on a scale | Standard Deviation 0.94 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -1.07 scores on a scale | Standard Deviation 0.91 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -1.12 scores on a scale | Standard Deviation 0.92 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -1.34 scores on a scale | Standard Deviation 0.93 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -1.35 scores on a scale | Standard Deviation 0.95 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.97 scores on a scale | Standard Deviation 0.87 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.82 scores on a scale | Standard Deviation 0.81 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -1.22 scores on a scale | Standard Deviation 0.96 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -1.20 scores on a scale | Standard Deviation 0.92 |
Secondary
Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population
The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Time frame: Baseline, Week 24
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Baseline | 4.26 scores on a scale | Standard Deviation 1.02 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Change at Week 24 | 0.95 scores on a scale | Standard Deviation 1.03 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Week 24 | 5.23 scores on a scale | Standard Deviation 1.07 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Baseline | 4.31 scores on a scale | Standard Deviation 1.08 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Change at Week 24 | 1.13 scores on a scale | Standard Deviation 1.14 |
| Dupilumab 200 mg q2w | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Week 24 | 5.46 scores on a scale | Standard Deviation 1.12 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Week 24 | 5.30 scores on a scale | Standard Deviation 1.15 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Baseline | 4.30 scores on a scale | Standard Deviation 1.03 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Change at Week 24 | 1.02 scores on a scale | Standard Deviation 1.1 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Baseline | 4.28 scores on a scale | Standard Deviation 1.05 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Change at Week 24 | 1.17 scores on a scale | Standard Deviation 1.11 |
| Dupilumab 300 mg q2w | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population | Week 24 | 5.47 scores on a scale | Standard Deviation 1.09 |
Secondary
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population
EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable).
Time frame: Baseline, Weeks 12, 24, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 36 | 9.70 scores on a scale | Standard Deviation 18.24 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 52 | 8.35 scores on a scale | Standard Deviation 18.51 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 36 | 0.08 scores on a scale | Standard Deviation 0.19 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 52 | 0.07 scores on a scale | Standard Deviation 0.2 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 12 | 0.07 scores on a scale | Standard Deviation 0.17 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 12 | 7.69 scores on a scale | Standard Deviation 17.43 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 24 | 8.33 scores on a scale | Standard Deviation 17.58 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 24 | 0.07 scores on a scale | Standard Deviation 0.17 |
| Dupilumab 200 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 12 | 11.10 scores on a scale | Standard Deviation 18.9 |
| Dupilumab 200 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 36 | 11.61 scores on a scale | Standard Deviation 19.09 |
| Dupilumab 200 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 52 | 0.10 scores on a scale | Standard Deviation 0.19 |
| Dupilumab 200 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 24 | 0.09 scores on a scale | Standard Deviation 0.17 |
| Dupilumab 200 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 24 | 11.44 scores on a scale | Standard Deviation 18.48 |
| Dupilumab 200 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 52 | 12.98 scores on a scale | Standard Deviation 18.71 |
| Dupilumab 200 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 36 | 0.09 scores on a scale | Standard Deviation 0.2 |
| Dupilumab 200 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 12 | 0.09 scores on a scale | Standard Deviation 0.18 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 24 | 0.08 scores on a scale | Standard Deviation 0.18 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 36 | 0.10 scores on a scale | Standard Deviation 0.18 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 12 | 0.08 scores on a scale | Standard Deviation 0.18 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 12 | 6.39 scores on a scale | Standard Deviation 20.42 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 52 | 0.08 scores on a scale | Standard Deviation 0.19 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 24 | 8.59 scores on a scale | Standard Deviation 20.37 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 36 | 9.31 scores on a scale | Standard Deviation 20.09 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 52 | 9.52 scores on a scale | Standard Deviation 20.81 |
| Dupilumab 300 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 52 | 11.90 scores on a scale | Standard Deviation 19.6 |
| Dupilumab 300 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 12 | 0.09 scores on a scale | Standard Deviation 0.18 |
| Dupilumab 300 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 24 | 0.08 scores on a scale | Standard Deviation 0.2 |
| Dupilumab 300 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 36 | 0.09 scores on a scale | Standard Deviation 0.2 |
| Dupilumab 300 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | Single Index: Change at Week 52 | 0.10 scores on a scale | Standard Deviation 0.2 |
| Dupilumab 300 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 24 | 9.21 scores on a scale | Standard Deviation 19.61 |
| Dupilumab 300 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 36 | 11.41 scores on a scale | Standard Deviation 19.4 |
| Dupilumab 300 mg q2w | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population | VAS Score: Change at Week 12 | 9.80 scores on a scale | Standard Deviation 19.56 |
Secondary
Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.05 scores on a scale | Standard Deviation 0.45 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.39 scores on a scale | Standard Deviation 0.73 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.33 scores on a scale | Standard Deviation 0.72 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.11 scores on a scale | Standard Deviation 0.59 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.41 scores on a scale | Standard Deviation 0.74 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.24 scores on a scale | Standard Deviation 0.64 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.26 scores on a scale | Standard Deviation 0.66 |
| Dupilumab 200 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.56 scores on a scale | Standard Deviation 0.81 |
| Dupilumab 200 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.45 scores on a scale | Standard Deviation 0.72 |
| Dupilumab 200 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.41 scores on a scale | Standard Deviation 0.7 |
| Dupilumab 200 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.52 scores on a scale | Standard Deviation 0.78 |
| Dupilumab 200 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.57 scores on a scale | Standard Deviation 0.84 |
| Dupilumab 200 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.27 scores on a scale | Standard Deviation 0.61 |
| Dupilumab 200 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.17 scores on a scale | Standard Deviation 0.48 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.30 scores on a scale | Standard Deviation 0.68 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.06 scores on a scale | Standard Deviation 0.45 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.14 scores on a scale | Standard Deviation 0.58 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.22 scores on a scale | Standard Deviation 0.63 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.36 scores on a scale | Standard Deviation 0.72 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.39 scores on a scale | Standard Deviation 0.75 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.42 scores on a scale | Standard Deviation 0.75 |
| Dupilumab 300 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.40 scores on a scale | Standard Deviation 0.7 |
| Dupilumab 300 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.61 scores on a scale | Standard Deviation 0.78 |
| Dupilumab 300 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.56 scores on a scale | Standard Deviation 0.8 |
| Dupilumab 300 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.29 scores on a scale | Standard Deviation 0.64 |
| Dupilumab 300 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.16 scores on a scale | Standard Deviation 0.52 |
| Dupilumab 300 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.52 scores on a scale | Standard Deviation 0.73 |
| Dupilumab 300 mg q2w | Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.46 scores on a scale | Standard Deviation 0.73 |
Secondary
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
FEF is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF25-75% is defined as the mean forced expiratory flow between the 25% and 75% of the FVC.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 0.16 liters/sec | Standard Deviation 0.45 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 0.16 liters/sec | Standard Deviation 0.5 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 0.18 liters/sec | Standard Deviation 0.45 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 0.09 liters/sec | Standard Deviation 0.4 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 0.17 liters/sec | Standard Deviation 0.47 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 0.18 liters/sec | Standard Deviation 0.46 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 0.18 liters/sec | Standard Deviation 0.49 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 0.34 liters/sec | Standard Deviation 0.57 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 0.36 liters/sec | Standard Deviation 0.63 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 0.35 liters/sec | Standard Deviation 0.59 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 0.24 liters/sec | Standard Deviation 0.48 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 0.29 liters/sec | Standard Deviation 0.52 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 0.22 liters/sec | Standard Deviation 0.47 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 0.30 liters/sec | Standard Deviation 0.53 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 0.22 liters/sec | Standard Deviation 0.49 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 0.24 liters/sec | Standard Deviation 0.55 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 0.22 liters/sec | Standard Deviation 0.56 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 0.19 liters/sec | Standard Deviation 0.5 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 0.15 liters/sec | Standard Deviation 0.44 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 0.11 liters/sec | Standard Deviation 0.44 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 0.20 liters/sec | Standard Deviation 0.49 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 0.36 liters/sec | Standard Deviation 0.55 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 0.36 liters/sec | Standard Deviation 0.56 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 0.27 liters/sec | Standard Deviation 0.48 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 0.29 liters/sec | Standard Deviation 0.48 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 0.32 liters/sec | Standard Deviation 0.51 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 0.35 liters/sec | Standard Deviation 0.53 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 0.35 liters/sec | Standard Deviation 0.54 |
Secondary
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 0.08 liter | Standard Deviation 0.42 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 0.11 liter | Standard Deviation 0.45 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 0.13 liter | Standard Deviation 0.41 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 0.13 liter | Standard Deviation 0.41 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 0.11 liter | Standard Deviation 0.45 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 0.12 liter | Standard Deviation 0.39 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 0.08 liter | Standard Deviation 0.45 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 0.28 liter | Standard Deviation 0.45 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 0.30 liter | Standard Deviation 0.52 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 0.29 liter | Standard Deviation 0.49 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 0.23 liter | Standard Deviation 0.44 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 0.26 liter | Standard Deviation 0.45 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 0.29 liter | Standard Deviation 0.53 |
| Dupilumab 200 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 0.29 liter | Standard Deviation 0.48 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 0.18 liter | Standard Deviation 0.42 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 0.12 liter | Standard Deviation 0.38 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 0.18 liter | Standard Deviation 0.46 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 0.10 liter | Standard Deviation 0.37 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 0.18 liter | Standard Deviation 0.44 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 0.19 liter | Standard Deviation 0.47 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 0.18 liter | Standard Deviation 0.45 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 0.29 liter | Standard Deviation 0.5 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 0.31 liter | Standard Deviation 0.5 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 0.31 liter | Standard Deviation 0.52 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 0.25 liter | Standard Deviation 0.46 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 0.27 liter | Standard Deviation 0.47 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 0.29 liter | Standard Deviation 0.51 |
| Dupilumab 300 mg q2w | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 0.29 liter | Standard Deviation 0.51 |
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population
The HADS is a general scale to detect states of anxiety and depression already used and validated in asthma, which includes HADS-A and HADS-D subscales. The instrument is comprised of 14 items: 7 related to anxiety (HADS-A) and 7 to depression (HADS-D). Each item on the questionnaire is scored from 0-3. The anxiety/depression score is the sum of the scores of the 7 related items; one can score between 0 and 21 for either anxiety or depression. And the total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher anxiety/depression complains.
Time frame: Baseline, Weeks 12, 24, 36, and 52
Population: Analysis was performed on ITT population; 29 participants in Japan who received an incorrectly translated HADS questionnaire were excluded. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 12 | -2.11 scores on a scale | Standard Deviation 5.29 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 24 | -2.17 scores on a scale | Standard Deviation 5.71 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 36 | -2.52 scores on a scale | Standard Deviation 5.89 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 52 | -2.00 scores on a scale | Standard Deviation 6.29 |
| Dupilumab 200 mg q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 24 | -1.93 scores on a scale | Standard Deviation 5.97 |
| Dupilumab 200 mg q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 36 | -2.02 scores on a scale | Standard Deviation 6.34 |
| Dupilumab 200 mg q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 52 | -2.36 scores on a scale | Standard Deviation 6.28 |
| Dupilumab 200 mg q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 12 | -1.91 scores on a scale | Standard Deviation 5.65 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 36 | -2.67 scores on a scale | Standard Deviation 6.8 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 24 | -1.73 scores on a scale | Standard Deviation 6.36 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 52 | -1.86 scores on a scale | Standard Deviation 6.79 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 12 | -1.55 scores on a scale | Standard Deviation 6.11 |
| Dupilumab 300 mg q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 52 | -2.17 scores on a scale | Standard Deviation 7.04 |
| Dupilumab 300 mg q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 24 | -1.88 scores on a scale | Standard Deviation 6.39 |
| Dupilumab 300 mg q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 12 | -1.98 scores on a scale | Standard Deviation 5.89 |
| Dupilumab 300 mg q2w | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population | Change at Week 36 | -2.13 scores on a scale | Standard Deviation 6.67 |
Secondary
Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 12 | 9.85 liters/min | Standard Deviation 50.4 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 12 | 3.24 liters/min | Standard Deviation 53.42 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 2 | 4.19 liters/min | Standard Deviation 31.3 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 8 | 2.82 liters/min | Standard Deviation 50.1 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 24 | 5.55 liters/min | Standard Deviation 53.27 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 8 | 7.42 liters/min | Standard Deviation 49.3 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 52 | -6.43 liters/min | Standard Deviation 62.82 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 24 | -4.89 liters/min | Standard Deviation 55.07 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 36 | 3.24 liters/min | Standard Deviation 61.68 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 2 | 3.33 liters/min | Standard Deviation 36.81 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 4 | 6.23 liters/min | Standard Deviation 42.42 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 4 | 5.01 liters/min | Standard Deviation 45.09 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 52 | 2.85 liters/min | Standard Deviation 64.6 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 36 | -6.75 liters/min | Standard Deviation 62.44 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 52 | 29.86 liters/min | Standard Deviation 75.44 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 2 | 13.80 liters/min | Standard Deviation 40.59 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 8 | 21.06 liters/min | Standard Deviation 61.8 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 4 | 17.94 liters/min | Standard Deviation 55.3 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 36 | 21.79 liters/min | Standard Deviation 75 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 8 | 25.70 liters/min | Standard Deviation 58.52 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 2 | 15.21 liters/min | Standard Deviation 39.45 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 12 | 27.81 liters/min | Standard Deviation 65.3 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 52 | 18.77 liters/min | Standard Deviation 77.37 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 24 | 19.95 liters/min | Standard Deviation 71.5 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 24 | 28.71 liters/min | Standard Deviation 69.64 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 36 | 31.19 liters/min | Standard Deviation 71.59 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 12 | 19.75 liters/min | Standard Deviation 68.14 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 4 | 21.81 liters/min | Standard Deviation 53.85 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 52 | 10.99 liters/min | Standard Deviation 64.68 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 2 | 3.45 liters/min | Standard Deviation 28.95 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 4 | 5.55 liters/min | Standard Deviation 43.69 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 8 | 12.22 liters/min | Standard Deviation 50.5 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 12 | 14.23 liters/min | Standard Deviation 56.18 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 24 | 15.43 liters/min | Standard Deviation 60.83 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 36 | 12.57 liters/min | Standard Deviation 61.88 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 12 | 8.52 liters/min | Standard Deviation 56.74 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 2 | 3.87 liters/min | Standard Deviation 33.98 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 4 | 2.73 liters/min | Standard Deviation 46.83 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 8 | 7.68 liters/min | Standard Deviation 56.73 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 24 | 7.56 liters/min | Standard Deviation 63.25 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 36 | 2.64 liters/min | Standard Deviation 65.21 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 52 | 2.83 liters/min | Standard Deviation 67.01 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 52 | 26.67 liters/min | Standard Deviation 71.63 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 36 | 23.93 liters/min | Standard Deviation 65.04 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 24 | 23.74 liters/min | Standard Deviation 63.71 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 12 | 25.88 liters/min | Standard Deviation 57.09 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 12 | 18.70 liters/min | Standard Deviation 55.6 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 24 | 15.82 liters/min | Standard Deviation 61.91 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 8 | 23.18 liters/min | Standard Deviation 52.65 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 4 | 19.67 liters/min | Standard Deviation 46.47 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 52 | 15.58 liters/min | Standard Deviation 72.51 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 36 | 14.35 liters/min | Standard Deviation 64.66 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 4 | 14.90 liters/min | Standard Deviation 47.42 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 2 | 11.35 liters/min | Standard Deviation 36.1 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | AM: Change at Week 2 | 14.46 liters/min | Standard Deviation 36.29 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | PM: Change at Week 8 | 17.26 liters/min | Standard Deviation 53.37 |
Secondary
Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0= No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.07 scores on a scale | Standard Deviation 0.43 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.38 scores on a scale | Standard Deviation 0.69 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.35 scores on a scale | Standard Deviation 0.69 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.16 scores on a scale | Standard Deviation 0.59 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.41 scores on a scale | Standard Deviation 0.71 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.26 scores on a scale | Standard Deviation 0.64 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.30 scores on a scale | Standard Deviation 0.64 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.54 scores on a scale | Standard Deviation 0.81 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.45 scores on a scale | Standard Deviation 0.71 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.40 scores on a scale | Standard Deviation 0.68 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.52 scores on a scale | Standard Deviation 0.76 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.55 scores on a scale | Standard Deviation 0.84 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.26 scores on a scale | Standard Deviation 0.59 |
| Dupilumab 200 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.18 scores on a scale | Standard Deviation 0.49 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.30 scores on a scale | Standard Deviation 0.69 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.09 scores on a scale | Standard Deviation 0.49 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.16 scores on a scale | Standard Deviation 0.61 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.25 scores on a scale | Standard Deviation 0.62 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.36 scores on a scale | Standard Deviation 0.73 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.38 scores on a scale | Standard Deviation 0.76 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.41 scores on a scale | Standard Deviation 0.78 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.37 scores on a scale | Standard Deviation 0.7 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.60 scores on a scale | Standard Deviation 0.79 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.56 scores on a scale | Standard Deviation 0.77 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.27 scores on a scale | Standard Deviation 0.64 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.15 scores on a scale | Standard Deviation 0.5 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.50 scores on a scale | Standard Deviation 0.73 |
| Dupilumab 300 mg q2w | Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.44 scores on a scale | Standard Deviation 0.72 |
Secondary
Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.25 number of nocturnal awakenings/night | Standard Deviation 0.74 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.24 number of nocturnal awakenings/night | Standard Deviation 0.69 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.18 number of nocturnal awakenings/night | Standard Deviation 0.65 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.10 number of nocturnal awakenings/night | Standard Deviation 0.61 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.06 number of nocturnal awakenings/night | Standard Deviation 0.49 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.23 number of nocturnal awakenings/night | Standard Deviation 0.78 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.21 number of nocturnal awakenings/night | Standard Deviation 0.66 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.15 number of nocturnal awakenings/night | Standard Deviation 0.55 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.35 number of nocturnal awakenings/night | Standard Deviation 0.88 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.36 number of nocturnal awakenings/night | Standard Deviation 0.81 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.19 number of nocturnal awakenings/night | Standard Deviation 0.66 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.33 number of nocturnal awakenings/night | Standard Deviation 0.75 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.29 number of nocturnal awakenings/night | Standard Deviation 0.72 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.34 number of nocturnal awakenings/night | Standard Deviation 0.81 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.26 number of nocturnal awakenings/night | Standard Deviation 0.74 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.04 number of nocturnal awakenings/night | Standard Deviation 0.62 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.11 number of nocturnal awakenings/night | Standard Deviation 0.7 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.17 number of nocturnal awakenings/night | Standard Deviation 0.62 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.18 number of nocturnal awakenings/night | Standard Deviation 0.67 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.26 number of nocturnal awakenings/night | Standard Deviation 0.65 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.26 number of nocturnal awakenings/night | Standard Deviation 0.71 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.28 number of nocturnal awakenings/night | Standard Deviation 0.73 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.24 number of nocturnal awakenings/night | Standard Deviation 0.72 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.41 number of nocturnal awakenings/night | Standard Deviation 0.78 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.36 number of nocturnal awakenings/night | Standard Deviation 0.74 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.20 number of nocturnal awakenings/night | Standard Deviation 0.67 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.11 number of nocturnal awakenings/night | Standard Deviation 0.67 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.30 number of nocturnal awakenings/night | Standard Deviation 0.73 |
Secondary
Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded daily by the participants in an electronic diary/peak expiratory flow (PEF) meter. In the case that Nebulizer solutions were used as an alternative delivery method, the nebulizer dose was converted to number of puffs as per following conversion factor: salbutamol/albuterol nebulizer solution (2.5 mg) corresponds to 4 puffs.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.52 Number of puffs of reliever medication | Standard Deviation 2.28 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.77 Number of puffs of reliever medication | Standard Deviation 2.6 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.21 Number of puffs of reliever medication | Standard Deviation 1.55 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.90 Number of puffs of reliever medication | Standard Deviation 2.58 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.99 Number of puffs of reliever medication | Standard Deviation 2.49 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.50 Number of puffs of reliever medication | Standard Deviation 2.23 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.26 Number of puffs of reliever medication | Standard Deviation 2.19 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -1.30 Number of puffs of reliever medication | Standard Deviation 2.99 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -1.27 Number of puffs of reliever medication | Standard Deviation 3.05 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -1.02 Number of puffs of reliever medication | Standard Deviation 2.86 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -1.45 Number of puffs of reliever medication | Standard Deviation 3.33 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.68 Number of puffs of reliever medication | Standard Deviation 2.61 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.56 Number of puffs of reliever medication | Standard Deviation 1.96 |
| Dupilumab 200 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -1.23 Number of puffs of reliever medication | Standard Deviation 3.03 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.99 Number of puffs of reliever medication | Standard Deviation 3.21 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -1.06 Number of puffs of reliever medication | Standard Deviation 3.57 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -1.12 Number of puffs of reliever medication | Standard Deviation 3.64 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.10 Number of puffs of reliever medication | Standard Deviation 1.71 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.34 Number of puffs of reliever medication | Standard Deviation 3.42 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.65 Number of puffs of reliever medication | Standard Deviation 2.96 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.89 Number of puffs of reliever medication | Standard Deviation 3.06 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.73 Number of puffs of reliever medication | Standard Deviation 2.42 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.47 Number of puffs of reliever medication | Standard Deviation 1.91 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -1.15 Number of puffs of reliever medication | Standard Deviation 2.83 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -1.08 Number of puffs of reliever medication | Standard Deviation 2.72 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -1.39 Number of puffs of reliever medication | Standard Deviation 2.97 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -1.23 Number of puffs of reliever medication | Standard Deviation 3.01 |
| Dupilumab 300 mg q2w | Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.94 Number of puffs of reliever medication | Standard Deviation 2.86 |
Secondary
Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 5.09 percent predicted of FEV1 | Standard Deviation 12.99 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 4.38 percent predicted of FEV1 | Standard Deviation 12.85 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 4.25 percent predicted of FEV1 | Standard Deviation 12.06 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 4.55 percent predicted of FEV1 | Standard Deviation 11.69 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 2.58 percent predicted of FEV1 | Standard Deviation 11.36 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 4.93 percent predicted of FEV1 | Standard Deviation 12.3 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 5.02 percent predicted of FEV1 | Standard Deviation 12.1 |
| Dupilumab 200 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 9.98 percent predicted of FEV1 | Standard Deviation 13.94 |
| Dupilumab 200 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 7.92 percent predicted of FEV1 | Standard Deviation 12.81 |
| Dupilumab 200 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 9.27 percent predicted of FEV1 | Standard Deviation 13.13 |
| Dupilumab 200 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 7.10 percent predicted of FEV1 | Standard Deviation 12.28 |
| Dupilumab 200 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 10.12 percent predicted of FEV1 | Standard Deviation 14.61 |
| Dupilumab 200 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 9.22 percent predicted of FEV1 | Standard Deviation 13.87 |
| Dupilumab 200 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 10.08 percent predicted of FEV1 | Standard Deviation 14.79 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 6.68 percent predicted of FEV1 | Standard Deviation 13.56 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 6.82 percent predicted of FEV1 | Standard Deviation 13.54 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 4.13 percent predicted of FEV1 | Standard Deviation 11.41 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 6.41 percent predicted of FEV1 | Standard Deviation 14.02 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 3.32 percent predicted of FEV1 | Standard Deviation 10.98 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 5.90 percent predicted of FEV1 | Standard Deviation 13.02 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 6.08 percent predicted of FEV1 | Standard Deviation 12.55 |
| Dupilumab 300 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 11.02 percent predicted of FEV1 | Standard Deviation 14.59 |
| Dupilumab 300 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 10.28 percent predicted of FEV1 | Standard Deviation 14.44 |
| Dupilumab 300 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 8.44 percent predicted of FEV1 | Standard Deviation 13.2 |
| Dupilumab 300 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 9.20 percent predicted of FEV1 | Standard Deviation 14.1 |
| Dupilumab 300 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 9.70 percent predicted of FEV1 | Standard Deviation 14.15 |
| Dupilumab 300 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 10.14 percent predicted of FEV1 | Standard Deviation 14.75 |
| Dupilumab 300 mg q2w | Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 10.94 percent predicted of FEV1 | Standard Deviation 15.06 |
Secondary
Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
Population: Analysis was performed ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | -0.02 liter | Standard Deviation 0.31 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.05 liter | Standard Deviation 0.36 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.02 liter | Standard Deviation 0.31 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | -0.03 liter | Standard Deviation 0.34 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.08 liter | Standard Deviation 0.38 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | -0.02 liter | Standard Deviation 0.33 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.07 liter | Standard Deviation 0.31 |
| Dupilumab 200 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 0.10 liter | Standard Deviation 0.39 |
| Dupilumab 200 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 0.12 liter | Standard Deviation 0.44 |
| Dupilumab 200 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 0.12 liter | Standard Deviation 0.44 |
| Dupilumab 200 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 0.10 liter | Standard Deviation 0.37 |
| Dupilumab 200 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 0.13 liter | Standard Deviation 0.43 |
| Dupilumab 200 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 0.12 liter | Standard Deviation 0.4 |
| Dupilumab 200 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 0.12 liter | Standard Deviation 0.4 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 0.01 liter | Standard Deviation 0.35 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 0.03 liter | Standard Deviation 0.35 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | -0.01 liter | Standard Deviation 0.4 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 0.01 liter | Standard Deviation 0.38 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | -0.04 liter | Standard Deviation 0.36 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | -0.02 liter | Standard Deviation 0.39 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | -0.04 liter | Standard Deviation 0.33 |
| Dupilumab 300 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 52 | 0.11 liter | Standard Deviation 0.4 |
| Dupilumab 300 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 2 | 0.09 liter | Standard Deviation 0.34 |
| Dupilumab 300 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 4 | 0.10 liter | Standard Deviation 0.36 |
| Dupilumab 300 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 8 | 0.11 liter | Standard Deviation 0.37 |
| Dupilumab 300 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 24 | 0.10 liter | Standard Deviation 0.39 |
| Dupilumab 300 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 36 | 0.11 liter | Standard Deviation 0.39 |
| Dupilumab 300 mg q2w | Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population | Change at Week 12 | 0.11 liter | Standard Deviation 0.38 |
Secondary
Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis
RQLQ(S)+12 is a self-administered questionnaire with standardized activities developed to measure health-related quality of life signs and symptoms that are most problematic in those 12 to 75 years of age, as a result of perennial or seasonal allergic rhinitis. There are 28 items on RQLQ(S) in 7 domains: activities (3 items), sleep (3 items), non-nose/eye symptoms (7 items), practical problems (3 items), nasal symptoms (4 items), eye symptoms (4 items) and emotional (4 items). RQLQ(S)+12 responses are based on 7-point likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). Individual items within RQLQ(S)+12 are equally weighted. The overall score is calculated as the mean score of all items. Higher scores indicated more health-related quality of life impairment (lower scores better).
Time frame: Baseline, Weeks 12, 24, 36, and 52
Population: Analysis was performed on ITT population with comorbid allergic rhinitis. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 12 | -0.50 scores on a scale | Standard Deviation 0.98 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 24 | -0.50 scores on a scale | Standard Deviation 0.92 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 36 | -0.56 scores on a scale | Standard Deviation 0.96 |
| Placebo (for Dupilumab 200 mg) q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 52 | -0.41 scores on a scale | Standard Deviation 0.97 |
| Dupilumab 200 mg q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 24 | -0.73 scores on a scale | Standard Deviation 1.09 |
| Dupilumab 200 mg q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 36 | -0.78 scores on a scale | Standard Deviation 1.15 |
| Dupilumab 200 mg q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 52 | -0.90 scores on a scale | Standard Deviation 1.17 |
| Dupilumab 200 mg q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 12 | -0.70 scores on a scale | Standard Deviation 0.99 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 36 | -0.58 scores on a scale | Standard Deviation 1.2 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 24 | -0.54 scores on a scale | Standard Deviation 1.1 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 52 | -0.47 scores on a scale | Standard Deviation 1.33 |
| Placebo (for Dupilumab 300 mg) q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 12 | -0.44 scores on a scale | Standard Deviation 1.05 |
| Dupilumab 300 mg q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 52 | -0.76 scores on a scale | Standard Deviation 1.13 |
| Dupilumab 300 mg q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 24 | -0.60 scores on a scale | Standard Deviation 1.1 |
| Dupilumab 300 mg q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 12 | -0.64 scores on a scale | Standard Deviation 1.06 |
| Dupilumab 300 mg q2w | Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis | Change at Week 36 | -0.75 scores on a scale | Standard Deviation 1.12 |
Secondary
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Week 12
Population: Analysis was performed on ITT population. 'Overall number of participants analyzed'=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population | 10.16 percent change | Standard Deviation 23.88 |
| Dupilumab 200 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population | 18.74 percent change | Standard Deviation 30.86 |
| Placebo (for Dupilumab 300 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population | 11.87 percent change | Standard Deviation 26.4 |
| Dupilumab 300 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population | 20.89 percent change | Standard Deviation 34.14 |
Comparison: Analysis performed using MMRM model(n=954 for 300 vs placebo)with percent change from baseline in FEV1 values up to Week 12 as response variable; \& treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value \& baseline-by-visit interaction as covariates. Hierarchical testing procedure used to control type I error \& handle multiple secondary endpoint analyses. Here, it is test no. 5 of testing order.p-value: <0.000195% CI: [5.74, 13.07]Mixed Models Analysis
Secondary
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Week 12
Population: Analysis was performed on ITT population with baseline eosinophil \>=0.15 Giga/L. 'Overall number of participants analyzed'=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | 11.43 percent change | Standard Deviation 24.71 |
| Dupilumab 200 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | 22.04 percent change | Standard Deviation 31.96 |
| Placebo (for Dupilumab 300 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | 13.49 percent change | Standard Deviation 25.18 |
| Dupilumab 300 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L | 24.04 percent change | Standard Deviation 35.71 |
Secondary
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Week 12
Population: Analysis was performed on ITT population with baseline eosinophil \>=0.3 Giga/L. 'Overall number of participants analyzed'=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | 13.40 percent change | Standard Deviation 27.01 |
| Dupilumab 200 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | 26.41 percent change | Standard Deviation 33.69 |
| Placebo (for Dupilumab 300 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | 13.05 percent change | Standard Deviation 25.27 |
| Dupilumab 300 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L | 30.58 percent change | Standard Deviation 38.22 |
Secondary
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Week 12
Population: Analysis was performed on ITT population with high dose ICS at baseline. 'Overall number of participants analysed'=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline | 8.47 percent change | Standard Deviation 20.94 |
| Dupilumab 200 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline | 17.99 percent change | Standard Deviation 28.43 |
| Placebo (for Dupilumab 300 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline | 13.22 percent change | Standard Deviation 26.52 |
| Dupilumab 300 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline | 23.41 percent change | Standard Deviation 37.26 |
Secondary
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: Baseline, Weeks 2, 4, 8, 24, 36, and 52
Population: Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 2 | 5.78 percent change | Standard Deviation 23.36 |
| Placebo (for Dupilumab 200 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 4 | 9.61 percent change | Standard Deviation 25.54 |
| Placebo (for Dupilumab 200 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 8 | 10.27 percent change | Standard Deviation 25.6 |
| Placebo (for Dupilumab 200 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 24 | 9.42 percent change | Standard Deviation 26.76 |
| Placebo (for Dupilumab 200 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 36 | 10.57 percent change | Standard Deviation 26.41 |
| Placebo (for Dupilumab 200 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 52 | 8.37 percent change | Standard Deviation 23.59 |
| Dupilumab 200 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 52 | 19.96 percent change | Standard Deviation 33.35 |
| Dupilumab 200 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 24 | 19.76 percent change | Standard Deviation 30.64 |
| Dupilumab 200 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 2 | 14.32 percent change | Standard Deviation 26.55 |
| Dupilumab 200 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 8 | 18.81 percent change | Standard Deviation 29.8 |
| Dupilumab 200 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 4 | 16.11 percent change | Standard Deviation 28.12 |
| Dupilumab 200 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 36 | 19.92 percent change | Standard Deviation 32.26 |
| Placebo (for Dupilumab 300 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 4 | 8.67 percent change | Standard Deviation 23.55 |
| Placebo (for Dupilumab 300 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 8 | 12.24 percent change | Standard Deviation 25.78 |
| Placebo (for Dupilumab 300 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 24 | 12.86 percent change | Standard Deviation 28.14 |
| Placebo (for Dupilumab 300 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 52 | 12.89 percent change | Standard Deviation 27.7 |
| Placebo (for Dupilumab 300 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 36 | 13.45 percent change | Standard Deviation 27.69 |
| Placebo (for Dupilumab 300 mg) q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 2 | 6.60 percent change | Standard Deviation 21.84 |
| Dupilumab 300 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 36 | 22.08 percent change | Standard Deviation 35.93 |
| Dupilumab 300 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 52 | 21.57 percent change | Standard Deviation 34.08 |
| Dupilumab 300 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 4 | 18.77 percent change | Standard Deviation 32.73 |
| Dupilumab 300 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 24 | 20.75 percent change | Standard Deviation 35.35 |
| Dupilumab 300 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 2 | 17.38 percent change | Standard Deviation 30.82 |
| Dupilumab 300 mg q2w | Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population | Change at Week 8 | 19.85 percent change | Standard Deviation 33.63 |
Secondary
Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population
The time to first LOAC event was defined as follows: date of the first event - first dose date +1. For participants who had no event on or before last dose date + 14 days or last contact date, the time was censored at the last dose date + 14 days or the last contact date, whichever was earlier.
Time frame: Baseline up to Week 52
Population: Analysis was performed on ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | 110.0 days |
| Dupilumab 200 mg q2w | Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | 230.0 days |
| Placebo (for Dupilumab 300 mg) q2w | Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | 102.0 days |
| Dupilumab 300 mg q2w | Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | 264.0 days |
Secondary
Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population
The time to first severe exacerbation was defined as follows: date of the first event - randomization date +1. For participants who had no event on or before Visit 18 (Week 52) or last contact date, the time was censored at the date of Visit 18 or the last contact date, whichever was earlier. The median time to first severe exacerbation was not estimated; therefore, the probability of severe exacerbation at Weeks 12, 24, 36, and 52, are presented as the descriptive statistics.
Time frame: Baseline up to Week 52
Population: Analysis was performed on ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (for Dupilumab 200 mg) q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 12 | 0.165 probability of severe exacerbation |
| Placebo (for Dupilumab 200 mg) q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 24 | 0.275 probability of severe exacerbation |
| Placebo (for Dupilumab 200 mg) q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 36 | 0.364 probability of severe exacerbation |
| Placebo (for Dupilumab 200 mg) q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 52 | 0.434 probability of severe exacerbation |
| Dupilumab 200 mg q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 24 | 0.177 probability of severe exacerbation |
| Dupilumab 200 mg q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 36 | 0.235 probability of severe exacerbation |
| Dupilumab 200 mg q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 52 | 0.295 probability of severe exacerbation |
| Dupilumab 200 mg q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 12 | 0.094 probability of severe exacerbation |
| Placebo (for Dupilumab 300 mg) q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 36 | 0.376 probability of severe exacerbation |
| Placebo (for Dupilumab 300 mg) q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 24 | 0.297 probability of severe exacerbation |
| Placebo (for Dupilumab 300 mg) q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 52 | 0.437 probability of severe exacerbation |
| Placebo (for Dupilumab 300 mg) q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 12 | 0.193 probability of severe exacerbation |
| Dupilumab 300 mg q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 52 | 0.325 probability of severe exacerbation |
| Dupilumab 300 mg q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 24 | 0.211 probability of severe exacerbation |
| Dupilumab 300 mg q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 12 | 0.137 probability of severe exacerbation |
| Dupilumab 300 mg q2w | Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population | Probability at Week 36 | 0.268 probability of severe exacerbation |