Asthma
Conditions
Brief summary
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691). Secondary Objectives: To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study. To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to: * Systemic exposure * Anti-drug antibodies * Biomarkers
Detailed description
A screening period, up to 3 weeks, applied only for participants who came from DRI12544 study. The total study duration, per participant, was a maximum of 108 weeks (or 111 weeks considering a maximum screening period of 3 weeks for study DRI12544) for the participants enrolled prior to Amendment 04 approval and a maximum of 60 weeks for the participants enrolled after Amendment 04 approval. Following amendment 04 (dated 31 Oct 2016) the open-label treatment duration was amended to 48 weeks (1 year); and the 16-week post-treatment period was shortened to 12 weeks.
Interventions
DRUGDupilumab
Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Participants with asthma who completed the treatment period in a previous dupilumab asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544.
Exclusion criteria
\- Participants who experienced any hypersensitivity reactions to Investigational Medicinal Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab, may present an unreasonable risk for the participant. The above information was not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks) | An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment emergent AE period (time from first dose of investigational medicinal product \[IMP\] in LTS12551 up to the last dose of dupilumab plus 14 weeks). A Serious AE (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks) | Criteria for potentially clinically significant abnormalities: * Hemoglobin (Hb): ≤ 115 grams per liter (g/L)(Male \[M\]), ≤ 95 g/L (Female\[ F\]) (\< 100 g/L Adolescents); ≥ 185 g/L (M), ≥ 165 g/L (F) (≥ 200 g/L Adolescents); DFB ≥ 20 g/L. * Hematocrit: ≤ 0.37 volume/volume (v/v) (M); ≤ 0.32 v/v (F) (\<0.32 v/v Adolescents); ≥ 0.55 v/v (M); 0.5 v/v (F) (\>0.47 v/v Adolescents). * RBCs: ≥ 6 Tera/L. * Platelets: \< 100 Giga(G)/L; ≥ 700 G/L. TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks. |
| Number of Severe Exacerbation Events | From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks) | Severe asthma exacerbation events were defined as a deterioration of asthma which required: use of systemic corticosteroids for ≥ 3 days, (participants from study EFC13691 (NCT02528214), and who were taking systemic corticosteroids: the use of systemic corticosteroids at least double the current dose and for ≥3 days.) or, hospitalization or emergency room visit because of asthma, required systemic corticosteroids. |
| Annualized Event Rate Per Participant-Years for Severe Exacerbation | From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks) | The annualized event rate per participant-years was defined as the total number of events that occurred during the treatment period divided by the total number of participant-years during the treatment period. |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Baseline of parent study, Week 48 and Week 96 of this extension study | FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline. |
| Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Baseline of parent study, Week 48 and Week 96 of this extension study | FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline. |
| Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Baseline of parent study, Week 48, and Week 96 of this extension study | FVC was a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline. |
| Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Baseline of parent study, Week 48, and Week 96 of this extension study | FEF was the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline. |
| Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Baseline of parent study, Weeks 24, and 48 of this extension study | The ACQ-5 had 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 mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control. For this analysis, baseline was defined as respective parent study baseline. |
| Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | At Weeks 24, and 48 of this extension study | ACQ-5 response was defined as change from baseline in ACQ-5 scores ≥ 0.5. The ACQ-5 had 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 mean 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 Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Baseline of parent study, Weeks 24, and 48 of this extension study | The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), and environmental stimuli (4 items). Each item was scored on a 7-point likert scale ranged from 1=severely impaired to 7=not impaired. The 32 items of the questionnaire were averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired); higher scores indicated better quality of life. For this analysis, baseline was defined as respective parent study baseline. |
| Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | At Weeks 24, and 48 of this extension study | AQLQ global response was defined as participants with change from baseline in AQLQ global score ≥ 0.5. The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=severely impaired, 7=not impaired). 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). Higher scores indicated better quality of life. |
| Serum Concentrations of Dupilumab Over Time Till Week 96 | Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study | For this analysis, baseline was defined as respective parent study baseline. Here, 'number analyzed'=number of participants with available data for each specified category. |
| Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks) | Criteria for potentially clinically significant vital sign abnormalities: * Systolic blood pressure (SBP): Less than or equal to (≤) 95 Adults (≤90 Adolescents) millimeters of mercury (mmHg) and decrease from baseline (DFB) greater than or equal to (≥) 20 mmHg; ≥ 160 Adults (≥ 119 Adolescents) mmHg and increase from baseline (IFB) ≥ 20 mmHg. * Diastolic blood pressure (DBP): ≤ 45 Adults (≤54 Adolescents) mmHg and DFB ≥ 10 mmHg; ≥ 110 Adults (≥78 Adolescents) mmHg and IFB ≥ 10 mmHg. * Heart rate (HR): ≤ 50 beats per minute (bpm) and DFB ≥ 20 bpm; ≥ 120 bpm and IFB ≥ 20 bpm. * Respiratory rate: less than (\<) 12 breaths/min(b/m); greater than (\>) 20 b/m. * Weight (kg): ≥ 5 percent (%) DFB; ≥ 5% IFB. * Temperature: ≥ 38.0 degree Celsius (°C) rectal/ear/temporal; ≥ 37.5°C oral; ≥ 37.2°C axillary. TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks. |
| Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Baseline of parent study, Week 48 and Week 96 of this extension study | For this analysis, baseline was defined as respective parent study baseline. |
| Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 | Baseline of parent study, Week 48 and Week 96 of this extension study | The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Morning PEF was performed within 15 minutes after arising (between 5:30 AM and 10 AM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent study DRI12544 baseline. |
| Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 | Baseline of parent study, Week 48 and Week 96 of this extension study | The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Evening PEF was performed in the evening (between 5:30 PM and 10 PM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent DRI12544 study baseline. |
| Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 | Baseline of parent study, Week 48 and Week 96 of this extension study | 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 ranges from 0 to 4 as: 0=no asthma symptoms, slept through the night, 1=slept well, but some complaints in the morning. No nighttime 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; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline. |
| Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 | Baseline of parent study, Week 48, and Week 96 of this extension study | 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; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline. |
| Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544 | Baseline of parent study, Week 48, and Week 96 of this extension study | The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations was recorded daily by the participants in an electronic diary/PEF meter. Mean number of inhalations in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline. |
| Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544 | Baseline of parent study, Week 48 and Week 96 of this extension study | The number of nocturnal awakening because of asthma symptoms were recorded every morning by the participants in an electronic diary. Mean number of awakenings in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline. |
| Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691 | Baseline of parent study, Weeks 48 and 96 of this extension study | OCS was allowed as background controller medication for the participants from study EFC13691 only. For this analysis, baseline was defined as parent study EFC13691 baseline. |
| Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691 | Weeks 48 and 96 of this extension study | OCS was allowed as background controller medication for the participants from study EFC13691 only. Percentage of participants who achieved a reduction of ≥ 50% in OCS dose were reported. |
| Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691 | Weeks 48, and 96 of this extension study | OCS was allowed as background controller medication for the participants from study EFC13691 only. Number of participants who gradually discontinued or reduced therapeutic dose were reported in this outcome measure. |
| Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544 | Baseline of parent study, Week 48 and Week 96 of this extension study | EQ-5D-3L: validated and reliable self-report health status questionnaire consisted of EQ-5D descriptive system and visual analogue scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: no problem, some problems, and severe problems. The 5 dimensional 3-level systems was converted into single index utility score, and the score was 0 - 100, where 100=best health state; and 0=worst health state; where higher scores indicated better outcome. For this analysis, baseline was defined as parent DRI12544 study baseline. |
| Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544 | Baseline of parent study, Week 48 and Week 96 of this extension study | EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. For this analysis, baseline was defined as parent DRI12544 study baseline. |
| Percentage of Participants With Antidrug Antibodies (ADA) Response | From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks) | ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as an ADA positive response in the assay post first dose in LTS12551, when baseline results were negative or missing. 2) Treatment boosted was defined as: an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. The criteria for positive was defined as 30 to \> 10,000, where low titer (\< 1,000); moderate (1,000 ≤ titer ≤ 10,000) and high titer (\> 10,000). |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Study was initiated at 365 sites in 27 countries. Participants who successfully completed treatment in studies DRI12544 (NCT01854047),EFC13579 (NCT02414854),EFC13691 (NCT02528214) and PDY14192 (NCT02573233) were eligible to continue their treatment in this extension study LTS12551. Total of 2282 participants were enrolled and treated in this study.
Pre-assignment details
The Total study duration was maximum of 108 weeks for participants enrolled prior to amendment 4 approval and a maximum of 60 weeks for participants enrolled after amendment 4. Following amendment 4 (dated 31 Oct 2016) open-label treatment duration was amended to 48 weeks (1 year); and the 16-week post-treatment period was shortened to 12 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Participants From DRI12544: Placebo/Dupilumab Participants who completed treatment of placebo (for dupilumab) and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. | 111 |
| Participants From DRI12544: Dupilumab/Dupilumab Participants who completed the treatment of dupilumab and post-treatment period in study DRI12544, received a loading dose of dupilumab 600 mg on Day 1 followed by a SC dose of dupilumab 300 mg q2w for 96 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. | 421 |
| Participants From EFC13579: Placebo/Dupilumab Participants who completed the treatment of placebo (for dupilumab) in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. | 517 |
| Participants From EFC13579: Dupilumab/Dupilumab Participants who completed the treatment for dupilumab in study EFC13579 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with ICS therapy/LABA therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. | 1,013 |
| Participants From EFC13691: Placebo/Dupilumab Participants who completed the treatment of placebo (for dupilumab) in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. | 97 |
| Participants From EFC13691: Dupilumab/Dupilumab Participants who completed the treatment of dupilumab in study EFC13691 and, who were enrolled before amendment 4 received a SC dose of dupilumab 300 mg q2w for 96 weeks and those who were enrolled after amendment 4 received a SC dose of dupilumab 300 mg q2w for 48 weeks in combination with OCS and ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. | 90 |
| Participants From PDY14192: Placebo/Dupilumab Participants who completed the treatment of placebo (for dupilumab) in study PDY14192 received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. | 19 |
| Participants From PDY14192: Dupilumab/Dupilumab Participants who completed the treatment of dupilumab in study PDY14192, received a SC dose of dupilumab 300 mg q2w for up to 96 weeks in combination with ICS therapy in this extension study. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. | 14 |
| Total | 2,282 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 19 | 13 | 32 | 4 | 5 | 1 | 2 |
| Overall Study | Lack of Efficacy | 1 | 0 | 3 | 2 | 1 | 2 | 1 | 0 |
| Overall Study | Other unspecified | 4 | 22 | 33 | 64 | 8 | 6 | 2 | 1 |
| Overall Study | Poor compliance to protocol | 1 | 1 | 3 | 7 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Participants From DRI12544: Placebo/Dupilumab | Participants From DRI12544: Dupilumab/Dupilumab | Participants From EFC13579: Placebo/Dupilumab | Participants From EFC13579: Dupilumab/Dupilumab | Participants From EFC13691: Placebo/Dupilumab | Participants From EFC13691: Dupilumab/Dupilumab | Participants From PDY14192: Placebo/Dupilumab | Participants From PDY14192: Dupilumab/Dupilumab | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18-64 years | 101 Participants | 374 Participants | 422 Participants | 826 Participants | 81 Participants | 80 Participants | 19 Participants | 14 Participants | 1917 Participants |
| Age, Customized <18 years | 0 Participants | 0 Participants | 32 Participants | 55 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 89 Participants |
| Age, Customized 65-74 years | 8 Participants | 40 Participants | 59 Participants | 112 Participants | 14 Participants | 8 Participants | 0 Participants | 0 Participants | 241 Participants |
| Age, Customized 75-84 years | 2 Participants | 7 Participants | 4 Participants | 20 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 35 Participants |
| Age, Customized ≥85 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 70 Participants | 51 Participants | 116 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 257 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 8 Participants | 17 Participants | 43 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 75 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 4 Participants | 9 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 23 Participants |
| Race (NIH/OMB) White | 88 Participants | 339 Participants | 445 Participants | 844 Participants | 91 Participants | 86 Participants | 17 Participants | 12 Participants | 1922 Participants |
| Sex: Female, Male Female | 69 Participants | 259 Participants | 335 Participants | 618 Participants | 57 Participants | 53 Participants | 7 Participants | 10 Participants | 1408 Participants |
| Sex: Female, Male Male | 42 Participants | 162 Participants | 182 Participants | 395 Participants | 40 Participants | 37 Participants | 12 Participants | 4 Participants | 874 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 3 / 421 | 0 / 517 | 1 / 1,013 | 0 / 97 | 0 / 90 | 0 / 19 | 0 / 14 |
| other Total, other adverse events | 80 / 111 | 323 / 421 | 357 / 517 | 666 / 1,013 | 56 / 97 | 55 / 90 | 18 / 19 | 13 / 14 |
| serious Total, serious adverse events | 14 / 111 | 42 / 421 | 48 / 517 | 106 / 1,013 | 12 / 97 | 10 / 90 | 0 / 19 | 4 / 14 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment emergent AE period (time from first dose of investigational medicinal product \[IMP\] in LTS12551 up to the last dose of dupilumab plus 14 weeks). A Serious AE (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
Time frame: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Population: Analysis was performed on exposed population which included participants who actually received at least 1 dose or part of a dose of the IMP in LTS12551 study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 88 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any treatment emergent SAE | 14 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to permanent discontinuation | 3 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to death | 0 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 369 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any treatment emergent SAE | 42 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to death | 3 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to permanent discontinuation | 19 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any treatment emergent SAE | 48 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to permanent discontinuation | 12 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 414 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to death | 0 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 789 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to permanent discontinuation | 31 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any treatment emergent SAE | 106 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to death | 1 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to permanent discontinuation | 4 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any treatment emergent SAE | 12 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 74 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to death | 0 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to death | 0 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any treatment emergent SAE | 10 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to permanent discontinuation | 5 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 70 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any treatment emergent SAE | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 18 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to permanent discontinuation | 1 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to death | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to death | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any treatment emergent SAE | 4 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 13 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE leading to permanent discontinuation | 2 Participants |
Secondary
Annualized Event Rate Per Participant-Years for Severe Exacerbation
The annualized event rate per participant-years was defined as the total number of events that occurred during the treatment period divided by the total number of participant-years during the treatment period.
Time frame: From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Population: Analysis was performed on exposed population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Annualized Event Rate Per Participant-Years for Severe Exacerbation | 0.314 exacerbation per participant-years |
| Participants From DRI12544: Dupilumab/Dupilumab | Annualized Event Rate Per Participant-Years for Severe Exacerbation | 0.330 exacerbation per participant-years |
| Participants From EFC13579: Placebo/Dupilumab | Annualized Event Rate Per Participant-Years for Severe Exacerbation | 0.351 exacerbation per participant-years |
| Participants From EFC13579: Dupilumab/Dupilumab | Annualized Event Rate Per Participant-Years for Severe Exacerbation | 0.331 exacerbation per participant-years |
| Participants From EFC13691: Placebo/Dupilumab | Annualized Event Rate Per Participant-Years for Severe Exacerbation | 0.302 exacerbation per participant-years |
| Participants From EFC13691: Dupilumab/Dupilumab | Annualized Event Rate Per Participant-Years for Severe Exacerbation | 0.391 exacerbation per participant-years |
| Participants From PDY14192: Placebo/Dupilumab | Annualized Event Rate Per Participant-Years for Severe Exacerbation | 0.149 exacerbation per participant-years |
| Participants From PDY14192: Dupilumab/Dupilumab | Annualized Event Rate Per Participant-Years for Severe Exacerbation | 0.077 exacerbation per participant-years |
Secondary
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48
The ACQ-5 had 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 mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control. For this analysis, baseline was defined as respective parent study baseline.
Time frame: Baseline of parent study, Weeks 24, and 48 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 24 | -1.37 score on a scale | Standard Deviation 0.91 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 48 | -1.33 score on a scale | Standard Deviation 1.07 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 24 | -1.48 score on a scale | Standard Deviation 1.1 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 48 | -1.57 score on a scale | Standard Deviation 1.11 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 24 | -1.61 score on a scale | Standard Deviation 1.08 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 48 | -1.64 score on a scale | Standard Deviation 1.08 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 24 | -1.68 score on a scale | Standard Deviation 1.05 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 48 | -1.69 score on a scale | Standard Deviation 1.08 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 24 | -1.09 score on a scale | Standard Deviation 1.1 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 48 | -1.21 score on a scale | Standard Deviation 1 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 24 | -1.15 score on a scale | Standard Deviation 1.17 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 48 | -1.06 score on a scale | Standard Deviation 1.25 |
| Participants From PDY14192: Placebo/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 48 | -0.89 score on a scale | Standard Deviation 1.02 |
| Participants From PDY14192: Placebo/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 24 | -0.96 score on a scale | Standard Deviation 1.03 |
| Participants From PDY14192: Dupilumab/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 24 | -0.80 score on a scale | Standard Deviation 0.46 |
| Participants From PDY14192: Dupilumab/Dupilumab | Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 | Week 48 | -0.87 score on a scale | Standard Deviation 0.58 |
Secondary
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48
The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), and environmental stimuli (4 items). Each item was scored on a 7-point likert scale ranged from 1=severely impaired to 7=not impaired. The 32 items of the questionnaire were averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired); higher scores indicated better quality of life. For this analysis, baseline was defined as respective parent study baseline.
Time frame: Baseline of parent study, Weeks 24, and 48 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed for the participants from Studies DRI12544, EFC13579, and EFC13691 only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Week 24 | 1.07 score on a scale | Standard Deviation 0.99 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Week 48 | 1.07 score on a scale | Standard Deviation 1.13 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Week 24 | 1.28 score on a scale | Standard Deviation 1.24 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Week 48 | 1.40 score on a scale | Standard Deviation 1.19 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Week 24 | 1.38 score on a scale | Standard Deviation 1.15 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Week 48 | 1.39 score on a scale | Standard Deviation 1.17 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Week 24 | 1.38 score on a scale | Standard Deviation 1.16 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Week 48 | 1.40 score on a scale | Standard Deviation 1.18 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Week 24 | 0.99 score on a scale | Standard Deviation 1.1 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Week 48 | 1.06 score on a scale | Standard Deviation 0.98 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Week 24 | 0.97 score on a scale | Standard Deviation 1.26 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 | Week 48 | 1.00 score on a scale | Standard Deviation 1.23 |
Secondary
Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96
For this analysis, baseline was defined as respective parent study baseline.
Time frame: Baseline of parent study, Week 48 and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 96 | -0.074 10^9 cells/L | Standard Deviation 0.251 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 48 | 0.007 10^9 cells/L | Standard Deviation 0.475 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 96 | -0.081 10^9 cells/L | Standard Deviation 0.562 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 48 | -0.041 10^9 cells/L | Standard Deviation 0.588 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 48 | -0.096 10^9 cells/L | Standard Deviation 0.428 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 96 | -0.161 10^9 cells/L | Standard Deviation 0.391 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 96 | -0.114 10^9 cells/L | Standard Deviation 0.354 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 48 | -0.099 10^9 cells/L | Standard Deviation 0.36 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 48 | 0.098 10^9 cells/L | Standard Deviation 0.45 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 96 | -0.051 10^9 cells/L | Standard Deviation 0.399 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 96 | 0.083 10^9 cells/L | Standard Deviation 0.642 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 48 | 0.016 10^9 cells/L | Standard Deviation 0.382 |
| Participants From PDY14192: Placebo/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 96 | -0.103 10^9 cells/L | Standard Deviation 0.039 |
| Participants From PDY14192: Placebo/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 48 | -0.066 10^9 cells/L | Standard Deviation 0.181 |
| Participants From PDY14192: Dupilumab/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 48 | -0.026 10^9 cells/L | Standard Deviation 0.187 |
| Participants From PDY14192: Dupilumab/Dupilumab | Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 | Week 96 | 0.025 10^9 cells/L | Standard Deviation 0.134 |
Secondary
Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544
EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. For this analysis, baseline was defined as parent DRI12544 study baseline.
Time frame: Baseline of parent study, Week 48 and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | 10.10 score on a scale | Standard Deviation 15.4 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | 9.90 score on a scale | Standard Deviation 18.92 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | 12.88 score on a scale | Standard Deviation 18.76 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | 13.95 score on a scale | Standard Deviation 18.81 |
Secondary
Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544
EQ-5D-3L: validated and reliable self-report health status questionnaire consisted of EQ-5D descriptive system and visual analogue scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: no problem, some problems, and severe problems. The 5 dimensional 3-level systems was converted into single index utility score, and the score was 0 - 100, where 100=best health state; and 0=worst health state; where higher scores indicated better outcome. For this analysis, baseline was defined as parent DRI12544 study baseline.
Time frame: Baseline of parent study, Week 48 and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | 0.13 score on a scale | Standard Deviation 0.2 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | 0.12 score on a scale | Standard Deviation 0.18 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | 0.14 score on a scale | Standard Deviation 0.21 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | 0.13 score on a scale | Standard Deviation 0.21 |
Secondary
Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
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; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.
Time frame: Baseline of parent study, Week 48, and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | -0.47 score on a scale | Standard Deviation 0.81 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | -0.49 score on a scale | Standard Deviation 0.94 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | -0.72 score on a scale | Standard Deviation 0.85 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | -0.79 score on a scale | Standard Deviation 0.88 |
Secondary
Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Evening PEF was performed in the evening (between 5:30 PM and 10 PM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent DRI12544 study baseline.
Time frame: Baseline of parent study, Week 48 and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | 4.65 L/min | Standard Deviation 75 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | 1.16 L/min | Standard Deviation 79.47 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | 11.97 L/min | Standard Deviation 72.19 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | 10.05 L/min | Standard Deviation 79.47 |
Secondary
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96
FEF was the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.
Time frame: Baseline of parent study, Week 48, and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 96 | 0.28 liters/second | Standard Deviation 0.57 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 48 | 0.27 liters/second | Standard Deviation 0.55 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 48 | 0.31 liters/second | Standard Deviation 0.55 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 96 | 0.32 liters/second | Standard Deviation 0.55 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 48 | 0.39 liters/second | Standard Deviation 0.57 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 96 | 0.38 liters/second | Standard Deviation 0.53 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 96 | 0.36 liters/second | Standard Deviation 0.61 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 48 | 0.39 liters/second | Standard Deviation 0.66 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 48 | 0.34 liters/second | Standard Deviation 0.56 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 96 | 0.42 liters/second | Standard Deviation 0.64 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 96 | 0.27 liters/second | Standard Deviation 0.53 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 48 | 0.29 liters/second | Standard Deviation 0.66 |
| Participants From PDY14192: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 48 | 0.23 liters/second | Standard Deviation 0.44 |
| Participants From PDY14192: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 96 | 0.19 liters/second | Standard Deviation 0.41 |
| Participants From PDY14192: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 96 | 0.04 liters/second | Standard Deviation 0.14 |
| Participants From PDY14192: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 | Week 48 | 0.04 liters/second | Standard Deviation 0.26 |
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96
FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.
Time frame: Baseline of parent study, Week 48 and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 48 | 0.24 liters | Standard Deviation 0.42 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 96 | 0.22 liters | Standard Deviation 0.44 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 48 | 0.28 liters | Standard Deviation 0.45 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 96 | 0.27 liters | Standard Deviation 0.46 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 48 | 0.34 liters | Standard Deviation 0.44 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 96 | 0.33 liters | Standard Deviation 0.44 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 48 | 0.36 liters | Standard Deviation 0.53 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 96 | 0.31 liters | Standard Deviation 0.47 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 48 | 0.31 liters | Standard Deviation 0.5 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 96 | 0.36 liters | Standard Deviation 0.66 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 48 | 0.33 liters | Standard Deviation 0.53 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 96 | 0.25 liters | Standard Deviation 0.46 |
| Participants From PDY14192: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 96 | 0.14 liters | Standard Deviation 0.41 |
| Participants From PDY14192: Placebo/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 48 | 0.23 liters | Standard Deviation 0.4 |
| Participants From PDY14192: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 48 | 0.01 liters | Standard Deviation 0.21 |
| Participants From PDY14192: Dupilumab/Dupilumab | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 | Week 96 | 0.01 liters | Standard Deviation 0.12 |
Secondary
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96
FVC was a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. For this analysis, baseline was defined as respective parent study baseline.
Time frame: Baseline of parent study, Week 48, and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 48 | 0.22 liters | Standard Deviation 0.45 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 96 | 0.16 liters | Standard Deviation 0.47 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 48 | 0.25 liters | Standard Deviation 0.5 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 96 | 0.22 liters | Standard Deviation 0.52 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 48 | 0.30 liters | Standard Deviation 0.48 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 96 | 0.27 liters | Standard Deviation 0.48 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 48 | 0.35 liters | Standard Deviation 0.6 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 96 | 0.25 liters | Standard Deviation 0.5 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 48 | 0.29 liters | Standard Deviation 0.56 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 96 | 0.38 liters | Standard Deviation 0.82 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 48 | 0.38 liters | Standard Deviation 0.56 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 96 | 0.22 liters | Standard Deviation 0.42 |
| Participants From PDY14192: Placebo/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 96 | 0.08 liters | Standard Deviation 0.29 |
| Participants From PDY14192: Placebo/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 48 | 0.21 liters | Standard Deviation 0.42 |
| Participants From PDY14192: Dupilumab/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 48 | 0.05 liters | Standard Deviation 0.3 |
| Participants From PDY14192: Dupilumab/Dupilumab | Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 | Week 96 | 0.05 liters | Standard Deviation 0.4 |
Secondary
Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544
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 ranges from 0 to 4 as: 0=no asthma symptoms, slept through the night, 1=slept well, but some complaints in the morning. No nighttime 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; higher scores indicated more severe symptoms. For this analysis, baseline was defined as parent DRI12544 study baseline.
Time frame: Baseline of parent study, Week 48 and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | -0.49 score on a scale | Standard Deviation 0.78 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | -0.52 score on a scale | Standard Deviation 0.9 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | -0.68 score on a scale | Standard Deviation 0.79 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | -0.76 score on a scale | Standard Deviation 0.81 |
Secondary
Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544
The PEF was a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at morning and evening. Morning PEF was performed within 15 minutes after arising (between 5:30 AM and 10 AM) prior to taking any salbutamol/albuterol or levosalbutamol/levalbuterol. For this analysis, baseline was defined as parent study DRI12544 baseline.
Time frame: Baseline of parent study, Week 48 and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | 13.26 liters per minute (L/min) | Standard Deviation 76.71 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | 13.63 liters per minute (L/min) | Standard Deviation 83.88 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | 22.95 liters per minute (L/min) | Standard Deviation 70.06 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | 21.69 liters per minute (L/min) | Standard Deviation 77.7 |
Secondary
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544
The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations was recorded daily by the participants in an electronic diary/PEF meter. Mean number of inhalations in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.
Time frame: Baseline of parent study, Week 48, and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | -0.00 inhalations per day | Standard Deviation 3.65 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | -0.14 inhalations per day | Standard Deviation 4.17 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | 0.68 inhalations per day | Standard Deviation 4.8 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | -0.82 inhalations per day | Standard Deviation 5.18 |
Secondary
Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544
The number of nocturnal awakening because of asthma symptoms were recorded every morning by the participants in an electronic diary. Mean number of awakenings in last 7 days prior to each visit was calculated and was used in computation of data reported. For this analysis, baseline was defined as parent DRI12544 study baseline.
Time frame: Baseline of parent study, Week 48 and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study DRI12544 and not for the participants from other studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | -0.27 nocturnal awakenings | Standard Deviation 0.54 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | -0.29 nocturnal awakenings | Standard Deviation 0.58 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544 | Week 48 | -0.43 nocturnal awakenings | Standard Deviation 0.89 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544 | Week 96 | -0.49 nocturnal awakenings | Standard Deviation 0.96 |
Secondary
Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96
FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. For this analysis, baseline was defined as respective parent study baseline.
Time frame: Baseline of parent study, Week 48 and Week 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 48 | 9.21 percent predicted FEV1 | Standard Deviation 13.61 |
| Participants From DRI12544: Placebo/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 96 | 8.86 percent predicted FEV1 | Standard Deviation 14.47 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 48 | 10.42 percent predicted FEV1 | Standard Deviation 14.61 |
| Participants From DRI12544: Dupilumab/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 96 | 10.68 percent predicted FEV1 | Standard Deviation 15.1 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 48 | 11.74 percent predicted FEV1 | Standard Deviation 14.27 |
| Participants From EFC13579: Placebo/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 96 | 12.53 percent predicted FEV1 | Standard Deviation 14.5 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 48 | 12.16 percent predicted FEV1 | Standard Deviation 16.58 |
| Participants From EFC13579: Dupilumab/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 96 | 11.25 percent predicted FEV1 | Standard Deviation 14.55 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 48 | 10.45 percent predicted FEV1 | Standard Deviation 15.03 |
| Participants From EFC13691: Placebo/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 96 | 13.06 percent predicted FEV1 | Standard Deviation 19.57 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 48 | 12.41 percent predicted FEV1 | Standard Deviation 18.27 |
| Participants From EFC13691: Dupilumab/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 96 | 10.00 percent predicted FEV1 | Standard Deviation 15.79 |
| Participants From PDY14192: Placebo/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 96 | 4.20 percent predicted FEV1 | Standard Deviation 9.6 |
| Participants From PDY14192: Placebo/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 48 | 5.88 percent predicted FEV1 | Standard Deviation 10.06 |
| Participants From PDY14192: Dupilumab/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 48 | 1.36 percent predicted FEV1 | Standard Deviation 8.35 |
| Participants From PDY14192: Dupilumab/Dupilumab | Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 | Week 96 | 2.00 percent predicted FEV1 | Standard Deviation 2.83 |
Secondary
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period
Criteria for potentially clinically significant abnormalities: * Hemoglobin (Hb): ≤ 115 grams per liter (g/L)(Male \[M\]), ≤ 95 g/L (Female\[ F\]) (\< 100 g/L Adolescents); ≥ 185 g/L (M), ≥ 165 g/L (F) (≥ 200 g/L Adolescents); DFB ≥ 20 g/L. * Hematocrit: ≤ 0.37 volume/volume (v/v) (M); ≤ 0.32 v/v (F) (\<0.32 v/v Adolescents); ≥ 0.55 v/v (M); 0.5 v/v (F) (\>0.47 v/v Adolescents). * RBCs: ≥ 6 Tera/L. * Platelets: \< 100 Giga(G)/L; ≥ 700 G/L. TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.
Time frame: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: DFB ≥ 20 g/L | 13 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≥ 185 g/L, ≥ 165 g/L(≥ 200 g/L) | 1 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≤ 115 g/L, ≤ 95 g/L (< 100 g/L) | 2 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≤ 0.37 v/v; ≤ 0.32 v/v(<0.32 v/v) | 6 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≥ 0.55 v/v; ≥ 0.5 v/v(>0.47 v/v) | 3 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | RBCs: ≥ 6 Tera/L | 1 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: < 100G/ L | 0 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: ≥ 700 G/L | 0 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≥ 0.55 v/v; ≥ 0.5 v/v(>0.47 v/v) | 6 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: DFB ≥ 20 g/L | 41 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | RBCs: ≥ 6 Tera/L | 5 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: < 100G/ L | 2 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≤ 115 g/L, ≤ 95 g/L (< 100 g/L) | 7 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≤ 0.37 v/v; ≤ 0.32 v/v(<0.32 v/v) | 19 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≥ 185 g/L, ≥ 165 g/L(≥ 200 g/L) | 3 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: ≥ 700 G/L | 1 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: < 100G/ L | 2 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≥ 0.55 v/v; ≥ 0.5 v/v(>0.47 v/v) | 26 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: ≥ 700 G/L | 1 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: DFB ≥ 20 g/L | 40 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | RBCs: ≥ 6 Tera/L | 8 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≤ 0.37 v/v; ≤ 0.32 v/v(<0.32 v/v) | 23 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≤ 115 g/L, ≤ 95 g/L (< 100 g/L) | 12 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≥ 185 g/L, ≥ 165 g/L(≥ 200 g/L) | 8 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: ≥ 700 G/L | 0 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≥ 185 g/L, ≥ 165 g/L(≥ 200 g/L) | 4 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≤ 115 g/L, ≤ 95 g/L (< 100 g/L) | 29 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≤ 0.37 v/v; ≤ 0.32 v/v(<0.32 v/v) | 47 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: DFB ≥ 20 g/L | 118 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≥ 0.55 v/v; ≥ 0.5 v/v(>0.47 v/v) | 36 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | RBCs: ≥ 6 Tera/L | 15 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: < 100G/ L | 1 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≤ 0.37 v/v; ≤ 0.32 v/v(<0.32 v/v) | 3 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: < 100G/ L | 1 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: DFB ≥ 20 g/L | 11 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≤ 115 g/L, ≤ 95 g/L (< 100 g/L) | 0 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: ≥ 700 G/L | 0 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≥ 0.55 v/v; ≥ 0.5 v/v(>0.47 v/v) | 3 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | RBCs: ≥ 6 Tera/L | 0 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≥ 185 g/L, ≥ 165 g/L(≥ 200 g/L) | 2 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: ≥ 700 G/L | 0 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≥ 185 g/L, ≥ 165 g/L(≥ 200 g/L) | 1 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: DFB ≥ 20 g/L | 7 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≤ 115 g/L, ≤ 95 g/L (< 100 g/L) | 3 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: < 100G/ L | 0 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | RBCs: ≥ 6 Tera/L | 2 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≥ 0.55 v/v; ≥ 0.5 v/v(>0.47 v/v) | 3 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≤ 0.37 v/v; ≤ 0.32 v/v(<0.32 v/v) | 5 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: DFB ≥ 20 g/L | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≥ 185 g/L, ≥ 165 g/L(≥ 200 g/L) | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≤ 0.37 v/v; ≤ 0.32 v/v(<0.32 v/v) | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≥ 0.55 v/v; ≥ 0.5 v/v(>0.47 v/v) | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | RBCs: ≥ 6 Tera/L | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: ≥ 700 G/L | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: < 100G/ L | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≤ 115 g/L, ≤ 95 g/L (< 100 g/L) | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: ≥ 700 G/L | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | RBCs: ≥ 6 Tera/L | 1 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≥ 0.55 v/v; ≥ 0.5 v/v(>0.47 v/v) | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hematocrit: ≤ 0.37 v/v; ≤ 0.32 v/v(<0.32 v/v) | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: DFB ≥ 20 g/L | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≥ 185 g/L, ≥ 165 g/L(≥ 200 g/L) | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Hb: ≤ 115 g/L, ≤ 95 g/L (< 100 g/L) | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period | Platelets: < 100G/ L | 1 Participants |
Secondary
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period
Criteria for potentially clinically significant vital sign abnormalities: * Systolic blood pressure (SBP): Less than or equal to (≤) 95 Adults (≤90 Adolescents) millimeters of mercury (mmHg) and decrease from baseline (DFB) greater than or equal to (≥) 20 mmHg; ≥ 160 Adults (≥ 119 Adolescents) mmHg and increase from baseline (IFB) ≥ 20 mmHg. * Diastolic blood pressure (DBP): ≤ 45 Adults (≤54 Adolescents) mmHg and DFB ≥ 10 mmHg; ≥ 110 Adults (≥78 Adolescents) mmHg and IFB ≥ 10 mmHg. * Heart rate (HR): ≤ 50 beats per minute (bpm) and DFB ≥ 20 bpm; ≥ 120 bpm and IFB ≥ 20 bpm. * Respiratory rate: less than (\<) 12 breaths/min(b/m); greater than (\>) 20 b/m. * Weight (kg): ≥ 5 percent (%) DFB; ≥ 5% IFB. * Temperature: ≥ 38.0 degree Celsius (°C) rectal/ear/temporal; ≥ 37.5°C oral; ≥ 37.2°C axillary. TEAE period was defined as the time from first dose of IMP in LTS12551 up to the last dose of dupilumab plus 14 weeks.
Time frame: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≥ 110 (≥78) & IFB ≥ 10 mmHg | 0 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: < 12 b/m | 5 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 38.0°C | 0 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≤ 50 & DFB ≥ 20 bpm | 0 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% IFB | 45 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≥ 160 (≥119) & IFB ≥ 20 mmHg | 2 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.2°C | 3 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≥ 120 & IFB ≥ 20 bpm | 0 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≤ 95 (≤90) & DFB ≥ 20 mmHg | 4 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≤ 45 (≤54) & DFB ≥ 10 mmHg | 1 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% DFB | 32 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: > 20 b/m | 23 Participants |
| Participants From DRI12544: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.5°C | 1 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: > 20 b/m | 104 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% DFB | 106 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≥ 120 & IFB ≥ 20 bpm | 0 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: < 12 b/m | 17 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 38.0°C | 0 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≤ 95 (≤90) & DFB ≥ 20 mmHg | 12 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.2°C | 21 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.5°C | 0 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≤ 50 & DFB ≥ 20 bpm | 3 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≥ 110 (≥78) & IFB ≥ 10 mmHg | 4 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≤ 45 (≤54) & DFB ≥ 10 mmHg | 1 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≥ 160 (≥119) & IFB ≥ 20 mmHg | 17 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% IFB | 181 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% IFB | 189 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≥ 120 & IFB ≥ 20 bpm | 2 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≥ 160 (≥119) & IFB ≥ 20 mmHg | 21 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% DFB | 146 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: < 12 b/m | 18 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: > 20 b/m | 88 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.5°C | 9 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≤ 45 (≤54) & DFB ≥ 10 mmHg | 11 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 38.0°C | 1 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≥ 110 (≥78) & IFB ≥ 10 mmHg | 15 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.2°C | 4 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≤ 95 (≤90) & DFB ≥ 20 mmHg | 19 Participants |
| Participants From EFC13579: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≤ 50 & DFB ≥ 20 bpm | 2 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% IFB | 378 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.2°C | 16 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: > 20 b/m | 195 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≥ 160 (≥119) & IFB ≥ 20 mmHg | 45 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.5°C | 6 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≤ 45 (≤54) & DFB ≥ 10 mmHg | 15 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 38.0°C | 1 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≥ 110 (≥78) & IFB ≥ 10 mmHg | 20 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: < 12 b/m | 24 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≤ 50 & DFB ≥ 20 bpm | 12 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≤ 95 (≤90) & DFB ≥ 20 mmHg | 40 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≥ 120 & IFB ≥ 20 bpm | 5 Participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% DFB | 261 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≥ 160 (≥119) & IFB ≥ 20 mmHg | 6 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≤ 95 (≤90) & DFB ≥ 20 mmHg | 0 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≤ 45 (≤54) & DFB ≥ 10 mmHg | 0 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≥ 110 (≥78) & IFB ≥ 10 mmHg | 2 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≤ 50 & DFB ≥ 20 bpm | 0 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≥ 120 & IFB ≥ 20 bpm | 1 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: < 12 b/m | 4 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: > 20 b/m | 18 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% DFB | 22 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% IFB | 29 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 38.0°C | 0 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.5°C | 0 Participants |
| Participants From EFC13691: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.2°C | 0 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: < 12 b/m | 0 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≥ 120 & IFB ≥ 20 bpm | 0 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≤ 95 (≤90) & DFB ≥ 20 mmHg | 1 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% DFB | 29 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≤ 50 & DFB ≥ 20 bpm | 0 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% IFB | 37 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≥ 110 (≥78) & IFB ≥ 10 mmHg | 0 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.2°C | 1 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 38.0°C | 0 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≤ 45 (≤54) & DFB ≥ 10 mmHg | 0 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≥ 160 (≥119) & IFB ≥ 20 mmHg | 1 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.5°C | 0 Participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: > 20 b/m | 12 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: < 12 b/m | 2 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≥ 120 & IFB ≥ 20 bpm | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.2°C | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: > 20 b/m | 4 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.5°C | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% DFB | 3 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 38.0°C | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≤ 45 (≤54) & DFB ≥ 10 mmHg | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≤ 50 & DFB ≥ 20 bpm | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≤ 95 (≤90) & DFB ≥ 20 mmHg | 2 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≥ 110 (≥78) & IFB ≥ 10 mmHg | 0 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≥ 160 (≥119) & IFB ≥ 20 mmHg | 1 Participants |
| Participants From PDY14192: Placebo/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% IFB | 8 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: > 20 b/m | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% IFB | 5 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≤ 95 (≤90) & DFB ≥ 20 mmHg | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≤ 45 (≤54) & DFB ≥ 10 mmHg | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Respiratory rate: < 12 b/m | 3 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 38.0°C | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | SBP: ≥ 160 (≥119) & IFB ≥ 20 mmHg | 3 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≥ 120 & IFB ≥ 20 bpm | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Weight: ≥ 5% DFB | 3 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | HR: ≤ 50 & DFB ≥ 20 bpm | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.5°C | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | DBP: ≥ 110 (≥78) & IFB ≥ 10 mmHg | 0 Participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period | Temperature: ≥ 37.2°C | 0 Participants |
Secondary
Number of Severe Exacerbation Events
Severe asthma exacerbation events were defined as a deterioration of asthma which required: use of systemic corticosteroids for ≥ 3 days, (participants from study EFC13691 (NCT02528214), and who were taking systemic corticosteroids: the use of systemic corticosteroids at least double the current dose and for ≥3 days.) or, hospitalization or emergency room visit because of asthma, required systemic corticosteroids.
Time frame: From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Population: Analysis was performed on exposed population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Number of Severe Exacerbation Events | 62 number of events |
| Participants From DRI12544: Dupilumab/Dupilumab | Number of Severe Exacerbation Events | 242 number of events |
| Participants From EFC13579: Placebo/Dupilumab | Number of Severe Exacerbation Events | 234 number of events |
| Participants From EFC13579: Dupilumab/Dupilumab | Number of Severe Exacerbation Events | 437 number of events |
| Participants From EFC13691: Placebo/Dupilumab | Number of Severe Exacerbation Events | 35 number of events |
| Participants From EFC13691: Dupilumab/Dupilumab | Number of Severe Exacerbation Events | 41 number of events |
| Participants From PDY14192: Placebo/Dupilumab | Number of Severe Exacerbation Events | 3 number of events |
| Participants From PDY14192: Dupilumab/Dupilumab | Number of Severe Exacerbation Events | 1 number of events |
Secondary
Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48
ACQ-5 response was defined as change from baseline in ACQ-5 scores ≥ 0.5. The ACQ-5 had 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 mean 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: At Weeks 24, and 48 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 24 | 82.7 percentage of participants |
| Participants From DRI12544: Placebo/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 48 | 79.0 percentage of participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 48 | 82.3 percentage of participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 24 | 80.8 percentage of participants |
| Participants From EFC13579: Placebo/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 24 | 84.0 percentage of participants |
| Participants From EFC13579: Placebo/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 48 | 85.7 percentage of participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 48 | 86.7 percentage of participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 24 | 86.5 percentage of participants |
| Participants From EFC13691: Placebo/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 48 | 75.6 percentage of participants |
| Participants From EFC13691: Placebo/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 24 | 67.7 percentage of participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 48 | 70.5 percentage of participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 24 | 70.1 percentage of participants |
| Participants From PDY14192: Placebo/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 48 | 60.0 percentage of participants |
| Participants From PDY14192: Placebo/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 24 | 57.9 percentage of participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 24 | 69.2 percentage of participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 | Week 48 | 72.7 percentage of participants |
Secondary
Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48
AQLQ global response was defined as participants with change from baseline in AQLQ global score ≥ 0.5. The AQLQ was designed to measure the functional impairments that are most troublesome to adults as a result of their asthma. The AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=severely impaired, 7=not impaired). 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). Higher scores indicated better quality of life.
Time frame: At Weeks 24, and 48 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed for the participants from Studies DRI12544, EFC13579, and EFC13691 only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | Week 24 | 67.6 percentage of participants |
| Participants From DRI12544: Placebo/Dupilumab | Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | Week 48 | 65.0 percentage of participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | Week 24 | 73.6 percentage of participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | Week 48 | 76.3 percentage of participants |
| Participants From EFC13579: Placebo/Dupilumab | Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | Week 24 | 77.6 percentage of participants |
| Participants From EFC13579: Placebo/Dupilumab | Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | Week 48 | 77.4 percentage of participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | Week 24 | 77.2 percentage of participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | Week 48 | 78.4 percentage of participants |
| Participants From EFC13691: Placebo/Dupilumab | Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | Week 24 | 64.2 percentage of participants |
| Participants From EFC13691: Placebo/Dupilumab | Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | Week 48 | 73.3 percentage of participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | Week 24 | 61.4 percentage of participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 | Week 48 | 68.4 percentage of participants |
Secondary
Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691
OCS was allowed as background controller medication for the participants from study EFC13691 only. Percentage of participants who achieved a reduction of ≥ 50% in OCS dose were reported.
Time frame: Weeks 48 and 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study EFC13691 and not for the participants from other studies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691 | Week 48 | 64.9 percentage of participants |
| Participants From DRI12544: Placebo/Dupilumab | Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691 | Week 96 | 82.1 percentage of participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691 | Week 48 | 86.0 percentage of participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691 | Week 96 | 94.7 percentage of participants |
Secondary
Percentage of Participants With Antidrug Antibodies (ADA) Response
ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as an ADA positive response in the assay post first dose in LTS12551, when baseline results were negative or missing. 2) Treatment boosted was defined as: an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. The criteria for positive was defined as 30 to \> 10,000, where low titer (\< 1,000); moderate (1,000 ≤ titer ≤ 10,000) and high titer (\> 10,000).
Time frame: From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks)
Population: Analysis was performed on ADA population which consisted of all participants who had actually received at least one dose or part of a dose of dupilumab in the LTS12551 study, with at least one pre-dose sample that was assayed successfully using the ADA assay after the first dose of dupilumab in the LTS12551 study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-emergent ADA | 10.8 percentage of participants |
| Participants From DRI12544: Placebo/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-boosted ADA | 0 percentage of participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-emergent ADA | 12.1 percentage of participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-boosted ADA | 0 percentage of participants |
| Participants From EFC13579: Placebo/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-emergent ADA | 9.5 percentage of participants |
| Participants From EFC13579: Placebo/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-boosted ADA | 0 percentage of participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-emergent ADA | 4.5 percentage of participants |
| Participants From EFC13579: Dupilumab/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-boosted ADA | 0 percentage of participants |
| Participants From EFC13691: Placebo/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-emergent ADA | 7.4 percentage of participants |
| Participants From EFC13691: Placebo/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-boosted ADA | 1.1 percentage of participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-emergent ADA | 8.9 percentage of participants |
| Participants From EFC13691: Dupilumab/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-boosted ADA | 0 percentage of participants |
| Participants From PDY14192: Placebo/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-boosted ADA | 0 percentage of participants |
| Participants From PDY14192: Placebo/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-emergent ADA | 0 percentage of participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-emergent ADA | 7.1 percentage of participants |
| Participants From PDY14192: Dupilumab/Dupilumab | Percentage of Participants With Antidrug Antibodies (ADA) Response | Treatment-boosted ADA | 0 percentage of participants |
Secondary
Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691
OCS was allowed as background controller medication for the participants from study EFC13691 only. Number of participants who gradually discontinued or reduced therapeutic dose were reported in this outcome measure.
Time frame: Weeks 48, and 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study EFC13691 and not for the participants from other studies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691 | Week 48 | 31.2 percentage of participants |
| Participants From DRI12544: Placebo/Dupilumab | Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691 | Week 96 | 42.9 percentage of participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691 | Week 48 | 59.6 percentage of participants |
| Participants From DRI12544: Dupilumab/Dupilumab | Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691 | Week 96 | 78.9 percentage of participants |
Secondary
Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691
OCS was allowed as background controller medication for the participants from study EFC13691 only. For this analysis, baseline was defined as parent study EFC13691 baseline.
Time frame: Baseline of parent study, Weeks 48 and 96 of this extension study
Population: Analysis was performed on exposed population. Here, 'number analyzed' = number of participants with available data for each specified category. Data were planned to be collected and analyzed only for the participants from Study EFC13691 and not for the participants from other studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691 | Week 48 | 55.32 percent change | Standard Deviation 42.98 |
| Participants From DRI12544: Placebo/Dupilumab | Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691 | Week 96 | 71.37 percent change | Standard Deviation 29.37 |
| Participants From DRI12544: Dupilumab/Dupilumab | Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691 | Week 48 | 80.23 percent change | Standard Deviation 30.44 |
| Participants From DRI12544: Dupilumab/Dupilumab | Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691 | Week 96 | 88.16 percent change | Standard Deviation 26.83 |
Secondary
Serum Concentrations of Dupilumab Over Time Till Week 96
For this analysis, baseline was defined as respective parent study baseline. Here, 'number analyzed'=number of participants with available data for each specified category.
Time frame: Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study
Population: Analysis was performed on Pharmacokinetics (PK) population which consisted of all the participants who had actually received at least one dose or part of a dose of dupilumab in the LTS12551 study, with at least one non-missing and evaluable pre-dose serum concentration value after the first dose of dupilumab in the LTS12551 study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From DRI12544: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 96 | 42431.08 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 59.222 |
| Participants From DRI12544: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 12 | 54467.13 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 50.267 |
| Participants From DRI12544: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 4 | 46848.70 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 43.149 |
| Participants From DRI12544: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 24 | 47023.84 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 51.645 |
| Participants From DRI12544: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 72 | 44771.52 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 56.256 |
| Participants From DRI12544: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 0 | 0.00 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 0 |
| Participants From DRI12544: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 48 | 46355.26 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 52.612 |
| Participants From DRI12544: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Baseline | 0.00 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 0 |
| Participants From DRI12544: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 96 | 42661.18 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 59.658 |
| Participants From DRI12544: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 24 | 49730.56 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 53.625 |
| Participants From DRI12544: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 0 | 0.00 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 0 |
| Participants From DRI12544: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Baseline | 0.00 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 1990.64 |
| Participants From DRI12544: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 4 | 40704.77 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 47.293 |
| Participants From DRI12544: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 72 | 46842.64 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 53.335 |
| Participants From DRI12544: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 48 | 45919.75 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 55.932 |
| Participants From DRI12544: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 12 | 48155.26 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 52.353 |
| Participants From EFC13579: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 48 | 41867.50 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 60.345 |
| Participants From EFC13579: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 12 | 45406.55 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 51.399 |
| Participants From EFC13579: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 72 | 45628.10 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 56.232 |
| Participants From EFC13579: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 96 | 38908.58 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 64.633 |
| Participants From EFC13579: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 24 | 50984.57 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 53.744 |
| Participants From EFC13579: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 4 | 25847.86 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 49.371 |
| Participants From EFC13579: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 24 | 54897.58 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 54.044 |
| Participants From EFC13579: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Baseline | 0.00 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 2286.888 |
| Participants From EFC13579: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 0 | 37230.97 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 73.261 |
| Participants From EFC13579: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 4 | 50566.66 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 55.104 |
| Participants From EFC13579: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 12 | 55140.49 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 53.114 |
| Participants From EFC13579: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 48 | 41849.96 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 62.049 |
| Participants From EFC13579: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 72 | 46372.55 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 57.719 |
| Participants From EFC13579: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 96 | 39088.60 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 62.897 |
| Participants From EFC13691: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 4 | 25868.25 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 53.45 |
| Participants From EFC13691: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 24 | 57363.72 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 57.889 |
| Participants From EFC13691: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 48 | 36219.47 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 67.53 |
| Participants From EFC13691: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 96 | 49810.65 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 65.546 |
| Participants From EFC13691: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 12 | 44064.95 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 57.1 |
| Participants From EFC13691: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 72 | 60117.76 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 62.39 |
| Participants From EFC13691: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 12 | 50904.34 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 51.233 |
| Participants From EFC13691: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 24 | 44219.42 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 55.383 |
| Participants From EFC13691: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 96 | 19030.70 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 67.237 |
| Participants From EFC13691: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 48 | 36564.41 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 60.959 |
| Participants From EFC13691: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 4 | 48295.93 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 52.655 |
| Participants From EFC13691: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 72 | 32029.19 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 66.785 |
| Participants From EFC13691: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 0 | 40754.49 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 54.858 |
| Participants From EFC13691: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Baseline | 0.00 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 0 |
| Participants From PDY14192: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 24 | 63080.82 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 51.224 |
| Participants From PDY14192: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 96 | 42360.37 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 49.409 |
| Participants From PDY14192: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 48 | 24864.79 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 58.016 |
| Participants From PDY14192: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 12 | 49026.51 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 41.619 |
| Participants From PDY14192: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 72 | 40362.88 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 55.567 |
| Participants From PDY14192: Placebo/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 4 | 23336.89 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 50.542 |
| Participants From PDY14192: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 48 | 53320.11 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 46.714 |
| Participants From PDY14192: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 24 | 60643.16 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 41.617 |
| Participants From PDY14192: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Baseline | 0.00 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 0 |
| Participants From PDY14192: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 4 | 56486.58 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 45.755 |
| Participants From PDY14192: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 12 | 55365.35 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 53.317 |
| Participants From PDY14192: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 72 | 26383.90 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 120.013 |
| Participants From PDY14192: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 0 | 52545.41 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 44.678 |
| Participants From PDY14192: Dupilumab/Dupilumab | Serum Concentrations of Dupilumab Over Time Till Week 96 | Week 96 | 56378.01 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 7.14 |