Atopic Eczema, Moderate-to-Severe Atopic Dermatitis
Conditions
Keywords
Eczematous Lesions, Pruritus
Brief summary
The study is focused on skin of color participants who have moderate-to-severe atopic dermatitis. Atopic dermatitis, also referred to as eczema, is a condition that causes the skin to become itchy, dry, and cracked. From the previous studies on the study drug, it is seen that the study drug has an acceptable safety and effectiveness in participants with atopic dermatitis. The aim of this study is to get additional information on the safety and effectiveness of the study drug, particularly the information on aspects of atopic dermatitis in skin of color participants. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in your blood at different times * How much the study drug improves quality of life and mental health
Interventions
DRUGdupilumab
Administered by subcutaneous (SC) injection once every 2 weeks (Q2W) following a loading dose
OTHERTopical emollient (moisturizer)
Moisturizer should be applied twice daily, as per physician's recommendation, as defined in protocol.
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
Key Inclusion Criteria: 1. Skin of color, defined as Fitzpatrick skin type ≥4 at screening visit 2. Diagnosis of moderate-to-severe atopic dermatitis (AD) that cannot be adequately controlled with topical AD medications, as defined in protocol 3. Has applied a stable dose of topical emollient (moisturizer) twice daily as per physician recommendation starting at screening visit Key
Exclusion criteria
1. Self-reported Caucasian or White race 2. Adolescent body weight less than 30 kg at screening 3. Prior use of dupilumab within 6 months of screening 4. Concomitant skin diseases or other pigmentary disorder that could confound AD assessments 5. Current or prior use, within 12 weeks before the screening visit, of phototherapy or tanning beds 6. Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline 7. Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 7 days prior to baseline 8. Planned or anticipated use of any prohibited medications and procedures, as defined in protocol 9. Has received a COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study drug NOTE: Other Protocol Defined Inclusion /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ≥75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75) | Week 24 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1 | Weeks 2, 4, 8, 12, 16, 20, and 24 | IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Percentage of participants with IGA "0" or "1" are reported at each visit. |
| Percent Change From Baseline in EASI Score | Weeks 2, 4, 8, 12, 16, 20, and 24 | The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. |
| Change From Baseline in EASI Score | Weeks 2, 4, 8, 12, 16, 20, and 24 | The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. |
| Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50) | Weeks 2, 4, 8, 12, 16, 20, and 24 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to the given time point. |
| Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75) | Weeks 2, 4, 8, 12, 16, 20, and 24 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to the given time point. |
| Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90) | Weeks 2, 4, 8, 12, 16, 20, and 24 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to the given time point. |
| Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score | Weeks 2, 4, 8, 12, 16, 20, and 24 | The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). |
| Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50) | Weeks 2, 4, 8, 12, 16, 20, and 24 | SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs insomnia, etc.) were assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease). A decrease in score indicated improvement. SCORAD-50 was defined as ≥50% reduction from baseline in SCORAD score. |
| Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3 | Weeks 2, 4, 8, 12, 16, 20, and 24 | Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement. |
| Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4 | Weeks 2, 4, 8, 12, 16, 20, and 24 | Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement. |
| Percent Change From Baseline in Weekly Average of Daily PP NRS Score | Weeks 2, 4, 8, 12, 16, 20, and 24 | Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement. |
| Change From Baseline in Weekly Average of Daily PP NRS Score | Weeks 2, 4, 8, 12, 16, 20, and 24 | Peak Pruritus NRS is an assessment tool used by subjects to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement. |
| Percent Change From Baseline in Percent Body Surface Area (BSA) | Weeks 2, 4, 8, 12, 16, 20, and 24 | BSA affected by AD was assessed for each section of the body using the rule of nines (the possible highest score for each region was: head and neck \[9%\], interior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]). BSA was reported as a percentage of all major body sections combined. |
| Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score | Weeks 2, 4, 8, 12, 16, 20, and 24 | DLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on QOL; over the past week, with an overall scoring of 0 (no effect on QoL) to 30 (extremely large effect on QoL). A decrease in score indicated improvement. |
| Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score | Weeks 2, 4, 8, 12, 16, 20, and 24 | CDLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on quality of life (QOL); over the past week, with an overall scoring of 0 (no effect on QoL) to 30 (extremely large effect on QoL) in children. A decrease in score indicated improvement. |
| Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score | Weeks 2, 4, 8, 12, 16, 20, and 24 | POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (Higher score indicative of more severe symptoms). Total score was an average of the disease symptoms assessed. A decrease in score indicated improvement. |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score | Weeks 2, 4, 8, 12, 16, 20, and 24 | The Hospital Anxiety and Depression Scale (HADS) is a screening tool designed to assess anxiety and depression. The scale consists of 14 items, divided into two subscales: Anxiety (HADS-A): 7 items; Depression (HADS-D): 7 items. The range of the total score is 0-42 (sum of HADS-A and HADS-D), with higher score indicating more severe overall psychological distress. The two subscales can be reported separately, each with a score range of 0-21, with higher score indicating more severe symptoms of anxiety or depression. A decrease in either the total score or a subscale score indicates improvement. |
| Change From Baseline in Skin Pain NRS (SP NRS) Score | Weeks 2, 4, 8, 12, 16, 20, and 24 | SP NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants selected the number between 0 and 10 that fit best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain imaginable). A decrease in score indicated improvement. |
| Change From Baseline in Weekly Average Sleep Quality NRS Score | Weeks 2, 4, 8, 12, 16, 20, and 24 | Sleep Quality NRS is an 11-point scale (0 to 10) in which 0 indicated worst possible sleep while 10 indicated best possible sleep. An increase in score indicated improvement. |
| Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms | Weeks 2, 4, 8, 12, 16, 20, and 24 | PGID is a single 1-item questionnaire designed to assess participant's overall impression of disease severity during the past 7 days with a 5-level scale of no symptoms, mild, moderate, severe or very severe. Data are reported for the percentage of participants with a PGID response of "No symptoms" at the specified timepoints. |
| Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms | Weeks 2, 4, 8, 12, 16, 20, and 24 | PGID is a single 1-item questionnaire designed to assess participant's overall impression of disease severity during the past 7 days with a 5-level scale of no symptoms, mild, moderate, severe or very severe. Data are reported for the percentage of participants with a PGID response of "No symptoms" or "Mild symptoms" at the specified timepoints. |
| Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better" | Weeks 2, 4, 8, 12, 16, 20, and 24 | The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change in eczema symptoms since starting treatment as rated on a 7-point Likert scale anchored by (1) "much better" to (7) "much worse", with (4) = "no change". Data are reported for the percentage of participants who rated their eczema symptoms as "Much better" at the specified timepoints. |
| Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better" | Weeks 2, 4, 8, 12, 16, 20, and 24 | The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change in eczema symptoms since starting treatment as rated on a 7-point Likert scale anchored by (1) "much better" to (7) "much worse", with (4) = "no change". Data are reported for the percentage of participants who rated their eczema symptoms as "Moderately better" at the specified timepoints. |
| Number of Participants With Non-herpetic Skin Infection Treatment-emergent Adverse Events (TEAEs) | Day 1 through Week 24 | A TEAE is any untoward medical occurrence in a participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Data are reported for the number of participants with non-herpetic skin infection TEAEs. A summary of all serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Change From Baseline in Total Immunoglobulin (E) IgE | Weeks 4, 12 and 24 | Serum samples were collected to measure concentrations of IgE. |
| Percent Change From Baseline in Total IgE | Weeks 4, 12 and 24 | Serum samples were collected to measure concentrations of IgE. |
| Trough Concentration of Functional Dupilumab in Serum | Week 12 and Week 24 | Adolescents and adults received 1 of 2 dose regimens based on age and body weight. The trough concentration of functional dupilumab in serum for the 2 dose regimens at the specified time points are presented. Participants treated and had at least one evaluable post-first-dose concentration measurement. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Participant flow
Pre-assignment details
This study was conducted at a total of 30 sites located in the United States. A total of 166 participants were screened for the study, of which 124 were enrolled and were treated with dupilumab.
Participants by arm
| Arm | Count |
|---|---|
| Dupilumab Participants received dupilumab by SC injection Q2W for 24 weeks following a loading dose based on age and body weight. | 120 |
| Total | 120 |
Baseline characteristics
| Characteristic | Dupilumab |
|---|---|
| Age, Continuous | 37.6 years STANDARD_DEVIATION 16.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Race Asian | 13 Participants |
| Race/Ethnicity, Customized Race Black or African American | 98 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants |
| Race/Ethnicity, Customized Race White | 3 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 124 |
| other Total, other adverse events | 0 / 124 |
| serious Total, serious adverse events | 7 / 124 |
Outcome results
Primary
Percentage of Participants With ≥75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75)
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 24.
Time frame: Week 24
Population: Here 'n' = number of evaluable participants at the specified timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dupilumab | Percentage of Participants With ≥75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75) | 76.0 percentage of participants |
Secondary
Change From Baseline in EASI Score
The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Change From Baseline in EASI Score | Week 2 | -7.105 score on scale | Standard Deviation 7.504 |
| Dupilumab | Change From Baseline in EASI Score | Week 20 | -20.985 score on scale | Standard Deviation 11.249 |
| Dupilumab | Change From Baseline in EASI Score | Week 24 | -20.980 score on scale | Standard Deviation 11.071 |
| Dupilumab | Change From Baseline in EASI Score | Week 4 | -12.097 score on scale | Standard Deviation 9.338 |
| Dupilumab | Change From Baseline in EASI Score | Week 8 | -17.779 score on scale | Standard Deviation 10.178 |
| Dupilumab | Change From Baseline in EASI Score | Week 12 | -18.475 score on scale | Standard Deviation 9.768 |
| Dupilumab | Change From Baseline in EASI Score | Week 16 | -19.460 score on scale | Standard Deviation 11.663 |
Secondary
Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score
CDLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on quality of life (QOL); over the past week, with an overall scoring of 0 (no effect on QoL) to 30 (extremely large effect on QoL) in children. A decrease in score indicated improvement.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score | Week 2 | -4.2 score on a scale | Standard Deviation 5.4 |
| Dupilumab | Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score | Week 4 | -5.0 score on a scale | Standard Deviation 5.2 |
| Dupilumab | Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score | Week 8 | -5.1 score on a scale | Standard Deviation 4.2 |
| Dupilumab | Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score | Week 12 | -6.3 score on a scale | Standard Deviation 7 |
| Dupilumab | Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score | Week 16 | -8.5 score on a scale | Standard Deviation 5.6 |
| Dupilumab | Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score | Week 20 | -8.6 score on a scale | Standard Deviation 5.4 |
| Dupilumab | Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score | Week 24 | -7.8 score on a scale | Standard Deviation 5.5 |
Secondary
Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score
DLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on QOL; over the past week, with an overall scoring of 0 (no effect on QoL) to 30 (extremely large effect on QoL). A decrease in score indicated improvement.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score | Week 2 | -4.5 score on a scale | Standard Deviation 5.4 |
| Dupilumab | Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score | Week 4 | -5.6 score on a scale | Standard Deviation 7.1 |
| Dupilumab | Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score | Week 8 | -6.7 score on a scale | Standard Deviation 6.5 |
| Dupilumab | Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score | Week 12 | -7.6 score on a scale | Standard Deviation 5.7 |
| Dupilumab | Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score | Week 16 | -7.6 score on a scale | Standard Deviation 6.7 |
| Dupilumab | Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score | Week 20 | -8.5 score on a scale | Standard Deviation 6.5 |
| Dupilumab | Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score | Week 24 | -8.3 score on a scale | Standard Deviation 7.1 |
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score
The Hospital Anxiety and Depression Scale (HADS) is a screening tool designed to assess anxiety and depression. The scale consists of 14 items, divided into two subscales: Anxiety (HADS-A): 7 items; Depression (HADS-D): 7 items. The range of the total score is 0-42 (sum of HADS-A and HADS-D), with higher score indicating more severe overall psychological distress. The two subscales can be reported separately, each with a score range of 0-21, with higher score indicating more severe symptoms of anxiety or depression. A decrease in either the total score or a subscale score indicates improvement.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score | Week 4 | -2.3 score on a scale | Standard Deviation 5.5 |
| Dupilumab | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score | Week 2 | -1.8 score on a scale | Standard Deviation 5 |
| Dupilumab | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score | Week 8 | -2.8 score on a scale | Standard Deviation 5.6 |
| Dupilumab | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score | Week 12 | -3.7 score on a scale | Standard Deviation 5.5 |
| Dupilumab | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score | Week 16 | -3.4 score on a scale | Standard Deviation 5.8 |
| Dupilumab | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score | Week 20 | -3.4 score on a scale | Standard Deviation 6.1 |
| Dupilumab | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score | Week 24 | -3.2 score on a scale | Standard Deviation 6.3 |
Secondary
Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score
POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (Higher score indicative of more severe symptoms). Total score was an average of the disease symptoms assessed. A decrease in score indicated improvement.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score | Week 20 | -11.3 score on a scale | Standard Deviation 7 |
| Dupilumab | Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score | Week 24 | -11.5 score on a scale | Standard Deviation 7 |
| Dupilumab | Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score | Week 16 | -11.2 score on a scale | Standard Deviation 7 |
| Dupilumab | Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score | Week 2 | -5.6 score on a scale | Standard Deviation 6 |
| Dupilumab | Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score | Week 4 | -8.3 score on a scale | Standard Deviation 6.6 |
| Dupilumab | Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score | Week 8 | -10.3 score on a scale | Standard Deviation 6.5 |
| Dupilumab | Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score | Week 12 | -11.0 score on a scale | Standard Deviation 6.3 |
Secondary
Change From Baseline in Skin Pain NRS (SP NRS) Score
SP NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants selected the number between 0 and 10 that fit best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain imaginable). A decrease in score indicated improvement.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Change From Baseline in Skin Pain NRS (SP NRS) Score | Week 2 | -2.3 score on a scale | Standard Deviation 3.6 |
| Dupilumab | Change From Baseline in Skin Pain NRS (SP NRS) Score | Week 4 | -2.6 score on a scale | Standard Deviation 4 |
| Dupilumab | Change From Baseline in Skin Pain NRS (SP NRS) Score | Week 8 | -3.2 score on a scale | Standard Deviation 3.5 |
| Dupilumab | Change From Baseline in Skin Pain NRS (SP NRS) Score | Week 12 | -3.3 score on a scale | Standard Deviation 3.5 |
| Dupilumab | Change From Baseline in Skin Pain NRS (SP NRS) Score | Week 16 | -3.0 score on a scale | Standard Deviation 3.4 |
| Dupilumab | Change From Baseline in Skin Pain NRS (SP NRS) Score | Week 20 | -3.0 score on a scale | Standard Deviation 3.2 |
| Dupilumab | Change From Baseline in Skin Pain NRS (SP NRS) Score | Week 24 | -2.9 score on a scale | Standard Deviation 3.5 |
Secondary
Change From Baseline in Total Immunoglobulin (E) IgE
Serum samples were collected to measure concentrations of IgE.
Time frame: Weeks 4, 12 and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Change From Baseline in Total Immunoglobulin (E) IgE | Week 4 | -493.277 kU/L | Standard Deviation 1964.991 |
| Dupilumab | Change From Baseline in Total Immunoglobulin (E) IgE | Week 12 | -2284.021 kU/L | Standard Deviation 5579.402 |
| Dupilumab | Change From Baseline in Total Immunoglobulin (E) IgE | Week 24 | -3177.471 kU/L | Standard Deviation 6959.014 |
Secondary
Change From Baseline in Weekly Average of Daily PP NRS Score
Peak Pruritus NRS is an assessment tool used by subjects to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Change From Baseline in Weekly Average of Daily PP NRS Score | Week 2 | -1.234 score on a scale | Standard Deviation 1.663 |
| Dupilumab | Change From Baseline in Weekly Average of Daily PP NRS Score | Week 4 | -2.058 score on a scale | Standard Deviation 2.021 |
| Dupilumab | Change From Baseline in Weekly Average of Daily PP NRS Score | Week 8 | -2.939 score on a scale | Standard Deviation 2.379 |
| Dupilumab | Change From Baseline in Weekly Average of Daily PP NRS Score | Week 12 | -3.237 score on a scale | Standard Deviation 2.266 |
| Dupilumab | Change From Baseline in Weekly Average of Daily PP NRS Score | Week 16 | -3.741 score on a scale | Standard Deviation 2.369 |
| Dupilumab | Change From Baseline in Weekly Average of Daily PP NRS Score | Week 20 | -3.823 score on a scale | Standard Deviation 2.184 |
| Dupilumab | Change From Baseline in Weekly Average of Daily PP NRS Score | Week 24 | -3.981 score on a scale | Standard Deviation 2.326 |
Secondary
Change From Baseline in Weekly Average Sleep Quality NRS Score
Sleep Quality NRS is an 11-point scale (0 to 10) in which 0 indicated worst possible sleep while 10 indicated best possible sleep. An increase in score indicated improvement.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Change From Baseline in Weekly Average Sleep Quality NRS Score | Week 16 | 1.239 score on a scale | Standard Deviation 2.097 |
| Dupilumab | Change From Baseline in Weekly Average Sleep Quality NRS Score | Week 2 | 0.473 score on a scale | Standard Deviation 1.565 |
| Dupilumab | Change From Baseline in Weekly Average Sleep Quality NRS Score | Week 4 | 0.910 score on a scale | Standard Deviation 1.937 |
| Dupilumab | Change From Baseline in Weekly Average Sleep Quality NRS Score | Week 8 | 1.204 score on a scale | Standard Deviation 2.459 |
| Dupilumab | Change From Baseline in Weekly Average Sleep Quality NRS Score | Week 12 | 1.281 score on a scale | Standard Deviation 2.173 |
| Dupilumab | Change From Baseline in Weekly Average Sleep Quality NRS Score | Week 20 | 1.045 score on a scale | Standard Deviation 2.631 |
| Dupilumab | Change From Baseline in Weekly Average Sleep Quality NRS Score | Week 24 | 1.210 score on a scale | Standard Deviation 2.696 |
Secondary
Number of Participants With Non-herpetic Skin Infection Treatment-emergent Adverse Events (TEAEs)
A TEAE is any untoward medical occurrence in a participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Data are reported for the number of participants with non-herpetic skin infection TEAEs. A summary of all serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Day 1 through Week 24
Population: Safety Set: All participants who were enrolled in the study and received at least 1 dose of dupilumab during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dupilumab | Number of Participants With Non-herpetic Skin Infection Treatment-emergent Adverse Events (TEAEs) | 1 Participants |
Secondary
Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as Much Better
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change in eczema symptoms since starting treatment as rated on a 7-point Likert scale anchored by (1) much better to (7) much worse, with (4) = no change. Data are reported for the percentage of participants who rated their eczema symptoms as Much better at the specified timepoints.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as Much Better | Week 16 | 50.5 percentage of participants |
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as Much Better | Week 20 | 55.2 percentage of participants |
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as Much Better | Week 2 | 15.8 percentage of participants |
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as Much Better | Week 4 | 23.7 percentage of participants |
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as Much Better | Week 8 | 44.1 percentage of participants |
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as Much Better | Week 12 | 45.6 percentage of participants |
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as Much Better | Week 24 | 53.8 percentage of participants |
Secondary
Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as Moderately Better
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change in eczema symptoms since starting treatment as rated on a 7-point Likert scale anchored by (1) much better to (7) much worse, with (4) = no change. Data are reported for the percentage of participants who rated their eczema symptoms as Moderately better at the specified timepoints.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as Moderately Better | Week 20 | 25.0 percentage of participants |
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as Moderately Better | Week 2 | 14.0 percentage of participants |
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as Moderately Better | Week 4 | 27.2 percentage of participants |
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as Moderately Better | Week 8 | 23.4 percentage of participants |
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as Moderately Better | Week 12 | 28.2 percentage of participants |
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as Moderately Better | Week 16 | 27.6 percentage of participants |
| Dupilumab | Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as Moderately Better | Week 24 | 23.1 percentage of participants |
Secondary
Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50)
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to the given time point.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50) | Week 2 | 17.2 percentage of participants |
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50) | Week 4 | 47.9 percentage of participants |
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50) | Week 8 | 77.9 percentage of participants |
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50) | Week 12 | 84.3 percentage of participants |
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50) | Week 16 | 84.3 percentage of participants |
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50) | Week 20 | 89.7 percentage of participants |
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50) | Week 24 | 89.0 percentage of participants |
Secondary
Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50)
SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs insomnia, etc.) were assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease). A decrease in score indicated improvement. SCORAD-50 was defined as ≥50% reduction from baseline in SCORAD score.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50) | Week 2 | 9.1 percentage of participants |
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50) | Week 4 | 16.2 percentage of participants |
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50) | Week 8 | 39.3 percentage of participants |
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50) | Week 12 | 52.9 percentage of participants |
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50) | Week 16 | 59.8 percentage of participants |
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50) | Week 20 | 68.1 percentage of participants |
| Dupilumab | Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50) | Week 24 | 70.2 percentage of participants |
Secondary
Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75)
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to the given time point.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dupilumab | Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75) | Week 2 | 3.4 percentage of participants |
| Dupilumab | Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75) | Week 4 | 23.1 percentage of participants |
| Dupilumab | Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75) | Week 8 | 50.4 percentage of participants |
| Dupilumab | Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75) | Week 12 | 56.5 percentage of participants |
| Dupilumab | Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75) | Week 16 | 63.9 percentage of participants |
| Dupilumab | Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75) | Week 20 | 74.2 percentage of participants |
| Dupilumab | Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75) | Week 24 | 76.0 percentage of participants |
Secondary
Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90)
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to the given time point.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dupilumab | Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90) | Week 2 | 0.9 percentage of participants |
| Dupilumab | Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90) | Week 4 | 5.1 percentage of participants |
| Dupilumab | Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90) | Week 8 | 15.0 percentage of participants |
| Dupilumab | Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90) | Week 12 | 27.8 percentage of participants |
| Dupilumab | Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90) | Week 16 | 38.9 percentage of participants |
| Dupilumab | Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90) | Week 20 | 41.2 percentage of participants |
| Dupilumab | Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90) | Week 24 | 42.0 percentage of participants |
Secondary
Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Percentage of participants with IGA 0 or 1 are reported at each visit.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dupilumab | Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1 | Week 16 | 35.2 percentage of participants |
| Dupilumab | Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1 | Week 20 | 45.4 percentage of participants |
| Dupilumab | Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1 | Week 2 | 0.9 percentage of participants |
| Dupilumab | Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1 | Week 4 | 6.8 percentage of participants |
| Dupilumab | Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1 | Week 8 | 15.9 percentage of participants |
| Dupilumab | Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1 | Week 12 | 25.9 percentage of participants |
| Dupilumab | Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1 | Week 24 | 44.0 percentage of participants |
Secondary
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3 | Week 4 | 31.6 percentage of participants |
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3 | Week 8 | 48.2 percentage of participants |
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3 | Week 2 | 14.3 percentage of participants |
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3 | Week 12 | 54.6 percentage of participants |
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3 | Week 16 | 64.8 percentage of participants |
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3 | Week 20 | 68.0 percentage of participants |
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3 | Week 24 | 65.6 percentage of participants |
Secondary
Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4 | Week 2 | 8.4 percentage of participants |
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4 | Week 4 | 19.7 percentage of participants |
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4 | Week 8 | 32.5 percentage of participants |
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4 | Week 12 | 38.9 percentage of participants |
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4 | Week 16 | 44.4 percentage of participants |
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4 | Week 20 | 47.6 percentage of participants |
| Dupilumab | Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4 | Week 24 | 52.7 percentage of participants |
Secondary
Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms
PGID is a single 1-item questionnaire designed to assess participant's overall impression of disease severity during the past 7 days with a 5-level scale of no symptoms, mild, moderate, severe or very severe. Data are reported for the percentage of participants with a PGID response of No symptoms at the specified timepoints.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dupilumab | Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms | Week 2 | 4.0 percentage of participants |
| Dupilumab | Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms | Week 4 | 4.0 percentage of participants |
| Dupilumab | Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms | Week 8 | 14.6 percentage of participants |
| Dupilumab | Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms | Week 12 | 10.0 percentage of participants |
| Dupilumab | Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms | Week 16 | 12.0 percentage of participants |
| Dupilumab | Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms | Week 20 | 14.3 percentage of participants |
| Dupilumab | Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms | Week 24 | 23.8 percentage of participants |
Secondary
Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms
PGID is a single 1-item questionnaire designed to assess participant's overall impression of disease severity during the past 7 days with a 5-level scale of no symptoms, mild, moderate, severe or very severe. Data are reported for the percentage of participants with a PGID response of No symptoms or Mild symptoms at the specified timepoints.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dupilumab | Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms | Week 2 | 26.7 percentage of participants |
| Dupilumab | Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms | Week 4 | 46.0 percentage of participants |
| Dupilumab | Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms | Week 8 | 59.4 percentage of participants |
| Dupilumab | Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms | Week 12 | 65.6 percentage of participants |
| Dupilumab | Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms | Week 16 | 68.5 percentage of participants |
| Dupilumab | Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms | Week 20 | 64.3 percentage of participants |
| Dupilumab | Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms | Week 24 | 67.5 percentage of participants |
Secondary
Percent Change From Baseline in EASI Score
The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Percent Change From Baseline in EASI Score | Week 2 | -25.929 percent change | Standard Deviation 29.782 |
| Dupilumab | Percent Change From Baseline in EASI Score | Week 4 | -46.092 percent change | Standard Deviation 30 |
| Dupilumab | Percent Change From Baseline in EASI Score | Week 8 | -67.270 percent change | Standard Deviation 25.689 |
| Dupilumab | Percent Change From Baseline in EASI Score | Week 12 | -70.999 percent change | Standard Deviation 25.798 |
| Dupilumab | Percent Change From Baseline in EASI Score | Week 16 | -73.276 percent change | Standard Deviation 32.975 |
| Dupilumab | Percent Change From Baseline in EASI Score | Week 20 | -79.185 percent change | Standard Deviation 23.612 |
| Dupilumab | Percent Change From Baseline in EASI Score | Week 24 | -79.941 percent change | Standard Deviation 25.634 |
Secondary
Percent Change From Baseline in Percent Body Surface Area (BSA)
BSA affected by AD was assessed for each section of the body using the rule of nines (the possible highest score for each region was: head and neck \[9%\], interior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]). BSA was reported as a percentage of all major body sections combined.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Percent Change From Baseline in Percent Body Surface Area (BSA) | Week 8 | -53.09 Percentage of change | Standard Deviation 30.67 |
| Dupilumab | Percent Change From Baseline in Percent Body Surface Area (BSA) | Week 2 | -17.91 Percentage of change | Standard Deviation 24.92 |
| Dupilumab | Percent Change From Baseline in Percent Body Surface Area (BSA) | Week 4 | -31.07 Percentage of change | Standard Deviation 31.06 |
| Dupilumab | Percent Change From Baseline in Percent Body Surface Area (BSA) | Week 12 | -60.04 Percentage of change | Standard Deviation 31.45 |
| Dupilumab | Percent Change From Baseline in Percent Body Surface Area (BSA) | Week 16 | -64.65 Percentage of change | Standard Deviation 32.79 |
| Dupilumab | Percent Change From Baseline in Percent Body Surface Area (BSA) | Week 20 | -71.03 Percentage of change | Standard Deviation 28.5 |
| Dupilumab | Percent Change From Baseline in Percent Body Surface Area (BSA) | Week 24 | -73.69 Percentage of change | Standard Deviation 28.31 |
Secondary
Percent Change From Baseline in Total IgE
Serum samples were collected to measure concentrations of IgE.
Time frame: Weeks 4, 12 and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Percent Change From Baseline in Total IgE | Week 12 | -39.703 percent change | Standard Deviation 25.145 |
| Dupilumab | Percent Change From Baseline in Total IgE | Week 24 | -50.375 percent change | Standard Deviation 69.291 |
| Dupilumab | Percent Change From Baseline in Total IgE | Week 4 | -6.277 percent change | Standard Deviation 62.301 |
Secondary
Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score
The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score | Week 2 | -18.5 percent change | Standard Deviation 17.8 |
| Dupilumab | Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score | Week 4 | -30.2 percent change | Standard Deviation 22.6 |
| Dupilumab | Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score | Week 8 | -44.4 percent change | Standard Deviation 22.8 |
| Dupilumab | Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score | Week 12 | -50.5 percent change | Standard Deviation 23 |
| Dupilumab | Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score | Week 16 | -53.2 percent change | Standard Deviation 26 |
| Dupilumab | Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score | Week 20 | -55.6 percent change | Standard Deviation 24.3 |
| Dupilumab | Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score | Week 24 | -59.3 percent change | Standard Deviation 26 |
Secondary
Percent Change From Baseline in Weekly Average of Daily PP NRS Score
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. A decrease in score indicated improvement.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: Here 'n' = Number of evaluable participants at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Percent Change From Baseline in Weekly Average of Daily PP NRS Score | Week 2 | -16.253 Percentage of change | Standard Deviation 25.364 |
| Dupilumab | Percent Change From Baseline in Weekly Average of Daily PP NRS Score | Week 4 | -28.672 Percentage of change | Standard Deviation 28.427 |
| Dupilumab | Percent Change From Baseline in Weekly Average of Daily PP NRS Score | Week 8 | -41.010 Percentage of change | Standard Deviation 33.346 |
| Dupilumab | Percent Change From Baseline in Weekly Average of Daily PP NRS Score | Week 12 | -45.944 Percentage of change | Standard Deviation 31.358 |
| Dupilumab | Percent Change From Baseline in Weekly Average of Daily PP NRS Score | Week 16 | -52.706 Percentage of change | Standard Deviation 30.812 |
| Dupilumab | Percent Change From Baseline in Weekly Average of Daily PP NRS Score | Week 20 | -54.138 Percentage of change | Standard Deviation 28.698 |
| Dupilumab | Percent Change From Baseline in Weekly Average of Daily PP NRS Score | Week 24 | -56.337 Percentage of change | Standard Deviation 31.036 |
Secondary
Trough Concentration of Functional Dupilumab in Serum
Adolescents and adults received 1 of 2 dose regimens based on age and body weight. The trough concentration of functional dupilumab in serum for the 2 dose regimens at the specified time points are presented. Participants treated and had at least one evaluable post-first-dose concentration measurement.
Time frame: Week 12 and Week 24
Population: Pharmacokinetic (PK) Analysis Set: All participants who received any study drug and who had at least 1 non-missing PK result following the first dose of any study drug. Analysis was based on the treatment received. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab | Trough Concentration of Functional Dupilumab in Serum | Dose Regimen 1: Week 12 | 40.8 mg/L | Standard Deviation 28.7 |
| Dupilumab | Trough Concentration of Functional Dupilumab in Serum | Dose Regimen 2: Week 12 | 43.9 mg/L | Standard Deviation 28.4 |
| Dupilumab | Trough Concentration of Functional Dupilumab in Serum | Dose Regimen 1: Week 24 | 43.9 mg/L | Standard Deviation 28 |
| Dupilumab | Trough Concentration of Functional Dupilumab in Serum | Dose Regimen 2: Week 24 | 49.6 mg/L | Standard Deviation 33.4 |