Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Change From Baseline in Total Immunoglobulin (E) IgE

Serum samples were collected to measure concentrations of IgE.

Time frame: Weeks 4, 12 and 24

Percent Change From Baseline in Total IgE

Serum samples were collected to measure concentrations of IgE.

Time frame: Weeks 4, 12 and 24

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