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ADULT STUDY DESIGNS

In the treatment of adults with uncontrolled moderate-to-severe
atopic dermatitis

Studied in 3 adult pivotal trials

>1300 adults studied
across both monotherapy
and concomitant TCS
trials1

DUPIXENT was evaluated in a total of 917 adult patients in SOLO 1 and SOLO 2 (16-week trials), and DUPIXENT + TCS was evaluated in 421 adult patients in CHRONOS (52-week trial) whose moderate-to-severe atopic dermatitis was inadequately controlled on topical Rx therapies.

Disease severity was defined by an IGA score ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.1,a

Adult (18+ years of age)1,2
Number of
patients

>2100

Pivotal trialsb

2 Monotherapy
(SOLO 1 and SOLO 2)
1 Concomitant
TCS (CHRONOS)c

Dosingd

A loading dose of 600 mg (2 x 300 mg SC injections) of DUPIXENT at Week 0 followed by 300 mg (1 SC injection) Q2We

Disease severity at baselinef
Moderate atopic
dermatitis (IGA 3)
Severe atopic
dermatitis (IGA 4)

52%

48%

Disease extent at baseline
Mean EASI score
Mean body surface
area involvement
33
out of 72

55%

Itch severity at baselineg
Peak Pruritus NRS
7
out of 10

aThese baseline characteristics are not meant for comparison.1

bIn atopic dermatitis, AD-1021 was a dose-ranging trial to evaluate the safety of DUPIXENT monotherapy through Week 16. SOLO CONTINUE evaluated multiple DUPIXENT monotherapy dose regimens for maintaining treatment response for 36 weeks.1

cIn CHRONOS, as needed, subjects received topical calcineurin inhibitors for problem areas only, such as the face, neck, and intertriginous and genital areas.1

dEmollient background regimen was required.1

eStudied vs placebo.1

fIGA scale was defined as 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.1

gWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).1

Primary endpoint across all 3 adult pivotal trials: The proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and a ≥2-point improvement at Week 16.1

Other endpoints included the proportion of subjects with EASI-75 at Week 16 and ≥4-point improvement in the Peak Pruritus NRS at Week 16. CHRONOS also assessed endpoints at Week 52.1

EASI, Eczema Area and Severity Index; IGA, Investigator's Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; SC, subcutaneous; TCS, topical corticosteroids.

VIEW IGA Results VIEW PEAK PRURITUS NRS RESULTS VIEW EASI RESULTS VIEW REAL-WORLD STUDIES IN ADULTS AND ADOLESCENTS VIEW 52-WEEK ADULT SAFETY PROFILE

Dosage and administration

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