A total of 917 adult patients in Trials 1 and 2 (16‑week trials) and 421 adult patients in Trial 3 (52‑week trial) with moderate‑to‑severe atopic dermatitis not adequately controlled with topical prescription treatments were randomized to DUPIXENT 300 mg Q2W or placebo. For all patients in Trial 3, lesions were treated with concomitant TCS.1
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
Primary endpoint across all 3 adult pivotal trials: Change from baseline to Week 16 in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and a ≥2-point improvement1
(18+ years of age)1-3
|Number of patients||>2100|
2 Monotherapy (Trials 1 and 2)
1 Concomitant TCS (Trial 3)
|Dosingc||A loading dose of
600 mg (2 x 300 mg SC injections)
of DUPIXENT at Week 0 followed by
300 mg (1 SC injection) Q2Wd
|Disease severity at baseline
Moderate atopic dermatitis (IGA 3)
|Severe atopic dermatitis (IGA 4)||48%|
|Disease extent at baseline
Mean EASI score
|33 out of 72|
|Mean body surface area involvement||55%|
|Itch severity at baselinee
Peak Pruritus NRS
|7 out of 10|
Adult clinical trials included monotherapy (Trials 1 and 2) and with concomitant TCS (Trial 3); all trials initiated with two 300 mg DUPIXENT or placebo subcutaneous injections at Week 0, and emollient background regimen was required.1
Treatment effects in subgroups in Trials 1, 2, and 3 were generally consistent with the results in the overall adult study population1,f
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.
aThese baseline characteristics are not meant for comparison.
bIn atopic dermatitis, Trial 4 was a dose‑ranging trial to evaluate the safety of DUPIXENT monotherapy through Week 16. Trial 5 evaluated multiple DUPIXENT monotherapy dose regimens for maintaining treatment response for 36 weeks.
cEmollient background regimen was required.
dStudied vs placebo.
eWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).
fSubgroup analysis was based on all 3 adult trials.