Evaluated in >1300 adults 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
patients
>2100
Pivotal
trialsb
2 Monotherapy
(
1 Concomitant
TCS (CHRONOS)c
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
atopic
dermatitis
(IGA 3)
atopic
dermatitis
(IGA 4)
52%
48%
score
surface
area
involvement
out of 72
55%
at baselineg
Pruritus
NRS
out of 10
aThese baseline characteristics are not meant for comparison.
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.
cIn CHRONOS, as needed, subjects received topical calcineurin inhibitors for problem areas only, such as the face, neck, and intertriginous and genital areas.
dEmollient background regimen was required.
eStudied vs placebo.
fIGA scale was defined as 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
gWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).
Primary endpoint across all 3 adult pivotal trials: Change from baseline in 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 change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%) and itch reduction defined by ≥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.