The largest clinical trial program for AD in adults6*

The DUPIXENT® phase 3 trial program enrolled nearly 2,119 patients worldwide, both as monotherapy and with TCS for up to 52 weeks1

Patients

≥2,100

patients

Three randomized, double-blind, placebo-controlled trials (SOLO 1, SOLO 2, and CHRONOS) enrolled a total of 2,119 subjects 18 years of age and older with moderate-to-severe AD not adequately controlled with topical prescription therapies or when those therapies are not advisable.1
 

Showing the study designs of the DUPIXENT monotherapy and combination therapy studies. SOLO 1 and SOLO 2 were both monotherapy studies, while CHRONOS assessed the efficacy of DUPIXENT in combination with topical corticosteroids. 671 patients were enrolled in SOLO 1, 708 patients in SOLO 2, and 740 patients in CHRONOS. Both SOLO 1 and 2 were 16-week studies, while CHRONOS was a 52-week study.

† Patients received DUPIXENT® or placebo with concomitant use of TCS starting at baseline using a standardized regimen. Patients were also permitted to use topical calcineurin inhibitors (TCI).1
Adapted from the Product Monograph.1

Patients recruited in the DUPIXENT® clinical trial program had a long history of disease along with high disease burden1,5†

Extensive lesion severity:1

mean EASI score of 33/72

Moderate AD:1

52% of subjects had a baseline IGA of 3

Intense pruritus:1

weekly average peak severity of 7/10

Severe AD:1

48% of subjects had a baseline IGA of 4

† High disease burden was defined as a mean baseline EASI score of 19-31.7

Disease severity at baseline1

Adapted from the Product Monograph.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

Visual presentation of AD in patients at baseline8

52%

moderate atopic dermatitis (IGA 3)

48%

severe atopic dermatitis (IGA 4)

Not actual patients. May not be representative of all patients.

TCS : topical corticosteroids; IGA: Investigator’s Global Assessment; EASI: Eczema Area and Severity Index
* Comparative clinical significance has not been established.


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MAT-CA-2300298
Last updated: 06/2023

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