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DUPIXENT was studied in child patients (aged 6–11) with severe atopic dermatitis (AD), who were inadequately controlled by topical treatments2

Recruited paediatric patients had high baseline disease severity and high disease burden2

Extensive lesion severity:

≥37

out of 72

median EASI score

Intense pruritus:

>7

out of 10

median peak severity

Quality of life affected:

>14%

out of 30

CDLQI score

33.5%

total patients on placebo (n=120) and

33.2%

of total patients on DUPIXENT 300 mg Q4W (n=120) received prior systemic treatments for AD

AD-16522

16-week, randomised, placebo-controlled, double-blind, parallel-group, Phase 3 trial including patients aged 6–11 years old with severe AD, and were not adequately controlled by topical treatment

STUDY STUDY DURATION (WEEKS) NUMBER OF PATIENTS TREATMENT ARMS PRIMARY ENDPOINTS
AD-1652
16
367*
Patients were randomised (1:1:1), to 16 weeks of treatment with

a) 300 mg DUPIXENT Q4W + TCS (n=122) (licenced dose),

b) 100 mg (weight, <30 kg) or 200 mg (weight, ≥ 30 kg) DUPIXENT Q2W + TCS (n=122) or

c) placebo + TCS (n=123).
The proportion of patients with IGA 0/1 (clear/almost clear) and the proportion of patients achieving 75% improvement in EASI (EASI-75) from baseline to Week 16.
*Patients were 6–11 years old with severe AD inadequately controlled by topical therapies. Inclusion criteria was defined by IGA score 4, EASI score ≥21, pruritus NRS ≥4 and a minimum BSA involvement ≥15%.

600 mg loading dose for >60 kg.

Rescue treatment with high-potency TCS or systemic therapy was permitted for patients with IGA=4 and/or intolerable symptoms during the treatment period. Very-high-potency TCS were prohibited, even as rescue. The use of rescue treatment resulted in patient being classed as a non-responder.

AD, atopic dermatitis; BSA, body surface area; CDLQI, Children Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, Numerical Rating Scale; Q2W, once very two weeks; Q4W, once every four weeks; TCS, topical corticosteroids.

References

  1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: July 2021.
  2. Paller AS, et al. J Am Acad Dermatol. 2020;83(5):1282–1293.