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Dupixent was studied in adolescent patients (aged 12–17) with moderate-to-severe atopic dermatitis (AD) who were inadequately controlled by topical treatments1

Recruited adolescent patients had high baseline disease severity and high disease burden2,3

Extensive lesion severity:

≥35

out of 72

mean EASI score

Intense pruritus:

>7

out of 10

mean peak severity

Quality of life affected:

>13%

out of 30

CDLQI score

38.8%

total patients on placebo (n=85) and

42.7%

of total patients on DUPIXENT Q2W (n=82) received prior systemic treatments for AD

AD-15262

16-week, randomised, double-blind, placebo-controlled, multi-centre, parallel-group, Phase 3 trial including adolescent patients who had moderate-to-severe AD, and were not adequately controlled by topical treatment

STUDY STUDY DURATION (WEEKS) NUMBER OF PATIENTS TREATMENT ARMS PRIMARY ENDPOINTS
AD-1526 16 251* Patients were randomised (1:1:1) to 16 weeks of treatment with
a) 200 mg (weight, <60 kg) or 300 mg (weight, ≥60 kg) DUPIXENT Q2W (n=82) (licensed dose),
b) 300 mg DUPIXENT Q4W (n=84) or c) placebo Q2W (n=85).
One patient in the DUPIXENT Q4W group was randomised but did not receive treatment.
The proportion of patients with both 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 12 to 17 years old with moderate-to-severe AD inadequately controlled by topical therapies. Inclusion criteria was defined by IGA score ≥3, and EASI score ≥16, pruritus NRS ≥4, and a minimum BSA involvement of ≥10.


Topical therapy and other systemic atopic dermatitis therapies were prohibited but allowed as rescue treatment for intolerable symptoms. The use of rescue treatment resulted in patient being classed as a non-responder.

AD, atopic dermatitis; BSA, body surface area; CDLQI, Children’s Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; 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 A, et al. Dupilumab for Adolescents With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 3, Randomized, Double-Blinded Trial (Poster 10051) presented at the 77th annual meeting of the American Academy of Dermatology, Washington, DC, USA, March 1–5 2019.
  3. Simpson EL, et al. Dupilumab Efficacy and Safety in Adolescents With Moderate-to-Severe Atopic Dermatitis: Results From a Multicenter, Randomized, Placebo Controlled, Double-Blind, Parallel-Group, Phase 3 Study (Poster PA-17) presented at the 43rd annual Hawaii Dermatology Seminar; Waikoloa, HI, USA, February 17–22 2019.