Improvement in lesion extent and severity compared to placebo at 16 weeks2


DUPIXENT with TCS was studied in a Phase 3 clinical trial in children aged 6–11 years old with severe atopic dermatitis (AD), for up to 16 weeks2

Efficacy with DUPIXENT + TCS compared to placebo2

  • AD-1652: Proportion of child patients achieving EASI-75 at Week 16*2

    At 16 weeks, 70% of patients on DUPIXENT + TCS achieved ≥75% improvement in lesion extent and severity (EASI-75) compared to 27% of patients on placebo + TCS2

      AD-1652: A randomised (1:1:1), placebo-controlled, double-blind, parallel-group, Phase 3 trial of child patients aged 6–11 years (N=367) with severe AD whose disease was inadequately controlled by topical treatment, randomised to receive either a) 300 mg DUPIXENT Q4W + TCS (n=122), b) 100 mg or 200mg DUPIXENT Q2W + TCS (n=122) or c) placebo + TCS (n=123) for 16 weeks.2

      The co-primary endpoints were the proportion of patients with IGA 0 or 1 at Week 16 and the proportion of patients with EASI-75 at Week 16.2

      The key secondary endpoints were the percentage change from baseline in EASI at Week 16 and the percentage change in weekly average of daily peak pruritus NRS.2

      Other secondary endpoints were proportion of patients with ≥3-point improvement in peak pruritus NRS, proportion of patients with ≥4-point improvement in peak pruritus NRS, percentage of patients with EASI-50 and EASI-90, percentage change in SCORAD, change in CDLQI and POEM, change from baseline in PROMIS patient anxiety and depression and SCORAD sleep loss scores from baseline.2

  • AD-1652: Proportion of child patients achieving IGA 0 or 1 at Week 16†2

    At 16 weeks, 33% of patients on DUPIXENT + TCS achieved IGA score of 0 or 1 with a reduction of ≥2 points on a 0–4 IGA scale compared to 11% of patients on placebo + TCS2

      AD-1652: A randomised (1:1:1), placebo-controlled, double-blind, parallel-group, Phase 3 trial of child patients aged 6–11 years (N=367) with severe AD whose disease was inadequately controlled by topical treatment, randomised to receive either a) 300 mg DUPIXENT Q4W + TCS (n=122), b) 100 mg or 200mg DUPIXENT Q2W + TCS (n=122) or c) placebo + TCS (n=123) for 16 weeks.2

      The co-primary endpoints were the proportion of patients with IGA 0 or 1 at Week 16 and the proportion of patients with EASI-75 at Week 16.2

      The key secondary endpoints were the percentage change from baseline in EASI at Week 16 and the percentage change in weekly average of daily peak pruritus NRS.2

      Other secondary endpoints were proportion of patients with ≥3-point improvement in peak pruritus NRS, proportion of patients with ≥4-point improvement in peak pruritus NRS, percentage of patients with EASI-50 and EASI-90, percentage change in SCORAD, change in CDLQI and POEM, change from baseline in PROMIS patient anxiety and depression and SCORAD sleep loss scores from baseline.2

  • Visible results demonstrated in child patients at Week 16 with DUPIXENT + TCS6

    Baseline


    Week 16


    Baseline


    Week 16


    Baseline


    Week 16


    Clinical photographs are actual patients treated with DUPIXENT in the AD-1526 adolescent trial and are used with patient consent. Individual results may vary.

    Responder:

    achieved at least 75% improvement in lesion extent and severity (EASI score) or an IGA of 0 or 1 with a reduction of ≥2 points on a IGA 0–4 scale6

    Non-responder:

    did not achieve at least 75% improvement in lesion extent and severity (EASI score) or an IGA of 0 or 1 with a reduction of ≥2 points on a IGA 0–4 scale6

      AD-1652: A randomised (1:1:1), placebo-controlled, double-blind, parallel-group, Phase 3 trial of child patients aged 6–11 years (N=367) with severe AD whose disease was inadequately controlled by topical treatment, randomised to receive either a) 300 mg DUPIXENT Q4W + TCS (n=122), b) 100 mg or 200mg DUPIXENT Q2W + TCS (n=122) or c) placebo + TCS (n=123) for 16 weeks.2

      The co-primary endpoints were the proportion of patients with IGA 0 or 1 at Week 16 and the proportion of patients with EASI-75 at Week 16.2

      The key secondary endpoints were the percentage change from baseline in EASI at Week 16 and the percentage change in weekly average of daily peak pruritus NRS.2

      Other secondary endpoints were proportion of patients with ≥3-point improvement in peak pruritus NRS, proportion of patients with ≥4-point improvement in peak pruritus NRS, percentage of patients with EASI-50 and EASI-90, percentage change in SCORAD, change in CDLQI and POEM, change from baseline in PROMIS patient anxiety and depression and SCORAD sleep loss scores from baseline.2

How is efficacy measured in DUPIXENT trials?

Learn more about how the patients were assessed in lesion
extent/severity, itch and quality of life.


Child pruritus and CDLQI

Learn more about how DUPIXENT can improve child  quality of life.




Find out more


Safety Profile

Learn more about safety profile of DUPIXENT.





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Dosing

Learn more about how to administer DUPIXENT.





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    *An EASI score is based on a clinician’s weighted score (0 to 72) of four affected areas grading the physical signs of AD (erythema, oedema/papulation, excoriation, lichenification).3,4
    An IGA scale for AD assesses the severity of erythema, induration/papulation, lichenification, oozing/crusting, by using the following grades: clear: IGA, 0; almost clear: IGA, 1; mild: IGA, 2; moderate: IGA, 3; and severe: IGA, 4.5

    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; POEM, Patient Oriented Eczema Measure; PROMIS, Patient-Reported Outcomes Measurement Information System; Q2W, once every two weeks; Q4W, once every four weeks; SCORAD, SCORing Atopic Dermatitis; TCS, topical corticosteroids.

    References

    1. DUPIXENT Summary of Product Characteristics. September 2021.
    2. Paller AS, et al. J Am Acad Dermatol. 2020;83(5):1282–1293.
    3. Leshem YA, et al. Br J Dermatol. 2015;172(5):1353–1357.
    4. EASI User Guide. HOME – Harmonising Outcome Measures for Eczema website. Available at: http://www.homeforeczema.org/documents/easi-user-guide-dec-2016v2.pdf. Date accessed: September 2021.
    5. Suh TP, et al. J Am Acad Dermatol. 2020;82(5):1187–1194.
    6. Shumel B and Rossi AB. The Dermatologist. 2020;28(8):42–46.

MAT-IE-2100181(v4.0) | Date of preparation: February 2022