Improvement in lesion extent and severity compared to placebo at 16 weeks2–4


DUPIXENT was studied in a Phase 3 clinical trial in adolescents with moderate-to-severe atopic dermatitis (AD) as a monotherapy for up to 16 weeks2–4

Efficacy as monotherapy compared to placebo4

  • AD-1526: Proportion of adolescent patients achieving EASI-75 at Week 16*2

    At 16 weeks, 42% of patients on DUPIXENT achieved ≥75% improvement in lesion extent and severity (EASI-75) compared to 8% of patients on placebo2

      AD-1526: A randomised, placebo-controlled, double-blind, parallel-group, multicentre, Phase 3 trial of adolescent patients (n=251) with moderate-to-severe AD whose disease was inadequately controlled by topical treatment, randomised to receive either a) 200/300 mg DUPIXENT Q2W (n=82) (licensed dose), b) 300 mg DUPIXENT Q4W (n=84) or c) placebo Q2W for 16 weeks.4

      The co-primary endpoints were 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 16.3,4

      The key secondary endpoints were the percentage change in EASI from baseline to Week 16, the percentage change in peak pruritus NRS score from baseline, proportion of patients with ≥3-point improvement in peak pruritus NRS score from baseline to Week 16, proportion of patients with ≥4-point improvement in peak pruritus NRS score from baseline to Week 16.4

      Other secondary endpoints were the proportion of patients achieving at least 50% improvement in EASI (EASI-50), change from baseline in percent body surface area affected (BSA) by AD, percentage change from baseline in SCORing Atopic Dermatitis (SCORAD), and changes from baseline in Children’s Dermatology Life Quality Index (a clinically meaningful improvement in CDLQI is defined as a ≥6-point improvement on a 0–13 scale), Patient-Oriented Eczema Measure (POEM) and SCORAD sleep loss scores from baseline to Week 16.4

  • AD-1526: Proportion of adolescent patients achieving IGA 0 or 1 at Week 16†3,4

    At 16 weeks, 24% of patients on DUPIXENT achieved an IGA score of 0 or 1 with a reduction of ≥2 points on a 0–4 IGA scale compared to 2% of patients on placebo3,4

      AD-1526: A randomised, placebo-controlled, double-blind, parallel-group, multicentre, Phase 3 trial of adolescent patients (n=251) with moderate-to-severe AD whose disease was inadequately controlled by topical treatment, randomised to receive either a) 200/300 mg DUPIXENT Q2W (n=82) (licensed dose), b) 300 mg DUPIXENT Q4W (n=84) or c) placebo Q2W for 16 weeks.4

      The co-primary endpoints were 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 16.3,4

      The key secondary endpoints were the percentage change in EASI from baseline to Week 16, the percentage change in peak pruritus NRS score from baseline, proportion of patients with ≥3-point improvement in peak pruritus NRS score from baseline to Week 16, proportion of patients with ≥4-point improvement in peak pruritus NRS score from baseline to Week 16.4

      Other secondary endpoints were the proportion of patients achieving at least 50% improvement in EASI (EASI-50), change from baseline in percent body surface area affected (BSA) by AD, percentage change from baseline in SCORing Atopic Dermatitis (SCORAD), and changes from baseline in Children’s Dermatology Life Quality Index (a clinically meaningful improvement in CDLQI is defined as a ≥6-point improvement on a 0–13 scale), Patient-Oriented Eczema Measure (POEM) and SCORAD sleep loss scores from baseline to Week 16.4

  • AD-1526: Proportion of adolescent patients achieving EASI-50 at Week 16*3

    At 16 weeks, 61% of patients on DUPIXENT achieved ≥50% improvement in lesion extent and severity (EASI-50) compared to 13% of patients on placebo3

      AD-1526: A randomised, placebo-controlled, double-blind, parallel-group, multicentre, Phase 3 trial of adolescent patients (n=251) with moderate-to-severe AD whose disease was inadequately controlled by topical treatment, randomised to receive either a) 200/300 mg DUPIXENT Q2W (n=82) (licensed dose), b) 300 mg DUPIXENT Q4W (n=84) or c) placebo Q2W for 16 weeks.4

      The co-primary endpoints were 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 16.3,4

      The key secondary endpoints were the percentage change in EASI from baseline to Week 16, the percentage change in peak pruritus NRS score from baseline, proportion of patients with ≥3-point improvement in peak pruritus NRS score from baseline to Week 16, proportion of patients with ≥4-point improvement in peak pruritus NRS score from baseline to Week 16.4

      Other secondary endpoints were the proportion of patients achieving at least 50% improvement in EASI (EASI-50), change from baseline in percent body surface area affected (BSA) by AD, percentage change from baseline in SCORing Atopic Dermatitis (SCORAD), and changes from baseline in Children’s Dermatology Life Quality Index (a clinically meaningful improvement in CDLQI is defined as a ≥6-point improvement on a 0–13 scale), Patient-Oriented Eczema Measure (POEM) and SCORAD sleep loss scores from baseline to Week 16.4

  • AD-1526: Proportion of adolescent patients achieving EASI-90 at Week 16*3

    At 16 weeks, 23% of patients on DUPIXENT achieved ≥90% improvement in lesion extent and severity (EASI-90) compared to 2% of patients on placebo3

      AD-1526: A randomised, placebo-controlled, double-blind, parallel-group, multicentre, Phase 3 trial of adolescent patients (n=251) with moderate-to-severe AD whose disease was inadequately controlled by topical treatment, randomised to receive either a) 200/300 mg DUPIXENT Q2W (n=82) (licensed dose), b) 300 mg DUPIXENT Q4W (n=84) or c) placebo Q2W for 16 weeks.4

      The co-primary endpoints were 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 16.3,4

      The key secondary endpoints were the percentage change in EASI from baseline to Week 16, the percentage change in peak pruritus NRS score from baseline, proportion of patients with ≥3-point improvement in peak pruritus NRS score from baseline to Week 16, proportion of patients with ≥4-point improvement in peak pruritus NRS score from baseline to Week 16.4

      Other secondary endpoints were the proportion of patients achieving at least 50% improvement in EASI (EASI-50), change from baseline in percent body surface area affected (BSA) by AD, percentage change from baseline in SCORing Atopic Dermatitis (SCORAD), and changes from baseline in Children’s Dermatology Life Quality Index (a clinically meaningful improvement in CDLQI is defined as a ≥6-point improvement on a 0–13 scale), Patient-Oriented Eczema Measure (POEM) and SCORAD sleep loss scores from baseline to Week 16.4

  • Visible results demonstrated in adolescent patients at Week 16 with DUPIXENT monotherapy5,6

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

    Non-responder:

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

      AD-1526: A randomised, placebo-controlled, double-blind, parallel-group, multicentre, Phase 3 trial of adolescent patients (n=251) with moderate-to-severe AD whose disease was inadequately controlled by topical treatment, randomised to receive either a) 200/300 mg DUPIXENT Q2W (n=82) (licensed dose), b) 300 mg DUPIXENT Q4W (n=84) or c) placebo Q2W for 16 weeks.4

      The co-primary endpoints were 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 16.3,4

      The key secondary endpoints were the percentage change in EASI from baseline to Week 16, the percentage change in peak pruritus NRS score from baseline, proportion of patients with ≥3-point improvement in peak pruritus NRS score from baseline to Week 16, proportion of patients with ≥4-point improvement in peak pruritus NRS score from baseline to Week 16.4

      Other secondary endpoints were the proportion of patients achieving at least 50% improvement in EASI (EASI-50), change from baseline in percent body surface area affected (BSA) by AD, percentage change from baseline in SCORing Atopic Dermatitis (SCORAD), and changes from baseline in Children’s Dermatology Life Quality Index (a clinically meaningful improvement in CDLQI is defined as a ≥6-point improvement on a 0–13 scale), Patient-Oriented Eczema Measure (POEM) and SCORAD sleep loss scores from baseline to Week 16.4

How is efficacy measured in DUPIXENT trials?

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


Adolescent pruritus and CDLQI

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




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Safety Profile

Learn more about safety profile of DUPIXENT.





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Dosing

Learn more about how the 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).7,8
    An IGA score is based on the clinician’s impression of a patients AD based on severity of erythema, infiltration, papulation and oozing/crusting.9

    AD, atopic dermatitis; BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; TCS, topical corticosteroids.

    References

    1. DUPIXENT Summary of Product Characteristics. September 2021.
    2. 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 (Presentation 4640) presented at the 27th EADV Congress, Paris, France, September 12–16 2018.
    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.
    4. Paller AS, 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.
    5. Paller AS, et al. Early and Clinically Meaningful Responses With Dupilumab Treatment in a Phase 3 Trial in Adolescents With Moderate-to-Severe Atopic Dermatitis (Presentation) presented at the 19th European Society for Pediatric Dermatology Annual Meeting, Dubrovnik, Croatia, May 2–4 2019.
    6. Simpson EL, et al. Dupilumab Provides Clinically Meaningful Responses Versus Placebo: A Post Hoc Analysis of a Phase 3 Trial in Adolescents With Moderate-to-Severe AD Among Patients Not Achieving Investigator’s Global Assessment Score of 0/1 (Poster) presented at the Annual Conference of the Pediatric Dermatology Research Alliance, Chicago, IL, USA, November 14–16 2019.
    7. Leshem YA, et al. Br J Dermatol. 2015;172(5):1353–1357.
    8. EASI User Guide. HOME – Harmonising Outcome Measures for Eczema website. Available at: http://www.homeforeczema.org/documents/easi-user-guide-dec-2016-v2.pdf. Date accessed: September 2021.
    9. Chopra R, et al. Br J Dermatol. 2017;177:(5):1316–1321.

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