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EFFICACY RESULTS

Adbry demonstrated statistically significant improvements across all primary and secondary endpoints1

CLINICAL STUDIES

The efficacy of Adbry was assessed in three randomized, double-blind, placebo-controlled trials in a total of 1934 patients1-3

  • The efficacy of Adbry was assessed in three randomized, double-blind, placebo-controlled trials (Trial 1 [ECZTRA 1], Trial 2 [ECZTRA 2], and Trial 3 [ECZTRA 3]; NCT 03131648, 03160885, and 03363854, respectively):

    Study Participants

    • A total of 1934 patients
    • 18 years of age and older
    • Moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s)

    Disease severity was defined by:

    • An Investigator's Global Assessment (IGA) score of ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4
    • Eczema Area and Severity Index (EASI) score of ≥16 on a scale of 0 to 72
    • Minimum body surface area (BSA) involvement of ≥10 %
    Baseline characteristics table
    Endpoints
    Primary endpoints
    • The proportion of subjects with an IGA of 0 or 1 ("clear" or "almost clear") at Week 16
    • An EASI-75 (improvement of at least 75% in EASI score from baseline) at Week 16
    Secondary endpoint
    • The reduction of Worst Daily Pruritus NRS (weekly average) of at least 4 points on the 11-point itch NRS from baseline to Week 16
    Study designs

     

    *

    Responders defined as achieving the primary endpoints of IGA 0 or 1 or EASI-75 at Week 16. Nonresponders at Week 16 and subjects who lost clinical response during the maintenance period were placed on open-label treatment with Adbry 300 mg every other week and optional use of TCS.

    Placebo responders continued on placebo to maintain blind participation and were not included in analyses after Week 16.

    Responders defined as achieving the primary endpoints of IGA 0 or 1 or EASI-75 at Week 16. Subjects who did not achieve clinical response at Week 16 received Adbry 300 mg every other week+TCS for another 16 weeks.

    §
    A midpotency TCS (ie, mometasone furoate 0.1% cream) was dispensed at each dosing visit. The subjects were instructed to apply a thin film of the dispensed TCS as needed, once daily, to active lesions from Week 0 to Week 32, and were to discontinue treatment with TCS when control was achieved. An additional, lower-potency TCS or TCI could be used at the investigator's discretion on areas of the body where use of the supplied TCS was not advisable, such as areas of thin skin.

     

STUDY RESULTS

Icon depicting a bar chart

Adbry demonstrated statistically significant improvements across all primary and secondary endpoints1-4

  • Adbry achieved the primary endpoint of IGA 0 or 1 at Week 16

    *

    Full Analysis Set (FAS) includes all subjects randomized and dosed.

    Subjects who received rescue treatment were considered nonresponders. Subjects with missing data at Week 16 were imputed as nonresponders.

     

    Note: Difference and 95% CI are based on the CMH test stratified by region and baseline IGA score.

  • Adbry achieved the primary endpoint of EASI-75 at Week 16

    *

    Full Analysis Set (FAS) includes all subjects randomized and dosed.

    Subjects who received rescue treatment were considered nonresponders. Subjects with missing data at Week 16 were imputed as nonresponders.

  • Adbry achieved the secondary endpoint of peak pruritus NRS reduction at Week 16
    • Reduction of Worst Daily Pruritus NRS (weekly average) of at least 4 points on the 11-point itch NRS from baseline to Week 16

    *

    Number of subjects with baseline Worst Daily Pruritus NRS (weekly average) score ≥4.

    Subjects who received rescue treatment were considered nonresponders. Subjects with missing data at Week 16 were imputed as nonresponders.

  •  

     

    Graphic of Maintenance Chart

    *Responders were defined as patients who achieved IGA 0/1 (“clear” or “almost clear”) or EASI-75 at Week 16.

Learn About Adbry Safety Results

 

 

References: 1. Adbry Prescribing Information, LEO Pharma. 2. Wollenberg A, Blauvelt A, Guttman-Yassky E, et al; ECZTRA 1 and ECZTRA 2 study investigators. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021;184(3):437-449. doi:10.1111/bjd.19574. 3. Silverberg JI, Toth D, Bieber T, et al; ECZTRA 3 study investigators. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021;184(3):450-463. doi:10.1111/bjd.19573. 4. Data on file. LEO Pharma A/S. 2021.