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EFFICACY RESULTS

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

CLINICAL STUDIES

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

  • The efficacy of Adbry was assessed in three randomized, double-blind, placebo-controlled trials1-3:
    • 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 by1:

    • 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 %
    Adbry Baseline Characteristics Table 

    *Ecztra 1, 2, and 3 pooled.
    NRS= Numeric Rating Scale

    Endpoints1
    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 designs1-3

     

    Adbry was administered via subcutaneous injection.

     

    *

    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

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Adbry demonstrated statistically significant improvements across all primary and secondary endpoints1

  • Adbry demonstrated significant improvements in skin clearance1-4

    IGA 0/1 at week 16 depiction: Adbry monotherapy primary endpoint. Graph depicting Adbry monotherapy primary endpoint and Adbry + TCS as needed primary endpoint

    *

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

    Subjects who received rescue treatmentor missing data were considered as nonresponders.

  • Adbry demonstrated ≥75% improvement in lesion extent and severity1-4

    EASI-75 at week 16 demonstrated >75% improvement in lesion extent severity.

    A higher proportion of subjects in the ADBRY 300 mg every other week arm achieved EASI-90 compared to placebo in the three pivotal trials at week 16

    Visible improvement in atopic dermatitis lesions at Week 16 with Adbry every other week1-4

    Peak Pruritus NRS Before and After Image

    *

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

    Subjects who received rescue treatmentor missing data were considered as nonresponders.

  • Adbry demonstrated significant itch relief

    Graph depicting Adbry 300mg every other week vs. placebo.

    *

    Subjects with baseline Worst Daily Pruritus NRS (weekly average) score ≥4.

    Subjects who received rescue treatment or with missing data were considered as nonresponders.

  • Nearly 9 out of 10 responders at Week 16 experienced lasting disease control at Week 32 with Adbry 300 mg every other week+TCS as needed1*†

    Graphic depicting percentage of patients who maintained response to Adbry: 92% EASI-75 89% IGA 0/1 Graphic depicting percentage of patients who maintained response to Adbry: 92% EASI-75 89% IGA 0/1

     

    Maintenance period, Weeks 16-32: Concomitant TCS Trial (Trial 3)1

    Chart: Maintenance period, weeks 16-32 concomitant TCS Trial (trial 3)

    *

    Responders were defined as subjects with an IGA 0 or 1 (“clear” or “almost clear”) or EASI-75 at Week 16. At Week 16, responders were re-randomized to Adbry 300 mg every other week with TCS or Adbry every 4 weeks with TCS for another 16 weeks.

    Subjects who received rescue treatment or with missing data were considered as nonresponders.

     

    Patients achieved lasting disease control with Adbry1

    Chart: Maintenance period, weeks 16-52: monotherapy trial 1

     

    Chart: Maintenance period, weeks 16-52: monotherapy treatment trial 2

     

    *

    Responders were defined as subjects with an IGA 0 or 1 (“clear” or “almost clear”) or EASI-75 at Week 16. At Week 16, responders were rerandomized to Adbry 300 mg every other week with TCS or Adbry every 4 weeks with TCS for another 16 weeks.

    Subjects who received rescue treatment or with missing data were considered as nonresponders.

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.