About Adbry Efficacy Results Safety Results Support Program
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When topical Rx therapies only go so far
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  • Adbry is the first and only biologic developed to specifically target and neutralize IL-131

  • Adbry demonstrated significant improvements in skin clearance, and improvements in lesion extent and severity and in itch relief at Week 161-4

  • Adbry achieved lasting disease control at Weeks 32 and 521

  • Demonstrated long-term safety through 52 Weeks1

  • The flexibility to treat with Q2W or Q4W dosing after 16 Weeks of treatment (for patients with body weight <100 kg [220 lb]) who achieve clear or almost clear skin 1

  • Adbry has no boxed warning and no requirement for initial lab testing or ongoing lab monitoring in its Prescribing
    Information

Mechanism of Action

References

  1. ADBRY (tralokinumab-ldrm) [package insert]. Madison, NJ: LEO Pharma, Inc; Revised January 2022.
  2. 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.
  3. 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.
  4. Data on file. LEO Pharma A/S. 2021.

Baseline Characteristics and Study Designs1,3

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 ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4
  • Eczema Area and Severity Index (EASI) score ≥16 on a scale of 0 to 72
  • Minimum body surface area (BSA) involvement of ≥10%
Results From Study
Trial 1 & 2 Study Designs Trial 3 Study Designs

IGA 0/11-4

Primary endpoint

  • The proportion of subjects with an IGA of 0 or 1 ("clear" or "almost clear") at Week 16
IGA Study

EASI-751-4 (Primary Endpoint)

Adbry demonstrated > 75% improvement in lesion extent and severity

EASI Study Atopic Dermatitis Treatment

Worst Daily Pruritus NRS at Week 16 (Secondary Endpoint)

Worst Daily Pruitus NRS (Secondary Endpoint)

Maintenance Period¹¯³

References

  1. ADBRY (tralokinumab-ldrm) [package insert]. Madison, NJ: LEO Pharma, Inc; Revised January 2022.
  2. 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.
  3. 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.
  4. Data on file. LEO Pharma A/S. 2021

Safety Trials Results¹

THE SAFETY OF ADBRY WAS DEMONSTRATED IN AN EXTENSIVE CLINICAL PROGRAM

The safety of Adbry was evaluated in a pooled analysis of 5 randomized, double-blind, placebo-controlled trials in subjects with moderate-to-severe atopic dermatitis, including three phase 3 studies (Trial 1, Trial 2, and Trial 3), a dose-finding trial, and a vaccine-response trial.

SAFETY POPULATION AT BASELINE

Safety Population At Baseline
  • In these 5 atopic dermatitis trials, 1964 subjects were treated with subcutaneous injections of Adbry, with or without concomitant topical corticosteroids (TCS). A total of 807 subjects were treated with Adbry for at least 1 year
  • Trial 1 and Trial 2 compared the safety of Adbry monotherapy to placebo through Week 52. Trial 3 compared the safety of
    Adbry+TCS to placebo+TCS through Week 32

Safety: Weeks 0-16 (Trials 1, 2, and 3)1,2

The table below summarizes the adverse reactions identified in the pool of 3 trials (Trials 1, 2, and 3) and that occurred at a rate of at least 1% in the Adbry 300 mg every 2 weeks monotherapy group, and in the Adbry 300 mg every other week+TCS study, all at a higher rate than placebo during the first 16 weeks of treatment.

  • In the monotherapy trials (Trials 1 and 2) through Week 16, the proportion of subjects who discontinued treatment due to adverse reactions was 0.7% in the Adbry 300 mg every other week group and 0% of the placebo group. In the concomitant TCS trial (Trial 3) through Week 16, the proportion of subjects who discontinued treatment due to adverse reactions was 0.8% in the Adbry 300 mg every other week+TCS group and 0% of the placebo+TCS group
  • The most common adverse reactions leading to discontinuation in the Adbry group compared to the placebo group were injection site reaction (0.3% v. 0) and eosinophilia (0.3% v. 0) in Trials 1 and 2; and injection site reaction (0.4% v. 0) and conjunctivitis (0.4% v. 0) in Trial 3

Adbry has no boxed warning, and no requirement for initial lab testing or ongoing lab monitoring in the
Prescribing Information.

Key to Symbols From Table

Safety: Weeks 16-52 (Trials 1 and 2) and Weeks 16-32 (Trial 3)¹:

The safety profile of Adbry 300 mg every other week with or without TCS during maintenance treatment was consistent with that in the initial 16-week treatment period. In addition, the frequency of adverse reactions with Adbry 300 mg every other week and every 4 weeks in Trials 1 and 2 was 44% and 34%, respectively, and 43% and 26% with Adbry 300 mg+TCS every other week and every 4 weeks in Trial 3, respectively.

Reference

  1. ADBRY (tralokinumab-ldrm) [package insert]. Madison, NJ: LEO Pharma, Inc; Revised January 2022.

LEO Pharma is committed to helping ensure that patients can access and initiate therapy with Adbry, including through the Adbry™ Advocate™ Program. See Full Terms, Conditions, and Eligiblity Rules, Restrictions apply. For eligible patients, the Program consists of:

Adbry Advocate Informational Graphic

You or your eligible patients can access all Adbry patient support programs by calling 844-MYADBRY (1-844-692-3279)

Dosing¹

Adbry Dosing Chart

Reference

1. ADBRY (tralokinumab-ldrm) [package insert]. Madison, NJ: LEO Pharma, Inc; Revised January 2022.