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About Adbry Efficacy Results Safety Results Dosing & Support
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© 2022 LEO Pharma Inc. All rights reserved. MAT-61420 | December 2022

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When topical Rx therapies only go so far
Start with Adbry and SEE PROGRESS CONTINUE

  • Adbry is the first and only biologic developed to specifically target and neutralize IL-131

  • Adbry demonstrated significant skin clearance and itch relief at Week 161,2

  • Itch reduction observed at Week 1 with Adbry monotherapy3*

  • Adbry achieved lasting disease control at Weeks 32 and 521,3

  • 3 years of data in an OLE (Open-Label Extension) trial4

  • Demonstrated long-term safety through 52 Weeks1

  • The only biologic for atopic dermatitis with a reduced-maintenance dosing schedule (Q4W) for appropriate patients1

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

  • *See efficacy and safety results, and applicable Data Limitations for more information.

Mechanism of Action

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.
  3. Data on file. LEO Pharma.
  4. Langley R, Reich K, Simpson E, et al. Long-term improvements in disease severity, itch, and quality of life after 3 years of tralokinumab treatment in adults with moderate-to-severe atopic dermatitis. Poster presented at 4th Annual
    Revolutionizing Atopic Dermatitis Conference, April 9-11, 2022.

Adbry was extensively studied in 3 robust pivotal trials

The efficacy and safety of Adbry were assessed in 3 randomized, double-blind, placebo-controlled trials1

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 Clinical Study

Adbry was assessed in monotherapy and combination therapy trials

Primary Endpoints1

  • Improvement of at least 75% in EASI (EASI-75) at Week 16
  • Achievement of IGA 0 or 1 (clear or almost clear skin) at Week 16

Secondary Endpoint1

  • Reduction of Worst Daily Pruritus NRS (weekly average) of at least 4 points on the 11-point itch NRS from baseline to Week 16
Trial 1 & 2 Study Designs Trial 3 Study Designs

Significant improvements in skin clearance, lesion extent and severity1,4

Monotherapy Study
  • Significantly more patients achieved the primary endpoints of EASI-75 and IGA 0/1 at Week 16 with Adbry + TCS vs
    placebo + TCS
  • In monotherapy trials, 2x to 3x as many patients treated with Adbry vs placebo achieved improvements in the primary
    endpoints of EASI-75 and IGA 0/1 at Week 16
MonoTherapy References

Visible improvement you can see at 16 weeks

Monotherapy Image

Topical corticosteroid use (as needed) with Adbry at
Week 15-164

Ecztra 3

Limitations:

  • Analyses of TCS use as needed were based on the provided TCS only (mometasone furoate 0.1% cream provided every
    other week applied once daily as needed). Additional low potency TCS and TCI were allowed as needed and not accounted for
    in this analysis
  • Analyses were prespecified but not adjusted for multiplicity. Conclusions should be made with caution

TCI=topical calcineurin inhibitor; TCS=topical corticosteroid.

Patients experienced significant itch relief with Adbry

Patients taking Adbry experienced significant itch reduction (≥4-point reduction in Worst Daily Pruritus NRS [weekly average])
at Week 16 vs placebo1,2,4

Worst Daily Pruitus NRS (Secondary Endpoint)

Itch reduction observed with Adbry monotherapy at Week 14

Worst Daily Ecztra 1 & 2

Limitations:

  • Itch reduction as defined by ≥4-point reduction in Worst Daily Pruritus NRS (weekly average) was a prespecified endpoint at
    Week 16 in each of the pooled trials. This analysis was not prespecified and not adjusted for multiplicity. Conclusions should
    be made with caution

Itch reduction with Adbry + TCS (as needed)

Worst Daily Ecztra 3

Limitations:

  • Itch reduction as defined by ≥4-point reduction in Worst Daily Pruritus NRS (weekly average) was a prespecified endpoint at
    Week 16. This analysis and the timepoints were not prespecified and not adjusted for multiplicity. Conclusions should be
    made with caution

With Adbry, achieve lasting disease control for your patients at Week 321

Ecztra 3 Combination Therapy Patient Lasting Disease Control Achieving EASI-75

Limitations:

  • EASI-75 was a prespecified endpoint at Week 16 and 32. Other timepoints and pooling of data and Q2W and Q4W
    treatment arms after Week 16 were not prespecified. Analyses were not adjusted for multiplicity. Conclusions should be made
    with caution

EASI-90 improvement through 32 weeks with Adbry + TCS
(as needed)4

Achieving EASI-90

Limitations:

  • EASI-90 was a prespecified endpoint at Week 16. Other timepoints and pooling of data and Q2W and Q4W treatment arms
    after Week 16 were not prespecified. Analyses were not adjusted for multiplicity and conclusions should be made with caution

See lasting control with Adbry monotherapy at Week 524

Achieving Ecztra 1 & 2

The ECZTEND OLE (Open-Label Extension) trial results up to
3 years

The ECZTEND OLE trial is an ongoing long-term assessment of safety and efficacy5

  • The ECZTEND study is an ongoing, 5-year, single-arm, open-label, long-term extension trial. Patients were permitted to
    enter ECZTEND after completion of the Adbry parent trials and a skin-barrier function study, regardless of treatment
    response or whether they were treated with Adbry or placebo. Patients received a 600 mg loading dose followed by 300 mg
    Q2W + optional TCS (as needed)
  • Patients in the 3-year efficacy cohort were treated with Adbry (Q2W or Q4W monotherapy or Q2W + optional TCS [as
    needed] in parent trials ECZTRA 1 and 2 open-label arm) for 52 weeks in parent trials ECZTRA 1 and 2, followed by up to
    104 weeks of treatment in ECZTEND
  • This safety analysis cohort includes patients from parent trials ECZTRA 1, 2, 3, 4, 5, and 7 (n=1,430) as of data cutoff,
    regardless of duration of treatment exposure4
Median EASI Change Patient Lasting Disease Control

Limitations:

  • Limitations and context associated with the open-label study design and data are described above and include decreasing
    sample size, potential continued involvement of responders, and attrition of nonresponders. Data presented are descriptive
    in nature and no statistical comparisons are made

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.
  5. Langley R, Reich K, Simpson E, et al. Long-term improvements in disease severity, itch, and quality of life after 3 years of
    tralokinumab treatment in adults with moderate-to-severe atopic dermatitis. Poster presented at 4th Annual
    Revolutionizing Atopic Dermatitis Conference, April 9-11, 2022.

The safety of Adbry was demonstrated in an extensive
clinical program¹

The safety of Adbry was evaluated in a pool of 5 randomized, double-blind, placebo-controlled trials in subjects with moderate-
to-severe atopic dermatitis, including three phase 3 studies ECZTRA 1, 2, and 3, a dose-finding trial, and a vaccine-response
trial¹

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 year¹
  • ECZTRA 1 and ECZTRA 2 compared the safety of Adbry monotherapy to placebo through Week 52. ECZTRA 3 compared
    the safety of Adbry+TCS to placebo+TCS through Week 32¹

Demonstrated safety profile through 16 weeks

Adbry demonstrated safety in 5 extensive clinical trials.

Demonstrated safety profile through 52 weeks

Weeks 16-52 (ECZTRA 1 and ECZTRA 2) and Weeks 16-32 (ECZTRA 3):

  • The safety profile of Adbry 300 mg Q2W with or without TCS during maintenance treatment was consistent with that in the initial 16-week treatment period1,2
  • The frequency of adverse reactions with Adbry 300 mg Q2W and Q4W in ECZTRA 1 and ECZTRA 2 was 44% and 34%, respectively, and 43% and 26% with Adbry 300 mg + TCS (as needed) Q2W and Q4W in ECZTRA 3, respectively.1

In a pooled analysis of 5 studies (initial treatment period, Adbry n=1582, placebo n=669)2:

  • Most AEs (>90%) were mild or moderate in severity. The majority of AEs were recovered/resolved for Adbry (61%) and
    placebo (63%)2*
  • Of the conjunctivitis cases that occurred, 2% were severe. The majority (98%) were mild to moderate and resolved during treatment2†
  • The percentage of patients treated with Adbry who experienced skin infection requiring systemic treatment was 2.6% vs 5.5%
    of patients treated with placebo2*

References

  1. Adbry Prescribing Information, LEO Pharma.
  2. Data on file. LEO Pharma.

Adbry is the only biologic for atopic dermatitis with a
reduced-maintenance dosing option for appropriate patients¹

Adbry Dosing Chart

SAVINGS AND SUPPORT WITH THE
ADBRY™ ADVOCATE™ PROGRAM

Personalized treatment support for your eligible patients starts here*

*See Full Terms, Conditions, and Eligiblity Rules.

The Adbry™ Advocate™ Program provides coverage and insurance support for patients who qualify.

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. For eligible patients, the
Program consists of:

Adbry Advocate Informational Graphic

Your eligible patients can access Adbry patient support programs
by calling 844-MYADBRY from 8AM-8PM EST (844-692-3279)

Reference

  1. Adbry Prescribing Information, LEO Pharma.