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FOR US
HEALTHCARE
PROFESSIONALS

Strongly recommended by AAD and AAAAI guidelines as a systemic therapy for moderate-to-severe atopic dermatitis in adult patients1,2

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CLINICAL STUDIES

Significant improvements in skin clearance and itch relief with Adbry®

Kalvin, a real Adbry patient

Kalvin, a real Adbry patient. Individual results may vary.

EASI, IGA, and Pruritus NRS at Week 16

 

Significant improvements in skin clearance, lesion extent and severity with both monotherapy and combination therapy3,6

SEE CLINICAL RESULTS

Additional Clinical Results

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BASELINE CHARACTERISTICS

Adbry was extensively studied in 3 robust pivotal trials

The efficacy and safety of Adbry were assessed in 3 randomized, double-blind, placebo-controlled trials6

Baseline characteristics of the Adbry patient
population (ECZTRA 1, 2, and ECZTRA 3 pooled)3,6
Chart: Baseline characteristics of the Adbry patient population (ECZTRA 1,2, and ECZTRA 3 pooled)

*Proportion of patients.
†Worst Daily Pruritus NRS scale ranges from 0-10.

BSA=Body Surface Area; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; NRS=Numeric Rating Scale.

Adbry was studied in nearly 2000 patients graphic

Adbry was assessed as monotherapy and as combination therapy (with TCS as needed)

Primary Endpoints6

  • 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 Endpoint6

  • Reduction of Worst Daily Pruritus NRS (weekly average) of at least 4 points on the 11-point itch NRS from baseline to Week 16
Flowchart illustrating the Adbry® monotherapy clinical trial process, including a 3:1 randomization for screening, initial treatment, and maintenance treatment phases.

q2w=every 2 weeks; q4w=every 4 weeks; TCS=topical corticosteroid.

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.

Flowchart showing the Adbry® combination therapy clinical trial, including a 2:1 randomization for screening, initial treatment, and maintenance treatment phases.

Adbry was administered via subcutaneous injection.

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

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EASI & IGA

Adbry demonstrated significant improvements in skin clearance and lesion extent and severity3,6

  • 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
Week 16 chart: improvements in ECZTRA 1,2 and ECZTRA 3

*Full Analysis Set (FAS) includes all subjects randomized and dosed.
†Subjects who received rescue treatment or with missing data were considered nonresponders.
‡Percentage of patients who achieved response.

Visible improvement you and your patients can see as early as 4 weeks16

Patients treated with Adbry (no TCS) showed improvements in atopic dermatitis lesions at Week 16 in the INJECZTRA open-label trial16

ADBRY MONOTHERAPY Q2W
Progression of atopic dermatitis treatment on an arm using Adbry® monotherapy, showing results before treatment, at Week 4, and at Week 16.
Progression of atopic dermatitis treatment on an arm using Adbry® monotherapy, showing results before treatment, at Week 4, and at Week 16.

Limitations:

Week 16 was a prespecified timepoint. This analysis was not prespecified and not adjusted for multiplicity. Conclusions should be made with caution.

Example of improvement in EASI from baseline to Week 16 in a patient receiving Adbry in the INJECZTRA study.16 Individual patient results may vary.

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WORST DAILY PRURITUS (NRS)

Adbry itch response data

Patients taking Adbry experienced significant itch reduction
(≥4-point reduction in Worst Daily Pruritus NRS [weekly
average]) at Week 16 vs placebo3,6,13

SECONDARY ENDPOINT (Q2W)

Week 16 hart: itch reduction in Worst Daily Pruritus NRS

*Subjects who received rescue treatment or with missing data were considered nonresponders.
†Subjects with baseline Worst Daily pruritus NRS (weekly average) score ≥4.

Beth, a real Adbry clinical trial patient

Beth, a real Adbry clinical trial patient. Individual results may vary.

Itch relief as early as 48 hours* and up to 3 years3,4

Tayttum, a real Adbry patient, smiling with arms crossed while wearing a light blue sweater. Individual results may vary.

Tayttum, a real Adbry patient. Individual results may vary.

Itch reduction was observed with Adbry as early as 48 hours3*

ECZTRA 1 + 2† monotherapy pooled data (q2w)3

Line graph from ECZTRA 1+2 trials showing Adbry vs placebo in Worst Daily Pruritus NRS improvement. At Week 1, Adbry improved by 8.6% vs 3.0% placebo, and by Week 16, Adbry reached 35% vs 21% placebo.

*LS means for % improvement from treatment start in Worst Daily Pruritus NRS: 7.4% with Adbry vs 3.6% with placebo at 48 hours.3

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.

†Patients who received rescue treatment or with missing data were considered nonresponders.

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MAINTENANCE OF RESPONSE

With Adbry, achieve lasting disease control for your patients at Week 32 and Week 526

Analysis of patients achieving EASI-75 at Week 323*

ECZTRA 3: Proportion of patients achieving EASI-753†‡

Chart: Percentage of patients receiving Adbry + TCS who achieved EASI-75 response through Week 32

*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 Q2W + TCS or Adbry Q4W + TCS for another 16 weeks.
†Subjects who received rescue treatment or with missing data were considered nonresponders.
‡All patients randomized to Adbry Q2W + TCS (as needed) in the initial treatment period (Weeks 0 to 16) were pooled for this post-hoc analysis, irrespective of response at Week 16 or tralokinumab dosing regimen (Q2W or Q4W) beyond Week 16. Patients who achieved IGA 0/1 or EASI-75 at Week 16 without use of rescue medication were re-randomized 1:1 to Adbry + TCS Q2W or Q4W. Week 16 nonresponders received Adbry + TCS Q2W.

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)3

ECZTRA 3: Proportion of patients achieving EASI-903†

Chart: Percentage of patients receiving Adbry + TCS who achieved EASI-90 response through Week 32

*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 Q2W + TCS or Adbry Q4W + TCS for another 16 weeks.
†Subjects who received rescue treatment or with missing data were considered nonresponders.
‡All patients randomized to Adbry Q2W + TCS (as needed) in the initial treatment period (Weeks 0 to 16) were pooled for this post-hoc analysis, irrespective of response at Week 16 or tralokinumab dosing regimen (Q2W or Q4W) beyond Week 16. Patients who achieved IGA 0/1 or EASI-75 at Week 16 without use of rescue medication were re-randomized 1:1 to Adbry + TCS Q2W or Q4W. Week 16 nonresponders received Adbry + TCS Q2W.

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 Adbry3

Percentage of responders who maintained response through Week 523*†

Pooled analysis of ECZTRA 1 and 2.

No TCS use graphic

Not an actual size

In ECZTRA 1 and 2,

MORE THAN HALF OF RESPONDERS

at Week 16 maintained response at Week 52

with Adbry 300 mg Q2W as monotherapy without any TCS use in a pooled analysis10*†

Maintenance of response after Adbry discontinuation
(pooled analysis of ECZTRA 1 and 2)3

A remittive effect was seen in ~1/3 of Adbry patients who responded at Week 16 but withdrew from treatment3

IGA-0/1:33% (15/45)   EASI-75:26% (18/70)

Q2W=every 2 weeks; Q4W=every 4 weeks; TCS=topical corticosteroid.
*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 Q2W, Adbry Q4W, or placebo every other week for another 36 weeks.
†Subjects who received rescue treatment or with missing data were considered nonresponders.

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OPEN-LABEL EXTENSION RESULTS

Long-term efficacy results

The ECZTEND OLE (open-label extension) study demonstrated long-term results with up to 4 years of data4

For those patients who remained on Adbry for up to 6 years, response was maintained3§

Graph showing median EASI improvement with Adbry® up to 4 years from parent trials and ECZTEND trial.

EASI=Eczema Area and Severity Index.

*Median EASI score at pivotal trial baseline: 26.7; at ECZTEND baseline: 4.7; at week 152: 1.4.3
†Variable time between last treatment in parent trial and first treatment in ECZTEND (maximum 26 weeks).
‡A total of 2666 patients from the ECZTRA 1, 2, 3, 5, 6, 7, and 8 parent trials were enrolled in ECZTEND as of data cutoff. Data presented from a post-hoc interim analysis of an OLE trial represent a selected subgroup of patients (n=347) from the parent trials ECZTRA 1 and 2 who elected to enter the ECZTEND trial and had consistently received Adbry for a total of up to 4 years at data cutoff (April 30, 2022). As such, data may not be generalizable to the full Adbry population.
§Up to 1 year in parent trials plus up to 5 years in ECZTEND.

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.

ECZTEND was a Phase 3, long-term, five-year, open-label, single-arm extension trial to evaluate the safety and efficacy of Adbry in patients with AD who participated in the previous Adbry parent trials. Patients were permitted to enter ECZTEND after completion of the parent trial regardless of their treatment response or whether they were treated with Adbry or placebo. Patients received a loading dose followed by 300 mg q2w plus optional TCS as needed.4

Long-term safety with Adbry for up to 4.5 years was generally similar to the parent trials’ initial treatment period with respect to overall frequency of most common AEs (≥2.0%).3

SEE SAFETY RESULTS
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