Evidence map›Paper›PMID 39249591›Full record

Trial reportAdvances in therapy2025

Improvement Across Dimensions of Disease with Lebrikizumab Use in Atopic Dermatitis: Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Monotherapy Trials (ADvocate1 and ADvocate2).

Eric Simpson, Pablo Fernández-Peñas, Marjolein de Bruin-Weller, Peter A Lio, Chia-Yu Chu, Khaled Ezzedine, Helena Agell, Marta Casillas, Yuxin Ding, Fan Emily Yang and 2 more

Erratum issued 2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04146363 phase3completednot on this map

A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis

TypeinterventionalSponsorEli Lilly and CompanyRan2019 to 2022Enrolled424ConditionsAtopic DermatitisArmsLebrikizumab, Placebo
NCT04178967 phase3completednot on this map

A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis.

TypeinterventionalSponsorEli Lilly and CompanyRan2019 to 2022Enrolled445ConditionsAtopic DermatitisArmsLebrikizumab, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Eric SimpsonOregon Health & Science University, Portland, OR, USA. simpsone@ohsu.edu.ORCID 0000-0003-0853-0252
Pablo Fernández-PeñasWestmead Hospital, Sydney Medical School, The University of Sydney, Sydney, Australia.
Marjolein de Bruin-WellerNational Expertise Center of Atopic Dermatitis, University Medical Center Utrecht, Utrecht, The Netherlands.
Peter A LioNorthwestern University, Chicago, IL, USA.
Chia-Yu ChuNational Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
Khaled EzzedineHenri Mondor University Hospital and Université Paris-Est Créteil University, Créteil, France.
Helena AgellAlmirall, S.A., Barcelona, Spain.
Marta CasillasEli Lilly and Company, Indianapolis, IN, USA.
Yuxin DingEli Lilly and Company, Indianapolis, IN, USA.
Fan Emily YangEli Lilly and Company, Indianapolis, IN, USA.
Evangeline PierceEli Lilly and Company, Indianapolis, IN, USA.
Thomas BieberUniversity Hospital Bonn, Bonn, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAtopic dermatitis is a complex, chronic, inflammatory skin disease that requires long-term control of symptoms like itch and sleep loss and improvement in quality of life, in addition to reduction of clinical signs. Lebrikizumab is a selective interleukin-13 inhibitor approved in the European Union, United Kingdom, United Arab Emirates, Canada, and Japan for treatment of moderate-to-severe atopic dermatitis in adults and adolescents. Here, we assess the magnitude of changes across signs and symptoms of atopic dermatitis with lebrikizumab monotherapy over the 16-week induction period in two phase 3 studies, ADvocate1 and ADvocate2.

methodsEligible adults (aged ≥ 18 years) and adolescents (aged 12 to < 18 years and weighing ≥ 40 kg) with moderate-to-severe atopic dermatitis were randomized to receive either 250 mg of lebrikizumab or placebo subcutaneously every two weeks. Least squares mean percentage change from baseline through week 16 was compared between lebrikizumab and placebo using mixed model repeated measure analysis for the following endpoints: Eczema Area and Severity Index (EASI), Pruritus Numeric Rating Scale (NRS), Sleep-Loss Scale, Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI).

resultsIn both trials, significant (P < 0.05) improvements were observed for lebrikizumab treatment compared with placebo at each 2-week timepoint for EASI, Pruritus NRS, Sleep-Loss Scale, and POEM, and at each 4-week timepoint for DLQI, through week 16. Statistically significant (P < 0.001) improvements were observed at 16 weeks for lebrikizumab treatment versus placebo in ADvocate1/ADvocate2 for EASI (71.9%/75.0% vs. 35.6%/43.3%), Pruritus NRS (53.3%/46.3% vs. 21.4%/18.0%), Sleep-Loss Scale (57.7%/55.6% vs. 23.9%/25.5%), POEM (54.4%/45.8% vs. 18.8%/16.9%), and DLQI (64.2%/60.5% vs. 28.5%/32.2%). Patient photos show improvements in skin appearance when disease measures improve.

conclusionsLebrikizumab monotherapy resulted in significant and fast improvements in multiple dimensions of disease (clinical signs, symptoms, and quality of life) over 16 weeks in patients with moderate-to-severe atopic dermatitis.

trial registrationClinicalTrials.gov identifiers, NCT04146363; NCT04178967.

Indexed as

Antibodies, MonoclonalDermatitis, AtopicAdolescentAdultChildDouble-Blind MethodFemaleHumansMalePruritusQuality of LifeSeverity of Illness IndexTreatment OutcomeYoung AdultAntibodies, MonoclonallebrikizumabAtopic dermatitisItchLebrikizumabPatient-reported outcomesQuality of lifeSkinSleep

Identifiers

PMID39249591
PMCPMC11782436

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.