Evidence map›Paper›PMID 39123054›Full record

ArticleDermatology and therapy2024

Patients with Moderate-to-Severe Atopic Dermatitis Maintain Stable Response with No or Minimal Fluctuations with 1 Year of Lebrikizumab Treatment.

Jonathan I Silverberg, Andreas Wollenberg, Linda Stein Gold, James Del Rosso, Gil Yosipovitch, Peter Lio, Jose-Manuel Carrascosa, Gaia Gallo, Yuxin Ding, Zhenhui Xu and 4 more

Erratum issued 2 registry-linked trialsAbstract read
In one paragraph

Article in Dermatology and therapy, 2024. 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, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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 synthesis or guideline pooled it.

  1. Pooled it
  2. Memory Cells in Atopic Dermatitis: Paving the Way to Disease Modification.International journal of molecular sciences · 2026
    Review
  3. Review
  4. Review
  5. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Jonathan I SilverbergGeorge Washington University School of Medicine, Washington, DC, USA. jonathanisilverberg@gmail.com.ORCID http://orcid.org/0000-0003-3686-7805
Andreas WollenbergDepartment of Dermatology and Allergy, University Hospital Augsburg, Augsburg, Germany.ORCID http://orcid.org/0000-0003-0177-8722
Linda Stein GoldHenry Ford Health System, Detroit, MI, USA.ORCID http://orcid.org/0000-0002-2758-1605
James Del RossoJDR Dermatology Research, Las Vegas, NV, USA.ORCID http://orcid.org/0000-0003-4215-7340
Gil YosipovitchMiller School of Medicine, University of Miami, Miami, FL, USA.ORCID http://orcid.org/0000-0001-6303-1822
Peter LioNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.ORCID http://orcid.org/0000-0001-7600-0152
Jose-Manuel CarrascosaHospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, IGTP, Barcelona, Spain.ORCID http://orcid.org/0000-0003-4266-0771
Gaia GalloEli Lilly and Company, Indianapolis, IN, USA.
Yuxin DingEli Lilly and Company, Indianapolis, IN, USA.
Zhenhui XuCIMS Global LLC, Somerset, NJ, USA.ORCID http://orcid.org/0000-0003-0821-1008
Marta CasillasEli Lilly and Company, Indianapolis, IN, USA.ORCID http://orcid.org/0000-0002-6339-5279
Evangeline PierceEli Lilly and Company, Indianapolis, IN, USA.ORCID http://orcid.org/0000-0002-8287-2835
Helena AgellAlmirall S.A., Barcelona, Spain.
Sonja StänderCenter for Chronic Pruritus and Department of Dermatology, University Hospital Münster, Münster, Germany.ORCID http://orcid.org/0000-0003-3612-7786

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLebrikizumab is a novel monoclonal antibody with established efficacy in patients with moderate-to-severe atopic dermatitis (AD) in multiple Phase 3 trials. One of the ultimate treatment goals for patients with moderate-to-severe AD is to achieve stable disease control without concern for planning future life events.

methodsIn ADvocate1 and ADvocate2, lebrikizumab-treated patients meeting the protocol-defined response criteria at Week 16 were re-randomized 2:2:1 to receive lebrikizumab every 2 weeks (Q2W), lebrikizumab every 4 weeks (Q4W), or placebo Q2W (lebrikizumab withdrawal) for 36 additional weeks. In this post hoc analysis, we evaluated the proportions of patients with no or minimal fluctuations of efficacy during the 36-week maintenance period and plotted individual patient trajectories. We defined no or minimal fluctuations as achieving and maintaining the defined endpoint (≥ 75% improvement in the Eczema Area and Severity Index [EASI 75], ≥ 90% improvement in EASI, Pruritus Numeric Rating Scale [NRS] ≥ 4-point improvement, or Pruritus NRS ≥ 3-point improvement) for ≥ 80% of the study visits. If patients used rescue medication, discontinued treatment, or transferred to the escape arm, data collected at or after the event were imputed as non-response.

resultsThe proportions of lebrikizumab responders who maintained EASI 75 with no or minimal fluctuations were 70.8% (lebrikizumab Q2W), 71.2% (lebrikizumab Q4W), and 60.0% (lebrikizumab withdrawal). Of the patients with baseline Pruritus NRS ≥ 4 and who achieved ≥ 4-point improvement at Week 16, 66.1% (lebrikizumab Q2W), 62.7% (lebrikizumab Q4W), and 55.2% (lebrikizumab withdrawal) maintained ≥ 4-point Pruritus NRS improvement with no or minimal fluctuations.

conclusionsPatients who met the response criteria at Week 16 and continued treatment with lebrikizumab Q2W or Q4W demonstrated a stable response with no or minimal fluctuations of efficacy in measures of skin and itch up to Week 52. CLINICAL

trial registrationNCT04146363 (ADvocate1) and NCT04178967 (ADvocate2).

Indexed as

Atopic dermatitisEczemaFluctuationsLebrikizumabResponseStability

Identifiers

PMID39123054
PMCPMC11333651

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.