Evidence map›Paper›PMID 37195407›Full record

Trial reportAmerican journal of clinical dermatology2023

Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: An Integrated Analysis of Eight Clinical Trials.

Linda Stein Gold, Diamant Thaçi, Jacob P Thyssen, Melinda Gooderham, Vivian Laquer, Angela Moore, Chitra R Natalie, Fangyi Zhao, Eric Meskimen, Hany Elmaraghy and 4 more

8 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American journal of clinical dermatology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 8 registered trials, which are not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
17.7field-weighted citation impact, top 1% of its field
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.

NCT02340234 phase2completednot on this map

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lebrikizumab in Patients With Persistent Moderate to Severe Atopic Dermatitis That is Inadequately Controlled by Topical Corticosteroids

TypeinterventionalSponsorHoffmann-La RocheRan2015 to 2016Enrolled212ConditionsAtopic DermatitisArmsLebrikizumab, Placebo, TCS Cream
NCT02465606 phase2completednot on this map

An Open-Label Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Persistent, Moderate to Severe Atopic Dermatitis

TypeinterventionalSponsorHoffmann-La RocheRan2015 to 2016Enrolled55ConditionsAtopic DermatitisArmsLebrikizumab, Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)
NCT03443024 phase2completednot on this map

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

TypeinterventionalSponsorEli Lilly and CompanyRan2018 to 2019Enrolled280ConditionsAtopic DermatitisArmsLebrikizumab, Placebo
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
NCT04250337 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy and Safety of Lebrikizumab When Used In Combination With Topical Corticosteroid Treatment In Patients With Moderate-To-Severe Atopic Dermatitis

TypeinterventionalSponsorEli Lilly and CompanyRan2020 to 2021Enrolled228ConditionsAtopic DermatitisArmsLebrikizumab, Placebo, Topical Corticosteroid
NCT04250350 phase3completednot on this map

An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorEli Lilly and CompanyRan2020 to 2022Enrolled206ConditionsAtopic DermatitisArmsLebrikizumab
NCT04392154 phase3completednot on this map

A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)

TypeinterventionalSponsorEli Lilly and CompanyRan2020 to 2025Enrolled1,153ConditionsAtopic DermatitisArmsLebrikizumab
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.

  1. European Guideline (EuroGuiDerm) on atopic eczema: Living update.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    Guideline
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. From Pathways to Patients in Atopic Dermatitis: Advanced Systemic Therapies.International journal of molecular sciences · 2025
    Review
  11. Review
  12. Article
  13. Article
  14. A Clinician's Guide to Dupilumab-related Ocular Surface Disease.The Journal of clinical and aesthetic dermatology · 2025
    Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 6 countries.

Linda Stein GoldDepartment of Dermatology, Henry Ford Health System, Detroit, MI, USA. lstein1@hfhs.org.
Diamant ThaçiInstitute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
Jacob P ThyssenBispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
Melinda GooderhamSKiN Centre for Dermatology, Peterborough, ON, Canada.
Vivian LaquerFirst OC Dermatology Research, Fountain Valley, CA, USA.
Angela MooreArlington Research Center, Arlington, TX, USA.
Chitra R NatalieEli Lilly and Company, Indianapolis, IN, USA.
Fangyi ZhaoEli Lilly and Company, Indianapolis, IN, USA.
Eric MeskimenEli Lilly and Company, Indianapolis, IN, USA.
Hany ElmaraghyEli Lilly and Company, Indianapolis, IN, USA.
Sonia MontmayeurEli Lilly and Company, Indianapolis, IN, USA.
Gaia GalloEli Lilly and Company, Indianapolis, IN, USA.
Gemma JimenezAlmirall, S.A., Barcelona, Spain.
Marjolein de Bruin-WellerUniversity Medical Center Utrecht, Utrecht, The Netherlands.
Eli Lilly (United States) · USAlmirall (Spain) · ESBaylor University Medical Center · USHenry Ford Health System · USQueen's University · CAUniversity Medical Center Utrecht · NLUniversity of Copenhagen · DKUniversity of Lübeck · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLebrikizumab is a monoclonal antibody that binds with high affinity to interleukin (IL)-13, thereby blocking the downstream effects of IL-13 with high potency.

objectivesTo report integrated safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis from phase 2 and 3 studies.

methodsFive double-blind, randomized placebo-controlled studies; one randomized open-label study; one adolescent open-label, single-arm study; and one long-term safety study were summarized in two datasets: (1) placebo-controlled week 0-16 (All-PC Week 0-16) in patients who received lebrikizumab 250 mg every 2 weeks (LEBQ2W) versus placebo and (2) patients who received any dose of lebrikizumab at any time during the studies (All-LEB). Exposure-adjusted incidence rates (IR)/100 patient-years (PY) are provided.

resultsA total of 1720 patients received lebrikizumab (1637.0 PY exposure). In All-PC Week 0-16, the frequency of treatment-emergent adverse events (TEAEs) was similar between treatment groups; most events were nonserious and mild or moderate in severity. The most frequently reported TEAEs were atopic dermatitis (placebo) and conjunctivitis (LEBQ2W). Frequencies of conjunctivitis cluster were 2.5% (placebo) and 8.5% (LEBQ2W), and all events were mild or moderate (All-LEB 10.6%, IR, 12.2). Frequencies of injection site reactions were 1.5% (placebo) and 2.6% (LEBQ2W; All-LEB 3.1%, IR, 3.3). Frequencies of adverse events leading to treatment discontinuation were 1.4% (placebo) and 2.3% (LEBQ2W; All-LEB 4.2%, IR, 4.5).

conclusionThe safety profile for lebrikizumab consisted of TEAEs that were mostly nonserious, mild or moderate in severity, and did not lead to treatment discontinuation. The safety profile was similar in both adults and adolescents. CLINICALTRIALS: GOV: NCT02465606, NCT02340234, NCT03443024, NCT04146363, NCT04178967, NCT04250337, NCT04250350, NCT04392154 Safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis: an integrated analysis of eight clinical trials (MP4 34165 KB).

Indexed as

ConjunctivitisDermatitis, AtopicAdolescentAdultAntibodies, MonoclonalDouble-Blind MethodHumansInterleukin-13Severity of Illness IndexTreatment OutcomeAntibodies, MonoclonalInterleukin-13lebrikizumab

Identifiers

PMID37195407
PMCPMC10191071
OpenAlexW4376871458

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 2 more above

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.