Evidence map›Paper›PMID 41217071›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2026

Efficacy of up to 4 years of tralokinumab in adults with moderate-to-severe atopic dermatitis.

Melinda Gooderham, Mahreen Ameen, H Chih-Ho Hong, Norito Katoh, Richard G Langley, Ketty Peris, Kristian Reich, Juan F Silvestre, Eric Simpson, Thomas Werfel and 4 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03131648 phase3completednot on this map

A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

TypeinterventionalSponsorLEO PharmaRan2017 to 2019Enrolled802ConditionsAtopic DermatitisArmsTralokinumab, Placebo
NCT03160885 phase3completednot on this map

A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

TypeinterventionalSponsorLEO PharmaRan2017 to 2019Enrolled794ConditionsAtopic DermatitisArmsTralokinumab, Placebo
NCT03587805 phase3completednot on this map

An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials

TypeinterventionalSponsorLEO PharmaRan2018 to 2024Enrolled1,672ConditionsAtopic DermatitisArmsTralokinumab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Efficacy of up to 4 years of tralokinumab in adults with moderate-to-severe atopic dermatitis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Trial
  2. Article
  3. Review
  4. 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.

Melinda GooderhamSKiN Centre for Dermatology, Peterborough, Ontario, Canada.ORCID https://orcid.org/0000-0001-8926-0113
Mahreen AmeenDepartment of Dermatology, Royal Free London National Health Services Foundation Trust, London, UK.
H Chih-Ho HongDepartment of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada.
Norito KatohDr. Chih-ho Hong Medical Inc., Surrey, British Columbia, Canada.
Richard G LangleyDivision of Clinical Dermatology and Cutaneous Science, Dalhousie University, Halifax, Nova Scotia, Canada.
Ketty PerisDermatology, Catholic University, Rome, Italy.ORCID https://orcid.org/0000-0003-1957-6600
Kristian ReichTranslational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID https://orcid.org/0000-0001-5248-4332
Juan F SilvestreDermatology Department, Hospital General Universitario Dr Balmis, ISABIAL, Alicante, Spain.ORCID https://orcid.org/0000-0002-8532-6338
Eric SimpsonDepartment of Dermatology, Oregon Health & Science University, Portland, Oregon, USA.ORCID https://orcid.org/0000-0003-0853-0252
Thomas WerfelDepartment of Dermatology and Allergy, Hannover Medical School, Hannover, Germany.
Le GjerumLEO Pharma A/S, Ballerup, Denmark.
Ann-Marie TindbergLEO Pharma A/S, Ballerup, Denmark.
Christian Bjerregård ØlandPreviously LEO Pharma A/S, Ballerup, Denmark.
Andrew BlauveltBlauvelt Consulting, LLC, Annapolis, Maryland, USA.ORCID https://orcid.org/0000-0002-2633-985X

Funding

LEO Pharma A/S
6 · The paper itself

Abstract

backgroundAtopic dermatitis (AD) is a relapsing and remitting skin disease often requiring long-term treatment. Tralokinumab, a monoclonal antibody specifically neutralizing interleukin-13, is approved for moderate-to-severe AD treatment in multiple countries.

objectivesAssess long-term efficacy of tralokinumab in adults with moderate-to-severe AD treated for up to 4 years.

methodsThis post hoc interim analysis included the subgroup of patients (n = 347) who completed 52 weeks of tralokinumab in the Phase 3 ECZTRA 1 or ECZTRA 2 (NCT03131648/NCT03160885) trials and subsequently enrolled in the open-label extension trial ECZTEND (NCT03587805; receiving tralokinumab plus optional topical corticosteroids/calcineurin inhibitors [TCS/TCI]) ≥152 weeks prior to data cut-off (30-April-2022).

resultsAt ECZTEND Week 152, 52.6% (95% CI 45.2; 59.8) of patients achieved Investigator's Global Assessment 0/1 (clear or almost clear skin) and 84.5% (95% CI 78.4; 89.1) achieved ≥75% improvement in Eczema Area and Severity Index (EASI) from parent trial baseline; additionally, 84.5% (95% CI 78.4; 89.1), 68.0% (95% CI 60.8; 74.5) and 79.0% (95% CI 72.1; 84.6) reached EASI ≤7 (no-to-mild disease), Worst Weekly Pruritus Numeric Rating Scale ≤4 (no-to-mild itch) and Dermatology Life Quality Index ≤5 (no-to-small effect on quality of life), respectively. Responses were stable over time, with 71.4% (95% CI 66.3; 76.0) of patients maintaining EASI ≤7 at ≥80% of days between Week 16 and 152 in ECZTEND. During ECZTEND, 28.5% of patients discontinued: 7.5% due to lack of efficacy and 5.8% due to adverse events (AEs). The most frequently reported AEs in ECZTEND were consistent with the known safety profile of tralokinumab, including nasopharyngitis (IR = 13.6), upper respiratory tract infection (IR = 4.4) and conjunctivitis (IR = 2.3).

conclusionsThese data suggest that tralokinumab plus optional TCS/TCI provides long-term stable disease control, equivalent to no-to-mild disease, in a subgroup of adults with moderate-to-severe AD who completed 1 year of treatment in parent trials and up to 3 years in ECZTEND.

Indexed as

Antibodies, MonoclonalDermatitis, AtopicDermatologic AgentsAdultFemaleHumansMaleMiddle AgedQuality of LifeSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalDermatologic Agentstralokinumabatopic dermatitisclinical trialpruritus/itchquality of lifetralokinumab

Identifiers

PMID41217071
PMCPMC13109762

What OpenQuestion holds

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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.