Evidence map›Paper›PMID 33000503›Full record

Trial reportThe British journal of dermatology2021

Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial.

J I Silverberg, D Toth, T Bieber, A F Alexis, B E Elewski, A E Pink, D Hijnen, T N Jensen, B Bang, C K Olsen and 3 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The British journal of dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 130 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
130citing papers in PubMed, 9 pooled it
25.7field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

130 citing papers in PubMed, 9 syntheses or guidelines pooled it, 307 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. European S2k Guideline on Chronic PruritusActa dermato-venereologica · 2025
    Guideline
  3. Pooled it
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  10. 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
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70 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 6 countries.

J I SilverbergDepartment of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.ORCID 0000-0003-3686-7805
D TothXLR8 Medical Research and Probity Medical Research, Windsor, ON, Canada.
T BieberDepartment of Dermatology and Allergy, University Medical Center, Bonn, Germany.ORCID 0000-0002-8800-3817
A F AlexisDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
B E ElewskiDepartment of Dermatology, University of Alabama, Birmingham, AL, USA.ORCID 0000-0002-1475-2874
A E PinkSt John's Institute of Dermatology, Guy's and St Thomas' Hospitals, London, UK.ORCID 0000-0001-5151-5539
D HijnenDepartment of Dermatology, Erasmus University Medical Center, Rotterdam, the Netherlands.ORCID 0000-0003-3379-3425
T N JensenLEO Pharma A/S, Ballerup, Denmark.
B BangLEO Pharma A/S, Ballerup, Denmark.ORCID 0000-0003-1837-3393
C K OlsenLEO Pharma A/S, Ballerup, Denmark.ORCID 0000-0002-6449-7066
A KurbasicLEO Pharma A/S, Ballerup, Denmark.ORCID 0000-0002-1910-2619
S WeidingerDepartment of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.ORCID 0000-0003-3944-252X
ECZTRA 3 study investigators
Leo Pharma (Denmark) · DKErasmus MC · NLGeorge Washington University · USIcahn School of Medicine at Mount Sinai · USProbity Medical Research · CASt Thomas' Hospital · GBUniversity Hospital Bonn · DEUniversity Hospital Schleswig-Holstein · DEUniversity of Alabama at Birmingham · US

Funding

LEO Pharma A/S N/A
6 · The paper itself

Abstract

backgroundTralokinumab is a fully human monoclonal antibody that specifically neutralizes interleukin-13, a key driver of atopic dermatitis (AD).

objectivesTo evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids (TCS) in patients with moderate-to-severe AD who were candidates for systemic therapy.

methodsThis was a double-blind, placebo plus TCS controlled phase III trial. Patients were randomized 2 : 1 to subcutaneous tralokinumab 300 mg or placebo every 2 weeks (Q2W) with TCS as needed over 16 weeks. Patients who achieved an Investigator's Global Assessment (IGA) score of 0/1 and/or 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16 with tralokinumab were rerandomized 1 : 1 to tralokinumab Q2W or every 4 weeks (Q4W), with TCS as needed, for another 16 weeks.

resultsAt week 16, more patients treated with tralokinumab than with placebo achieved IGA 0/1: 38·9% vs. 26·2% [difference (95% confidence interval): 12·4% (2·9-21·9); P = 0·015] and EASI 75: 56·0% vs. 35·7% [20·2% (9·8-30·6); P < 0·001]. Of the patients who were tralokinumab responders at week 16, 89·6% and 92·5% of those treated with tralokinumab Q2W and 77·6% and 90·8% treated with tralokinumab Q4W maintained an IGA 0/1 and EASI 75 response at week 32, respectively. Among patients who did not achieve IGA 0/1 and EASI 75 with tralokinumab Q2W at 16 weeks, 30·5% and 55·8% achieved these endpoints, respectively, at week 32. The overall incidence of adverse events was similar across treatment groups.

conclusionsTralokinumab 300 mg in combination with TCS as needed was effective and well tolerated in patients with moderate-to-severe AD.

Indexed as

Dermatitis, AtopicEczemaAdrenal Cortex HormonesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansSeverity of Illness IndexTreatment OutcomeAdrenal Cortex HormonesAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedtralokinumab

Identifiers

PMID33000503
PMCPMC7986183
OpenAlexW3090227268

What OpenQuestion holds

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Registered trials

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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.