Evidence map›Paper›PMID 37682422›Full record

ArticleAmerican journal of clinical dermatology2023

Tralokinumab Efficacy Over 1 Year in Adults with Moderate-to-Severe Atopic Dermatitis: Pooled Data from Two Phase III Trials.

Eric L Simpson, Andrew E Pink, Andrew Blauvelt, Melinda Gooderham, April W Armstrong, Margitta Worm, Norito Katoh, Ketty Peris, Luis Puig, Sébastien Barbarot and 4 more

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article 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 2 registered trials, which are not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
8.0field-weighted citation impact, top 2% 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.

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
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 28 citations in OpenAlex.

  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. Trial
  3. Trial
  4. Article
  5. Defining the Potential for Disease Modification in Atopic Dermatitis.American journal of clinical dermatology · 2026
    Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Upadacitinib dose adjustment in moderate-to-severe atopic dermatitis: insights from a multicenter real-world study.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025
    Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Review
  20. Managing Atopic Dermatitis with Dupilumab in Special Populations: A Case Series Study.Clinical, cosmetic and investigational dermatology · 2025
    Article
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 12 institutions in 10 countries.

Eric L SimpsonDepartment of Dermatology, Oregon Health and Science University, Portland, OR, USA.
Andrew E PinkSt. John's Institute of Dermatology, Guy's and St, Thomas' NHS Foundation Trust, London, UK.
Andrew BlauveltOregon Medical Research Center, Portland, OR, USA.
Melinda GooderhamSKiN Centre for Dermatology, Department of Dermatology, Queen's University, and Probity Medical Research, Peterborough, ON, Canada.
April W ArmstrongKeck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Margitta WormDivision of Allergy and Immunology, Department of Dermatology, Venereology and Allergology, Campus Charité Mitte, Universitätsmedizin Berlin, Berlin, Germany.
Norito KatohKyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan.
Ketty PerisDepartment of Dermatology, Catholic University of the Sacred Heart, Rome, Italy.
Luis PuigDepartment of Dermatology, IIB SANT PAU, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Sébastien BarbarotDepartment of Dermatology, University Hospital of Nantes, Nantes, France.
Thomas MarkLEO Pharma A/S, Ballerup, Denmark.
Louise Abildgaard SteffensenLEO Pharma A/S, Ballerup, Denmark.
Ann-Marie TindbergLEO Pharma A/S, Ballerup, Denmark.
Andreas WollenbergDepartment of Dermatology and Allergy, Ludwig Maximilian University of Munich, Munich, Germany. wollenberg@lrz.uni-muenchen.de.
Leo Pharma (Denmark) · DKCentre Hospitalier Universitaire de Nantes · FRCharité - Universitätsmedizin Berlin · DEErasmus Hospital · BEGuy's and St Thomas' NHS Foundation Trust · GBKyoto Prefectural University of Medicine · JPOregon Health & Science University · USOregon Medical Research Center · USQueen's University · CAUniversità Cattolica del Sacro Cuore · ITUniversitat Autònoma de Barcelona · ESUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTwo phase III trials, ECZTRA 1 and 2, confirmed the efficacy and safety of tralokinumab versus placebo in adults with moderate-to-severe atopic dermatitis (AD). To further explore the long-term efficacy of tralokinumab for AD, a pooled analysis of these trials was conducted.

methodsECZTRA 1 and 2 patients (n = 1596 total) were randomized to tralokinumab 300 mg or placebo every 2 weeks (q2w) over 16 weeks. Patients achieving Investigator's Global Assessment of clear/almost clear skin (IGA 0/1) and/or 75% improvement in the Eczema Area and Severity Index (EASI-75) at Week 16, were re-randomized to tralokinumab q2w, every 4 weeks (q4w), or placebo (tralokinumab withdrawal) for another 36 weeks. Patients not achieving the response criteria at Week 16 received open-label tralokinumab q2w plus optional topical corticosteroids (TCS). A pooled, prespecified analysis assessed the proportions of Week 16 responders that maintained IGA 0/1 and/or EASI-75 at Week 52. Pooled data from all patients initiated with tralokinumab, regardless of the response at Week 16 or dosing regimen received thereafter, were analyzed post hoc.

resultsIn patients who achieved the primary endpoints at Week 16, IGA 0/1 responses were maintained at Week 52 without rescue treatment (including TCS) by 55.9%, 42.4%, and 34.0% of patients re-randomized to tralokinumab q2w, q4w, or placebo (tralokinumab withdrawal), respectively, while EASI-75 responses were maintained by 57.3%, 50.4%, and 26.4%, respectively (prespecified analysis). In a post hoc analysis of all patients initiated with tralokinumab, response rates improved over time with continued tralokinumab treatment beyond Week 16 to Week 52 for EASI-50 (63.1-82.7%), EASI-75 (37.6-61.8%), EASI-90 (20.4-37.3%), and IGA 0/1 (23.0-36.2%).

conclusionsTralokinumab treatment provides progressive and sustained improvement over 1 year in the extent and severity of AD in patients with moderate-to-severe AD. CLINICAL

trial registrationNCT03131648 (ECZTRA 1); study start date: 30 May 2017; primary completion date: 7 August 2018; study completion date: 10 October 2019. NCT03160885 (ECZTRA 2); study start date: 12 June 2017; primary completion date: 4 September 2019; study completion date: 14 August 2019. INFOGRAPHIC.

Indexed as

Dermatitis, AtopicDermatologic AgentsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedClinical Trials, Phase III as TopicDouble-Blind MethodGlucocorticoidsHumansImmunoglobulin AInjections, SubcutaneousRandomized Controlled Trials as TopicSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDermatologic AgentsGlucocorticoidsImmunoglobulin Atralokinumab

Identifiers

PMID37682422
PMCPMC10570233
OpenAlexW4386529783

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.