Evidence map›Paper›PMID 40721559›Full record

ArticleDermatology and therapy2025

Clinically Meaningful Improvements in Adolescents with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab who did not Achieve Clear or Almost Clear Skin at Week 16.

Amy S Paller, Andrew Blauvelt, Weily Soong, H Chih-Ho Hong, Marie L A Schuttelaar, Shannon K R Schneider, Eric L Simpson

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03526861 (A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT03526861 phase3completednot on this map

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy

TypeinterventionalSponsorLEO PharmaRan2018 to 2021Enrolled301ConditionsAtopic DermatitisArmsTralokinumab, Placebos
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

7 authors.

Amy S PallerDepartments of Dermatology and Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. apaller@northwestern.edu.
Andrew BlauveltBlauvelt Consulting, LLC, Annapolis, MD, USA.
Weily SoongAllerVie Health-Alabama Allergy and Asthma Center, Birmingham, AL, USA.
H Chih-Ho HongDepartment of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada.
Marie L A SchuttelaarUniversity Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.
Shannon K R SchneiderLEO Pharma Inc., Madison, NJ, USA.
Eric L SimpsonDepartment of Dermatology, Oregon Health & Science University, Portland, OR, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInvestigator's Global Assessment (IGA) of clear/almost clear (0/1) skin is a high standard to achieve after 16 weeks of treatment for patients with moderate-to-severe atopic dermatitis (AD) and does not capture clinically meaningful responses in other patient domains, such as improvement in itch and/or quality of life. To better evaluate the effect of tralokinumab in adolescents, we assessed the clinically meaningful impact of tralokinumab versus placebo in patients who did not meet IGA 0/1 at week 16 without rescue medication in ECZTRA 6.

methodsThese post hoc analyses included adolescents from the ECZTRA 6 (NCT03526861) phase 3 trial who did not achieve IGA 0/1 at week 16 without rescue medication (referred to as IGA >1). Clinically meaningful responses were defined as either ≥50% improvement from baseline in Eczema Area and Severity Index (EASI-50), ≥3-point improvement in Adolescent Worst Pruritus Numeric Rating Scale (itch NRS), or ≥6-point improvement in Children's Dermatology Life Quality Index (CDLQI) at week 16.

resultsAmong IGA >1 patients (n = 247), significantly greater percentages receiving tralokinumab (150 mg or 300 mg) versus placebo achieved EASI-50 (31.2% or 41.3% versus 10.0%), ≥3-point improvement in itch NRS (21.6% or 22.8% versus 8.0%), or ≥1 clinically meaningful measure (36.4% or 52.5% versus 21.1%) at week 16. The majority of IGA >1 patients who continued with open-label tralokinumab beyond week 16 achieved EASI-50 and ≥3-point improvement in itch NRS and about 40% met EASI-90 at week 52.

conclusionsClinically meaningful responses in both clinician-measured and patient-reported outcomes were observed in tralokinumab-treated (150 mg or 300 mg) adolescents who did not achieve IGA 0/1 at week 16 without rescue medication. Utilizing validated outcome measures of both efficacy and patient quality of life, alongside IGA scores, can enhance clinical decision-making regarding tralokinumab treatment responses in adolescents with moderate-to-severe AD.

trial registrationClinicalTrials.gov identifier, NCT03526861 (ECZTRA 6); study start date: 19 June 2018; primary completion date: 15 April 2020; study completion date: 16 March 2021. A Graphical Abstract is available for this article.

Indexed as

AdolescentClinically meaningful responsesECZTRAPhase 3Post hocTralokinumab

Identifiers

PMID40721559
PMCPMC12454845

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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.