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The impact of tralokinumab on quality of life and school in patients aged 12–17 with atopic dermatitis: results from the phase 3 ECZTRA 6 trial
Amy S. Paller1, Jonathan I. Silverberg2, H. Chih-ho Hong3, Michael Cork4, Luis Puig5, Petra Arlert6, Azra Kurbasic6, Lise Soldbro6, Eric L. Simpson7

1Departments of Dermatology and Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago IL, USA; 2Department of Dermatology, George Washington University, Washington DC, USA; 3Department of Dermatology and Skin Science, University of British Columbia and Probity Medical Research, Surrey, BC, Canada; 4Sheffield 

Dermatology Research, Department of Infection, Immunity, and Cardiovascular Disease, The University of Sheffield and Sheffield Teaching Hospitals, NIHR Clinical Research Facility, Sheffield, UK; 5Department of Dermatology, Hospital de la Santa Creu i Sant Pau-Universitat Autònoma de Barcelona, Barcelona, Spain; 6LEO Pharma, A/S, Ballerup, 

Denmark; 7Department of Dermatology, Oregon Health & Science University, Portland, OR, USA 

• Tralokinumab resulted in significantly greater adjusted CDLQI mean change vs placebo, and increased 
proportions of patients with CDLQI ≥6

• Tralokinumab improved several patient-reported outcomes that encompass psychosocial effects of AD in this 
vulnerable paediatric age group, as measured by the CDLQI

• Tralokinumab had a substantial benefit on the impact of AD on subdomains in the CDLQI related to 
school/holiday at Week 16

• There was a trend towards treatment benefit with tralokinumab vs placebo across multiple other psychosocial 
domains

• The largest improvements in QoL were seen in the tralokinumab 300 mg group

Conclusions

References 

1. Bieber T. Allergy. 2020;75:54–62; 2. Tsoi LC, et al. J Invest Dermatol. 2019;139:1480–89; 3. Popovic B, et al. 

J Mol Biol. 2017;429:208–19; 4. Ng M, et al. Australas J Dermatol. 2018;59:e114-e17; 5. Ghio D, et al. Br J 

Health Psychol. 2021;26:214-31; 6. Manjunath J, et al. J Eur Acad Dermatol Venereol. 2022;36:e346–e48; 7.

Wollenberg A, et al. Presented at European Society for Pediatric Dermatology 21st Annual Meeting 2022; 8.

Paller A, et al. Presented at 2021 Fall Clinical Dermatology Conference 40th Annual Meeting.

Disclosures
Amy S. Paller has served as an investigator for AbbVie, Anaptysbio, Incyte, Janssen, KrystalBio, LEO Pharma, Regeneron, and UCB, received 

honorarium for consultancy from AbbVie, Abeona, Almirall, Anaptysbio, Arena, Azitra, BiomX, Boehringer Ingelheim, Castle Biosciences, Catawba, 

Dermira, Exicure, Forté, Kamari, LEO Pharma, Lilly, LifeMax, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Seanergy, and UCB, and served on a Data 

Safety Monitory Board for AbbVie, Bausch, Galderma, and Novan. Jonathan I. Silverberg is an investigator for AbbVie, Celgene, Eli Lilly and 

Company, GSK, Kiniksa, LEO Pharma, Menlo Therapeutics, Realm Therapeutics, Regeneron, Roche, and Sanofi; a consultant for Pfizer Inc., AbbVie, 

Anacor, AnaptysBio, Arena Pharmaceuticals, Asana Biosciences, Dermira, Dermavant, Eli Lilly and Company, Galderma, GSK, Glenmark, Incyte, 

Kiniksa, LEO Pharma, MedImmune, Menlo Therapeutics, Novartis, Realm Therapeutics, Regeneron, and Sanofi; a speaker for Regeneron and Sanofi; 

and is on advisory boards for Pfizer Inc., Dermira, LEO Pharma, and Menlo Therapeutics. H. Chih-ho Hong is a researcher, consultant, and/or advisor 

for AbbVie, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, Celgene, Dermavant, Dermira, DS Biopharma, Galderma, GlaxoSmithKline, Incyte, 

Janssen, LEO Pharma, Lilly, MedImmune, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, and UCB. Michael Cork has served as a 

clinical trial investigator for Astellas, Galapagos, Johnson & Johnson, LEO Pharma, La Roche-Posay, MSD, Novartis, Perrigo, Regeneron, Sanofi 

Genzyme, and Stiefel; has served as an advisory board member, consultant, and/or invited lecturer for Pfizer Inc., Amgen, Astellas, Bayer, Johnson &

Johnson, LEO Pharma, L’Oréal, MSD, Novartis, Regeneron, Sanofi Genzyme, Stiefel, and Unilever; has received honoraria from Astellas, Johnson & 

Johnson, LEO Pharma, Novartis, Regeneron, Sanofi Genzyme, and Stiefel; and has received research funding from Bayer. Luís Puig has received 

consultancy/speaker’s honoraria from and/or participated in clinical trials sponsored by Abbvie, Almirall, Amgen, Baxalta, Biogen, Boehringer 

Ingelheim, Celgene, Gebro, Janssen, JSC BIOCAD, Leo-Pharma, Lilly, Merck-Serono, MSD, Mylan, Novartis, Pfizer, Regeneron, Roche, Sandoz, 

Samsung-Bioepis, Sanofi and UCB. Petra Arlert, Azra Kurbasic, and Lise Soldbro are employees of LEO Pharma A/S. Eric L. Simpson is a consultant 

and investigator for Regeneron/Sanofi, Dermira, Menlo Pharmaceuticals, Lilly, Abbvie, Genentech, Medimmune, GSK, LEO Pharma, Celgene, and 

Pfizer.

Acknowledgements
The ECZTRA 6 clinical trial was sponsored by LEO Pharma A/S (Ballerup, 

Denmark). This poster is an encore of a previous presentation at the 12th 

International Symposium on Atopic Dermatitis, 17 – 19 October 2022. Editorial 

support from Alphabet Health (New York, NY, USA) by Juliel Espinosa, PhD 

and Meredith Whitaker, PhD was funded by LEO Pharma (USA).

Affect of AD on CDLQI domains: Weeks 0-16

• At Week 16, AD had ‘not at all’:

• affected how embarrassed or self-conscious the patient was over the past 7 days in 49.0/47.9% of 
tralokinumab (150/300 mg) treated patients vs 37.0% receiving placebo (Figure 2A)

• affected friendships over the past 7 days in 82.3/80.2% of tralokinumab (150/300 mg) treated patients vs 
71.7% receiving placebo (Figure 2B)

• influenced clothes you wear over the past 7 days in 55.2/55.2% of tralokinumab (150/300 mg) treated 
patients vs 43.5% receiving placebo (Figure 2C)

• affected going out, play, or hobbies over the past 7 days in 54.2/59.4% of tralokinumab (150/300 mg) 
treated patients vs 43.5% receiving placebo (Figure 2D)

• At Week 16, 60.4/61.5% of tralokinumab (150/300 mg) treated patients had ‘not at all’ avoided swimming or 
other sports due to AD over the past 7 days vs 51.1% receiving placebo (Figure 2E)

• At Week 16, AD had ‘not at all’:

• affected school/holiday over the past 7 days in 44.8/49.0% of tralokinumab (150/300 mg) treated patients 
vs 28.3% receiving placebo (Figure 2F)

• impacted trouble with other people over the past 7 days in 83.3/82.3% of tralokinumab (150/300 mg) 
treated patients vs 78.3% receiving placebo (Figure 2G)

• At Week 16, problem with treatment affected patients ‘not at all’ over the past 7 days in 50.0/59.4% of 
tralokinumab (150/300 mg) treated patients vs 39.1% receiving placebo (Figure 2H)

0

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0 2 4 6 8 10 12 14 16

31.0

39.5

15.9Tralokinumab 150 mg Q2W (n=84)

Placebo (n=82)

Tralokinumab 300 mg Q2W (n=81)

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 (
%

)

Week

CDLQI reduction ≥6b

-8

-6

-4

-2

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0 2 4 6 8 10 12 14 16

–6.1
–6.7

–4.1

Tralokinumab 150 mg Q2W (n=95)

Placebo (n=89)

Tralokinumab 300 mg Q2W (n=94)

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CDLQIa8

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Week

A B

aData collected after permanent discontinuation of tralokinumab or initiation of rescue medication after Week 2 were not included. Repeated measurements model: Change = 
Treatment*Week+Baseline*Week+Region+Baseline IGA. In case of no post-baseline assessments, the Week 2 change was imputed as 0. bPatients who received rescue medication 
after Week 2 were considered non-responders, as were patients with missing data at Week 16.

*Mantel-Haenszel risk difference compared with placebo, stratified by region and baseline IGA *p<0.05 vs placebo; **p<0.01 vs placebo; ***p<0.001 vs placebo. Patients with at 
least baseline data available were included in the CDLQI adjusted mean change analysis (A), and patients with CDLQI ≥6 at baseline were included in the CDLQI reduction ≥6 
analysis (B).
CDLQI, Children's Dermatology Life Quality Index; IGA, Investigator’s Global Assessment; Q2W, every 2 weeks.

Figure 1. (A) Adjusted mean change in CDLQI and (B) reduction of CDLQI ≥6 by week 

Materials and Methods

Study design

• Adolescents with moderate-to-severe AD (n=289) received tralokinumab 150 mg or 300 mg or placebo every 2 
weeks (Q2W) during the initial phase (Weeks 0–16)

• QoL and impact on school was measured using the CDLQI, a 10-item questionnaire assessing 
patient/caregiver-reported AD impact

• This analysis presents the results for most of the CDLQI subdomains (excluding ‘How Itchy, Sore, Painful’ 
and ‘Affected Sleep’, which are addressed by other analyses elsewhere)

• Change and proportion of patients with ≥6-point reduction (minimal important difference) from baseline to 
Week 16 in total CDLQI were evaluated using a linear mixed model for repeated measures and Cochran-
Mantel-Haenszel test, respectively

• Individual CDLQI domains were evaluated with the Pearson chi-square test

• Rescue medication [topical calcineurin inhibitor (TCI), TCS, systemic treatment] was used if medically necessary 
(i.e., to control intolerable AD symptoms)

Objective

• To examine the impact of tralokinumab on AD-related QoL and school in adolescents during Weeks 0–16 of 
the ECZTRA 6 trial (NCT03526861)

Results

Change in CDLQI and reduction of CDLQI ≥6: Weeks 0-16

• At Week 16, adjusted mean change from baseline in CDLQI was significantly greater with tralokinumab 150 mg 
(–6.1) and 300 mg (–6.7) vs placebo (–4.1); difference* –2.0 (p=0.04) and –2.6 (p=0.007) respectively (Figure 1A)

• More patients had ≥6-point reduction (minimal important difference in adolescents) with tralokinumab 150 mg 
(31.0%) and 300 mg (39.5%) vs placebo (15.9%); difference* 14.1% (p=0.029) and 23.9% (p<0.001), respectively 
(Figure 1B)

Introduction

• Tralokinumab is a fully human monoclonal antibody that binds with high affinity to interleukin-13, a key driver of 
atopic dermatitis (AD) pathogenesis1–3

• AD is a chronic inflammatory skin disease associated with poor quality of life (QoL) and a substantial 
psychosocial impact in adolescents4,5

• AD is associated with poor school behaviours in adolescent patients, including poor task completion, poor 
connectedness and impulsivity6

• The phase 3 ECZTRA 6 trial (NCT03526861) of patients aged 12–17 years with moderate-to-severe AD showed:

• Tralokinumab monotherapy had superior efficacy to placebo for all primary and key secondary efficacy 
endpoints, including change in Children’s Dermatology Life Quality Index (CDLQI) from baseline to Week 167

• Here we present a detailed analysis of CDLQI results from ECZTRA 6

Introduction

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Figure 2. Affect of AD on CDLQI domains (Weeks 0-16)

Last observation carried forward (LOCF) was used for patients who used rescue medication or discontinued treatment (observation prior to rescue initiation/treatment discontinuation) or had missing data. Sensitivity analyses used observed data, and LOCF was used for patients missing data. Rescue medication was 
used by 56.4%, 33.7% and 29.9% in the placebo, tralokinumab 150 mg and 300 mg arms, respectively. Across arms, >70% of patients used topical corticosteroids only. 
P values = Pearson chi-square test vs placebo

A

B

C

D

How Embarrassed, Self Conscious 

Affected Friendships

Influenced Clothes You Wear

Affected Going Out, Play, Hobbies 

Avoided Swimming or Other Sports

Problems at School or Holiday 

Trouble With Other People

How Much a Problem Is Treatment 

E

F

G

H


	Slide 1: The impact of tralokinumab on quality of life and school in patients aged 12–17 with atopic dermatitis: results from the phase 3 ECZTRA 6 trial