Objective

● Atopic dermatitis is a chronic inflammatory disease characterized by 
 eczematous skin lesions and multiple symptoms, including pruritus, 
 sleep disturbance, and depression1-4

● Tralokinumab is a high-affinity, fully human monoclonal antibody designed 
 to specifically neutralize interleukin-13, a key driver of the underlying 
 inflammation in atopic dermatitis5-7

● Phase 3 trials have established the efficacy and safety of tralokinumab for 
 up to 52 weeks in adult patients with moderate-to-severe atopic 
 dermatitis8,9

● An ongoing, open-label extension trial, ECZTEND (NCT03587805), is 
 investigating the long-term safety and efficacy of tralokinumab in patients 
 with atopic dermatitis who participated in previous tralokinumab trials

● To present interim ECZTEND efficacy data collected through April 30, 2020 
 from a patient cohort receiving tralokinumab for at least 56 weeks

Conclusions
● In this ECZTEND interim analysis of the Week 56 cohort, tralokinumab 300 mg q2w plus optional TCS 
 demonstrated sustained long-term improvements in itch, sleep, and the extent and severity of atopic 
 dermatitis up to Week 56, with maintenance of robust EASI response rates (61% of patients achieved EASI-90 
 at Week 56)
● Overall, tralokinumab plus optional TCS was well tolerated in patients enrolled in ECZTEND at data cut-off, 
 with a safety profile consistent with the parent trials

Long-Term Improvements Observed in Tralokinumab-Treated Patients with Moderate-to-Severe 
Atopic Dermatitis: an ECZTEND Interim Analysis

Andrew Blauvelt,1 Jean-Philippe Lacour,2 Darryl Toth,3 Vivian Laquer,4 Stefan Beissert,5 Andreas Wollenberg,6 Pedro Herranz,7 Andrew Pink,8 Ketty Peris,9 Stine Fangel,10 Hidehisa Saeki11

Patient demographics Total (n=1174)

Parent trial, n (%)

ECZTRA 1 (52-week monotherapy) 450 (38.3)

ECZTRA 2 (52-week monotherapy) 293 (25.0)

ECZTRA 3 (32-week combination therapy) 282 (24.0)

ECZTRA 5 (16-week monotherapy) 149 (12.7)

Median (IQR) age, years 38 (27.0-50.0)

Male, n (%) 675 (57.5)

Region, %

North America 46.2

Europe 46.5

Japan 7.3

Median (IQR) duration of AD at baseline, years 27 (18.0-40.0)

Median (IQR) BSA at parent trial baseline, % 44.5 (30.0-67.0)

Median (IQR) time from last dose in parent trial, days 36 (15.0-85.0)

Baseline characteristics All parent trials ECZTEND

Median (IQR) EASI score 26.6 (19.7-37.2) 4.7 (1.8-11.7)

Median (IQR) IGA score 3.0 (3.0-4.0) 2.0 (1.0-3.0)

Median (IQR) DLQI score 17.0 (11.0-22.0) 5.0 (2.0-10.0)

Median (IQR) SCORAD 67.4 (59.8-78.0) 30.2 (18.7-45.0)

Median (IQR) POEM 24.0 (20.0-27.0) 12.0 (6.0-18.0)

Table 1. Baseline characteristics of all patients from parent trials 
ECZTRA 1, 2, 3, and 5 enrolled in ECZTEND at data-cut off

Reason for withdrawal, n (%)a Total (n=1174)

Total patients withdrawing from the study 139 (11.8)

Adverse event 19 (1.6)

Lost to follow-up 29 (2.5)

Withdrawal by patient 16 (1.4)

Lack of efficacy (investigator or patient opinion) 24 (2.0)

Otherb 51 (4.3)

Table 2. Withdrawal from ECZTEND

60

50

40

30

20

10

0
Week 56 LOCFc

(n=612)
Week 56 NRId

(n=612)

R
e

sp
o

n
d

e
rs

, %

Week 56 observedb

(n=513)

49.7%
47.1%

41.7%

Figure 5. IGA 0/1 response rate at Week 56 with tralokinumab 
(Week 56 cohorta)

1Oregon Medical Research Center, Portland, OR, USA; 2Department of Dermatology, University Hospital of Nice Côte d’Azur, Nice, France; 3Probity Medical Research, Windsor, Ontario, Canada; 4First OC Dermatology, Fountain Valley, CA, USA; 5Department of Dermatology, University of Dresden, Dresden, Germany; 6Department of Dermatology and Allergology, Ludwig-Maximilian University of Munich, Munich, Germany; 
7Department of Dermatology, Hospital Universitario La Paz, Madrid, Spain; 8St John’s Institute of Dermatology, Guy’s and St Thomas’ Hospitals, London, UK; 9Institute of Dermatology, Catholic University of the Sacred Heart, Rome, Italy; 10LEO Pharma A/S, Ballerup, Denmark; 11Department of Dermatology, Nippon Medical School, Tokyo, Japan

Introduction Results

Methods

Figure 3. Patient cohorts in ECZTEND interim analysis 
(April 30, 2020 data cut-off)

Safety
analysis set

(n=1174)

Week 56
cohort
(n=612)

2-year
cohort
(n=345)

Patients previously treated
with tralokinumab monotherapy
for 52 weeks in ECZTRA 1 and 2,

followed by 56 weeks of
treatment in ECZTEND

All patients who reached the
1-year time point (Week 56)

or would have reached
that time point had they
not discontinued earlier

All patients transferred
from ECZTRA 1, 2, 3, and 5

Figure 4. Mean EASI and percentage change up to Week 56 with 
tralokinumab (Week 56 cohorta)

Enrollment time in ECZTEND, weeks

Total (n) 612 612 591 585 571 565 554 542 513

Total (n) 612 612 591 585 571 565 554 542 513

M
e

a
n

 E
A

S
I p

e
rc

e
n

ta
g

e
 c

h
a

n
g

e
 f

ro
m

 p
a

re
n

t-
tr

ia
lb

a
se

lin
e

0BP 42 8 12 16 24 32 40 48 56

0BP 42 8 12 16 24 32 40 48 56

0

–90

–80

–70

–60

–50

–40

–30

–20

–10

–100

M
e

a
n

 E
A

S
I

35

30

25

20

15

10

5

0

Enrollment time in ECZTEND, weeks

Mean (SD) –86.8 (17.5)

Median –93.6

Q1; Q3 –98.5; –81.4

Mean (SD) 4.2 (6.1)

Median 1.8

Q1; Q3 0.4; 5.6

Figure 7. Mean worst weekly pruritus NRS and eczema-related weekly 
sleep NRS scores up to Week 56 with tralokinumab (Week 56 cohorta)

Total (n) 609 592 585 571 563 555 541 514

Total (n) 609 592 585 571 563 555 541 514

Worst weekly pruritus NRS by visit

M
e

a
n

 s
co

re

10

9

8

7

6

5

4

3

2

1

0

10

9

8

7

6

5

4

3

2

1

0

Week

Eczema-related weekly sleep NRS by visit

M
e

a
n

 s
co

re

Week

Mean (SD) 3.3 (2.6)

Median 3.0

Q1; Q3 1.0; 5.0

Mean (SD) score at parent trial baselineb 7.7 (1.4)

Mean (SD) 2.0 (2.4)

Median 1.0

Q1; Q3 0.0; 3.0

Mean (SD) score at parent trial baselineb 6.9 (2.1)

0 42 8 16 24 32 40 48 56

0 42 8 16 24 32 40 48 56

Figure 1. Patient recruitment from parent trialsa

H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2
2017 2018 2019 2020 2021 2022 2023 2024

FPFV to LPLV

FPFV: September 18, 2018

ECZTRA 1 (monotherapy)
ECZTRA 2 (monotherapy)

ECZTRA 3 (TCS combination)

ECZTRA 5 (vaccine)
ECZTRA 6 (adolescent)

ECZTRA 7 (CsA failure/intolerantb)

ECZTRA 8
(TCS combination)

TraSki (IIS)
ECZTEND (LTE)

ECZTRA 4 (DDI)

Figure 2. ECZTEND trial design

Weeks from first treatment in ECZTEND

Site visit. IGA, EASI, SCORAD, 
worst weekly pruritus NRS,
eczema-related sleep NRS,
use of topical treatment 
Screening and follow-up visits
Home use training
POEM, DLQI/CDLQI, EQ-5D-5Lb

ADA/pharmacokinetics measurement

TCS use allowed

Screening period Visit schedule until end of May 2021a
SFU 16 weeks
after last IMP

2485640322416 484 8-2 0

Figure 6. Proportion of patients achieving EASI-50, EASI-75, and EASI-90 at Week 56 with tralokinumab (Week 56 cohorta)

R
e

sp
o

n
d

e
rs

, %

513

100

80

60

40

20

0
612 612 513 612 612 513 612 612

EASI-50 EASI-75 EASI-90
n

Week 56 observed

Week 56 LOCFc

Week 56 NRId

b

Figure 8. Proportion of patients achieving EASI-50, EASI-75, and EASI-90 with tralokinumab at Week 56 (52 weeks in parent study plus 56 weeks in ECZTENDa)

2-year (108-week)
tralokinumab arms observedb

2-year (108-week)
tralokinumab arms LOCFc

291 345

EASI-50

291 345

EASI-75

291 345

EASI-90

R
e

sp
o

n
d

e
rs

, %

100

80

60

40

20

0
n

52
weeks

56
weeks

ECZTEND
(LTE)

ECZTRA 1
(tralokinumab)

ECZTRA 2
(tralokinumab)

Table 3. Overall safety profile of tralokinumab

AD safety pool (ECZTRA 1, 2, 3, and 5, Phase 2b)a

Initial treatment period
ECZTEND safety analyses setb 

Trial start to April 30, 2020

Tralokinumab q2w  TCS

(n=105, PYE=473.19)

Placebo q2w  TCS

(n=80, PYE=193.1)

Tralokinumab q2w 1 optional TCS

(n=1174, PYE=1235.7)

n adj. % adj. R n adj. % adj. R n % R

All adverse events 1080 65.7 639.5 449 67.2 678.3 844 71.9 237.8

Serious adverse events 37 2.1 7.4 18 2.8 11.9 55 4.7 4.8

Severity

Mild 881 53.2 429.8 326 49.0 391.0 695 59.2 158.2

Moderate 518 31.5 189.5 258 39.0 254.3 435 37.1 72.1

Severe 77 4.6 20.2 40 6.3 33.0 62 5.3 7.5

Leading to drug withdrawal 38 2.3 9.9 20 2.8 13.3 28 2.4 2.3

Most frequently reported adverse events (>5% of patients)

Viral upper respiratory tract infection 
(most commonly reported as common cold)

256 15.7 65.1 78 12.2 53.5 250 21.3 29.3

Atopic dermatitis 272 15.4 68.0 167 26.2 139.7 158 13.5 20.6

Upper respiratory tract infection 92 5.6 20.8 33 4.8 18.5 83 7.1 9.1

Safety areas of interest

Conjunctivitis, including conjunctivitis, allergic 
conjunctivitis, bacterial conjunctivitis, viral 
conjunctivitis, and atopic conjunctivitis

126 7.5 29.0 21 3.2 12.3 65 5.9 6.9

Patients
● ECZTEND is an ongoing, up to 268-week, open-label, single-arm, 
 multicenter, long-term extension trial in patients with atopic dermatitis 
 who participated in parent tralokinumab trials (ECZTRA 1-8 and TraSki) 
 (Figure 1)
Key Inclusion Criteria
 — Completed treatment period(s) in a tralokinumab parent trial 
  (ECZTRA 1-8 or TraSki) without any safety concerns

 — Complied with the clinical trial protocol in the parent trial

 — Able and willing to self-administer tralokinumab, or have it administered 
  by a caregiver, at home after the initial 3 injection visits at trial site

 — Applied a stable dose of emollient (minimum twice daily) for at least 
  14 days before baseline

ECZTEND Trial Design
● Patients received subcutaneous tralokinumab 300 mg every 2 weeks (q2w) 
 plus optional topical corticosteroids (TCS) after a 300 mg or 600 mg 
 loading dose of tralokinumab (Figure 2)

ECZTEND Trial Design
● Study primary and secondary endpoints:

 — Number of adverse events from baseline up to Week 268

 — Investigator’s Global Assessment (IGA) score of 0/1 from Week 16 to 
  Week 248

 — Eczema Area and Severity Index reduction of at least 75% (EASI-75) 
  a from Week 16 to Week 248

Week 56 interim analysis:
 — Included patients from parent trials ECZTRA 1, 2, 3, and 5 enrolled in 
  ECZTEND at least 60 weeks before data cut-off (n=612)

 — Efficacy outcomes assessed include:

 • Mean EASI up to Week 56

 • IGA 0/1 response rate at Week 56 

 • EASI-50, EASI-75, EASI-90,a and EASI 7 response rates at Week 56

 • Mean worst weekly pruritus Numeric Rating Scale (NRS) and 
  eczema-related weekly sleep interference NRS scores up to Week 56

Disclosures
Andrew Blauvelt has served as a scientific adviser and/or clinical study investigator for AbbVie, Abcentra, Aligos, Almirall, Amgen, Arcutis, Arena, Athenex, 
Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Evommune, Forte, Galderma, Incyte, Janssen, Landos, LEO Pharma, Novartis, Pfizer, Rapt, 
Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma. Jean-Philippe Lacour has received grants or honoraria as an investigator, advisory board 
member, or speaker from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi 
Darryl Toth has served as an investigator for AbbVie, Amgen, Arcutis, Boehringer Ingelheim, Bond Avillion, Bristol Myers Squibb, Celgene, Centocor, Dermira, 
Eli Lilly, Galderma, GSK, Incyte, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, UCB Pharma, and Valeant. Vivian Laquer has received grants from 
AbbVie, Eli Lilly, Galderma, LEO Pharma, and Novartis. Stefan Beissert has served as an advisory board member for or received speaker honoraria from 
AbbVie Deutschland & Co, Actelion Pharmaceuticals, Almirall Hermal, Amgen, Bristol Myers Squibb, Celgene, Galderma, GSK, Hexal-Sandoz, Janssen-
Cilag, La Roche-Posay, LEO Pharma, Lilly Deutschland, Menlo Therapeutics, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi-Aventis Deutschland, and 
UCB Pharma. Andreas Wollenberg has received grants, personal fees, or nonfinancial support from AbbVie, Almirall, Beiersdorf, Bioderma, Chugai, Eli Lilly, 
Galapagos, Galderma, Hans Karrer, LEO Pharma, L’Oréal, Maruho, MedImmune, Novartis, Pfizer, Pierre Fabre, Regeneron, Santen, and Sanofi-Aventis.  
Pedro Herranz has served as a consultant, speaker, or investigator for Amgen, Eli Lilly, Janssen, LEO Pharma, Novartis, Parexel, Pfizer, and Sanofi. 
Andrew Pink reports personal fees and nonfinancial support from LEO Pharma, Novartis, and UCB Pharma; and personal fees from AbbVie, Almirall, Eli 
Lilly, Janssen, La Roche-Posay, and Sanofi. Ketty Peris reports grants or personal fees for participation in advisory boards from AbbVie, Almirall, Eli Lilly, 
Galderma, Janssen, LEO Pharma, Novartis, Pierre Fabre, Sanofi, and Sun Pharma. Stine Fangel are employee of LEO Pharma. Hidehisa Saeki has received 
lecture fees from Kyorin, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe, Sanofi, Taiho, and Tokiwa; and scholarship donations from Esai, Maruho, 
Mitsubishi Tanabe, and Torii. The ECZTEND study is sponsored by LEO Pharma.

References
1. Weidinger S, Novak N. Lancet. 2016;387:1109-22.
2. Eckert L, et al. J Am Acad Dermatol. 2017;77:274-9.e273.
3. Silverberg JI, et al. Ann Allergy Asthma Immunol. 2018;121:340-7.
4.  Dalgard FJ, et al. J Invest Dermatol. 2015;135:984-91.
5. Bieber T. Allergy. 2020;75:54-62.
. Tsoi LC, et al. J Invest Dermatol. 2019;139:1480-9.

7.  Popovic B, et al. J Mol Biol. 2017;429:208-19.
8.  Wollenberg A, et al. Br J Dermatol. 2021;184:437-49.
9. Silverberg JI, et al. Br J Dermatol. 2021;184:450-63.
10. Leshem YA, et al. Br J Dermatol. 2015;172:1353-7.
11. Hongbo Y, et al. J Invest Dermatol. 2005;125:659-64.

aEASI-50, EASI-75, and EASI-90 are calculated based on baseline EASI in parent trial.

Patient Cohorts (Figure 3)

Baseline Characteristics
● At ECZTEND baseline, patients had mild atopic dermatitis, based on median  
 EASI score, and the median Dermatology Life Quality Index score indicated 
 that atopic dermatitis had a small effect on their quality of life10,11 (Table 1)

● Based on EASI, the overall ECZTEND cohort and Week 56 cohort had similar 
 baseline disease severity

Withdrawal From ECZTEND
● Analysis includes all patients from parent trials ECZTRA 1, 2, 3, and 5 enrolled 
  in ECZTEND at data cut-off (April 30, 2020) (Table 2)

● The median (interquartile range) duration from first tralokinumab dose to 
 last visit at data cut-off (follow-up period) was 58.1 (46.4-66.3) weeks

Analysis includes all patients from parent trials ECZTRA 1, 2, 3, and 5 enrolled in ECZTEND at 
data cut-off (April 30, 2020).
aData are subject to change as the ongoing ECZTEND study progresses; bWithdrawal from 
ECZTEND due to pregnancy, protocol deviation (concomitant medication/eligibility), physician 
decision, or administrative reasons (patient moved/relocated/busy/transportation issues/
personal reasons).

Mean EASI up to Week 5 With Tralokinumab
● Mean EASI reduced from a score equivalent to moderate-to-severe atopic 
 dermatitis at parent trial baseline to mild-to-moderate atopic dermatitis 
 at ECZTEND baseline, and was sustained over time in ECZTEND (Figure 4)

IGA 0/1 Response Rate at Week 5 With 
Tralokinumab
● A high level of IGA 0/1 response rate was sustained with tralokinumab at 
 Week 56 in ECZTEND (Figure 5)

aWeek 56 cohort included all patients from parent trials ECZTRA 1, 2, 3, and 5 enrolled at least 
60 weeks before data cut-off (April 30, 2020); bPatients who reached Week 56; cMissing data 
imputed using LOCF; dMissing data imputed as non-response.
IGA, Investigator’s Global Assessment; LOCF, last observation carried forward; 
NRI, non-responder imputation.

Proportion of Patients Achieving EASI-50, EASI-75, 
and EASI-90 at Week 5 With Tralokinumab
● A high level of EASI-50, EASI-75, and EASI-90 response rates were sustained 
 with tralokinumab at Week 56 in ECZTEND (Figure )

 —  61% of patients achieved EASI-90 at Week 56

● At Week 56, 79.7% of patients achieved EASI 7, a category corresponding 
 to mild atopic dermatitis

Mean Worst Weekly Pruritus NRS and 
Eczema-related Weekly Sleep NRS Scores up to 
Week 5 With Tralokinumab
● Mean worst weekly pruritus NRS and eczema-related weekly sleep NRS 
 scores were sustained over time in ECZTEND with tralokinumab (Figure 7)

 — Patients achieved scores equivalent to mild-to-moderate itch and mild 
  sleep interference at Week 56

Proportion of Patients Achieving EASI-50, EASI-75, 
and EASI-90 at Week 5 With Tralokinumab
● Patients treated with tralokinumab for a total of 2 years at ECZTEND data 
 cut-off demonstrated high levels of EASI-50, EASI-75, and EASI-90 response 
 rates, which were consistent with the overall Week 56 cohort (Figure 8)

Safety
● The overall safety profile of tralokinumab was consistent with parent trials 
 (Table 3)

AD, atopic dermatitis; BSA, body surface area; DLQI, Dermatology Life Quality Index; EASI, 
Eczema Area and Severity Index; IGA, Invstigator’s Global Assessment; IQR, interquartile 
range; POEM, Patient-Oriented Eczema Measure; SCORAD, SCORing Atopic Dermatitis.

aPrevious treatment regimens in parent trials included tralokinumab q2w, q4w, or placebo 6 TCS; bStudy in patients with atopic dermatitis who are not adequately controlled with or have 
contraindications to oral CsA. CsA, cyclosporine; DDI, drug–drug interaction; FPFV, first patient first visit; IIS, investigator-initiated study; LPLV, last patient last visit; LTE, long-term extension; 
q2w, every 2 weeks; q4w, every 4 weeks; TCS, topical corticosteroids.

aAfter May 2021, some site visits will be switched to telephone visits; bPatients from the parent trial ECZTRA 6 will not perform the EQ-5D-5L. ADA, anti-drug antibodies; CDLQI, Children’s 
Dermatology Life Quality Index; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; EQ-5D-5L, EuroQol 5-Dimension Health Questionnaire 5-Level; IGA, Investigator’s 
Global Assessment; IMP, investigational medicinal product; NRS, Numeric Rating Scale; POEM, Patient-Oriented Eczema Measure; q2w, every 2 weeks; SCORAD, SCOring Atopic Dermatitis; SFU, 
safety follow-up; TCS, topical corticosteroids.

aWeek 56 cohort included all patients from parent trials ECZTRA 1, 2, 3, and 5 enrolled at least 60 weeks before data cut-off (April 30, 2020); bPatients who reached Week 56; cMissing data 
imputed using LOCF; dMissing data imputed as non-response. EASI, Eczema Area and Severity Index; LOCF, last observation carried forward; NRI, non-responder imputation.

aWeek 56 cohort included all patients from parent trials ECZTRA 1, 2, 3, and 5 enrolled at least 
60 weeks before data cut-off (April 30, 2020). Data were analyzed as observed
bParent trial baseline value based on patients from ECZTRA 1, 2, and 3 only.
NRS, Numeric Rating Scale; SD, standard deviation.

a2-year cohort included all patients who received treatment with tralokinumab for 52 weeks in parent trials ECZTRA 1 and 2, followed by treatment with tralokinumab for 56 weeks in ECZTEND at data 
cut-off (April 30, 2020); bPatients who reached Week 56; cMissing data imputed using LOCF. EASI, Eczema Area and Severity Index; LOCF, last observation carried forward;  LTE, long-term extension.

aIncludes patients from parent trials ECZTRA 1, 2, 3, 5, and Phase 2b; bIncludes all patients from parent trials ECZTRA 1, 2, 3, and 5 enrolled in ECZTEND at data cut-off (April 30, 2020). %, percentage 
of patients with ≥1 event; AD, atopic dermatitis; adj. %, adjusted percentage calculated using Cochran–Mantel–Haenszel weights; adj. R, adjusted rate calculated using Cochran–Mantel–Haenszel 
weights; PYE, patient-years of exposure; q2w, every 2 weeks; R, rate (number of adverse events divided by patient-years of exposure multiplied by 100); TCS, topical corticosteroids.

aWeek 56 cohort included all patients from parent trials ECZTRA 1, 2, 3, and 5 enrolled at least 
60 weeks before data cut-off (April 30, 2020). Data were analyzed as observed.
BP, parent trial baseline; EASI, Eczema Area and Severity Index; SD, standard deviation.

Originally presented at American Academy of Dermatology (AAD) VMX, April 23-25, 2021.