Eric L. Simpson, MD, MCR,1 Robert Bissonnette, MD, FRCPC,2 Michael E. Kuligowski, MD, PhD, MBA,3 May E. Venturanza, MD,3 Kang Sun, PhD,3  
Jonathan I. Silverberg, MD, PhD, MPH4

Introduction
 ● Atopic dermatitis (AD) is a highly pruritic inflammatory skin disease 

that often involves the head and/or neck (HN)1,2

 ● There is a need for well-tolerated treatments that can be used long 
term on body regions that are prone to irritation/burning and to side 
effects from topical steroid use, such as the face3

 ● In two phase 3 randomized studies of identical design (TRuE-
AD1 [NCT03745638] and TRuE-AD2 [NCT03745651]), ruxolitinib 
cream, a topical selective inhibitor of Janus kinase (JAK) 1/JAK2, 
demonstrated anti-inflammatory activity with antipruritic action vs 
vehicle and was well tolerated in patients with AD4

Objective
 ● To describe the effect of ruxolitinib cream in adolescent and adult 

patients with AD with HN involvement using pooled data from two 
phase 3 trials

Methods
Study Design and Patients

 ● Eligible patients were aged ≥12 years with AD for ≥2 years and had 
an Investigator’s Global Assessment (IGA) score of 2 or 3 and  
3%–20% affected body surface area (excluding scalp)

 ● Key exclusion criteria were unstable course of AD, other types of 
eczema, immunocompromised status, use of AD systemic therapies 
during the washout period and during the study, use of AD topical 
therapies (except bland emollients) during the washout period and 
during the study, and any serious illness or medical condition that 
could interfere with study conduct, interpretation of data, or patients’ 
well-being

 ● TRuE-AD1 and TRuE-AD2 had identical study designs (Figure 1)
 – In both studies, patients were randomized (2:2:1) to 1 of 2 

ruxolitinib cream strength regimens (0.75% twice daily [BID] 
or 1.5% BID) or vehicle cream BID for 8 weeks of double-blind 
continuous treatment

 – Patients on ruxolitinib cream subsequently continued treatment 
for 44 weeks; patients initially randomized to vehicle were re-
randomized 1:1 (blinded) to either ruxolitinib cream regimen

Figure 1. Study Design

• Treat as needed for 44 weeks
• Stop treatment 3 days after lesion clearance
• Rescue treatment not permitted

• Continuous treatment for 8 weeks
• Rescue treatment not permitted

Vehicle-controlled period Long-term safety period

Patients initially randomized 
to RUX remain on their regimen 

Patients on vehicle rerandomized 1:1 
to 0.75% RUX BID or 1.5% RUX BID

Patients 
Randomized

2:2:1
RUX†

Visits every 4 weeks

Week 52Day 1 Week 8

Recurrence of 
lesions 

Clearance of 
lesions 

1.5% RUX BID
(n=~240 in each study)

0.75% RUX BID
(n=~240 in each study)

Vehicle BID
(n=~120 in each study)

AD, atopic dermatitis; BID, twice daily; BSA, body surface area; RUX, ruxolitinib cream. 
†  Patients self-evaluated recurrence of lesions between study visits and treated lesions with active AD (≤20% BSA). If lesions cleared between study 

visits, patients stopped treatment 3 days after lesion disappearance. If new lesions were extensive or appeared in new areas, patients contacted the 
investigator to determine if an unscheduled additional visit was needed.

Assessments
 ● Pooled efficacy at Week 8 was assessed by achievement of the 

following endpoints in patients with HN involvement at baseline and 
the overall population:

 – IGA-treatment success (IGA-TS; IGA of 0/1 and ≥2-grade 
improvement from baseline)

 – ≥50%, ≥75%, and ≥90% improvement in Eczema Area and 
Severity Index vs baseline (EASI-50, EASI-75, and EASI-90 
[overall and HN region])

 – ≥4-point improvement in itch numerical rating scale score vs 
baseline (NRS4)

1Oregon Health & Science University, Portland, OR, USA; 
2Innovaderm Research, Montreal, QC, Canada; 3Incyte 
Corporation, Wilmington, DE, USA; 4George Washington 
University, Washington DC, USA

Presented at the

Fall Clinical Dermatology Conference
Las Vegas, NV • October 21–24, 2021

 ● Percentage change from baseline in EASI score (overall and HN 
region) was also assessed

 ● Safety and application site tolerability were also assessed
Statistical Analyses

 ● All analyses were conducted using the pooled data from both 
studies

 ● EASI percentage change from baseline was analyzed by mixed-
effect model with repeated measures with statistical significance 
determined at Weeks 2, 4, and 8

 ● All other efficacy endpoints were analyzed by logistic regression 
with statistical significance determined at Week 8

 ● The efficacy population consisted of 1208 patients (vehicle, n=244; 
0.75% ruxolitinib cream, n=483; 1.5% ruxolitinib cream, n=481)

Results
Patients

 ● Of 1249 randomized patients, 696 (55.7%) had HN involvement at 
baseline 

 ● Distribution of baseline demographics and clinical characteristics 
was similar across treatment groups (Table 1)

Table 1. Patient Demographics and Baseline Clinical Characteristics

Characteristic
Vehicle 
(n=250)

0.75% RUX
 (n=500)

1.5% RUX 
(n=499)

Total 
(N=1249)

Age, median (range), y 34.0 (12–82) 33.0 (12–85) 31.0 (12–85) 32.0 (12–85)

Female, n (%) 159 (63.6) 304 (60.8) 308 (61.7) 771 (61.7)

Race, n (%)

White 170 (68.0) 345 (69.0) 355 (71.1) 870 (69.7)

Black 61 (24.4) 118 (23.6) 113 (22.6) 292 (23.4)

Asian 10 (4.0) 16 (3.2) 20 (4.0) 46 (3.7)

Other 9 (3.6) 21 (4.2) 11 (2.2) 41 (3.3)

Region, n (%)

North America 172 (68.8) 342 (68.4) 341 (68.3) 855 (68.5)

Europe 78 (31.2) 158 (31.6) 158 (31.7) 394 (31.5)

BSA, mean (SD), % 9.6 (5.5) 10.0 (5.3) 9.6 (5.3) 9.8 (5.4)

EASI, mean (SD) 7.8 (4.8) 8.1 (4.9)  7.8 (4.8) 8.0 (4.8)

EASI HN score* 1.2 (0.9)             1.2 (1.0)             1.1 (0.8) NA

IGA, n (%)

2 64 (25.6) 125 (25.0) 123 (24.6) 312 (25.0)

3 186 (74.4) 375 (75.0) 376 (75.4) 937 (75.0)

Itch NRS score, mean (SD) 5.1 (2.4) 5.2 (2.4) 5.1 (2.5) 5.1 (2.4)

≥4, n (%) 159 (63.6) 324 (64.8) 315 (63.1) 798 (63.9)

Duration of disease, median 
(range), y

16.5  
(0.8–79.1)

15.1  
(0.1–68.8)

16.1  
(0–69.2)

15.8  
(0–79.1)

Facial involvement, n (%)† 93 (37.2) 195 (39.0) 197 (39.5) 485 (38.8)

Number of flares in last 12 
mo, mean (SD)† 

7.3 (25.7) 5.2 (6.7) 6.0 (17.6) 5.9 (16.5)

BSA, body surface area; EASI, Eczema Area and Severity Index; HN, head and/or neck; IGA, Investigator’s Global Assessment; NA, not available;  
NRS, numerical rating scale; RUX, ruxolitinib cream.  
* Patients with HN involvement in the efficacy-evaluable population (vehicle, n=136; 0.75% RUX, n=265; 1.5% RUX, n=262). 
† Patient reported.

Efficacy
 ● IGA-TS (Figure 2) and itch NRS4 (Figure 3) were achieved by 

significantly more patients who applied ruxolitinib cream compared 
with vehicle at Week 8 (P<0.0001)

 – Response rates were numerically greater among patients with 
HN involvement vs the overall population 

 ● Significantly greater improvements from baseline in total EASI and 
HN region scores were observed with ruxolitinib cream vs vehicle at 
Week 8 (P<0.0001; Figure 4)

 ● Significantly more patients who received ruxolitinib cream vs  
vehicle achieved EASI-50 (Figure 5; P<0.0001), EASI-75  
(Figure 6; P<0.0001), and EASI-90 (Figure 7; P<0.0001) at Week 8

 – Response rates were numerically greater among patients with 
HN involvement vs the overall population

Figure 2. IGA-TS in the HN and Overall Populations

Vehicle
(n=136)

0.75% RUX
(n=265)

1.5% RUX
(n=262)

Vehicle
(n=244)

0.75% RUX
(n=483)

1.5% RUX
(n=481)

0

10

20

30

40

50

60

70

80

90

100

Week 2 Week 4 Week 8 Week 2 Week 4 Week 8

2.2
4.4

8.1

3.7
6.1

11.5

26.0

47.2

54.3

19.9

39.1

44.7

29.4

48.9

56.5

26.2

45.1

52.6

****
****

****

****

HN Involvement Overall Population

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s 
Ac

hi
ev

in
g 

IG
A-

TS
, %

†

HN, head and/or neck; IGA-TS, Investigator’s Global Assessment-treatment success; RUX, ruxolitinib cream. 
**** P<0.0001 vs vehicle.
†  Defined as patients achieving an IGA score of 0 or 1 with an improvement of ≥2 points from baseline. Patients with missing post-baseline values were 

imputed as nonresponders at Weeks 2, 4, and 8.

Figure 3. Itch NRS4 in the HN and Overall Populations

Vehicle
(n=90)

0.75% RUX
(n=181)

1.5% RUX
(n=170)

Vehicle
(n=158)

0.75% RUX
(n=313)

1.5% RUX
(n=307)

0

10

20

30

40

50

60

70

80

90

100

Week 2 Week 4 Week 8 Week 2 Week 4 Week 8

HN Involvement Overall Population

5.6

10.0
13.3

5.1

12.0
15.8

29.3

40.3

48.1

26.8

38.3
41.5

38.2

57.6
59.4

32.9

48.5
51.5****

****

****

****

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s 
Ac

hi
ev

in
g 

Itc
h 

NR
S4

, %
†

HN, head and/or neck; NRS4, ≥4-point improvement in itch numerical rating scale score from baseline; RUX, ruxolitinib cream.
**** P<0.0001 vs vehicle.
†  Patients in the analysis had an itch NRS score ≥4 at baseline. Patients with missing post-baseline values were imputed as nonresponders at Weeks 2, 

4, and 8.

Effects of Ruxolitinib Cream in Patients With Atopic Dermatitis With Head and/or 
Neck Involvement

 

Safety
 ● Application site reactions were less frequent in patients who applied 

ruxolitinib cream regardless of HN involvement compared with 
vehicle (Table 2)

 ● Among patients who applied ruxolitinib cream, application site pain 
(ie, stinging/burning) was reported in 5/555 patients (0.9%) with HN 
involvement and 7/999 (0.7%) in the overall population (vs 8/141 
[5.7%] and 12/250 [4.8%] among patients who applied vehicle, 
respectively)

 – No application site reactions were serious

Table 2. Application Site Reactions in the HN and Overall Populations

AE, n (%)

HN Population Overall Population

Vehicle 
(n=141)

RUX 
(Combined)

(n=555)
Vehicle 
(n=250)

RUX 
(Combined)

(n=999)
Application site reactions* 13 (9.2) 14 (2.5) 18 (7.2) 19 (1.9)

Pain 8 (5.7) 5 (0.9) 12 (4.8) 7 (0.7)
Pruritus 5 (3.5) 4 (0.7) 7 (2.8) 6 (0.6)
Irritation 2 (1.4) 2 (0.4) 2 (0.8) 2 (0.2)
Erythema 2 (1.4) 0 2 (0.8) 1 (0.1)
Dryness 0 1 (0.2) 0 1 (0.1)
Folliculitis 0 1 (0.2) 0 2 (0.2)
Exfoliation 0 1 (0.2) 0 1 (0.1)
Papules 0 1 (0.2) 0 1 (0.1)
Swelling 0 0 1 (0.4) 0

AE, adverse event; RUX, ruxolitinib cream. 
* Patients may report more than 1 type of application site reaction.

Conclusions
 ● In patients with AD with HN 

involvement, ruxolitinib cream 
showed superior efficacy compared 
with vehicle

 ● Ruxolitinib cream was well tolerated 
(ie, low rates of stinging/burning) in 
patients with HN involvement with 
a safety profile comparable to the 
overall population

Disclosures
ELS is an investigator for AbbVie, Eli Lilly, Galderma, Kyowa Hakko Kirin, LEO Pharma, Merck, 
Pfizer, and Regeneron; and is a consultant with honorarium for AbbVie, Eli Lilly, Forte Bio, 
Galderma, Incyte Corporation, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, 
Sanofi Genzyme, and Valeant. RB is a consultant with honoraria for AbbVie, Arena, Bluefin, 
Boehringer Ingelheim, CARA Therapeutics, Kyowa Kirin, Pfizer, and Respivant; an investigator 
with grants/research funding for AbbVie, Arcutis, Arena, Asana BioSciences, Bellus, Boehringer 
Ingelheim, CARA Therapeutics, Eli Lilly, Incyte Corporation, Pfizer, RAPT, and Sanofi Genzyme; 
an advisor with honoraria for Arena, Eli Lilly, Galderma, Incyte Corporation, LEO Pharma, 
Pfizer, and RAPT; and an employee and shareholder of Innovaderm Research. MEK was an 
employee and shareholder of Incyte Corporation at the time of development of the original 
presentation. MEV and KS are employees and shareholders of Incyte Corporation. JIS received 
honoraria for advisory board, speaker, and consultant services from AbbVie, Asana, Bluefin, 
Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, 
Glenmark, Incyte Corporation, Kiniksa, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, 
Realm, Regeneron, and Sanofi; and research grants for investigator services from Galderma 
and GlaxoSmithKline.

Acknowledgments
The authors thank the patients, investigators, and investigational sites whose participation made 
the study possible. Support for this study was provided by Incyte Corporation (Wilmington, DE, 
USA). Writing assistance was provided by Tania Iqbal, PhD, an employee 
of ICON (North Wales, PA, USA), and was funded by Incyte Corporation.

References
1. Langan SM, et al. Lancet. 2020;396(10247):345-360. 2. Silverberg JI, et al. 
J Eur Acad Dermatol Venereol. 2019;33(7):1341-1348. 3. Eichenfield LF, 
et al. J Am Acad Dermatol. 2014;71(1):116-132. 4. Papp K, et al. J Am Acad 
Dermatol. 2021;85(4):863-872.

Figure 4. EASI Percentage Change From Baseline in the (A) HN and 
Overall Populations and (B) Based on HN Region Score

Vehicle 0.75% RUX 1.5% RUX

M
ea

n 
(9

5%
 C

I) 
Pe

rc
en

ta
ge

 
Ch

an
ge

 F
ro

m
 B

as
el

in
e 

in
 

EA
SI

 S
co

re
, %

M
ea

n 
(9

5%
 C

I) 
Pe

rc
en

ta
ge

 
Ch

an
ge

 F
ro

m
 B

as
el

in
e 

in
 

EA
SI

 H
N 

Re
gi

on
 S

co
re

, %

Week 2 Week 4 Week 8 Week 2 Week 4 Week 8

–13.1

–55.6 –58.8

–19.7

**** ****

****

–72.7 –74.2
–76.5 –79.3**** **** **** ****

–34.5

–14.8

–48.9
–53.2

–22.3

–66.9
****

–68.9

–34.7

–73.4 –76.0**** ****
**** ****

Number of Patients 
Vehicle
0.75% RUX
1.5% RUX

124
252
254

115
253
252

110
246
245

226
461
461

211
457
461

202
430
450

0

HN Involvement
A)

B)

Overall Population

–20

–40

–60

–80

–100

20

0

–20

–40

–60

–80

–100

BL 2 4 8

Number of Patients 
Vehicle
0.75% RUX
1.5% RUX

124
252
253

115
253
251

110
246
245

–13.4
–22.4

–45.0
–55.8

–71.3 –78.7
–59.3

–70.4
–70.0

****
****

**** ****

****
****

Vehicle 0.75% RUX 1.5% RUX

BL, baseline; EASI, Eczema Area and Severity Index; HN, head and/or neck; RUX, ruxolitinib cream.
**** P<0.0001 vs vehicle.

Figure 5. EASI-50 in the (A) HN and Overall Populations and (B) Based 
on HN Region Score

Vehicle
(n=136)

0.75% RUX
(n=265)

1.5% RUX
(n=262)

Vehicle
(n=244)

0.75% RUX
(n=483)

1.5% RUX
(n=481)

A)

B)
Vehicle
(n=136)

0.75% RUX
(n=256)

1.5% RUX
(n=262)

0

10

20

30

40

50

60

70

80

90

100

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s 
Ac

hi
ev

in
g 

EA
SI

-5
0,

 %
†

0

20

40

60

80

100

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s 
Ac

hi
ev

in
g

 E
AS

I-5
0 

HN
 R

eg
io

n,
 %

BL 2 4 8
Time, wk

Week 2 Week 4 Week 8 Week 2 Week 4 Week 8
HN Involvement Overall Population

49.3

76.6

84.4
****

****

26.5

36.8

66.0

79.266.8

80.2

16.2

26.5

36.0

57.0

76.2

63.7

79.4 79.2
**** 81.7

****

18.0

28.3

38.9

49.5

69.2
72.5

58.2

73.8
78.8

****
****

BL, baseline; EASI-50, ≥50% improvement in Eczema Area and Severity Index score from baseline; HN, head and/or neck; RUX, ruxolitinib cream.
**** P<0.0001 vs vehicle.
† Patients with missing post-baseline values were imputed as nonresponders at Weeks 2, 4, and 8.

Figure 6. EASI-75 in the (A) HN and Overall Populations and (B) Based 
on HN Region Score

Vehicle
(n=136)

0.75% RUX
(n=265)

1.5% RUX
(n=262)

Vehicle
(n=244)

0.75% RUX
(n=483)

1.5% RUX
(n=481)

A)

B)
Vehicle
(n=136)

0.75% RUX
(n=256)

1.5% RUX
(n=262)

4.4

11.0

18.4

31.3

55.5

62.6

34.4

57.6

67.2****
****

Week 2 Week 4 Week 8 Week 2 Week 4 Week 8

HN Involvement Overall Population

4.9

12.3

19.7

28.0

47.0

53.8

33.9

54.7

62.0
****

****

0

10

20

30

40

50

60

70

80

90

100

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s 
Ac

hi
ev

in
g 

EA
SI

-7
5,

 %
†

31.6

63.8

74.0
****

****

11.0

21.3

45.3
65.3

45.0

66.0

0

20

40

60

80

100

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s 
Ac

hi
ev

in
g 

EA
SI

-7
5 

HN
 R

eg
io

n,
 %

BL 2 4 8
Time, wk

BL, baseline; EASI-75, ≥75% improvement in Eczema Area and Severity Index score from baseline; HN, head and/or neck; RUX, ruxolitinib cream.
**** P<0.0001 vs vehicle.
† Patients with missing post-baseline values were imputed as nonresponders at Weeks 2, 4, and 8.

Figure 7. EASI-90 in the (A) HN and Overall Populations and (B) Based 
on HN Region Score

Vehicle
(n=136)

0.75% RUX
(n=265)

1.5% RUX
(n=262)

Vehicle
(n=244)

0.75% RUX
(n=483)

1.5% RUX
(n=481)

A)

B)
Vehicle
(n=136)

0.75% RUX
(n=256)

1.5% RUX
(n=262)

0

10

20

30

40

50

60

70

80

90

100

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s 
Ac

hi
ev

in
g 

EA
SI

-9
0,

 %
†

0

20

40

60

80

100

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s 
Ac

hi
ev

in
g 

EA
SI

-9
0 

HN
 R

eg
io

n,
 %

9.6
15.4

25.0

34.0
49.4

52.8

32.4

51.5
63.0****

****

BL 2 4 8
Time, wk

0.7 2.2
5.9

15.1

34.0

42.6

19.5

36.3

45.4****
****

1.6
3.3

7.0
11.8

28.2

36.6

17.9

34.5

43.9
****

****

Week 2 Week 4 Week 8 Week 2 Week 4 Week 8
HN Involvement Overall Population

BL, baseline; EASI-90, ≥90% improvement in Eczema Area and Severity Index score from baseline; HN, head and/or neck; RUX, ruxolitinib cream.
**** P<0.0001 vs vehicle.
† Patients with missing post-baseline values were imputed as nonresponders at Weeks 2, 4, and 8. To download a copy of thisposter, scan code.