Andrew Blauvelt, MD, MBA,1 Jacek C. Szepietowski, MD, PhD, FRCP (Edin),2 Kim Papp, MD, PhD,3 Eric L. Simpson, MD, MCR,4 Jonathan I. Silverberg, MD, PhD, MPH,5 
Brian S. Kim, MD, MTR,6 Shawn G. Kwatra, MD,7 Michael E. Kuligowski, MD, PhD, MBA,8 May E. Venturanza, MD,8 Kang Sun, PhD,8 Leon Kircik, MD9 

Introduction
● Atopic dermatitis (AD) is a highly pruritic, chronic, inflammatory skin disease1

● Itch is reported to be the most burdensome symptom of AD2; some patients with AD report
itch every day3

– Inadequate control of AD is associated with greater itch interference with daily living4

– The negative impact of itch in patients with AD highlights the need for achievement of
an itch-free state

● Janus kinases (JAKs) play an important role in the pathogenesis of AD and the development
of itch by mediating proinflammatory cytokines in skin and sensory neurons5,6

● Ruxolitinib cream is a topical formulation of ruxolitinib, a selective inhibitor of JAK1 and JAK27

● In two phase 3 randomized studies of identical design (TRuE-AD1 [NCT03745638] and
TRuE-AD2 [NCT03745651]), ruxolitinib cream demonstrated anti-inflammatory activity 
with rapid and sustained antipruritic action vs vehicle and was well tolerated in patients 
with AD7

Objective
● To describe the effect of ruxolitinib cream on achievement of an itch-free state in

adolescent and adult patients with AD 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 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], 1.5% BID) or vehicle cream BID for 8 weeks of
double-blinded treatment

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

Figure 1. Study Design 

• Continuous treatment for 8 weeks
• Rescue treatment not permitted

• Treat as needed for 44 weeks
• Stop treatment 3 days after lesion clearance
• 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
● The effects of ruxolitinib cream on itch were assessed by the proportion of patients

achieving an itch numerical rating scale score of 0 or 1 (NRS 0/1)
– Patients were given an electronic diary to be completed each evening and were

instructed to report their worst level of itch during the past 24-hour period from
0 (no itch) to 10 (worst imaginable itch)

– The by-visit itch NRS score for post-baseline visits (Weeks 2, 4, 8) was determined
by averaging the 7 daily itch NRS scores before the study visit; if ≥4 daily scores were
missing, the itch NRS score for the study visit was classified as missing

● The effects on eczema-related itch were also assessed using the proportion of patients
reporting no days of itch per item 1 (frequency of itch; Q1) of the Patient-Oriented Eczema
Measure (POEM)8 at baseline and Weeks 2, 4, and 8

● Itch-free state was also assessed stratified by baseline itch NRS score (<6 or ≥6)
Statistical Analyses
● All analyses were conducted using the pooled data from the vehicle-controlled portion of

both studies
● The proportion of patients achieving itch NRS 0/1 and the number of days with no itch per

POEM Q1 were assessed using logistic regression

● Cumulative incidence plots were created for time to itch NRS 0/1
– A log-rank test was used for between-group comparisons

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

Results
Patients
● A total of 1249 patients (median age, 32 years) were randomized in the VC period
● The mean (SD) itch NRS score at baseline was 5.1 (2.4)
● 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)
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)
Baseline POEM Q1 (itch frequency) 
response, n (%)*

No days 5 (2.1) 9 (1.9) 13 (2.8) 27 (2.3)
1–2 days 18 (7.5) 30 (6.3) 35 (7.4) 83 (7.0)
3–4 days 33 (13.8) 75 (15.8) 63 (13.3) 171 (14.4)
5–6 days 29 (12.1) 44 (9.3) 50 (10.6) 123 (10.4)
Every day 155 (64.6) 317 (66.7) 311 (65.9) 783 (66.0)

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; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; POEM Q1, Patient-Oriented Eczema Measure–
Question 1; RUX, ruxolitinib cream.  
* Data available for 1187 patients (vehicle, n=240; 0.75% RUX, n=475; 1.5% RUX, n=472).
† Patient reported.

Efficacy
● A significantly higher proportion of patients who applied 0.75% and 1.5% ruxolitinib cream

achieved itch NRS 0/1 vs vehicle as early as Day 2 (approximately 36 hours after first
application; 19.1% and 22.3% for 0.75% and 1.5% ruxolitinib cream, respectively, vs 9.2%;
both P<0.01; Figure 2)

Figure 2. Daily Proportion of Patients Achieving Itch NRS 0/1 in the First 7 Days

Pr
op

or
tio

n 
of

 P
at

ie
nt

s 
Ac

hi
ev

in
g

Itc
h 

NR
S 

0/
1,

 %

0

10

20

30

40

50

70

60

1 2 3 4 5 6 7
Study Day

Vehicle 0.75% RUX 1.5% RUX

Number of Patients
Vehicle
0.75% RUX
1.5% RUX

Day 1
223
444
445

Day 4
215
432
435

Day 7
220
429
436

10.8 9.2 11.0 10.2
13.2 15.2 14.1

12.6 19.1
23.9

29.4 28.0 31.3
32.6

13.0

22.3
25.9

30.8
34.4

38.0 39.4

****

**

****

***

****

****

****

****

****

****

****

****

NRS, numerical rating scale; RUX, ruxolitinib cream.
** P<0.01 vs vehicle; *** P<0.001 vs vehicle; **** P<0.0001 vs vehicle.

● At Week 8, the proportion of patients achieving itch NRS 0/1 (average of daily NRS
measurements over the 7 days before the Week 8 visit) was significantly higher for
patients who applied ruxolitinib cream (0.75%/1.5%) compared with vehicle (45.5%/51.5%
vs 23.1%; both P<0.0001; Figure 3)

Figure 3. Proportion of Patients Achieving Itch NRS 0/1 

****

****

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s
Ac

hi
ev

in
g 

Itc
h 

NR
S 

0/
1,

 %

0

10

20

30

40

50

70

60

2 4 8
Time, wk

Vehicle 0.75% RUX 1.5% RUX

Number of Patients
Vehicle
0.75% RUX
1.5% RUX

210
425
429

198
423
421

173
374
400

10.5
15.2

23.129.6

39.2
45.535.2

46.3 51.5

NRS, numerical rating scale; RUX, ruxolitinib cream. 
**** P<0.0001 vs vehicle.

● Median time to achieve the first observed day with itch NRS 0/1 was shorter for ruxolitinib
cream (12.0 and 8.0 days for 0.75% and 1.5% ruxolitinib cream, respectively) vs vehicle
(51.0 days; Figure 4); cumulative incidence rates for achieving ≥1 day with itch NRS 0/1
were significantly higher for ruxolitinib cream (log-rank P<0.0001 [both])

Figure 4. Kaplan-Meier Curve of Time to Achieve Itch NRS 0/1 

Vehicle
Censored

Number of Patients
Vehicle
0.75% RUX
1.5% RUX

Pr
ob

ab
ili

ty
 o

f
Ac

hi
ev

in
g 

Itc
h 

NR
S 

0/
1

0.0

0.6

0.8

0 8015105 302520 454035 605550 757065

1.0

0.4

0.2

0.5

0.3

0.1

0.7

0.9

Time to Event, d

0.75% RUX 1.5% RUX

242
479
480

99
116
85

110
123
96

116
141
109

125
159
119

3
3
1

8
7
8

11
0
0

71
79
73

93
103
81

138
175
132

147
192
153

160
216
183

173
255
216

194
318
301

0

NRS, numerical rating scale; RUX, ruxolitinib cream.

● Significantly more patients reported no days of itch with ruxolitinib cream per POEM Q1 at
Week 8 (28.3% and 32.9% for 0.75% and 1.5% ruxolitinib cream, respectively) vs vehicle
(9.0%; both P<0.0001; Figure 5)

Figure 5. Patients Reporting No Days of Itch per POEM Q1

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s 
Re

po
rti

ng
 N

o 
Da

ys
 o

f I
tc

h 
pe

r P
OE

M
 Q

1,
 %

0

10

20

30

40

50

70

60

2 4 8
Time, wk

Vehicle 0.75% RUX 1.5% RUX

Number of Patients
Vehicle
0.75% RUX
1.5% RUX

224
455
455

209
453
459

200
427
444

4.5 5.7 9.0
18.0

23.0
28.3

23.1
29.0 32.9

****

****

POEM Q1, Patient-Oriented Eczema Measure–Question 1; RUX, ruxolitinib cream.
**** P<0.0001 vs vehicle.

● As assessed by itch NRS 0/1 or POEM, more patients achieved itch-free status at Week 8
with ruxolitinib cream vs vehicle (47.7% and 52.0% for 0.75% and 1.5% ruxolitinib cream,
respectively, vs 23.4%; both P<0.0001; Figure 6) regardless of baseline itch score
(Figure 7)

Figure 6. Patients Achieving Itch NRS 0/1 or No Days of Itch per POEM Q1

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s 
Ac

hi
ev

in
g 

Itc
h 

NR
S 

0/
1 

or
 N

o 
Da

ys
 o

f I
tc

h 
pe

r P
OE

M
 Q

1,
 %

Time, wk

Vehicle 0.75% RUX 1.5% RUX

Number of Patients
Vehicle
0.75% RUX
1.5% RUX

226
461
461

212
456
462

201
432
450

0

10

20

30

40

50

60

70

2 4 8

11.5
15.6 23.4

33.0

41.4
47.738.6

48.7 52.0
****

****

NRS, numerical rating scale; POEM Q1, Patient-Oriented Eczema Measure–Question 1; RUX, ruxolitinib cream.
**** P<0.0001 vs vehicle.

Figure 7. Patients Achieving Itch NRS 0/1 or No Days of Itch per POEM Q1 by Baseline 
Itch NRS Score

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s 
Ac

hi
ev

in
g 

Itc
h 

NR
S 

0/
1 

or
 N

o 
Da

ys
 o

f I
tc

h 
pe

r P
OE

M
 Q

1,
 %

Time, wk

Baseline Itch NRS <6

Baseline Itch NRS ≥6

Vehicle 0.75% RUX 1.5% RUX

Number of Patients
Vehicle
0.75% RUX
1.5% RUX

122
258
270

113
257
276

109
249
265

0

10

20

30

40

50

60

70

2 4 8

16.4
22.1 27.5

44.6
48.6

57.4
47.8

55.1 58.1
****

****

Pr
op

or
tio

n 
(S

E)
 o

f P
at

ie
nt

s 
Ac

hi
ev

in
g 

Itc
h 

NR
S 

0/
1 

or
 N

o 
Da

ys
 o

f I
tc

h 
pe

r P
OE

M
 Q

1,
 %

Time, wk

Vehicle 0.75% RUX 1.5% RUX

Number of Patients
Vehicle
0.75% RUX
1.5% RUX

90
176
172

86
170
168

79
158
167

0

10

20

30

40

50

60

70

2 4 8

4.4 5.8
17.716.5

32.4
34.225.0

38.7 41.3
***

**

NRS, numerical rating scale; POEM Q1, Patient-Oriented Eczema Measure–Question 1; RUX, ruxolitinib cream.
** P<0.01 vs vehicle; *** P<0.001 vs vehicle; **** P<0.0001 vs vehicle.

Safety
● Ruxolitinib cream was well tolerated with an adverse event (AE) profile similar to vehicle7;

no serious AEs were related to ruxolitinib cream

Conclusions

● A significantly greater number of patients
treated with ruxolitinib cream achieved
and sustained an itch-free state vs vehicle
during the 8-week treatment period

● Patients who applied ruxolitinib cream
had a substantially shorter median time
to itch NRS 0/1 vs vehicle

Disclosures
AB has served as a scientific advisor and/or clinical study investigator for AbbVie, Abcentra, Aligos, 
Almirall, Amgen, Arcutis, Arena, Aslan, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, 
Dermavant, Eli Lilly and Company, Evommune, Forte, Galderma, Incyte Corporation, Janssen, 
Landos, LEO Pharma, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, and 
UCB Pharma. JCS has served as an advisor for AbbVie, LEO Pharma, Menlo Therapeutics, 
Novartis, Pierre Fabre, and Trevi; has received speaker honoraria from AbbVie, Eli Lilly, Janssen-
Cilag, LEO Pharma, Novartis, Sanofi Genzyme, and Sun Pharma; and has received clinical trial 
funding from AbbVie, Almirall, Amgen, Galapagos, Holm, Incyte Corporation, InflaRX, Janssen-
Cilag, Menlo Therapeutics, Merck, Novartis, Pfizer, Regeneron, Trevi, and UCB. KP has received 
honoraria or clinical research grants as a consultant, speaker, scientific officer, advisory board 
member, and/or steering committee member for AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, 
Bausch Health/Valeant, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite, Celgene, 
Coherus, Dermira, Dow Pharmaceuticals, Eli Lilly, Galderma, Gilead, GlaxoSmithKline, Incyte 
Corporation, InflaRx, Janssen, Kyowa Hakko Kirin, LEO Pharma, Meiji Seika Pharma, Merck 
(MSD), Merck Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, 
Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharmaceuticals, Takeda, and UCB. 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. 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. BSK has served as a consultant to AbbVie, Almirall, Amagma, 
Cara Therapeutics, Daewoong, Incyte Corporation, OM Pharma, and Pfizer; has served on 
advisory boards for AstraZeneca, Boehringer Ingelheim, Cara Therapeutics, Celgene Corporation, 
Regeneron Pharmaceuticals, Sanofi Genzyme, and Trevi Therapeutics; is a shareholder in 
Locus Biosciences; and has a pending patent for JAK inhibitors in chronic itch. SGK has served 
as an advisory board member or consultant for AbbVie, Galderma, Incyte Corporation, Kiniksa 
Pharmaceuticals, Regeneron Pharmaceuticals, and Pfizer Inc; and has received grant funding 
from Pfizer Inc, Galderma, and Kiniksa Pharmaceuticals. 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. LK has served as an investigator, consultant, 
or speaker for AbbVie, Amgen, Anaptys, Arcutis, Dermavant, Eli Lilly, Glenmark, Incyte Corporation, 
Kamedis, LEO Pharma, L’Oreal, Menlo Therapeutics, Novartis, Ortho Dermatologics, Pfizer, 
Regeneron, Sanofi, Sun Pharma, and Taro.

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). The authors thank Shaoceng Wei, PhD, of Incyte Corporation for providing statistical 
analysis support. Writing assistance was provided by Vicky Kanta, 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.
Ann Allergy Asthma Immunol. 2018;121(3):340-347. 3. Chrostowska-Plak D,
et al. Acta Derm Venereol. 2009;89(4):379-383. 4. Wei W, et al.
J Dermatol. 2018;45(2):150-157. 5. Bao L, et al. JAKSTAT. 2013;2(3):e24137.
6. Oetjen LK, et al. Cell. 2017;171(1):217-228. 7. Papp K, et al. J Am Acad
Dermatol. 2021;85(4):863-872. 8. Charman CR, et al. Arch Dermatol.
2004;140(12):1513-1519.

1Oregon Medical Research Center, Portland, OR, USA; 
2Wroclaw Medical University, Wroclaw, Poland; 3K. Papp  
Clinical Research and Probity Medical Research, Waterloo, ON, 
Canada; 4Oregon Health & Science University, Portland, OR, 
USA; 5George Washington University, Washington, DC, USA; 
6Washington University School of Medicine, St. Louis, MO, USA; 
7Johns Hopkins University School of Medicine, Baltimore, MD, 
USA; 8Incyte Corporation, Wilmington, DE, USA; 9Icahn School 
of Medicine at Mount Sinai, New York, NY, USA

Itch-Free State in Patients With Atopic Dermatitis Treated With Ruxolitinib Cream 
Presented at the

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

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