101102042_Cobi_Pop_PK_L1a


Presented at the Winter Clinical Dermatology Conference; January 13-18, 2023; Kohala Coast, Hawaii

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BACKGROUND 
• Skin pain is a commonly reported and burdensome symptom in patients with 

atopic dermatitis (AD)1

• Abrocitinib is an oral once-daily, Janus kinase 1–selective inhibitor approved for 
the treatment of patients with moderate-to-severe AD2,3

OBJECTIVE
• To assess the efficacy of abrocitinib on skin pain in adult and adolescent patients 

with moderate-to-severe AD

METHODS
• Data were analyzed from trials with abrocitinib as monotherapy (pooled phase 

2b trial [age 18-75 years] and phase 3 trials JADE MONO-1 [NCT03349060] and 
MONO-2 [NCT03575871; both age ≥12 years]) or in combination with topical 
therapy (phase 3 trials JADE COMPARE [NCT03720470; age ≥18 years] and  
JADE TEEN [NCT03796676; age 12-17 years])

• Patients received oral abrocitinib 200 mg or 100 mg or placebo once daily
 – JADE COMPARE also included an active-control arm (dupilumab 300 mg 

administered subcutaneously every other week)
• Patients rated their skin pain score from 0 (not painful) to 10 (extremely painful) 

over a 24-hour period using the Pruritus and Symptoms Assessment for Atopic 
Dermatitis (PSAAD) instrument4

• Least squares mean change from baseline in PSAAD item # 2 (“How painful was 
your skin over the past 24 hours?”) was assessed in: 

 – Adult and adolescent patients from the pooled monotherapy trials
• Results from JADE COMPARE and JADE TEEN have been presented 

previously5

 – A subset of patients across the trials who were classified as nonresponders per 
Investigator’s Global Assessment (IGA)
• IGA response was defined as achieving an IGA score of 0/1 and a ≥2-point 

improvement from baseline

RESULTS
Patients
• Baseline demographics for patients in the pooled monotherapy, JADE COMPARE, 

and JADE TEEN trials are shown in Table 1

Table 1. Baseline Characteristics (full analysis set)

Pooled  
monotherapya

N=942

JADE  
COMPARE

N=837

JADE  
TEEN

N=285

Age, y 
mean ± SD
median (IQR)

35.0 ± 15.9
NA

37.7 ± 14.7
NA

NA
15.0 (13.0-17.0)

Age <18 years of age, n (%) 124 (13.2) 0 (0.0) 284 (99.6)b

Duration of disease, y, 
mean ± SD 23.0 ± 15.5 22.7 ± 15.4 10.0 ± 5.2

EASI score, mean ± SD 28.8 ± 12.7 30.9 ± 12.8 29.9 ± 12.5

PP-NRS total score, mean ± 
SD 7.0 ± 1.9 7.3 ± 1.7 7.0 ± 1.8

DLQI total score, mean ± 
SD 14.6 ± 6.9 15.7 ± 6.6 NA

CDLQI total score, mean ± 
SD 12.7 ± 6.0 NA 14.0 ± 6.6

HADS Anxiety score, mean 
± SD 6.1 ± 4.1 5.3 ± 3.8 5.5 ± 4.0

HADS Depression score, 
mean ± SD 4.3 ± 3.8 3.9 ± 3.5 3.6 ± 3.2

PSAAD item # 2 score, 
mean ± SD 5.6 ± 2.5f 5.6 ± 2.6g 5.0 ± 2.6h

CDLQI, Children’s Dermatology Life Quality Index; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index;  
HADS, Hospital Anxiety and Depression Scale; IQR, interquartile range; NA, not applicable; PP-NRS, Peak Pruritus Numerical Rating Scale 
(used with permission from Regeneron Pharmaceuticals, Inc., and Sanofi); PSAAD, Pruritus and Symptoms Assessment for Atopic Dermatitis. 
aPooled monotherapy population includes patients from the phase 2b and the phase 3 JADE MONO-1 and JADE MONO-2 trials. 
b1 patient in the placebo group was enrolled at age 18 years, which was a protocol deviation. 
fN=802. 
gN=780. 
hN=254.

Efficacy of Abrocitinib in the Pooled Monotherapy Population 
• Abrocitinib monotherapy improved skin pain in both adult and adolescent 

patients as early as week 2, and improvements were maintained through week 12 
(Figure 1)

 – Improvements with abrocitinib were greater than placebo at all evaluated time 
points and were dose dependent

Figure 1. Change From Baseline to Week 12 in Skin Pain in (A) Adult and  
(B) Adolescent Patients in the Pooled Monotherapy Population

0.5
0.0

−2.5

−4.5

−2.0

−4.0

−1.5

−3.5

−1.0
−0.5

−3.0

Week

A

128420

*Weeks 2, 4, 8, 12 (vs placebo)
*Weeks 2, 4, 8, 12 (vs placebo)

LS
M

 C
fB

 in
 P

S
A

A
D

Ite
m

 #
2 

(9
5%

 C
I)

0.5
0.0

−2.5

−4.5

−2.0

−4.0

−1.5

−3.5

−1.0
−0.5

−3.0

Week

B

128420

*Weeks 2, 4, 8, 12 (vs placebo)
*Weeks 2, 4, 8, 12 (vs placebo)

LS
M

 C
fB

 in
 P

S
A

A
D

Ite
m

 #
2 

(9
5%

 C
I)

Abrocitinib 200 mg QD (n=271)
Placebo (n=148) Abrocitinib 100 mg QD (n=268)

Abrocitinib 200 mg QD (n=46)
Placebo (n=23) Abrocitinib 100 mg QD (n=46)

CfB, change from baseline; LSM, least squares mean; PSAAD, Pruritus and Symptoms Assessment for Atopic Dermatitis; QD, once daily.
*Nominal P<0.05 for abrocitinib versus placebo.
Pooled monotherapy population includes patients from the phase 2b, and phase 3 JADE MONO-1 and JADE MONO-2 trials. Results from 
JADE COMPARE and JADE TEEN have been presented previously.5

Efficacy of Abrocitinib Treatment in Nonresponders per IGA
• Improvements in skin pain were observed among patients classified as 

nonresponders per IGA after treatment with abrocitinib as monotherapy (Figure 2A)  
or in combination with topical treatment in JADE COMPARE (Figure 2B) and 
JADE TEEN (Figure 2C)

 – Skin pain improvement was seen as early as week 1 in a dose-dependent 
manner across all studies

 – Improvements were maintained through week 12 or week 16 of treatment 

Abrocitinib Reduces Skin Pain in Adolescent and Adult Patients  
With Moderate-to-Severe Atopic Dermatitis

Jacob P. Thyssen,1 Anthony Bewley,2 Sonja Ständer,3 Carla Castro,4 Laurent Misery,5 Brian S. Kim,6 Pinaki Biswas,7 Gary Chan,8 Daniela E. Myers,9 Melissa Watkins,7 Justine Alderfer,9 Erman Guler,10 Jonathan I. Silverberg11
1Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark; 2Barts Health NHS Trust, London, United Kingdom; 3Center for Chronic Pruritus, Münster University Hospital, Munster, Germany; 4Hospital Universitario Austral, Pilar, Argentina; 5University Hospital of Brest, Brest, France;  

6Washington University School of Medicine, St. Louis, MO, USA; 7Pfizer Inc., New York, NY, USA; 8Pfizer Inc., Groton, CT, USA; 9Pfizer Inc., Collegeville, PA, USA; 10Pfizer Inc., Istanbul, Turkey; 11The George Washington University School of Medicine and Health Sciences, Washington DC, USA

Figure 2. Change From Baseline to Week 12/16 in Skin Pain Among 
Nonresponders per IGAa in (A) the Monotherapy Pool,b (B) JADE COMPARE, 
and (C) JADE TEEN

0.5

0.0

−2.5

−4.0

−2.0

−1.5

−3.5

−1.0

−0.5

−3.0

Week

C

128 9 10 1131 5 6 7420

*Weeks 1–7, 9, 11, 12 (vs placebo)
*Weeks 1–12 (vs placebo)

LS
M

 C
fB

 in
 P

S
A

A
D

Ite
m

 #
2 

(9
5%

 C
I)

0.5

0.0

−2.5

−4.0

−2.0

−1.5

−3.5

−1.0

−0.5

−3.0

Week

A

128 9 10 1131 5 6 7420

*Weeks 1–12 (vs placebo)
*Weeks 1–12 (vs placebo)

LS
M

 C
fB

 in
 P

S
A

A
D

Ite
m

 #
2 

(9
5%

 C
I)

0.5

0.0

−2.5

−4.0

−2.0

−1.5

−3.5

−1.0

−0.5

−3.0

Week

B

1615131198 10 12 1431 5 6 7420

*Weeks 16 (vs placebo)
*Weeks 2–16 (vs placebo)

LS
M

 C
fB

 in
 P

S
A

A
D

Ite
m

 #
2 

(9
5%

 C
I)

Abrocitinib 200 mg QD (n=150)
Placebo (n=154) Abrocitinib 100 mg QD (n=208)

Abrocitinib 200 mg QD (n=78)
Placebo (n=93) Abrocitinib 100 mg QD (n=91)

Abrocitinib 200 mg QD (n=32)
Placebo (n=56) Abrocitinib 100 mg QD (n=41)

CfB, change from baseline; LSM, least squares mean; PSAAD, Pruritus and Symptoms Assessment for Atopic Dermatitis; QD, once daily. 
*Nominal P<0.05 for abrocitinib vs placebo.
aIGA response was defined as achieving an IGA score of 0/1 and a ≥2-point improvement from baseline. 
bPooled monotherapy population includes patients from the phase 2b and the phase 3 JADE MONO-1 and JADE MONO-2 trials. 

CONCLUSIONS
• Abrocitinib as monotherapy or in combination with topical therapy rapidly and consistently reduced skin pain in adult and adolescent patients with moderate-to-severe AD, 

including those who did not achieve IGA response

REFERENCES
1. Vakharia PP et al. Ann Allergy Asthma Immunol. 2017;119:548-552.e3
2. Cibinqo (abrocitinib). Prescribing information. Pfizer Labs; January 2022. 
3. Cibinqo (abrocitinib). Summary of product characteristics.  

European Medicines Agency; December 17, 2021.
4. Hall R et al. Dermatol Ther (Heidelb). 2021;11:221-233. 
5. Thyssen J et al. Presented at: 3rd Annual Revolutionizing Atopic Dermatitis 

Virtual Conference; December 11-13, 2021. Abstract 639. 

ACKNOWLEDGMENTS
Editorial/medical writing support under the guidance of authors was provided  
by Renata Cunha, PharmD, and Jaya Kolipaka at ApotheCom, San Francisco,  
CA, USA, and was funded by Pfizer Inc., New York, NY, USA, in accordance with 
Good Publication Practice (GPP 2022) guidelines (Ann Intern Med. 2022; 
10.7326/M22-1460).
This study was sponsored by Pfizer Inc.
Previously presented at the 4th Annual Revolutionizing Atopic Dermatitis 
Conference (RAD); April 9-11, 2022; Hybrid, Baltimore, MD.

DISCLOSURES
JPT is an advisor for Pfizer Inc., AbbVie, Almirall, Arena Pharmaceuticals, Aslan Pharmaceuticals, Coloplast, Eli Lilly and Company,  
OM Pharma, LEO Pharma, Regeneron, Sanofi Genzyme, and Union Therapeutics and a speaker for Pfizer Inc., AbbVie, Almirall, Eli Lilly  
and Company, LEO Pharma, Regeneron, and Sanofi Genzyme and has received research grants from Pfizer Inc., Regeneron, and 
Sanofi Genzyme. AB reports consultancy for and travel grants from AbbVie, Almirall, Eli Lilly and Company, Galderma, Janssen,  
LEO Pharma, Novartis, Sanofi, and UCB. SST is an investigator for Dermasence, Galderma, Kiniksa, Menlo Therapeutics, Novartis, 
Sanofi, Trevi Therapeutics, and Vanda; roles as a member of scientific advisory boards, consultant, and/or speaker for Pfizer Inc., 
AbbVie, Almirall, Beiersdorf, Bellus Health, Benevolent, Bionorica, Cara, Clexio, Escient, Galderma, Grünenthal, Kiniksa, LEO Pharma, 
Eli Lilly and Company, Menlo Therapeutics, P.G. Unna Academy, Sanofi, Trevi Therapeutics, and Vifor. CC is a principal or sub-investigator 
for Pfizer Inc., AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Novartis, and Sanofi and a speaker and/or advisor for Pfizer Inc., 
AbbVie, Andromaco, Cerave, Galderma, Isdin, La Roche-Posay, Novartis, and Sanofi. LM is an investigator for Pfizer Inc., AbbVie, 
Galderma, Kiniksa, Eli Lilly and Company, Menlo Therapeutics, Novartis, Sanofi, and Trevi Therapeutics and a consultant for AbbVie, 
Beiersdorf, Clexio, Galderma, Eli Lilly and Company, Menlo Therapeutics, Novartis, Sanofi, Sienna Biopharmaceuticals, and Trevi 
Therapeutics. BSK is a consultant and advisor for Pfizer Inc., AbbVie, Boehringer Ingelheim, Cara Therapeutics, Kiniksa, Menlo 
Therapeutics, and Sanofi-Regeneron; has received research grants from Cara Therapeutics, Celgene, and LEO Pharma; and is founder 
and stockholder in Nuogen Pharma. PB, GC, DEM, MW, JA, and EG are employees and shareholders of Pfizer Inc. JIS served as an 
investigator for Celgene, Eli Lilly and Company, F. Hoffmann-La Roche, Menlo Therapeutics, Realm Therapeutics, Regeneron, and 
Sanofi; as a consultant for Pfizer Inc., AbbVie, Anacor, AnaptysBio, Arena Pharmaceuticals, Dermavant, Dermira, Eli Lilly and  
Company, Galderma, GlaxoSmithKline, Glenmark, Incyte, Kiniksa Pharmaceuticals, LEO Pharma, Menlo Therapeutics, Novartis,  
Realm Therapeutics, Regeneron, and Sanofi; and as a speaker for Regeneron and Sanofi.