101102042_Cobi_Pop_PK_L1a


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INTRODUCTION

• AD is a chronic inflammatory skin disease; patients with AD are at 
higher risk for other atopic comorbidities, such as food allergies1

• The prevalence of food allergy in AD ranges from 20% to 80% in 
this population2

 – Although it is not clear whether the presence of food allergies makes 
AD more difficult to treat, there is an association between ingestion 
of food that triggers an allergic reaction and AD exacerbation3

• Crisaborole ointment, 2%, is an anti-inflammatory nonsteroidal 
PDE4 inhibitor for the treatment of patients aged ≥3 months (≥2 years 
of age outside the United States) with mild-to-moderate AD4

 – Initial regulatory approval was based on the results from 2 
identically designed, vehicle-controlled, phase 3 clinical studies: 
CORE 1 (NCT02118766) and CORE 2 (NCT02118792)5

OBJECTIVE

• To ascertain the efficacy and safety of crisaborole 
for the treatment of AD in patients with or without 
food allergies in a post hoc pooled analysis from 
the phase 3 studies CORE 1 and CORE 2

METHODS

Patients and Treatment
• CORE 1 and CORE 2 were 2 identically designed, randomized, 

double-blind, vehicle-controlled, phase 3 studies conducted to 
compare crisaborole and vehicle in patients with AD, per Hanifin 
and Rajka criteria,6 who had mild-to-moderate disease per the ISGA 
and %BSA of ≥5 (excluding the scalp)

• Patients were randomly assigned in a 2:1 ratio to receive crisaborole 
ointment, 2%, or vehicle applied twice daily to all areas affected by 
AD, except the scalp, for 28 days

• Patients were not permitted to use any topical agents on AD lesions 
or rescue medications during the study 

• For this post hoc analysis, patients were stratified based on their 
medical history of food allergies

Outcomes and Assessments
• The ISGA, a 5-point physician-reported scale of AD severity,5 was 

assessed at baseline and weekly thereafter

• Pruritus severity was assessed using the SPS, a validated patient- 
or caregiver-reported 4-point rating scale,7 and reported twice daily 
(morning and evening) via electronic diary 

• Efficacy outcomes were

 – Proportion of patients who achieved ISGA success (defined as an 
ISGA of clear [0] or almost clear [1] with a ≥2-grade improvement 
from baseline) at day 29

 – Proportion of patients who achieved ISGA clear (0) or almost 
clear (1) at day 29

 – Proportion of patients who experienced improvement in SPS score 
(defined as a weekly average SPS score ≤1 point with ≥1-point 
improvement from baseline) at week 4

• Safety outcomes that included TEAEs (all cause and treatment 
related), serious AEs, and AEs of special interest (eg, anaphylaxis) 
were collected throughout the study

Efficacy and Safety of 
Crisaborole in Patients 
With Mild-to-Moderate 

Atopic Dermatitis  
With and Without  

Food Allergies

Michael S. Blaiss,1 Michael J. Cork,2 Peter Lio,3,4 Aharon Kessel,5,6 
Liza Takiya,7 John L. Werth,7 Michael A. O’Connell,7 Chuanbo Zang,7 

Jonathan M. Spergel8

1Medical College of Georgia, Augusta University, Augusta, GA, USA; 2Sheffield Dermatology 
Research, IICD, University of Sheffield, Sheffield Children’s Hospital, Sheffield, United Kingdom;  

3Northwestern University Feinberg School of Medicine, Chicago, IL, USA; 4Chicago Integrative  
Eczema Center, Chicago, IL, USA; 5Bnai Zion Medical Center, Haifa, Israel; 6Bruce and Ruth  

Rappaport Faculty of Medicine, Technion, Haifa, Israel; 7Pfizer Inc., Collegeville, PA, USA;  
8Children’s Hospital of Philadelphia and Perelman School of Medicine, University of Pennsylvania,  

Philadelphia, PA, USA

Acknowledgments
Editorial/medical writing support under the guidance of the authors was provided by  

Christopher M. Goodwin, PhD, at ApotheCom, San Francisco, CA, USA, and was funded by Pfizer 
Inc., New York, NY, USA, in accordance with Good Publication Practice (GPP3) guidelines (Ann 

Intern Med. 2015;163:461-464).

Disclosures
MSB has served as an investigator or consultant for Pfizer and Regeneron/Sanofi Genzyme.  

MJC has served as an investigator or consultant for Astellas, Boots, Dermavant, Eli Lilly, 
Galapagos, Galderma, Hyphens, Johnson & Johnson, Kymab, L’Oreal, LEO, Menlo Therapeutics, 

Novartis, Oxagen, Perrigo (ACO Nordic), Pfizer, Procter & Gamble, Reckitt Benckiser,  
Regeneron/Sanofi Genzyme, and UCB Pharma. PL is a board member of the National Eczema 

Association; has served as an advisor or consultant for Regeneron/Sanofi Genzyme, Pfizer, 
Galderma, LEO, AbbVie, Eli Lilly, La Roche Posay, Pierre Fabre, Level Ex, Unilever, Menlo 

Therapeutics, Theraplex, IntraDerm, Exeltis, AOBiome, Arbonne, Amyris, Bodewell, Burt’s Bees, 
and Kimberly Clark; holds stock in Altus Labs, Micreos, and Yobee Care; has received honoraria 
from UCB, Dermavant, Kiniksa, Verrica, Realm, and Johnson & Johnson, as well as fees from 

Regeneron/Sanofi Genzyme and Pfizer; and has served on speaker bureaus for Regeneron/Sanofi 
Genzyme, Pfizer, and Galderma. AK has served as an investigator or consultant for Pfizer, Sanofi, 
Takeda, Novartis, GSK, Rafa, AstraZeneca, and Kamada and has received honoraria or fees from 

Pfizer, Sanofi, Takeda, Novartis, GSK, Rafa, Teva, and Kamada. JMS has served as an investigator 
or consultant for Regeneron/Sanofi Genzyme, Celgene, Allakos, Novartis, and DBV Technology;  
has served on speaker bureaus for Abbot, Medscape, and Sanofi; and is an associate editor for  

the Annals of Allergy, Asthma & Immunology. LT, JLW, MAO, and CZ are employees and 
stockholders of Pfizer Inc.

Presented at the 2021 Winter Clinical Dermatology Conference;  
January 16-24, 2021

Abbreviations %BSA, percentage of treatable body surface area; AD, atopic dermatitis; AE, adverse event; ISGA, Investigator’s Static Global 
Assessment; PDE4, phosphodiesterase 4; SPS, Severity of Pruritus Score; TEAE, treatment-emergent adverse event.

References 1. Dharmage SC et al. Curr Opin Allergy Clin Immunol. 2004;4(5):379-385. 2. Werfel T, Breuer K. Curr Opin Allergy Clin Immunol. 
2004;4(5):379-385. 3. Robison RG, Singh AM. J Allergy Clin Immunol Pract. 2019;7(1):35-39. 4. Eucrisa (crisaborole) ointment, 2%, for topical 
use [package insert]. New York, NY: Pfizer Labs; April 2020. 5. Paller AS et al. J Am Acad Dermatol. 2016;75(3):494-503.e496. 6. Hanifin JM, 
Rajka G. Acta Derm Venereol. 1980;60(92):44-47. 7. Yosipovitch G et al. Itch. 2018;3:e13.

This study was funded by Pfizer Inc.

RESULTS

Patients 
• In the pooled study population, 1016 patients received crisaborole 

and 506 received vehicle

 – Among them, 251 reported a past medical history of food allergies 
and 1271 did not have a past medical history of food allergies

 – Baseline demographics were generally similar between treatment 
arms and between those who did and those who did not have 
food allergies

 – Regarding baseline disease characteristics, for those with a past 
medical history of food allergies, a relatively greater proportion  
(1) used systemic corticosteroids previously, (2) used antihistamines 
concurrently, (3) had moderate AD per ISGA at baseline, and  
(4) had greater %BSA involvement with AD lesions (Table 1)

Table 1. Baseline Demographics and Disease  
Characteristics in Patients With and Patients  
Without Food Allergies

Demographic or  
Characteristic

HIstory of  
Food Allergies

No History of  
Food Allergies

Vehicle
n=99

Crisaborole
n=152

Vehicle
n=407

Crisaborole
n=864

Age, y
Mean (SD)
Median (min, max)

8.3 (5.9)
8.0 (2, 36)

10.8 (10.1)
8.0 (2, 57)

13.0 (12.5)
10.0 (2, 79)

12.6 (12.5)
9.0 (2, 79)

Female, % (n) 51.5 (51) 45.4 (69) 56.5 (230) 57.5 (497)

White, % (n) 62.6 (62) 61.2 (93) 60 (244) 60.7 (524)

%BSA
Mean (SD)
Median (min, max)

23.4 (20.9)
16.0 (5, 90)

23.2 (21.9)
15.0 (5, 90)

16.9 (16.1)
10.0 (5, 90)

17.5 (17.1)
10.0 (5, 95)

ISGA, % (n)
Mild (2)
Moderate (3)

21.2 (21)
78.8 (78)

29 (44)
71.1 (108)

42.3 (172)
57.7 (235)

40.4 (349)
59.6 (515)

SPS, % (n)
None (0)
Mild (1)
Moderate (2)
Severe (3)

 
0

20.2 (20)
33.3 (33)
30.3 (30)

 
3.3 (5)

16.5 (25)
34.9 (53)
30.3 (46)

 
4.7 (19)
24.3 (99)
32.9 (134)
26 (106)

 
3.5 (30)

23.6 (204)
32.2 (278)
30.3 (262)

Prior use of systemic 
corticosteroids,a % (n) 44.4 (44) 44.7 (68) 31.7 (129) 28.1 (243)

Concurrent use of  
antihistamines, % (n) 49.5 (49) 48.7 (74) 20.9 (85) 19.8 (171)

aWithin 90 days before starting study treatment.

Efficacy
• The proportion of patients who achieved ISGA success at day 29 

was significantly greater in the crisaborole-treated group than in the 
group receiving vehicle, regardless of past medical history of food 
allergies (Figure 1)

• Similarly, in patients with or without food allergies, a significantly 
greater proportion of crisaborole-treated patients achieved ISGA clear 
or almost clear at day 29 than those given vehicle (Figure 2)

• At week 4, a numerically greater proportion of patients with or without 
history of food allergies in the crisaborole group than in the vehicle 
group achieved improvement in SPS score; however, it was only 
statistically significant in the patients without history of food allergies 
(Figure 3)

Figure 1. Proportion of Patients Who Achieved 
ISGA Successa at Day 29

0
10
20
30
40
50
60
70
80
90
100

P
ro

po
rt

io
n 

of
 P

at
ie

nt
s,

 %
 (9

5%
 C

I)

History of food allergies No history of food allergies

P=0.01 P=0.001

17.0 23.131.3 32.3

Vehicle Crisaborole

aISGA success defined as ISGA of clear or almost clear with ≥2-grade improvement from baseline.

Figure 2. Proportion of Patients Who Achieved 
ISGA Clear or Almost Clear at Day 29

0
10
20
30
40
50
60
70
80
90
100

P
ro

po
rt

io
n 

of
 P

at
ie

nt
s,

 %
 (9

5%
 C

I)

History of food allergies No history of food allergies

Vehicle Crisaborole

P=0.003
P<0.0001

22.4 38.540.7 51.8

Figure 3. Proportion of Patients Who Achieved 
Improvement in SPSa Score at Week 4

0
10
20
30
40
50
60
70
80
90
100

P
ro

po
rt

io
n 

of
 P

at
ie

nt
s,

 %
 (9

5%
 C

I)

History of food allergies No history of food allergies

Vehicle Crisaborole

P=0.1
P<0.0001

16.9 21.927.4 37.3

aImprovement in SPS score defined as weekly average SPS score ≤1 point with a ≥1-point improvement from baseline.

Safety
• The safety profile was generally similar between patients with food 

allergies and those without food allergies

• Among patients with food allergies, 61 crisaborole-treated patients 
(40.1%) and 40 vehicle-treated patients (40.8%) experienced at 
least 1 all-cause TEAE

 – Among crisaborole-treated patients with food allergies, 22 (14.5%) 
experienced a mild TEAE, 37 (24.3%) experienced a moderate 
TEAE, and 2 (1.3%) experienced a severe TEAE

• Individual TEAEs were infrequent (Table 2)
• The most common treatment-related TEAE in patients with food 

allergies and those without food allergies (crisaborole vs vehicle) was 
application site pain (7.2% vs 3.1% and 4.0% vs 0.7%, respectively)

• 1 crisaborole-treated patient with food allergies experienced a serious 
TEAE (pneumonia, 0.7%), and no patients (0%) given vehicle 
experienced a serious TEAE; the serious TEAE was not considered 
related to treatment

• No anaphylaxis was reported in any group

Table 2. Most Common (in >2% Patients) TEAEs  
(all cause) in Patients With and Patients Without  
Food Allergies

History of  
Food Allergies

No History of  
Food Allergies

Vehicle
n=98

Crisaborole
n=152

Vehicle
n=401

Crisaborole
n=860

AE (all cause), % (n) 
Application site pain
Upper respiratory 
   tract infection
Viral upper respiratory  
   tract infection
Pyrexia
Eczema infected
Cellulitis
Staphylococcal skin 
infection
Asthma
Cough
Nasal congestion

3.1 (3)

1.0 (1)

1.0 (1)
3.1 (3)
1.0 (1)
2.0 (2)

2.0 (2)
1.0 (1)
5.1 (5)
2.0 (2)

7.2 (11)

5.3 (8)

2.0 (3)
2.6 (4)
2.0 (3)
0.7 (1)

0.7 (1)
2.6 (4)
1.3 (2)
3.3 (5)

0.7 (3)

4.0 (16)

2.5 (10)
1.2 (5)
0.2 (1)
0.2 (1)

0.7 (3)
0

1.0 (4)
0

4.0 (34)

3.0 (26)

2.7 (23)
2.3 (20)
0.1 (1)
0.1 (1)

0
0.5 (4)

1.6 (14)
0.5 (4)

TEAEs of special interest, 
% (n)

Anaphylaxis 0 0 0 0

Limitations
• These post hoc analyses were not powered to detect treatment 

differences in food allergy subgroups; therefore, additional studies 
are necessary to confirm these results 

• The CORE-1 and CORE-2 studies were not specifically designed to 
evaluate crisaborole effects on food allergies 

CONCLUSIONS

• Regardless of whether patients have food allergies, 
crisaborole is effective in treating mild-to-moderate 
symptoms of AD

• The safety profile was generally similar between 
patients with food allergies and those without 
food allergies; no new safety signals were observed

• Crisaborole should be considered for management 
of AD in patients with or without a history of 
food allergies