Presented at the 40th Annual Fall Clinical Dermatology Conference (Fall CDC 2020); Virtual Congress; October 29 – November 1, 2020.

BACKGROUND
• Dupilumab is a fully human monoclonal antibody1,2 that 

blocks the shared receptor component for interleukin-4 
and interleukin-13 and has a demonstrated safety profile 
and sustained efficacy in adult and pediatric patients  
(aged ≥ 6 years) with moderate-to-severe atopic 
dermatitis (AD)3–6

• There is currently a paucity of information on patients who 
receive dupilumab in a real-world setting

• We present baseline data from a real-world registry 
of adult AD patients, initiating commercial dupilumab 
treatment for AD per approved prescribing information

OBJECTIVE
• To report baseline disease severity and 

treatment burden of AD in patients 
initiating dupilumab using data from the 
PROSE registry

Baseline Characteristics of Atopic Dermatitis (AD) and AD Treatments in a Cohort of Adult AD 
Patients Initiating Dupilumab in a Real-World Registry (PROSE)

Daniel I. Shrager1, Scott Guenthner2, David Cohen3, Haixin Zhang4, Daniel Richman5, Andrew Korotzer4, Shikha Bansal4
1Alpha Dermatology of PA, LLC, Sellersville, PA; 2The Indiana Clinical Trials Center, PC, Plainfield, IN; 3Skin Care Physicians of Georgia, Macon, GA; 4Regeneron Pharmaceuticals, Inc., Tarrytown, NY;  

5Sanofi Genzyme, Cambridge, MA; USA

CONCLUSIONS
• Patients initiating dupilumab in routine clinical practice had significant burden of disease 

as determined by both patient- and clinician-assessed outcomes of AD lesions and quality 
of life

• AD symptomology extended beyond itch and included skin sensitivity to touch and 
disturbances to sleep

• More than half of the patients in PROSE were on ≥ 1 medication at study baseline, that included 
oral and topical corticosteroids and systemic AD treatments, signifying a high treatment burden

References: 1. Macdonald LE, et al. Proc Natl Acad Sci U S A. 2014;111:5147-52. 2. Murphy AJ, et al. Proc Natl Acad Sci U S A. 2014;111:5153-8. 3. Blauvelt A, et al. Lancet. 2017;389:2287-303. 4. de Bruin-Weller M, et al. Br J Dermatol. 2018;178:1083-101. 5. Simpson EL, et al. N Engl J Med. 2016;375:2335-48. 6. Beck LA, et al. Am J Clin Dermatol. 2020;21:567-77.
Acknowledgments: Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT03428646. Medical writing/editorial assistance provided by Toby Leigh Bartholomew, PhD, of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc. 
Disclosures: Shrager DI: Regeneron Pharmaceuticals, Inc. – investigator. Guenthner S: AbbVie, Amgen, Encore Dermatology, Genentech, Janssen, LEO Pharma, Eli Lilly, Pfizer, Sun Pharma, UCB – investigator and/or speaker. Cohen D: AbbVie, Amgen, Eli Lilly, Jansen, LEO Pharma, Novartis, Ortho Dermatologics, Regeneron Pharmaceuticals, Inc., Sanofi, Sun Pharma, UCB – advisor and speaker.  
Zhang H, Korotzer A, Bansal S: Regeneron Pharmaceuticals, Inc. – employees and shareholders. Richman D: Sanofi Genzyme – employee, may hold stock and/or stock options in the company.

METHODS
Study design
• PROSE (NCT03428646) is a multicenter, longitudinal, 

prospective, up-to-5-years observational registry in 
the USA and Canada characterizing patients receiving 
dupilumab treatment for AD in a real-world setting

• Standard AD investigator assessments as well as patient-
reported outcomes were utilized

• The investigator-led Overall Disease Severity (ODS) 
instrument was introduced on an exploratory basis

 – ODS is a 5-point categorical tool that takes all important 
aspects characterizing AD severity into account at a 
given timepoint

• Baseline data were recorded on the date at which 
dupilumab treatment was initiated

Table 1. Baseline demographics.
N = 315

Age, mean (SD), years 42.5 (16.99)
Female sex, n (%) 174 (55.2)
Race, n (%)
 White 187 (59.4)
 Black or African American 56 (17.8)
 Asian 51 (16.2)
 Othera 7 (2.2)
 Not reported 14 (4.4)
Height, mean (SD), cm 168.03 (10.27)
Weight, mean (SD), kg 79.72 (20.60)
BMI, mean (SD), kg/m2 28.24 (7.23)
aIncludes American Indian or Alaskan Native and Native Hawaiian or Other Pacific Islander.  
BMI, body mass index; SD, standard deviation.

Table 2. Summary of current medication.
Therapeutic class
 Chemical class

N = 315

≥ 1 current medication 182 (57.8)
Corticosteroids, dermatological preparations 81 (25.7)
 Moderately potent (group II) 43 (13.7)
 Potent (group III) 24 (7.6)
 Very potent (group IV) 26 (8.3)
  Moderately potent in combination with antibiotics 1 (0.3)
Corticosteroids for systemic use 39 (12.4)
 Glucocorticoids 37 (11.7)
 Anticorticosteroids 2 (0.6)
Other dermatological preparations 63 (20.0)
  Agents for dermatitis, excluding corticosteroids 61 (19.4)
 Antihidrotics 2 (0.6)
 Other 2 (0.6)
All data are reported as number of patients (%). Classification is based on the World Health Organization 
Drug Dictionary, March 2019 B3 format.

Table 4. Disease characteristic analysis by baseline ODS.

Baseline ODS

No disease 
(n = 2)

Minimal 
disease  
(n = 4)

Mild disease 
(n = 26)

Moderate 
disease  

(n = 176)

Severe 
disease  

(n = 105)

Missing 
(n = 2)

Total 
(N = 315)

Baseline EASI total score 0 3.18 (2.49) 3.93 (2.60) 13.41 (8.58) 26.66 (15.45) 30.00 (N/A) 16.90 (13.36)

Baseline POEM total score 7.0 (N/A) 2.0 (0) 16.9 (5.82) 17.8 (6.77) 20.6 (5.72) N/A (N/A) 18.5 (6.65)

Baseline DLQI total score 1.0 (N/A) 1.5 (2.12) 10.4 (7.19) 11.5 (7.22) 15.5 (7.19) N/A (N/A) 12.7 (7.52)

All values are mean (SD). N/A, not available.

METHODS (cont.) RESULTS (cont.)
Analysis
• Data presented here are from the first interim analysis set of 

adult patients receiving dupilumab (data cutoff: July 2019) 

• All analyses are descriptive, without imputation for missing 
values

• At baseline, 57.8% of patients were using ≥ 1 medication, 
including topical corticosteroids that were used by 25.7% 
of patients (Table 2)

 – 12.4% of patients used systemic corticosteroids 
(Table 2)

Disease characterization
• The mean duration of AD was 19.7 years, with mean EASI 

of 16.9 (Table 3)

• Mean POEM score was 18.5 (on a scale of 0 to 28) and 
mean DLQI was 19.0 (on a scale of 0 to 30), consistent 
with moderate-to-severe AD (Table 3)

Table 3. Baseline disease characteristics.
N = 315

AD duration, mean (SD), years 19.7 (17.30)
EASI, mean (SD), N1 16.90 (13.36), 314
ODS, n (%)
 No disease (scale = 0) 2 (0.6)
 Minimal disease (scale = 1) 4 (1.3)
 Mild disease (scale = 2) 26 (8.3)
 Moderate disease (scale = 3) 176 (55.9)
 Severe disease (scale = 4) 105 (33.3)
 Missing 2 (0.6)
BSA affected by AD, mean (SD), %, N1 26.76 (23.670), 313
Peak Pruritus NRS, mean (SD), N1 6.9 (2.30), 227
 Peak Pruritus NRS ≥ 3, n/N1 (%) 215 (68.3)
Skin pain/soreness NRS, mean (SD), N1 5.3 (2.99), 227
 Skin pain/soreness NRS ≥ 3, n (%) 177 (56.2)
Skin feeling hot NRS, mean (SD), N1 4.6 (3.09), 226
 Skin feeling hot NRS ≥ 3, n (%) 157 (49.8)
Skin sensitivity NRS, mean (SD), N1 5.1 (3.17), 227
 Skin sensitivity NRS ≥ 3, n (%) 166 (52.7)
Sleep disturbance NRS, mean (SD), N1 5.4 (3.26), 224
 Sleep disturbance NRS ≥ 3, n (%) 171 (54.3)
POEM, mean (SD), N1 18.5 (6.65), 233
DLQI, mean (SD), N1 19.0 (7.71), 227
PGAD, n (%)
 Poor (Scale = 1) 5 (1.6)
 Fair (Scale = 2) 22 (7.0)
 Good (Scale = 3) 77 (24.4)
 Very good (Scale = 4) 69 (21.9)
 Excellent (Scale = 5) 53 (16.8)
 Missing 89 (28.3)
BSA, body surface area; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; 
N1, number of patients with measurement; NRS, Numerical Rating Scale; ODS, Overall Disease Severity; 
PGAD, Patient Global Assessment of AD; POEM, Patient-Oriented Eczema Measure.

RESULTS
Baseline demographics and current 
treatment use
• 315 patients were enrolled in the PROSE cohort at data 

cutoff

• Patient demographics are shown in Table 1
 – The mean age was 42.5 years; 55.2% of patients were 
female; and 59.4% White

• Most patients reported significant skin and sleep 
disturbance symptoms; 68.3% of patients had Peak 
Pruritus NRS scores of 3 or more (Table 3)

 – The proportions of patients with scores ≥ 3 in Skin pain/
soreness NRS, Skin feeling hot NRS, Skin sensitivity to 
touch NRS and Sleep disturbance NRS were 56.2%, 
49.8%, 52.7%, and 54.3%, respectively (Table 3)

 – One-quarter of patients assessed their disease status 
as “Good” at baseline (Table 3)

• There was a tendency for baseline EASI, POEM scores, 
and DLQI to increase with severity assessed according to 
ODS (Table 4)


	_Hlk532340640
	_Hlk20913887