PowerPoint Presentation


Winter Clinical Miami • Feb 17 – 20th, 2023

• Moderate-to-severe atopic dermatitis (AD) has a significant negative impact on quality 
of life in adults and adolescents1,2

• Despite being eligible for advanced systemic therapy (AST) due to uncontrolled 
moderate or severe AD, many adolescent patients do not progress to AST

• This study characterizes the population of adolescent (age 12-17) patients with 
moderate-to-severe AD who were AST-treated to those who were not AST-treated 
(AST-naïve) to better understand progression to AST-usage in these patients.

Results

AST-usage
• Less than 50% of patients were treated with an AST among the 91 adolescents who met study criteria: 

55% (N=50) were AST-naïve, and 45% (N=41) were AST-treated
• All AST treatment was with dupilumab, no upadacitinib usage reported
• Of 44 physicians, 36 (82%) were dermatologists and 8 (18%) allergists in this analysis. All 41 AST-treated 

patients (100%) saw a dermatologist, and none saw allergist (0%), of the AST-naïve 42 (84%) saw a 
dermatologist and 8 (16%) an allergist (p=0.008)

AST-naïve vs. AST-treated descriptive analysis
• No significant differences were observed between AST-usage groups for age, gender, race, insurance type, 

treatment center, vIGA-AD, CDLQI, POEM, PROMIS Depression, PROMIS Anxiety, or prior use of topical 
therapies at enrollment

• AST-treated had significantly higher median enrollment severity on two measures of disease severity 
• BSA (35% vs 15%, p=0.0076)
• vIGA-AD x BSA (105 vs 48, p<0.0066)

• AST-treated had a significantly higher PO-SCORAD at enrollment vs AST-naïve (45.8 vs. 31.1, p<0.03) 

AST-naïve vs AST-treated multivariate analysis
• In multivariate analysis controlling for sex, age, insurance, and race, only higher BSA at enrollment was 

associated with AST-usage
• BSA of 5% OR=1.09 (1.01-1.19)
• BSA of 10% OR = 1.2 (1.01-1.42)
• BSA of 20% OR = 1.43 (1.02-2.01)

1 Rady Children’s Hospital, San Diego, CA 2 University of California San Diego, San Diego, CA 3 Target RWE, Durham, NC 4 LEO Pharma Inc., Madison, NJ 5 George Washington School of Medicine, Washington DC 6 University of Lübeck, Lübeck Germany

Use of advanced systemic therapy in adolescent patients with moderate-to-severe atopic dermatitis in the 
TARGET-DERM Registry
Haft M1,2, Knapp K3, Claxton A4, Hernandez B3, Balu S4, Schneider S4, Silverberg J5, Thaci D6, Eichenfield L1,2 on behalf of TARGET-DERM Investigators

Conclusion

• More than half of the patients with considerable disease severity and who 
experienced negative QOL from moderate-to-severe AD were not prescribed 
AST

• Compared to AST-naïve patients, descriptive analysis showed that the AST-
treated were slightly more severe as indicated by significantly higher 
baseline BSA, higher vIGA-ADxBSA, and higher PO-SCORAD at enrollment. 

• In multivariate analysis to adjust for baseline characteristics, higher BSA at 
enrollment was significantly associated with use of an AST. 

• Longitudinal follow-up is needed to determine the outcomes associated with 
these treatment patterns to evolve therapeutic interventions and outcomes 
in these adolescent patients.

Variables of Interest:

• Patient demographics

• Site and physician type

• Prior and concomitant topical AD therapy (any, 
calcineurin inhibitor, corticosteroid, 
phosphodiesterase)

Disease severity measures:

• vIGA-AD (scores 0-4)

• Total Body Surface Area (BSA) (score 0-100%)

• vIGA-AD x BSA (score 0-400)

Patient Population:

• Adolescent (12-17 years) 

• Moderate or severe AD defined as a score of 3 or 4 on the 
validated Investigator Global Assessment - AD (vIGA-AD) at 
enrollment 

• Treatment history: had prior exposure to at least one of the 
following: topical corticosteroid, systemic corticosteroid, 
immunomodulator or phototherapy

• Had at least 1 post-enrollment visit

• Excluded were clinical trial patients and any patient treated 
with an AST prior to enrollment

Methods

TARGET-DERM AD
All patients 

N=2549

Age 12-17
(N=327)

Met treatment history 
criteria (N=186)                                      

Study population N=91
• AST-naïve (n=50)
• AST-treated (N=41)

AST-treated N=41
• Moderate N=23
• Severe N=18

AST-naïve N=50
• Moderate N=37
• Severe N=13

Excluded: AST users 
prior to enrollment 
(N=34) and clinical 
trial patients (N=0)

Had 1+ follow-up visits 
(N=125)                                

Moderate or severe AD: 
vIGA-AD of 3 or 4

(N=191)

Figure 1. Patient Disposition

Acknowledgements and Disclosures
Target RWE communities are collaborations among academic & community investigators, the pharmaceutical industry, and patient community
advocates. Target RWE communities are sponsored by TARGET PharmaSolutions Inc (d.b.a., Target RWE). The authors would like to thank all the
investigators, participants, and research staff associated with TARGET-DERM AD. ClinicalTrials.gov Identifier: NCT03661866.
LEO PHARMA is a Target RWE industry partner which subscribes for data access. MH has no financial disclosures. KK and BH are employees of TARGET RWE. AC, SB, and SS are employees of LEO PHARMA. JS received
honoraria as a consultant and/or advisory board member for Abbvie, Afyx, Aobiome, Arena, Asana, Aslan, BioMX, Biosion, Bluefin, Bodewell, Boehringer-Ingelheim, Cara, Castle Biosciences, Celgene, Connect
Biopharma, Dermavant, Dermira, Dermtech, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, Leo Pharma, Luna, Menlo, Novartis, Optum, Pfizer, RAPT, Regeneron, Sanofi-Genzyme, Shaperon, Sidekick Health,
Union; speaker for Abbvie, Eli Lilly, Leo Pharma, Pfizer, Regeneron, Sanofi-Genzyme; institution received grants from Galderma, Pfizer; DT AbbVie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Dermira, Eli
Lilly, Galderma, GSK, Janssen-Cilag, Leo-Pharma, Novartis, Pfizer, Regeneron, Roche, Sandoz-Hexal, Sanofi, and UCB; consultant: AbbVie, Almirall, Amgen, Dignity, Galapagos, Leo Pharma, Maruho, Mitsubishi,
Novartis, Sanofi, Pfizer, Regeneron, Target-Solution, and UCB; lectures: AbbVie, Almirall, Amgen, Janssen, Leo Pharma, MSD, Novartis, Pfizer, Roche-Posay, Sandoz-Hexal, Sanofi, and UCB; scientific advisory board:
AbbVie, Boehringer Ingelheim, Eli Lilly, Galapagos, Janssen-Cilag, Leo Pharma, Morphosis, Novartis, Pfizer, Regeneron, Sanofi, and UCB; LE has served as a scientific adviser, consultant, and/or clinical study
investigator for AbbVie, Almirall, Arcutis, Arena, Aslan, Dermavant, Eli Lilly, Forté, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Ortho, Otsuka, Pfizer, Regeneron, Sanofi Genzyme

Fig 2a. Patient characteristics by AST-usage

Patient reported outcomes:
• CDLQI: Children’s Dermatology Life 

Quality Index (scores 0-30)
• POEM: Patient-Oriented Eczema Measure 

(scores 0-28)
• PO-SCORAD: Patient-Oriented Scoring 

Atopic Dermatitis (scores 0-103)
• Patient-Reported Outcomes Measurement 

Information System (PROMIS) Depression 
(scores 41.0-79.4) and PROMIS Anxiety 
(scores 40.9-85.2)

References
1. Nutten, S., Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab, 2015. 66 Suppl 1: p. 8-16.
2. AD Langan SM, Irvine AD, Weidinger S. Lancet. 2020 Aug 1;396(10247):345-360.
3. Abuabara, K. International observational atopic dermatitis cohort to follow natural history and treatment course: TARGETDERM AD study design and 
rational BMJ Open 2020;10:e0399282020. 

Figure 3. Factors associated with AST-Treatment. Significant values are in blue.

• TARGET-DERM AD is an ongoing, longitudinal, observational study of adult and 
adolescent dermatology patients managed in clinical practice at 32 community 
(n=15) or academic (n=17) sites in the United States; first patients were enrolled in
Jan. 25th, 2019. 3 The data cutoff for this analysis was Aug 11, 2022.

• AST is defined as dupilumab (adolescent indication approved 05/262020) and 
upadacitinib (adolescent indication approved 01/11/22)

• , approved treatments for adolescents with moderate-to-severe AD. 

• Patients were classified into two unique AST usage groups: AST-treated (any AST 
usage at or after enrollment) or AST-naïve (no AST usage at or after enrollment).

• Data was analyzed descriptively. The association between clinical/PROs and AST-
usage was estimated by multivariate binary logistic regression controlling for age, 
race, gender, insurance, and site type. 

• All analysis was conducted on enrollment (baseline) data

Introduction

Figure 2b. Median Clinical and PRO Scores by AST-usage

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In addition to the covariates listed above, other factors were considered, but were not found to be significant; data 
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OR (95% CI)

0.98 (0.4 – 2.43)

1.17 (0.44 – 3.11)

0.88 (0.37 – 2.12)

0.68 (0.27 – 1.75)

1.17 (0.46 – 2.98)

1.09 (1.01 – 1.19)

1.2 (1.01 – 1.42)

1.43 (1.02 – 2.01)

Age: 15-17 

vs. 12-14

Race: Non NH-White vs 

NH-White

Sex: Male vs. Female

Insurance: Non-Private 

vs Private

Site type: Academic vs 

Community

Increase in 5% of BSA

Increase in 10% of BSA

Increase in 20% of BSA

P=0.0076

P=0.0066

P=0.0241

__P=0.008__


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