Relationships between clinical response endpoints and other outcome measures: data from the updacitinib atopic dermatitis phase 2B trial

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Presentation

Background and Objective

• The Eczema Area and Severity Index (EASI) and Investigator Global Assessment (IGA) are often used as primary endpoint measures for assessing clinical response in atopic dermatitis (AD) studies¹
• Other AD outcome measures, such as those assessing pruritus, AD severity and symptoms, impact on sleep, and impact on daily activities, are also used²,³
• However, it is not fully understood how a clinical response on EASI and IGA assessments translate to improvements in other outcome measures
• The objective of this observed-case post-hoc analysis was to assess relationships between common clinical response definitions (EASI and IGA) and other outcome measures at week 16 using data from a phase 2b upadacitinib trial in adult patients with moderate to severe AD

Study design

This analysis included all patients regardless of treatment received.

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Outcomes at Week 16

Measure	Concept	Score Range	Score Interpretation and Assessed Outcomes
EASI (1)	AD severity and extent	0-72	% improvement from baseline (50%–74%, 75%–89%, 90%–99%, 100%)
IGA	AD severity	0-4	Clear: 0 Almost clear: 1
SCORAD (1)	AD severity	0-103	Clear: <10 Mild: 10-29
POEM (2)	Symptom Frequency	0-28	Clear or Almost Clear: 0-2 Mild: 3-7
Pruritus NRS	Itch	0-10	No/Minimal Itch: 0-1 Mild Itch: 2-3
PGIS	Patient-Reported Severity	0-7	Absent/Minimal: 0-1 Mild: 2
ADERM-SS (3)	Symptom Intensity	11 items, 0–10 per item	No symptom: 0 Worst imaginable symptom: 10
ADERM-IS (3)	Impact of AD	10 items, 0–10 per item	No impact: 0 Extreme impact: 10

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Results

Of the 167 patients in the intent-to-treat population, 137 had both baseline and week 16 EASI and IGA data and were included in this observed-case analysis.

Characteristics, mean (SD)	Overall Population N=137
Male, n (%)	88 (64.2)
Age, y	40.1 (15.7)
Diagnosis duration, y	25.4 (16.3)
Symptom duration, y	27.2 (16.7)
EASI	31.1 (13.8)
IGA, moderate, n (%)	77 (56.2)
Pruritus NRS weekly average	6.5 (1.9)

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Correlation of EASI and IGA at Week 16

• Statistically significant (P<0.001) positive correlation was observed between EASI/IGA and other outcome measures at week 16, although correlation magnitudes varied greatly
• Higher degree of correlation observed with total SCORAD score (a clinician-reported measure) compared with patient-reported measures

Correlation	EASI	IGA
Total SCORAD	0.867* n=130	0.921* n=130
POEM	0.594* n=135	0.723* n=135
Pruritus NRS	0.589* n=124	0.628* n=124
ADerm-SS items (range)	0.476–0.584* n=87 or 114	0.578–0.726* n=87 or 114
ADerm-IS items (range)	0.506–0.617* n=87 or 114	0.539–0.667* n=87 or 114
PGIS	0.622* n=132	0.681* n=132

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Relationship between EASI and IGA at Week 16

Statistically significant positive correlation was observed between EASI and
IGA at week 16 (0.892; P<0.001)

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Relationship between EASI improvement and other outcomes

Higher EASI responses trended toward greater proportions of patients achieving better SCORAD, POEM, Pruritus NRS, and PGIS scores at week 16.

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Mean ADerm-SS and ADerm-IS item scores based on EASI and IGA responses

Lower ADerm-SS and ADerm-IS item mean scores were observed with higher EASI and IGA responses at week 16.

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Conclusions

• These findings suggest that there is a relationship between EASI- and IGA-based clinical response definitions and other outcomes among patients with moderate to severe AD
• Correlations of EASI/IGA with other outcome measures at week 16 suggest that response patterns may vary across the assessed domains
• Higher thresholds of efficacy (EASI 90/100, IGA 0/1) consistently led to better outcomes in pruritus, AD severity, symptoms, sleep, and other aspects of quality of life

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Conflict of interest :

K Reich has served as an advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Centocor, Covagen, Dermira, Forward Pharma, Fresenius Medical Care, Galapagos, GlaxoSmithKline, Janssen-Cilag, Kyowa Kirin, Leo, Lilly, Medac, Merck Sharp & Dohme, Miltenyi Biotec, Novartis, Ocean Pharma, Pfizer, Regeneron, Samsung Biopepis, Sanofi, Sun Pharma, Takeda, UCB, Valeant, and Xenoport.

M De Bruin-Weller received grants for principal investigator services from AbbVie, Regeneron Pharmaceuticals, Inc., Pfizer, and Sanofi Genzyme; honoraria for advisory board member from AbbVie, Eli Lilly, Regeneron Pharmaceuticals, Inc., Pfizer, Sanofi Genzyme, and UCB, and for consultant services from Regeneron Pharmaceuticals, Inc. and Sanofi Genzyme.

BM Calimlim, HD Teixeira, and M Wu are full-time employees of AbbVie and own AbbVie stock or stock options.

JI Silverberg received honoraria for advisory board, speaker, and consultant services from AbbVie, Anaptysbio, Asana, Dermavant, Eli Lilly, Galderma, GlaxoSmithKline, Glenmark, Kiniksa, Leo, Menlo, Novartis, Pfizer, Realm and Regeneron-Sanofi, and received research grants for investigator services from GlaxoSmithKline.

Acknowledgment

AbbVie funded this study, and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the presentation. No honoraria or payments were made for authorship. Medical writing support was provided by Maria Hovenden, PhD, and Janet E. Matsuura, PhD, at ICON (North Wales, PA), and was funded by AbbVie.