Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD).
BACKGROUND
Moderate to severe atopic dermatitis (AD) is associated with substantial patient burden despite current therapies.


OBJECTIVE
We sought to evaluate dupilumab treatment on patient-reported outcomes in adults with moderate to severe AD.


METHODS
Adults (N = 380) with moderate to severe AD inadequately controlled by topical medications were randomized to 16 weeks of double-blind, subcutaneous treatment with dupilumab 100 mg every 4 weeks, 200 mg every 2 weeks, 300 mg every 2 weeks, 300 mg once weekly, or placebo. Patient-reported outcomes included pruritus numeric rating scale; patient-reported sleep item on Scoring AD scale; Patient-Oriented Eczema Measure; Hospital Anxiety and Depression Scale; Dermatology Life Quality Index; and 5-dimension 3-level EuroQol.


RESULTS
Dupilumab reduced peak itch at 16 weeks relative to placebo by 1.1 to 3.2 points on numeric rating scale (P < .0001 all doses, except 100 mg every 4 weeks P < .05); improved sleep and health-related quality of life on Dermatology Life Quality Index and 5-dimension 3-level EuroQol (P < .05 all doses, except 100 mg every 4 weeks); and reduced anxiety and depression symptoms (P < .05 all doses). Dupilumab's effects appeared early and achieved clinically relevant improvements without significant safety concerns.


CONCLUSIONS
There are potential cultural differences affecting patient-reported outcome responses. Outcomes were secondary or exploratory end points.


CONCLUSIONS
Dupilumab produced early and sustained patient-reported and clinically relevant improvements in sleep, mental health, and health-related quality of life; the two 300-mg dose regimens resulted in greatest benefits.
Department of Dermatology, Oregon Health and Science University, Portland, Oregon. Electronic address: simpsone@ohsu.edu.
Eric L
EL
Simpson
Regeneron Pharmaceuticals Inc, Tarrytown, New York.
Abhijit
A
Gadkari
Department of Dermatology and Allergy, Charité University, Berlin, Germany.
Margitta
M
Worm
Alabama Allergy and Asthma Center, Birmingham, Alabama.
Weily
W
Soong
Oregon Medical Research Center, Portland, Oregon.
Andrew
A
Blauvelt
Sanofi, Paris, France.
Laurent
L
Eckert
Regeneron Pharmaceuticals Inc, Tarrytown, New York.
Richard
R
Wu
Regeneron Pharmaceuticals Inc, Tarrytown, New York.
Marius
M
Ardeleanu
Regeneron Pharmaceuticals Inc, Tarrytown, New York.
Neil M H
NMH
Graham
Sanofi, Bridgewater, New Jersey.
Gianluca
G
Pirozzi
Sanofi, Cambridge, Massachusetts.
E Rand
ER
Sutherland
Regeneron Pharmaceuticals Inc, Tarrytown, New York.
Vera
V
Mastey
D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D003876:Dermatitis, Atopic / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D011788:Quality of Life; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C582203:dupilumab
adults; atopic dermatitis; disease burden; dupilumab; patient-reported outcomes; pruritus; quality of life