EVALUATED IN 133 AD PATIENTS (12+ YEARS) IN AD‑HAFT1,2,a

The clinical trial in atopic dermatitis patients with uncontrolled moderate-to-severe hand and/or foot involvement included monotherapy treatment of hand and/or foot lesions (AD-HAFT). DUPIXENT was evaluated in a total of 133 atopic dermatitis patients aged 12 years and older with moderate-to-severe hand and/or foot involvement inadequately controlled with or intolerant to topical Rx therapies.

In AD-HAFT, patients ≥60 kg were initiated with a DUPIXENT loading dose (2 x 300 mg) or placebo (subcutaneous injection) at Week 0 followed by 1 DUPIXENT (300 mg) dose or placebo every 2 weeks. Patients weighing <60 kg were initiated with a DUPIXENT loading dose (2 x 200 mg) or placebo (subcutaneous injection) at Week 0, followed by 1 DUPIXENT (200 mg) dose or placebo every 2 weeks. Participants included subjects with both hand and foot involvement (n=71), foot-only involvement (n=4), and hand-only involvement (n=58).

Disease severity was defined by an IGA hand and foot score ≥3 in the overall assessment of atopic dermatitis hand and/or foot lesions on a severity scale of 0 to 4 and a hand and foot Peak Pruritus NRS score for maximum itch intensity >4. Fifty-three (53) percent (N=70/133) of the subjects also had moderate-to-severe AD outside of the hands or feet (IGA global ≥3).a

Atopic dermatitis with hand and/or foot involvement (ages 12+ years)1,2,a

Number of patients

133

Pivotal trial

1 double-blind DUPIXENT vs
placebo trial (AD-HAFT)

Dosing

All DUPIXENT-treated adults and adolescents ≥60 kg received 300 mg Q2W after a 600 mg loading dose and adolescents <60 kg received 200 mg Q2W after a 400 mg loading doseb

Disease severity
at baseline
Moderate atopic
hand and foot
dermatitis
(IGA 3)
Severe atopic
hand and foot
dermatitis
(IGA 4)

72%

28%

Disease extent at baseline
Mean HECSI score
46.8
out of 360
Itch severity at baselinec
Mean hand and foot Peak Pruritus NRS
7.1
out of 10

aThese baseline characteristics are not meant for comparison.1

bStudied vs placebo.

cWeekly averaged hand and foot Peak Pruritus NRS score (10 indicates the most severe).1

Primary endpoint of the AD-HAFT pivotal trial: the proportion of patients achieving clear or almost-clear skin (IGA hand and foot 0 or 1).1

Key secondary endpoints were patients who achieved ≥4-point improvement in hand and foot Peak Pruritus NRS at Week 16 and the proportion of patients achieving HECSI-75 (≥75% improvement from baseline) at Week 16.1

Dosing for DUPIXENT in this study was consistent with the approved dosage in the Prescribing Information1,2

See DOSAGE

EXPLORE MORE RESULTS

VIEW IGA HAND AND
FOOT RESULTS VIEW HAND AND FOOT PEAK PRURITUS NRS RESULTS VIEW HECSI-75 RESULTS VIEW REAL-WORLD STUDIES IN ADULTS AND ADOLESCENTS

Dosage and administration

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