Adult Study Designs

A robust clinical development program including patients aged 6+ years

Take a closer look at the 16- and 52-week study designs behind the adult data

DUPIXENT was evaluated in a total of 917 adult patients in Trials 1 and 2 (16-week trials) and DUPIXENT + TCS was evaluated in 421 adult patients in Trial 3 (52-week trial) whose moderate-to-severe atopic dermatitis was inadequately controlled on topical Rx therapies1

Disease severity was defined by an IGA score ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.1,a

Primary endpoint across all 3 adult pivotal trials: Change from baseline to Week 16 in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and a ≥2-point improvement1

Adult (18+ years of age)1,2
Number of
patients

>2100

Pivotal
trialsb

2 Monotherapy
(Trials 1 and 2)

1 Concomitant
TCS
(Trial 3)

Dosingc

A loading dose
of 600 mg
(2 x 300 mg SC
injections) of
DUPIXENT at
Week 0
followed by
300 mg
(1 SC injection) Q2Wd

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

52%

48%

Disease extent at baseline
Mean EASI score
Mean body surface
area involvement
33
out of 72

55%

Itch severity at baselinee
Peak Pruritus NRS
7
out of 10

aThese baseline characteristics are not meant for comparison.

bIn atopic dermatitis, Trial 4 was a dose‑ranging trial to evaluate the safety of DUPIXENT monotherapy through Week 16. Trial 5 evaluated multiple DUPIXENT monotherapy dose regimens for maintaining treatment response for 36 weeks.

cEmollient background regimen was required.

dStudied vs placebo.

e Weekly averaged Peak Pruritus NRS score (10 indicates the most severe).

Treatment effects in subgroups in Trials 1, 2, and 3 were generally consistent with the results in the overall adult study population1,f

Weight

Age

Gender

Race

Prior treatment, including
immunosuppressants

SC, subcutaneous; TCS, topical corticosteroids.

fSubgroup analysis was based on all 3 adult trials.

See the 52-week adult safety
profile

References:

  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.

Important Safety
Information and Indication

CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including generalized urticaria, rash, erythema nodosum, anaphylaxis and serum sickness or serum sickness-like reactions, were reported in <1% of subjects who received DUPIXENT in clinical trials. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Advise patients to report new onset or worsening eye symptoms to their healthcare provider.

Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical or inhaled corticosteroids abruptly upon initiation with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Atopic Dermatitis Patients with Comorbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1% at Week 16) in adult patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye. The safety profile in children and adolescents through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT in adolescents and children observed through Week 52 was consistent with that seen in adults with atopic dermatitis.

DRUG INTERACTIONS: Avoid use of live vaccines in patients treated with DUPIXENT.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. Healthcare providers and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or obtain information about the registry. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
  • Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

Please see accompanying full Prescribing Information.

Indication

DUPIXENT is indicated for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.